Frequently Asked Questions about REACH
Version 5.2 - 27 November 2012
Please click on the the topic to see the content.
* By insertion of new FAQs or by removal of FAQs which are out of date, existing FAQs may have been renumbered
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2.4, 6.3.3, 6.3.6, 6.3.7, 10.5, 12.4, 12.5
2.1, 3.2, 4.1,4.2, 4.4, 4.5, 6.3.2, 6.3.5, 6.4.1, 6.6, 7.1, 7.5, 9.4, 12.1
3.3, 6.3.8, 6.8, 6.9, 6.10, 8.5, 9.10, 9.11, 12.2.1, 12.6, 12.7, 13.1
1.3, 2.4, 6.3.1, 6.4, 6.6, 6.7, 8.2, 10.1, 10.2, 10.5, 11.1
6.1.1, 6.3.9, 6.3.10, 6.3.11, 6.3.12
2.5*, 4.6, 13.1*, 13.2, 13.3
1.1, 1.61, 2.3, 2.4, 5.1, 5.5, 6.3.1, 8.3, 9.5, 10.1, 11.2, 12.2, 12.6, 12.7
9.12, 9.13, 9.14, 9.15, 9.16, 9.17, 9.18
4.1, 9.1, 9.2, 9.3, 9.51, 9.6, 9.7, 9.8, 9.9, 9.10, 9.11
3.4, 6.3.13, 6.11, 6.12, 6.13, 6.14, 10.6, 11.3, 11.4, 11.5
1.1, 1.31, 1.4, 1.5, 2.1, 2.2, 2.3, 2.5, 3.1, 3.2, 3.3, 4.2, 4.4, 4.5, 5.12, 5.2, 5.3, 5.4, 5.5, 6.1, 6.2, 6.3, 6.3.1, 6.3.2, 6.3.3, 6.3.5, 6.3.7, 6.4, 6.4.11, 6.6, 6.7, 6.8, 6.9, 6.10, 7.1, 7.4, 8.1, 8.2, 8.3, 8.4, 8.5, 10.1, 10.22, 10.4, 10.5, 11.1, 11.2, 12.1, 12.2, 12.3, 12.61, 12.7, 13.4
6.3.14, 6.15, 6.16, 7.8, 12.8, 12.9
4.7, 4.8, 6.6*, 6.18, 6.19, 10.1^, 10.2^, 10.3^, 10.4^, 10.5^, 10.6^, 10.7, 10.8
6.20, 6.21, 6.22, 8.7, 8.8, 8.9, 9.19, 9.20, 9.21, 9.22, 11.8, 14.5
12.2, 12.3, 12.4, 12.5, 13.3
6.23, 8.10, 8.11, 10.9, 15.1
13.10, 13.11, 13.12, 13.13, 13.14
6.3.13, 6.3.14, 9.22, 10.11, 12.6, 12.7, 13.14, 13.15, 13.16, 13.17, 14.6
2 Merged with another FAQ
3 Revision of all the FAQs to align them with the update of various guidance documents. In some of the FAQs other editorial changes have been also performed.
This Frequently Asked Questions document contains information on obligations under the REACH Regulation (hereafter referred to as REACH or the REACH Regulation) explaining how to fulfil them. This FAQ document has been agreed by and between the correspondents of the national helpdesks of the Member States, representatives of the European Commission and the European Chemicals Agency within the Help Net Steering Group.
However, users are reminded that the text of the REACH Regulation (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC) is the only authentic legal reference and that the information in this document does not constitute legal advice. The European Chemicals Agency does not accept any liability with regard to the contents of this document.
Reproduction is authorised provided that the source is acknowledged.
Please click on the general topic to see the relevant questions
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
The objective of the Corrigenda to REACH of 29 May 2007 was to rectify mostly linguistic errors but not to make changes on the content of the text. Most of the corrections are applicable to language versions other than English. One change to be mentioned here is within Article 64 (8) of REACH where a printing error has been corrected: the reference to the procedure to arrive at a final decision on granting or refusing the authorisation has been corrected to Article 133(3) of REACH, being the regulatory committee procedure.
In accordance with Articles 125 and 126 of REACH, Member States shall enact national provisions defining controls and sanctions for non-compliance with the REACH Regulation. It is recommended that you contact the relevant enforcement authorities in your country to learn about the national control procedures in place. You may also contact the customs authorities and the national helpdesk for further information.
There are a number of contact points from which you can obtain assistance and information on REACH:
- The first point of contact for questions on REACH is the national 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, organisation of enforcement authorities, etc.). The list of contact details of the national REACH helpdesks is available on the ECHA website.
- For advice on fulfilling the obligations of REACH, 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 who have questions on REACH provisions but also on IUCLID 5, REACH-IT and the administration of submitted dossiers. Although non-EEA companies do not have direct obligations under the REACH Regulation, they also may approach ECHA, if they are looking for information on REACH. If their questions are related to the conditions in a particular country, they may also turn to the corresponding national REACH helpdesk. A network between the national REACH helpdesks and ECHA has been established with the overall objective of achieving the best, most consistent and most harmonised advice possible to manufacturers, importers, downstream users and interested parties, in particular SMEs.
Yes, because there are several obligations under REACH. Registration requirements only apply to substances that are manufactured or imported in quantities of 1 tonne or more per year per registrant (see FAQ section 6 on registration). However if a substance is manufactured/imported at less than 1 tonne per year per registrant, other obligations under REACH may still apply if the substance falls within the scope of REACH. These obligations, which may apply irrespectively of the volume, include obligations concerning use of the substance, restrictions, authorisation and communication in the supply chain, such as the provision of safety data sheets.
For help in identifying your obligations, the use of the Navigator tool is recommended: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations
According to Article 2(7)(a) of REACH, substances listed in Annex IV are exempt from registration. Modified substances derived from a substance listed in Annex IV of REACH are also exempt if the modified substance is still covered by the same EINECS entry. Whether or not a modification of a substance is covered by the same EINECS entry as the non modified substance 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 of that substance are explicitly covered in the EINECS entry. Compared to that, chemical modification (e.g. hydrogenation) is not mentioned and hence considered not to be covered. For further information, please consult Article 3, Definition 40, of the REACH Regulation and Section 184.108.40.206- '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 according to 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 nano particles.
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.
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.
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.
A non-EEA company (that can appoint an only representative, see FAQ 4.1) 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 220.127.116.11- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
There are no detailed requirements or criteria regarding what is regarded as "sufficient background in the practical handling of substances and the information related to them" other than what is laid down in Article 8(2) of REACH.
Yes, an only representative can represent one or several non-EEA companies that manufacture substances, formulate mixtures or produce articles which are exported to the European Economic Area (EEA), even for the same substance. More information on the duties of the only representative is 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.
An only representative must be able to document who he is representing (i.e. the name of the non-EU manufacture should be given in section 1.7 of IUCLID) and is advised to attach a document from the "non-EU manufacturer" appointing him as only representative in section 1.7 of IUCLID. It is not mandatory to include this information in the registration dossier, but it needs to be presented to the enforcement authorities upon request.
Furthermore an only representative is advised to include the "list of importers" in section 1.7 in IUCLID.
There is no fee for pre-registration. However, according to Article 74 of REACH that specifies the requirements for fees, there is a fee for registration. For more information on the registration fee please see FAQ 6.8.
According to Article 28(4) of REACH, ECHA has published on its website the list of pre-registered substances. This list does not contain the names of the pre-registrants. Thus, in order to find out whether a substance has been pre-registered in a particular supply chain, a downstream user should enquire to his supplier or other actors further up his supply chain.
Only a natural or legal person established within the European Economic Area (EEA) can be a registrant. Registration must take place when this person:
(1) manufactures a substance within the EEA in quantities of 1 tonne or more per year,
(2) is responsible for import into the EEA of quantities of 1 tonne or more per year or
(3) has been appointed as an only representative according to Article 8 of REACH.
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.
Please note that a company that is not established within the EEA does not have direct obligations under REACH. It is the importers introducing the non-EEA company's products into the EEA that need to comply with the obligations of REACH. However, to relieve the importers of their obligations, a company not established within the EEA, which is a manufacturer of substances, formulator or producer of articles, may decide to appoint an "only representative" (see FAQ section 4).
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. Therefore, the trigger to consider whether a natural or legal person is required to register is whether they undertake a process of manufacturing a substance in accordance with the definition of Article 3(8) of the REACH Regulation.
