Frequently Asked Questions about REACH

1. What is REACH and where do I find more information about it?

   REACH stands for the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH Regulation entered into force on 1st 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.

2. Does REACH apply to substances (either on their own, in mixtures or in articles) manufactured or imported in volumes below 1 tonne per year?

   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. 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.

3. Do substances used in biocides and plant protection products (PPP) have to be registered under REACH?

   Active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Directive 98/8/EC (Biocidal Products Directive). However, several conditions have to be fulfilled to benefit from the exemption. These conditions are laid down in Article 15(2) of the REACH Regulation and explained in section 1.6.5.1 of the Guidance on registration.

   Active substances for use in plant protection products (PPPs) are regarded as registered as the plant protection products and their active ingredients are covered by Directive 91/414/EEC (Directive on plant protection products). Please note that even though co-formulants are mentioned in Article 15(1) of the REACH Regulation, currently they do not meet the conditions laid down in this Article. Therefore co-formulants used in biocides do not qualify for the exemption and are not regarded as registered. This is further explained in section 1.6.5.2 of the Guidance on registration.

   It is important to note, that only the quantities of the active substance for use in biocidal products and for use in PPPs are considered registered under REACH. Thus, if the substance is not used as an active ingredient in a biocidal product or a PPP, then the exemption would not apply to this other use and the quantity of the substance for the non-biocidal or non-PPP use would have to be registered.

4. Does REACH apply to substances occurring in nature?

   REACH also applies to substances occurring in nature as defined by Article 3(39) of the REACH Regulation. However, Annex V of the REACH Regulation states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal. Other substances occurring in nature are exempted from registration if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f). The term "not chemically modified substance" is defined in Article 3(40) of the REACH Regulation.

   Please note that Annex V of the REACH Regulation was amended by Regulation EC 987/2008 in October 2008. Additional guidance giving more explanations and background information on the different exemptions in Annex V will be included in the Guidance on registration. A draft version of this additional guidance is available on the ECHA Guidance website.

   For particular guidance on polymer substances occurring in nature you may consult section 3.2.1.3 of the Guidance for monomers and polymers.

5. Are synthetic analogues of natural substances exempted from Registration in accordance with Article 2 (7)b and Annex V?

   No. In order to avail of the exemption foreseen in Article 2(7)(b) and Point (8) of Annex V, as amended, to the REACH Regulation, substances must occur in nature as defined in Article 3(39) of the REACH Regulation. Such substances will include substances derived from geological rocks, plants, animals, micro-organisms, etc. These substances can only be processed by certain means (e.g. dissolution in water, flotation) which are specified in Article 3(39) and do not include chemical modification (Article 3(40)).

   Since the synthetic analogues of naturally occurring substances do not meet this criterion, any manufacturer or importer of these substances in quantities of 1 tonne or more per year is required to submit a registration to ECHA.

6. Do substances at nano-scale fall under the scope of 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.

7. To which territories does REACH apply?

   REACH is a European Community 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.

8. What are the obligations of non-EEA companies?

   Manufacturers established outside of the European Economic Area (EEA) do not have direct obligations under the REACH Regulation. It is the importer established within the EEA who needs to comply with the REACH obligations.

   According to Article 3(9) of the REACH Regulation, a manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community. Non-EEA companies exporting substances on their own, in preparations or in articles to the EEA may (but are not obliged to) appoint an "only representative" according to Article 8 of the REACH Regulation to fulfil the obligations of importers. More guidance on only representatives can be found in section 1.5.3.4 of the Guidance on registration.

9. Who can appoint an only representative?

   According to Article 8(1) of the REACH Regulation, a natural or legal person established outside of the EU who manufactures substances (to be used on their own, in preparations and/or to produce articles), formulates preparations or produces articles, can nominate an only representative located within the EU to carry out the required registration of their substances that are imported (as such, in preparations and/or in articles) into the EU. Distributors are not mentioned in Article 8(1) and thus cannot appoint an only representative.

   The reference to the EU covers both the EU countries and the EFTA countries that have adhered to the EEA (European Economic Area) Agreement, that is Iceland, Liechtenstein and Norway.

   The only representative will have to fulfil the registration obligations of importers (Title II of REACH) and comply with all other obligations of importers under the REACH Regulation. More information on the only representative role is provided in the Guidance on Registration (Section 1.5.3.4 – Only representatives of “non-Community manufacturer”).

