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REACH stands for the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH Regulation entered into force on 1 June 2007 to streamline and improve the former legislative framework for chemicals of the European Union (EU). REACH also created the European Chemicals Agency (ECHA) which has a central co-ordination and implementation role in the overall process. ECHA is located in Helsinki, Finland and manages the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the countries in which REACH applies.
The following sources of information about REACH are available:
- The REACH Regulation and other related pieces of legislation published in the Official Journal of the European Union; links to these texts can be found in the section on Regulations of the ECHA website: http://echa.europa.eu/regulations
- The "Understanding REACH" section of the ECHA website provides concise and basic information on REACH: http://echa.europa.eu/regulations/reach/understanding-reach
- The REACH guidance documents provide explanatory and supplementary information to the legal text. They are the result of both consultation of relevant stakeholders and close co-operation between the National Competent Authorities and the European Commission. Final guidance documents and draft versions in the process of being updated as well as fact sheets and formats are available on the ECHA website on Guidance on REACH and CLP implementation http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation
- The Navigator will help you to identify your specific obligations under REACH. You can find a link to the Navigator on the ECHA website. Please follow the link below and choose under title "Use the Navigator" the link "Start a new Navigator session": http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations
Member States endorse national provisions defining controls and sanctions for non-compliance with REACH. We recommend you to contact the relevant enforcement authorities in your country for information on the national control procedures in place. You can also contact the customs authorities and the national helpdesk for further information:
The first points of contact on REACH are the national REACH helpdesks established in each country of the European Economic Area (EEA). They provide services in their local language(s) and know the national conditions (e.g. national legislation, enforcement authorities, etc.). : http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks
Trade associations, sector groups, chambers of commerce and other organisations, which are particularly familiar with sector-specific terminology, have set up stakeholder helpdesks to provide tailor-made support for their industrial sectors and products; e.g. plastics, minerals, mineral oils, paints.
ECHA provides assistance particularly to those companies that are registering substances and who have questions on e.g. REACH provisions, ECHA's IT systems and the administration of submitted dossiers.
For non-EU companies we have collected REACH information particularly concerning them, available at: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries. If the questions are related to the conditions in a particular country, you may also turn to the corresponding national REACH helpdesk (see the link above) before contacting ECHA.
Substances fulfilling one or more of the criteria specified in Article 57 of the REACH Regulation can be identified as "substances of very high concern" (SVHC) and put on the "Candidate List". These SVHC can be:
- substances meeting the criteria for classification as carcinogenic, mutagenic or reprotoxic (CMR) category 1 A or 1B (in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008)
- persistent, bioaccumulative and toxic (PBT) substances or very persistent and very bioaccumulative (vPvB) substances (according to the criteria of Annex XIII of the REACH Regulation)
- substances identified on a case-by-case basis for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern (Article 57(f) of REACH Regulation), e.g. endocrine disruptors
The Candidate List is available on the website of ECHA. It has been established according to the procedure described in Article 59 of the REACH Regulation (SVHC identification).
The Candidate List is updated when substances are identified as Substances of Very High Concern. This is normally done twice per year (in June and December). To allow interested parties to be aware of substances which might be included in the Candidate List, a Registry of Intentions is published on the website of ECHA. As a producer, importer or supplier of articles, you are advised to regularly check the Registry of Intentions. This can help you to prepare for possible obligations that could arise when a substance is included in the Candidate List: https://echa.europa.eu/candidate-list-obligations.
You can find further information at: https://echa.europa.eu/substances-of-very-high-concern-identification-explained
Article 3(3) of the REACH Regulation defines an article as "an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition". Chapter 2 of the Guidance on requirements for substances in articles provides information on how to determine if an object fulfils the above definition, including instructions on how to address borderline cases (Appendices 3 and 4).
The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
Packaging is considered a separate article under REACH. Please refer to section 2.5 of the Guidance on requirements for substance in articles for more information.
The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
There is no fee charged for the notification.
If the production/import ended before the substance was included in the Candidate List or before the notification obligation starts to apply (i.e. 6 months after a substance has been included in the Candidate List or 1 June 2011 for substances placed on the Candidate List before 1 December 2010) then you do not have to notify. Please note, however, that for the information requirements specified in Article 33 of the REACH Regulation, the date of supply of the article is the relevant date, i.e. these obligations also apply to producers and importers at the moment when they supply articles which were produced or imported before the substance was included in the Candidate List and are supplied after the inclusion. Please refer to section 3.2.1 of the Guidance on requirements for substances in articles for additional information.
The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
Once a substance enters the Candidate List you have to determine if you have the obligation to notify. One of the inputs needed to determine this is the tonnage of the substance in imported/produced articles per calendar year (or the average of the three previous years if the article has been imported/produced during three years before the start of the notification obligation). In this calculation, you have to include the tonnage in articles imported/produced for the full calendar year, i.e. if applicable, also before the date of the inclusion of the substance in the Candidate List. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.
The notification obligation also applies to producers or importers of articles containing recycled material. If you are a producer or importer, you must assess whether the articles you produce or import fall under the criteria of Article 7(2). It may be difficult to know the exact concentration of a Candidate List substance in, for example, recovered polymers where the concentration varies between each batch.
If your company concludes that the articles contain less than 0.1% of the Candidate List substance, we recommend you to document your basis for this conclusion in case of enforcement.
Yes. A non-EU producer of articles may appoint an Only Representative (OR) to submit a substance in articles notification.
The role and obligations of an Only Representative (OR) are explained in detail in chapter 2 of the Guidance on registration.
The Guidance on registration is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
The notifications will not trigger a request to register the substance in articles, as such. However, the notification information can be used in addition to several other sources (e.g. registration information) to support identification of further needs for risk management.
If there are grounds for suspecting that the substance is released from the articles under normal or reasonably foreseeable conditions of use and such a release presents a risk to human health or the environment, you may be required as a producer or importer of articles to submit a registration. These decisions will be taken on a case-by-case basis and are not restricted to Candidate List substances.
Enforcement of the REACH Regulation, including the communication and notification obligations of Candidate List substances in articles, is in the remit of the authorities of the individual Member States.
You can find the contact details at: http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks.
You should contact your national REACH helpdesk: http://echa.europa.eu/support/helpdesks/national-helpdesks
If you have questions on technical issues on REACH-IT, the link is available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it and for questions related to IUCLID 6 at: http://iuclid.eu/ or if you are not in the European Economic Area (EEA), you may contact the ECHA Helpdesk: http://echa.europa.eu/contact
If you would like to check your general obligations under the REACH Regulation and how to fulfil them, you should use the Navigator: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.
For general guidance on the provisions of REACH that apply to substances in articles, you should consult the Guidance on requirements for substances in articles available at: http://echa.europa.eu/guidance-documents/guidance-on-reach.
For guidance on how to submit a notification (Article 7(2) of REACH), you should consult:
- the "Notifying substances in articles" page: http://echa.europa.eu/support/dossier-submission-tools/reach-it/notifying-substances-in-articles
- the Manual "How to prepare a substance in articles notification" if you are preparing an IUCLID dossier for your notification, but it also includes relevant advice and examples for all notifiers: http://echa.europa.eu/manuals
You are exempted from submitting a Candidate List substance in articles notification to ECHA if:
- you can exclude exposure of humans and the environment to the Candidate List substance in the articles during normal or reasonably foreseeable conditions of use, including disposal. Chapter 3.3.2 of the Guidance on requirements for substances in articles provides detailed information on the exemption based on “exclusion of exposure”
- the substance has already been registered for that use. Chapter 3.3.1 of the Guidance on requirements for substances in articles provides advice on how to find out if the substance is already registered for that use
The Guidance on registration is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
If you conclude that you are exempted from notifying, in line with one of the two cases above, we recommend that you carefully document the basis for and the reasoning behind this conclusion. In this way, you will be prepared for any enforcement activities at national level.
Note that it might require more resources and be more difficult to properly assess and document exclusion of exposure or to find out if the substance is already registered for the use, than to prepare and submit a substance in articles notification.
Note that it may require more resources and be more difficult to demonstrate “no exposure” than to prepare and submit a substance in articles notification.
A producer/importer of an article wanting to demonstrate 'exclusion of exposure' has to ensure that the Candidate List substance does not come into contact with humans or the environment during the use, including disposal, of the article. Such a justification needs to show that no exposure to humans or the environment takes place during the article service life and the waste stage. For more information on “exclusion of exposure”-based exemption from notification, see chapter 3.3.2 of the Guidance on requirements for substances in articles at: http://echa.europa.eu/guidance-documents/guidance-on-reach
Note that it might require more resources and be more difficult to find out if the substance is already registered for the use, than to prepare and submit a substance in articles notification.
A substance can be considered as having already been registered for a particular use, if two conditions are fulfilled:
- the substance in question is the same as the substance already registered; and
- the use in question is the same as the use described in a registration of this substance, i.e. the registration refers to the use in the article.
In this context, “use” includes the use of the substance in the production of an article and, after being incorporated into the article, the use of the substance in the article during the article’s service life stages, including the waste stage.
For more information, see chapter 3.3.1 of the Guidance on requirements for substances in articles.
ECHA’s dissemination portal for substance information, which can be accessed via the ECHA website: https://echa.europa.eu/information-on-chemicals, contains information on registered substances provided by companies in their registration dossiers. It includes a variety of information on the substances which companies manufacture or import and may include information on the uses of the substance, unless the companies have claimed this information as confidential, including use of the substance in articles. The description of the use available here for all life cycle steps consists mainly of elements of the use descriptor system, as well as use name and in some cases contributing activity names. The information will normally not be sufficient on its own to conclude on the sameness of two uses for the purpose of establishing whether an exemption on the basis of Article 7(6) applies. Therefore, the use in question has to be described more in detail than just by using elements of the use descriptor system. For example, the published information that a substance has been registered for use in the Article Category 'Plastic articles' does not necessarily mean the registration is made to cover all plastic articles and all plastic materials. It could mean that use of the substance in production of some specific plastic articles is covered and described in the registration, while other plastic articles are not covered and assessed. The uses of two very different plastic articles may lead to very different exposures to humans and the environment. If the exposure related to the use of your article is not adequately assessed in a registration dossier, it cannot be considered a registered use.
Please note that there are limited possibilities to include information in section 3.5 of an IUCLID registration dossier, apart from the use descriptors. Section 3.5 of the IUCLID registration dossier may however contain 'free text' information, which is not based on the use descriptor system. Whether such information is sufficient to conclude on the sameness of use has to be examined on a case-by-case basis.
Most producers of articles are also downstream users under the REACH Regulation and as such have certain obligations outlined in Title V of the REACH Regulation. Since most substances on the Candidate List are already registered, producers of articles should already have communicated their use to the registrant for the purpose of registrations. Producers of articles may therefore not have to notify if their communicated uses are covered in the registration dossier.
Importers of articles may not have access to detailed information on registered uses. If you are not certain that your specific use is already registered, you should notify.
Notification requirements apply only to substances already included in the Candidate List and meeting the criteria in Article 7(2) of the REACH Regulation. Therefore, if a substance is not yet in this list there is no need to notify. However, please note that CMR/PBT/vPvB and substances of equivalent concern that fulfil the criteria of Article 57 of the REACH Regulation can be included in the Candidate List. It is advised to keep track of the use of these substances in your articles and to follow the development of the Candidate List via the Registry of Intentions. By signing up for the ECHA e-News (http://echa.europa.eu/news-and-events/news-alerts) you will be alerted every time the Candidate List (http://echa.europa.eu/candidate-list-table) or Registry of Intentions (http://echa.europa.eu/addressing-chemicals-of-concern/registry-of-intentions) is updated with new substances.
One of the conditions that triggers your obligation to notify is when the concentration of the Candidate List substance exceeds 0.1% w/w in the article.
You should calculate the concentration of the substance for each article as produced or imported. This threshold applies to each article of an imported object made up of more than one article, which were joined or assembled together.
For more information and examples, see chapter 18.104.22.168 of the Guidance on requirements for substances in articles.
One of the conditions that triggers the obligation for you to notify is when the total amount of the Candidate List substance present in all articles produced and/or imported exceeds one tonne per actor per year.
The articles concerned should contain more than 0.1% w/w of the substance. If an article contains the substance at a concentration below 0.1% w/w, this article does not have to be included in the tonnage calculation.
The calculation of the total amount in tonnes of the same Candidate List substance in all articles produced or imported (either isolated or incorporated in complex objects) by the same actor requires 3 steps:
1. Determination on whether the Candidate List substance in question is present at above the 0.1% w/w concentration threshold for each article produced or imported.
The calculation of the concentration of the Candidate List substances in articles or complex objects is done as described in Table 5 of the Guidance on requirements for substances in articles.
2. Calculate the amount in tonnes of the Candidate List substance in each article or article type produced or imported per year where it is present above the 0.1% w/w concentration threshold.
3. Calculate the total amount in tonnes for all articles by summing up the amounts calculated for each article or article type according to point 2 above.
The one tonne per year limit applies to the total tonnage produced/imported, in the European Economic Area (EEA) by the same legal entity.
If you believe you are close to one of the thresholds but are unsure whether you exceed it or not, we recommend you to notify.
Chapter 22.214.171.124 of the Guidance on requirements for substances in articles provides further explanations, namely on the concept of article type, and examples on how to calculate the tonnage.
Identifying substances in articles, namely Candidate List substances, and quantifying their amounts is in many cases only possible if the respective information is made available by the actors in the supply chain. Supply chain communication is therefore the most important and efficient way of gathering the information needed in order to identify your obligations under REACH. This information can be obtained via, e.g.:
- Standardised REACH information from suppliers in the EU, e.g. safety data sheets (SDSs)
- Voluntary information tools to exchange information on articles, e.g. IT systems and tools
- Requesting information up the supply chain
It is advised that the information received from suppliers is properly evaluated.
The information you need can often be derived from standardised information that is obtained from suppliers of substances/mixtures based in the European Economic Area - EEA (e.g. SDSs or, where a SDS is not required, safety information and regulatory requirements (Article 32 of the REACH)). In the EEA, suppliers of articles containing more than 0.1% w/w of a Candidate List substance must provide available and relevant safety information (Article 33 of the REACH), including, as a minimum, the name of that substance.
Please be aware that the communication obligations arise from the presence of the Candidate List substance in the article. These obligations apply regardless of whether or not the supplier is aware of the presence of the substances. Therefore, it is in the interests of the supplier to seek information on the presence of Candidate List substances. Proactive requests in the supply chain are often useful to obtain the necessary information, in particular when the supplier of the article is outside the EEA.
Chemical analysis, although a possible way to identify and quantify substances in articles, is time consuming, costly and difficult to organise. If other approaches to obtaining information fail or become too complicated, conducting chemical analysis may nevertheless be an option to obtain information on the composition of articles. Chemical analysis may be helpful in certain situations. It can serve to obtain information needed for compliance with REACH and to confirm the information received from suppliers.
For more information, see Chapter 5 and Appendix 5 of the Guidance on requirements for substances in articles:
The obligation to notify under Art. 7(2) of REACH and to communicate down the supply chain under Art. 33 of REACH only applies to articles which contain Candidate List substances.
Certain boron substances included in the Candidate List, such as diboron trioxide, boric acid and disodium tetraborate, are involved in processes leading to the production of articles containing “borosilicate glass”. In these processes, the boron substances are usually first chemically transformed into a manufactured glass substance. The glass substance is subsequently processed into articles. In these usual cases, the boron substances are completely transformed and are not present as such in the final glass article. Consequently, there is no obligation to notify under Art. 7(2) of REACH, nor to communicate information down the supply chain under Art. 33 of REACH.
Please note that it remains the responsibility of companies to assess for their specific use of the Candidate List boron substances whether these are completely transformed into glass in the manufacture of “borosilicate glass” and whether the Candidate List substance is present in the boron glass articles.
This information should be provided in your substance in articles notification. As a minimum, it should include the substance name and/or EC and CAS numbers.
You can find information on substance identity in the Candidate List available at: http://echa.europa.eu/candidate-list-table
Substance identity information, namely for group entries, may also be available in the "supporting documentation column" of the same webpage.
If you decide to prepare your notification online in REACH-IT, you only need to select your substance/Candidate List entry by typing the name, EC or CAS number in the correspondent field in the substance identification section of the wizard.
If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, to facilitate the submission process, ECHA publishes pre-filled substance datasets with substance identity information in the Candidate List. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
This information should be provided in your substance in articles notification.
If you decide to prepare your notification online in REACH-IT, the classification is pre-filled automatically by the wizard for your selected Candidate List substance/entry. The classification is pre-filled for your Candidate List substance/entry as follows:
- If there is a match with an entry of Annex VI to CLP, the harmonised classification is included in your notification.
- If there is no match with an entry of Annex VI to CLP, the following information is included in your notification: “No harmonised classification according to Annex VI of CLP is available for this Candidate List entry”.
- If there are two or more matches with the entries of Annex VI to CLP, you need to select one; the selected harmonised classification entry is included in your notification.
If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, to facilitate the submission process, ECHA publishes pre-filled substance datasets with classification information in the Candidate List. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
The Candidate List can be found at: /candidate-list-table
This information should be provided in your substance in articles notification by using the technical function descriptor, i.e. indicating the function of the Candidate List substance in the article, i.e. the role that the substance fulfils when it is used in the article (what it actually does in your article or in a mixture incorporated in the article).
If you decide to prepare your notification online in REACH-IT, in the Article(s)/Use(s) section of the wizard, you can describe the use(s) of the substance in the article(s) by using the “Technical function of the substance during use” field in each service life record.
If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, you can describe the use(s) of the substance in the article(s) by using the "Technical function of the substance during use" field in section 3.5.6 of IUCLID. Chapter 126.96.36.199. of the manual "How to prepare a substance in articles notification" provides guidance on how to fill this IUCLID section.
Further details on the use(s) of the substance in the article(s) can be provided in the free text fields “Further description of use” of the on-line wizard or IUCLID, in the sections mentioned above, or if appropriate, by using other use descriptors (e.g. Process categories - PROC).
The manual "How to prepare a substance in articles notification" is available on the ECHA website at:
Further information on the use descriptors can be found on the Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.12 on use description available on the ECHA website at: https://echa.europa.eu/documents/10162/13632/information_requirements_r12_en.pdf/ea8fa5a6-6ba1-47f4-9e47-c7216e180197
In your notification you should identify all articles containing the Candidate List substance and provide for each one of them:
- a description of the article and its different integral parts (e.g. coating);
- a description where in the article the Candidate List substance is present, and if applicable, a description of the complex object where the article is joined or assembled as a component;
- if the article is to be used by consumers and/or workers; and
- a brief description of the use(s) of the article, including disposal.
The brief description of the use of the article during its service life, including disposal, should be provided by using relevant use descriptors as explained in detail in the Chapter R.12 on use description of the Guidance on Information Requirements and Chemical Safety Assessment. For articles the relevant descriptors are the following:
- Article category (AC) related to service life of articles containing the substance (and waste stage)
- Environmental release category (ERC)
- Process category (PROC) for production of articles and their use by workers
- Technical function (TF) of the substance in the article
You should also provide exposure-related information when describing the use(s) of your articles, including disposal. You may also wish to include information on the substance tonnage present in the article(s) and on the safe and proper use/handling of the article(s), as well as appropriate instructions for its disposal that you communicate under REACH Article 33.
Similar articles with similar uses can be grouped under the same use description.
The description of the use(s) of your article(s) must be provided in each created service life record created in the
- section Article(s)/Use(s) of the wizard, if you decide to prepare your notification online in REACH-IT, following the instructions in the help text; or
- section 3.5.6 of IUCLID, if you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT; chapter 188.8.131.52. of the manual "How to prepare a substance in articles notification" provides guidance on how to fill this IUCLID section.
The manual "How to prepare a substance in articles notification", which also includes useful advice and examples for an online notification preparation, is available on the ECHA website at:
Further information on the use descriptors can be found on the Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.12 on use description available on the ECHA website at: https://echa.europa.eu/documents/10162/13632/information_requirements_r12_en.pdf/ea8fa5a6-6ba1-47f4-9e47-c7216e180197
This information should be provided in your substance in articles notification. As a minimum requirement, the tonnage range is to be provided.
If you decide to prepare your notification online in REACH-IT, in the section Tonnage, you must report the tonnage band of the substance contained in the articles and if you wish provide the actual estimated quantities. The help text of the wizard provides you guidance on how to fill this section.
If you decide to prepare your notification beforehand in a IUCLID dossier, you are required to report the tonnage band of the substance contained in the articles in the IUCLID Dossier Header, when creating the dossier to be uploaded to REACH-IT. In section 3.2 of IUCLID, you can indicate the tonnage of the Candidate List substance contained in the produced/imported articles. Chapters 7.3.1. and 8 of the manual "How to prepare a substance in articles notification" provides guidance on how to fill these IUCLID sections, including which years to base the calculation on.
You have the possibility to provide the tonnage of substance per article/use if you so wish in each created service life record created in the section Article(s)/Use(s) of the online wizard or in section 3.5.6 of IUCLID.
The manual "How to prepare a substance in articles notification" is available on the ECHA website at:
See also Q&A 536
Only producers of articles who produce their articles in the European Economic Area (EEA) will have to enter their production sites. Article importers do not need to fill in this information.
If your company has several sites producing articles, you can list all the sites in one notification. Different notifications should not be made for different sites if the sites belong to the same legal entity.
If you decide to prepare your notification online in REACH-IT, please provide information on your production sites in section Role(s) in the supply chain after reporting your role as producer of article by selecting “Manufacturer”. Please refer to the help text of the online wizard for additional information.
If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, please refer to chapters 3 and 7.3.2 of the manual "How to prepare a substance in articles notification" for additional information.
The manual "How to prepare a substance in articles notification" is available on the ECHA website at:
This question is not relevant to notifications prepared online in REACH-IT.
To facilitate the submission of substance in articles notifications ECHA has made available pre-filled substance datasets in IUCLID format (i6z files) for substances on the Candidate List. These datasets are only relevant if you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT. They contain information on substance identification, composition and classification and labelling. Each substance has its own pre-filled dataset, which can be downloaded from the Candidate List webpage.
Chapters 5 and 6 of the manual "How to prepare a substance in articles notification" provide information on how to download and use the datasets. This manual is available on the ECHA website at:
The Candidate List is published on ECHA's website at: http://echa.europa.eu/candidate-list-table
The registration number only needs to be included in the notification dossier if the substance has already been registered and the registration number is available to the notifier. If the article is imported from outside the EU, this field does not need to be filled. Producers of articles, incorporating the Candidate List substance into the article themselves, should normally have access to the registration number via the Safety Data Sheet (SDS) for the substance. In this case, the article producer is likely to be exempt from the notification obligation however he should verify that his use is indeed covered by the registration (see Q&A 530).
If available, the registration number should be provided in your substance in articles notification.
It can be inserted in the
- section Administrative information of the wizard, if you decide to prepare your notification online in REACH-IT, following the instructions in the help text; or
- section 1.3 of IUCLID, if you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT; chapter 7.1.3. of the manual "How to prepare a substance in articles notification" provides guidance on how to enter this information in IUCLID. This manual is available on the ECHA website at:
Article 3(30) of the REACH Regulation specifies that "per year" means "per calendar year", i.e. 1st January – 31st December. However, for the purpose of the tonnage calculation, if the article has been manufactured or imported for at least three consecutive years the average volume of the preceding three years is recommended to be used. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.
Notification is required from producers or importers of articles, therefore you have to notify only when the object manufactured/imported is an article. Please refer to Chapter 2 of the Guidance on requirements for substances in articles for additional information on the distinction between a substance/mixture and an article. You should also refer to Tables 3 and 4 of the Guidance, in chapter 3.2.2, if you are dealing with coated articles and complex objects.
A notification of a substance in articles shall be made at the latest 6 months after the substance has been included on the Candidate List. The obligation started to apply from 1 June 2011.
If you have the obligation to notify a substance in your articles and the deadline has already passed, you are encouraged to notify immediately. You might face national enforcement sanctions if you fail to meet the deadline. Although ECHA accepts notifications after the legal deadline, this does not prevent your national enforcement authorities to impose sanctions on you.
If the import of the substance in articles starts after the notification deadline has expired (i.e. 6 months after the inclusion in the Candidate List), notifications must be made without undue delay as soon as the conditions related to the notification obligation are met, i.e. as soon as the 1 tonne per year threshold has been reached.
One notification should be submitted for all the articles produced or imported containing the same substance by/to one legal entity. You are however requested to indicate the uses for each different type of article in your notification.
If you are producing or importing new articles containing the Candidate List substance above 0.1% w/w, which are not reported in your submitted notification, you must update your notification without undue delay, given that the conditions related to the notification obligation are met.
No, it is necessary to submit a separate notification for each substance and for each importer/manufacturer.
In order to be able to demonstrate compliance with your obligations, you are recommended to update your notification if the information included in the notification changes. Examples of important changes could be: change in tonnage range.
However, if you are producing or importing new articles containing the Candidate List substance above 0.1% w/w, which are not reported in your submitted notification, you must update your notification without undue delay, given that the conditions related to the notification obligation are met.
You cannot update a notification that was submitted with the webform. Instead, a new notification will need to be created from scratch and submitted to ECHA.
If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality.
The update of your notification needs to be initiated from the reference number page in REACH-IT. You can access to this page by log in to your REACH-IT account at https://idp-industry.echa.europa.eu/idp/
At the top of the reference number page in REACH-IT, you can update your notification by clicking on
- “Create and submit online an update”, if you have prepared your notification online in REACH-IT or you have submitted it via web form (closed since October 2017); To prepare and submit your notification update online, please follow the wizard instructions.
- “Submit a IUCLID dossier update”, if you have submitted your notification by uploading a IUCLID dossier; After updating your IUCLID dataset and creating your updated notification IUCLID dossier, you can submit the dossier update via REACH-IT, by uploading it; Please follow the submission wizard instructions.
If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality in the reference number page.
Please find further guidance on REACH-IT at https://www.echa.europa.eu/support/dossier-submission-tools/reach-it
The obligations of the importer of the mixture depend on the interpretation of each specific entry in Annex XVII to REACH for the substance concerned, taking account of the wording, the context and the purpose of the restriction in question.
For instance, if a substance were completely banned, then it could not be placed on the market, not even as an impurity in a substance in an imported mixture. On the other hand, some Annex XVII entries specify limits above which a substance cannot be placed on the market. This limit may not be exceeded, no matter what is the source of the substance in the mixture. However, this can only be determined on a case-by-case basis depending on the substance, the restriction and the concentration of the substance as an impurity in the imported mixture.
It should be noted that the impurity may be permissible at any concentration if the use of the imported mixture is not covered in the ‘conditions of restriction' listed in Annex XVII for the substance.
In special cases where, due to the size or shape of the packaging, it is technically not possible to include the protective gloves inside the packaging, it is considered to be sufficient that the gloves are fixed tightly to the packaging in a manner that they cannot be unintentionally removed during handling and transport. The gloves must not obstruct the label and the removal of the gloves must not destroy the label. In addition, both the packaging containing the mixture and the protective gloves must be placed on the market as a single unit, which explicitly signals to the consumer that the mixture may only be used with the protective gloves .
The new legal act may explicitly state that references to the repealed act must be construed as references to the new legal act (e.g., Article 139 of REACH).
- Entry 19 (paragraph 4) exempts certain uses of arsenic compounds for wood preservation if they are authorised in accordance with Directive 98/8/EC. This Directive was replaced by Regulation (EU) 528/2012, which explicitly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 96).
- Entry 45 (paragraph 3) exempts electrical and electronic equipment within the scope of Directive 2002/95/EC from the restriction of diphenylether, octabromo, derivative. This Directive was replaced by Directive 2011/65/EU, which explicitly states that references to the repealed Directive must be interpreted as reference to the new directive (Article 26).
- Entry 50 (paragraph 3) defines tyres covered by the PAH restriction as tyres for vehicles covered by three directives, including Directive 2002/24/EC. This Directive was replaced by Regulation (EU) 168/2013, which expressly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 81).
Article 31(6) of the REACH Regulation provides that the safety data sheet (SDS) shall contain a Section 15 entitled ‘regulatory information’. Annex II to REACH provides requirements for the compilation of the SDS. Section 15(1) specifically mentions that, if the substance or mixture covered by the SDS is the subject of specific provisions in relation to the protection of human health or the environment at Union level (e.g. restrictions under Title VIII), these provisions must be mentioned, unless this information is already mentioned in other parts of the SDS. Thus, all restriction entries applicable to the specific substance or mixture covered by the SDS need to be indicated therein. As an example, SDSs including carcinogenic, mutagenic or toxic to reproduction substances (as such or in a mixture) listed in appendices 1 to 6 to REACH, need to refer to entries 28, 29 or 30 of Annex XVII. If another specific restriction exists for these substances, this needs to be mentioned as well in the SDS.
Moreover, Article 31(9) of the REACH Regulation requires suppliers to update the SDS without delay once a restriction has been imposed. In Section 16 (other information), a clear indication of where changes to the previous version have been made needs to be included, unless such indication is given elsewhere in the safety data sheet, with an explanation of the changes.
To further clarify the exemption (within Article 67(1) of the REACH Regulation, manufacture, placing on the market or use of a substance in scientific research and development (SRD) is exempted for restrictions), note that under the authorisation process the following Q&As (concerning the exemption in Article 56 for the use of Annex XIV substances in scientific research and development) has been provided. The same approach can be broadly considered as applicable to restrictions.
- Q&A 1153 states that sampling for further analysis is not exempted and thus not regarded as scientific research and development. However, “activities considered to form part of the use of the sample in performing analytical activities” fall within the exemption.
- Q&A 1030 explains that the uses of a substance upstream preceding an exempted end-use in scientific research and development are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to certain conditions.
- Q&A 585 explains that the exemption from authorisation also applies to the use of a substance in analytical activities such as monitoring and quality control under certain conditions. This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities, but does not cover sampling activities.
Many entries in the Restriction List (Annex XVII) cover articles. Such entries are, for instance, entries 50 - 52, 61 and 63. These may address types of textiles and leather articles, even if these are not explicitly mentioned.
The following entries in the Restriction List (Annex XVII) are specific to textiles:
Entry 4 ((2,3 dibromopropyl) phosphate, CAS No 126-72-7);
Entry 7 (Tris(aziridinyl)phosphinoxide, CAS No 545-55-1; EC No 208-892-5) and
Entry 8 (Polybromobiphenyls; Polybrominated biphenyls (PBB), CAS No 59536-65-1).
These entries state that these substances “Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.”
The following entries in the Restriction List (Annex XVII) restrict substances in relation to textiles and/or leather articles:
Entry 18, restriction on mercury compounds in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;
Entry 20 (paragraph 6), restriction on dioctyltin (DOT) compounds in textile articles intended to come into contact with the skin;
Entry 23 (paragraph 6), restriction on cadmium and its compounds in textiles and clothing;
Entry 43, restriction on azocolourants and azodyes in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity (indicative list is provided);
Entry 46 (paragraph 3) restriction on nonylphenol and nonylphenol ethoxylates in textiles and leather processing (with some exceptions);
Entry 46a, restriction on nonylphenol ethoxylates in textile articles which can reasonably be expected to be washed in water during their normal lifecycle, and
Entry 47 (paragraphs 5-7), restriction on chromium VI compounds in leather articles coming into contact with the skin.
The following entries of the Restriction List (Annex XVII) specifically include a derogation for electrical and electronic equipment:
Entry 45 (paragraph 3) provides a derogation from the restriction on diphenylether, octabromo derivative (C12H2Br8O) for electrical and electronic equipment within the scope of Directive 2002/95/EC, which has been replaced by Directive 2011/65/EU (on the restriction of the use of certain hazardous substances in electrical and electronic equipment), and
Entry 63 (paragraph 8) excludes articles within the scope of Directive 2011/65/EU from the restriction on lead and its compounds in articles supplied to the general public.
In addition, the following entries in the Restriction List (Annex XVII) explicitly restrict the placing on the market of paints and/or paint strippers:
Entry 16, restriction on certain lead carbonates in substances or mixtures intended for use as paint;
Entry 17, restriction on certain lead sulphates in substances or mixtures intended for use as paint;
Entry 20, restriction of organostannic compounds acting as biocide in free association paint;
Entry 20 (paragraph 5), restriction on dibutyltin (DBT) compounds in paints and coatings;
Entry 23 (paragraph 2), restriction on cadmium and its compounds in paints with codes  and  and in painted articles;
Entries 28-30 (paragraph 1), restriction on CMRs as substances, as constituents of other substances or in mixtures (including paints), for supply to the general public; (paragraph 2) derogation for artists’ paints covered by Regulation (EC) No 1272/2008;
Entry 48, restriction on toluene (CAS No 108-88-3; EC No 203-625-9) in spray paints intended for supply to the general public;
Entry 54, restriction on (2-(2-methoxyethoxy)ethanol (DEGME) (CAS No 111-77-3; EC No 203-906-6) for supply to the general public, as a constituent of paints and paint strippers;
Entry 55, restriction on 2-(2-butoxyethoxy)ethanol (DEGBE) (CAS No 112-34-5; EC No 203-961-6) for supply to the general public, as a constituent of paints and paint strippers and in spray paints and
Entry 59, restriction on dichloromethane in paint strippers under certain conditions.
In general, cleaning refers to any removal of dirt or pollution from articles or places, both in industrial and institutional facilities as well as in households.
In some entries cleaning may be specified by reference to a particular user group(s) or potential exposure pattern to which the restriction applies. For example, column 2, paragraph 1 of entries 32-38 refer to the substance or mixture being intended for supply to the general public and/or intended for diffusive applications where releases can occur from multiple sources such as surface cleaning and cleaning of fabrics. Column 2, paragraph 1 of entry 46 applies to industrial and institutional cleaning systems (e.g. in schools, hospitals), with the exception of dry cleaning done in a controlled closed system where the washing liquid is recycled or incinerated and other cleaning systems where special treatment is used with recycling or incineration of the washing liquid. Column 2, paragraph 2 entry 46 applies to all domestic cleaning.
The term ‘article’, as interpreted by the European Court of Justice (ECJ) in its judgement of 10 September 2015 in case C-106/14 applies in the same way to restrictions in Annex XVII as to the other aspects of the REACH Regulation. The judgement is available here: http://curia.europa.eu/juris/liste.jsf?language=en&td=ALL&num=C-106/14.
For the purposes of REACH, the term 'article' has the specific meaning set out in Article 3(3) of the REACH Regulation. Article 3(3) defines an article as ‘an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition’.
'Complex objects' are made up of more than one article which meet the criteria laid down in Article 3(3) of REACH, e.g. a bicycle is a complex object made up of several articles, such as handlebar grips, cables, screws etc. Complex objects are explained in the ECHA Guidance on requirements for substances in articles. Please note the term ‘complex object’ corresponds to ‘complex product’ that is used in the ECJ Judgement referred to above (see footnote 12 of the above guidance).
The ECJ, in its judgment, observed that the REACH Regulation does not contain any provisions specifically governing complex products and that consequently, in the absence of specific provisions, there is no need to draw a distinction between articles of their own (e.g. screw) or when incorporated as components of a complex product (e.g. a screw in a bike). Therefore, when incorporated into a complex product, an 'article' remains an article within the meaning of REACH, as long as the article retains its special shape, surface or design, which is more decisive for its function than its chemical composition.
Entries in Annex XVII restricting 'articles' cover any object meeting the criteria in Article 3(3) of the REACH Regulation. Therefore, if an entry restricts the placing on the market of articles containing/releasing substance X and the restriction affects complex objects, the presence/release of substance X in each of the individual articles should be checked.
If a restriction entry refers to ‘parts of articles’, this should be understood as referring to an integral part of an article. Please note questions and answers (Q&As) and guidelines for some entries in Annex XVII have been developed which provide further information. The Q&As and guidelines are available on the ECHA website here: https://echa.europa.eu/information-restricted-substances.
The REACH Regulation does not provide a specific definition for paints.
According to a general meaning, paint is a mixture, usually of a liquid with a solid pigment. Furthermore, Commission Decision 2009/544/EC (establishing the ecological criteria for the EU Ecolabel to indoor paints and varnishes) provides the following definition: 'Paint' means a pigmented coating material, in liquid or in paste or powder form, which when applied to a substrate, forms an opaque film having protective, decorative or specific technical properties.
The abovementioned definitions provide an indication of what could be generally considered as a paint in the context of entries 16-17 of Annex XVII (to REACH) provisions.