In this regard, an entity that manufactures a substance on behalf of a third party is to be considered a manufacturer for the purposes of REACH and, consequently, is required to register. If the entity running the manufacturing process is different from the entity owning the production facility, nevertheless one of these entities must act as the registrant under REACH. More explanations on which actors in the supply chain have registration obligations and responsibilities can be found in Section 2.1- 'Who has to register?' of the Guidance on Registration: http://echa.europa.eu/guidance-documents/guidance-on-reach
2This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.
In the situation where a company group is composed of several natural or legal persons, each of those must determine if they qualify as registrants according to Article 3(7) of REACH. All legal entities based in the EEA have to comply with REACH (See FAQ 6.9). International companies sometimes have several daughter companies in the EEA, often spread over several countries. If these subsidiaries of the parent companies are separate legal entities from the parent company, (a natural or legal person as defined under applicable national law), then they may be a registrant under REACH. Please see FAQ 6.1 on who has to register a substance.
- as defined in Article 3(1) of REACH;
- manufactured in or imported into the EU in quantities of 1 tonne or more per registrant per year;
- unless they are exempted from registration or regarded as being already registered, according to provisions in Articles 2, 9, 15 or 24 of the REACH Regulation;
- irrespective of whether they are classified as dangerous or not.
The REACH Regulation refers to alloys as "special mixtures" (Recital (31), Annex I (0.11.), as amended by Regulation (EC) No 1272/2008). Therefore, an alloy is to be treated in the same way as other mixtures under REACH, which means that the alloy as such is not subject to registration but the alloying elements (e.g. metals), irrespectively of the production process of the alloy are. However, components which are not important for the properties of the alloy should be considered as impurities (i.e. they are part of a substance in the mixture) and therefore need not be registered separately.
Please note that intermetallic compounds are often wrongly regarded as alloys, although they have a well defined stoichiometry. Such substances are listed in EINECS (e.g. "aluminium, compound with iron (1:1)", "iron, compound with titanium (2:1)", etc.) and cannot be regarded as mixtures, therefore these intermetallic compounds have to be registered as such. This means that e.g. separate (pre-)registrations of the substances Al and Fe do not cover the substances "aluminium, compound with iron (1:1)" or "aluminium, compound with iron (1:3)". For each intermetallic compound with a different metal ratio a separate (pre-)registration is required.
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 6.3). 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.
Substances occurring in nature are exempted from the duty to register in accordance with Article 2(7)(b) and Annex V, point 8 of REACH, as long as they are not chemically modified, not classified as dangerous in accordance with Directive 67/548/EEC, nor substances of very high concern, such as PBT or vPvB substances. If a process is applied to extract such a substance, it has to be verified whether the process applied is one of those listed in Article 3(39) of the REACH Regulation. If this is the case, the substance still qualifies as substance that occurs in nature that does not have to be registered.
The processes mentioned in Article 3(39) of REACH are manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, heating solely to remove water and extraction from air. Please note that extraction with solvents other than water, like e.g. hexane or ethanol, are not covered by Article 3(39) of REACH. Substances which are extracted with these solvents do not qualify as a substance that occurs in nature and cannot be exempted from registration on the basis of Annex V, point 8 of REACH.
Lavender oil, for example, is extracted from flowers of certain species of lavender (which occur in nature) by means of steam distillation. The subsequent spontaneous separation of oil and water allows an easy isolation of the lavender oil. As this extraction process is mentioned in Article 3(39) of REACH, the lavender oil can be regarded as a substance that occurs in nature.
On the contrary, chrysanthemum oil, for example, which is extracted from chrysanthemum blossoms and leaves (which occur in nature) with a solvent mixture of water and ethanol (1:10), cannot be regarded as a substance that occurs in nature.
In general, it is important to remember that it is up to the manufacturer to assess the process applied and to determine if the definition of Article 3(39) of REACH is applicable or not.
According to Article 3 (22) of the REACH Regulation PPORD is defined as "any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance".
Any scientific development of a substance consisting of, for example, campaign(s) for the scaling-up, improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.
In order to promote innovation, Article 9 of the REACH Regulation specifies that substances manufactured or imported on their own or in mixtures, as well as substances incorporated in articles or imported in articles for the purpose of PPORD can be exempted from the duty to register for a period of 5 years. To be exempted a company needs to submit a PPORD notification to the ECHA. Upon request, ECHA may further extend this exemption for up to another 5 years, or 10 years for the development of medicinal products (for human or veterinary use) as well as for substances that are not placed on the market. Further information is provided by the specific Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD): http://echa.europa.eu/guidance-documents/guidance-on-reach.
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, manufacturers or importers of substances, or producers of articles wishing to continue their PORD activities after 1 June 2008, need to submit a PPORD notification according to Article 9 of the REACH Regulation, to benefit from the registration exemption. For guidance on how to prepare and submit a PPORD notification in practice, please consult the Data Submission Manual 1: http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals
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 22.214.171.124- 'Notified substances according to Directive 67/548/EEC' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Yes. Article 6 of the REACH Regulation requires a manufacturer of a substance in quantities of more than 1 tonne per year to submit a registration, irrespective of whether this substance will subsequently be exported outside of the EEA. Therefore, substances manufactured in the EEA above this limit that do not meet any of the criteria for exemption from registration in accordance with Article 2 of the REACH Regulation and which are subsequently exported to non-EEA countries must be registered. The rationale for this duty is that the exposure resulting from manufacture and any other activity before export could be relevant for workers and the environment in the EEA.
The surface treatment of a substance is a "two dimensional" modification of macroscopic particles. A "two dimensional" modification means a chemical reaction between the functional groups only on the surface of a macroscopic particle with a substance which is called a surface treating substance.
By this definition it becomes clear that this kind of modification means a reaction of only a minor part (surface) of a macroscopic particle with the surface treating substance, i.e. most of the macroscopic particle is unmodified.
Therefore a chemically surface treated substance cannot be regarded as a mixture nor be defined by the criteria of the Guidance for identification and naming of substances under REACH: http://echa.europa.eu/guidance-documents/guidance-on-reach.
With the same reasoning, a chemically surface treated substance could not be reported for EINECS nor be notified according to Directive 67/548/EEC because it was covered by the separate EINECS entries of both the basis substance (macroscopic particle) and the surface treating substance.
Taking this decision up under REACH means a consequent continuation of former decisions. Using the same line of arguments, chemically surface treated substances should not be registered as such under REACH, but the following requirements should be fulfilled:
- Registration of the basis substance (macroscopic particle)
- Registration of the surface treating substance
- Description of the use "surface treatment" in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
- Any specific hazards or risks of the surface treated substance should be appropriately covered by the classification and labelling and by the chemicals safety assessment and resulting exposure scenarios.
The answer to this question depends on the role of the entity at the time when the registration obligation applies.
Article 5 of the REACH Regulation provides that "...substances shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required." (emphasis added)
Articles 6, 7, 17 and 18 establish the registration obligation and specify to whom this registration obligation applies. These Articles only impose registration obligations on manufacturers or importers (and, in specific cases, on producers or importers of articles) and do not impose registration obligations upon downstream users, distributors or suppliers of substances. In principle a manufacturer/importer can simultaneously also fulfil the definition of a "supplier of a substance" when placing it on the market.
Hence, the registration obligation does not apply to manufacturers or importers that have manufactured or imported pre-registered substances before the registration deadline and ceased such activities and simply act as suppliers of these substances after the registration deadline. This equally applies for any downstream user, distributor or supplier down the supply chain.
On the contrary, if the manufacturing/importing activities have not ceased before the relevant registration deadline, the manufacturer/importer keeps his status and must submit a registration dossier for all quantities of the substance manufactured before and after the respective registration deadline to continue the manufacture/import and placing on the market of these substances. However, in case the manufacturer/importer has not submitted registration, any actor down the supply chain who is not subject to the registration obligation may continue to use and/or supply quantities of the substance that have been supplied to them by the manufacturer/importer before the registration deadline.
According to Annex V, point 6 of the REACH Regulation hydrates of a substance or hydrated ions, formed by association of a substance with water are exempted from registration, provided that the substance (i.e. the anhydrous form) has been registered by its manufacturer or importer.
Hydrates of a substance are characterised by the fact that water molecules are linked by molecular interactions, in particular by hydrogen bonds, to other molecules or ions of the substance. For the purposes of Annex V, hydrates and water free forms (anhydrous) of compounds shall be regarded as the same substance (e.g. CuSO4.5H2O and CuSO4).
