Want to search for the relevant question and answer in your own language? Change the language in the dropdown menu above.
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.
A toll manufacturer is normally understood to be a company that manufactures a substance (on its own, in a mixture or in an article) in its own technical facilities following the instructions of a third party in exchange for an economic compensation. The substance is generally put on the market by the third party. This construction is, for example, used for an intermediate step in the production process for which sophisticated equipment is needed (distillation, centrifugation etc.). According to the REACH Regulation, manufacturers of substances are required to register the substances they manufacture above one tonne per year. From this point of view the toll manufacturer is a manufacturer and has to register the substance.
This scenario is further discussed in the factsheet ‘Toll manufacturer under the REACH Regulation' available under the following link:
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.
It depends under which type of intermediate as described under Article 3(15) of the REACH Regulation your intermediate falls, whether you have registration obligations or not.
- Non-isolated intermediates:
For the use of a substance as a non-isolated intermediate, there are no obligations under the REACH Regulation.
- On-site isolated intermediates:
A manufacturer of on-site isolated intermediates in quantities of 1 tonne or more per year needs to register their substances (if they are not otherwise exempted from registration (see FAQ ID=30). However registrants of on-site isolated intermediates can provide reduced registration information according to Article 17(2) of the REACH Regulation if they confirm that the substance is manufactured and used under strictly controlled conditions as described under Article 17(3) of REACH.
- Transported isolated intermediates:
A manufacturer or importer of transported isolated intermediates in quantities of 1 tonne or more per year needs to register his substances if they are not otherwise exempted from registration. However, a registrant of transported isolated intermediates can provide reduced registration information according to Article 18(2) of the REACH Regulation if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under Article 18(4) of REACH. In this case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.
When and how the specific provisions for the registration of intermediates under REACH can be used are described in the Guidance for intermediates: http://echa.europa.eu/guidance-documents/guidance-on-reach.
More information can be found at: http://echa.europa.eu/documents/10162/13655/pg16_intermediate_registration_en.pdf
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 126.96.36.199- '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 188.8.131.52- '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).
Each registrant has to calculate the yearly tonnage for the registration dossier. The yearly tonnage is calculated as the volume per manufacturer/importer per calendar year, unless stated otherwise. For phase-in substances that have been imported or manufactured for at the least three consecutive years, quantities are calculated on the basis of the average production or import volumes for the three preceding calendar years (Article 3 (30) of the REACH Regulation). Detailed guidance and practical examples are provided in Section 2.2.6 'Calculation of the volume to be registered' of the Guidance on registration: 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 184.108.40.206- '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.
The registration fee for a substance depends on the tonnage of the registration, size of the company and the type of submission. Additionally:
- Lower fees apply to joint submissions as compared to individual submissions. This does not apply in case you decide to opt-out of the joint submission;
- SMEs benefit from a reduced fee in all categories;
- An additional fee is levied for confidentiality.
No fee is required for the registration of substances if you are entitled to a fee waiver. Further information related to the fee waiver can be found under Q&A 1237
All these provisions are specified in Articles 12(1)(a) and 74 of REACH, taking into account Recital 34 of the regulation. The fee amounts can be found in the REACH Fee Regulation (No. 340/2008, and subsequent amendments).
Further information can be found under Invoicing and Payments..
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
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.
You should register if you are the legal entity established in the EU who is responsible for importing.
The responsibility for importing depends on many factors such as:
- Who orders?
- Who pays?
- Who is dealing with the customs formalities?
However, this might not be conclusive on its own.
A sales agency established in the EU that acts as an intermediary, i.e. they transmit orders from buyers to non-EU suppliers (and are paid for this service). However, they take no responsibility for the goods or the payment of the goods and do not own the goods at any stage. In this case, the sales agency is not considered to be an importer for the purposes of REACH. The sales agency is not responsible for the physical introduction of the goods.
In many instances, this will be the ultimate receiver of the goods (the consignee) who is the legal entity responsible for importing the goods.
For further information and examples see chapter 220.127.116.11 "Who is responsible for registration in case of import?" in the Guidance on registration:
If your suppliers are located outside the EU and decide to appoint an only representative, they will confirm this to all the importers. You should preferably also obtain confirmation in writing from the only representative that your imported tonnage and use is indeed covered by the registration dossier.
This would not only provide you with a contact point with whom you can make your use known, but would also clearly document that your imports are indeed covered by the registration of the only representative.