It should be noted that the restrictions in entries 16-17 of Annex XVII only allow Member States to permit the use of paints containing the restricted substances for the restoration and maintenance of works of art and historic buildings and their interiors. Thus children's paint sets and other stationery-type paints such as artist paints and do-it-yourself (DIY) decorations for t-shirts must not contain the restricted substances.
Concerning children's paint sets, these may also be covered by the Toys Directive (Directive 2009/48/EC on the safety of Toys), which lays down limits for the presence of lead in toys.
The REACH Regulation does not provide a definition of measuring devices (often referred to as measuring instruments). However, in the context of entry 18(a), it has to be noted that:
- The restriction provision in paragraph 1 of entry 18(a) covers those measuring devices that are intended for sale to the general public and provides an indicative list of these (thermometers, manometers, barometers, sphygmomanometers etc.)
- Furthermore paragraphs 5 and 7 provide exhaustive lists of mercury-containing measuring devices intended for industrial and professional uses which have not been allowed to be placed on the market after 10 April 2014 (barometers; hygrometers; manometers; sphygmomanometers; strain gauges to be used with plethysmographs; tensiometers; thermometers and other non-electrical thermometric application; mercury pycnometers; mercury metering devices for determination of the softening point; mercury triple point cells other than those used for the calibration of platinum resistance thermometers).
For the purposes of Directive 2004/22/EC on measuring instruments, ‘measuring instrument' means any device or system with a measurement function that is covered by Articles 1 and 3. According to the European Standardisation organisation-CEN, "measuring instruments allow for testing the accuracy and calibration of measuring devices (e.g. water meters, gas meters, electricity meters, etc.)". (http://www.cencenelec.eu/standards/sectors/mid/pages/default.aspx)
The abovementioned definitions provide an indication of what could generally be considered as a measuring device in the context of entry 18(a) of Annex XVII to REACH provisions.
Paragraph 4b) of Annex XVII to REACH concerning arsenic compounds provides for a list of applications for which wood treated with CCA may be used. This is not a list of examples of possible uses but an exhaustive list of authorised applications. It flows both from the actual wording of those provisions and from their objective that the derogation provided for in paragraph 4 must necessarily be subject to a strict interpretation, as confirmed by the Court of Justice (case C-358/11, pp. 40-43).
Consequently, wood treated with CCA cannot be used for other applications than the ones listed in paragraph 4 b). Wood treated with CCA can, therefore, not be used for railway sleepers installed above ground.
Organostannic compounds covered by entry 20 in Annex XVII to REACH, must contain a carbon-tin bond. Substances like tin salts or organotin compounds, for which tin is bound to an atom other than carbon (for example hexanoic acid, 2-ethyl-, tin(2+) salt (CAS-No. 301-10-0)) are not covered by entry 20 in Annex XVII to REACH.
(a) Yes, they do. Entry 20 in the Restriction List (Annex XVII) to REACH imposes DOT compounds restrictions for childcare articles, which are not toys. The REACH Regulation does not contain a definition of toys. The definition of toys in Directive 2009/48/EC on the Safety of Toys is illustrative in determining what should be considered as a “toy” in the context of this restriction (see Q&A 0982).
However, paragraph 6(a) of entry 20 restricts DOT compounds in textile toys as in any other textile article intended to come into contact with the skin. Furthermore, organic tin (including DOT) in toys is restricted by paragraph 13 of Part III (Chemical Properties) of Annex II to Directive 2009/48/EC on the safety of toys, which specifies maximum migration limits.
(b) and (c)
In addition to derogation in paragraph 5(d), the other derogations currently applicable to TBT, DBT and DOT compounds in articles relate to the continued placing on the market of articles that were already in use in the EU before the 1 July 2010 for TBT (paragraph 4(b), before the 1 January 2012 (paragraph 5(b)) for DBT and before the 1 January 2012 for DOT (paragraph 6(b)).
Yes. Packaging can be considered as an article (or a product composed of different articles) in its own right. More information can be found in the ECHA guidance on requirements for substances in articles available at https://echa.europa.eu/guidance-documents/guidance-on-reach (in particular in chapter 2).
Therefore, with regard to entry 20, packaging should comply with the restrictions for tri-substituted (TBT, TPT) and dibutyltin (DBT) compounds. The restriction of dioctyltin compounds (DOT) which applies only to certain listed articles for the general public, applies to textile packaging.
With reference to paragraph 10 of the Annex to Commission Regulation (EU) 494/2011 amending entry 23 of Annex XVII of the REACH Regulation (cadmium) the concentration threshold of cadmium applies in each metal part of jewellery. The wording used by the legislator, i.e. "metal parts of the jewellery and imitation jewellery" implies that each metal part is relevant; therefore in order to determine if the restriction applies the calculation of the concentration in this case is to be done for each metal part. Therefore, if there are several metal layers as coatings on the surface of an inner (metallic) part of the jewellery these should be regarded as integral part of the metal part and the concentration limit of 0,01% is calculated for this whole metal part. In case the inner part is not metal, but the coating is made of metal layers, this coating is regarded as one metal part. If the jewellery article contains several metal parts, each of them should comply with the concentration limit.
The prohibition of the placing on the market of jewellery and imitation jewellery articles containing cadmium includes sales from the manufacturers to distributors and from distributors to retailers, as well as imports. However, Commission Regulation (EU) 494/2011 contains derogation for articles that were placed on the market before 10 December 2011 (for the date see corrigendum published in OJ L 136/105). This means that jewellery and imitation jewellery articles placed on the market for the first time before 10 December 2011 do not need to comply with the prohibition thus they can be sold following entry into force of the new restriction for example to a retailer or on the second-hand market.
Paragraph 8 of entry 23 of Annex XVII to the REACH Regulation states that cadmium and its compounds shall not be used in brazing fillers in a concentration equal to or greater than 0,01 % by weight. In addition, brazing fillers shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight. The paragraph also states that brazing shall mean a joining technique using alloys and undertaken at a temperature above 450°C. In accordance with the following paragraph 9, by way of derogation paragraph 8 shall not apply to brazing fillers used in defence and aerospace applications nor to brazing fillers used for safety reasons.
The safety aspect in relation to this derogation is if the use of cadmium containing brazing filler may prevent accidents causing human suffering or environmental pollution.
For the enforcement purposes examples of applications are given. It can be considered that the derogation on uses of cadmium containing brazing fillers for safety reasons in paragraph 9 of entry 23 covers the current uses, such as:
- Brazing fillers used in turbine wheels in power plant technology in temperature below 650°C.
Turbine wheels in power plant technology are parts of speed drivers for gas compressors and boiler feed pumps, where rotational speed is approximately from 1000 revolutions per minute (rpm) up to 20 000 rpm. Cadmium containing brazing fillers are needed as they can be used below 650 °C without decreasing the strength of the parent material (base metal). Cadmium-free brazing fillers require higher temperatures which causes the weakening of the parent material. Weakening of the parent material could lead to the breakdown of the turbine wheel. Due to high rotational speed the parts and pieces of shrapnel may cause injuries to workers and others in the vicinity of the wheel. The breakdown of the turbine wheel may result also in a complete shutdown of the power plant, the compressor station of a gas pipeline, or of a refinery.
- Brazing fillers used in pipes and tubes where acetylene is transferred in high pressure (1.5 – 17 bar).
Cadmium containing brazing fillers are needed in the joining process for pipes and tubes, where acetylene is transferred in order to avoid formation of explosive substances. Acetylene forms explosive substances with copper and silver as well as other materials (e.g. formation of copper acetylide and silver acetylide). Cadmium reduces the overall percentage of copper and silver in the brazing fillers to the level where formation of explosive substances does not exist. Another reason to use cadmium in brazing fillers for this application is that cadmium facilitates the capillary action and solder penetration ensuring a good quality joint with high integrity for pipes and tubes where acetylene is transferred in high pressure (1.5-17 bar). Release of acetylene from pipes and tubes may as well cause serious risk, as acetylene is extremely flammable gas and explosive with and without contact with air.
Other applications that would like to benefit from the derogation need to show the similar kind of safety aspects as described above.
Such considerations should take into account the availability on the market of cadmium-free brazing fillers which can address the safety aspects of the specific application of the brazing fillers in an equivalent manner.
See also ECHA´s report "The use of brazing fillers containing cadmium for safety reasons" [PDF].
Paragraph 1 of entry 23 of Annex XVII to the REACH Regulation provides a restriction on cadmium and its compounds in mixtures and articles produced from certain synthetic organic materials (plastic materials) and paragraph 2 provides a restriction on cadmium and its compounds in paints (Tariff codes 3208 and 3209). The following paragraph 3 states that by way of derogation the restrictions in paragraphs 1 and 2 do not apply to articles coloured with mixtures containing cadmium for safety reasons.
There are two safety aspects in relation to this derogation. The first relates to the use of a specific colour or pigment with certain properties which is necessary to prevent accidents. The second relates to the use of a specific colour or pigment with certain properties in safety equipment.
For the enforcement purposes example of applications are given. Based on above, it can be considered that the derogation in paragraph 3 of entry 23 covers current applications of articles such as:
- Coloured wire insulation and cable jackets used in aircraft electrical and control systems for the purpose of fire detection and extinguishing systems, flight control systems or during flight tests.
The wire and cable connections are often used in in a high temperature application (greater than 150ºC ambient temperature). Cadmium pigments are used to keep the colour from changing or fading over time in the high temperature. Changing established colour conventions could introduce a significant risk of maintenance errors, which may lead to a risk of passengers.
- Outdoor safety equipment, such as:
- parts of rescue boats for ships (e.g. safety belts, water pockets of life rafts, canopies) and
- parts of safety equipment for outdoor applications (e.g. seats, reels and diverse technical parts).
The other applications that would like to benefit from the derogation need to show the similar kind of safety aspects than described above.
Such considerations should take into account the availability on the market of alternative substances which can address the safety aspects of the specific application in an equivalent manner.
See also ECHA´s report "The use of cadmium and its compounds in articles coloured for safety reasons" [PDF].
Entry 23 (paragraph 10 (i)) of Annex XVII to the REACH Regulation states that cadmium and its compounds must not be used or placed on the market if the concentration of cadmium is equal to or greater than 0,01 % by weight of the metal in metal beads and other metal components for jewellery making (see Q&A, 158). In addition, it should be noted that articles produced from plastic material referred to in paragraph 1 of the entry must not be placed on the market if the concentration of cadmium is equal to or greater than 0.01 % by weight of the plastic material.
Thus, in the case of plastic coated metal beads (CCB beads), both the plastic material and the metallic part of the bead need to comply with entry 23 (cadmium restriction).
Please also note that if the article is painted, then paragraph 2 will also apply to this article.
Note that metallic articles containing cadmium may be covered under other EU legislation. For example, (1) electrical and electronic equipment falls under Directive 2011/65/EU on the Restriction of the use of certain Hazardous Substances and must comply as well with the maximum concentration limits for cadmium set in that Directive and (2) toys are covered under Directive 2009/48/EC on the Safety of Toys.
Entry 27 of Annex XVII to REACH states that nickel may not be used "in articles intended to come into direct and prolonged contact with the skin, if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0.5 Jg/cm²/week". The aim of this restriction to protect consumers against nickel allergy which may be caused by prolonged contact of the skin with nickel-releasing articles that come into direct and prolonged contact with the skin such as jewellery, buttons, tighteners, zips and rivets in items of clothing. It has emerged that some mobile telephones contain nickel in surface material and that consumers are at risk of developing eczema through skin contact with the mobile telephone. As mobile telephones are clearly intended to come into direct contact with the skin, and as they are used on a daily basis often for prolonged periods of time, it is considered that mobile telephones fulfil the condition of "direct and prolonged contact with the skin". Therefore mobile telephones are covered by the restriction and should comply with the conditions set in Entry 27 of Annex XVII to REACH.
Prolonged contact with the skin is defined as contact with the skin to articles containing nickel of potentially more than
- 10 minutes on three or more occasions within two weeks, or
- 30 minutes on one or more occasions within two weeks.
The skin contact time of 10 minutes applies when there are three or more occasions of skin contacts within a two-week time period. The skin contact time of 30 minutes applies when there is at least one occasion within a two-week time period.
Substances within the scope of entries 28-30 are not allowed to be placed on the market or used for supply to the general public as substances, as constituents of other substances or in mixtures when the concentration is equal to or greater than the specified limits. Certain derogations apply to this restriction as listed in paragraph 2. CMR substances that are present in articles are not within the scope of the restriction imposed by entries 28-30, but other restrictions may be applicable to these substances, when present in articles. In addition, notification and communication obligations under REACH may apply; see the ECHA website: https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.
It should be noted that entries 28 and 29 are applicable to the substances that are listed in Appendices 1 & 2 (carcinogenic (C), categories 1A and 1B) and Appendices 3 & 4 (mutagenic (M), categories 1A and 1B). Entry 30 is applicable to substances which are classified as reproductive toxicants (R), categories 1A and 1B and listed in Appendices 5 and 6. These Appendices are regularly updated by including new substances, after the adoption of a harmonised classification for a substance as CMR, category 1A or 1B according to Regulation (EC) No 1272/2008.
The REACH Regulation does not define aerosols or aerosol dispensers.
According to the ordinary meaning of the word, an aerosol is considered to be "a substance enclosed under pressure and released as a fine spray by means of a propellant gas". (Oxford advanced dictionary definition). The term may in certain contexts be used for a mixture enclosed under pressure and released as a fine spray by means of a propellant gas, or the dispenser or package used to change the ingredient inside the container into a spray by the use of a propellant gas. The European Aerosol Federation uses the term "aerosol" for both the suspension and the dispenser/package.
Furthermore, it should be noted that according to Article 2.3.1 of the CLP Regulation (for "Classification, Labelling and Packaging"), the term "aerosol dispenser" means: any non-reusable container made of metal, glass or plastic and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state.
The CLP definition is very similar to the definition provided in Article 2 of the Aerosol Dispensers Directive (ADD) (75/324/EEC).
The above definitions provide an indication of what could be generally considered as ‘aerosols/aerosol dispensers' in the context of Entry 40 of Annex XVII. Note that aerosol generators should be regarded as aerosol dispensers, as the original restriction discusses aerosol generators.
Entry 40 prohibits the use of flammable, highly flammable or extremely flammable substances in "aerosol dispensers where these aerosol dispensers are intended for supply to the general public for entertainment and decorative purposes". Paragraph 1 provides an indicative list of examples of products that are covered by the restriction. These examples are all products to be used to decorate, for instance, venues for festivities (e.g. Christmas, weddings, and carnivals) or parties (e.g. birthday parties and fancy-dress parties) and for entertainment use, for instance, during festivities and parties. None of the examples listed in the entry are cosmetic products within the meaning of Regulation (EC) No 1223/2009 on cosmetic products.
Coloured hair sprays and body glitter would fall within the definition of cosmetic products in Regulation (EC) No 1223/2009, as they are intended "to be placed in contact with an external part of the human body" with a view to "changing its appearance" and therefore have a similar use to more classical cosmetic products, such as normal hair sprays. Coloured hair sprays and body glitter should not be considered as having an entertainment or decorative purpose, and therefore they are not covered by entry 40 of Annex XVII to REACH.
Through a literature search and consultation with experts in this area it was not found any structural connection between optical brighteners (or better called fluorescent dyes) and azodyes since either the NH bonds in the fluorescent dyes are connected to heterocyclic NC structures and therefore cannot form any of the 22 banned arylamines or they do not contain any azo bonds where reductive cleavage could take place to generate any of the aromatic amines covered by the azodyes ban. Therefore at the present time, this information confirms that the restriction in Entry 43 to Annex XVII does not cover optical brightening agents (OBAs). Should the chemical structure of optical brightening agents be different from the definition as reported above, this answer may change accordingly.
Entry 43(3) of Annex XVII restricts the placing on the market of substances and mixtures containing over 0.1% of the azodyes listed in Appendix 9, when they are intended for colouring textile and leather articles, and also the actual use of the substance or mixture for that purpose. Therefore, the presence of these substances in imported articles is not restricted.
However, pursuant to paragraphs 1 and 2 of the restriction, if an azodye in Appendix 9 releases one or more of the aromatic amines listed in Appendix 8 in a concentration above 30 mg/kg (0,003 % by weight, it cannot be used in textile and leather articles which may come into direct and prolonged contact with human skin or the oral cavity (such as those listed in paragraph 1). Those textile and leather articles cannot be placed on the market unless they comply with that concentration limit.
Yes. The intention of the legislator was to cover all isomers, linear and branched, of nonylphenol and their ethoxylates and therefore all of them are covered by the restriction.
The restriction on nonylphenol and nonylphenol ethoxylates was based on the risks identified in the risk assessment report prepared by the United Kingdom under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. The risk assessment report states that "It is understood that nonylphenol (CAS Number: 25154-52-3) as originally defined by CAS (Chemical Abstract Service) covered all nonylphenols. However, subsequent revisions redefined it to cover only straight chain nonylphenol, other isomers having different CAS numbers. Given the method of manufacture of nonylphenols, very little if any straight chain nonylphenol is produced. That which is produced is only likely to be present at very low levels in commercial mixtures. The commercially produced nonylphenols are predominantly 4-nonylphenol with a varied and undefined degree of branching in the alkyl group. This assessment covers commercially produced material (predominantly 4-nonylphenol, branched). This material will also contain smaller amounts of other isomers and impurities, and falls under the CAS Number 84852-15-3."
Therefore Council Directive 76/769/EEC, as amended by Directive 2003/53/EC, did not specify any CAS or EC numbers for nonylphenol. In the revision of the REACH restriction by Regulation 552/2009/EC, which made several technical changes, the CAS and EC numbers were added. This will be corrected by a technical amendment to reflect the intention of the legislator.
Paragraphs (1) to (9) of entry 46 list the ‘purposes' to which the restriction applies. Following paragraph (7) "cosmetic products" is paragraph (8) "other personal care products". It therefore seems that cosmetics are to be considered as a subcategory of personal care products.
REACH does not define "cosmetic products". According to Regulation (EC) No 1223/2009 on cosmetic products, "cosmetic product" means "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance protecting them, keeping them in good condition or correcting body odours."
Based on the above, it can be interpreted that "other personal care products" within the meaning of entry 46 include, but are not limited to, any product meeting the conditions indicated in the above definition for substances and mixtures and other products used for personal hygiene, such as toilet papers, some female hygiene products, nappies, cotton pads, etc. This interpretation can be broadly considered as a perception of the average consumer for this product category.
Entry 48 prohibits the placing on the market for supply to the general public of toluene as a substance or in mixtures, in a concentration equal to or greater than 0.1% by weight, where the substance or the mixture is used in adhesives and spray paints. Adhesive tapes consist of a layer of adhesive coated on a flexible substrate. As the restriction concerns the concentration of toluene in adhesives, the concentration of toluene must be calculated with reference to the amount of adhesive on the tape, and not with reference to the total weight of the adhesive and substrate.
As stated in Recital 8 of the Directive 2005/69/EC (OJ L323, 9.12.2005, p.51), there are at present no harmonized test methods for measuring PAHs in the extender oils, or for measuring PAHs in tyres that contain such oils. Until suitable harmonized methods are available, the only named method that is permitted for measuring the PAH content of extender oils is the IP346 analysis method. This method is permitted providing that certain additional conditions are met. These additional conditions are necessary because the IP346 method does not measure the PAH content directly. In fact IP346 measures the total content of polycyclic aromatic compounds (PCA) rather than the PAH content. The PCAs are a group of substances to which PAHs belong, but in which PAHs are present in only very small amounts. The legal limit for PAHs in extender oils, which is 1 part per million (ppm) of BaP and 10ppm total PAH content, is considered to be met if the total PCA content is <3%. In other words, the PCA content of 3% is taken as a proxy measurement for a PAH content of 10ppm. The proxy measurements will be valid only if the ratio between the PAH and PCA content in the extender oil is known and does not change over time. The additional conditions therefore require an initial calibration of the technique (measurement of the PAH/PCA ratio) and recalibration at intervals of six months, or after "major operational change", in order to ensure that the measurements remain valid over time. The term "major operational change" should therefore be taken to mean any change in materials or processes that could invalidate the results of the proxy measurement. The principle cause of invalid results would be a change in the PAH/PCA ratio in the extender oil. However, it should be remembered that not only is IP346 a proxy method for measuring PAH, but that the quantity that it does measure, namely PCA content, is meaaured in a rather indirect way, namely by a change in the refractive index of a solution, and that PCAs are not the only substances that affect the refractive index of a solution. The potential for obtaining invalid results is therefore quite high and the method should therefore be used with considerable caution. It would therefore be advisable to recalibrate in case of doubt. The provision to control the calibration of the PAH/PCA ratio every six months is to safeguard the validity of the IP346 results against unintentional or unknown changes. This would apply for the case where the manufacturing process and materials used remain the same, and where there is no reason be expect a change in the PAH/PCA ratio. However, it is possible to imagine, for example, that a tyre manufacturer receives a reformulated extender oil from his supplier without being made aware of the change that has been made, and the results from the IP346 could be invalidated as a consequence. A six month recalibration interval was considered sufficient to cover such occurrences. Conclusion: The provision to control the calibration of the PAH/PCA ratio after each "major operational change" is to safeguard the validity of the IP346 results. A major operational change is therefore a deliberate change to materials or processes that might be expected to significantly influence the PAH/PCA ratio, or otherwise affect the validity of the measurement. Examples of such a change would be where the source of supply for the extender oil is changed, or where the method of using the oil is changed. Judgment of whether a particular change is sufficiently important to trigger the need for recalibration will necessarily be made case-by-case and will require expert opinion.
Standard reference tyres are produced and imported solely for the purpose of providing a reference performance for other newly developed tyres. They are not placed on the market to be fitted on vehicles intended for final users. For the purpose of entry 50, tyres are defined as tyres for vehicles covered by Directives 2007/46/EC on motor vehicles and their trailers, Directive 2003/37/EC on agricultural or forestry tractors, and Directive 2002/24/EC on two and three-wheeler motor vehicles. It appears that Reference Tyres are not intended to be used on vehicles covered by the Directives 2007/46/EC, 2003/37/EC and 2002/24/EC. In conclusion these tyres should not be considered as covered by the provisions of the restriction in Entry 50 of Annex XVII.
The threshold of 0.1% is the standard threshold used in Annex XVII. The value of 0.1% has been chosen because it represents a measurable quantity. It is being used to take into account impurities, not to allow the use of certain substances, e.g. phthalates in toys and childcare articles. One should be aware that in order to plasticise a toy or childcare article concentrations of phthalates of more than 10 per cent are needed. Different restrictions are applied to each of the two groups of phthalates. The limit value of 0.1% should therefore be applied for each group of phthalates combined, i.e. the concentration of DEHP, DBP and BBP combined should not be higher than 0.1% and the concentration of DINP, DIDP and DNOP combined should also not be higher than 0.1%. Conclusion: A toy or childcare article would not comply with the Entry 51 or Entry 52 respectively if it contained either more than 0.1% of DEHP, DBP and BBP combined or more than 0.1% of DINP, DIDP and DNOP combined. However, it would be considered compliant if it contained only 0.09% of DEHP, DBP and BBP combined and 0.09% of DINP, DIDP and DNOP combined.
The entries 51 and 52 specify that "Childcare article" means "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children." As these articles are intended to facilitate the hygiene of children they should be considered as "childcare articles" as defined by the entries 51 and 52. In conclusion, articles which are used for the hygienic care of children such as bathtubs, articles for the bath, bathtub mats, hairbrushes, bath thermometers, or nail cutters are therefore covered by the Entries 51 and 52 and use of phthalates and should conform to the prescriptions of the entries.
The definition of childcare articles contained in Annex XVII to REACH is as follows: "Childcare articles" are defined as "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children". Further explanation is provided by the Commission services' guidance document on the interpretation of the concept "which can be placed in the mouth". It gives the following examples: "The main purpose of pyjamas is to dress children when sleeping and not to facilitate sleep. Pyjamas should therefore be regarded as textiles and, like other textiles, do not fall under the scope of the Directive. Sleeping bags are designed to facilitate sleep, and should therefore fall under the Directive." Taking this into account, and also taking into account that the guidance document explicitly contains a description and a photo of a mattress cover, it can be confirmed that mattress protectors are childcare articles as defined in Annex XVII. This means that the three phthalates DEHP, BBP and DBP listed in entry 51 of Annex XVII may not be used in mattress protectors. The other three, DINP, DIDP and DNOP, listed in the entry 52, are only restricted in those articles that can be placed in the mouth by children.
The guidance document contains an example of a mattress cover that is not directly mouthable in normal and foreseeable use conditions. The edges and corner are not accessible for mouthing by the child – by design (the mattress should fit snugly in the cot to avoid entrapment risks), and the mattress is covered with a sheet in normal use and the surface is sufficiently taut (by design – to avoid suffocation risks) to prevent PVC from being mouthed through the sheet. This is based on the observation that inaccessible parts of articles can not be taken into the mouth. Articles or parts of articles should be considered inaccessible if, during proper use or reasonably foreseeable improper use by children, they can not be reached. However, there will be other cases when parts of certain articles can be taken into the mouth under normal and foreseeable conditions, for example when the mattress protector is placed on the sheet or cannot be completely fixed. In conclusion, mattress protectors that can be placed above sheets or that cannot be tightly fixed to the mattress have to comply with the restriction contained in entry 52 of Annex XVII to REACH. Authorities competent for market surveillance should assist manufacturers/importers in making a case-by-case assessment on the basis of the criteria described above and in the guidance document.
The restriction in entry 52 concerns the substance "Di-isodecyl phthalate" (DIDP) which is listed with CAS Numbers 26761-40-0 and 68515-49-1. Di-2-propyl heptyl phthalate (DPHP) is an isomer of decyl phthalate and has the CAS No 53306-54-0. According to the information at the Commission's disposal, DPHP (CAS # 53306-54-0) is different from DIDP and therefore not covered by entry 52 of Annex XVII. In conclusion, the substance is not covered under the entry 52 of Annex XVII. The uses of the substance may be regulated in the future on a Community-wide basis, if it appears from the information which will become available that it causes unacceptable risks to human health or the environment. In addition DPHP is explicitly not promoted by its manufacturers for use in toys, food packaging or medical products.
This guideline aims at providing some criteria and examples to help identify those toys and childcare articles which can be placed in the mouth by children. The guideline lists the main criteria of "size dimension" and "accessible parts" (according to the EN 71-European Standard on the safety of toys) which would therefore facilitate the judgement - on a case by case – whether a toy or childcare article can be placed in the mouth by children. The guideline also provides pictures as examples in order to better indicate which toys and childcare articles or parts of them can be taken into the mouth.
The 0.1% limit was set up in order to eliminate the use of phthalates. Such limit was set up in order to be respected in each bit/piece of plasticised material by itself, regardless of whether there are other pieces or not. Therefore the reference to 0.1%, intended also as the sum up to the 3 phthalates, has to be calculated in each piece of plasticised material of each homogenous material. In the example referred to in the question the calculation should therefore be based on the weight of the plasticised material of the head of the doll and not the entire weight of all plasticised material of the whole toy.
A childcare article is defined by entries 51 (4) and 52(4) as "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children" (see Q&A 983). A baby monitor does not facilitate the sleep or relaxation of the baby, it allows parents to be alerted when the baby is crying or making other noise. Therefore baby monitors fall outside the scope of entries 51-52 of Annex XVII.
The polymeric MDI, with CAS number 9016-87-9, is not included in the definition of the substance with CAS 26447-40-5 and moreover is not classified as dangerous in Annex VI of Regulation (EC) No 1272/2008 (CLP). In the Risk assessment report and Risk reduction strategy performed by the Belgian Rapporteur, two main products were analysed during the exposure assessment and throughout the decision making process: the one-component foams and hot melt adhesives, both containing respectively 10% and 2% of MDI. Other products with MDI content below 0.1% did not pose any risk and therefore were excluded by the final consideration on the risk reduction measures under Directive 76/769/EEC. However, polymeric MDI present in mixtures is covered by the restriction when such mixtures contain more than 0.1% of MDI (as defined in the RAR). Therefore, dimers and polymeric forms of MDI are out of the scope of the current restriction except if they are part of mixtures containing more than 0.1% of MDI.
In entry 58, the terms "including natural or legal persons licensed or authorised in accordance with Council Directive 93/15/EEC" should be read as an example of operators that benefit from the exemption. Therefore the derogation in paragraph 2(a) covers all downstream users and distributors as defined in Article 3(13) and 3(14) of REACH. As a consequence, mixtures containing more than 16% of nitrogen in relation to ammonium nitrate may be placed on the market after 27 June 2010 for supply to downstream users and distributors as defined in REACH. As consumers are not downstream users nor distributors, mixtures containing more than 16% of nitrogen in relation to ammonium nitrate may not be placed on the market for supply to consumers.
If a downstream user uses ammonium nitrate to produce a mixture containing ammonium nitrate below the threshold, it may place this mixture on the market for supply the general public. But downstream users should not use ammonium nitrate in order to produce a mixture containing ammonium nitrate above the threshold for supply to the general public. The restriction is applicable to medical devices as well as to other mixtures containing more than 16% of nitrogen in relation to ammonium nitrate for supply to the general public. For example, instant cold packs which contain more than 16% of nitrogen in relation to ammonium nitrate may not be sold to the general public since 27 June 2010.
The restriction is not applicable to downstream users who use ammonium nitrate for their industrial or professional activities in order to transform it into other substances for different purposes. Therefore, for example the use of ammonium nitrate to produce nitrous oxide for use in the production of pressurised foods or for use as anaesthetics is not restricted.
No. Ink strippers, adhesive removers and degreasing agents are not within the scope of the restriction. The restriction covers paint strippers, including also varnish removers and lacquer removers.
This document echa.europa.eu/documents/10162/13563/lead_guideline_information_en.pdf aims at providing a guideline concerning the interpretation of the scope of the restriction provisions in paragraphs 7 to 10 of entry 63 of Annex XVII to REACH Regulation (EU) No 1907/2006 on lead and its compounds in articles supplied to the general public. It has been drawn up to (i) clarify certain terms that define the scope of the restriction (e.g. "accessible part of articles", "normal/reasonably foreseeable conditions of use") (ii) provide non-exhaustive lists of article types (and examples of sub-types) which fall within (or out of ) the scope of the restriction.
The substances affected by this restriction are those described in column 1 of entry 68. There are many substances that meet the criteria in column 1 of entry 68 and as such it is difficult to produce a comprehensive list of these substances. Further explanatory information on the scope of this restriction may be found on pages 28-41 of the compiled RAC/SEAC opinion from the restriction procedure on the ECHA website here: https://echa.europa.eu/documents/10162/13641/rest_pfoa_compiled_opinions_en.pdf/2f0dfce0-3dcf-4398-8d6b-2e59c86446be
In addition, Appendix B.1 of the Background Document to the compiled RAC/SEAC opinion from the restriction procedure lists examples of PFOA-related substances here:
From 4 July 2020 the concentration limit ‘equal to or above 25 ppb’ applies to the use of perfluorooctanoic acid (PFOA, CAS 335-67-1, EC 206-397-9) and its salts in the production of, or placing on the market in, another substance, as a constituent, a mixture or an article.
From 4 July 2020, the concentration limit of ‘equal to or above 1000 ppb’ applies to the use of one or a combination of PFOA-related substances that are identified in the second and third paragraphs of column 1 in the production of, or placing on the market in, another substance, as a constituent, a mixture or an article. The following PFOA-related substances are identified in the second and third paragraph of column 1:
- Any related substance (including its salts and polymers) having a linear or branched perfluoroheptyl group with the formula C7F15- directly attached to another carbon atom, as one of the structural elements’.
- Any related substance (including its salts and polymers) having a linear or branched perfluorooctyl group with the formula C8F17- as one of the structural elements’.
A useful discussion of the rationale for these concentratrion limits is given on pages 30-31 of the compiled RAC/SEAC opinion from the restriction procedure on the ECHA website here:
The restriction entry 68, paragraph 3(b)(i) provides a longer transition period for textiles used to protect workers from risks to their health and safety, i.e. paragraphs 1 and 2 shall apply from 4 July 2023 to the use of PFOA and PFOA related substances in the production of, or placing on the market in such textiles. This transition period is thought to be sufficient time to allow the development of cost-effective alternatives for all relevant applications where the textiles are required to provide human health/life protecting functions (e.g. due to very strong oil or chemical repellence).
The workers requiring this type of protection are e.g. firefighters, policemen that are exposed to risks from oil and chemicals and therefore need personal protective equipment, as well as workers in the healthcare sector. A non-exhaustive list of clothing for worker protection that need to comply with the restriction is given in Appendix B.2.2.5 of the final background document supporting the RAC and SEAC opinions. The list includes high visibility jackets, flame-retardant trousers and surgical gowns and is available here:
The substances restricted by the entry (column 1) shall not be used in the production of, or placed on the market in fire-fighting foam mixtures from 4 July 2020 (paragraph 2(b)) at or above concentrations specified in the entry. However, the concentration limits in the restriction (column 2, paragraph 2) do not apply to fire-fighting foam mixtures (paragraph 5(a)), placed on the market before 4 July 2020.
The restriction does not apply to the concentrated fire-fighting foam mixtures that are placed on the market before 4 July 2020 and which are to be used or are used in other fire-fighting foam mixtures (paragraph 4(e)). Thus concentrated fire-fighting foam mixtures that exceed the concentration limits specified in paragraph 2 of the entry can still be used in the production of other fire-fighting foam mixtures, if these concentrated fire-fighting foam mixtures were placed on the market before 4 July 2020.
In addition, fire-fighting foam mixtures produced using the above mentioned concentrated fire-fighting foam mixtures can be placed on the market. They can be used for training purposes provided that the emissions to the environment are minimised and effluents collected are safely disposed of.
The substances restricted by the entry (column 1) shall not be used in the production of, or placed on the market in medical devices other than implantable medical devices within the scope of Directive 93/42/EEC (to be replaced with Regulation (EU) 2017/745) from 4 July 2032 (column 2, paragraph 3 (c)) at or above the concentrations specified in the entry.
There is a derogation for implantable medical devices that are within the scope of Directive 93/42/EEC (to be replaced with Regulation (EU) 2017/745) in the following terms:
- The restricted substances are allowed to be manufactured and placed on the market and used or placed on the market as a constituent of another substance or in a mixture for the production of these devices (paragraph 4(d)(i)) and
- Implantable medical devices produced according to paragraph 4(d)(i) can be placed on the market without specific concentration limits (paragraph 6(b)).
Yes, the substances in column 1 shall not be placed on the market in, or used in the production of cosmetics.
Article 67(2) REACH foresees that Annex XVII restrictions do not apply to the use of substances in cosmetic products in the case of restrictions addressing human health risks within the scope of the Cosmetic Products Regulation (Regulation (EC) 1223/2009). This is not the case for entry 68: all substances covered by the restriction are either persistent, bioaccumulative and toxic (PBT) or are considered to have the potential to degrade or be transformed to PFOA. The concentration limits in the restriction ensure the emissions of these substances to the environment are decreased.
Manufacture or import does not need to be interrupted during the completeness check of a dossier when the dossier is submitted to update an existing registration, which already has a registration number assigned, for the following reasons: (i) when the reason for the update is to respond to an ECHA communication or decision requesting additional information; or (ii) the registrant has new and relevant information about the substance, and its uses and properties. However, if the update is made to increase the scope of the registration (e.g. increase of tonnage band, or change from an Article 17/18 registration to an Article 10 registration), the new scope cannot be applied in the manufacture/import until the dossier has successfully passed the completeness check.
For new dossiers submitted to obtain a registration number, the following scenarios exist:
- In the case of a non phase-in substance for which the manufacture or import is to be started, the waiting period must be respected as the assignment of the registration number, and the right to manufacture or import the substance, rely on the submission of a complete registration dossier to ECHA and the granting by ECHA of a registration number.
- In the case of a phase-in substance which was pre-registered, and for which the relevant registration deadline has not yet passed, there is no requirement to interrupt manufacture of import during the completeness check. Such substances may be manufactured and imported until their relevant registration deadline without a registration number. If a dossier for a pre-registered substance is submitted immediately before its relevant registration deadline, but fails the completeness check, ECHA will set a deadline by when the dossier has to be completed. The manufacture or import of the substance may continue during this time even if the registration deadline is passed. However, if the dossier is not completed by the set completeness check deadline, ECHA will issue a decision rejecting the registration. If the relevant registration deadline has passed at this moment, the registrant cannot continue manufacture or import until they successfully submit a new registration dossier and receive a registration number for the substance.