In contrast, a metal hydroxide (e.g. Ca(OH)2) and a metal oxide (e.g. CaO) cannot be regarded as the same substance as both substances have different structures, regardless of the manufacturing process. The formation of the hydroxide involves forming new covalent bonds, which is different from forming a hydrate which only involves weak intermolecular bonds. Therefore a metal hydroxide manufactured from the metal oxide is not covered by the exemption from registration in Annex V, point 6.
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 6.3 explains which substances have to be (pre-)registered.
There is no explicit legal obligation for registrants to update their registration dossier every time an import is made from a new non-EU source. However, according to Article 22(1)(b) of REACH, there is a legal obligation to update the composition of the substance as given in Section 2 of Annex VI. The registrant has to assess the sameness of the substance every time an import of the substance is made from a new source, according to Guidance for identification and naming of substances available on the ECHA website.
There are three possible outcomes of this assessment:
- Registrants find that the substance has the same impurity profile as previous imports and is already registered by them. They do not have to update the registration dossier for the substance.
- Registrants find that the substance has a different impurity profile from previous imports. They then have to update the relevant sections of the registration dossier (e.g. concentration ranges or changes in C&L) with the new composition of the substance.
According to ATTACHMENT 1: IONIC MIXTURES of the Annex V Guidance document, ionic substances in an aqueous solution are exempted from registration if:
- All starting substances (salts, acids and bases) of the aqueous solution are registered;
- None of the salts in the aqueous solution are isolated from the solution; and
- The salts remain in their ionic form in the solution.
The third condition is not fulfilled, because the salts do not remain in their ionic form in the complex. Therefore, this exemption does not apply, and the complex would be subject to registration.
- The REACH Regulation creates a special transition regime for phase-in substances (Section 126.96.36.199- 'Phase-in substances' of the Guidance on registration). In order to benefit from the extended registration deadlines for phase-in substances (Section 2.3.2- 'Deadlines for Registration' of the Guidance on registration, these substances must be pre-registered (see also FAQ 5.1). Depending on its intrinsic properties and its tonnage, a pre-registered substance needs to be registered before 1 December 2010, 1 June 2013 or 1 June 2018.
- Non-phase-in substances and phase-in substances which have not been pre-registered must be registered before manufacture or import can continue. In this case the registrant may have to wait for 3 weeks before continuing manufacture or import (Article 21 of the REACH Regulation). Prior to registration of such substances, the manufacturer or importer has a duty to make an inquiry to ECHA regarding any previous registration for that substance.
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 188.8.131.52- '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 Data Submission Manual: Part 4 and Data Submission Manual: Part 5.
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 5 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 5 software is downloadable free of charge from the IUCLID website http://iuclid.echa.europa.eu/.
The registration fee for a substance varies depending on the tonnage of registration, size of the company and type of submission. A fee is not required for the registration of substances in a quantity between 1 and 10 tonnes per year for which a registration dossier containing the full information in Annex VII to the REACH Regulation is submitted. Lower fees and charges apply to joint submissions as compared to separate submissions. Moreover, a reduced fee is set in all categories for SMEs. However, an additional fee is levied for confidentiality requests submitted in accordance with Article 10(a)(xi) of the REACH Regulation.
Article 74 of the REACH Regulation lays down the basic provisions on the requirements for fees. The fees are specified in the Commission Regulation No. 340/2008 on fees and charges payable to ECHA. Further information can be found in the REACH-IT FAQs on "Invoices and payments": http://echa.europa.eu/support/faqs/reach-it-frequently-asked-questions
To fulfil his duties as a registrant an EEA-based importer of mixtures has to have information on the composition of the mixtures he imports into the EEA. This obligation already existed under the previous legislation as regards substances to be classified as dangerous. Under REACH, an importer needs to know at least the identity and percentage content of all substances in the mixtures he imports that could exceed the amount of one tonne/year.
If the non-EEA supplier is not willing or not able to provide the required information, the importer has the following options:
- identify the formulator of the mixture (if different from the supplier) and ask him directly for the required information,
- propose to the non-EEA formulator that he appoints an only representative in accordance with Article 8 of the REACH Regulation,
- establish the composition of the mixture by analytical means,
- find an alternative supplier who is prepared to provide all required information for the mixture.
No. According to Article 4 of the REACH Regulation a manufacturer, importer or downstream user may appoint a third party representative for all proceedings under Article 11, 19, Title III (Data sharing and unnecessary testing) and Article 53 of the REACH Regulation involving discussions with other manufacturers, importers or, where relevant, downstream users. These proceedings do not include the submission of registrations. Unlike an only representative, a third party representative only plays a part in the negotiations between the (potential) registrants, while the appointing company retains full responsibility for complying with its registration obligations.
If a registration for a substance has been submitted, the obligations to update the registration (Article 22) and to keep information (Article 36) apply. This means that a registrant ceasing manufacture and import of this substance has to inform the Agency about the new total tonnage manufactured and imported (in this case zero t/a). Furthermore this registrant has to keep available all the information he required to carry out his duties under REACH for a period of at least 10 years after he last manufactured, imported, supplied or used the substance (as such or in a mixture). In this regard, the period of at least 10 years does not start if the registrant, who ceased manufacture and import, still supplies or uses the substance.
The wording of Article 23(1)(a) and (b) of the REACH Regulation "classified as [...] in accordance with Directive 67/548/EEC" refers to both, substances listed in Annex I with their harmonised classification and to self-classified substances.
It may be inferred from Articles 4 and 6 of Directive 67/548/EEC that substances shall be classified (by manufacturers/importers) according to the criteria in Annex VI of that Directive. In addition, Annex I of that Directive contains the list of substances classified by the Commission, following discussions in expert groups. As the Directive covers both situations, substances should therefore be considered as classified in accordance with Directive 67/548 not only when listed with their harmonised classification in Annex I, but as soon as they meet the criteria for classification set out in Annex VI of that Directive, i.e. also when self-classified by the registrant, should the substance not (yet) be listed in Annex I. Both situations should be considered as "classification in accordance with Directive 67/548/EEC".
This interpretation is borne out by the very spirit of REACH and in particular the aim and objective of the deadlines provided for in Article 23 of REACH. The aim of the earlier deadline for registration of substances with properties of very high concern is to gather earlier the necessary information on the substances, on their uses and for industry to develop and recommend appropriate risk management measures. Given the specific health and/or environmental concerns in this case the objective was not to defer the application of the REACH provisions for further years. To this end, the aim of the legislature in setting the earlier registration deadlines was clearly to cover both cases, as there is no difference in the protected public interest. Substances with non-harmonized classification are equally a ground for the same concern as substances with harmonised classification.
A consequence of this interpretation is that, as from 1 December 2010, as soon as a manufacturer or importer obtains evidence that his substance fulfils the classification criteria set out in Art. 23(1)(a) or (b) of REACH after that date, he will be obliged to register that substance immediately.
A manufacturer or importer who has registered an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH does in general not have to update this registration in case of a change of tonnage band. However, such a registration would have to be updated due to a change of tonnage band in two cases.
Case 1: Where the registration is for a transported isolated intermediate and the 1000 t/a threshold is reached, the registrant must update his registration dossier by submitting the information specified in Annex VII of the REACH Regulation, if not already included in the dossier.
Case 2: Where the registrant ceases manufacture and import of the isolated intermediate, he has the duties described in FAQ 6.13, which include an update of the registration.
The "no data, no market" principle set out in Article 5 of the REACH Regulation applies to all substances that are manufactured or imported in quantities of 1 t/a or more where they have not been registered or pre-registered. This means that a company planning to start manufacture or import of 1 t/a or more of a phase-in substance after the relevant registration deadline given in Article 23 of REACH needs to have validly registered the substance before starting this activity.
According to Article 28(6) of REACH a first-time manufacturer or importer of a substance may submit a late pre-registration within 6 months of the date of first manufacture or import in quantities of 1 t/a or more of that substance and no later than 12 months before the relevant registration deadline given in Article 23 of REACH. Therefore, a company planning to start manufacture or import of 1 t/a or more of a phase-in substance less than 12 months before the relevant registration deadline also needs to have validly registered the substance before starting this activity.