10. Who can be appointed as an only representative?

    A non-EEA company (that can appoint an only representative, see previous question) 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 the REACH Regulation this representative shall comply with all obligations of importers under the REACH Regulation. Therefore the only representative is required to have sufficient background in the practical handling of substances and the information related to them. 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 the REACH Regulation.

11. Is it possible to benefit from the specific provisions for phase-in substances, if the substance was not pre-registered by 1 December 2008?

    In order to benefit from the extended registration deadlines for phase-in substances, they needed to be pre-registered between 1 June 2008 and 1 December 2008. However, in the case of a manufacturer or importer who manufactures or imports a substance in quantities of 1 tonne or more per year for the first time after the pre-registration deadline (1 December 2008) has passed a pre-registration may still be submitted. In this case, the manufacturer or importer can still benefit from the extended registration deadlines for phase-in substances even though he did not pre-register within the deadline for pre-registration. According to Article 28(6) of the REACH Regulation, first-time manufacturers or importers must pre-register within six months after first manufacture or import over the one-tonne threshold, and not later than 12 months before the relevant deadline for registration. First-time manufacturers or importers will therefore have to submit their pre-registration before 1 December 2009, 1 June 2012 or 1 June 2017, whichever is relevant as described in chapter 3.6 of the Guidance on data sharing.

12. Who has to register substances?

    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 the REACH Regulation.

    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".

13. Which substances have to be registered?

    Registration is required for all substances: as defined in Article 3(1) of the REACH Regulation; manufactured in or imported into the Community 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.

14. For how long is it allowed to sell phase-in substances from stock without registration?

    Article 5 of the REACH Regulation (“no data, no market”), that applies from 1 June 2008, states 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 Title II where this is required. 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).

    Based on these articles, it follows that:

    Substances manufactured before 1 June 2008 but not placed on the market in accordance with the definition above, need to be pre-registered (or registered as non phase-in substance) for being placed on the market after 1 June 2008.

    Quantities of substances on their own, in preparation or in articles that have already been placed on the market or imported before 1 June 2008 may be further used without (pre)registration provided that the placing on the market before 1 June 2008 can be documented.

15. When do I have to register my substances?

    Various aspects need to be taken into account when considering the registration deadlines. These include tonnage, dangerous properties, and whether it is a phase in or a non-phase in substance. Chapter 1.7 of the Guidance on registration provides information on these aspects.

    - The REACH Regulation creates a special transition regime for phase-in substances (section 1.7.1.1 of the Guidance on registration). In order to benefit from the extended registration deadlines for phase-in substances (Section 1.7.2 of the Guidance on registration), these substances must be pre-registered. Depending on its intrinsic properties and its tonnage, a pre-registered substance needs to be registered by 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.

16. Can a Non-EEA manufacturer of a substance register under REACH?

    No. The obligation to register a substance applies only to actors established within the European Economic Area (EEA). Thus, the registration of substances imported into the EEA on their own, in preparations or, in certain cases, in articles will have to be done by the importer established in the EEA. This implies that each individual importer needs to register the substance. However, according to Article 8(1) of the REACH Regulation manufacturers of substances, formulators of preparations or producers of articles established outside the EEA, can nominate an only representative (OR) established within the EEA to carry out the required registration. This will relieve the individual EEA importers within the supply chain of that non-EEA manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this OR. However, the registration obligation may still apply if the EEA-importers import the same substance from other non-EEA manufacturers.

17. Do I have to register polymers?
    

    According to Article 2(9) of the REACH Regulation polymers do not have to be registered, but according to Article 6(3), 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:
    1. 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);
    2. 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). 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.

18. Do I have to register substances in articles?

    The registration requirement for substances in articles according to Article 7(1) of the REACH Regulation applies only if all the following conditions deriving from Articles 7(1) and 7(6) are met: a) the substance is intended to be released during normal and reasonable foreseeable conditions of use; and b) the total amount of the substance present in the articles exceeds one tonne per producer or importer per year; and c) the substance has not yet been registered for that specific use.

19. What is an intended release of a substance from articles?

    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.

20. Does REACH require any changes in Safety Data Sheets?

    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.

For further details on the obligation to provide an SDS please consult the Guidance on information requirements and chemicals safety assessment (part G) and the Guidance on registration (Section 3.1.1). In addition, the Guidance for downstream users provides an overview on the new information in an SDS (table 25 on page 123).

Information was taken from http://echa.europa.eu website