In the case that you submitted your dossier before the compliance check deadline had passed, you may follow the deadline given in the TCC letter. ECHA will not continue with the Evaluation process before you have submitted the requested update for the technical completeness check failure.
Should also your second submission fail the TCC, the combination of your two submissions in response to the compliance check decision will be rejected. If at this point the compliance check deadline has already passed, it means that ECHA has not received a response to the compliance check decision and may proceed with further regulatory actions. It is therefore advisable not to leave the submission of updates to regulatory requests to the last moment.
This Q&A does not apply if your submission in response to an ECHA decision under compliance check was made after the deadline indicated in that decision. In such a case you should update the incomplete dossier without delay and inform ECHA about not meeting the compliance check deadline via the contact form: https://echa.europa.eu/contact
- To be legally on the market from 31 May 2018 onwards, any registrant (lead or member) that intends to benefit from the phase-in scheme of this particular registration deadline must have submitted a registration dossier to ECHA by this deadline. A dossier is considered to be submitted if it has been uploaded in REACH-IT and passed the business rules step, as long as it has not been rejected due to incompleteness caused by non-payment of the fee, or second failure of the technical completeness check. Please note the following in relation to a TCC failure close to the registration deadline:
- A member registrant cannot submit a dossier before the dossier of the lead registrant of that substance has been submitted. As soon as the lead registrant submits a dossier to ECHA (uploads it in REACH-IT and passes the business rules step), member registrants of that joint submission can submit their dossiers.
- Member registrants cannot receive their registration numbers before the lead dossier is found to be complete. This means that submitted member dossiers are ‘parked’ in the submission pipeline until a decision is taken on the completeness of the lead dossier.
- If a registration dossier fails the completeness check, ECHA informs the registrant of the missing/incomplete information and grants a deadline by which the registrant has one attempt to complete the information. If the registrant submits all the requested information to ECHA within the deadline, the dossier will receive a registration number and the registration date will be the date of the first submission. If this dossier is the lead registrant dossier, all submitted member dossier for that joint submission will be released from being ‘parked’ and will be processed for completeness.
- Should also the second submission result in a failure of the completeness check then the combination of the first and second submissions will be rejected and no registration number is issued for that registrant. In case the rejected submission is the lead registrant dossier, a registration number is also not issued for any member registrant of that joint submission.
The technical completeness check (including manual checks) is in general performed on each dossier within three weeks of its submission date. However, for phase-in substances submitted in the course of the two-month period immediately before the relevant registration deadline, the completeness check may take up to three months after the deadline. Registrants who wish to have the outcome of the completeness check in advance of the 2018 registration deadline may consider these timelines.
The completeness check is based on REACH Article 20(2). It applies to all registration dossiers submitted to ECHA; both dossiers submitted to obtain a new registration number, as well as dossiers submitted as updates of existing registrations. The completeness check consists of two parallel verifications: (i) the technical completeness check, in which ECHA verifies that all the required elements have been provided in the registration dossier; and (ii) the financial completeness check, in which ECHA verifies that the registration fee has been paid, if applicable to that submission.
If during the technical completeness check the registration dossier you submitted is found incomplete, ECHA will issue a deadline by which you have only one attempt to submit the missing or incomplete information. If you do not provide the requested information by the set deadline in the form of an update dossier, the submission will be rejected. In such a case, any registration fee you had paid in relation with this submission will not be refunded or otherwise credited.
You can find more information about the registration process on the REACH 2018 registration deadline pages: https://echa.europa.eu/support/registration/from-submission-to-decision
We also recommend you to have a look at our webinar on the technical completeness check process:
There is no need to change the data waiving justification from free text to an available picklist phrase. A free text justification will be considered equally complete to a picklist value, whenever it is in line with column 2 of REACH Annexes VII-X, or sections 2-3 of Annex XI.
However, when preparing a dossier in IUCLID 6 from IUCLID 5 data, please review the selection in the field ‘Endpoint’ in particular for IUCLID sections where different information requirements can be addressed (e.g. 4.13, 7.8.1) to ensure that you have clearly indicated that the appropriate requirement is being waived.
The manual verification applies to all registration dossiers submitted to ECHA. The manual checks focus on ensuring that registrants who waive or deviate from the standard information requirements provide justifications foreseen by the legislation. Therefore the extent of the verification depends on whether the dossier contains waiving of standard information or deviations from substance identification conventions, as well as on the specific requirements that apply to the registration type (i.e. lead, member, individual registration) and the registration scope (tonnage band, isolated intermediate).
For further information, please refer to the document Information on manual verification at completeness check available at: https://echa.europa.eu/manuals.
As a first step, ensure to prepare your registration/PPORD dataset and dossier according to the advice given in the manual How to prepare registration and PPORD dossiers available at: http://echa.europa.eu/manuals. Annexes 1-3 of the manual also give an overview of the business rules and technical completeness check rules that apply to registration and PPORD dossiers.
Next, use the IUCLID Validation assistant plug-in to help you detect business rules and technical completeness check failures present in your dataset and dossier. While the Validation assistant cannot replicate all the checks performed by ECHA (see below), it simulates the majority of the verifications done and helps you minimise the chance of failure during submission. It is important to keep in mind that any failure in the Validation assistant Submission checks tab that is left uncorrected before submitting your dossier in REACH-IT will lead to that your submission will not be accepted by ECHA.
To run the Validation assistant, right click on your dataset in the Navigation panel → Validate → follow the steps in the wizard. The same validation should be performed on the dossier to make sure that no failures have been introduced during dossier creation.
You can find a video tutorials on the use of the IUCLID Validation assistant in the link below :
If the Validation assistant does not indicate any failures, this is not an automatic confirmation of that your dossier is complete. As of 21 June 2016, the technical completeness check includes additional verifications of the registration dossier by ECHA staff. These checks cannot be replicated using the Validation assistant plug-in; the related completeness issues cannot be displayed by the tool.
Information on the areas of the additional verifications can be found in the following location; the document is regularly updated with advice based on the experience gained with incoming registrations: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf.
We also recommend you to have a look at our webinar on the completeness check process: https://echa.europa.eu/-/completeness-check-preparing-a-registration-dossier-that-can-be-successfully-submitted-to-echa.
The quality rules warn the user of common inconsistencies and shortcomings. These warnings will not prevent you from successfully submitting your dossier in REACH-IT; however leaving quality warnings uncorrected may lead to later clarification requests by ECHA.
En överenskommelse om kostnadsdelning kräver därför vanligen att parterna kommer överens om följande:
- Informationens tillförlitlighet, relevans och lämplighet (”datakvalitet”).
- Informationens ekonomiska värde (”datavärdet”).
- Hur det avtalade värdet ska delas mellan parterna (”kostnadsfördelning och ersättning”).
Registranterna behöver dela kostnaderna för den information som de behöver lämna in för att uppfylla registreringskravet. Företag kan inte tvingas betala för undersökningar som de inte behöver, inte heller kan de tvingas betala innan de verkligen behöver dem i sitt respektive viktintervall. Då en (potentiell) registrant begär data i förtid måste denne dock betala vid mottagningen av data. Andra element kan även övervägas. Det är i allmänhet att rekommendera att en överenskommelse gällande kostnadsdelning nås innan tillgänglig information lämnas ut.
Riktlinjerna för datadelning ger mera detaljer: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Dessutom finns det praktiska råd om datadelningsförhandlingar tillgängliga: http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations.
Du kan ha ytterligare skyldigheter att dela data efter att ha lämnat in din registrering. Detta kan ske då
- nya potentiella registranter kommer med i forumet för informationsutbyte om ämnen (SIEF) som sena förhandsregistranter av ett infasningsämne,
- den potentiella registranten av ett icke-infasningsämne eller en potentiell registrant av ett infasningsämne som inte har förhandsregistrerat sig informeras om de tidigare och andra potentiella registranterna (och tvärtom) av Echa efter en förfrågan,
- efter en lyckad inlämning av registreringsunderlaget närhelst ny information blir tillgänglig. I detta fall bör registranten enligt artikel 22 i Reach uppdatera det gemensamma registreringsunderlaget. Detta kan kräva föregående datadelning och kan påverka på beslut om klassificeringen och märkningen. Det kan också leda till ett behov att ändra i kemikaliesäkerhetsrapporten.
- som en följd av Echas utvärdering av det inlämnade underlaget (överensstämmelsekontroll eller bedömning av ett testningsförslag) eller utvärderingen av ämnet. Dessa processer kan leda till en begäran om inlämning av ytterligare information som måste åtgärdas av alla registranter av samma ämne. De bör vara överens om generering och delning av data och kostnader. Datadelning gäller därför inte endast ”befintliga” undersökningar utan även undersökningar som behövs för att säkerställa att registreringen är i överensstämmelse med Reach.
När en registrant inte är ägare till en undersökningsrapport som han/hon behöver för sin registrering bör han/hon avtala med ägaren om villkoren för att få använda undersökningsrapporten i REACH-registreringssyfte. Det står ägaren av data och registranten fritt att definiera rättigheterna som ges.
Om den fylliga rapportsammanfattningen av en undersökning redan har lämnats in till ECHA kan en registrant t.ex. hänvisa till den undersökningen i sina underlag, förutsatt att han/hon har tillstånd att göra det. I det sammanhanget måste registranten och ägaren av data komma överens om villkoren för rätten att hänvisa. LoA är en term som ofta används för att beskriva ett avtal om datadelning och rätt att hänvisa. Dataägarens immateriella rättigheter måste i alla fall respekteras av den potentiella registranten.
Kostnaden för delade data för varje ämne kan variera betydligt beroende på kostnaderna för undersökningen som det gäller, antalet registranter som delar data och andra faktorer.
ECHA har publicerat generiskt råd om vad som ska tas i betraktande under datadelningsförhandlingarna: http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations
ECHA kommer inte att delta i diskussionerna mellan (potentiella) registranter och har inget mandat att reglera eller bedöma fördelningen av kostnader. ECHA kan därför inte hjälpa en potentiell registrant i dennes förhandlingar med tidigare registranter eller dataägare. Som sista utväg, kan ECHA bistå vid lösning av tvister om datadelning mellan befintliga och potentiella registranter. Se datadelningssidorna på ECHA:s webbsida för närmare uppgifter: http://echa.europa.eu/regulations/reach/registration/data-sharing/data-sharing-disputes/data-sharing-disputes-in-practice
Användning av publicerade undersökningar för att möta dina informationskrav kräver att du har rätt att referera till den fullständiga undersökningsrapporten. Om du i ditt registreringsunderlag vill referera till en publicerad fullständig undersökningsrapport måste du därför kontrollera med upphovsrättsinnehavaren i vilken utsträckning du har rätt att använda den i ditt eget underlag. I detta fall bör du förhandla om en licens eller annan form av överenskommelse (t.ex fullmakt) som ger dig rätt att referera till de publicerade data. Av effektivitetsskäl bör en sådan överenskommelse säkerställa att alla medlemmar av den gemensamma anmälan har rätt att referera till data.
Upphovsrätten omfattar endast uttrycksformen men inte fakta och data som ingår i arbetet. Därför kan fakta och data inkluderas i underlaget utan upphovsrättsinnehavarens tillstånd förutsatt att texten från undersökningen inte kopieras som sådan in i ditt registreringsunderlag. Med andra ord kan du använda data för att producera din egen undersökningssammanfattning men du måste ge lämpliga referenser och citat till den ursprungliga undersökningen för att bekräfta informationskällan. Också i fall där du producerar din egen undersökningssammanfattning måste du dessutom ha rätt att referera till den fullständiga undersökningsrapporten för din registrering. För mera information se Vägledning i datadelning, avsnitt 184.108.40.206.
All potential registrants of a substance must examine all available information and apply the relevant classification and labelling for their substance as it has been mutually agreed within their SIEF.
If they disagree with this classification, they may decide to ‘opt-out’ from this information requirement and propose a different classification, as long as they appropriately justify their decision (Article 11(3)(c), REACH).
Nevertheless, potential registrants of a substance in a low tonnage band do not have to contribute to the cost of a study if this study is not required for a registration in their tonnage band (Article 11(2), REACH).
Kommunikationen inom ett forum för informationsutbyte om ämnen (SIEF) blir betydligt lättare om en av deltagarna går med på att spela rollen som samordnare. Samordnaren kan föreslå sätt att organisera utbyte av information om ämnet. SIEF kan redan i ett tidigt skede gå med på att ett företag tar över organisationen för informationsutbyte och förberedelsen för gemensam inlämning. Detta är emellertid inte obligatoriskt då Reach inte ställer några villkor i detta hänseende.
Om information för utbyte anses kommersiellt känsligt av en eller flera registrerade (t.ex. på grund av ett innehåll av orenheter kan ge indikation på en produktionsprocess) kan de till exempel föreslå ett sekretessavtal eller användning av en oberoende tredje part eller förvaltare som kan hantera den konfidentiella informationen för de potentiella registranternas räkning. Andra former av organisation är lika möjliga så länge som alla SIEF-deltagare har kommit överens om det.
Detaljerad information om hur man organiserar SIEF och underlättar kommunikation inom SIEF finns i Vägledning om gemensamt utnyttande av data: http://echa.europa.eu/guidance-documents/guidance-on-reach
Potentiella registranter bör arbeta för att bilda SIEFs så snart som möjligt, för att säkerställa att tillräcklig tid återstår för att organisera datadelning och förbereda registreringsdokoumentationen. Vägledningen i datadelning förklarar närmare hur och när ett SIEFbildas: http://echa.europa.eu/guidance-documents/guidance-on-reach
En datainnehavare är en person som har relevanta uppgifter/data för ett infasningsämne och är villig att dela med sig av dem. Datainnehavare kan exempelvis vara följande:
- tillverkare, importörer och enda representanter för tillverkare utanför EES av infasningsämnen i mängder under 1 ton per år som inte har förhandsregistrat sig,
- nedströmsanvändare av infasningsämnen,
- tredje parter som innehar information om infasningsämnen,
- varje part för vilken Echa har lämnat in information inom ramen för direktivet om utsläppande av växtskyddsmedel på marknaden (91/414/EG) eller direktivet om utsläppande av biocidprodukter på marknaden (98/8/EG) som uppfyller villkoren i artikel 15 i Reach.
Deltagande i ett forum för informationsutbyte om ämnen (SIEF) är obligatoriskt för aktörer som specificeras i artikel 29 i Reach, medan medlemskap i ett konsortium eller annan form av samarbete är frivilligt. Konsortier är en mer formell typ av samarbete mellan registranter.
Det anges ofta att ett ”konsortium” måste bildas (eller att konsortieavtal måste upprättas) för att organisera aktiviteterna inom ett SIEF såsom datadelning och gemensam inlämning av data. Varken användningen av ett fullständigt ”konsortieavtal” eller användningen av annat formellt skriftligt avtal krävs emellertid lagligen av Reach.
Om några eller alla av deltagarna i ett eller flera SIEF beslutar att bilda ett konsortium kan de fritt bestämma om sina arrangemang beträffande omfattning, syfte, längd, villkor för medlemskap eller utträde osv. så länge dessa inte står i strid med gemenskapens konkurrensregler. Dessutom måste konsortiemedlemmarna samarbeta med alla SIEF-medlemmar som inte är deltagare i konsortiet eller avtalet. Ytterligare information om former för samarbete finns i Vägledning om gemensamt utnyttjande av data: http://echa.europa.eu/guidance-documents/guidance-on-reach
Du kan inte lämna ett SIEF. Även om ditt företag upphör med sina aktiviteter gällande ämnet kvarstår du fortfarande som deltagare i SIEF. Du måste dela information som du innehar i enlighet med Reachs datadelningsföreskrifter. Du behöver emellertid inte delta i någon inlämning (eller uppdatering) som görs av medlemmar av SIEF eller delta i några ytterligare tillhörande kostnader.
Under förhands-SIEF-fasen kan du avaktivera dig från föhandsr-SIEF i Reach-IT för att visa att du inte är intresserad av registreringen av ämnet. Även som en icke-aktiv deltagare kan du ändå behöva dela dina data.
Om du registrerar ett infasningsämne före den 1 juni 2018 utan att tidigare förhandsregistrera det kommer du med i motsvarande forum för informationsutbyte om ämnen (Substance Information Exchange Forum - SIEF).
Om du är en potentiell registrant av ett infasningsämne men inte har förhandsregistrerat måste du lämna in en förfrågan till Echa. information om deltagarna i forum för informationsutbyte om ämnen (Substance Information Exchange Forum - SIEF) och deras förpliktelser ges i Vägledning om gemensamt utnyttjande av data: http://echa.europa.eu/guidance-documents/guidance-on-reach
ECHAs har ingen roll i bildandet av ett Utbytesforum för ämnesinformation (SIEF), varken bekräftar eller förkastar skapandet av ett speciellt SIEF. Det är på deltagarnas i SIEF ansvar att definiera precis ämnet för vilket ett SIEF bildas.
Samordnaren för upprättande av SIEF-forum (SFF) är inte formellt erkänd i REACH-förordningen, medan rollen som ledande registrant (LR) är specifikt förutsedd och nödvändig för gemensamma registreringar. Detta betyder att potentiella registranter inte har någon skyldighet att använda en SFF för att bilda ett SIEF. De kan till och med förbigå SFF för att börja pre-SIEF-diskussioner, om SFF inte agerar. Däremot måste SIEF välja en LR som lämnar in den gemensamma registreringen innan de andra registranterna i SIEF kan lämna in sitt individuella (”medlems-”)underlag för registrering.
Ytterligare ledning gällande SFF:s roll finns i Vägledning i datadelning http://echa.europa.eu/guidance-documents/guidance-on-reach.
En samordnare (SFF) för SIEF kan inte kräva avgifter för sina tjänster om inte detta bestäms genom en ömsesidig överenskommelse. En SIEF-samordnare förväntas kontakta andra deltagare i en för-SIEF för att underlätta utbyte av information och data som behövs för att bilda ett SIEF. SSF har ingen roll som förvaltare utöver att underlätta diskussioner och han/hon har ingen laglig grund för att tvinga andra för-SIEF-deltagare att samarbeta med dem.
Skyldighet i REACH att dela data (och lämna in gemensamt) gäller endast flera registranter av samma ämne. Därför finns det inga lagliga mekanismer för att tvinga olika SIEF att dela data. Varje begäran om tillgång till undersökningar över olika Utbytesforum för ämnesinformation (SIEF) måste förhandlas från fall till fall av de berörda företagen. Vidare vägledning gällande regler mellan SIEF finns i avsnitt 3.2.7 - 'Inter-SIEF rules (grouping, read-across)’ i Vägledning i datadelning. http://echa.europa.eu/guidance-documents/guidance-on-reach.
Om SIEF-deltagare inte kan komma överens om vem som ska utföra det nya testet (för att det inte finns någon frivillig eller för att det finns fler än en frivillig) kan de be Echa (https://comments.echa.europa.eu/comments_cms/article302.aspx) att utse en registrant som ska utföra testet. På grundval av objektiva kriterier väljer Echa ut den registrant som ska utföra undersökningen.
För registreringstidsfristen 2018 kan det förväntas att valet i de flesta fall görs slumpmässigt då det inte finns några större skillnader mellan de olika registranterna.
Efter att testet har utförts ska alla SIEF-medlemmar som behöver ta del av undersökningen bidra till kostnaderna för den med den andel som motsvarar antalet deltagande potentiella registranter.
Detta förfarande tillämpas i situationer där SIEF-medlemmarna är överens om att testet behövs, men inte om SIEF-medlemmarna är oense om huruvida testet är nödvändigt eller motiverat.
Ytterligare uppgifter finns i avsnitt 3.4.1 i Vägledning om gemensamt utnyttjande av data (https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_sv.pdf).
Du kan utnämna en tredjepartsrepresentant till att företräda dig i den gemensamma anmälan och i datadelningsverksamheten.
Obs! Lagligen förblir tillverkaren eller importören förhandsregistrant eller registrant. Tredjepartsrepresentanten får inte förväxlas med den tredje parten som innehar information (dvs. datainnehavarna) eller med den enda representanten.
Mer information finns i Vägledning om gemensamt utnyttjande av data, avsnitt 220.127.116.11. I "Frågor och svar" 352 förklaras hur en tredjepartsrepresentant tillsätts i Reach-IT.
Du kan ange din passiva roll till dina medregistranter i Reach-IT. Även som en icke aktiv deltagare i förhands-SIEF kan du dock bli tillfrågad om att dela data i SIEF.
Förhandsregistrerings- och registreringskyldigheten påverkas inte av inaktiveringen som gjorts i förhands-SIEF i Reach-IT. Om du planerar att fortsätta tillverka eller importera ovannämnda ämne i mer än ett ton per år efter registreringens slutdatum år 2018 måste du registrera det.
Även om du är passiv under SIEF-arbetet har du ett delat ansvar för de data som inlämnats som en del av den gemensamma registreringen. Därför bör du förstå data och komma överens om dem med dina medregistranter även om du inte är aktivt engagerad i sammanställandet av dem.
Mer information om avaktivering i Reach-IT i Frågor och svar 347.
Då du har förhandsregistrerat dig har du blivit en del av SIEF för ämnet. Andra medlemmar av SIEF kan begära information av dig i registreringssyfte. Om du innehar sådan information bör du lämna ut den vid anmodan och är skyldig ekonomisk ersättning om tillämpligt.
När du lämnar in en förfrågan anger du de uppgiftskrav som behövs för mängdintervallet du ämnar registrera.
Du får då tillgång till medregistranternas sida i Reach-IT, där du får information om tidigare och potentiella registranter (de som gör en förfrågan) samt tillgång till information om förhands-SIEF (dvs. om andra potentiella registranter som är medlemmar i ett förhands-SIEF, alltså sådana som förhandsregistrerade sig (sent) men som ännu inte har registrerat sig).
Echa anger dessutom om (några) uppgifter har lämnats in för mer än 12 år sedan.
Det är viktigt att skilja mellan inlämningsdatumet och datumet då undersökningen utfördes, vilket föregår själva inlämningsdatumet. 12-årsregeln gäller från och med inlämningen av en viss undersökning, oavsett när den utfördes.
Dessutom behöver inte datumet för inlämning av ett särskilt testresultat till den behöriga myndigheten vara samma datum som det ursprungliga anmälningsdatumet.
Testet kan i själva verket ha lämnats in efteråt (t.ex. efter en ökning av mängdintervallet upp till nästa testningsnivå), varför 12-årsperioden kanske ännu inte har löpt ut. Mer information finns i det nya kapitlet (utkast) i Vägledning om gemensamt utnyttjande av data: ”4.6.1 12-årsregeln”.
Rapportsammanfattningarna eller de fylliga rapportsammanfattningarna som lämnats in åtminstone 12 år tidigare inom ramen för en registrering av samma ämne enligt Reach är bifogade till Echa-meddelandet som skickas till den som gör en förfrågan. Informationen i endpoint-sammanfattningarna som Echa ger är kanske inte tillräckliga för att godkännas i den tekniska fullständighetskontrollen av följande skäl:
- Vissa uppgifter har inte förts in i det obligatoriska IUCLID-formatet och måste korrigeras manuellt.
- Viss administrativ information kanske saknas i en del fält eller avdelningar.
Likaledes måste uppgifternas kvalitet bedömas av den potentiella registranten. Du kan behöva kontakta den tidigare registranten för att
be om ytterligare upplysningar eller så kan du överväga att söka bättre information i andra källor om kvaliteten är för låg.
Echa informerar även tidigare registranter om att en förfrågan har gjorts om ett av deras ämnen.
Om du vill få uppgifter som har lämnats in för mer än 12 år sedan för att använda som jämförelsemed strukturlika ämnen, kan du kontakta Echa och begära detta i enlighet med artikel 25.3. Observera att du måste göra följande:
- Visa att du verkligen har för avsikt att registrera eller uppdatera ditt registreringsunderlag, genom att förse Echa med förhandsregistreringsnummer, registreringsnummer eller förfrågningsnummer och EG-nummer för dina ämnen.
- Beskriv varför du behöver uppgifterna och hur du avser att använda dem (t.ex. för jämförelse med strukturlika ämnen).
- Intyga att ”Uppgifterna ska endast användas i registreringssyfte i enlighet med Reach-förordningen”.
- Lista de endpoints som du begär information om.
Notera också att tillgång till uppgifter inte ger äganderätt till dem. Enligt Reach kan uppgifter som har lämnats in mer än 12 år tidigare endast användas i registreringssyfte.
A non-EEA company (that can appoint an only representative, see FAQ ID=15) may, by mutual agreement, appoint a natural or legal person established in the European Economic Area (EEA) to act as his only representative. According to Article 8(2) of REACH this representative shall comply with all obligations of importers under REACH. Therefore the only representative is required to have sufficient background in the practical handling of substances and the information related to them. More information on the only representative is also provided in section 18.104.22.168- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Yes, an only representative can represent one or several non-EU companies that manufacture substances, formulate mixtures or produce articles which are exported to the European Economic Area (EEA), even for the same substance.
If an OR is appointed by several non-EU companies, then the OR needs to create several OR accounts in REACH-IT, one for each non-EU company they represent. There should be a 1-to-1 correspondence between an OR account in REACH-IT and the non-EU company they represent. If the same legal entity covers the role of a manufacturer/importer and the role of an OR, then they will need to create two different accounts in REACH-IT: one account for their role as manufacturer/importer and another account for their role as OR.More information on the duties of the only representative is provided in section 22.214.171.124- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration.
EU importers of a non-EU manufacturer can apply for an authorisation irrespective of whether they are covered by an OR for registration of the Annex XIV substance. If the appointment of the OR does not extend to also cover the fulfilment of the obligations of the importers with regard to authorisation, then the importers themselves can apply for an authorisation. In such a case, the importers will apply in their role as importers of an Annex XIV substance. Furthermore, the importers are not required to indicate the name of the non-EU manufacturer or the OR in their application for authorisation sent to ECHA, since the OR's appointment and their respective obligations are limited to the registration of the Annex XIV substance.
Yes, you need to notify ECHA about this change. You represent the non-EU manufacturer and, therefore, you need to communicate changes in their legal personality. You can notify ECHA using the legal entity change functionality in REACH-IT.
To change the legal personality in this case you need to:
- Create a new account in REACH-IT for your company to represent the new legal entity, reflecting their size. Note that in the "Company Size" information, you must indicate the size of the non-EU/EEA manufacturer you are representing and not the size of your own legal entity.
- Initiate a legal entity change (only representative changes)
- Include documents which clearly explain how you represent the new non-EU manufacturer
- Update the IUCLID files, in particular section 1.7 ‘Only Representative information'
- Submit a spontaneous update in the new legal entity to report the change in the dossier
You may need to pay a fee to complete the process. More information related to the outcome of a legal entity change can be found at Q&A 388.
Once you have submitted your inquiry dossier to ECHA, REACH-IT will execute a series of automatic verifications after which we will manually assess your dossier. The assessment can lead to two different outcomes:
- If we are able to process your inquiry dossier, you will receive a communication via REACH-IT providing you with an inquiry number as well as details of available (robust) study summaries, as appropriate. You will also receive a link to the Co-Registrants Page in REACH-IT, which will contain the contact details of the registrants and successful inquirers of the same substance. If you were assigned a list number and a list name, you will need to download the list number in .i6z file format to use it in your registration dossier. At the end of the Submission Report related to your inquiry dossier (in REACH-IT) there is a button that will allow you to download the i6z file to be used when preparing your registration dossier.
- If we are not able to process your inquiry dossier, due to missing and/or inconsistent substance identification information, you will receive a communication via REACH-IT detailing the changes that you need to make to your inquiry dossier. In this case, you will need to submit a new inquiry dossier.
In principle, the analytical data included in an inquiry or a registration dossier must reflect the substance as manufactured or imported. Hence, if you are an EU manufacturer, you must submit analytical data generated from a sample that you have manufactured. If you import from outside the EU, you must submit analytical data generated from a sample manufactured by the non-EU manufacturer.
We are aware that this can be problematic if you have to register your substance before taking up manufacture or import. For such cases we may accept submitting analytical data from another source.
For these exceptional cases, you need to explain the following in your inquiry dossier:
- Why the analytical data cannot be generated on the manufactured substance.
- Why the substance you intend to manufacture or import will be the same as the one used to generate the analytical data. For example, a statement that the manufacturing process and/or plant specification used to produce the analysed substance will mirror that for the inquired substance.
You also need to provide the following information in your inquiry dossier:
- The source of the analysed substance i.e. manufacturing site name and address.
- A short description of the production process and the raw materials for both the inquired substance and the analysed substance.
- The foreseen manufacturing or import volume for the inquired substance.
- A statement from the owner of the analytical data indicating that you have their permission to use their analytical data.
You are required to update the substance identification information in the registration dossier within 6 months after the submission to reflect the substance as manufactured or imported. If the registration is not updated, ECHA may initiate a targeted compliance check on substance identity.
We display on the Co-Registrant page in REACH-IT the contact details of the third party representative (TPR) to registrants and successful inquirers. However, we communicate the result of the inquiry process to the inquirer and not to a designated TPR.
The REACH Regulation does not impose any timeframe on ECHA for processing an inquiry dossier. Whilst the internal timeframe is 20 working days, we aim to provide the inquiry result as promptly as possible.
Inquiry and registration of intermediates are regarded as two distinct processes. For this reason, it is not necessary to specify in your inquiry dossier the type of registration you plan to submit.
Yes. Irrespective of the type of registration, you have to submit analytical data as part of your inquiry. The analytical data has to be sufficient to allow ECHA to verify the identity of your substance. This is to enable ECHA to provide you with the contact details of registrants and successful inquirers of the same substance.
When preparing your inquiry dossier, we recommend that you read the following documents:
- Guidance for identification and naming of substances under REACH and CLP
- Q&A on Substance Identification
- Q&A on Inquiry
- Data Submission Manual - How to prepare an Inquiry dossier
Before submitting any dossier, we recommend that you use the "Validation Assistant", which will identify the fields of your dossier which deserve particular attention. You can download it via the IUCLID 6 website https://iuclid6.echa.europa.eu/.
The Validation Assistant supports the preparation of your IUCLID 6 dossier in two ways:
- It performs a check of most of the business rules applied to dossiers in REACH-IT. This enables the user to detect and correct failures before submitting the dossier to ECHA. For further information on the business rule check, please consult the Data Submission Manual - part 4 (How to Pass Business Rule Verification ("Enforce Rules")), available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-manuals.
- It performs a so-called "Substance Identity check", identifying the IUCLID fields of an inquiry dossier that should be filled in or that need particular attention. It is advisable to use the Validation Assistant both for preparing the inquiry substance dataset and the final dossier. We strongly recommend addressing all the reported inconsistencies and shortcomings. Please note that the "Substance Identity check" will not assess whether the information submitted is adequate but only if all required fields are filled in.
ECHA will not publish any substance identity information submitted as part of an inquiry.
ECHA uses the information submitted for the purposes of inquiry solely to determine whether the same substance has been previously registered or inquired about. We make available the contact details and list of information requirements only within the relevant Co-Registrants page in REACH-IT. The EC/list name, EC/list number and/or EC/list description is the only substance identity information disclosed to registrants and successful inquirers of the same substance.
Yes. Before submitting your registration, you need to wait until you have received a communication from ECHA which includes the inquiry number. We will also provide you with the link to the relevant Co-Registrants page in REACH-IT, where you will find the details of registrants and successful inquirers of the same substance. This will support you in complying with your obligations to share data and submit a joint registration.
Yes, but only if you need additional information to update your registration.
- Availability of data submitted AT LEAST 12 years previously
- if the data requested was submitted at least 12 years previously (e.g. under the previous legislation), you will see the comment "attached" and you will receive a copy of the corresponding robust study summary (as attachment to the inquiry annotation);
- if such data is not available, you will see the comment "not available";
- Availability of data submitted LESS THAN 12 years previously
- if the data requested were submitted less than 12 years previously, the name of the company that submitted the data for the given endpoint will be displayed. You can find their contact details in the Co-Registrant Page;
- if such data is not available, you will see the comment "not available".
Note that the analysis performed by ECHA of the availability of data is based on the existing registration dossier(s) which passed the check of completeness of the technical dossier.
There are various ways to search for the lead registrant:
- The Co-Registrants Page in REACH-IT, where you can see everyone who has already registered or inquired about your substance.
- The list of the lead registrants published on the ECHA webpage: https://echa.europa.eu/registration-statistics-infograph. You can click on the link ‘Find your lead registrant’ below the infograph.
- In REACH-IT, by searching for the joint submission. Q&A 1220 explains how to do this.
- More information is available at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/ids/1226-1223-1227-1222
- You can also find further tips under the following link: http://echa.europa.eu/support/registration/finding-your-co-registrants/preparing-to-join-an-existing-sief.
It is the common responsibility of the potential and the existing registrant(s) to negotiate and agree on the content of the joint registration dossier, submitted by a lead registrant. In the case of information submitted less than 12 years prior to the inquiry, REACH (as per Article 27(2) and (3)) requires both the potential and previous registrants to make every effort to agree on the sharing of the information and its costs in a fair, transparent and non-discriminatory way. You can find practical advice on data sharing negotiations at: http://echa.europa.eu/support/registration/working-together/practical-advice-for-data-sharing-negotiations
In case you fail to reach such an agreement you may, as a last resort, contact ECHA in accordance with Article 27(5) or Article 30(3) of the REACH Regulation. For more details, please find more information at: http://echa.europa.eu/support/registration/working-together/data-sharing-disputes/data-sharing-disputes-in-practice
No. REACH requires that new testing of a substance involving vertebrate animals can only be carried out as a last resort. Therefore, you need to wait until you have received the communication from ECHA, which states your inquiry number together with the list of the requested (robust) study summaries available to ECHA. This will then allow you to determine which further studies may need to be conducted.
For chemicals manufactured or imported in a quantity of 100 tonnes or more, you are not allowed to conduct any vertebrate testing for the information requirements specified in Annexes IX and X of the REACH Regulation. Instead, you must submit a testing proposal in your registration dossier. We will then evaluate whether the testing proposal is adequate before such a test is performed.
This communication is for your information only (as per Article 26(3)), so you do not need to take any action. However, in case your information was submitted 12 years prior to the inquiry, and if a potential registrant requests this information from you, REACH requires that you respond in order to enter into negotiation to reach an agreement on the sharing of this information and their associated costs (as per Article 27(2), (3) and (4)). You are required to make every effort to reach a fair, transparent and non-discriminatory agreement on sharing the data and its cost. You may also consider preparing for the potential request for data sharing by ensuring that you comply with the criteria outlined in the Implementing Regulation on joint submission and data sharing. For more information, see the new draft Guidance on data sharing, Chapter "5. Cost sharing".
The co-registrants page helps registrants fulfil their data sharing and joint submission obligation. It is accessible to existing registrants and potential registrants who have successfully inquired. It displays their contact details and, in case of inquirers who requested endpoints data, the list of requested information. Also the role of the registrants within the joint submission is visible for all, so the lead can be easily identified and directly contacted for the purpose of data sharing.
Registrants can see different information depending on their status:
- Potential registrants, during the 12 months after successfully submitting their inquiry, can see all registrants. However only the leads are identified.
- Potential registrants, beyond the 12 months of their successful submission and if they have not registered, can only see new potential registrant(s) or registrant(s) that have inquired. They can no longer see the existing registrants that did not inquire.
- Registrants can see the roles of all co-registrants, i.e. whether they are lead or member and can see the potential registrants.
In case the substance subject to the inquiry process has been pre-registered, inquirers will also be informed about the pre-SIEF members.
Multiple registrants of the same substance share two main obligations under the REACH regulation: data sharing and joint submission obligations. Registrants can identify who else has registered their substance and therefore shares common obligations under REACH.
It is the common responsibility of all (potential) registrants, yourself included, to form a single joint submission. ECHA strongly recommends that all registrants use this new page as a tool to ensure compliance with these obligations. For example, no role is displayed next to a registrant that has submitted a registration dossier outside of an existing joint submission. They are required to contact the lead registrant, as they share the same responsibility as the other multiple registrants. Registrants of the same substance are obligated to make every effort and to ensure that they are part of the same joint registration dossier. Existing registrants outside the joint submission are required to negotiate access to the joint submission with their co-registrants – regardless whether they need to share data or not.