In both cases, prior to registration the company planning to start manufacture or import has to submit an inquiry according to Article 26 of REACH. Further information can be found in section 4.4- 'Substances subject to the inquiry process' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach
After the submission of the registration dossier it may take up to three weeks before ECHA informs the registrant whether his registration is complete or not. Manufacture or import of a substance cannot start before the end of this period and can only start once ECHA has informed the registrant that the registration is complete and a registration number has been assigned.
After you have submitted your registration dossier you may realise that your registration dossier has to be corrected or modified for reasons other than those triggering the need for an update of the registration according to Article 22 of the REACH Regulation. This might be the case, for example, if you accidentally introduced faulty information in the dossier (e.g. incorrect information in one of the study summaries, which however does not affect the assessment of the substance made) and noticed this only after you submitted the dossier to ECHA. In this case you should make a spontaneous dossier update via REACH-IT, indicating in the dossier header the reason(s) why you are spontaneously updating it as well as the references of the previous valid submission (i.e. the "last submission number"). Such an update would not be subject to a fee.
If the mistake leads to a failure in the business rule verification, then instead of a spontaneous update submission an initial submission has to be made, as if it was the first dossier submission. Part 4 of the REACH-IT Data Submission Manual describes how to pass the business rule verification.
In case the registrant fails to complete his/her registration for the second time within the deadline set, the Agency will reject the registration and the registration fee will not be reimbursed. According to Article 5 of the REACH Regulation, substances may not be manufactured, or placed on the market unless they have been registered. By virtue of Article 23(1), 23(2) or 23(3) of REACH, as applicable, neither Article 21 nor Article 5 apply to the registration dossiers for substances benefiting from the extended registration deadlines of Article 23 of REACH until the respective deadline in question. This means that if a registration is rejected before the respective deadline in Article 23 of REACH, manufacturing or importing of this substance within the EEA can continue until this deadline.
In case the manufacture or import is only to be started, e.g. in case of a non phase-in substance, the waiting period must be respected.
On the other hand, there is no requirement to interrupt manufacture or import of phase-in substances during the TCC. However, when the initial submission of a phase-in substance was incomplete, ECHA will give the registrant a deadline to complete the dossier. Until the end of this deadline, the registrant is allowed to continue his activities. If he does not update the dossier, the registrant must cease manufacture or import by this deadline at the latest. If he updates his dossier, the registrant can continue the manufacture or import of the substance until he receives the decision by ECHA on the outcome of the completeness check. If he receives a decision rejecting his registration, he must cease manufacture or import of the substance.
REACH does not provide for the assignation of registration numbers to active substances in biocidal products. It is reminded that registration numbers are assigned exclusively for substances:
- where complete registration dossiers were submitted to ECHA by the registrant according to Article 20 of REACH;
- which were notified under Directive 67/548/EEC and the registration number was claimed by the notifier according to Article 24 of REACH.
Regarding the information on active substances in biocidal products, this is held by the European Commission, and certain information is publicly available via its website at http://ec.europa.eu/environment/biocides.
ECHA has access to the information necessary for data sharing purposes.
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:
- Include the new TPR in the REACH-IT company information section. The registrant should select < Company > - < View > and add the TPR in the TPR tab.
- Select manually the new TPR for every single pre-registration and Joint Submission Object (JSO) where a registration dossier has not been submitted yet using the pre-registration and JSO functionalities respectively. If a registration number had already been assigned to a specific substance, the registrant will not be able to modify the TPR of its pre-registration but he is able to update its TPR in the JSO.
Since the inclusion of a TPR in a registration dossier is not required by REACH during the submission of a registration dossier, an update of the TPR related to a registration is also not legally required. Article 22 of REACH does not include the update of a TPR as a case where the registrant shall be responsible for update on his own initiative. However, if the registrant wishes to communicate a change of TPR for a specific registration, i.e. while submitting a registration dossier update for any of the reasons established in Article 22 of REACH, they may do so.
No fee is required if the TPR is updated in a registration dossier.
According to Article 26 of REACH, every potential registrant of a non-phase-in substance or a phase-in substance which has not been pre-registered must inquire to ECHA as to whether a registration has already been submitted for the same substance. The potential registrant has to follow the inquiry process even if contact with the LR is already established and the potential registrant has access to the appropriate 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 Q&A document on inquiry and substance identification Further guidance can be found in the Questions and Answers document on inquiry and substance identification: http://echa.europa.eu/regulations/reach/substance-registration/inquiry.
According to Article 2(9) of REACH polymers do not have to be registered, but according to Article 6(3) of REACH, the monomer substance(s) and other substances of the polymers that have not already been registered by an actor up the supply chain, are to be registered if both the following conditions are met:
- the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) (i.e. free or unbound monomers shall not be considered when checking this condition);
- the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year (the total quantity in this context is the total quantity of monomer or other substance ending up in the final polymer unbound or chemically bound to the polymer)
The REACH Regulation defines polymers in Article 3(5) and monomers in Article 3(6) of REACH.
The European Commission may according to Article 138(2) of the REACH Regulation present legislative proposals with requirements for the registration of polymers once a practicable and cost-effective way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established.
Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
According to Article 6 (2) of REACH, the reduced registration provisions with regard to on-site isolated and transported intermediates do not apply to monomers. This means that a full registration dossier must be submitted even if a monomer is used as an intermediate under strictly controlled conditions.
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
Some substances are commonly added to polymers for the purpose of adjusting or improving their appearance and/or the physicochemical properties of polymeric material.
Additives which are necessary to preserve the stability of a polymer must be regarded as a part of the polymer in accordance with Article 3(1) of REACH. Any other unbound "additive" must be regarded as a component of a mixture and not as an additive in accordance with Article 3(1) of REACH.
Thus, the importer of a polymer containing additives does not need to register these additives provided that the additives are added to preserve the stability of the polymer. Note however that there is the general obligation to register substances imported in a polymer mixture in quantities of at least 1 tonne per year. Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: 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 fulfil 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.
According to Article 6(3) of the REACH Regulation any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that meet the criteria mentioned in the respective article. However, monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) in natural polymers can, for practical reasons, be treated as "non-isolated intermediates" and do not have to be registered.
3This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.
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 fulfill 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.
4This 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 shall include spectral data and a chromatogram of the original monomer or other substance used in the manufacture of the polymer. If it is not technically possible, or if it does not appear scientifically necessary to include this information, the reasons shall 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 in the manufacture of the polymer.
It may be the case that a company imports a type of polymer from different sources, and thus 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 he considers that the substances from the different sources are the same, he shall submit just one registration for this substance with one set of spectral data and one representative chromatogram. In this process he might still have found out that the substance from the different sources has different impurity profiles. He shall then refer to these different compositions of the substance in his registration dossier.
- 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 articles exceeds one tonne per producer or importer per year; and
- the substance has not yet been registered for that specific use.
Substances meeting the criteria outlined in Article 57 of the REACH Regulation are commonly referred to as substances of very high concern (SVHC). Notification is required under Article 7(2) of the REACH Regulation for SVHC present in articles and for which the following conditions are met:
- the substance has been included in the candidate list of SVHC for authorisation: http://echa.europa.eu/candidate-list-table 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 SVHC) exceeds one tonne per producer or importer per year and
- the substance has not yet been registered for that specific use.
However, there is no obligation to notify if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal.
As indicated in Article 7(7) of the REACH Regulation the notification of a SVHC in articles shall be made at the latest 6 months after it has been included on the candidate list for authorisation but only starting from 1st June 2011. Information on a substance on the candidate list contained in articles is to be forwarded by the supplier of the articles to the recipients as soon as possible after the substance is included in that list (Article 33). The candidate list will be updated continuously when substances have been identified as meeting the criteria of Article 57 of the REACH Regulation. Further information can be found in http://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.
Provided that the substance has been registered by any manufacturer/importer for that specific use, paragraphs 1 to 5 of Article 7 of the REACH Regulation shall not apply. This means that it is not relevant whether the registration was done within the same supply chain or within another supply chain.
No, because Article 7(6) of the REACH Regulation only applies if the substance has already been registered for that use.
A substance is intended to be released from articles if it fulfils an accessory function which would not be achieved if the substance were not released. Scented children's toys, for example, are articles with intended release of substances, because fragrance substances contained in the toys are released in order to fulfil an accessory function, namely to scent. Consequently, substances that are released because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, are generally not intended releases, 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 or functionality of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.