You need to keep exact documents on which imported quantities of the substance are covered by the only representative registration and which imported quantities are not. For further information see chapter 18.104.22.168 "Only representative of a non-EU manufacturer" in the Guidance on registration:
Substances which have been registered, exported and then re-imported are exempted from registration under certain conditions.
To benefit from this exemption, you need to document that the following conditions are fulfilled:
- The substance must have been registered before it was exported from the EU.
- The substance already registered and exported must be the same, as the substance being re-imported.
- The substance must not only be the same but it must actually proceed from the same supply chain in which the substance was registered.
- The re-importer must have been provided with information on the exported substance as required by REACH (e.g. safety data sheet).
For further information, see chapter 22.214.171.124 "Re-imported substance" in the Guidance on registration:
If substances are in temporary storage with a view to re-exportation and remain under customs supervision, they are not subject to REACH.
To rely on this exemption, you need to document that the following conditions are fulfilled:
- The substances are put in a free zone or free warehouse as defined under customs legislation or placed under another relevant customs procedure (transit procedure, temporary storage).
- The substances are kept under the supervision of the customs authorities.
- The substances do not undergo any form of treatment or processing during their stay in the EU. A free zone or a free warehouse in the EU territory is part of the EU.
For further information see chapter 126.96.36.199 "Substances under customs supervision" in the Guidance on registration:
Substances may be intended to be released from articles to provide "added value". Scented children's toys, for example, are articles made with the intent of releasing substances. The release is an additional quality of the toy and is therefore intended because it gives added value, namely a pleasant smell.
As a counter-example, consider the case of a printer cartridge or a wet cleaning wipe. In these cases, the substances can be physically separated from the article. Therefore, they cannot be considered as substances in an article, but rather as substances in a container.
The consequence is that the supplier of cartridges is considered as a supplier of substances and the general registration obligations therefore apply.
For further information see the Guidance on requirements for substances in articles:
In most cases, if you want to find out for which uses a substance has been registered, you will have to ask other actors up your supply chain.
For this purpose, you need to describe the function of the substance in the article, the process by which the substance is included in the article and into which type of article. This description should be in line with the use descriptor system.
Safety data sheets (SDSs) can be helpful as they contain information on uses of the substance or mixture as far as they are known by the supplier. If the SDS also includes a registration number, it may be possible, depending on the accuracy of the use descriptions in the SDS, to conclude that a particular use of this substance has already been registered. However, if you have doubts, you should seek confirmation from the actual registrant up the supply chain.
Alternatively, you could identify and ask manufacturers or importers of that substance from any supply chain for the uses they have registered this substance for, or whether they have registered it for a particular use.
A good way to identify manufacturers and importers of a substance is to launch a corresponding request within the substance information exchange forum (SIEF) for this substance, provided that you have pre-registered the substance or joined the SIEF as a data holder.
For further information see the Guidance on requirements for substances in articles:
As an only representative, you are fully responsible and liable for fulfilling all obligations of importers for the substances you are responsible for. These do not only pertain to registration but also to all other obligations of importers under REACH. As an only representative, you need to register the imported quantities depending on the contractual arrangements with the ‘non-EU manufacturer'.
You can represent one or several ‘non-EU manufacturers'. If you act on behalf of several ‘non-EU manufacturers', you must submit a separate registration for each of these manufacturers.
Your registration dossier should contain all uses of the importers covered by the registration. You need to keep an up-to-date list of importers within the same supply chain of the ‘non-EU manufacturer' and the tonnage covered for each of them, as well as information on the supply of the latest update of the safety data sheet.
For further information see chapter 188.8.131.52 "Only representative of a non-EU manufacturer" in the Guidance on registration:
Each year, you need to calculate your yearly tonnage as the average over the three preceding years.
If you have yearly volumes of 60 tonnes in 2013, 90 tonnes in 2014, 140 tonnes in 2015 and 200 tonnes in 2016. The three-year average tonnage in 2016 is 97 tonnes per year, but the three-year average in 2017 is 143 tonnes.
In this case, you would need to register the substance as soon as possible as the registration deadline for substances over 100 tonnes per year has passed on 31 May 2013. The registration requirements should be based on the 2017 tonnage calculated as the average over 2014-2016, i.e. 143 tonnes.
As the yearly tonnage is based on a three-year average it should be easier for companies to anticipate any increase of yearly tonnage.