For further information see Guidance Chapter "6 Registration: Joint Submission" Please also note the partial exceptions applicable for intermediate registrants.
The contact details of the companies which did not claim a registration number for a substance notified under the previous legislation are not available in REACH-IT and therefore cannot be displayed. Following an inquiry, we send registered mails to those companies that did not claim their registration number to inform them that there is an inquirer for a substance they have notified.
Yes. You can appoint or change your Third Party Representative (TPR) by updating your registration dossier.
Before submitting the registration for a non-phase-in substance, you will need to submit an inquiry (Article 26 of the REACH Regulation). Upon the successful processing of your inquiry, ECHA will provide you with a list number which you will be requested to use when submitting your registration.
Please note that you will also need to submit an inquiry for an EINECS-listed substance which you did not pre-register.
För varje ämne du har förhandsregistrerat läggs en sida upp för ett förhands-SIEF i Reach-IT. På sidan för förhands-SIEF hittar du kontaktuppgifter till de andra företag som har förhandsregistrerat ett ämne med samma identitetsbeteckning (t.ex. EG-nummer).
Ni måste kontakta varandra för att ta reda på vem som ska bli den ledande registranten för ämnet och om det rör sig om samma ämne.
Inom ett SIEF delar du med dig av din information om ämnet till medregistranterna, delar på kostnader och förbereder det gemensamma registreringsunderlaget.
Syftet med ett SIEF är att undvika dubbeltester av ämnen och att enas om klassificering och märkning. I ett SIEF måste företagen gemensamt utnyttja resultaten av djurförsök för att hålla nere sådana försök till ett absolut minimum. De kan också gemensamt utnyttja annan information som är relevant för Reach. Det ger möjlighet att på ett kostnadseffektivt sätt producera och inhämta registreringsinformation som krävs enligt Reachförordningen.
Enligt artikel 28 i Reachförordningen kan en förhandsregistrant utnyttja de förlängda tidsfristerna för registrering som anges i artikel 23. Förhandsregistrering medför ingen skyldighet att upprätthålla tillverkning eller import av ett ämne. Du bör dock tänka på att andra SIEF-deltagare kan be dig om sådan information som krävs för registrering och att du, om du har den informationen, är skyldig att lämna den.
Nej, det är det inte. Varken inlämningsnummer eller förhandsregistreringsnummer är ett bevis på att ditt ämne har infasningsstatus.
För att avgöra om ämnet är ett infasningsämne eller ett icke-infasningsämne hänvisar vi till avsnitt 1.7.1 i Vägledning om registrering på http://echa.europa.eu/support/guidance.
Vid förhandsregistrering av ett infasningsämne utan EG‑nummer behöver inte den potentiella registranten inge skriftligt bevis på att ämnet har infasningsstatus i den mening som avses i artikel 3.20 i Reachförordningen (se artikel 28.1 i Reachförordningen).
Förhandsregistranterna måste dock vid förhandsregistreringen bekräfta att de är villiga att begära infasningsstatus för sitt ämne. Tillverkare/importörer måste när som helst kunna ge denna information till medlemsstaternas tillsynsmyndigheter.
Förhandsregistreringsnumret är en bekräftelse på att Echa har tagit emot förhandsregistreringen. Det är upp till förhandsregistranterna själva att avgöra hur de använder informationen.
Användningen av förhandsregistreringsnumret styrs i regel inte av Reachförordningen. Eftersom medlemsstaterna är ansvariga för att genomföra Reach kan enskilda medlemsstater ha nationella krav på hur och när förhandsregistreringsnumret ska anges.
Registreringsnumret måste dock (när det väl har tilldelats) anges på säkerhetsdatabladet, enligt föreskrifterna i punkt 1.1 i bilaga II till Reachförordningen. Mer information om registreringsnummer finns i avsnitt 7.4 i Vägledning om registrering, som finns på Echas webbplats: http://echa.europa.eu/support/guidance
Echa offentliggör förteckningen över förhandsregistrerade ämnen på https://echa.europa.eu/information-on-chemicals/pre-registered-substances.
Den offentliggjorda informationen kommer att omfatta
- ämnets Einecs-nummer och CAS‑nummer (om detta finns) och andra identitetskoder,
- den planerade första tidsfristen för registrering,
- namn på och andra identitetsbeteckningar för besläktade ämnen som förhandsregistranter har, dvs. sådana som den tillgängliga informationen kan vara relevant för när det gäller att anpassa testkrav med användning av interpolering, (kvantitativa) struktur-aktivitetssamband och/eller gruppering av ämnen.
I Echas publicerade förteckning visas inte förhandsregistranternas identitet. För att ta reda på om ett ämne har förhandsregistrerats i en viss distributionskedja bör nedströmsanvändare fråga sina leverantörer eller andra aktörer högre upp i den egna distributionskedjan.
Denna information är också synlig i Reach-IT för dem som har förhandsregistrerat samma ämne och för dem som har förhandsregistrerat besläktade ämnen för interpolering.
Nej, det går inte att överföra förhandsregistreringar från importörer till en enda representant.
Mer information om den allmänna principen om ändring av juridisk enhet finns i kapitel 126.96.36.199 i Vägledning om registrering på https://echa.europa.eu/guidance-documents
Ämnen som uppfyller minst ett av följande kriterier kan betraktas som infasningsämnen i enlighet med artikel 3.20 i Reach-förordningen:
- Ämnen som finns angivna i Einecs (European Inventory of Existing Commercial Chemical Substances).
- Ämnen som är tillverkade inom EU (inklusive de länder som var anslutningsländer den 1 januari 2007) men som inte har släppts på EU-marknaden efter den 1 juni 1992.
- Ämnen som betecknas som så kallade före detta polymerer.
Detaljerad information finns i avsnitt 188.8.131.52 om infasningsämnen i Vägledning omregistrering på http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation.
I artikel 23 i Reach-förordningen finns ett schema över olika tidsfrister för registrering för så kallade infasningsämnen, beroende på ämnets mängdintervall och hur farligt ämnet är.
De olika tidsfristerna för att inge ett registreringsunderlag till Echa är följande:
- Den 30 november 2010 för CMR-ämnen (klassificeras som cancerframkallande, mutagena eller reproduktionstoxiska, kategorierna 1 och 2, i enlighet med direktiv 67/548/EEG). ≥ 1 ton/år, R50–53 (klassificeras som mycket giftigt för vattenlevande organismer, kan orsaka skadliga långtidseffekter i vattenmiljön (R50–53) i enlighet med direktiv 67/548/EEG). ≥ 100 ton/år och andra ämnen ≥ 1 000 ton/år, eller
- den 31 maj 2013 för andra ämnen ≥ 100 ton/år, eller
- den 31 maj 2018 för andra ämnen ≥ 1 ton/år.
Den relevanta tidsfristen för registrering fastställs med hjälp av faktisk tillverkningsmängd och/eller importmängd, beräknad vikt och hur farligt ämnet är. Den tilltänkta årsmängden måste beräknas per kalenderår.
Detaljerad vägledning och praktiska exempel ges i Vägledning om registrering (avsnitt 1.6.2 – Beräkning av den volym som ska registreras, och artikel 3.30 i Reachförordningen): http://echa.europa.eu/support/guidance
Varje (sent) förhandsregistrerat infasningsämne tilldelas ett referensnummer för (sen) förhandsregistrering. Detta nummer är unikt för varje företag och för varje förhandsregistrerat ämne.
Numret för (sen) förhandsregistrering har följande struktur:
05 - 1234567890 - 49 - 0000
17 - 1234567890 - 49 - 0000
- 05 är förhandsregistrering (gjord före 1.12.2008),
- 17 är sen förhandsregistrering (gjord mellan 1.12.2008 och 31.5.2017),
- 1234567890 är ett slumpvis tilldelat unikt 10-siffrigt nummer,
- 49 är en beräknad kontrollsiffra (2-siffrigt variabelt nummer),
- 0000 är indexnumret.
Numret för (sen) förhandsregistrering har samma format som andra referensnummer som tilldelas automatiskt genom Reach-IT.
Nej, det finns ingen funktion i Reach‑IT som innehåller och tillhandahåller sådan information, eftersom den skulle kunna betraktas som konfidentiell affärsinformation. Nedströmsanvändare rekommenderas att ingå överenskommelser med sina leverantörer för att se till att de uppfyller Reach och har en giltig förhandsregistrering.
Om du är osäker och vill ha en bekräftelse ber vi dig kontakta din lokala tillsynsmyndighet för mer information.
En nedströmsanvändare som inte tillverkar eller importerar ämnen behöver enligt Reachförordningen inte förhandsregistrera ett infasningsämne. Men nedströmsanvändare av ett ämne som inte ingår i den förteckning över förhandsregistrerade ämnen som Echa offentliggjort kan anmäla sitt intresse av ämnet till Echa och lämna sina kontaktuppgifter och uppgifter om sin leverantör. Echa kan då skicka nedströmsanvändarens kontaktuppgifter till en potentiell registrant.
På Echas webbplats finns offentlig information och dokument från Reachprocesser, som t.ex. förteckningen över förhandsregistrerade ämnen eller nedströmsanvändares anmälningar allteftersom de blir tillgängliga: https://echa.europa.eu/information-on-chemicals.
Mer information om nedströmsanvändares skyldigheter finns på 22 EU‑språk i Vägledning för nedströmsanvändare. Du byter språk högst upp till höger på https://echa.europa.eu/guidance-documents.
En förhandsregistrering kan justeras med undantag för det ämnes-ID och den UUID som har tilldelats förhandsregistreringen. Du kan manuellt ändra kontaktinformationen (både intern och till en tredje part som är representant), liknande ämnen, mängd/tidsfrist och informationen i kommentarsfältet för förhands-SIEF.
Hur du raderar, avaktiverar eller ändrar en förhandsregistrering förklaras närmare i Q&A 346.
Ja, det kan de, och de uppmuntras att göra det om de har tillgång till viktiga uppgifter som är värdefulla för registranterna när de sammanställer sina registreringsunderlag. I praktiken måste nedströmsanvändare tillhandahålla viss information (ämnesidentifiering, kontaktuppgifter) till Echa för att godkännas som datainnehavare för ett ämne, varefter Echa sätter dem i kontakt med de potentiella registranterna.
Datainnehavare har rätt till ersättning för data som används vid registrering. Mer detaljerad information finns i avsnitt 184.108.40.206 i Vägledning om gemensamt utnyttjande av data. https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_sv.pdf
Ett förhands-SIEF kanske har många deltagare, men det kan vara så att de flesta är osäkra på om de ska registrera sig, eller har bestämt sig för att inte göra det. Statusen ”Inactive” (inaktiv) i ett förhands-SIEF indikerar att företaget inte kommer att registrera sig, men det är inte alla företag som använder sig av statusen.
Om företagen inte svarar på dina mejl kan du försöka kontakta dem på annat sätt, om det skulle vara så att deras mejladress är inaktuell. Detta tillvägagångssätt bör du bara tillämpa på företag du känner till och som du tror kan komma att registrera sig.
Du kan också regelbundet ladda ner pdf‑filen med förhandsregistranter för att se om kontaktuppgifterna har ändrats. Tänk på att meddelanden kan filtreras bort som skräppost.
Om du inte får svar vid ytterligare kontaktförsök ber vi dig dokumentera dessa försök och förbereda dig för att registrera ditt ämne på egen hand. Meddela de andra i forumet via mejl om utvecklingen. Överväg att bli kontaktperson för skapande av forum (SFF), så att du kan ange i forumet hur andra kan kontakta dig.
Om ditt ämne är komplext bör du tänka på att andra tillverkare/importörer av ämnet kan ha använt andra identitetsbeteckningar för ämnet och finns i ett annat förhands-SIEF. Leta i förteckningen över förhandsregistrerade ämnen efter förhands-SIEF som du eventuellt skulle kunna slå dig ihop med.
För att slå ihop flera forum måste du göra följande:
- Kontakta det andra forumet.
- Bestäm vilken förhandsregistrant som ska vara ledande registrant för det gemensamma inlämnandet.
- Den ledande registranten bör skapa ett gemensamt inlämnande i Reach-IT för ämnet.
- Den ledande registranten får bara använda förhandsregistreringsnumret för att skapa det gemensamma inlämnandet om den information som registranten har angett i förhandsregistreringen identifierar det ämne som ska registreras på ett specifikt och korrekt sätt.
- Varje deltagare i det gemensamma inlämnandet bör använda samma kemiska identitetsbeteckningar som den ledande registranten har använt för att skapa det gemensamma inlämnandet i Reach-IT.
- Deltagarna i ett gemensamt inlämnande ska, på samma sätt som andra registranter, var för sig ge information om det egna ämnets identitet och sammansättningar. Denna information bör motsvara deras ämne så som det tillverkas. Deltagarna i ett gemensamt inlämnande bör således inte ange generiska sammansättningar eller kopior av sammansättningar som andra registranter har angett.
För att dela upp ett förhands-SIEF måste du göra följande för varje ämne som omfattas av forumet:
- Bestäm vilken av förhandsregistranterna med samma ämne som ska vara den ledande registranten för det gemensamma inlämnandet.
- Den ledande registranten bör skapa ett gemensamt inlämnande i Reach-IT för detta ämne.
- Den ledande registranten bör så långt möjligt se till att det kan göras skillnad mellan identiteten för det ämne som har angetts i det gemensamma inlämnandet och andra ämnen som också omfattas av förhands-SIEF. Den ledande registranten kan i detta syfte behöva ange ämnets korrekta och specifika identitet manuellt i stället för att använda förhandsregistreringsnumret.
- Varje deltagare i det gemensamma inlämnandet bör använda samma kemiska identitetsbeteckningar som den ledande registranten har använt för att skapa det gemensamma inlämnandet i Reach-IT.
- Deltagarna i ett gemensamt inlämnande ska, på samma sätt som andra registranter, var för sig ge information om det egna ämnets identitet och sammansättningar. Denna information bör motsvara deras ämne så som det tillverkas. Deltagarna i ett gemensamt inlämnande bör således inte ange generiska sammansättningar eller kopior av sammansättningar som andra registranter har angett.
No. The deadline to benefit from the specific provisions for phase-in substances was 31 May 2017.
If you are a first-time manufacturer or importer of a substance, you will need to submit an inquiry to ECHA. You can find further information on the inquiry process under Q&A 444.
An overview of what must and what may be jointly submitted for registration based on Article 11 of the REACH Regulation is provided in Section 6.2- 'Overview of the part of the technical dossier that may be jointly submitted for Registration' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Some information of the registration has to be submitted jointly whereas other information needs to be submitted separately. Additionally, there is information the registrant(s) may decide themselves whether to submit jointly or separately, according to the criteria defined in Article 11(3) of REACH.
The following information must be submitted jointly: information on the classification and labelling of the substance, (robust) study summaries and an indication as to which of the submitted information on classification and labelling, study summaries and robust study summaries has been reviewed by an assessor. Under specific conditions, which should be explained in the dossier, a separate submission of these data is allowed (see also Q&A 109).
Additionally, each registrant must submit individually: the identity of the manufacturer or importer, the identity of the substance, information on the manufacture and use(s), exposure information for substances in quantities of 1 to 10 tonnes and an indication of which of the submitted information on manufacture and use has been reviewed by an assessor. The registrants may decide to submit the following information jointly or separately: guidance on safe use of the substance, a Chemical Safety Report (CSR) when required and an indication which of the information submitted for the CSR has been reviewed by an assessor.
Member registrants can submit the following information separately, as specified in Article 10(a) (iv), (vi), (vii) or (ix) of REACH:
- The classification and labelling;
- Study summaries of the information derived from the application of Annexes VII to XI;
- Robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I; and
- Proposal for testing where listed in Annexes IX to X.
Article 11(3) of REACH allows an "opt-out" under specific conditions. Such an "opt out" can only cover some or all of the endpoints submitted by the lead registrant on behalf of all member registrants. However, the member registrants have to remain part of the joint submission regardless of whether information is shared.
According to Article 29(2) of the REACH Regulation, one of the main aims of the SIEF is to agree on classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.
Nevertheless if all member registrants agree, the lead registrant may include different classifications of the substance in the joint part of the registration dossier, e.g. if different impurity profiles lead to different classifications.
In this case, member registrants should leave the pertinent section of their member dossier empty to avoid being treated as an opt-out for the classification and labelling of the substance.
If the member registrants cannot agree on the inclusion of all the different classifications of the substance in the joint part of the registration dossier, one or more of the member registrants may decide to provide their substance classification separately (by filling in the respective section in their member dossier). If this is the case, a justification in accordance with Article 11(3) of REACH is required. In addition, in cases where a harmonised C&L for a substance is provided in Annex VI to the CLP Regulation, then that harmonised C&L must be used.
Further information can be found in the manual ‘How to prepare registration and PPORD dossiers’ at: https://echa.europa.eu/manuals
Yes. According to Annex VI to the REACH Regulation any physicochemical, toxicological and ecotoxicological information that is available and relevant must be provided in the registration dossier.
In practice, after gathering and assessing all existing information, the registrant has to select the information that is reliable, relevant and adequate.
For key studies, robust study summaries have to be provided; for supporting studies, study summaries are sufficient.
Further guidance on information gathering and evaluation is also provided in chapters R.3 and R.4 of the Guidance on information requirements and chemical safety assessment available at: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
According to Article 11(1) of the REACH Regulation, the information specified in Article 10(a)(ii), i.e. details on the substance identity including spectral data and chromatograms, have to be submitted separately by each member registrant of a joint submission.
This information is necessary for ECHA to be able to check the sameness of the substance submitted by the different member registrants. Therefore, generic spectral data or chromatograms must not be used. Each member registrant of a joint submission has to provide the specific spectral data and chromatograms for the substance they intend to register.
The REACH Regulation does not prevent the change of a lead registrant.
It is up to SIEF participants to agree on who is the lead registrant, who acts with the assent of the other registrants for the same substance. The SIEF/co-registrants can agree to transfer the lead role to another registrant at any point.
Information on how to transfer the lead role in REACH-IT can be found in Q&A 0380.
Yes, it is possible. It is the common responsibility of multiple registrants/notifiers of the same substance to submit only one joint registration dossier.
A NONS notifier who successfully claims a registration number for a notification under the Dangerous Substances Directive (67/548/EEC) can propose to the existing (potential) registrants that they themselves (i.e. the notifier) become the lead registrant of the joint dossier.
If there was not yet another lead registrant and the notifier’s role has been accepted, they must, firstly, update their registration dossier to fulfil the data requirements for registrations under REACH and, secondly, create a joint submission.
In parallel, the lead registrant needs to communicate with other (potential) registrants both on the choice of data (and the related costs) and on the token (to confirm joint submission membership). Similarly, existing registrants must update their dossiers, after they confirm their membership, as a member dossier of the joint submission.
For more information, see the Guidance on Data Sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
You should appoint a new lead registrant together with the other registrants of the substance as soon as possible. Of course, you can offer to become the lead registrant.
A lead registrant is a legal requirement under Article 11 REACH. Moreover, there are important practical reasons why you should have a lead registrant. As such, you have an own interest in ensuring that there is a lead registrant to your registration.
For example, a lead registrant is needed to give potential registrants access to the joint submission and to confirm that they may refer to the information in the lead dossier. A lead registrant is also a natural first contact point for data sharing negotiations, and thus facilitates all registrants’ compliance with their data sharing obligations. In addition, a lead registrant is needed to update the information that was jointly submitted for a substance. Without a lead registrant, each registrant must update its registration individually with new information about the substance.
After the lead registrant has disappeared, the remaining registrants need to discuss among each other to appoint a new lead registrant as soon as possible. Once you have agreed on a new lead registrant, you should contact ECHA via the contact form, and request the transfer of the lead registrant role.
If you know that your lead registrant for a substance will disappear, you and the other registrants are encouraged to appoint a new lead registrant before the disappearance. Like that you ensure that there is no time without a lead registrant. This is easier to do in practice, because the old lead registrant can hand over the lead registrant role with an electronic “handshake”. Q&A 0380 explains what to do step-by-step.
In case there is a disagreement regarding a specific endpoint, potential registrant may opt-out of information according to Article 11(3) (or 19(2) in case of intermediates) if:
- it is disproportionately costly to submit this information jointly; or
- it would lead to the disclosure of information which he considers to be commercially sensitive and may cause substantial detriment; or
- there is disagreement on the selection of this information.
In such cases, you can partially or fully opt-out of the joint submission and include all endpoints you want to opt out of to your member dossier. An opt-out (partial or full) does not allow submitting a registration dossier outside the framework of the joint submission. Even if you fully opt-out, you may still be requested to participate in the cost sharing of the relevant administrative fees associated with the management of the joint submission.
In case of an opt-out, you are required to:
- remain part of the joint submission
- submit your own information to cover the data requirement
- submit a clear and reasoned justification for opting out
- include opt-out information in section 14 of IUCLID 6 dossier
REACH registration dossier of a member registrant
- Sections 2, 4, 5, 6, 7 and 8 of the member dossier should be left empty if the member registrant relies on the information provided in the lead dossier.
- If a member registrant submits a dossier with any of these sections filled in, the submission is regarded as an opt-out (see picture below).
Please note, when a member only opts out of IUCLID section 2 (Classification and Labelling), the opt out status in the joint submission page will be marked as ‘no’. The opt out status is only marked as ‘yes’, when the member opts out of data requirements other than Classification and Labelling.
A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’. If fully opting-out you need to answer all four points of template ‘a’. If partially opting-out you need to answer the first three points only.
Information expected in the justification:
- Cost of accessing the jointly submitted data. You should have received this information from the lead registrant. If you have not been able to obtain this information from the lead registrant you should explain the actions you took to try and obtain this information and the lead registrant’s response.
- Cost to you of completing and submitting your opt-out dossier. Bear in mind your own possible internal costs related to preparing the dossier. You should not provide a figure of zero for this answer.
- Explain why submitting this data jointly would be disproportionately costly. Question 3 of template ‘a’ includes a list of elements that can be relevant to this explanation.
- If you are fully opting-out explain why the justification you gave in question 3 covers all the data. You should therefore explain why a partial opt-out was not feasible.
A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’. If fully opting-out you need to answer all three points of template 'b'. If partially opting-out you need to answer the first two points only.
Information expected in the justification:
- You need to specify precisely which information is commercially sensitive.
- You need to explain why you believe submitting this information jointly would cause substantial commercial detriment. You explanation should show your reasoning for believing substantial commercial detriment would be caused.
- If you are fully opting-out you will need to explain why you couldn’t partially opt-out instead. Your explanation should therefore address why you couldn’t opt-out of only the commercially sensitive data.
A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided in the 'Justification' field of the record 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field (click the icon A). The template questions are also available in Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’. If fully opting-out you need to answer all three points of template 'c'. If partially opting-out you need to answer the first two points only.
Information expected in the justification:
- You need to explain why you disagree on the data selected. Question 1 of template ‘c’ includes a list of elements that can be relevant to this explanation.
- You need to describe what actions you had taken to try and add your data to the lead dossier and why it had not been possible to reach an agreement to add this data.
- If you are fully opting-out you should explain why you could not partially opt-out of only the data you disagree with. Why was it necessary to perform a full opt-out?
The opt-out justification requirement also applies when opting-out only for classification and labelling (C&L) information. A justification to explain why the information can be submitted separately in accordance with Article 11(3) or 19(2) of the REACH Regulation must be provided. This justification must be included in the 'Justification' field of the endpoint 'Opt-out information for REACH registration' in IUCLID section 14 'Information requirements'. To help you provide a valid justification there are templates available in the 'Justification' field. These templates cover opting-out because of 'a': cost, 'b': commercially sensitive information and 'c': data. The template questions are also available in Annex 7 of the manual ‘How to prepare registration and PPORD dossiers’ which is available at: http://echa.europa.eu/manuals.
If you are fully opting-out, you will need to answer all the points of one template. If you are partially opting-out you do not need to answer the last point of the template but should still answer the other points.
Before opting-out for C&L information, you should bear in mind that this information can be jointly submitted in the lead registration dossier even if it differs from the C&L of the other registrants in the joint submission. In this case, the lead registration dossier should have a separate C&L record in section 2.1 with a link to a relevant ‘boundary composition of the substance’ in section 1.2. If you decide to opt-out for the C&L information, you should therefore explain in your justification why an agreement to include the information in the lead registration dossier could not be reached. For further information on how to report the boundary composition you can consult the Questions & Answers - substance identity profile.
Guidance on preparing an opt-out dossier can be found in sections 9.9.2 and 10.2 of the manual ‘How to prepare registration and PPORD dossiers’.
Only the section 2.1 and 4-7 endpoint study record documents that you link to the section 14 endpoint ‘Opt-out information for REACH registration’ will be included in the dossier. Ensure that you have linked all the study record documents that you planned to include in the dossier to this section 14 endpoint before you finalise the dossier creation.
If you have different justifications for the data that you opt-out with, group the linked documents per blocks so that the justification you provide is relevant for the documents in the same block.
Endpoint summaries are not considered as opt-out information but are still required if you are opting-out with endpoint information or are providing your own Chemical Safety Report.
When opting-out, some of the sections that are mandatory for a complete dossier are not automatically pre-selected for inclusion in the IUCLID dossier when you use the joint submission member template. Therefore, when creating your dossier endpoint summary records including section 6 ‘Ecotoxicological information’ and section 7 ‘Toxicological information’ must be selected manually. Guidance on how to include the endpoint summaries in the opt-out dossier can be found in section 10.2 of the manual ‘How to prepare registration and PPORD dossiers’.
Registrants cannot challenge the inclusion of a substance into the CoRAP (Community Rolling Action Plan).
However, registrant(s) may provide input into the evaluation process. Registrant(s) of a substance in the CoRAP, particularly those substances on the current year of the CoRAP are encouraged to contact the evaluating Member State Competent Authority (eMSCA) early on in the evaluation process. The contact details for the eMSCA are published in the CoRAP. If the dialogue has not already started, the eMSCA will usually contact the lead registrant when the evaluation starts and offer the opportunity to meet to discuss technical issues related to substance evaluation. The registrants should consider nominating a representative for interacting with the eMSCA. The interaction between registrant(s) and the eMSCA at this phase of the evaluation is informal.
When the outcome of a substance evaluation is that an information request to clarify the suspected concern is deemed necessary (i.e. the evaluating MSCA prepares a draft decision on substance evaluation), the registrant(s) will get the opportunity to formally comment within 30 calendar days on any draft decision as part of the decision making process (Articles 50-52 of the REACH Regulation). The evaluating MSCA shall take the comments of the registrant(s) into account and decide whether the draft decision needs to be amended on the basis of the comments/additional information provided by the registrant(s) (Article 50(1) of REACH).
ECHA communicates to the registrant(s) the draft decision as notified to the other MSCAs and ECHA and the received proposals for amendment. At this stage, the registrant(s) will have the opportunity to comment on the proposals for amendment (Article 51(5) of REACH). Registrants are reminded of their obligation to always keep their registration dossier up to date, cf article 22(1).
Substance Evaluation is an integral part of the REACH implementation. It aims to clarify whether a substance, which has been identified as being of potential concern, poses an actual risk to human health and/or the environment. To clarify the risks, the registrants may be asked for more information on the substance. Substance evaluation shall be carried out by the Member States, whilst ECHA coordinates the procedure. The substances to be evaluated annually are listed in the CoRAP (Community Rolling Action Plan).
Member States may volunteer to evaluate a substance. Two Member States may also decide to make a joint evaluation. However, in all cases only one Member State will be designated as the responsible Member State for the evaluation. Final allocation of the substances to the Member States is decided with the adoption of the CoRAP by ECHA, based on the opinion of the Member State Committee (MSC) on the draft CoRAP. Thus, the CoRAP will include for each substance on the list the Member State responsible for the evaluation. The contact information of the responsible competent authority will also be reported for the substances to be evaluated in the first year, to inform the stakeholders about the body handling each substance.
In case of joint evaluations by two Member States, the co-evaluating Member State is also indicated in the CoRAP.
From the publication of the CoRAP, the respective Member States have one year to evaluate substances listed for the first year (n) and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. The evaluation of the substances listed for the second and third year starts only after the publication of the CoRAP update in year n+1 and year n+2 respectively.
Dossier evaluation comprises the examination of testing proposals and compliance check of registration dossiers. Testing proposals are triggered by the REACH information requirements and all testing proposals submitted by the registrants must be examined by ECHA. The aim of this examination is to decide on the most appropriate testing in order to fulfil the REACH information requirements. ECHA can perform a compliance check on any registration dossier to verify whether the REACH information requirements are met. Dossiers can be chosen for compliance check based on random selection or prioritised based on a specific concern.
The substance evaluation process is triggered as a result of risk-based concerns and aims to clarify whether a substance poses a risk for human health or the environment. Substance evaluation is targeted at substances (including aggregated tonnages, all uses, etc.). Under substance evaluation any information (beyond the REACH requirements) can be requested provided that it is considered necessary for the purposes of risk assessment of the substance.
Substance evaluation is carried out by the Member States, while ECHA is responsible for dossier evaluation.
The decision making process is essentially the same for both processes.
Substance Evaluation may identify risks that could otherwise be missed. This process can further create additional value in respect of:
- Concerns that go beyond the control of the individual registrant, like regional risks or the potential additional risk caused by aggregated exposures of a (sub)population or releases into the environment.
- The assessment of groups of similar substances to predict cumulative effects and potentially increased risk levels from exposures to the different substances in the group.
- If considered scientifically necessary and proportionate, the request for additional information can go beyond the standard information requirements in REACH.
The REACH Regulation Article 44(1) provides the general criteria for substances to be selected for substance evaluation. The legal text defines that prioritisation shall be on a risk-based approach. According to Article 44(1): "(...) the criteria shall consider:
hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;
exposure information; tonnage, including aggregated tonnage from the registrations submitted by several registrants".
The criteria have been refined by ECHA in cooperation with the Member States and are published on ECHA's website: Selection criteria to prioritise substances for Substance Evaluation (2011 CoRAP selection criteria) http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf.
These criteria are applied in the initial step of the identification of substances with potential concerns. A further screening and selection process takes into consideration whether the substances are already subject to regulatory measures and the effectiveness of the substance evaluation to clarify the concern by requesting further information on the substance. Thus, meeting the risk-based criteria alone does not automatically mean an inclusion of the substance in the CoRAP.
According to Article 45(5) of the REACH Regulation, a Member State may notify ECHA of a substance, whenever it is in possession of information suggesting that the substance is a priority for evaluation. Thus, the CoRAP may also contain substances that have been included based on notifications from Member States.
Both hazard and exposure information (or a lack of it) is taken into consideration upon prioritising the substances. In the first CoRAP with many substances, the initial concerns are generally related to potential PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive or consumer use(s) and/or high tonnages. In general, the uses of these substances cover various areas and do not focus on any particular industrial, professional or consumer uses.
The final published CoRAP also contains a general indication of the reasons why the substance was prioritised and selected for substance evaluation (grounds for concern). Before inclusion in the CoRAP, the substances have not been evaluated and thus the indicated grounds for concern are just an indication of the possible areas of risk, based on the selection criteria. The initial grounds for concern should not be taken as a statement on a known risk or as a statement on what the evaluation will cover. During the evaluation, other areas of concern may be identified and investigated further. Only after the substance evaluation is completed, risks can be defined and communicated. The Member States have agreed that from the first update of the CoRAP in 2013, more detailed justification documents regarding selection of each substance will be prepared and published.
The listing of a substance on the CoRAP does not in itself have any legal impact on the registrant and thus does not require any further action by the registrants. When the CoRAP is adopted/updated, the registrants of substances listed for the first year of the CoRAP may expect to receive a draft decision requesting further information after the evaluation period of 12 months. At that point of time, the registrants will be given an opportunity to comment before any final decision to request further information is taken. The final decision will contain a deadline by which the additional information must be submitted.
On the other hand, if the evaluating Member State comes to the conclusion that no further information is necessary to clarify the risk, the substance evaluation process is concluded without a decision to request further information.
Inclusion of a substance in the CoRAP does not automatically mean that the substance poses a risk to human health or the environment, but rather that there is a concern that it may pose a risk, which needs to be clarified (confirmed or dismissed). It also does not automatically trigger, for example, the restriction or authorisation process. However, the Member State responsible for the evaluation of a substance may consider these options once the evaluation is finished, if the risk is confirmed.
The REACH Regulation does not foresee any formal interaction during the 12 month evaluation process i.e. before the possible draft decision is prepared. Once the draft decision is issued, the registrants will be contacted via REACH-IT. During the decision making procedure registrants will be consulted on any prepared draft decision and proposals made to amend this draft decision. The registrants may submit comments that will be taken into account in the decision making of the evaluating Member State and by the Member State Committee, if the draft decision is referred to the Committee.
The possibility for registrants/stakeholders to interact with the evaluating Member State during the evaluation phase may differ between Member States and substances that are evaluated. However, interaction between the registrants / stakeholders and the evaluating Member State is appreciated in general under substance evaluation. Thus, all relevant information available to the registrants of the substances should be included in the registration dossiers by the start of evaluation (i.e. March each year).
If the evaluating Member State considers that further information is necessary to clarify a potential risk caused by the substance, it may draft a decision specifying the additional data requests. The initially identified concern in the CoRAP does not limit the evaluation made by the Member States and thus the potential request can address any property or exposure scenario of the substance. The registrants of that substance will have an opportunity to provide comments on the draft decision. Such a draft decision will be reviewed and agreed by the other Member States and ECHA, and in the case of proposals for amendment also by the Member State Committee. After this procedure, ECHA will take the final decision in line with the agreement in the Member State Committee. If no unanimous agreement is reached by the Member State Committee, the decision will be taken by the European Commission. The decision will contain a deadline by which the registrants must submit the requested information. It may also be that no request for information is needed because the risks can be clarified with the information already available. In such cases, the substance evaluation is considered to be completed.
Once the registrants submit the requested information, the responsible Member State has another 12 months to assess this information and decide whether a further request for information is necessary or whether the evaluation can be concluded. In this latter case, the responsible Member State should consider whether and how to use the information obtained for the purposes of Community level risk management measures. The Member States may conclude:
- EU-wide risk management measures are necessary (e.g. EU wide restriction, EU-wide authorisation, EU-harmonised classification and labelling, occupational exposure limits, measures for the protection of the environment under the Water Framework Directive) or
- Actions at national level should be taken.
The conclusion can also be that the risks are sufficiently under control with the measures already in place. ECHA informs the European Commission, the registrant and the other Member States about the conclusions.
The decisions on data requests and evaluation reports will be made publicly available once finalised. It should be noted that as the production of the information requested may, in some cases, take several years (e.g. in the case of long term studies and annual environmental monitoring) finishing a final evaluation report may also take several years from the adoption of the CoRAP.
From the publication of the CoRAP (March each year), the Member States have 12 months to prepare a draft decision for a substance included for evaluation during the first year, i.e. by end of February of the following year. After that, the decision making process may take approximately four to eight months depending on whether the Member State Committee is involved or not. Thus under favourable conditions, first decisions are likely to be taken between the middle and end of the following year after CoRAP inclusion. The registrants will have the opportunity to comment on the draft decision before the final decision is taken.
The decision will define the deadline by which the registrant(s) must provide the necessary information. Depending on the type of information, the deadline may be between some months and several years.
"Follow up" under substance evaluation means: once the requested information is available and evaluated by the Member State, it will consider whether and how to use the information obtained for the purposes of Community level risk management measures. The follow up can either be no action or recommendation to take further actions, such as to propose EU wide risk management measures.
A follow up conclusion under substance evaluation is not directly initiating further risk management measures. Any proposed Community-wide actions will be subject to a separate decision making process and Member States need to file a notification for this purpose. For authorisation, restriction and/or harmonised classification under the REACH and the CLP Regulations, stakeholders are consulted at all relevant stages of the process and decisions are taken on the basis of the opinions adopted by the ECHA Committees.
Information on the substances is available on the ECHA website. This website contains non-confidential information on the properties and uses of the substances that have been retrieved from the registrations for each substance.
Decisions on requests of further information and substance evaluation reports prepared by the Member States will also be published on the ECHA website, when they are available.
Informationen behövs för att verifiera ditt ämnes sammansättning och kontrollera att de kemiska identitetsbeteckningarna, såsom IUPAC-namn och CAS-nummer, är tillämpliga.