The transition point of steel and steel semi-finished products from substances/mixtures to articles during processing is to be determined by comparing the importance of physical and chemical characteristics for achieving the object's function. If it can be unambiguously concluded that the shape/surface/design are more relevant for the function than the chemical composition, the object that it is assessed is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or mixture. To determine whether or not steel semi-finished products constitute an article one can use the indicative questions given in Section 2.4- 'Deciding whether an object is an article or not' of the Guidance on requirements for substances in articles http://echa.europa.eu/guidance-documents/guidance-on-reach
ECHA also advises industry to consult sector-specific guidance documents provided by business associations. However, it is up to the individual companies to examine their specific situation and determine whether their product may be considered as an article.
There is no fee charged for the notification of SVHC in articles.
If the production/import ended before the SVHC was included in the Candidate List or before the notification obligation starts to apply (i.e. 1 June 2011 for substances placed on the Candidate List before 1 December 2010 or 6 months after a substance has been included in the Candidate List) 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.
For articles which have been produced/imported for at least three consecutive years, the tonnage to be reported must correspond to the average tonnage of the substance in the article produced/imported during these three full years. If the substance in the article has only been produced or imported for two full years, the average of these two full years must be notified. However, if the substance in the article has been produced or imported only since the previous calendar year, the tonnage will be calculated based on the previous calendar year only and no averaging will be made.
For instance, substances that had been placed on the Candidate List before 1 December 2010 must have been notified by the producer or importer of the article by 1 June 2011. The producer or importer should have provided the average tonnage of the three or two preceding years, or the tonnage of 2010, depending on for how many consecutive years they had imported or produced the article.
Thus, there are situations, where volumes of the substance predating the inclusion in the candidate list are considered in the tonnage calculation for the notification of a substance in an article.
Where production/import of the article starts in the current year, you are advised to notify as soon as the 1 tonne threshold is exceeded. In that case please indicate an expected tonnage range for the whole year.
While registrations of substances in articles must be updated with relevant new information, there is no legal requirement to update a "notification of substances in articles" dossier. However, ECHA recommends that notifiers update their notification dossier whenever there is a change in the information that was notified. Furthermore, it is also in the interest of the notifier to maintain an updated dossier, because based on the notification, ECHA may take a decision according to Article 7 (5) of REACH to require producers or importers of articles to submit a registration.
The possibilities that companies have to verify whether a substance has been registered for a particular use are clarified in the Guidance on requirements for substances in articles. It should be noted that the sameness of both the substance identity and the use must be ensured. The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
Sources of such information are e.g. the safety data sheets, supply chain communication and trade associations. The ECHA website also provides information from registration dossiers. The amount of available information will often be larger for EU-producers of articles than for importers of articles. Thus it may often be easier - particularly for importers of articles - to notify an SVHC in an article than to document that the substance has already been registered for the particular use in the specific article.
The rules on data sharing and avoidance of unnecessary testing are contained within Title III of the REACH Regulation. Article 25 sets out the objective of these rules, which is to reduce testing on vertebrate animals (such tests shall be carried out only as the last resort) and to avoid the duplication of tests, thus reducing the costs for industry and increasing the efficiency of the registration system.
The aim of a SIEF is to facilitate the exchange between potential registrants of information necessary for the registration of the same phase-in substance in order to avoid duplication of studies and to agree on the classification and labelling (C&L) of the substance. The SIEF also serves as a platform for data holders to share their substance data/studies. Moreover, when the available information is not sufficient for registration, a SIEF collectively identifies the need for further studies.
The pre-SIEFs are supported by REACH-IT via substance web pages. These allow for the posting of information on the creation of SIEFs via two dedicated free-text fields on the substance web page. In the first free-text field, writing rights are only given to the SIEF Formation Facilitator; in the second free-text field, all pre-registrants of the substance have writing rights. All messages in these two free-text fields are the exclusive responsibility of the authors and ECHA will neither verify nor approve or disapprove of their contents.
It is recommended that the SIEF Formation Facilitator uses the first free-text field to post messages on the creation of a SIEF and to give contact details and information on further communication tools (e.g. dedicated industry websites). The second free-text field allows other pre-registrants to give comments (e.g. in case of disagreement with the SIEF Formation Facilitator). Both free-text fields allow only a limited number of characters and should therefore only be used for key messages and referring to further contact details and/or communication tools. In addition, pre-registrants can communicate that they are no longer interested in registering by de-activating themselves in the pre-SIEF (see also FAQ 9.14).
Potential registrants should work towards forming SIEFs as soon as possible, in order to ensure that sufficient time remains available to organise data sharing and prepare the registration dossiers; this is of particular relevance for high volume substances, in view of the registration deadline of 30 November 2010. The Guidance on data sharing (section 3.2) explains in more detail how and when a SIEF is formed: http://echa.europa.eu/guidance-documents/guidance-on-reach
Who can be (and who must be) a SIEF participant is explained in detail in Section 3.2.3- 'The SIEF Participants' of the Guidance on data sharing. Also the role of data holders is discussed there: http://echa.europa.eu/guidance-documents/guidance-on-reach.
A data holder is any person holding information/data relevant to a phase-in substance and willing to share it. They can sign up in REACH-IT with a view of becoming a participant in the SIEF for that substance and can provide information to other SIEF members by submitting to ECHA any or all of the relevant information listed in Article 28(1).
Data holders may include:
- Manufacturers, importers and only representatives of a non-EEA manufacturer of phase-in substances in quantities of less than 1 tonne per year who have not pre-registered.
- Downstream Users of phase-in substances
- Third Parties holding information on phase-in substances
In addition, the following parties will automatically be participants in SIEF, as they have already submitted information on phase-in substances either (1) as registrants or (2) in the framework of EU legislation on plant protection products and/or biocidal products:
- Any manufacturer or importer or only representative of a non-EEA manufacturer and any producer or importer of an article with intended release under normal or reasonably foreseeable conditions of use who has registered a phase-in substance before 1 June 2018 automatically becomes a data holder. This includes operators that do not pre-register as well as operators that, having pre-registered, decide to register before the relevant deadline.
- Any party for which ECHA has information submitted in the framework of the Plant Protection Product Directive (91/414/EC) or the Biocidal Product Directive (98/8/EC) that meet the conditions established in Article 15 of REACH.
As data gathering induces costs, data sharing implies some form of cost sharing. As required under Article 27(3) of the REACH Regulation, parties sharing data must make "every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way". Further information on sharing of cost for tests required as a result of a decision of the Agency can be found in Article 53 of the REACH Regulation.
Agreement on cost sharing usually requires parties to agree on:
- the reliability, relevance and adequacy of the data ("Data Quality")
- the economic value of the data ("Data Valuation"), and
- how the agreed value is shared among parties ("Cost Allocation and Compensation")
These elements should serve primarily as a checklist in order to ensure that all interested parties identify relevant factors when organising data quality review, data valuations and other cost sharing activities. Registrants are only required to share the costs of information that they are required to submit to satisfy their registration requirement. Therefore, companies cannot be forced to pay for studies that they do not need and they also cannot be forced to pay before they actually need them in their respective tonnage band. However whenever the (potential) registrant requests data earlier, he has to pay on receipt of the data. Other elements might be considered as well. In general, it is recommended that an agreement on cost sharing is reached prior to the disclosure of available information by participants.
The cost sharing guidance referred to in Article 27 and 30 of the REACH Regulation has been published by ECHA as Chapter 5- 'Cost sharing' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
A SIEF itself has no prescribed legal form. It is a group of potential registrants, downstream users and third parties (according to Article 29 of the REACH Regulation) that have an interest in the same substance and thus may have data sharing duties or data sharing opportunities under REACH. The REACH Regulation does not impose any obligation on SIEF participants to form or join a consortium or any other form of cooperation agreement. Thus, participation in a SIEF is mandatory for actors specified in Article 29 of the REACH Regulation, whilst membership of a consortium or any other form of cooperation agreement is entirely voluntary. If some or all participants of one or more SIEF(s) decide to form a consortium, they are free to determine their arrangements regarding scope, purpose, duration, conditions for membership or leaving etc. as long as these do not contravene Community competition rules. In addition, it is important to note that when a SIEF has members that are not part of a consortium or another form of agreement, the members of the consortium must nevertheless cooperate with the SIEF participants that are not participants in the consortium or agreement. Additional information can be found in Chapter 8 'Forms of cooperation' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach
No, it is not. If a company which is a member of a SIEF subsequently ceases its activities with respect to the substance, that company still remains a participant in the SIEF. In particular, it will be required to share information it holds in accordance with the data sharing provisions of REACH. However, it is not required to participate in any submission (or update) made by the members of the SIEF, nor is it required to participate in any additional related costs.
