Lexikon
directive 98/8/EC of the European Parliament and of the Council of 16 february 1998, concerning the placing of biocidal products on the market.
Biocidal products are active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
Harmful is an organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment.
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Pursuant to Directive 98/8/EC, Member States may only authorise the placing on the market of biocidal products containing active substances included in Annex I, to that Directive.
Biocidal products containing active substances listed in Annex II to the Regulation 1451/2007 for which a decision was taken not to include these active substances for certain or all of their notified product types in Annex I (or IA) to Directive
98/8/EC, shall no longer be placed on the market.
Annex I and Annex II list can be find in: http://ecb.jrc.ec.europa.eu/legislation/2007R1451EC.pdf
Sourcec: http://ecb.jrc.ec.europa.eu/legislation/1998L0008EC.pdf, and
http://ecb.jrc.ec.europa.eu/legislation/2007R1451EC.pdf
Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products was adopted in 1998. According to the Directive, Member States had to transpose the rules before 14 May 2000 into national law.
The Commission adopted the original proposal for the Directive in 1993. Directive 91/414/EEC on plant protection products, adopted in 1991, served as a model for the new Directive.
The Biocidal Product Directive aims to harmonise the European market for biocidal products and their active substances. At the same time it aims to provide a high level of protection for humans, animals and the environment.
biocides are defined in Article 2 (1) of the Biocidal Products Directive (98/8/EC) as:
"Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means."
Note, however, that many substances or preparations which meet this definition are excluded from the Biocidal Products Directive on the basis of being covered by other legislation such as the Plant Protection Products Directive (91/414/EEC) and many other Directives relating to veterinary medicines, proprietary medicinal products etc. Therefore, for a complete definition of a biocidal products you should consult the Biocidal Products Directive and its associated guidance.
In general terms, the scope of the Biocidal Products Directive is very wide, covering 23 different product types. This includes disinfectants for home and industrial use, preservatives for manufactured and natural products, non-agricultural pesticides for use against insects, rodents and other vertebrates and specialised products such as embalming/taxidermist fluids and antifouling products. A full list of product types is in Annex V of the BPD.
Under Article 15 (2) of the REACH Regulation, active substances which are regulated as biocides are regarded as being already registered under REACH.
Directive 98/8/EC, Articles 1 and 2.; REACH Article 15 (2).