Echa begär minst UV-, IR- och NMR-spektrum (avsnitt 2.3.5 i bilaga VI till Reachförordningen). Du kan också lämna ett masspektrum i stället för ett NMR-spektrum. För vissa ämnen är denna information inte tillräcklig eller lämplig. I så fall måste du lämna andra typer av spektraldata. För oorganiska ämnen är sannolikt röntgendiffraktion (XRD), röntgenfluorescens (XRF) eller atomabsorptionsspektroskopi (AAS) lämpligare tekniker.
Nej. Echa skyddar skyddar sekretessen för analytisk information som lämnas av (potentiella) registranter.
En godtagbar motivering bör bygga på teknisk genomförbarhet eller vetenskaplig nödvändighet, vilket innebär en hållbar vetenskaplig argumentation.
Ja. Summan av de normala koncentrationerna av varje beståndsdel ska bli 100 procent.
När du utarbetar underlaget som ska skickas till Echa rekommenderar vi att du också läser följande dokument:
- Vägledning om identifiering och namngivning av ämnen enligt Reach och CLP: http://echa.europa.eu/documents/10162/13643/substance_id_en.pdf
- Relevanta inlämningshandböcker: http://echa.europa.eu/manuals
- Frågor och svar om ämnesidentifiering http://echa.europa.eu/support/qas-support/qas
- Frågor och svar om förfrågan http://echa.europa.eu/support/qas-support/qas
Ja. För att bekräfta närvaron av jonerna måste du uppge analysdata för identifiering och kvantifiering av varje jon.
Ja. Joniska ämnen i vattenlösning är undantagna från registrering endast om
- alla utgångsämnen (salter, syror och baser) i vattenlösningen är registrerade,
- inga av salterna i vattenlösningen isoleras från lösningen, och
- salterna blir kvar som joner i lösningen.
I detta specifika fall är det tredje villkoret inte uppfyllt eftersom salterna inte är kvar som joner i komplexet. Därför gäller inte undantaget och komplexet omfattas av registreringsplikten. Detta fall diskuteras i bilaga, 1 ”Jonblandningar”, till vägledningen för bilaga V.
Komplex som utgörs av kelaterade joner måste registreras om de själva tillverkas, importeras eller släpps ut på marknaden. Det finns dock olika undantag i bilaga V som kan vara möjliga, till exempel om komplexet bildas genom att en kelatbildare fungerar som avsett (”ämnen som inte själva tillverkas, importeras eller släpps ut på marknaden och som själva är ett resultat av en kemisk reaktion som inträffar när (a) [...] kelatbildare [...] fungerar som avsett').
För registreringsändamål betraktas hydraterna av ett ämne och det vattenfria ämnet som samma ämne. Om det vattenfria ämnet registreras av tillverkaren/importören och det företaget använder det ämnet för att tillverka det hydrerade ämnet betraktas det företaget som nedströmsanvändare. Därför måste respektive registreringsunderlag innehålla nödvändig information för det vattenfria och det hydrerade ämnet där de uppträder i distributionskedjan, dvs. kemikaliesäkerhetsbedömning med exponeringsbedömningar och riskkarakteriseringar av hydrerade ämnen och det vattenfria ämnet. Denna information måste förmedlas längs distributionskedjan i säkerhetsdatablad som ska innehålla alla fakta som krävs, t.ex. exponeringsscenarier och identifierade användningar för såväl det vattenfria som det hydrerade ämnet som uppträder i distributionskedjan. Registreringsnumret för det registrerade vattenfria ämnet måste anges i avsnitt 1 i säkerhetsdatabladet. Bestämmelserna för nedströmsanvändare enligt artiklarna 37 och 38 kan tillämpas både för hydraterna av ett ämne och det vattenfria ämnet.
Registranter ska i sin kemikaliesäkerhetsbedömning ta hänsyn till potentiella följder av specifika former av ämnet för nedströmsanvändare, i synnerhet när formen ändras under nedströmsanvändning.
Konfigurationsisomerer (t.ex. enantiomerer, diastereomerer, regioisomerer) betraktas som olika beståndsdelar. Därför kan ditt ämne endast betraktas som ett monokomponentämne om en viss isomer förekommer i en koncentration på minst 80 procent.
Förutsatt att ditt väldefinierade ämne består av alla möjliga stereoisomera former och att dessa utgör ämnets huvudbeståndsdelar, kan du identifiera ditt ämne i avsnitt 1.1 endast med ämnets IUPAC-namn utan att ange de stereokemiska förhållandena. Du bör dock ändå identifiera ditt ämne som ett multikomponentämne. Information om identitet och koncentration för varje enskild stereoisomer bör anges i avsnitt 1.2 i IUCLID.
När ditt ämne innehåller föroreningar som du inte kan identifiera måste du skapa ett generiskt referensämne för dem i IUCLID. För referensämnet måste du uppge
- ”unknown impurities” (okända föroreningar) i namnfältet i IUPAC, och
- antal och enskilt koncentrationsintervall för varje okänd förorening i anmärkningsfältet.
Dessutom måste normal koncentration och koncentrationsintervall uppges för de okända föroreningarna.
Ett åskådliggörande exempel på hur okända föroreningar rapporteras i IUCLID finns i avsnitt 9.4.2 i handboken Hur man sammanställer registrerings- och PPORD-underlag, som finns på http://echa.europa.eu/manuals
Ja. Du måste rapportera koncentrationsgränser (dvs. både minimi- och maximivärden) för varje beståndsdel. Värdena ska vara representativa för ämnet så som det tillverkas/importeras, och du kan ta dem exempelvis från de certifierade specifikationsgränser som ofta ingår i ett analyscertifikat (CoA). Det är viktigt att koncentrationsintervallen är realistiska och inte täcker olika ämnen.
Reach-IT kommer att ge dig ett listnummer när din registrering passerar kontrollen av verksamhetsreglerna. Du kommer att kunna ladda ned detta automatiskt skapade EG-nummer som en i5z-fil från Reach-IT. Du kommer att uppmanas att ange detta listnummer varje gång du lämnar in en uppdatering av din registrering.
Du ska rapportera det kemiska namnet på ditt UVCB-ämne i fältet ”IUPAC name” (IUPAC-namn) i avsnitt 1.1 i IUCLID. Namngivningskonventionerna för att härleda det kemiska namnet på UVCB-ämnen finns i kapitel 4.3 i Vägledningen om identifiering och namngivning av ämnen enligt Reach och CLP. Ett exempel på ett kemiskt namn på ett UVCB-ämne är ”Reaktionsprodukt av oligomerisering av formaldelhyd och fenol”.
Du ska rapportera det kemiska namnet på ditt multikomponentämne i fältet ”IUPAC name” (IUPAC-namn) i avsnitt 1.1 i IUCLID. Det generiska formatet för det kemiska ämnet är ”Reaction mass of” (reaktionsblandning av) följt av namnet på varje huvudbeståndsdel, åtskilda av ”and” (och). Namnet på huvudbeståndsdelarna ska i princip följa IUPAC-reglerna. Ett exempel på ett kemiskt namn på multikomponentämnen är ”Reaction mass of ethylbenzene and m-xylene and o-xylene” (reaktionsblandning av etylbensen och m-xylen och o-xylen).
Normalt ska du rapportera varje enskild isomer med dess normala, övre och undre koncentrationsnivåer separat i avsnitt 1.2 i IUCLID.
I undantagsfall kan du rapportera isomererna i en post i avsnitt 1.2 av IUCLID. Det tillvägagångssättet kan vara lämpligt när isomererna föreligger i en racemisk blandning eller om antalet isomerer är stort. I så fall ska du göra följande:
- Ange den generella normala, övre och undre koncentrationsnivån för de isomerer som ingår i posten i relevanta fält i avsnitt 1.2 av IUCLID.
- Ange den relativa andelen av isomererna i fältet ”Remarks” (anmärkningar) i det repeterbara blocket för posten. Om den relativa andelen av isomererna varierar ska du rapportera intervallen.
- Ange att enskilda isomerer inte har rapporterats separat i fältet ”Justification for deviations” (motivering till avvikelse).
Nej. "Legal entity composition of the substance" (den juridiska enhetens sammansättning av ämnet) ska endast användas för att rapportera sammansättningarna av det ämne som sådant som du tillverkar eller importerar. Om ditt ämne exempelvis formuleras med ett lösningsmedel vid tillverkningen ska du endast rapportera ämnets sammansättning utan lösningsmedlet som ”Legal entity composition of the substance” (den juridiska enhetens sammansättning av ämnet).
Om ditt ämne endast görs tillgängligt som komponent i en blandning ska den juridiska enhetens sammansättning av ämnet som rapporteras ändå vara för ämnet som sådant.
En blandning är inte samma sak som ett multikomponentämne eller ett UVCB-ämne. Enligt Reach och CLP får man en blandning genom att blanda två eller flera ämnen utan någon kemisk reaktion. Ämnen i en blandning ska registreras separat. Ett multikomponentämne eller ett UVCB-ämne får man normalt från en kemisk reaktion. Ett multikomponentämne eller ett UVCB-ämne ska registreras som ett sådant.
Du ska göra så här.
- Välj referensämne för det vattenfria ämnet och väj motsvarande typ av ämne (monokomponentämne, multikomponentämne eller UVCB-ämne) i avsnitt 1.1.
- Av tekniska skäl ska du rapportera sammansättningen hos det vattenfria ämnet som den första sammansättningen som är av typen den juridiska enhetens sammansättning av ämnet i avsnitt 1.2.
- Om du tillverkar eller importerar det vattenfria ämnet ska du uppge detta ämnes sammansättning som den första sammansättningen.
- Om du inte tillverkar eller importerar det vattenfria ämnet måste du ändå uppge en sammansättning som motsvarar det vattenfria ämnet som den första sammansättningen i avsnitt 1.2. I sådana fall rekommenderar vi att du uppger en teoretisk sammansättning där referensämnet för det vattenfria ämnet uppges ha en normal koncentration på 100 viktprocent. Välj ”Legal entity composition of the substance” (den juridiska enhetens sammansättning av ämnet) som ”type of composition” (typ av sammansättning). I fältet ”Description of composition” (beskrivning av sammansättningen) anger du att den uppgivna sammansättningen är teoretisk. I fältet ”Justification for deviation” (motivering till avvikelse) anger du följande: ”This composition is neither manufactured nor imported.” (Denna sammansättning är varken tillverkad eller importerad.) ”It is only reported for technical reasons because the derogation for the registration of hydrates is applied.” (Den rapporteras endast av tekniska skäl eftersom undantaget för hydrater från registreringsplikten tillämpas.)
- Ange alla andra relevanta sammansättningar, inklusive de olika hydratiserade former av ämnet som omfattas av registreringen. För sammansättningarna som hänvisar till hydrater anger du "Hydrate covered by the registration of the anhydrous substance" (hydrat som omfattas av registreringen av det vattenfria ämnet) i fältet "Justification for deviation" (motivering till avvikelse). Typen av sammansättning för det hydrat som registreras ska vara ”legal entity composition of the substance” (den juridiska enhetens sammansättning av ämnet).
Du ska lämna tillräckligt med analytisk information för att det ska gå att verifiera identiteten av den monomer du registrerar. Det rör sig normalt om spektral- och kromatografidata och ett kromatogram av ursprungsmonomeren eller ett annat ämne som används vid tillverkningen av monomeren. För mer information, se Q&A 72 som överenskommits med nationella stöd- och informationspunkter.
Nej. Du ska lämna tillräcklig information i avsnitt 1.4 för att det ska gå att identifiera den monomer som ska registreras.
Om du har svårt att få fram information från tillverkaren/leverantören av polymeren utanför EES kan du välja något av följande alternativ:
- Föreslå för tillverkaren av polymeren utanför EES att de utser en enda representant enligt artikel 8 i Reachförordningen.
- Identifiera tillverkaren av monomeren utanför EES och begär analytisk information direkt från dem.
- Om tillverkaren utanför EU redan har utsett en enda representant, föreslå att denna tar det rättsliga ansvaret för polymerimportörerna i enlighet med artikel 8 i Reach (se även Q&A 834).
Du kan också överväga en relevant vetenskaplig metod för att uppfylla detta informationskrav. Om du överväger information som inte är begränsad till analysdata om ursprungsmonomeren rekommenderar vi att du följer en tydlig och genomsynlig metod som du dokumenterar väl när du lämnar information i avsnitt 1.4 av IUCLID för din registrering.
The substance is in principle identified as an inorganic UVCB due to the variability of the molecular formula.
In this case please select “inorganic” as origin under the Type of substance heading of IUCLID section 1.1.
The variability in the stoichiometry should be reported under the molecular formula field (e.g. MxGyO2, x=a-b, y=c-d).
In case only one constituent block is reported in section 1.2 of the IUCLID dossier, a justification for reporting a single constituent in the composition of a UVCB substance (expected to have a variable complex composition) should be provided in the “justification for deviations” field.
One example of a valid justification would be:
“The substance is a UVCB due to variations at the elemental level and these variations cannot therefore be represented by reporting different constituents but only in the form of a variable molecular formula.”
Ja. En beskrivning av tillverkningsprocessen är en av de identifierande egenskaperna för UVCB-ämnen. Denna information ska ingå i fältet ”Description of composition” (beskrivning av sammansättningen) i avsnitt 1.2 av IUCLID. Beskrivningen består i allmänhet av
- utgångsmaterialens identitet och andel,
- en beskrivning av relevanta tillverkningssteg i den ordning de kommer,
- relevanta driftparametrar tillämpade på kontrollen av sammansättningen (t.ex. temperatur, tryck, lösningsmedel och typ av katalys),
- en beskrivning av eventuella extraktions-/isolerings-/reningssteg.
Dessutom kan du som en bilaga under rubriken ”Attached description” (bifogad beskrivning) i avsnitt 1.2 rapportera reaktionsscheman eller processarbetsflöden som komplement till beskrivningen av tillverkningsprocessen
No. The chemical name alone does not include all the process circumstances determining the composition of the UVCB substance and therefore its identity. For further details on the information expected to be reported on the manufacturing process of UVCB substances, please consult the Q&A 1199.
You first need to define which information on the manufacturing process is relevant for the identification of the UVCB substance. The Q&A 1199 will assist you in deciding which information on the manufacturing process matters for the identification of your UVCB substance.
The more you know about the composition of the UVCB substance, the less you will be dependent on the manufacturing process to identify your substance. For instance, you may not need to specify the ratio of reactants used to manufacture the substance if you can define the reaction yield and the content of residual starting materials from the compositional information. Be aware that in this case you will still need to explain why some elements of the manufacturing process expected to be submitted are not provided, as indicated in Q&A 1318.
If the missing information on the manufacturing process prevents you from identifying the substance and the non-EEA manufacturer does not share this information directly with you, you may propose to the non-EEA manufacturer of the UVCB substance that they appoint an only representative (OR) in accordance with Article 8 of the REACH Regulation.
ECHA has also prepared a template that can be used to collect the necessary information from the non-EEA manufacturer. The template is available through our website here.
You need to provide all the relevant information on the manufacturing process in IUCLID section 1.2 as instructed in the Q&A 1199. If you consider that some of the information is not relevant, you need to clearly explain why this information is not included in the same field where the manufacturing process description is provided (i.e. in the ‘Description’ field of IUCLID Section 1.2).
No. The manufacturing process description is necessary to circumvent the limitations of identifying UVCB substances by their composition only. You therefore need to provide both types of information (composition and manufacturing process description) in IUCLID section 1.2. For further information on how to report the manufacturing process description and the composition of UVCB substance, please refer the Q&A 1199 and chapter 9.4.2 of the manual ‘How to prepare registration and PPORD dossiers’ available on the ECHA website: https://echa.europa.eu/manuals.
No. ECHA will not disseminate the manufacturing process description reported by registrants in compositions of the type ’legal entity composition of the substance’ in IUCLID section 1.2. This concerns both the information reported in the field ‘Description’ and any document included as ‘Attached description’.
Lead registrants need to additionally provide generic information on the manufacturing process of the jointly registered UVCB substance in the section 1.2 field ‘Description’ in compositions of the type ‘boundary composition of the substance’. This information will be displayed on the REACH-IT Joint submission page for the members of that joint submission to see.
The manufacturing process description is one of the identifiers for petroleum UVCB substances. This description should contain the following information:
- The source material from which the petroleum stream is obtained. This could be crude oil in the case of straight-run atmospheric distillates and atmospheric residue. For other petroleum substances, the source materials are often intermediate stocks and the name of the petroleum stream(s) to which the refinery process is applied should be specified. For example, for reformate fractions the source material could be heavy naphtha fraction from the atmospheric distillation of crude oil; for vacuum distillates the source material could be the residue from the atmospheric distillation of crude oil; the source material for base oils is normally a vacuum distillate; the source used to manufacture a naphtha fraction as a result of cracking process could be a vacuum distillate or heavy atmospheric gas oil. For imported gas oil, the source material could be various petroleum streams derived from crude oil, however they need to be specified as far as possible.
- The refinery process(es) applied to the source material(s). This may include blending processes (blending to specification), for which specification described by an international standard (e.g. EN228, EN590, etc.) should be provided. For a light reformate fraction, for example, the refinery processes include crude oil fractionation, naphtha hydrotreatment, catalytic reforming and reformate fractionation.
- The description as to how the final fraction is collected (atmospheric distillation, distillate/residue fraction; vacuum distillation, distillate/residue fraction; solvent extraction, extract/raffinate phase, etc.).
- Specification of the registered substance. Measured typical values of boiling point range and carbon number range need to be provided. If a stream is defined in its EC description by other parameters, e.g. viscosity, they also need to be provided. The refinery specific process parameters (e.g. refining temperature, catalysts, solvents, etc.) do not need to be provided.
It is important to mention that all the relevant information on manufacturing process description should be included in the “Description” field in section 1.2 of IUCLID. Information on manufacturing process that cannot be provided as free text (graphs, schemes, etc.) should be provided in a document and attached as instructed in Q&A 1199.
REACH is a EU Regulation that directly applies in all Member States of the European Union. REACH is of EEA (European Economic Area) relevance as it has been incorporated into the Agreement on the European Economic Area. This means that REACH also applies in Iceland, Liechtenstein and Norway. Substances imported into the EEA from Switzerland (a non-EU country belonging to the European Free Trade Association but not to the EEA) are treated under REACH in the same way as substances imported from any other non-EEA country. The Member States are best placed to explain how REACH applies to their territories (autonomic areas or overseas territories). We therefore recommend contacting the national REACH helpdesk of the relevant country to clarify specific questions in this regard.
Manufacturers established outside of the European Economic Area (EEA)/EU do not have direct obligations under REACH, as the EU importer needs to comply with the obligations. Non-EU companies exporting substances to the EU can (but are not obliged to) appoint an "only representative" to fulfil the obligations of importers. More guidance on only representatives can be found at:
and in section 220.127.116.11- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration available at:
For further information, see also the webpage concerning the non-EU companies: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries
No. The importer is the natural or legal person established within the European Union (EU, for REACH and CLP also covering the European Economic Area, EEA) who is responsible for import, i.e. the physical introduction (of goods) into the customs territory of the EU (Article 3(10) of REACH).
The responsibility for import depends on many factors such as who orders, who pays, and who deals with the customs formalities or the "INCOTERMS" chosen, but these might not be conclusive on their own. In many instances, the end receiver of the goods (the consignee) will also be the legal entity responsible for the import. However, this is not always the case.
If, for example, you order goods from a company (Company B) established in the EU, which acts as a distributor, you probably do not know where the goods originate from. Company B may choose to order the goods from either an EU-based manufacturer or from a non-EU-based manufacturer.
If the Company B chooses to order from a non-EU-based manufacturer, the goods may be delivered directly from them to you to save on transportation costs. If this happens, your company will be stated as the consignee on the simplified administrative document form and customs handling will take place in your country. Payment for the goods will, however, be settled between you and Company B.
Company B should be considered the legal entity responsible for the physical introduction of the goods into the customs territory of the EEA (importer). You would then be a downstream user. The obligation to register would consequently lie with Company B.
You, on the other hand, will have to be able to prove through documentation to the enforcement authorities that you are a downstream user, for example, by showing that the order was placed to the distributor.
In addition, when interpreting the term "importer" according to the REACH Regulation, it is not possible to fall back upon the Community Customs Code (Regulation (EEC) No. 2913/92), recast in Regulation (EU) 952/2013.
Under some circumstances, article importers have to register or notify substances in articles to ECHA (see Article 7 of REACH): these obligations are in general the same as for producers of articles. When placing articles on the market in the EEA, importers of articles may also have to communicate information on substances in their articles to their customers. In order to establish whether registration, notification or communication duties apply, any importer of articles is advised to follow first the Guidance in a Nutshell on requirements for substances in articles: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/guidance-in-a-nutshell.
An importer is any natural or legal person established within the Community who is responsible for import (Article 3(11) of the REACH Regulation). Import means the physical introduction into the customs territory of the Community (Article 3(10)).
The scope of the customs territory of the Community is defined in the relevant Community legislation on customs that should be consulted for further information. [Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code].
It is important to note, however, that the REACH Regulation and the Customs legislation are independent from each other.
Please note that according to Article 3(12) of REACH, the import of a substance on its own, in mixtures or in articles manufactured or produced outside the European Union is considered to fulfil the conditions for placing the substance, mixture or article on the Union market.
As stated in Section 18.104.22.168 of the Guidance on Registration, the responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities, but this might not be conclusive on its own. This Guidance can be found on the ECHA website at: http://echa.europa.eu/support/guidance.
När du utför nya tester måste du följa förordningen om testmetoder (kommissionens förordning (EG) nr 440/2008) eller använda en annan metod som har erkänts av Europeiska kommissionen eller Echa (artikel 13.3 i Reachförordningen).
Enligt bilagorna VII–X till Reachförordningen om standardinformationskrav ska flera OECD-testriktlinjer användas (t.ex. OECD TG 414, 421 och 422).
OECD-metoderna finns på webbadressen http://www.oecd-ilibrary.org/
Förordningen om testmetoder finns på webbadressen http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:142:SOM:SV:HTML
Tänk på att kraven i bilagorna VII och VIII ändrades 2016 för följande slutpunkter: hud- och ögonirritation, hudsensibilisering och akut toxicitet för huden, så att testmetoder utan djurförsök har blivit standard.
Informationen kan fås fram med andra metoder (artikel 13.3) under förutsättning att villkoren i bilaga XI är uppfyllda. Detta omfattar bland annat att resultatet är tillräckligt för klassificering och märkning och/eller riskbedömning och att lämplig och tillräcklig dokumentation av den använda metoden lämnas (se bilaga XI för mer information).
Dessutom finns ett särskilt krav för ekotoxikologiska och toxikologiska tester: nya tester ska utföras enligt principen om god laboratoriesed (GLP) i direktiv 2004/10/EG, eftersom ingen annan motsvarande internationell standard hittills har erkänts. För fysikalisk-kemisk testning kan det vara önskvärt, men är inte obligatoriskt, att utföra tester enligt GLP-standarden.
Vägledningen om informationskrav och kemikaliesäkerhetsbedömning innehåller särskilda integrerade testningsstrategier för varje endpoint (t.ex. för akvatisk toxicitet, mutagena effekter) och ska konsulteras innan nya tester utförs. Vägledningen finns på webbadressen http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
Europeiska kommissionen har offentliggjort listor över inspekterade testanläggningar som lämnats av nationella tillsynsmyndigheter för GLP. Dokumentet finns på webbadressen
Det är de nationella myndigheter som förvaltar de nationella övervakningsprogrammen som har ansvaret för certifiering av laboratorier för god laboratoriesed (GLP).
Om laboratoriet finns i EU, Norge eller Schweiz finns motsvarande myndighet på webbplatsen för Europeiska kommissionens generaldirektorat för näringsliv på webbadressen
Om laboratoriet finns i ett annat land bör du kontrollera GLP-sidan på OECD:s webbplats:
När du har hittat den relevanta GLP-tillsynsmyndigheten kan du vända dig till den myndigheten för att få information om GLP-certifierade laboratorier i motsvarande land.
Laboratorier kan dessutom inspekteras av en GLP-tillsynsmyndighet även om de finns i ett land som inte har anslutit sig till OECD:s system för ömsesidigt erkännande av data. Information om dessa laboratorier kan erhållas från den tillsynsmyndighet som inspekterade dem (se även Q&A 122).
Generellt går det att använda uppgifter från tillförlitlig, vetenskapligt vedertagen referenslitteratur eller databaser, under förutsättning att det ämne som ska registreras och det ämne som beskrivs i referensen är jämförbara när det gäller homogenitet, föroreningar, partikelstorlek osv.
Dokumentationen över likheter ska lämnas in i form av ett registreringsunderlag. Hänvisningar till litteratur eller databaser innehåller ofta sekundära dataresurser. När sådana uppgifter används ska den ursprungliga källan citeras och kontrolleras av en expert.
Vissa användbara referensböcker och datasammanställningar med fackgranskade uppgifter anges under varje slutpunkt i kapitel R.7 a, b och c i vägledningen om informationskrav och kemikaliesäkerhetsbedömning. Särskild vägledning om endpoints finns på Echas webbplats på webbadressen http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
För vissa endpoints räcker det att använda data från referenslitteratur eller databaser för att uppfylla informationskravet. I regel måste de dock kombineras med andra belägg och lämnas in som en del av en sammanvägd bedömning eller interpolering för att styrka den motivering som föreslås för att anpassa kravet.
Enligt OECD:s beslut om ömsesidigt erkännande av data (Mutual Acceptance of Data, MAD) ska data från kemikalietestning i OECD:s medlemsländer som utförts enligt OECD:s testriktlinjer och principer för god laboratoriesed (GLP) godtas i de andra medlemsländerna när det gäller skydd av människors och djurs hälsa och miljön.
Systemet omfattar även länder som inte är OECD-medlemmar, men som har ansökt om att ansluta sig till OECD:s principer för god laboratoriesed och MAD-systemet. Länder som inte är OECD-medlemmar kan delas in i två grupper:
- Länder som fullständigt har anslutit sig till OECD:s MAD-system.
- Länder som preliminärt har anslutit sig till OECD:s MAD-system.
Länder som fullständigt har anslutit sig till OECD:s MAD-system godtar data som har tagits fram enligt MAD-villkoren från OECD-medlemsländer och andra anslutna länder. OECD-medlemsländer och anslutna länder måste dessutom godta icke-kliniska säkerhetsdata som utformats i dessa länder.
Länder som preliminärt har anslutit sig till OECD:s MAD-system måste godta data som har tagits fram enligt MAD-villkoren från OECD-medlemsländer och andra anslutna länder. Under den preliminära anslutningsperioden är dock de länder som fullständigt har anslutit sig till OECD:s MAD-beslut inte skyldiga att godta GLP-övervakningsaktiviteter som genomförs av en GLP-tillsynsmyndighet i ett land som har anslutit sig preliminärt.
Generellt godtar Echa data som GLP-data när dessa kommer
- från OECD-medlemsländer eller länder som är fullständigt anslutna till OECD:s system för ömsesidigt erkännande av data (Mutual Acceptance of Data, MAD), och
- från länder som preliminärt har anslutit sig till OECD:s system för ömsesidigt erkännande av data och där laboratorierna har inspekterats gemensamt av den berörda GLP-tillsynsmyndigheten och en GLP-tillsynsmyndighet som tillhör OECD.
Studier som har genomförts i laboratorier i länder som inte har anslutit sig till OECD:s system för ömsesidigt godkännande av data uppfyller GLP under följande villkor:
- Innan studien genomförs: att en kontroll av att laboratoriet uppfyller GLP har gjorts av en GLP-tillsynsmyndighet i EU (inklusive Norge genom EES-avtalet) eller av GLP-övervakningsmyndigheter i Israel, Japan och Schweiz med vilka EU har ingått avtal om ömsesidigt erkännande eller andra GLP-tillsynsmyndigheter i OECD-medlemsländer eller länder som fullständigt har anslutit sig till OECD:s system för ömsesidigt erkännande av data från fall till fall, och
- att slutsatsen har kunnat dras att laboratoriet uppfyller GLP.
Se även Q&A 119.
Inte nödvändigtvis. Omfattningen av den riskkarakterisering som du måste utföra som en del av kemikaliesäkerhetsbedömningen beror på ämnets riskprofil. Riskkarakteriseringen måste omfatta alla faror, inte bara de som leder till klassificering (punkterna 0.5 och 6 i bilaga I till Reachförordningen).
För det första måste alla identifierade fysiska risker, hälsorisker och miljörisker övervägas, även om klassificering inte krävs. Detta inbegriper insamling av uppskattad nolleffektkoncentration, härledd nolleffektnivå eller härledd minimal effektnivå (PNEC, DNEL eller DMEL) om så behövs.
Du bör även överväga relevanta tidsplaner, delar av miljön, befolkningsgrupper, hälsoeffekter och exponeringsvägar.
Härledd nolleffektnivå för irritation/korrosion kan endast härledas om dosresponsinformation finns tillgänglig. För endpoints som ögonirritation där det inte är möjligt att härleda nolleffektnivån krävs därför en mer kvalitativ metod för bedömning och kontroll av sådana risker. Så kan vara fallet om pH ledde till klassificering eller om endast QSAR-data finns tillgängliga.
Information om denna metod finns i kapitlen R.8 (del E) och R.10 i vägledningen om informationskrav och kemikaliesäkerhetsbedömning: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment.
Om det inte finns några andra risker är det tillräckligt att beskriva de åtgärder som säkerställer att risker för ögonen undviks eller hanteras i exponeringsscenarierna. Om andra risker har identifierats bör du även ta med dem i din bedömning.
Exponeringsbedömningen och den påföljande riskkarakteriseringen bör omfatta alla skeden i ämnets livscykel till följd av tillverkningen av ämnet och identifierade användningar.
Den praktiska vägledningen How to undertake a qualitative human health assessment and document it in a chemical safety report är användbar vid kvalitativa bedömningar som rör människors hälsa: http://echa.europa.eu/sv/practical-guides
Tips: Du kan använda Chesar som hjälp för att fastställa omfattningen av exponeringsbedömningen och typen av riskkarakterisering. Mer information om detta finns i Chesar User Manual, del 1, avsnitt 6 på webbadressen http://chesar.echa.europa.eu/web/chesar/support/manuals-tutorials
För testning av akvatisk toxicitet (avsnitt 9.1, bilagorna VII och VIII) innehåller kolumn 2-anpassningarna två kompletterande begrepp för vattenlöslighet.
Begreppet ”mycket olösligt i vatten” har samband med sannolikheten för akvatisk toxicitet, vilket innebär att ett generellt gränsvärde inte kan fastställas. Användningen av detta begrepp för att begära undantag från testning av akvatisk toxicitet kräver en ämnesspecifik bedömning.
I undantagsdeklarationen ska registranterna motivera att det är osannolikt att akvatisk toxicitet kan förekomma vid vattenlöslighetsgränsen. Detta kan kräva särskild information, t.ex. uppgifter från omvandlings-/upplösningsstudier eller genom att identifiera WAF-komponenterna (water accommodated fraction) (se webinarpresentationen Hints and Tips on Physicochemical, environmental and human health related endpoints – Aquatic Toxicity).
Om registranterna inte kan visa att det är osannolikt att akvatisk toxicitet förekommer, bör ämnet betraktas som ”svårlösligt i vatten”, inte som ”mycket olösligt i vatten”, vilket i sin tur innebär att långsiktig testning måste övervägas.
Begreppet ”svårlösligt i vatten” har samband med behovet av att överväga långsiktiga i stället för kortsiktiga testningar. I avsnitt R.7.8.5 (slutpunktspecifik vägledning R.7.b) i Echas vägledning om informationskrav och kemikaliesäkerhetsbedömning föreslås att vattenlöslighet under 1 mg/l eller under detektionsnivån för den analysmetod som används för att testa ämnet bör användas för att fastställa att ämnet är svårlösligt i vatten och för att utföra långsiktiga i stället för kortsiktiga testningar.
Närmare information om testning av akvatisk toxicitet finns i OECD:s vägledningsdokument Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures på webbadressen
As described in Appendix 4 of the Guidance on Intermediates (page 35)" due to the practical nature of manufacturing processes and to the fiscal attributes of manufacturing sites, one or more steps between the manufacturing of the substance (A) and its use in the manufacturing of substance (B) may be necessary to facilitate/ensure proper chemical processing in the synthesis of substance B." Therefore, necessary purification of the intermediate, which takes place after its manufacture and before the synthesis, does not prevent it from being considered an intermediate.
Article 3(15)(c) of the REACH Regulation does not require that the manufacture of the transported isolated intermediate and its synthesis is done on sites operated by the same legal entity.
However, in order to benefit from the reduced information requirements for registration dossiers submitted under Article 18 of the REACH Regulation, the registrant must ensure that the substance is handled under strictly controlled conditions throughout its lifecycle - also if it undergoes a purification. It must also be ensured that the substance is always manufactured for and consumed in or used in the synthesis of another substance.
The Guidance on Intermediates is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
Yes, under the conditions specified in the reasoning provided below.
Manufacturing of coke electrodes
Coal tar pitch, high temperature (CTPHT - EC number 266-028-2) and Anthracene oil (AO - EC number 292-602-7) are used in the manufacture of electrodes for applications in electrolytic processes in the aluminium industry (i.e. aluminium smelters). These substances are used specifically to manufacture the following types of electrodes:
- Søderberg electrodes – these are first manufactured directly in the electrolytic cell and subsequently used in the same cell.
- pre-baked electrodes - they are manufactured in dedicated units and later used in the electrolytic cells. Electrodes manufacturing units may be located in the same site as the electrolytic cells or in another site.
In both cases, the manufacturing process of the electrodes consists of the following stages:
- Mixing of the raw materials (so called filler grains usually petroleum coke or calcinated coke + CTPHT and/or AO)
- Shaping (to give the electrode the final shape which is required to fit it into the housing of the electrolytic cell)
The outcome from the baking process is "Coke", a new substance. The new substance is manufactured from petroleum coke or calcinated coke, AO and CTPHT that contribute to its structure.
In more detail the baking process works as follows:
- Coke substances are carbonaceous materials obtained from coking processes such as baking at relatively high temperature. These substances are characterised by a high carbon elemental content and can display unique structures presenting a high carbon-to-hydrogen ratio. The exact composition of coke is generally complex and depends on the source used and the conditions applied for the coking. As a source of carbon, coke substances find applications in processes such as aluminium manufacturing by electrolysis. In this specific case, CTPHT and AO are themselves chemically transformed into coke during the manufacturing process of pre baked and Søderberg electrodes. These transformations involve complex chemical reactions including polycondensation and polymerisation of the constituents which CPTHT and AO consist of. These reactions begin during the baking process in a low oxygen atmosphere at temperatures of ~400 C. The transformation process into coke is completed at around ~700 C with the condensation of all polyaromatic hydrocarbons. The transformation leads to a carbonaceous material of high carbon elemental content and CTPHT and AO contribute to the structure of the coke substance intended to be manufactured. In this case, the baking process is carried out in the presence of readily available coke filler grains. The result is a homogenous coke displaying specific electrical conductivity (a required feature for the coke to be used as an electrode) and mechanical strength. In this specific case, the resulting coke would in principle not have the chemical structure that would enable its use as a source of carbon in electrolytic processes without the combined use of the AO and CPTHT as precursors and readily available coke grains.
- The outcome from the manufacturing process (i.e. the coke electrode) is, in this specific case, a substance under REACH and not an article as defined in Article 3(3) of REACH. The shape of the electrode is decided to fit it into the housing of the electrolytic cell, which can be different from case to case. Furthermore, during theuse of the electrodethe carbon from coke is consumed. The specific shape, surface and design given to the electrodes during their manufacture are therefore less relevant for its use in the aluminium production process than its chemical composition.
According to Article 3(15) of REACH, an intermediate is a substance which is "manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (…referred to as synthesis)".
Whenever a substance is used to achieve another function than its transformation into another substance (e.g. as an individual step in the production process of an article), it cannot be regarded as an intermediate. It is also recognised that, due to the practical nature of manufacturing processes and to the fiscal attributes of manufacturing sites, one or more steps between the manufacturing of a substance (A) and its use as an intermediate in the manufacturing of another substance (B) may be necessary to facilitate/ensure proper chemical processing in the synthesis of that other substance (B) (see Appendix IV of ECHA's Guidance on intermediates, December 2010).