Please note that during the pre-SIEF phase you can de-activate yourself from the pre-SIEF to indicate that you are not interested in registering the substance e.g. in a situation where you decide to cease manufacture or import of the specific substance. Note, however, that even as a non-active participant you still may be required to share your data.
Parties holding information relevant to a phase-in substance, and willing to share it, can become members of the corresponding SIEF.
For this, parties who have not signed up yet as companies in REACH-IT have to sign-up as data holders. The functionality to indicate that you have data on a phase-in substance is called "provide information". The information as to which relevant studies/data you have can be put in the text field of the Remarks tab.
The "provide information" functionality is also available for parties that have signed-up already in REACH-IT as companies. Hence, these parties do not have to sign up as data holders separately.
As REACH does not provide for data holders to have an active role in the (pre-)SIEF, data holders have to wait until they are invited by the other participants to join a SIEF and share their studies/data with the potential registrants. Particularly data holders in possession of vertebrate animal test data for a substance have to be invited by the potential registrants of this substance to join their SIEF.
Further information on the role of data holders can be found in Section 184.108.40.206- 'Data Holders' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach
Yes, you will become a member of the SIEF. REACH-IT automatically placed companies who pre-registered substances with either the same name or chemical identifiers in the same pre-SIEF. Companies in each pre-SIEF must decide, based on detailed consideration of the substance identity, whether the substances they pre-registered can in fact be regarded as the same. Pre-registrants of the same substance will form one SIEF.
This, in principle, is irrespective of the intention to register, as pre-registration does not have to be followed by registration. However, pre-registrants should bear in mind that as SIEF members they may be asked by other participants in the SIEF for information required for the purpose of registration and, if they are in possession of such information, they will have to supply it.
If you are a member of a pre-SIEF for a given substance and have no intention to register this substance, you should deactivate your pre-SIEF membership to make this clear to the potential registrants who want to form a SIEF and prepare the joint submission. Guidance on how to deactivate your pre-SIEF membership is provided in Section 3.6- 'Deactivating your pre-SIEF membership' of the REACH-IT Industry User Manual Part 5 - Pre-SIEF. You can find the manual in the "Support" section of the ECHA website at http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals Additional information on SIEF formation is provided in the fact sheet "SIEF formation and Data sharing" document. You can find it at: http://echa.europa.eu/regulations/reach/substance-registration/substance-information-exchange-fora
ECHA will not participate in the discussions between potential registrants and will not play a role in confirming or rejecting the creation of a particular SIEF.
Each potential registrant should be aware of the identity of the substances manufactured and imported. It is therefore up to manufacturers, importers and only representatives to take the responsibility of defining precisely the substance for which a SIEF will be formed. They are furthermore free to choose how they communicate and organise themselves in the pre-SIEF.
The role of a SIEF Formation Facilitator (SFF) is not defined in the REACH Regulation. He is expected to take the initiative to contact other participants in the pre-SIEF in order to facilitate the exchange of information and data which is required in order to form a SIEF. However, SFFs have no management role beyond facilitating discussions, and they have no legal basis to force other pre-SIEF participants to cooperate with them. Consequently, SFFs cannot demand fees for their services unless mutually agreed.
Under REACH, only multiple registrants of the same substance have data sharing (and joint submission) obligations. Hence, it is not mandatory for participants in different SIEFs to share data, even though it is encouraged by REACH in order to reduce animal testing and curb compliance costs. Every request for access to studies across different SIEFs will have to be negotiated on a case by case basis by the concerned companies. Further guidance on inter-SIEF rules can be found in Section 3.2.7 - 'Inter-SIEF rules (grouping, read-across)' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach.
- certain data were not migrated into the IUCLID 5 format and will need to be manually corrected or/and
- certain administrative information may be missing in some fields or sections.
After the successful submission of the registration dossier, registrants may have further duties which may entail the need to share data.
This may happen, for instance, when new potential registrants join the SIEF as late pre-registrants of a phase-in substance. The same situation occurs where the potential registrant of a non phase-in substance or a potential registrant of a phase-in substance who did not pre-register is informed of the previous and other potential registrants (and vice versa) by ECHA, following an inquiry. Then the previous and potential registrants are obliged to share the data needed for the registration according to Articles 27 and 30 of REACH.
Data sharing obligations may also arise after the successful submission of the registration dossier whenever new information becomes available. In such a case, according to Article 22 of REACH, the existing registrants will have to update the joint registration dossier which may require prior data sharing and may have an impact on decisions on the classification and labelling. This may also lead to the need to change the CSR.
Similarly, a need to share data may be the consequence of the evaluation of the registration dossier by ECHA (compliance check or the assessment of a testing proposal) or of the substance evaluation. These processes may lead to a request to submit further information, which would need to be addressed among the registrants. They should agree on the generation and sharing of data and costs. Hence, data sharing does not only apply to "existing" studies but also to studies which will be needed for ensuring that the registration is compliant with REACH.
- the token needed to confirm the membership in REACH-IT has a validity of 30 days only (the lead registrant can always generate a new token);
- the company has to confirm its membership of the joint submission before submitting its member dossier; and
- its member dossier has to be submitted, after the lead dossier but before the registration deadline relevant for the member registrant (see FAQ 6.4).
Information relating to the receipt and processing of the lead dossier is sent by ECHA only to the lead registrant. As a member registrant, you do not receive this information from ECHA.
ECHA recommends that member registrants develop contractual arrangements with their lead registrant specifying the items about which the lead registrant must keep them informed (e.g. the submission of the lead dossier) and by which means (e.g. postal or electronic mail).
In any case, the "lead dossier status", which member registrants can see on the joint submission details page in REACH-IT, indicates whether the lead dossier has been accepted for processing by ECHA (status depicted by a green tick) or not (status depicted by a red cross). Section 3.3 of the REACH-IT Industry User Manual, Part 7 describes how to view the joint submission in REACH-IT: http://echa.europa.eu/joint-submission-lead.
The REACH Regulation, and in particular Article 11 of REACH, is based on the "one substance one registration" principle. In line with this principle Article 11(3) of REACH provides that part of the information, but not the whole dossier, may under certain conditions be submitted separately. From this, it follows that member registrants who opt out must submit their registration dossier as part of the joint submission (see FAQ 10.3), even if they opt out for all information specified in Article 10(a)(iv), (vi), (vii) and (ix) of REACH.
Registrants of the same substance are obliged to be part of the joint submission.
If the company only wants to join the respective joint submission, and does not upgrade its tonnage nor add any chargeable additional confidentiality claims, then ECHA will not issue an additional invoice for the change from an individual registrant to a member of a joint submission.
Due to the technical implementation in REACH-IT, the change from an individual registration to a joint submission requires registrants to submit an update. They indicate 'change in tonnage' as a reason for the update, although the tonnage of the registration does not change. Further information on how to submit a registration dossier as part of a Joint Submission is available in the Data Submission Manual 4 – How to pass business rule verification ("Enforce rules") available on the ECHA website at: http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals.
For the time being, no "other international test methods" within the meaning of Article 13(3) of the REACH Regulation have been recognised by the Commission or by ECHA.
Good Laboratory Practice (GLP) certification of laboratories is the responsibility of national authorities that administer the national GLP monitoring programmes. If the laboratory is located in the EU, Norway or Switzerland, the corresponding authority can be found at the website of DG Enterprise and Industry of the European Commission (http://ec.europa.eu/enterprise/contact/index_en.htm#chemicals).
If the laboratory is located in another country, you should check the section on Good Laboratory Practice of the OECD website
After you have identified the relevant GLP monitoring authority, you can consult this authority in order to find out the laboratories with GLP certification in the corresponding country.
If the laboratory is located in a country which has not joined the OECD Mutual Acceptance of Data system, but the laboratory has been inspected by a GLP Monitoring Authority before the test has been carried out in this laboratory information on these laboratories can be obtained from the GLP Monitoring Authority who has inspected these laboratories (see also FAQ 11.6).
In general, there is the possibility to use data from reliable, scientifically accepted reference literature or databases, provided that the substance to be registered and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc. References to literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert.
