Interlinkage with the REACH Regulation

The REACH Regulation, in force in the EU since 1 June 2007, is of relevance for the biocides regime.

Among other pieces of legislation repealed by the REACH Regulation the ones with direct relevance for biocides are: Council Directive 76/769/EEC ("Restrictions and Bans Directive", repealed with effect from 1 June 2009) and Commission Directive 91/155/EEC ("Safety Data Sheet Directive", repealed with effect from 1 June 2007) and the associated amendments of provisions in Directive 1999/45/EC ("Dangerous Preparations Directive"). (In addition many legal provisions will apply from later dates, see REACH Regulation Article 141).

The REACH Regulation applies to all chemical substances in biocidal products which, in principle, includes active biocidal substances. For the practice, however, it is stressed that active biocidal substances for biocidal uses are exempt from registration and authorisation under REACH (see REACH Regulation Chapter 2, Substances regarded as being registered, Article 15, Substances in plant protection and biocidal products, pt. 2; and Title VII, Authorisation, Chapter 1, Authorisation Requirement, Article 56 (4) b), General provisions, exemptions). Other parts of REACH, such as information provision and data sharing still apply.

Specific notes:

• In case an active biocidal substance also has non-biocidal, chemical uses, the REACH Regulation applies without exemptions to those quantities of active substances intended for non-biocidal uses. Many examples of active biocidal substances having non-biocidal uses can be quoted, e. g. ethanol, formaldehyde, quarternary ammonium compounds, aliphatic acids, etc. This is fully in line with the principle that only the use (and concentration in use) of a chemical substance (or microorganism) having the potential for a biocidal effect determines whether this substance is an active biocidal substance covered by the Biocidal Products Directive.

• The exemption from registration is confined to biocidal substances "...included either in Annexes I, IA or IB to ... the BPD ...or in Commission Regulation (EC) No 2032/2003 (2nd Review Regulation, recently replaced by Commission Regulation (EC) No 1451/2007)..., until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC...", which means i. a. that the REACH Regulation applies to a "new" biocidal substance until, upon application, it has been included in BPD Annex I/IA.

• While active biocidal substances for biocidal uses are exempt from the general REACH authorisation provisions for chemical substances (see above), active biocidal substances are in principle not exempt from being taken up in Annex XIV, List of Substances subject to Authorisation, whereby authorisation in this context means authorisations under REACH.

• REACH Regulation Title VIII, Restrictions, applies also to active substances used in biocidal products (see above). As Directive 76/769/EEC is repealed and replaced by the REACH Regulation as of 1 June 2009, restrictions on active substances in accordance with Article 16(4) of the Biocidal Products Directive will be dealt with in future under the REACH Regulation.