For further information see the Guidance on registration:
A polymer is a substance consisting of molecules characterised by the sequence of one or more types of monomer unit. Such molecules must be distributed over a range of molecular weights. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.
Under REACH, a polymer is defined as a substance meeting the following criteria:
- Over 50 percent of the weight consists of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and,
- The amount of molecules presenting the same molecular weight must be less than 50 percent of the weight.
For further information see chapter 184.108.40.206 of the Guidance on registration:
Full details on polymers are available in the Guidance for monomers and polymers:
In specific cases, REACH allows individual Member States to exempt certain substances from the application of REACH, in the interests of defence.
More information on national exemptions in the interest of defence in individual Member States is available on the European Defence Agency website:
A non-isolated intermediate is defined as an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.
For further information see the Guidance on registration:
When a substance is used in food for humans or feedingstuffs for animals in accordance with the Food Safety Regulation ((EC) No 178/2002), the substance does not have to be registered.
This includes the use of the substance:
- as a food additive in foodstuffs (Council Directive 89/107/ECC);
- as a flavouring in foodstuffs (Council Directive 88/388/ECC and Commission Decision 1999/217/EC);
- as an additive in feedingstuffs (Regulation (EC) No 1831/2003);
- in animal nutrition (Council Directive 82/471/EEC).
Amounts of the same substance used for other uses than food and feedingstuffs are not exempted from registration. Only the amounts of the substance used in food and feedingstuffs are exempted from the registration obligation under REACH.
For further information, see chapter 220.127.116.11 of the Guidance on registration:
When a substance is used in a medicinal product within the scope of either:
- The Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ((EC) No 726/2004); or
- The Directive on the Community code relating to veterinary medicinal Products (2001/82/EC); or
- The Directive on the Community code for medicinal products for human use (2001/83/EC); the substance does not have to be registered under REACH for that use.
The exemption does not distinguish between active or non-active ingredients as it applies to any substance ‘used in medicinal products'. Excipients used in medicinal products are therefore also exempted from registration.
Amounts of the same substance used for other uses than pharmaceuticals are not exempted. Only the amounts of the substance used in medicinal products are exempted from the registration obligation.
For further information, see chapter 18.104.22.168 of the Guidance on registration:
Active substances manufactured or imported for use in biocidal products are regarded as registered for the use in that biocidal product in the following situations:
- The active substance has been approved in accordance with Regulation (EU) No 528/2012 ("BPR"), or
- The active substance is under assessment in the review programme of existing active substances established under Article 16(2) of Directive 98/8/EC and continued under Article 89 BPR.
The list of approved active substances is available from the ECHA website:
To check which active substances are in the review programme, please see Annex II, part I to Commission Delegated Regulation (EU) No 1062/2014, also available from the ECHA website:
An exemption from REACH registration also applies in the following cases:
- The active substance is manufactured/imported for use in a biocidal product which has a simplified authorisation (Article 27 BPR)
- The active substance is manufactured/imported for use in a biocidal product which has a provisional authorisation (Article 55 BPR)
- The active substance is manufactured/imported for use exclusively in a biocidal product which is the subject of experiments or tests for the purposes of scientific or product and process-orientated research and development (Article 56 BPR).
If you manufacture or import a substance for biocidal and non-biocidal uses, you need to register it for the quantities of the substance used in non-biocidal products.
Active substances manufactured or imported for use in plant protection products, in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, are regarded as registered under REACH (for that use) if the active substance is approved and included in Commission Implementing Regulation (EU) No 540/2011 (list of approved active substances), or where the application for approval of the active substance is deemed admissible in accordance with Article 9 of Regulation (EC) No 1107/2009.
Amounts of the same active substance used for other uses than in plant protection products are not regarded as being registered even if they are approved. Also, other substances such as co-formulants, synergists, safeners and adjuvants are not regarded as being registered.
The Commission maintains an electronic list of the approved (and non-approved) active substances which is available at the following link:
A recovered substance should be registered as soon as it is no longer considered waste (when it reaches the end of waste criteria).
For further information on the end of waste criteria, see the following page:
To benefit from this exemption, you need to document that the following conditions apply:
- The same substance must have been registered.
- The substance must be the same.
- The company that did the recovery must have the information required by REACH available (e.g. safety data sheet).
For further information, see chapter 22.214.171.124 ‘Recovered substance already registered' in the Guidance on registration:
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.