Some useful reference books and data compilations containing peer reviewed data are listed under each endpoint in the Guidance on information requirements and chemical safety assessment, Chapters R.7a, b, c: Endpoint specific guidance available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment.
The OECD decision on Mutual Acceptance of Data (MAD) provides for data generated by testing of chemicals in an OECD member country in accordance with OECD test guidelines and OECD Principles of Good Laboratory Practice to be accepted in other member countries for purposes related to the protection of human health and the environment. This system also covers non-OECD countries which have requested adherence to the OECD GLP and to join the MAD system. These non-OECD countries can be divided in two groups:
- Countries which are full adherents to the OECD MAD system.
- Countries which are provisional adherents to the OECD MAD system.
Countries which are full adherents to the OECD MAD system will accept data from OECD member countries and other adhering countries generated under MAD conditions. In addition non-clinical safety data developed in these countries must be accepted by OECD and adhering countries.
Countries which are provisional adherents to the OECD MAD system need to accept data from OECD member countries and other adhering countries generated under MAD conditions. However, during the period of provisional adherence, GLP monitoring activities conducted by the GLP MA located in the country of the provisional adherence do not have to be accepted by the full members of the OECD MAD Decision.
In general, ECHA accepts data as GLP data where this data comes (i) from countries which are OECD member states or full adherents to the OECD Mutual Acceptance of Data (MAD) system and (ii) from countries which are provisional adherents to the OECD MAD system and in which laboratories have been inspected jointly by the GLP Monitoring Authority concerned and by an OECD GLP Monitoring Authority.
Studies that are conducted in a laboratory situated in a country which has not joined the OECD MAD system can be accepted by ECHA as GLP compliant studies under the following conditions:
- Prior to the performance of the study the GLP compliance of the laboratory has been inspected by:
- an EU GLP Monitoring authority (including Norway through EEA agreement) or
- GLP Monitoring Authorities in Israel, Japan and Switzerland with whom the EU holds Mutual Recognition Agreements or
- other GLP Monitoring Authorities of OECD member states or full adherents to the OECD Mutual Acceptance of Data (MAD) system on a case-by-case basis
- the laboratory has been found to be operating in compliance with GLP principles.
Interim RMM are to be included into the Chemical Safety Report (CSR) and to be communicated to the users of the substance (either under Article 31 or 32 of REACH, in form of Exposure Scenario (ES) or otherwise). Such RMMs need to describe how to handle a substance in an appropriate way in the absence of sufficient toxicological information and while waiting for the results of proposed testing for long-term hazards. If no Derived No-Effect Level (DNEL) is available, the registrant is expected to carry out a qualitative risk characterisation referring to the identified uses and the expected exposure and justifying that the measures are sufficient to control the risks (based on the available knowledge). Typical RMM applicable in such case are listed in the Table E.3-1 of Part E: Risk Characterisation 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
Where no or not enough hazard information on the substance is available, the registrant should demonstrate control of risks by minimizing the emission and/or exposure to the substance. In doing so, he can use a combination of containment and/or Local Exhaust Ventilation (LEV) and/or Personal Protective Equipment (PPE) as interim RMM to protect workers from exposure. Due to the interim nature of the measures, PPE may play a more prominent role compared to what is suggested in table E.3-1 of the abovementioned Guidance.
The registrant may need to update his CSR and ES once he receives the result of the test proposal and is able to derive a DNEL (or identify that minimisation of emission/exposure is required if "no threshold" effects had been identified in the testing). This applies in particular if the interim measures had been based on PPE instead of containment or other engineering measures.
The Candidate List of Substances of Very High Concern (SVHC) for authorisation (Candidate List) is available on ECHA's website at: http://echa.europa.eu/candidate-list-table.
Additional substances are regularly included in the Candidate List, once these have been identified as SVHC.
When the European Commission or a Member State considers that a substance may meet the criteria for identification as SVHC pursuant to Article 57 of REACH, ECHA (on request of the European Commission) or the Member State prepares an Annex XV SVHC dossier. With this Annex XV dossier ECHA or the Member State proposes the inclusion of the substance in the Candidate List by outlining the scientific evidence for identifying the substance as a SVHC.
ECHA's website includes a public registry of intentions in order to allow interested parties to be aware of the substances for which the authorities intend to submit Annex XV dossiers and thus facilitates timely preparation of the interested parties for commenting later in the process.
Once an Annex XV SVHC dossier has been prepared, a consultation of the Member States and interested parties is required, as specified in Article 59 of REACH. Further details on this consultation process are available on the ECHA website at http://echa.europa.eu/proposals-to-identify-substances-of-very-high-concern.
Following this consultation, the substance may be included in the Candidate List. The Candidate List is made available on ECHA's website in its last updated version at http://echa.europa.eu/candidate-list-table.
Substances included in the Candidate List may be prioritised for inclusion in Annex XIV of the REACH Regulation (the so called "Authorisation List"). The Authorisation List contains all substances which, after a certain deadline, may only be used and/or placed on the market after a specific authorisation has been granted.
ECHA has to make at least every second year a recommendation of priority substances for inclusion in Annex XIV to the European Commission. Interested parties are invited to submit comments during this process. In addition, the Member State Committee issues an opinion on the recommendation before it is submitted to the European Commission. The European Commission then decides using the comitology procedure which of the recommended substances are to be included in Annex XIV and specifies, based on ECHA's recommendation, the transitional arrangements and, where relevant, exemptions and review periods. Further details on the procedure for inclusion of substances in Annex XIV of the REACH Regulation are available on ECHA's website at http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list .
Applications for authorisation need to be made within the deadline (the so called "latest application date") that is specified in the "Authorisation List" for the corresponding substance if the applicant wishes to use the substance without interruption after the sunset date.
Authorisation applications need to be submitted to ECHA. Third parties can provide information on alternative substances and technologies during public consultations on the uses that authorisation has been applied for. These are made available on ECHA's web-site. The ECHA Committees for Risk Assessment (RAC) and Socioeconomic Analysis (SEAC) give draft opinions on the application. Applicants will have the opportunity to comment on these draft opinions. RAC and SEAC will adopt final opinions and ECHA sends them to the European Commission.
The European Commission decides, using the comitology procedure, whether an authorisation is granted or refused. ECHA will establish a publicly available database that will contain summaries of the Commission decisions.
Further details on the application for authorisation procedure are available on ECHA's website under the following links:
Applications for authorisation may be submitted in any one of the official EU languages selected by the applicant. This means that the whole application, including the attachments and the Chemical Safety Report, must be submitted in the same language. This is a legal requirement based on Article 104(1) of REACH and Article 2 of Regulation No 1 of 15 April 1958.
Authorisation is required for the use of a substance included in Annex XIV of REACH, either on its own or in a mixture. If a substance is used as such, this is a use of the substance on its own, and the exemptions in Article 56(6) (a) and (b) of REACH cannot be applied. If the substance is used in a mixture, then the aforementioned exemptions may be applied. These exemptions apply to SVHCs meeting the criteria of points (d), (e) and (f) of Article 57 of REACH below a concentration limit of 0.1 % w/w, and for all other substances below the lowest concentration limit specified in Directive 1999/45/EC or in Part 3 of Annex VI to the CLP Regulation, which results in the classification of the mixture as dangerous.
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. FAQ 6.3.10 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
Yes, according to Articles 31 and 32 of the REACH Regulation some changes in the Safety Data Sheet (SDS) are required. However, the duties and responsibilities for Safety Data Sheets (SDSs) remain largely the same. Guidance for the compilation of Safety Data Sheets is given in Annex II of the REACH Regulation.
The following list summarises the main changes:
- 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.
It is important to note that now SDSs are additionally required for substances assessed to be PBTs (Persistent, Bioaccumulative and Toxic) or vPvBs (very Persistent and very Bioaccumulative), for substances included in the candidate list for potential inclusion in Annex XIV of the REACH Regulation, as well as for mixtures containing any of these substances.
In principle, SDS need to comply with Annex I to Commission Regulation (EU) No 453/2010 since 1 December 2010 and until 1 June 2015, and with Annex II to Commission Regulation (EU) No 453/2010 as of 1 June 2015. However, there are specific transitional periods, so not all SDS need to be updated immediately.
According to Article 2 (6) of the Commission Regulation (EU) No 453/2010 the SDS of substances which were placed on the market before 1 December 2010 and which are not required to be relabelled and repackaged in accordance with Article 61 (4) of the CLP Regulation, need not be replaced with a SDS complying with Annex I to Commission Regulation (EU) 453/2010 before 1 December 2012.