In the current case, if all stages a, b and c are an integrated part of the coke manufacturing process installations, the use of AO and CTPHT may be considered the use as an intermediate.
However, whenever the mixing of AO, CTPHT and filler grains (stage a) is not carried out on the same site, this may indicate that the mixing step is not performed to facilitate/ensure proper chemical processing in the synthesis of the coke. In that case and AO and CTPHT cannot be regarded as intermediates.
In general, testing for human health endpoints can be adapted (‘waived'), if the substance is used in the EEA exclusively in cosmetic products falling within the scope of the Cosmetics Regulation, and if the testing would not be necessary to fulfil the REACH requirements for the assessment of worker exposure.
Two main scenarios are foreseen where cosmetics-based waiving could be applied.
- In cases where imported products fall within the scope of the Cosmetics Regulation (EC No 1223/2009) and which, from the time of import, are neither further processed nor repackaged inside the EEA, an adaptation of animal testing requirements for human health endpoints can be sought, based on the absence of relevant worker exposure;
- In other cases, you may be able to seek an adaptation of an information requirement by demonstrating that the substance is handled under strictly controlled conditions during all stages of the life-cycle, other than the use as a cosmetic product (i.e. manufacture, formulation and/or packaging stage).
In all circumstances, you shall provide a reasoned justification for requesting the waiver.
Where exposure to workers in the EEA is established, the REACH requirements apply. Note that the REACH provisions under Annexes VII to XI encourage the use of adaptations; animal testing should be performed as a last resort only (Article 25 of REACH).
Consequently, testing on vertebrate animals will be required only if there is no available information which meets the information requirements, and where no adaptation possibility under column 2 of REACH Annexes VII to X, or under Annex XI can be applied.
This will represent the only means to assess the potential human health risks arising from exposure to workers.
As for every adaptation of an information requirement in a registration dossier, you need to insert a justification in each of the relevant endpoints of the IUCLID dossier.
Two main types of scenarios have been identified:
- Where the substance is imported into the EEA in a cosmetic product that is not further processed in the EEA: in addition to following the instructions provided by ECHA (see below), you shall add, to the respective endpoint(s) in IUCLID, an explanatory note stating that the substance is solely used in cosmetics, imported in the finished state and not further processed nor repackaged inside the EEA;
- Where the substance/cosmetic product is further processed in the EEA, but where absence of worker exposure can be demonstrated: you may avail yourself of the regular adaptation possibilities, pursuant to Annex XI, section 3.1 of REACH, to waive the testing requirements addressed by sections 8.6 and 8.7 (repeated dose toxicity and reproductive toxicity respectively) of Annex VIII to REACH and the test in Annex IX and X.
When applying these adaptations, for the purpose of the justification required according to Annex XI, section 3.2, you do not need to consider the life-cycle stages related to the use of the finished cosmetic product, as these are regulated separately under the Cosmetics Regulation.
While testing for acute toxicity cannot normally be waived under Annex XI, section 3.2, for the purpose of registrations dossiers that cover only cosmetic uses, a similar waiver containing the elements of Annex XI, section 3.2 may be used for this endpoint.
See section 5.1 of the Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements for further details on how to make use of this adaptation possibility.
Furthermore, ECHA provides further specific recommendations to follow below when you create or update your registration dossier.
In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.
The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier.
Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.
If the substance is only imported in the EEA in a cosmetic product in its final state (neither further processed nor repackaged inside the EEA), the waiving possibility is only relevant for human health endpoints and is only based on the fact that there are no uses in any stage of the life-cycle which may be relevant to REACH (no exposure to workers; exposure to professionals and consumers is covered by the Cosmetics Regulation).
The following specific data waivers can be used only for human health information requirements (Sections 8 of REACH Annexes VII-X).
Selection / entry
Any Endpoint Study Record– Annexes VII to X *
’study waived due to provisions of other regulation’
Justification for data waiving
‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”
Justification for type of information
“The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state (i.e. the product is from the time of import neither further processed nor repackaged inside the EEA).
Waiving of animal testing requirements for human health endpoints is proposed based on the absence of uses other than in finished cosmetic products.”
Section 3.5.5 – Consumer uses **
Product category ***
Dossier submission remark
“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state. The product is from the time of import neither further processed nor repackaged inside the EEA.”
Spontaneous update, ‘Justification' ****
‘other' + ”Cosmetics Regulation / 2013”
* Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
** The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 22.214.171.124 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5
**** A separate justification should be entered for each reason for the update.
In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.
The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier. Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.
If the substance is further processed inside the EEA, i.e. it is imported or manufactured in the EEA, and still further formulated or re-packaged, before or after inclusion in the final cosmetic product, you need to demonstrate the absence of exposure to workers to benefit from the adaptation possibility.
This case also covers situations where you do not need to provide an exposure assessment: either no CSR is required due to the low tonnage of the substance manufactured or imported, or no exposure assessment is required because the substance does not require classification.
Consequently, you should document the absence of exposure as appropriate, using exposure scenarios and/or other approaches. You can apply for the following specific data waivers, specifically for the human health information requirements (Sections 8 of REACH Annexes VII-X).
Selection / entry
Endpoint Study Record corresponding to: *
-Annex VIII (except sections 8.6 and 8.7)
‘study waived due to provisions of other regulation’
Justification for data waiving
‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”
Justification for type of information
“The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.
Waiving of animal testing requirements for human health endpoints is proposed, since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:”
Endpoint Study Record corresponding to: *
-Section 8.6 and 8.7 of
Justification for data waiving
‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”
Justification for type of information
“The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.
Waiving of animal testing requirements for human health endpoints is proposed since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:”
Section 3.5.5 – Consumer uses **
Product category ***
Dossier submission remark
“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and /or further processed inside the EEA before/ after inclusion in the final cosmetic product. All manipulation of the substance outside the cosmetics use takes place under strictly controlled conditions.”
Spontaneous update, ‘Justification' ****
‘other:' + “Cosmetics Regulation / 2013”
*Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
**The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 126.96.36.199 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5.
**** A separate justification should be entered for each reason for the update.
Yes, the ECHA decision is legally valid and binding, so you have to comply with it.
However, if the substance is used exclusively in a cosmetic product and falls under one of the scenarios described, i.e. animal testing would only serve the purpose to address human health risks resulting from the exposure to the finished cosmetic product, you should be able to comply with the decision you received by requesting use of waiving possibilities, as per the REACH Annexes.
It is only where the required testing relates to potential human health effects for workers that animal tests may be required. In such circumstances, the tests are performed to meet the requirements of REACH.
No, the entry into force of the total marketing ban under the Cosmetics Regulation (EC) No 1223/2009 does not influence the REACH requirements.
However, if your registered substance is exclusively used in cosmetics, ECHA recommends that you spontaneously update your registration dossier to clearly indicate the uses, should you wish ECHA to take this into account in any subsequent examination. Please follow the instructions provided according to the scenarios described in Q&A 991.
If you have not registered your substance already, ECHA recommends that you follow the instructions provided according to the scenarios described in Q&A 991.
- For more information regarding the Cosmetics Regulation and the requirements therein, please visit theEuropean Commission website
- For more information on the interface of REACH and the Cosmetics Regulation, you may consult the factsheet ECHA has published in consultation with the European Commission.
- You may also contact the ECHA Helpdesk.
The registration requirement for substances in articles (as required by Article 7 (1) of REACH) applies only if all the following conditions are met:
- the substance is intended to be released during normal and reasonable foreseeable conditions of use; and
- the total amount of the substance present in the article exceeds one tonne per producer or importer per year; and
- the substance has not yet been registered for that specific use. Pre-registrations, however, do not relieve you from the obligation to register.
If the substance has already been registered for your specific use, then you do not need to register. This registration can be done in your supply chain or any other supply chain. Chapter 3.3.1 of the Guidance on requirements for substances in articles provides advice on how to find out if the substance is already registered for that use.
In order to determine what is an article in this context, especially regarding border line cases between containers and articles, you can consult the Guidance on requirements for substances in articles
Substances that meet the criteria outlined in Article 57 of the REACH Regulation are commonly referred to as substances of very high concern (SVHCs). You must notify SVHCs present in articles (Article 7(2)) if the following conditions are met:
- the substance has been included in the Candidate List of SVHCs for authorisation; and
- the substance is present in articles above a concentration of 0.1% weight by weight (w/w); and
- the total amount of the substance in those articles (i.e. those containing more than 0.1% (w/w) of the Candidate List substance) exceeds one tonne per producer or importer per year; and
- exemptions do not apply.
Two specific exemptions can apply to the notification of substance in articles:
(a) exemption based on exclusion of exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal (Article 7(3)) and
(b) exemption for substances already registered for that use (Article 7(6)).
You must notify Candidate List substances in articles at the latest six months after the SVHC has been included on the Candidate List for authorisation (Article 7(7)).
The Candidate List will be updated continuously when substances that meet the criteria of Article 57 are identified.
You can find further information at: http://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.
The Candidate List can be found at: http://echa.europa.eu/candidate-list-table.
A substance is intended to be released from articles if it fulfils an accessory function which would not be achieved if the substance was not released. A scented children's toy, for example, is an article with intended release of substances, because fragrance substances contained in the toy are released in order to fulfil an accessory function, namely to scent. Consequently, the release of a substance because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, is generally not considered as an intended release, as the release as such does not provide a function in itself.
An intended release of a substance from an article has furthermore to occur under normal or reasonably foreseeable conditions of use. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article's life cycle is not an intended release. Similarly, a release in an accident or due to any form of misuse which is not in accordance with the use instructions of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.
If the production/import ended before the SVHC was included in the Candidate List or before the notification obligation starts to apply (i.e. 6 months after a substance has been included in the Candidate List or 1 June 2011 for substances placed on the Candidate List before 1 December 2010) then you do not have to notify. However, you may still have obligation, under Article 33 of REACH, to provide the recipient of the article, or the consumer upon request, with sufficient information to allow safe use of the article, including, as a minimum, the name of that substance.
A permanent magnet should be considered as a substance or a mixture (and not an article) under REACH. This is because its shape, surface or design are less relevant for its function than its chemical composition. As a substance or a mixture, a permanent magnet is subject to the applicable provisions of the REACH and CLP regulations (e.g. it needs to be appropriately packaged and labelled).
Permanent magnets are used in different sizes and forms. They should create a (strong) permanent magnetic field and be stable to perform their main function of attracting or repelling other magnetic objects through a magnetic force (e.g. in cupboards to keep a door closed). They should also have high magnetic coercivity (i.e. they should be difficult to demagnetise).
The materials to be used to produce permanent magnets should either be either materials with permanent magnetic fields or materials with a susceptibility to be magnetised by applying an external magnetic field. The latter should also retain the imprinted magnetic pattern (high magnetic coercivity).
The magnetism is one example of a physical property that results from the chemistry of the materials an object is made of, given in the Guidance on requirements for substances in articles (subchapter 2.2). The Guidance also states that such material characteristics or properties are not to be confused with the shape, surface and design of an object.
The stability (magnetic coercivity) and the strength of the created permanent magnetic field appear to be the most important properties of a permanent magnet. Therefore, the magnetic properties of the permanent magnet, which are strongly related to its chemical composition, determine its function.
If you are a supplier of an article containing a substance, you have to provide to the recipient of the article (Article 33(1)) or to a consumer (Article 33(2)) relevant safety information, available to you, when both the following conditions are met:
- The substance is included in the Candidate List for authorisation, and
- The substance is present in the article produced and/or imported above a concentration of 0.1% (w/w).
The information is to be provided to the recipient of the article, i.e. industrial or professional users and distributors, when the article is supplied for the first time after the inclusion of the substance into the Candidate List and to the consumer upon request by that consumer, within 45 calendar days of that request and free of charge.
The communication of information at the request of a consumer is independent of whether the article was purchased by that particular consumer.
The information you should communicate must be sufficient to allow safe use of the article, considering all life cycle stages of the article including disposal. Section 3.4.1 of the Guidance on requirements for substances in articles describes in detail which information should be communicated.
If no particular information is necessary to allow safe use of the article containing a Candidate List substance, e.g. when exposure can be excluded at all life cycle stages of the article including disposal, as a minimum the name of the substance in question has to be communicated to the recipients of the article or to consumers.
In the Guidance on requirements for substances in articles, the term “complex object” refers to any object made up of more than one article. In complex objects, several articles can be joined or assembled together in various manners. For example, they can be mechanically assembled (e.g. pair of (metallic) scissors, foldback clips) or joined using substance(s)/mixture(s) (e,g. block of sticky notes, glued chip in a bank card, unpainted bicycle frame formed by welding together multiple steel tubes). The more articles it is made of, the more complex an object becomes.
Articles that are assembled or joined together in a complex object remain articles, as long as they keep a special shape, surface or design, which is more decisive for their function than their chemical composition, or as long as they do not become waste (as defined in the Waste Framework Directive - Directive 2008/98). An importer or a supplier of a complex object (e.g. foldback clip) is importer or supplier of the various articles the complex object is made from, and must therefore comply with the applicable communication and notification obligations for each one of them (e.g. the bent strip of steel and the two metallic wire handles of the foldback clip). Whether the complex object is an article depends on whether it fulfils the criteria of the definition of an article.
The determination of the concentration of a Candidate List substance, to check whether it is above the 0.1% w/w threshold or not, is essential to check whether communication and notification obligations apply.
Table 5 in the Guidance on requirements for substances in articles illustrates and explains in detail several scenarios on how to determine the concentration of a Candidate List substance (weight by weight (w/w)) in an article or in articles incorporated in a complex object (any object made up of more than one article). In summary:
- Scenario I. Article made from a Candidate List substance as such or in a mixture: the concentration is calculated over the total weight of the article (e.g. plastic chair produced by injection moulding)
- Scenario II. Candidate List substance as such or in a mixture used for joining two or more articles (complex object): the concentration of the Candidate List substance is calculated over the total weight of the complex object (e.g. unpainted bicycle frame formed by welding together multiple steel tubes, using a mixture containing the substance)
- Scenario III. Candidate List substance in coatings (e.g. paint, lacquer, varnish, functional coating) - III. A) Fully coated article; III. B) Partially coated article; III. C) Coated complex object: the concentration of the Candidate List substance in the (fully/partially) coated article is calculated over the total weight of the coated article or of the complex object
- Scenario IV. Very complex objects (e.g. sofa, bicycle, mobile phone, car and aircraft): the calculation rules set out for scenarios I to III above apply for each article or simpler complex object.
A distinction should be made between updates due to a tonnage band change, becoming a lead of a joint submission and other updates.
For a NONS registration update due to increase in the tonnage band or becoming a lead of a joint submission, a complete dossier in IUCLID 6 format has to be submitted to ECHA like for any other standard or transported isolated intermediate registration.
For other NONS updates, certain information is not required and may be waived until the next tonnage threshold is reached, provided that explanatory derogation statements are included in the dossier header.
In order to successfully update your registration dossier you should follow the steps outlined below:
- Migrate the SNIF file to IUCLID 5.6 and then import it to IUCLID 6 You can request your notification migrated into IUCLID format (IUCLID substance dataset) from your relevant Member State Competent Authority, or migrate it yourself using the SNIF migration plug-in tool available on the IUCLID web site http://iuclid.echa.europa.eu/.
- Update the substance dataset according to the REACH requirements. Please note that all registration updates undergo a technical completeness check according to the requirements of Article 20(2) of the REACH Regulation. You are advised to first check your tonnage band in REACH-IT, as described in Q&A 686.
To be considered as complete, your dossier should be filled-in as specified below:
- When updating a dossier due to an increase of tonnage band or becoming a lead of a joint submission, the registrant must be aware that the updated dossier must fully comply with all REACH information requirements. The update should not only contain the information required by REACH which corresponds to that higher tonnage threshold, but also any information which corresponds to lower tonnage thresholds. If your update involves a registration at or above the 10 tonnes threshold, a complete chemical safety report (CSR) should be included in section 13 of your IUCLID 6 dossier unless the conditions for not submitting a CSR as set out in Article 14(2) of the REACH Regulation are met (in which case a justification should be provided in section 13 instead).
For further information please consult the manual "How to prepare registration and PPORD dossiers" at: http://echa.europa.eu/manuals.
- For updates to include the classification and labelling according to the CLP Regulation. You have to update your registration dossier to include the classification and labelling according to Regulation (EC) No 1272/2008 (‘CLP Regulation') in case you manufacture or import your NONS substance in a volume of more than or equal to 1 tonne per year. For NONS notified below 1 tonne under Directive 67/548/EEC and for which no tonnage band update has been done, a separate notification to the Inventory will have to be made, and the registration dossier does not need to be updated.
If you only need to update the classification and labelling but your tonnage band remains unaltered, you only need to provide a minimum of information as explained in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.
- For updates to the joint submission status of the claimant, select an appropriate dossier template for your submission.
The lead of a joint submission uses a standard template accordingly to the tonnage band covered by the joint submission. The tonnage band of the lead registrant is indicated in the dossier header.
Members of a joint submission need to select a special template for a joint submission member. Two different kinds of member templates exist: general registration and intermediate registration. Intermediate template is used if the member registers only an isolated intermediate (transported or on-site).
When creating the dossier, the tick box ‘Joint submission' must be ticked in the dossier header. When submitting the dossier in REACH-IT, the submitter must select ‘joint submission:' and provide the name of the joint submission.
- For other types of updates, Other updates concern all other cases indicated under Article 22(1) of the REACH Regulation and updates following a decision made by the MSCA according to Article 16(1) or 16(2) of Directive 67/548/EEC. For such updates, the dossier does not need to include information requested under the REACH Regulation that was not required under the previous legislation (i.e. Directive 67/548/EEC).. The minimum information which needs to be submitted in these types of updates (when the tonnage band remains unaltered) is provided in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.
- In Section 1.3 ‘Identifiers' of your IUCLID 6 dossier, do not forget to specify your notification number under Directive 67/548/EEC, as well as your reference number under the REACH Regulation (the one you received when claiming your NONS via REACH-IT).
- In Section 1.7 ‘Suppliers' of your IUCLID 6 dossier, do not forget to attach all necessary contractual agreements if you are representing a non-Community manufacturer.
- When updating a dossier due to an increase of tonnage band or becoming a lead of a joint submission, the registrant must be aware that the updated dossier must fully comply with all REACH information requirements. The update should not only contain the information required by REACH which corresponds to that higher tonnage threshold, but also any information which corresponds to lower tonnage thresholds. If your update involves a registration at or above the 10 tonnes threshold, a complete chemical safety report (CSR) should be included in section 13 of your IUCLID 6 dossier unless the conditions for not submitting a CSR as set out in Article 14(2) of the REACH Regulation are met (in which case a justification should be provided in section 13 instead).
- Update your confidentiality claims.
In case you wish to keep confidential the information which was accepted as such under Directive 67/548/EEC, you are required to write in the justification field adjacent to each confidentiality flag the text ‘Claim previously made under Directive 67/548/EEC'. This will allow ECHA to invoice correctly and validate the claims already presented under Directive 67/548/EEC.
Please note that ECHA will only charge a fee for those confidentiality claims associated with new information submitted, or new confidentiality claims for existing information. This means that there will be no fee for confidentiality claims successfully made under Directive 67/548/EEC, provided that this is confirmed by the registrant in their dossier as indicated above.
Please note that the information listed below could not be claimed confidential under Directive 67/548/EEC.
- The name of the notifier (which under REACH is considered to be part of the information contained in the safety data sheet).
- The information contained in the safety data sheet (including registration number, uses and uses advised against).
- The trade name of the substance.
- If essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous.
For these claims, a full justification needs to be provided and the claim will be subject to the corresponding fee under REACH.
Please be aware that dissemination of information listed in Article 119(1) of the REACH Regulation includes the IUPAC names of substances included in Annex I to Directive 67/548/EEC and that, as a general rule, information listed both in Articles 119(1) and 119(2) of the REACH Regulation will be disseminated.
ECHA will not disseminate the information listed in Article 119(2) for which a party has submitted a justification, accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned.
More information about the confidentiality claims which are possible under REACH is available in the document "Dissemination and confidentiality under the REACH Regulation" at: http://echa.europa.eu/manuals.
You are able to simulate which information from your dossier will be made available on the ECHA website by using the dissemination tool available in IULID 6
- Create the IUCLID registration dossier
Once you have prepared your substance dataset, you need to create your registration dossier. To do this:
- Choose the correct IUCLID Template. Make sure that the template selected corresponds with the intended submission Further information in "How to prepare registration and PPORD dossiers " manual available at http://echa.europa.eu/manuals.
- Complete the dossier header information. For the specific case of NONS registration updates, you have to fill in the dossier header in IUCLID in the following way (see also screenshot below):
- Tick the box "Is the submission an update?".
- Indicate the submission number in the "Last submission number" field (the one you received when you claimed your registration number via REACH-IT) .
- Tick the box "Spontaneous update".
- Select the justification of the update. If there is more than one reason for your spontaneous update (e.g. change of tonnage band and change of classification and labelling), you should create several repeatable blocks under ‘Spontaneous update'.
Please remember that in case of NONS substances notified below 1 tonne and for which no tonnage band update has been done, you need to submit a ‘C&L notification' instead of an update of your registration dossier.
Other types of updates. In case of other types of spontaneous updates, you will have to select the proper justification. If you select ‘other', indicate clearly the reason for updating in the adjacent field.
For the specific case of an update according to Article 135 of the REACH Regulation (Transitional measures regarding notified substances), select ‘other' in the justification field and indicate the new information that you are updating in the free text field: "Article 135 of REACH – submission of test (specify test)".
Once you have created your IUCLID dossier, you need to submit it through REACH-IT. See Instructions in "How to prepare registration and PPORD dossiers" manual at: http://echa.europa.eu/manuals.
In the case that you are an Only Representative representing several non-Community companies under the REACH Regulation you need to submit a separate updated registration for each of the non-Community manufacturers you represent.
For a tonnage band increase (and only in this case). Before you submit your registration update you are required to inform ECHA of the additional information you would need to comply with the information requirements for the new tonnage level (Article 12(2) of the REACH regulation). In order to facilitate this process, you are required to submit an inquiry to ECHA. Upon receipt of this information, ECHA acts as in the inquiry process (Article 26(3) and (4) of the REACH Regulation) and will inform the registrant of the names and addresses of any previous registrants (and any potential registrants) and of any relevant study summaries already submitted by them. The purpose for this is to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated. The inquiry for a tonnage band increase should be submitted according to the procedures outlined in the manual "How to prepare and submit an inquiry" at: http://echa.europa.eu/manuals.
According to Article 24 of the REACH Regulation all notified substances under Directive 67/548/EEC (NONS) are considered already registered under the REACH Regulation at the relevant tonnage band.
A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from his notified substance as being considered registered (Cf. Section 188.8.131.52 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation).
In principle, any other parties intending to manufacture or import a notified substance but who have not notified such substance themselves cannot be assigned a registration number under Article 24 of the REACH Regulation. Such parties should submit an inquiry and subsequently register the substance in accordance with the provisions of the REACH Regulation. The European Chemicals Agency (ECHA) has assigned registration numbers to all notifications made in accordance with Directive 67/548/EEC.
These registration numbers can be requested from ECHA by the owner of the notification via the REACH-IT system using the "Claim Notified Substances" module. This procedure will confirm to ECHA the identity of the notifier and to whom the registration number should be sent to. In addition, the REACH-IT database will be updated with the latest contact details of the notifiers, which will also enhance the data-sharing process.
If the claimant's details specified in REACH-IT match those for the notification, ECHA will provide the registration number. If the claimant's details do not match, ECHA will not be able to allocate any registration number and the notifier is advised to contact its relevant Member State Competent Authority (MSCA) to resolve this issue. Claimants need to sign-up in REACH-IT for each type of role they had under Directive 67/548/EEC for the notified substance in question.
There are four potential types of claimant (role) that may request a registration number for a notified substance:
- The claimant was a Domestic Manufacturer under Directive 67/548/EEC (i.e. the Manufacturer was established within EU).
- The claimant was an Importer under Directive 67/548/EEC.
- The claimant was a Sole Representative under Directive 67/548/EEC.The claimant is a newly appointed Only Representative and will take the duties of a previous notifier (Sole Representative). Note that Only Representatives must sign up in REACH-IT for each non-community manufacturer they represent and submit a claim using the appropriate account.
It is not possible to use the same legal entity object (having the same company UUID) for multiple accounts, but it is possible to use the same company identification information (name, VAT, etc.). In case of a Sole Representative or newly appointed Only Representative, one registration number will be allocated per non-Community manufacturer represented. The claimant will have to submit, in REACH-IT, written evidence of the validity of his request. This provision is in line with the implementation already in place for an Only Representative in case of registration.
Once you have signed-up in REACH-IT and specified your company details, you can proceed with the request of your registration number. The distribution of registration numbers by ECHA will be made following your request via the "Claim Notified Substance" module in REACH-IT.
- Log-in to REACH-IT >> Menu >> Registration >> Claim notified substance
- Put the Notification number (standard format) without the 2 last digits corresponding to the version of the notification (you should specify XX-XX-XXXX in REACH-IT). And Put the ELINCS number of the notified substance and follow the wizard
If all the information specified is correct and matches with that in the notification dossier:
You will instantly receive a submission number, and a reference number via REACH-IT. You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.
If the information specified does not match with that in the notification, ECHA will not be able to allocate the registration number to you. You are advised to contact your relevant Member State Competent Authority to resolve the situation. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.
Depending on your role(s), you will usually only receive one registration number. The table below highlights the combinations of roles and indicates the corresponding number of requests and registration numbers received.
A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from being considered registered according to Article 24 of the REACH Regulation. Cf. Section 184.108.40.206 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation
Nevertheless, it may happen that a company with a legal personality that has notified a substance has transferred the responsibilities for manufacture and import of that substance to another company. In such circumstances the original notifier may have transferred its notification to the company that has taken over the original notifier's activities relating to the manufacture or import of the notified substance. Such an event may happen for example after a merger of two companies or, the company splits.
For instruction on the steps to take please consult "Practical guide 8: How to report changes in identity of legal entities" available at: http://echa.europa.eu/practical-guides
In a handful of cases, the New Chemicals Database (NCD) has not been adequately updated to reflect the current details for some notifications, in particular, for tonnage bands. As a result, this information may appear incorrectly in REACH-IT and the system may be unable to correctly accept a potential update of the registration dossier.
It is extremely important and very easy to check that the tonnage band of your notification is correctly indicated in REACH-IT before you submit any update of your registration dossier to ECHA to avoid potential delays in the submission process as a result of a business rules failure.
To confirm that the correct tonnage is indicated in REACH-IT:
- Log in to REACH-IT >> Menu >> Search>>Reference numbers >> Search reference number using the criteria displayed Click on the Reference number link >> Tonnage band info is displayed under "Dossier type".
There are several tonnage bands mentioned in REACH-IT because under the REACH Regulation there are three possible registration types: standard registration, transported isolated intermediate (TII), and on-site isolated intermediate (OSII). Under Directive 67/548/EEC there was no such specific distinction and only one type of standard notification was required. All NONS notifications are initially regarded as standard registrations in REACH-IT. Therefore, your notified substance will initially not include any tonnage for isolated intermediates.
In the ‘Reference number' page you will also find under "Payment information" the tonnage band information which will be taken into account for invoicing purposes ( i.e. "Maximum tonnage band" and "Maximum transported isolated intermediate")
Initially, here you will see the same tonnage bands indicated for the standard registration as for the transported isolated intermediate (TII). This is to ensure that ECHA does not charge fees for tonnage band updates in cases where this would not be legitimate.
In case you submit an update of your registration for a tonnage band that is different to what is reported in REACH-IT, you should select in your dossier header that the reason for the update is a change of tonnage band.
In case the information recorded in REACH-IT for your substance does not match with what was indicated in your notification, you will need to make a request for an amendment. This is achieved by contacting your relevant Member State Competent Authority, who will in turn confirm that an amendment is necessary and provide ECHA with the correct details.
You can find the contact details of all the Member State Competent Authorities at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities
Information for a notification under Directive 67/548/EEC was initially submitted to the Member State Competent Authority in the Summary Notification Interchange Format (SNIF). Thereafter, all the SNIF files were transmitted to the former European Chemicals Bureau (ex-ECB) at the Joint Research Centre. This information, stored in a central database called the new chemicals database (NCD) at the ex-ECB, was migrated into IUCLID 5 format and distributed back to the responsible Member State Competent Authority in 2 formats (read-only and editable).
Claimants (owners of the notification) should contact their Member State Competent Authority to receive their files in IUCLID 5 format. The editable format will enable them to fulfil their obligations under REACH, in particular when they need to update their registration in the case where the next tonnage threshold is reached.
The tool developed to migrate the SNIF file to IUCLID 5 format is also available to industry as an add-on to IUCLID 5 on the IUCLID web site http://iuclid.echa.europa.eu/. Please note though, the SNIF migration plug-in can only be used with IUCLID version 5.1.
In order to migrate to IUCLID 6, first migrate to IUCLID 5.1 and then import to 5.6 and after import to ICUID 6.
Please pay attention to the migrated file results and check the generated IUCLID 5 substance dataset carefully (e.g. Legal entity, confidentiality claims, endpoint study records, classification and labelling…) before using it for updating your registration via REACH-IT.
The registration dossier must be updated if at least one of the cases described in Article 22 or Article 24(2) of the REACH Regulation applies. This would also include any update referring to the inclusion of the information required under Article 40 of the CLP Regulation (notification to the Classification & Labelling Inventory).
It is important to verify the information available for your notification in REACH-IT before you start the dossier update. When updating a NONS registration, the following three scenarios have to be taken into account:
- Tonnage band update
- Update to become the lead or a member of a joint submission
- Other updates
For more details please continue to Annex 4 of the "How to prepare registration and PPORD dossier" manual at: http://echa.europa.eu/manuals/.
Your dossier will undergo a series of initial administrative checks called "business rules". A dossier is accepted for processing by ECHA only if all of the relevant business rules are satisfied. Once your dossier has been accepted for processing:
- Your dossier will be allocated a submission number.
- Your dossier will undergo a completeness check.
- You will receive an invoice, if applicable, for an appropriate fee (for tonnage band upgrades and chargeable confidentiality claims not made under Directive 67/548/EEC).
- Your dossier will be regarded as complete once ECHA has verified the completeness of the information you submitted and received the payment of the relevant fee in accordance with Article 20(2) of the REACH Regulation.
Yes. REACH requires that certain information on chemical substances, which is kept in ECHA's databases, is made available to the public, free of charge, over the internet. This concerns, in particular, information specified in Article 119 of REACH. ECHA is already providing public access via the internet to such information from registration dossiers on its website at:http://echa.europa.eu/information-on-chemicals/registered-substances.
Information from NONS notifications will be released in a stepwise approach in order to allow NONS registrants to adapt the content of their dossiers to the REACH format, and insert adequate confidentiality claims if required. NONS registrants who have claimed their notification are being individually informed of the timelines for publication and the actions they need to take in relation to their dossier via a message in REACH-IT.
Please refer to chapter 2.5 of "Dissemination and confidentiality under the REACH Regulation" manual at: http://echa.europa.eu/manuals.
Any Sole Representative agreements are invalid after 31st May 2008. Where the intention is to appoint an Only Representative under REACH, new documentation/contract from the non-Community manufacturer(s) you represent needs to be drawn up.
The company claiming the registration number must indicate in REACH-IT that he/she is entitled to act as the Only Representative.
Please note that Only Representatives have to sign-up in REACH-IT for each and every non-Community manufacturer they represent for the same notification and submit a claim for NONS using the appropriate accounts.
Once you have indicated the notification specifics in the ‘Claim notification module' follow the wizard and:
- Declare that you have the agreement and the consent of the non-Community manufacturer to become the Only Representative under the REACH Regulation and that you are entitled to claim the registration number (tick the relevant box).
- Specify the non-Community manufacturer that you will represent as Only Representative for the notified substance.
- Attach the following documentation from the non-Community manufacturer you represent:
- Individual letter(s)/contract(s) from the non-Community manufacturer declaring that you are entitled to become their Only Representative under the REACH Regulation for the notified substance. The letter(s) should be in PDF format and written in one of the official Community languages.
If all the information specified is correct and matches with that in the notification:
You will instantly receive a submission number, and a reference number for the non-Community manufacturer you represent via REACH-IT.
You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities .
If the information specified does not match with that in the notification, ECHA will not be able to allocate any registration number to you.
You are advised to contact your relevant Member State Competent Authority to resolve the situation (http://echa.europa.eu/contacts-of-the-member-state-competent-authorities).
Once you have indicated the notification specifics in the ‘Claim notification module':
You must first sign-up in REACH-IT for each type of claimant you are (role) for the notified substance in question under Directive 67/548/EEC and submit a claim for NONS using the appropriate REACH-IT account.
In addition, as a former Sole Representative you have to sign-up in REACH-IT for each non-Community manufacturer you represent and submit a claim for NONS using the appropriate accounts.
You should then first request your registration number as a domestic Manufacturer AND/OR Importer (see Q&A 683).
Then you should request your registration number as a Sole Representative (see the process described before).
Downstream users can use substances, irrespectively of whether they have been (pre-)registered or not. In this regard use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation. Placing on the market is however not to be regarded as a use. Q&A 40 explains the need for substances to be (pre-)registered in order to be placed on the market.
Please note that for the use of substances (whether (pre-)registered or not) certain requirements related to restrictions, authorisation and risk management may apply. Guidance on how to comply with these requirements is provided in the Guidance for downstream users available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
The carriage of hazardous substances and mixtures by rail, road, inland waterway, sea or air is exempted from the scope of the REACH Regulation (see Article 2(1)(d)). Transporting activities (including loading and unloading) by transport companies are not "uses" under REACH.
The loading and unloading operations performed by the workers of the transport company are covered by the Carriage of Dangerous Goods legislation, and hence they are outside of the scope of the REACH Regulation. Compared to that, the site-related activities before loading and after unloading will often be "uses" under REACH, which may need an exposure scenario and a chemicals safety assessment.
It is also important to note that the transfer of substances and mixtures occurring exclusively within an industrial plant is covered by REACH, even if this includes transportation carried out by an external company.
Downstream users may make uses known to the suppliers in their supply chain, before the manufacturer or importer submits his registration, with the aim of making these uses identified uses. This right is enshrined in Article 37(2) of the REACH Regulation. When registrants base their assessment on information from downstream users, this helps to ensure that the advice they receive is directly applicable and that the handling of exposure scenarios is easier.
The information to registrants flows most efficiently through sector organisations, many of whom are developing use maps that describe the typical uses of their sector. Use maps describe the typical uses and conditions of use in an agreed template. Downstream users should check whether their sector organisations are preparing a sector use map that covers their use(s). Individual companies can also use these templates if they need to communicate any niche applications to registrants.
If as a downstream user you use the substance (as such or in a mixture) outside the conditions communicated to you in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, you may choose one of the following options:
- Adapt your conditions of use to those described in the eSDS.
- Implement or recommend an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to you. Make the use known to the supplier with the aim of making it an identified use based on the manufacturer's chemical safety assessment.
- Perform your own chemical safety assessment for that particular use and record it in a Chemical Safety Report - CSR (if the total amount used is 1 tonne/year or more). Notify your use, including the information specified in Article 38(2) of the REACH Regulation to ECHA.
- Switch to another supplier of the substance if that supplier covers your specific use in his eSDS.
If as a downstream user you receive information from your customers intended to make a use known you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the mixture and eventually carry out your own downstream user Chemical Safety Assessment (CSA).
If as downstream user you hold information that puts into question the hazard or risk management information received from the supplier you need to communicate this information to the supplier.
An overview of how to decide whether or not your use is covered by the exposure scenario can be found in section 6-'Deciding if the use is not covered by the exposure scenario' in the Guidance for downstream users. Information on how to make a downstream user chemical safety report is given in Section 7-'Making a downstream user chemical safety report' of the same guidance available at the ECHA website: https://echa.europa.eu/guidance-documents/guidance-on-reach
If a substance is subject to authorisation (Annex XIV):
- You must use the substance according to the conditions laid down in the authorisation granted for that specific use to an actor up your supply chain or apply for an authorisation yourself if the authorisation of your supplier does not cover your use(s);
- You must notify to ECHA within 3 months after first supply, the use of the substance subject to authorisation.
If a substance is subject to restrictions (Annex XVII):
- Comply with the restrictions for placing on the market or use of substances as listed in Annex XVII of the REACH Regulation.
