Exemptions to REACH

Although in some cases the Exemptions given here are taken verbatim from the relevent legislation, they are purely intended as guidance. Please see Regulation EC/1907/2006 for the authoritative list and description of exemptions.

 

1	The provisions of Titles II (registration), V (evaluation), VI (authorisation) and VII (downstream user) shall not apply to the extent that a substance is used: (a) in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use; (b) in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use: (i) as a food additive in foodstuffs within the scope of Council Directive 89/107/EEC of 21 December 1988 on the  approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs  intended for human consumption; (ii) as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the  approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source  materials for their production and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of  flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the  European Parliament and of the Council; (iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament  and of the Council of 22 September 2003 on additives for use in animal nutrition; (iv) in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain  products used in animal nutrition.
2	The provisions of Title IV (supply chain) shall not apply to the following preparations in the finished state, intended for the final user: (a) medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC; (b) cosmetic products as defined in Directive 76/768/EEC; (c) medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as Directive 1999/45/EC; (d) food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use: (i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC; (ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC; (iii) as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003; and (iv) in animal nutrition within the scope of Directive 82/471/EEC
3	The following shall be exempted from Titles II (registration), V (evaluation) and VI (downstream user):  (a) substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties; (b) substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation; (c) substances on their own or in preparations, registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that: (i) the substance being re-imported is the same as the exported substance; (ii) he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance. (d) substances, on their own, in preparations or in articles, which have been registered in accordance with Title II and which are recovered in the Community if: (i) the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and (ii) the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery
4	On-site isolated intermediates and transported isolated intermediates shall be exempted from: (a) Chapter 1 of Title II (registration and information obligations), with the exception of Articles 8 (only representative) and 9 (PPROD registration); and (b) Title VII (authorisation)
5	The provisions of Titles II (registration) and VI (authorisation) shall not apply to polymers
6	Articles 5, 6, 7,  17, 18 and 21 (some general obligation to register and information requirements) shall not apply for a period of five years to a substance manufactured in the Community or imported for the purposes of product and process orientated research and development  (PPORD) by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development (Article 9)
7	For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 (registration requirements) shall not apply
8	Active substances and co-formulants manufactured or imported for use in plant protection products only and included either in Annex I to Directive 91/414/EEC1 or in Regulation (EEC) No 3600/922, Regulation (EC) No 703/20013, Regulation (EC) No 1490/20024, Decision 2003/565/EC5 and for any substance for which a Commission Decision on the completeness of the dossier has been taken pursuant to Article 6 of Directive 91/414/EEC shall be regarded as being registered and the registration as completed for manufacture or import for the use as a plant protection product and therefore as fulfilling the registration requirements of Chapters 1 and 5 of Title II (Article 15.1)
9	Active substances manufactured or imported for use in biocidal products only and included either in Annexes I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market1 or in Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC2, until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the registration requirements of Chapters 1 and 5 of Title II (Article 15.2)
10	A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the registration obligations on importers under Title II of REACH. Other importers from this natural or legal person have the obligations of a downstream user rather than those of an importer (Article 8)