Q&As

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REACH

Notifications of Substances in articles

A. General Q&As

Where can I find the Candidate List?

The Candidate List and additional useful information is published on ECHA's website at:

http://echa.europa.eu/candidate-list-table
 

What is the Candidate List?

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).

How is the Candidate List updated?

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

What is an article?

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

Is packaging considered an article?

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

Is there any fee for a substance in articles notification?

There is no fee charged for the notification.

I have stopped production/import of the article containing the Candidate List substance. Do I have to notify and communicate information down the supply chain and to consumers upon request?

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

Regarding the notification obligation, do I have to take into account the tonnage of the substance in articles produced/imported before the substance was put in the Candidate List?

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.

Do I need to notify Candidate List substances in articles made from recycled material?

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.

Can I appoint an only representative (OR) to submit a substance in articles notification?

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

 

What use will be made of the substance in article notifications? Will they trigger new registration requirements?

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.
 

What are the enforcement activities and the penalties foreseen?

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.

Who should I contact if I have further questions?

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:

 

Derogations

Am I exempted from the notification obligation?

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.

How can I demonstrate that there is no exposure to the Candidate List substance present in my article?

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

How do I find out if the substance is already registered for a particular use? Can I use information that is disseminated on the ECHA website?

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.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

I am using a CMR/PBT/vPvB in articles however this substance is not in the Candidate List. Do I need to 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.

How to determine if the notification obligation applies

How do I calculate the concentration of a Candidate List substance in my article?

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 3.2.3.1 of the Guidance on requirements for substances in articles.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

How do I calculate the total amount of the Candidate List substance in my 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 3.2.3.2 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.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

How do I know that a Candidate List substance is present in my article?

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:
http://echa.europa.eu/guidance-documents/guidance-on-reach

 

Do I need to notify and communicate information down the supply chain for certain boron substances included in the Candidate List, which are involved in the production of boron glass articles but not present as such in these 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.

Information Requirements

How can I provide substance identity information when notifying a substance in article?

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:
http://echa.europa.eu/manuals

How can I provide information on classification and labelling when notifying a substance in articles?

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:
/manuals  

The Candidate List can be found at: /candidate-list-table

 

How can I describe the use of the Candidate List substance in my article?

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 7.3.3.1. 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:
https://echa.europa.eu/manuals  

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

How can I describe the use of my article?

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 7.3.3.1. 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:
https://echa.europa.eu/manuals  

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

How can I provide the tonnage range?

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:
https://echa.europa.eu/manuals  

See also Q&A 536

When do I have to submit information on my production site? Is it possible to include several sites in the same notification?

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:
https://echa.europa.eu/manuals  

 

What are the pre-filled substance datasets?

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:
https://echa.europa.eu/manuals  

The Candidate List is published on ECHA's website at: http://echa.europa.eu/candidate-list-table

How can I find the registration number?

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).

How can I provide the registration number?

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:
    https://echa.europa.eu/manuals  

 

Which is the "per year" definition for notification purposes?

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.

At which stage of the manufacturing process do I have to notify?

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.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Submission of the notification dossier

What is the deadline for notification?

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.

What are the implications if one fails to submit a notification in time? Can it be done later?

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.

What if I start to import the substance in articles after it has been included in the Candidate List?

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. 

How many articles can I submit in one notification for the same substance?

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.  

Is it possible to submit a single notification for different substances or different importers/manufacturers?

No, it is necessary to submit a separate notification for each substance and for each importer/manufacturer.

Do I have to update my notification?

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.    

How can I update my notification of substances in articles using the webform?

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.

How can I update my notification of substances in articles using REACH-IT and IUCLID?

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

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