Suppliers must include information on authorisation and restriction in Section 15 of the safety data sheet or in other information provided in accordance with Article 32 of REACH.
You have to report to ECHA within 6 months of receipt of the safety data sheet for a registered substance when you:
- Need to prepare a downstream user chemical safety report; or
- Wish to benefit from the exemption to prepare a chemical safety report either because:
- you use the substance in total less than 1 tonne per year; or
- You use the substance for product and process oriented research.
You also have to report to ECHA if your classification of a substance differs from that of all of your suppliers. Reporting is not required if the downstream user uses the substance or mixture in a total quantity of less than one tonne per year.
If you use a substance included in the Authorisation List, for which an authorisation has been granted that covers your use, you have to notify ECHA of your use within three months of the first supply of the substance.
Downstream users or distributors must check the registration status of the substances on their own or in a mixture they place on the market, in order to comply with the obligation imposed by Article 5 of REACH to place on the market only substances that comply with the registration requirements under REACH.
Manufacturers and importers of a substance on its own or in a mixture are encouraged to communicate with the downstream users or distributors of the substance with regard to whether and by when they intend to register the substance to enable the downstream user or distributor to seek alternative sources of supply if necessary. Once the substance has been registered, there is an obligation for the supplier to communicate the registration number down the supply chain either in the safety data sheet according to Article 31 or, if applicable, according to Article 32 of REACH.
The obligations under REACH for a DU using a substance for the purpose of PPORD may differ, depending on whether or not the PPORD activity is covered by a PPORD notification made by the manufacturer or importer of the substance.
A DU, who is listed in a PPORD notification submitted by the manufacturer or importer as one of the customers, operates under the responsibility of his supplier and must respect any conditions set in accordance with Article 9(4) of REACH and/or communicated to him by his supplier. If the DU stops using the substance for the purpose of PPORD and, by this, ends the cooperation with his supplier, he needs to inform his supplier, as the supplier will need to update his notification to remove the DU from the list of customers.
Alternatively, a DU can use a substance for the purpose of PPORD under his own responsibility and initiative. Since a DU does not have the registration obligation of Articles 5 and 6 of REACH, there is no need for the DU to submit a notification under Article 9 of REACH to be exempted from the registration obligation.
If he adequately controls the risks to human health and the environment in accordance with the requirements of legislation for the protection of workers and the environment, the DU is not required to prepare a DU CSR, even if his conditions of use are not covered in the extended SDS of his supplier or the use is advised against (Article 37 (4) (f)). According to Art 38(1)(b), the DU must report to ECHA if using a registered substance at greater than 1 tonne for the purposes of PPORD and availing of the exemption in Art. 37(4)(f).
The list of pre-registered substances has been published on the ECHA website at: https://echa.europa.eu/information-on-chemicals/pre-registered-substances
On this page, you can find out if and when a substance you use, as such or in preparations, is intended to be registered.
If a substance you use is not on the list, you can express your interest in the substance to the Agency (see Chapter 3 of the Guidance for downstream users - http://guidance.echa.europa.eu).
ECHA will then publish the name of the substance on its website. If a potential registrant requests, the Agency will provide them with your contact details.
Please note that if your supplier has not pre-registered, you cannot place the substances concerned on the market until they are registered. You may also want to seek another supplier that pre-registered the substance. ECHA is, however, not in a position to provide you with any list of potential registrants that pre-registered your substance.
More Q&As on pre-registration can be found at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/REACH/Pre-registration
It could be. There may be a valid reason for not having registered the substance yet – for example, the tonnage is below one tonne per year.
However, if you suspect that your supplier should have registered the substance already, we recommend that you contact them immediately to check. Make sure that substances critical to your business are registered and that your uses are covered. See https://echa.europa.eu/regulations/reach/downstream-users/other-issues-affecting-downstream-users/registration-and-downstream-users.
If a safety data sheet (SDS) is required for your substance, you will continue to receive it. However, when the SDS is updated after registration, you will see the registration number under section 1.1. You should also notice a change in that the updated SDS may contain one or more exposure scenarios as annexes, if your supplier has registered the substance for 10 tonnes/year or more. These exposure scenarios outline the conditions of safe use of the substance for specific uses.
You need to identify which exposure scenario(s) apply to your use(s) and check whether your conditions of use are in line with them. You will also need to take this information into account when communicating on safe use for the products that you place on the market.
Note that the exact time for updating the SDS is not defined under REACH and will depend, among other things, on whether any new information on the hazards and risk management measures have been generated in the course of the registration process.
According to the legal text the 12 months starts as soon as the DU receives an SDS containing a REACH registration number (Article 39(1) REACH). Nonetheless, it is understood that the DU requires an ES to be attached to the SDS, or at least for “uses advised against” to be included in Section 1 of the SDS, in order to determine if their uses are indeed included or excluded in the registration dossier. In cases where the required information has not been provided in the SDS, it is advisable that the DU communicates with his supplier to check why, record this communication, and the date when they receive an ES.
An impurity in a polymer is defined as an unintended constituent present in the manufactured polymer substance. It may originate from the starting materials, such as the monomers or any other reactants, or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added. Examples of impurities in a polymer include unreacted monomers or other reactants, residual polymerisation catalyst, or any contaminant from the manufacturing process. The definition and detailed guidance on how to handle impurities can be found in Section 4.2.- 'Substances of well defined composition', Section 4.3.- 'UVCB substances', and Chapter 5- 'Criteria for checking if substances are the same' of the Guidance for identification and naming of substances Under REACH and CLP: http://echa.europa.eu/guidance-documents/guidance-on-reach
The provisions under the REACH Regulation with regard to information in the supply chain (Title IV), authorisation (Title VII), restrictions (Title VIII) and classification and labelling C&L (Title XI) may also apply to polymers. Further information on this issue is provided in Section 3.2.2- 'Application for authorisation', Section 3.2.3- 'Compliance with restrictions', 3.2.4- 'Classification and labelling', and Section 3.2.5- 'Information down the supply chain' of the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Natural polymers are understood as polymers, which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not meet the criteria set out in Article 3(39) of the REACH Regulation).
Following Article 2(9) of the REACH Regulation, any polymer meeting the criteria of Article 3(5) of the REACH Regulation does not have to be registered. This includes natural polymers, which are chemically modified (e.g. post-treatment of natural polymers).
Monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) originating from the natural polymer can for practical reasons be treated as "non-isolated intermediates" and do not have to be registered. The substances used to chemically modify the natural polymer and which are chemically bound within the final polymer need to be registered according to the REACH requirements.
This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.
Yes. The registration of a monomer or other substance chemically bound to a polymer has to include spectral data and a chromatogram of the original monomer or other substance used to manufacture the polymer.
If it is not technically possible, or if it does not appear scientifically necessary to include this information, the reasons need to be clearly stated. Generic spectral data or a generic chromatogram cannot be accepted as this would not reflect the actual composition of the monomer or other substance used to manufacture the polymer.
It may be the case that a company imports a type of polymer from different sources, and therefore a monomer or other substance used in the manufacture of this polymer probably also stems from different sources. Even when a company imports a polymer from just one source, it can happen that a monomer or other substance used in the manufacture of this polymer stems from different sources.
In these cases, the importer of the polymer is responsible for assessing the sameness of the monomer or other substance from the different sources. If they consider that the substances from the different sources are the same, they have to submit just one registration for this substance with one set of spectral data and one representative chromatogram. In this process, they might still have found out that the substance from the different sources has different impurity profiles. They need to then refer to these different compositions of the substance in their registration dossier.
Natural proteins may be considered as polymers under REACH provided that they have at least 50 weight percent of polymer molecules (in this case, molecules including a sequence of at least four amino acid monomer units) and the content of molecules presenting the same molecular weight remains below 50 weight percent.
Similarly, hydrolysed natural proteins may be considered as polymers if they fulfil the abovementioned criteria. If the degree of hydrolysis is to such an extent that less than 50 percent of the weight of the substance consists of polymer molecules (as defined in chapter 2.2 of the Guidance for monomers and polymers) and/or the amount of polymer molecules presenting the same molecular weight is at least 50 weight percent, the hydrolysed natural protein is not a polymer and, hence, is not covered by the registration exemption for polymers under REACH.
A downstream user chemical safety report documents the results of the chemical safety assessment undertaken by the downstream user. The assessment establishes conditions to ensure that the risk for the use(s) not covered in the received exposure scenarios is adequately controlled. The downstream user chemical safety report itself does not need to be submitted to ECHA.
A downstream user report is a report by a DU to ECHA when:
- He has to prepare a downstream user chemical safety report or is claiming exemption
- His classification of the substance is different to that of his supplier
- A downstream user notification is required when a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers the use.
A downstream user can make a testing proposal. ECHA examines this proposal and decides on appropriate testing in accordance with Article 40 of REACH. It is the responsibility of the downstream user to perform the test, unless other downstream users or registrants are also interested in carrying out such a test.The interested parties can agree on who will perform the test on behalf of all of them. If agreement is not reached, the Agency shall designate one of the parties to perform the test on behalf of all. All parties concerned share the cost of the study.
It is possible that a reference substance does not exist in the downloadable reference substance list. In this case, you will need to create the reference substance yourself. The reference substance needs to be included in the substance dataset. You can find more information on how to create a reference substance in section 6.1 of the manual How to prepare registration and PPORD dossier at: http://echa.europa.eu/manuals
Downstream users have to provide all the information as required by Article 38 of the REACH Regulation.Section 1.3 of IUCLID is where you provide the supplier's registration number for the substance, as required by Article 38(2)(b). If the registration number is not available to you, you must provide a justification for this in the same section.
Additionally, when updating a downstream user report, you should also include in this section the downstream user report's reference number.
Therefore, it is advised to follow the instructions included in the Manual: How to prepare a downstream user report at: http://echa.europa.eu/manuals.
- Option (i): The webform is the simpler option. It is recommended for most downstream users, especially those who have not used IUCLID before.
- Option (ii): Reporting via REACH-IT is recommended for downstream users who already use IUCLID and want to maintain all their report records in the REACH-IT/IUCLID system.Downstream users who need to report if their classification is different to that of their supplier can only use option (ii), via REACH-IT.
- the identity and contact details of the downstream user;
- the registration number of the substance, if available;
- the identity of the substance;
- the identity of the supplier;
- a brief general description of the unsupported use(s) and conditions of use; and
- a proposal for additional testing on vertebrate animals if this is considered necessary.
A tutorial is available on using the webform.
- Prepare a Downstream user report dossier in IUCLID 6 as explained in the manual: How a downstream user report at: http://echa.europa.eu/manuals.
- In the IUCLID 6 dataset, enter information on your classification and labelling of the substance as explained in the manual How to prepare a classification and labelling notification at: http://echa.europa.eu/manuals
- Create the downstream user report dossier and export it as explained in the downstream user manual
- Submit the report to ECHA via REACH-IT
No fee is charged for the submission of a downstream user report. ECHA fees and charges for services and their amounts are stated in the REACH Regulation and in Regulation (EC) No. 340/2008 (Fee Regulation).
Yes, because besides registration there are several obligations under REACH that apply irrespective of tonnage. These include restrictions, authorisation and communication in the supply chain (such as the provision of safety data sheets). The one tonne per year threshold applies to registration only.
To identify your obligations, we recommend you to use the Navigator tool: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations
Active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Regulation (EU) 528/2012 (Biocidal Products Regulation). However, several conditions have to be fulfilled to benefit from the exemption. These conditions are laid down in Article 15(2) of the REACH Regulation and explained in section 220.127.116.11- 'Substance for use in biocidal products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.
Active substances for use in plant protection products (PPPs) are regarded as registered as the plant protection products and their active ingredients are covered by Regulation (EC) 1107/2009. Please note that even though co-formulants are mentioned in Article 15(1) of the REACH Regulation, currently they do not meet the conditions laid down in this Article. Therefore co-formulants used in plant protection products do not qualify for the exemption and are not regarded as registered. This is further explained in section 18.104.22.168- 'Substance for use in plant protection products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.
It is important to note, that only the quantities of the active substance for use in biocidal products and for use in PPPs are considered registered under REACH. Thus, if the substance is not used as an active ingredient in a biocidal product or a PPP, then the exemption would not apply to this other use and the quantity of the substance for the non-biocidal or non-PPP use would have to be registered.
REACH applies both to substances occurring in nature, as defined by Article 3(39) of REACH, and to their synthetic analogues.
However, Annex V to REACH states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal. These substances can only be processed by certain means (e.g. dissolution in water, flotation), which are specified in Article 3(39) of REACH and do not include chemical modification (Article 3(40)).
Other substances occurring in nature are also exempted from registration if they are not chemically modified, unless:
- they meet the criteria for classification as dangerous according to the CLP Regulation (Regulation 1272/2008), or
- they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or
- they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).
Further explanations and background information on the different exemptions in Annex V are included in section 22.214.171.124 - 'Substances covered by Annex V of the REACH Regulation' of the Guidance on registration: http://www.echa.europa.eu/guidance-documents/guidance-on-reach
The REACH Registration Q&As provide guidance on substances occurring in nature that are obtained by extraction processes.
For particular guidance on polymer substances occurring in nature, see section 126.96.36.199 - 'Case of a natural polymer or a chemically modified natural polymer' of the Guidance for monomers and polymers: http://www.echa.europa.eu/guidance-documents/guidance-on-reach
Since the synthetic analogues of naturally occurring substances do not meet the criteria for substances occurring in nature as defined in Article 3(39) of REACH, any manufacturer or importer of these substances in quantities of one tonne or more per year is required to register them.
Substances listed in Annex IV to REACH are exempt from registration. Modified substances derived from these substances are also exempt if the modified substance is still covered by the same EINECS entry; whether the same EINECS entry applies is a case-by-case decision. For example, for plant oils such as soybean oil (EINECS no 232-274-4; CAS no 8001-22-7) the physically modified derivatives are explicitly covered in the EINECS entry. Whereas chemical modification (e.g. hydrogenation) is not mentioned and hence considered not to be covered. For further information, see Article 3(40) of REACH and Section 188.8.131.52- 'Substances included in Annex IV of the REACH Regulation' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach
Yes, they do and their health and environment properties must be assessed in accordance with the provisions of the REACH Regulation. Potential registrants should first consider whether they have obligations under REACH, irrespective of the particle size of the substances. Once it is established that the substance falls within the scope of REACH, further investigation of the detailed provisions of REACH may indicate that different provisions apply according to the hazard properties associated with the particle size of the substances. The evolving science of nanotechnology may necessitate further requirements in the future to reflect the particular properties of nanoparticles.
Yes, biomethane obtained by the purification of biogas is considered to be covered by the exemption from registration according to Annex V entry 12 to REACH. This exemption does not refer to biomethane as such, but to biogas (consisting mainly of methane) produced by the biological breakdown of organic matter (e.g. agricultural waste, municipal waste, sewage) in the absence of oxygen. Nevertheless, biomethane obtained by the purification of biogas to remove undesirable components is still considered as biogas and is, therefore, exempted from registration according to Annex V entry 12 to REACH.
For methane processed from raw natural gas, the exemption in Annex V entry 7 to REACH applies. Methane obtained from other sources than fossils is not regarded as natural gas and is, therefore, not covered by this entry.
Only a natural or legal person established within the European Economic Area (EEA)/EU can be a registrant. Registration must take place when this person:
- manufactures a substance within the EU in quantities of 1 tonne or more per year;
- imports a substance into the EU of quantities of 1 tonne or more per year; or
- has been appointed as an only representative according to Article 8 of REACH (see FAQs on Only Representative of non-EU manufacturer).
The national law of each country provides the specific provisions concerning natural or legal personality and when such a natural or legal person is established in its territory.
A company not established within the EU does not have direct obligations under REACH. For obligations of a non-EU company, please see to FAQ 12.
In order to identify your obligations, please use the Navigator tool:
This tool is designed to help companies in determining their obligations under REACH and find the appropriate guidance on how to fulfil them.
En legotillverkare anses i regel vara ett företag som mot ekonomisk ersättning tillverkar ett ämne (som sådant, ingående i blandning eller i en vara) i sina egna tekniska utrymmen enligt anvisningar från en tredje part. Ämnet släpps i regel ut på marknaden av den tredje parten. Till exempel används den här konstruktionen för mellanled i produktionsprocessen som kräver sofistikerad utrustning (destillation, centrifugering osv.). Enligt Reachförordningen måste tillverkare av ämnen i mängder om 1 ton eller mer per år registrera dem. Legotillverkare betraktas i detta avseende som tillverkare och måste registrera ämnet.
Detta scenario diskuteras närmare i faktabladet ”Legotillverkare enligt Reach-förordningen” som finns på följande adress:
International companies sometimes have several daughter companies in the EEA/EU, often spread over several countries. If these subsidiaries of the parent company are separate legal entities from it, (a natural or legal person as defined under applicable national law), then each of those must determine if they qualify as registrant under REACH.Please see FAQ ID=27 on who has to register a substance.
National Process Orientated Research and Development (PORD) exemptions for the notification of substances under Directive 67/548/EEC are no longer valid under REACH since 1 June 2008, because there are no such notifications under REACH. Therefore, to benefit from the registration exemption, manufacturers or importers of substances or producers of articles wishing to continue their PORD activities need to submit a PPORD notification (REACH, Article 9). For guidance on how to prepare and submit a PPORD notification in practice, please consult the Data Submission Manual 1, available at:
Yes, a notification under Directive 67/548/EEC as amended by Directive 92/32/EEC is nominal so that only the notifier benefits from the provision that notified substances are being considered registered. Therefore, any other parties manufacturing or importing the substance in quantities of more than one tonne per year who have not notified this substance, must register it unless another exemption from the duty to register applies. More information on notified substances can be found in Article 24 (2) of the REACH Regulation and in Section 184.108.40.206- 'Notified substances according to Directive 67/548/EEC' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
REACH imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). The registration obligation does not apply to downstream users or distributors. Therefore, the registration obligation does not apply to you if you have:
- manufactured or imported pre-registered substances before the registration deadline; and
- completely ceased such activities and only used the substances and/or supplied them after that.
For example, importers for whom the last batch of the substance was imported on 31 May 2018, at the latest, may continue to use and/or supply that substance after the deadline without a registration, without time-limitation. Since the pre-registered substance has not been registered, there is no obligation to notify ECHA of the cessation of manufacture/import. Article 50(2) and (3) of the REACH Regulation does not apply to this situation.
If you have not ceased your activities before the registration deadline, you have an obligation to register the substance according to Article 6 of REACH.
If you are a downstream user (or any other actor down the supply chain) who is not subject to the registration obligation, you can continue to use, without time-limitation, and/or supply quantities of the substance that were manufactured or imported before the registration deadline.
For the obligations of a downstream user or distributor and whether they are obliged to check the registration status of the substances on their own or in a mixture, please see Q&A 155
Yes. Substances are not exempted from (pre-)registration on the grounds that they are within the scope of Regulation (EC) No. 2037/2000 on substances that deplete the ozone layer. FAQ ID=30 explains which substances have to be (pre-)registered.
Information on the various aspects that need to be taken into account before registration is provided in Section 2.3- 'When to register?' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
The REACH Regulation created a transition regime involving a pre-registration phase for the registration of substances (Section 220.127.116.11- 'Phase-in substances' of the Guidance on registration). Depending on its intrinsic properties and its tonnage, a pre-registered substance needed to be registered before either of the relevant previous deadlines in 2010 and 2013, or by the last one on 31 May 2018.
Substances that were not pre-registered must be registered before the manufacture or import can continue at an annual quantity of one tonne or more. Before the registration of such substances, the manufacturer or importer has to make an inquiry to ECHA regarding any previous registration for that substance.
Upon registration, the registrant may have to wait for three weeks after the registration dossier is submitted before starting or continuing the manufacture or import of the substance (Article 21 of the REACH Regulation).
Alla registranter måste beräkna vilken årsvolym som ska uppges i registreringsunderlaget. Årsvolymen beräknas som volym per tillverkare/importör per kalenderår, om inget annat anges. För infasningsämnen som har importerats eller tillverkats i minst tre år i rad beräknas volymerna utifrån den genomsnittliga tillverknings- eller importvolymen under de tre föregående kalenderåren (artikel 3.30 i Reach-förordningen). Detaljerad vägledning och praktiska exempel finns i avsnitt 2.2.6 ,"Beräkning av den mängd som ska registreras", i vägledningen om registrering: http://echa.europa.eu/guidance-documents/guidance-on-reach
Yes. Companies are free to register a substance for a tonnage band which is above the actual tonnage of the substance. This is also reflected in Section 18.104.22.168- 'Calculation of the total volume' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.
This section clarifies that companies are free to register a substance for the intended tonnage band. A registration at a higher tonnage band will trigger a higher registration fee in accordance with Regulation (EC) No 340/2008. In addition, the technical dossier will need to comprise all the information required for the registered tonnage band. Practical advice on how to complete a IUCLID dossier is provided in the Manual: How to prepare registrations and PPORDS at: http://echa.europa.eu/manuals.
All registrations shall be submitted to ECHA. This shall be done using the REACH-IT Portal. For more information please visit the REACH-IT section of the ECHA website: http://echa.europa.eu/support/dossier-submission-tools/reach-it.
According to Article 111 of the REACH Regulation, registration dossiers have to be submitted in the format of IUCLID (International Uniform Chemical Information Database). IUCLID is a software tool for companies to store data on chemicals and prepare registration dossiers. Registrants are not obliged to use the IUCLID software, but they must submit their registration in the IUCLID format.
The IUCLID software is downloadable free of charge from the IUCLID website http://iuclid6.echa.europa.eu/home.
Registreringsavgiften för ett ämne beror på vilken mängd (volym) som ska registreras, företagets storlek och typen av inlämning. Dessutom gäller:
- Avgifterna är lägre för gemensamma inlämningar än för enskilda inlämningar. Detta gäller inte om du hoppar av från en gemensam inlämning.
- Avgiften för små och medelstora företag är lägre i alla kategorier.
- En extra avgift tas ut om man begär konfidentialitet.
Ingen avgift tas ut för registreringar av ämnen i mängder mellan 1 och 10 ton per år om registreringen innehåller all information som krävs enligt bilaga VII, där grundkraven fastställs för ämnen som tillverkas eller importeras i mängder på minst 1 ton.
Alla bestämmelser hittar du i artikel 74 i Reach. Avgifterna har fastställts i kommissionens förordning om avgifter ((EG) nr 340/2008). Du hittar mer information i Reach-IT:s "Frågor och svar" om fakturering (under "Invoicing"):
No, under REACH, a third party representative cannot register. A third party representative can be appointed by a manufacturer, importer or downstream user for data sharing issues and discussions with other manufacturers, importers or, where relevant, downstream users. Unlike an only representative, a third party representative only plays a part in the negotiations between the (potential) registrants, while the appointing company remains responsible for complying with its registration obligations.
If an inquiry for this substance is submitted to ECHA by a potential registrant, the contact details of the notifier are communicated to the potential registrant according to Article 26(3) of REACH. In this respect, claimed and non-claimed registration numbers are treated equally in REACH-IT.
A letter with contact details of the potential registrant will also be sent to the notifier. In the same letter ECHA will again remind the notifier to claim the registration number.
Under REACH, substances notified in accordance with Directive 67/548/EEC (known as NONS: Notification of New Substances) are regarded as registered by the manufacturer, importer, or sole representative who submitted the notification. You, as owner of the notification, can claim a registration number from ECHA for the tonnage notified. For practical details please see the Questions and Answers on NONS:
If the quantity of the manufactured or imported substance which you have notified reaches the next tonnage threshold, (1, 10, 100 or 1000 tonnes/year), you need to update your registration without 'undue delay'. You do not need to stop your manufacturing/importing while your updated dossier is processed unless otherwise indicated by ECHA.
When updating your registration dossier you need to comply both with:
- the information requirements of the new tonnage band; and
- the information requirements from the lower tonnage bands.
For example, if you increase your tonnage to 10 tonnes/year or more, you need to submit the information required for 10 tonnes or more (Annex VIII), the chemical safety report; and also the information required for 1 tonnes or more (Annex VII).
In order to avoid unnecessary testing on vertebrate animals, you have to inform ECHA immediately of the additional information requirements for the new tonnage level by submitting an inquiry dossier. Upon receipt of this information, ECHA acts as in the inquiry process which is further described in the chapter 'Update of registration dossier for substances regarded as being registered under REACH' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach. ECHA should inform you of the names and addresses of the previous registrants and of any relevant study summaries already submitted by them in order to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated.
If a registrant changes its TPR, the new TPR will have to create a REACH-IT account (provided he does not yet have a REACH-IT account).
In case of a change of TPR, the following steps shall be taken by the registrant in order to update the details of its TPR:
To update a TPR in a pre-registration or a registration submission: Go to menu -> Search -> Reference numbers -> Input the number in the search criteria -> Click on the results -> Click on Edit under Third party representative -> Add the new TPR.
No fee is required if the TPR is updated in a registration dossier.
Yes. You have to submit an inquiry to ECHA although you have established a contact with the lead registrant (LR) and therefore have access to the respective and most up to date data package.
The obligation to submit an inquiry serves to avoid unnecessary testing and in particular to reduce testing on vertebrate animals. In addition, it provides the potential registrants the advantage that ECHA has verified the identity of the substance foreseen for registration and puts them in contact with the correct previous registrants and inquirers. By contrast, it is up to the members of a SIEF themselves to verify that they register the same substance.
Further guidance can be found in the Questions and Answers documents on inquiry and substance identification available in the following web page:
Manufacturers and importers who have manufactured a substance in any of the current Member States of the EU at least once after 31 May 1992 (15 years before the entry into force of REACH) and never placed it on the EU market can benefit from the phase-in scheme. This benefit also applies if you were a manufacturer before the entry into force of REACH and became an importer after it.
For all other manufacturers and first time importers who did not manufacture the substance in the EU, the substance is considered as a non-phase-in substance.
A registrant needs to update their registration without undue delay as soon as the ‘annual or total quantities’ they manufacture or import reach the next tonnage band threshold, as required by Article 22(1)(c). As soon as the annual volume of a substance that has already been registered (regardless of its phase-in status before registration) reaches the next tonnage threshold, the manufacturer or importer has the duty to immediately inform ECHA of the additional data required, following Article 12(2).
Further information is available at: http://echa.europa.eu/support/registration/your-registration-obligations/do-i-reach-the-one-tonne-a-year-threshold
Om du är skyldig att registrera intermediärer beror på till vilken typ av intermediärer din intermediär hör enligt definitionen i artikel 3.15 i Reachförordningen.
- Icke-isolerade intermediärer:
Vid användning av ett ämne som en icke-isolerad intermediär finns det inga skyldigheter enligt Reachförordningen.
- Isolerade intermediärer som används på plats:
En tillverkare av isolerade intermediärer som används på plats i mängder på 1 ton eller mer per år måste registrera sina ämnen, om de inte är undantagna från registreringsplikten (se FAQ ID=30). Registranter av isolerade intermediärer som används på plats kan dock tillhandahålla reducerad registreringsinformation enligt artikel 17.2 i Reachförordningen, om de kan bekräfta att ämnet tillverkas och används under strängt kontrollerade förhållanden enligt beskrivningen i artikel 17.3 i Reach.
- Isolerade intermediärer som transporteras:
En tillverkare eller importör av isolerade intermediärer som transporteras i mängder på 1 ton eller mer per år måste registrera sina ämnen, om de inte är undantagna från registreringsplikten. Registranter av isolerade intermediärer som transporteras kan dock tillhandahålla reducerad registreringsinformation enligt artikel 18.2 i Reachförordningen, om de kan styrka att ämnet tillverkas och/eller används under strängt kontrollerade förhållanden och om de bekräftar eller uppger att de har fått bekräftelse från användaren om att ämnet används under strängt kontrollerade förhållanden enligt beskrivningen i artikel 18.4 i Reach. I sådant fall är både registranten och användarna ansvariga för sina egna uppgifter om de strängt kontrollerade förhållandena.
När och hur de olika bestämmelserna för registrering av intermediärer enligt Reach kan användas beskrivs i Vägledning om intermediärer: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Mer information finns på https://echa.europa.eu/documents/10162/13655/pg16_intermediate_registration_sv.pdf
The SFF role was created to initiate and conduct discussions after pre-registration, and to facilitate the exchange of information and data required to form the SIEF. However, the SFF role is not formally recognised under REACH and potential registrants have no legal obligation to use an SFF to form a SIEF. If no pre-SIEF member has taken the initiative to take on the role of SFF or the SFF is inactive, you should contact the other pre-SIEF members to know more about the status of your SIEF.
The pre-SIEF is the first step for recognising potential registrants of the same substance and help you to start discussions on substance identity and substance sameness. SIEFs are expected to start communicating and organising themselves outside the REACH-IT environment. ECHA recommends that potential registrants contact their relevant trade associations to receive further advice on how to evolve from pre-SIEFs to SIEFs.
When brought in contact with water, chromium trioxide (EC number 215-607-8) forms two acids and several oligomers: Chromic acid (EC number 231-801-5), Dichromic acid (EC number 236-881-5), Oligomers of chromic acid and dichromic acid.
These chemical species are identified as substances of very high concern (SVHC) and included in the Candidate List1 as two separate entries.
Chromic acids and their oligomers generated in water from chromium trioxide are commonly referred to as an aqueous solution of chromium trioxide. With regard to the obligation to register, it may be justifiable in some specific situations described in the table below, to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide. Hence, in these specific cases, chromic acids and their oligomers present in an aqueous solution of chromium trioxide can be covered by a registration dossier for chromium trioxide.
Important note: The presented approach is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. It derives from very specific aspects of the Chromium VI aqueous chemistry; the system in aqueous solution is a complex equilibrium between multiple chemical species which depends on several physico-chemical parameters and the different chemical species cannot be isolated from the aqueous solution. The approach can thus not be applied by analogy to any other substance.
Manufacturers and importers of chromium trioxide and chromic acids and their oligomers have to consider the following situations:
|Actor / Scenario||Legal requirement||Explanation|
|Manufacturer or importer of chromium trioxide who generates chromic acids and their oligomers in water||One registration according to Article 10 for chromium trioxide|| |
The generation of chromic acids and their oligomers by adding chromium trioxide to water and their further use have to be included in the registration dossier and have to be considered for the chemical safety assessment (CSA) and the chemical safety report (CSR).In case a downstream user (DU) generates chromic acids and their oligomers from chromium trioxide, this use has to be communicated up the supply chain and has to be included in the registration dossier.
Importer of both chromium trioxide and chromic acids and their oligomers generated in water from chromium trioxide
|One registration according to Article 10 for chromium trioxide||The registrant has to register chromium trioxide and chromic acids and their oligomers in one dossier for chromium trioxide. It has to become clear from the registration dossier that chromic acids and their oligomers are also imported. Therefore, at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to chromium trioxide; the second composition refers to the composition of chromic acids and their oligomers. A remark has to be entered to clarify the approach. The tonnage to be reported is the aggregated tonnage of both chromium trioxide and chromic acids and their oligomers. The tonnage has to be reported on the basis of equivalent chromium trioxide tonnage.|
|Importer of chromic acids and their oligomers generated in water from chromium trioxide|| Registration according to Article 10 |
either for chromic acids and their oligomers generated from chromium trioxide
or for chromium trioxide
In case the importer decides to register chromic acids and their oligomers in a dossier for chromium trioxide, it has to become clear from the registration dossier that what is actual imported are chromic acids and their oligomers.Therefore at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to the generic substance "chromium trioxide"; its purity and composition should be indicated as 100 %. The second composition shall refer to the actual composition of chromic acids and their oligomers which are imported. A remark has to be entered to clarify the approach.
| Manufacturer or importer of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water |
Importer who is unaware of the manufacturing methods of the chromic acids and their oligomers
|Registration according to Article 10 for chromic acids and their oligomers||The approaches described above cannot be applied as the starting material for manufacturing chromic acids and their oligomers is not chromium trioxide or is not known.|
Under REACH, manufacturing means producing or extracting substances in their natural state. It is a case-by-case decision to establish the extent to which the different steps in producing the substance are covered by the definition ‘manufacturing'.
A company that purchases registered substances from within the EU and then formulates these into mixtures (e.g. paints) would be regarded as a downstream user under REACH.
In layman's terms, this company might be considered to be a manufacturer of paints. However, within the context of REACH, the company would not be a manufacturer of a substance and so would have no registration obligations for these substances. For further information see the Guidance on registration (http://echa.europa.eu/documents/10162/13632/registration_en.pdf). Examples on manufacturing on intermediates available in the Guidance on intermediates and Practical Guide 16.
Du ansvarar för registreringen om du är den juridiska enhet som är etablerad i EU och ansvarar för importen.
Ansvaret för importen beror på många faktorer, bland annat:
- Vem är det som beställer?
- Vem betalar?
- Vem ansvarar för tullformaliteterna?
Men det är inte säkert att enbart detta är avgörande.
En försäljningsagentur som är etablerad i EU och som agerar som mellanhand, dvs. som förmedlar en beställning från en köpare till en leverantör utanför EU (och får betalt för denna tjänst), men som inte tar något som helst ansvar för varorna eller betalningen av varorna och som inte äger dem i något skede. I detta fall betraktas försäljningsagenturen inte som importör enligt Reach. Försäljningsagenturen ansvarar inte för den fysiska införseln av varorna.
I flera fall är försäljningsagenturen den sista varumottagaren som är den juridiska enhet som ansvarar för importen av varorna.
Mer information och ytterligare exempel finns i kapitel 22.214.171.124 ”Vem ansvarar för registreringen vid import?” i Vägledning om registrering:
Om dina leverantörer är etablerade utanför EU och bestämmer sig för att utse en enda representant kommer de att skicka en bekräftelse om detta till alla importörer. Du bör företrädesvis även få en skriftlig bekräftelse från den enda representanten på att den importerade mängden och användningen verkligen omfattas av registreringsunderlaget.
Detta ger dig inte bara en kontaktperson som du kan lämna information till om din användning, utan utgör även en tydlig dokumentation om att din import verkligen omfattas av den enda representantens registrering.
Du måste dokumentera exakt vilka mängder av det importerade ämnet som omfattas av registreringen av den enda representanten och vilka mängder som inte gör det. Mer information finns i kapitel 126.96.36.199 ”Enda representant för en 'tillverkare utanför EU'” i Vägledning om registrering:
Ämnen som har registrerats och som exporteras och därefter återimporteras är undantagna från registreringsplikten under vissa omständigheter.
För att kunna utnyttja detta undantag måste du dokumentera att följande villkor är uppfyllda:
- Ämnet måste ha registrerats innan det exporterades från EU.
- Det ämne som redan har registrerats och exporterats måste vara detsamma som det ämne som återimporteras.
- Ämnet måste inte bara vara detsamma utan måste även komma från den distributionskedja där ämnet registrerades.
- Återimportören måste ha försetts med information om det exporterade ämnet enligt kraven i Reach (t.ex. säkerhetsdatablad).
Mer information finns kapitel 188.8.131.52 ”Återimporterade ämnen” i Vägledning om registrering:
Om ämnen befinner sig i tillfällig förvaring för att återexporteras och förblir föremål för tullövervakning omfattas de inte av Reach.
För att kunna åberopa detta undantag måste du dokumentera att följande villkor är uppfyllda:
- Ämnena placeras i en frizon eller i ett frilager enligt tullagstiftningens definition eller blir föremål för annat relevant tullförfarande (transitering eller tillfällig lagring).
- Ämnena är föremål för tullmyndighetens övervakning.
- Ämnena genomgår inte någon behandling eller bearbetning medan de befinner sig i EU. En frizon eller ett frilager inom EU:s territorium ingår i EU.
Mer information finns i kapitel 184.108.40.206 ”Ämnen som är föremål för tullövervakning” i Vägledning om registrering:
Ett ämne kan vara avsett att avges från en vara för att ge den ett mervärde. Parfymerade barnleksaker är exempel på sådana varor med avsiktlig avgivning av ämnen, eftersom de doftämnen som ingår i leksaken är avsedda att avges för att ge varan ett mervärde, i det här fallet en behaglig doft.
Ett exempel på motsatsen är bläckpatroner eller våtservetter. I dessa fall är det möjligt att fysiskt separera ämnena från varan. De är därför inte att betrakta som ämnen i en vara, utan snarare som ämnen i en behållare.
Detta innebär att leverantören av bläckpatronerna betraktas som leverantör av ett ämne och den allmänna registreringsskyldigheten gäller.