However, if an update of the SDS is required by Article 31 (9) of REACH:
- if new information which may affect the risk management measures, or new information on hazards becomes available;
- an authorisation has been granted or refused; or
- a restriction has been imposed;
this transitional period does not apply.
For mixtures which are placed on the market before 1 June 2015 and which are not required to be relabelled and repackaged in accordance with Article 61 (4) of the CLP Regulation, Article 2 (6) of the Commission Regulation (EU) 453/2010 stipulates that the SDS need not be replaced with a SDS complying with Annex II of the Commission Regulation (EU) 453/2010 before 1 June 2017. Again, if an update of the SDS is required by Article 31 (9) of REACH for one of the above mentioned reasons, the transitional period does not apply.
For mixtures provided to any recipient at least once before 1 December 2010, Article 2 (7) of the Commission Regulation (EU) 453/2010 stipulates that SDS may continue to be used in the previous format and need not comply with Annex I to Commission Regulation (EU) 453/2010 until 30 November 2012. However, if an update of the SDS is required by Article 31 (9) of REACH for one of the above mentioned reasons, this transitional period does not apply.
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 preparation 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 carriage of dangerous substances and dangerous preparations 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 preparations occurring exclusively within an industrial plant is covered by REACH, even if this includes transportation carried out by an external company.
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.
Yes, they should.
According to Article 31(5) of REACH, the SDS shall be written 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(s) otherwise.
Therefore, substances currently listed in English only in Part 3 of Annex VI to CLP or in the C&L Inventory need to be translated into an official language of the Member State(s) where it is placed on the market unless the Member State(s) provides otherwise.
ECHA plans to make available the translated chemical names of the Annex VI entries in a later version of the public C&L Inventory.
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, not until 1 December 2012. The SDS for mixtures already placed on the market before 1 December 2010 may still use the old format of SDS according to the provisions of Annex II of REACH before its amendment by the Regulation 453/2010. If the mixture is labelled according to DPD, there is no obligation to update the SDS to include the CLP classification of its components (substances) in section 3 of the SDS.
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.
Yes it does. Ceasing the supply of a substance or mixture does not relieve a supplier from its duty to comply with REACH or its duty to pass on updated information within the supply chain. Therefore, an updated SDS with new information that could affect risk management measures, or new information on hazards, or the outcome of authorisation or restriction processes, shall be provided by that supplier to all recipients to whom the substance or mixture was supplied within the preceding 12 months. As such, an updated SDS shall be provided without delay by that supplier. This duty shall be understood as a duty to actually deliver the SDS on paper or electronically
Substances included in Annex IV and substances covered by Annex V are exempted from the registration requirement (Article 2 (7) (a) & (b) of REACH). Annex IV lists substances for which sufficient information is available to consider them as causing minimum risk to human health and the environment. Annex V covers 13 categories of substances for which registration is deemed to be inappropriate or unnecessary, if the conditions described therein are fulfilled. Recovered substances fulfilling the conditions of Article 2 (7) (d) of REACH are also exempted from the registration requirement. A recovery operator who establishes the sameness of a substance with one already registered and who possesses the required information according to Articles 31 or 32 of REACH is exempted from registration of that substance.
Manufacturers or importers that fall under any of these exemptions need not submit a registration dossier. In such a situation, the manufacturer or importer will not obtain a registration number and consequently will not be able to communicate such a registration number in the supply chain. In order to avoid confusion an explanation as to why there is no registration number for that substance may be given in the safety data sheet as explained in section 4.1 of the Guidance on the compilation of safety data sheets.
Companies that wish to benefit from such an exemption must assess whether their substances qualify for the exemption. They also have to provide the authorities (on request) with appropriate information to prove that their substances fulfil the exemption conditions.
Further information can be found in the factsheet providing key information for recipients of substances covered by Article 2(7) of REACH, covering what information they can generally expect from their supplier. You can find the fact sheet here:
No, there is no obligation to report the registration number for that corresponding substance in the mixture(s) SDS where an alternative name has been granted by a Member State Competent Authority or ECHA. First, it is important to note that Section 1.1. of the SDS needs to be applied according to the ECHA Guidance on the compilation of safety data sheet in the sense that the requirement to publish registration numbers as a product identifier is only applicable to an SDS for substances and not for mixtures. Second, for registered substances contained in mixtures, there is the general requirement in section 3.2.4 of the SDS to include the registration number, EC number and other precise chemical identifier for the registered substances. However, if an alternative name under Article 15 of Directive 1999/45/EC or Article 24 of Regulation (EC) No 1272/2008 has been granted for that registered substance in the mixture (s)(section 3.2.4 final subparagraph of Annex II of REACH), only the alternative chemical name of the registered substance with its corresponding classification needs to be included.
As a downstream user you should follow the risk management advice and the operational conditions of use described in the extended safety data sheet (eSDS) received from the supplier, including the exposure scenarios. If relevant, forward the advice to actors further down the supply chain. If you as a downstream user produce a mixture, you must ensure that the eSDS for that mixture includes all relevant information received from the suppliers of the individual components. Please note: This was also a duty of downstream users under previous legislation. The new element under REACH is the receiving and forwarding of use-specific risk management advice and risk management measures relating to exposure to humans or the environment.
If as a downstream user you receive information from your customers intended for the purpose of making 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 preparation and eventually carry out your own downstream user Chemical Safety Assessment (CSA).
If you as a downstream user hold information that puts into question the hazard or risk management information received from a supplier, you should communicate this information to the supplier.
An overview of the possible obligations of downstream users can be found in ECHA website: http://echa.europa.eu/web/guest/regulations/reach/downstream-users
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 the 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: http://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: Comply with the restrictions for placing on the market or use of substances as listed in Annex XVII of the REACH Regulation.
An overview of the possible obligations of the downstream users related to authorisation can be found in section 12-'Compliance with requirements related to authorisation' in the Guidance for downstream users at: http://echa.europa.eu/guidance-documents/guidance-on-reach
You do not have registration or notification obligations, for example, if all your suppliers are located within the EEA or have appointed an only representative, and you do not produce any new substance or article. However, there are also various other cases in which no registration and notification obligations apply.
In order to check whether in your particular supply chain situation you have registration or notification obligations or not you should use the Navigator tool on the ECHA website. This tool is designed to help companies to determine their obligations under REACH and find the appropriate guidance on how to fulfil these obligations. You can find the Navigator tool on the ECHA website at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations
You have to report to ECHA 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.
If reporting to ECHA is required, specific uses of less than 1 tonne per year do not need to be included in the report except from the following situation: if the reason you do not need to prepare a chemical safety report is that the total quantity you use is below 1 tonne, then all uses are to be reported.
You have six months to report to ECHA from the date you receive an extended safety data sheet with a registration number.
There are two different situations where a DU can use a substance for a PPORD activity as described in section 220.127.116.11 of the Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD:
- Where a substance has been registered under Article 6 of REACH, a DU can use that substance for the purposes of a PPORD activity on his own initiative. In such cases, he can inform his supplier of the registered substance about this use with the aim of having the use included in the SDS pursuant to Article 37(2) of REACH. If a DU does not want to disclose the PPORD use to his supplier, or if the use is not an identified use and therefore not indicated in the SDS, the DU would need to prepare a CSR pursuant to Article 37(4) of REACH. However, a DU is exempted from this obligation for PPORD uses according to Article 37(4)(f) of REACH, if the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment. If a DU relies on this exemption from the obligation to prepare a CSR, he will need to report the use to ECHA under Article 38(1)(b) of REACH.
- Where a substance has been notified under Article 9 of REACH and thereby exempt from registration, a DU can participate in a PPORD activity of the manufacturer or importer if the manufacturer or importer mentioned him, including his name and address, in its PPORD notification as listed customer. A DU himself can not submit a PPORD notification because the PPORD notification provides for an exemption from the registration requirement and DUs are not subject to the registration requirement.
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.
No, only substances listed in the relevant Appendices (1 - 6) of Annex XVII are covered by the restrictions in entries 28 - 30.
When substances are classified for the first time as CMR and included in an ATP of the CLP Regulation, the European Commission prepares a draft amendment to include these substances in the Appendices of REACH Annex XVII. The amendment then has to be adopted in accordance with Article 68(2) of REACH, before the new substances are covered by entries 28-30.
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.
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.