Mer information finns i Vägledning om krav för ämnen i varor:
Om man vill ta reda på vilka användningar ett ämne har registrerats för måste man i de flesta fall vända sig till andra aktörer högre upp i distributionskedjan.
För att göra detta måste du beskriva ämnets funktion i varan, processen genom vilken ämnet införlivas i varan och i vilken typ av vara det rör sig om. Beskrivningen bör följa systemet med användningsdeskriptorer.
Säkerhetsdatablad (SDS) kan vara till hjälp eftersom de innehåller information om användningar av ämnet eller blandningen i den utsträckning leverantören känner till dem. Om ett säkerhetsdatablad dessutom inbegriper ett registreringsnummer kan det, beroende på hur utförliga användningsbeskrivningarna i säkerhetsdatabladet är, vara möjligt att dra slutsatsen att en särskild användning av detta ämne redan har registrerats. Vid osäkerhet bör du dock vända dig till den faktiska registranten högre upp i distributionskedjan för bekräftelse.
Man kan också kontakta tillverkare eller importörer i en annan distributionskedja för att fråga vilka användningar de har registrerat ämnet för eller om de har registrerat ämnet för en särskild användning.
En bra metod för att leta upp tillverkare och importörer av ett ämne är att sända in en förfrågan inom forumet för informationsutbyte om ämnen (SIEF). Den som sänder in en förfrågan måste först ha förhandsregistrerat ämnet eller anslutit sig till forumet som datainnehavare.
Mer information finns i Vägledning om krav för ämnen i varor:
Som enda representant är du fullt ut ansvarig för att alla skyldigheter som gäller importörer fullgörs för de ämnen som du ansvarar för. Detta gäller inte enbart registreringen utan även alla andra skyldigheter som importörer har enligt Reach. Som enda representant ska du registrera de importerade mängderna, beroende på avtalen med ”tillverkaren utanför EU”.
Du kan representera en eller flera ”tillverkare utanför EU”. Om du representerar flera ”tillverkare utanför EU” måste du lägga fram en separat registrering för var och en av tillverkarna.
Registreringsunderlaget ska innehålla alla importörens användningar som omfattas av registreringen. Du ska spara en aktuell förteckning över de importörer som ”tillverkaren utanför EU” har inom samma distributionskedja och den mängd som omfattas för var och en av dessa, liksom information om den senaste uppdateringen av säkerhetsdatablad som har skickats ut.
Mer information finns i kapitel 220.127.116.11 ”Enda representant för en ’tillverkare utanför EU’” i Vägledning om registrering:
Varje år måste du beräkna den årliga volymen genom att ta fram ett genomsnitt för de tre föregående åren.
Ditt företags volymer är 60 ton 2013, 90 ton 2014, 140 ton 2015 och 200 ton 2016. Den genomsnittliga volymen för tre år i följd blir 97 ton/år för 2016 men 143 ton/år för 2017.
I detta fall måste du registrera ämnet så fort som möjligt eftersom tidsfristen för registrering av ämnen som uppgår till över 100 ton per år gick ut den 31 maj 2013. Registreringsskyldigheten baseras på volymen för 2017 som är ett genomsnitt för åren 2014–2016, dvs. 143 ton.
Eftersom årsvolymen bygger på ett genomsnitt för tre år borde det bli enklare för företagen att förutse en eventuell ökning av årsvolymen.
Mer information finns i vägledningen om registrering:
En polymer är ett ämne som består av molekyler som är uppbyggda av en sekvens av en eller flera typer av monomerenheter. Molekylerna ska vara fördelade över en rad molekylvikter. Skillnaden i molekylvikt kan främst hänföras till skillnader i antalet monomerenheter.
Enligt Reach definieras en polymer som ett ämne som uppfyller följande kriterier:
- Över 50 procent av vikten utgörs av molekyler som innehåller åtminstone tre monomerenheter kovalent bundna till åtminstone en annan monomerenhet eller en annan reaktant, samt
- mängden polymermolekyler som har samma molekylvikt måste utgöra mindre än 50 procent av vikten.
För mer information, se kapitel 18.104.22.168 ”Polymerer” i Vägledning om registrering:
Mer ingående information om polymerer finns i Vägledning beträffande monomerer och polymerer:
Reach-förordningen tillåter i vissa fall att enskilda medlemsstater av försvarsintresse undantar vissa ämnen från tillämpningen av Reach.
Mer information om nationella undantag av försvarsintresse i enskilda medlemsstater finns på Europeiska försvarsbyråns webbplats (http://www.eda.europa.eu/reach).
En icke-isolerad intermediär definieras som en intermediär som under syntesen inte avsiktligt avlägsnas från den utrustning i vilken syntesen sker (utom vid provtagning).
Mer information finns i Vägledning om registrering:
Då ett ämne används i livsmedel för människor eller i djurfoder i enlighet med livsmedelssäkerhetsförordningen (EG) nr 178/2002, behöver ämnet inte registreras.
Detta innefattar användningen av ämnet
- som livsmedelstillsats (rådets direktiv 89/107/EEG),
- som aromämne i livsmedel (rådets direktiv 88/388/EEG och kommissionens beslut 1999/217/EG),
- som djurfodertillsats (förordning (EG) nr 1831/2003),
- i djurfoder (rådets direktiv 82/471/EEG).
Mängder av samma ämne som används för andra användningar än livsmedel och djurfoder undantas inte från registreringsplikten. Endast de mängder av ämnet som används i livsmedel och djurfoder är undantagna från registrering enligt Reach.
För mer information, se kapitel 22.214.171.124 ”Livsmedel eller djurfoder” i Vägledning om registrering:
Ett ämne behöver inte vara registrerat enligt Reach för användningen i fråga om ämnet används i läkemedel som omfattas av följande förordning eller direktiv:
- Förordningen om inrättande av gemenskapsförfaranden för godkännande av och tillsyn över humanläkemedel och veterinärmedicinska läkemedel samt om inrättande av en europeisk läkemedelsmyndighet ((EG) nr 726/2004).
- Direktivet om upprättande av gemenskapsregler för veterinärmedicinska läkemedel (2001/82/EG).
- Direktivet om upprättande av gemenskapsregler för humanläkemedel (2001/83/EG).
Undantaget skiljer inte mellan aktiva och icke aktiva innehållsämnen, eftersom det gäller alla ämnen ”som används i läkemedel”. Därför är även hjälpämnen som används i läkemedel undantagna från registreringsplikten.
Mängder av samma ämnen som används för andra användningar än läkemedel är inte undantagna. Endast de mängder av ämnet som används i läkemedel är undantagna från registreringsplikten.
För mer information, se kapitel 126.96.36.199 i Vägledning om registrering:
Verksamma ämnen som tillverkas eller importeras för användning i biocidprodukter betraktas som registrerade för användningen i den biocidprodukten i följande situationer:
- Det verksamma ämnet har godkänts i enlighet med förordning (EU) nr 528/2012 (biocidförordningen, BPR), eller
- en granskning av det verksamma ämnet pågår inom ramen för granskningsprogrammet för befintliga verksamma ämnen som inrättades enligt artikel 16.2 i direktiv 98/8/EG och har fortsatt i enlighet med artikel 89 i BPR.
Förteckningen över godkända verksamma ämnen finns på Echas webbplats:
Om du vill kontrollera vilka verksamma ämnen som behandlas inom granskningsprogrammet, se bilaga II, del I till kommissionens delegerade förordning (EU) nr 1062/2014, som även finns på Echas webbplats:
Undantag från registreringsplikten enligt Reach gäller även i följande fall:
- Det verksamma ämnet tillverkas/importeras för användning i en biocidprodukt som godkänts i enlighet med det förenklade produktgodkännandeförfarandet (artikel 27 i BPR).
- Det verksamma ämnet tillverkas/importeras för användning i en biocidprodukt som har ett tillfälligt produktgodkännande (artikel 55 i BPR).
- Det verksamma ämnet tillverkas/importeras uteslutande för att användas i en biocidprodukt som används för experiment eller försök i forskningssyfte eller för produkt- och processinriktad forskning och utveckling (artikel 56 i BPR).
Om du tillverkar eller importerar ett ämne för användning i biocidprodukter och för annan användning måste du registrera ämnet för den mängd av ämnet som används i produkter som inte är biocidprodukter.
Verksamma ämnen som tillverkas eller importeras för användning i växtskyddsmedel i enlighet med förordning (EG) nr 1107/2009 om utsläppande av växtskyddsmedel på marknaden betraktas som registrerade enligt Reach (för den användningen) om det verksamma ämnet är godkänt och finns upptaget i kommissionens tillämpningsförordning (EG) nr 540/2009 (förteckning över godkända verksamma ämnen) eller om ansökan om godkännande av det verksamma ämnet har godtagits enligt 9 i förordning (EG) nr 1107/2009.
Mängder av samma verksamma ämne som används för andra ändamål än växtskyddsmedel betraktas inte som registrerade även om de är godkända. Dessutom betraktas andra ämnen, såsom formuleringsämnen, synergister, skyddsämnen och hjälpämnen, inte som registrerade.
Kommissionen upprätthåller en elektronisk förteckning över godkända (och icke-godkända) verksamma ämnen. Den finns tillgänglig via följande länk:
Ett återvunnet ämne ska registreras så snart det inte längre betraktas som avfall (när det uppfyller kriterierna för att upphöra vara avfall).
Mer information om kriterierna för när avfall upphör att vara avfall:
För att undantaget ska kunna utnyttjas måste du dokumentera att följande villkor är uppfyllda:
- Samma ämne måste ha varit registrerat.
- Ämnet måste vara detsamma.
- Företaget som genomförde återvinningen måste ha den information som krävs enligt Reach tillgänglig (t.ex. säkerhetsdatablad).
För mer information, se kapitel 188.8.131.52 ”Återvunnet ämne som redan registrerats” i Vägledning om registrering:
The list numbers published by ECHA are not official EC entries. However, we recommend you to assign such an entry to the phase-in substance you intend to register provided this list number is linked to a CAS number (list numbers starting with 6 or 8) or a chemical name (list numbers starting with 9) corresponding to a correct and specific identifier for your substance. If this entry is too generic for your substance and there is no appropriate EC entry available, you should not assign any list/EC number to your substance.
Consider taking specific measures in the SIEF to protect information that you consider CBI, but you nevertheless need to share with the SIEF to conclude on the substance sameness. You can, for example:
- Have confidentiality agreements that limit access to documents or other information to specific named persons, or departments; and
- Allow access to certain documents in a ‘reading room’ only (where copying is not allowed); and
- Agree to have certain documents reviewed and/or assessed only by a third party expert (independent consultant) or a trustee.
You can strengthen this by having additional personal confidentiality agreements for those who get access to the CBI documents.
As a minimum, you should specify to the other SIEF members that the information is indeed CBI and, therefore, you communicate it and it can be used only for purposes of the verification of substance identity under REACH.
For more information on CBI, see section 9 of the Guidance on Data-sharing (https://echa.europa.eu/guidance-documents/guidance-on-reach).
Your registration dossier remains your responsibility. You need to keep it up to date.
If you need to give your customers safety data sheets, you will need to include your registration number in the safety data sheets the next time you update them. In addition, if you have conducted a chemical safety assessment and needed to develop exposure scenarios, you have to attach them to the safety data sheet, outlining the use-specific conditions of safe use of the substance. This needs to be done as soon as possible.
If you have claimed you are an SME and have benefited from the reduced registration fees, ECHA may verify the size of your company. Make sure that your REACH-IT account includes all the necessary documentation to justify the size of your company.
We strongly recommended that you discuss within your joint submission and your company to put a mechanism in place to update the registration dossier, if necessary. For example, you must also share data and give access to the joint submission to newcomers. You can charge for access to the data by sharing the costs in a fair, transparent and non-discriminatory way.
ECHA will check the compliance of at least 5 % of the received registration dossiers to verify that the information submitted is compliant with the legal requirements. The outcome of this dossier evaluation may be a request for additional information. Additionally, by 1 June 2022, ECHA will examine the testing proposals included in the dossiers.
Remember to keep a close eye on your REACH-IT account – we will communicate with you only through it.
There can be a number of reasons for this. Have a look at the scenarios below.
If you submitted your registration on time, you can continue to manufacture or import your substance even if you have not yet received your registration number. You would need to cease manufacture or import only if ECHA rejects your registration.
Your dossier is considered as ‘submitted’ when it passes the business rules step. You are informed about it through your REACH-IT account and ECHA then assigns a submission number and a submission date to your dossier. The proof that you have submitted a registration dossier is this submission number and submission date that you have received in your submission report in REACH-IT. If you are a lead registrant, it is only after your lead registrant dossier has passed the business rules check that the member registrants can submit their own dossiers.
If your dossier has failed the business rules check, you have also been informed about it through your REACH-IT account. In this case, you have missed the legal deadline and are not entitled to manufacture, import or market the substance in the EU/EEA. You can only start manufacturing or importing again once you have submitted a complete registration dossier and received a registration number from ECHA. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40). Submit a registration dossier as a matter of urgency! Document your submission attempts so that you can demonstrate that you took corrective action as soon as you could.
Scenario 1: ECHA is still processing your dossier
ECHA has until the end of August 2018 to verify the completeness of the dossiers that were submitted in April and May 2018. Keep track of the progress through your REACH-IT account. In the meantime, you can continue manufacturing or importing your substance.
Scenario 2: You have not paid the registration fee
Your registration will only be complete once ECHA has confirmed that your registration includes all the required information and you have paid the fee indicated in the invoice you have received through your REACH-IT account.
If you do not pay by the initial payment deadline indicated in the invoice, you will automatically be granted an extension. However, if you do not pay by this extended deadline, ECHA will reject your registration. You will have to cease manufacturing or importing activities, as you can only legally manufacture, import or market your substance once you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).
Scenario 3: Your dossier has failed the first technical completeness check
In this scenario, we will tell you what needs to be done and what the deadline is for submitting the missing information. You will have at least four months for this, so invest time in fixing the errors reported before resubmitting the full information as an update. You only have this one last chance to update your dossier so that it passes the technical completeness check. Make sure that you follow the instructions carefully and provide all the information requested, and only resubmit when you are sure you have addressed all failures.
Use the Validation assistant tool in IUCLID to avoid the risk of failing again – you will not get a third chance. If you still have questions, contact ECHA to make sure you understand what you need to do to complete your dossier.
Scenario 4: Your dossier has been rejected as it has failed the technical completeness check a second time
You will have to start the registration process all over again and resubmit your dossier as an initial submission. Any fee that you paid in connection with your failed first registration will not be refunded.
You will have to stop manufacturing or importing activities, as you can only legally manufacture, import or market your substance if you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).
31 May 2018 was the last chance to submit a registration for existing (phase-in) substances manufactured or imported in amounts of more than one tonne per year. If the registration obligation applied to you, but you did not submit your dossier by then, as of 1 June you can no longer manufacture or import your substance legally in the EU/EEA. You may, however, continue placing on the market any stock that was manufactured/imported before the deadline.
If you missed the deadline, you should make yourself compliant without delay:
- If you have pre-registered or inquired about your phase-in substance, you can register it directly (until further notice, you can still use the pre-registration number).
- If you have not pre-registered or inquired about your phase-in substance, you need to submit an inquiry before registering it.
If you submit your dossier after 31 May, you will need to wait until you receive your registration number before resuming or starting manufacture or import of your substance.
In principle, pre-registration numbers do not carry any meaning anymore. Substances manufactured or imported in quantities of more than one tonne per year in the EU/EEA must be registered unless they are exempt from the obligations under the REACH Regulation.
Have a look at the lead registrant list, which is frequently updated. It shows the substances for which the registration process has been started and those to which a registration number has already been assigned. You can also check the list of registered substances on ECHA’s website. However, do note that not all registration dossiers have yet been published, as some are still being processed by ECHA.
You can see the names of registrants by viewing the information on ECHA’s website. The company names appear at the bottom of the ‘General Information’ section. However, in some cases, this may not include your specific supplier, such as when:
- your supplier is not the one manufacturing or importing the substance; or
- the registrant has successfully claimed the name as confidential or is an importer covered by a representative of the non-EU exporter.
The most reliable information should come from your supplier. Again, the longer the supply chain, the longer it will take for this confirmation to arrive to you.
You have several options, ranging from asking your supplier to include your use in their registration to preparing your own chemical safety report or adapting/stopping the use of the substance:
- Ask your supplier to include your use or conditions of use in their chemical safety report and to provide you with an exposure scenario for it. You need to make sufficient information available to your supplier to enable them to make such an assessment. Your sector organisation may have developed a convenient means of supplying this information specifically to your sector.
- Implement the conditions of use described in the exposure scenario you have received. This option may require changes to your processes or products.
- Eliminate the substance or activity or substitute it with a safer alternative.
- Find another supplier who can provide the substance with a safety data sheet and an exposure scenario covering your use.
- Carry out your own chemical safety assessment and prepare your own downstream user chemical safety report (DU CSR) for your uses and conditions of use, unless exemptions apply – see our practical guide How to prepare a downstream user chemical safety report for details. You will have to notify ECHA about this.
Yes. A request for a change of a substance identifier can be made by submitting a “Substance identity adaptation service web form”, which is accessible via ECHA’s website, at the following link: https://comments.echa.europa.eu/comments_cms/SubstanceIdentityAdaptation.aspx
It is technically not possible for registrants to change the substance identifier (EC or list number and name) of their registration dossier without requesting the change of identifiers service.
The request is normally made by the lead registrant, on behalf of the members of a joint submission. Member or individual registrants can also make the request. The request must include documentary evidence that all members of the joint submission agree with the changes specified in the request that affect their registration dossier.
Registrants will need to submit collectively the information included in the ‘Joint Submission Plan’ template, which is available on ECHA’s website: https://comments.echa.europa.eu/comments_cms/SubstanceIdentityAdaptation.aspx.
Once you submitted the request to change the substance identifier, the following steps take place:
- You receive an automatic email confirmation that includes the unique reference number of your request.
- ECHA assesses if the service can be provided based on the provided information. ECHA contacts you if the request is incomplete or cannot be provided.
- If ECHA considers that the service can be provided, it issues a service charge to each applicable registrant.
- After the registrants have paid the service charges, ECHA carries out the changes in REACH-IT.
- ECHA requests the registrants to update their registration dossiers using the new substance identifier and provides instructions on how to submit the dossier update.
- You and the applicable registrants submit dossier updates using the new substance identifier.
For further information about the service to change the substance identifier in a registration, please see “How to change your substance identifier” page on ECHA’s website, at the following link: https://echa.europa.eu/support/how-to-improve-your-dossier/how-to-change-your-substance-identifier.
The minimum charge is €300 for each registrant requiring the correction of a substance identifier. More information is available on ECHA’s website: https://echa.europa.eu/support/how-to-improve-your-dossier/how-to-change-your-substance-identifier.
The REACH Regulation does not impose any timeframe on ECHA for processing a change of substance identifier request. ECHA aims to assess whether the service can be provided within 1 month. The whole change of substance identifier process normally takes between 3-6 months, if all required information has been provided, the request can be granted, the invoices are paid in a timely fashion, and the dossiers are successfully updated without delay by the registrants.
For more information on the SIP, please read appendix III - Substance identification and joint submission of data - of the Guidance for identification and naming of substances under REACH and CLP available on ECHA’s website at https://echa.europa.eu/guidance-documents/guidance-on-reach. You can also find technical instructions on reporting substance identity information in IUCLID 6 format in the manual “how to prepare PPORD and registration dossiers” available on the ECHA website.
The SIP is the collective agreement between companies. The boundary composition is the technical reporting to reflect the compositions of all members in the joint submission. In some cases, the boundary composition includes, besides the composition information, also any other relevant parameter(s), such as the manufacturing process.
Yes. ECHA will disseminate the information reported in the boundary composition record by extracting it from registration dossiers submitted in IUCLID 6 format and will publish it through our Information on Chemicals part of the ECHA website. Information on chemicals can be searched through the Search box on the homepage of the ECHA website.
The boundary composition record will not be published until the lead registrant updates the registration in IUCLID 6.
There is a Dissemination Preview tool included in IUCLID with which users can see what data will be published and how. We strongly encourage registrants to use this to check their dossier before submitting it to ECHA.
Where your composition is outside the boundary composition of an existing joint submission, the first step would be for you to contact the existing registrant(s) and discuss with him whether the Annex VII-XI data reported in the joint registration would be sufficient as to apply to your substance. Where it is agreed that the data is sufficient, it would then be necessary for the lead registrant to update the boundary composition record reported in the lead dossier to expand its scope. This would mean updating the boundary composition to cover the compositions of both your composition and that of the existing registrants.
All parties would need to ensure that the criteria applied are transparent and that the relevant Annex VII-XI data collected/generated demonstrably covers all agreed compositions.
No. You only have to include a boundary composition record the next time you update your submission.
However, we strongly encourage lead registrants to discuss the boundary composition with their members and potential registrants and update their dossiers as soon as possible.
For a new registration, it is now mandatory for lead registrants to include the boundary composition record when they submit their IUCLID dossier.
It is important that the compositions and parameters defining the boundaries of the substance covered by the joint submission are agreed by all the co-registrants and are clearly documented in the boundary composition. Accordingly, the boundary composition may need to be modified or extended following the request of any new potential registrant, if all co-registrants agree that part or all of the jointly-submitted data is also relevant for the substance manufactured or imported by this registrant. However, the lead registrant is not obliged to amend the existing boundary composition if he and the other co-registrants consider that by doing so they could no longer rely on the data to address the hazard properties of the extended composition. The rationale would need to be transparently documented.
More than one boundary composition record may be reported depending on how the co-registrants want to structure the reporting of their joint Annex VII-XI data. For example if there are compositions that have impurities/constituents that triggered PBT assessment and/or have different classification and labelling, these can be reported in their own boundary composition record in IUCLID.
Only the lead registrant, with the agreement of the other co-registrants, is required to report the boundary composition(s) in his dossier and keep it up-to-date. Any change made by the lead registrant at the level of the boundary composition will be visible to every member of the joint submission in REACH-IT.
The level of detail reported for the boundary composition is not dependent on whether the substance is hazardous or not. However, the level of detail for the boundary composition should be customised around the considerations used to construct the hazard dataset, including also the relevant considerations made at the impurity level to derive the classification and/or PBT assessment of the substance.
- The risk management measures for the identified uses with regard to human health and the environment are to be summarised in section 8 (and 7). This includes consumer related measures communicated to a downstream user producing consumer preparation or articles. Also the relevant Derived No-Effect Levels (DNELs) and Predicted No-Effect Concentrations (PNECs) should be presented here.
- The information on physicochemical properties, toxicology and eco-toxicology in the SDS is to be updated in line with the information requirements of Annex VI to XI of the REACH Regulation.
- The results of the PBT and vPvB assessment are to be presented in section 12.
- The information on uses advised against in section 16 of the SDS may need to be updated depending on the outcome of the manufacturer's Chemicals Safety Assessment (CSA).
- Where Exposure Scenarios (ES) are developed as a result of conducting a chemical safety assessment in accordance with Article 14 of the REACH Regulation they must be annexed to the SDS and thereby be appropriately passed down the supply chain. The information on uses of the substance in section 1.2 of the SDS must be consistent with the short titles of the ES in the annex, indicating which uses are covered by the ES.
- Since REACH includes a requirement to include the waste disposal considerations into the manufacturer's chemicals safety assessment, section 13 of the SDS may need to be updated with substance specific waste management advice as contained in the ES.
According to Article 31(5) of the REACH Regulation, the safety data sheet (SDS) shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide otherwise. Placing on the market means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market (Article 3(12) of the REACH Regulation).
The above also applies to exposure scenarios, which are a part of an SDS. A document listing the languages required for safety data sheets and labels within the EU is available at http://echa.europa.eu/documents/10162/13562/languages_required_for_labels_and_sds_en.pdf
For a substance or mixture requiring a Safety Data Sheet (SDS) according to Article 31 of the REACH Regulation, Annex II of REACH requires that the registration number assigned in accordance with Article 20 of REACH be given in the SDS when it is available. Article 31(9) of REACH gives specific occasions on which an updated SDS should be supplied without delay. Receipt of a registration number per se is not listed as one of these occasions. However as the assignment of a registration number is of major potential interest to downstream users of the substance it may be recommendable to send existing customers an updated SDS either immediately or on the next supply of the substance or of a mixture containing it. The SDS should of course be updated to incorporate the registration number(s) for customers who are going to receive the substance or mixture for the first time. Note in particular that the final sentence of Article 31(9) requires that "any updates following registration shall contain the registration number". Please note that there are detailed provisions in Regulation (EU) No 453/2010 amending Annex II to the REACH Regulation regarding when the part of the registration number referring to the individual registrant of a joint submission (the last four digits of the original full registration number) may be omitted by a supplier who is a distributor or a downstream user.
Similarly, Article 32(1)(a) of REACH indicates that when registration numbers have to be communicated to customers according to Article 32 (Communication duties for substances and mixtures not requiring an SDS) the registration number, if available, should be supplied. The occasions on which an update without delay is required are given in Article 32(3) of REACH. Again, receipt of a registration number per se is not listed as one of these occasions. For similar reasons it may be deemed to be desirable to nonetheless send updated information. Note again that the last sentence of Article 32(3) of REACH also requires that "any updates following registration shall contain the registration number". Further guidance can be found in section 6.1.2-'Provide other information to customers' in the Guidance on Registration available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach.
The provisions of Articles 31 and 32 of REACH apply irrespectively of whether the relevant registration deadline is still to come or has already elapsed.
There is no obligation under REACH for suppliers of substances and mixtures meeting the criteria in Article 31 to provide a SDS to their non-EU customers. Article 31(1) refers to "recipients of the substance or mixture". Article 3(34) of REACH defines a "recipient of a substance or a mixture" as being downstream user or a distributor being supplied with a substance or a mixture. Both downstream users and distributors are, in line with their respective definitions in Article 3(13) and 3(14), natural or legal persons established within the Community. The obligation of Article 31 of REACH to provide an SDS therefore applies only to the recipients of the substance or mixture established in the EU.
However, it is notable that the obligation to provide a REACH compliant SDS to non-EU customers, in the context of export, may arise pursuant to other pieces of legislation. For example, Article 16(3) of Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals, implementing the Rotterdam Convention within the EU, requires companies exporting certain hazardous chemicals within the scope of this Regulation to provide a REACH compliant SDS when exporting them outside the EU.
No, it is not. Regarding section 2 of the SDS, either the full wording of the hazard classes or the hazard class and category code(s) may be used. If the full wording is used, it needs to be in the language of the SDS. If the hazard class and category code(s) are used, it is important to note that the abbreviations given for each hazard class are actually codes which cannot be translated. The codes must thus remain as they are given in Annexes VI and VII to CLP. If codes, other abbreviations and acronyms are used, their full text and explanation must be given in section 16 of the SDS, in the language of the SDS.
For mixtures, the codes as given in Annexes VI and VII to CLP can be used in section 3.2.3. Again, section 16 needs to contain the full wording.
No, manufacturers or importers do not have the obligation to inform downstream users that they have submitted a notification to the C&L Inventory. Furthermore, there is no need for downstream users to receive confirmation from upstream suppliers that substances have been notified to the C&L Inventory in order to continue the use of the substances in their own products. Similar to the REACH pre-registration number, the C&L notification number is for internal use for the importer/manufacturer as receipt/proof of notification. It does not need to be communicated to the DU/distributor.
A notification number cannot be considered as an identifier according to Article 18 CLP and it is not the inventory reference number published in the C&L Inventory.
Substances e.g. pre-registered, inquired or notified to the C&L Inventory with only a CAS number or without any numerical identifier are automatically assigned a list number. In contrast to the EINECS, ELINCS and NLP entries, the list numbers and the list inventory are not based on a legal act or requirement, and they have not been published in the Official Journal of the European Union. Therefore, the list numbers do not have the same significance as EC numbers but have only the numerical format in common. Most importantly, the vast majority of list numbers and their connected substance identification have never been checked for correctness, validity or whether the conventions outlined in the Guidance for Identification and naming of substances under REACH have been kept.
Therefore, industry is advised not to use list numbers in their documents.
However, when a supplier wishes to include a list number on a document, e.g. Safety Data Sheet, it shall be clearly indicated that this number is not an EC number and has no legal significance.
Distributors/formulators can truncate the registration number (omit the last four digits) of their suppliers' registration numbers in the SDS in accordance with points 1.1 and 3.2.4 of Annex II of REACH.
The first part of the registration number is the same for a given substance if the registrants have jointly submitted their registrations. Therefore, only one truncated registration number needs to be included. However, if a registrant has not registered in the context of the joint submission, this registration number is different. Therefore, all relevant (truncated) registration numbers should be mentioned in the SDS.
For registered substances for which a Chemical Safety Report (CSR) is required, the information appearing in section 1.2 of the SDS needs to be in line with the identified uses in the CSR (under REACH, the definition of use goes beyond the chemical function) and the Exposure Scenario (ES) annexed to the SDS. Intuitive ES titles can be reported in section 1.2. When the use descriptor system is used in the ES, it is advised that, in section 1.2, the uses of the substance are described in a generic wording while remaining consistent with that of the use descriptor system. Reporting the use descriptor codes in section 1.2 is not recommended as it may lead to lengthy lists. The Process and Product Categories in the use descriptor system can be used as an indication.
For registered substances for which a CSR is not required (between 1-10 tonnes/year), substances not yet registered or not subject to registration (e.g. below 1 tonne/year or listed in Annex IV or V) and mixtures, the intended uses known to the supplier need to be indicated, with a brief description of what the substance or mixture is intended to do, such as "flame retardant in textile fibres", "antioxidant in paints, cosmetics, detergents", etc.
Where an Exposure Scenario (ES) is developed as a result of conducting a chemical safety assessment as required by Article 14 or 37(4) of the REACH Regulation, it must be annexed to the safety data sheet (SDS), provided it is relevant for the customer.
According to Article 31(9) a supplier shall update his SDS without delay as soon as new information which may affect the risk management measures or new information on hazards becomes available. An ES is considered to be such new information, which normally triggers the need to update a SDS as soon as it becomes available. The SDS with annexed ES resulting from this update has to be provided without delay to all customers who have been supplied with the particular substance or mixture within the preceding 12 months. This provision applies since the entry into force of the REACH Regulation and irrespectively of whether the substances are registered or not.
Where the information in an ES that becomes available does not affect the risk management measures and the ES contains no new information on hazards, the SDS does of course not have to be updated.
Yes, if the conditions of Article 31(1) of the REACH Regulation are fulfilled, the supplier of a biocidal product that is a substance or a mixture must provide the recipient with a safety data sheet.
When a formulator produces a biocidal product, the relevant safety measures (or restrictions on use) indicated in the product authorisation should be communicated down the supply chain (with the SDS, where required).
An active substance which is either approved under the BPR at EU level or part of the BPR Review Programme, is considered as registered under REACH only for the use in a biocidal product.
There is no requirement to attach an exposure scenario to the SDS for the active substance used in a biocidal product. REACH exposure scenarios may, nevertheless, be received for co-formulants in the biocidal product. The formulator needs to take into account the relevant information in these exposure scenarios in the SDS, where required.
(See also BPR Q&A 908).
Yes, the SDS format can be used. Suppliers, who do not have to supply an SDS may be obliged to provide certain information in accordance with Article 32 of the REACH Regulation or they may chose to provide a SDS on a voluntary basis. They may use the SDS format to provide such information. In such cases, it is recommended that it is clearly stated that the SDS is not provided pursuant to Article 31 of REACH, but to facilitate the communication of information.
The suppliers of a substance or a mixture may also choose to provide information in the safety data sheet format even if they are not obliged to provide any information under Articles 31 or 32 under REACH. In this case, they should also clarify that the SDS is not provided pursuant to Article 31 of REACH, and then explain why they provide it.Among possible solutions would be the addition to the relevant SDS of a phrase such as ‘A safety data sheet is not required for this product under Article 31 of REACH’.
Yes it can if the information provided in the SDS fulfills the requirements of Annex II of REACH for each of those substances or mixtures. However, this condition can only be fulfilled in cases of minor variations of a substance or a mixture, for example for minor concentration changes of impurities or components, due to which the hazard profile does not change. A single SDS cannot be used for totally different substances or mixtures.
While it is not legally required under Annex II of the REACH Regulation to include EUH statements for substances in a mixture in section 3.2 of the SDS, it would be advisable and good practice to include those substances assigned a physical and health property as set out in Part 1 of Annex II and Table 1.2 of Annex VII as these were translated from risk phrases assigned under Directive 67/548/EEC e.g. EUH032. Furthermore, it would also be advisable and good practice to include these EUH statements in Section 2.1 and 2.2 of the SDS. For other EU hazard statements it is only necessary to include them in Section 2.2 of the SDS.
Note: COM may need to consider including provision for EU hazard statements relating to supplemental hazard information taken over from Directive 67/548/EEC in the next update of Annex II of REACH.
Yes, you do. The obligation to mention any European or national occupational exposure limits (OELs) is not connected to the physical form or to the classification of the mixture, or even to the fact that the mixture can be considered as a special mixture. Where an OEL exists for any constituent substances, you must indicate these in Section 8 of the safety data sheet (SDS).
An SDS must enable employers to determine whether any hazardous chemical agents are present in the workplace and to assess any risk to the health and safety of workers arising from their use.
It should also be taken into account that a user might use the paste in a way that it undergoes further processing.
According to Article 119(2)(d) of the REACH Regulation, ECHA has to make the information which is contained in the safety data sheet, and which is not already disseminated under other articles of REACH1 available over the internet, unless the registrant successfully claims confidentiality. Since a copy of the safety data sheet document as such is not part of the data
submitted to ECHA, it has been determined which information has to be listed in both the safety data sheet (as set out in Annex II of REACH) and the registration dossier (as set out in Article 10 and Annexes I and VI of REACH). Information meeting both criteria that is not already disseminated for other reasons (in accordance with Article 119 of REACH) is considered
to be “safety data sheet information”.
- registration number;
- registrant name;
- life cycle description and uses advised against information;
- exposure scenario elements;
- result of the PBT (Persistent, Bioaccumulative and Toxic chemicals) and vPvB (very Persistent and very Bioaccumulative) assessment;
- indication of whether a chemical safety assessment (CSA) was performed.
In the questions that follow, it will be explained in detail which data is concerned and how the data can be claimed confidential in IUCLID 5.4.
Safety data sheet information is disseminated from all registration dossiers, whether the substance requires a safety data sheet or not, unless claimed confidential. It should be stressed that confidentiality needs to be claimed separately for each item, using the confidentiality flags in the IUCLID dossier. In dossiers for substances which do not require a safety data sheet, it is deemed that the registrant ‘volunteers’ the safety data sheet information for publication if the information is not claimed confidential.
The information is disseminated on the ECHA website in the section on Registered Substances, at http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances.
Confidentiality claims on safety data sheet information are only charged if the substance requires a safety data sheet. The fee for confidentiality claims on safety data sheet information is detailed in Annex IV of the Fee regulation. The fee is charged only once per registration, regardless of the number of confidentiality claims on some or all of the specific items of SDS information. If the fee has been charged once, subsequently placed confidentiality claims on safety data sheet information will not be charged anymore. However, a specific justification for each of the types of information claimed confidential is still required.
It should be noted that confidentiality claims on the PBT assessment (section 2.3), on exposure scenarios and local assessment (section 3.7.1), and on whether a CSA was performed (section 13) are invoiced if the substance requires a safety data sheet and the registrant submits a CSR. As an example, if in a joint submission the lead registrant provides the CSR on behalf of the members, only the lead will be invoiced for the before mentioned specific sections (i.e. provided that in the member dossier it is indicated that the CSR is submitted by the lead on behalf of the member). If a member individually submits the CSR, they will be charged for all potential SDS confidentiality claims (including sections 2.3, 3.7.1 and 13) as described above.
If the substance does not require a safety data sheet, it is deemed that the confidentiality claim indicates that the registrant does not volunteer the publication of the information, and no fee is charged for keeping this information confidential. Registrants can verify whether they will be charged for a confidentiality claim on safety data sheet information using the Fee Calculation plug-in in IUCLID (see also question 11 below). Confidentiality claim on safety data sheet information for monomers
According to the REACH Regulation polymers are exempted from registration. However monomer substances have to be registered under certain circumstances. A safety data sheet is needed for the monomer substance if it meets the relevant hazard cr