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In the past, several European countries like the Sweden, United Kingdom, The Netherlands and Switzerland established registration and authorisation procedures for biocidal products including antifouling paints. In other European countries including Germany antifouling products could be marketed without registration, apart from selected dangerous substances already regulated by the EU. The marketing and the use of dangerous substances is regulated by the EU Directive 76/769/ECC¹.
As these differences between countries constitute barriers, not only to trade in biocidal products but also to trade in products treated with biocides, thereby affecting the functioning of the EU market, the Commission proposed the development of a common framework of biocide regulations. These relate not only to the market placement and use of biocidal products but also establish a higher degree of protection for humans, animals and the environment. To achieve this it was necessary to provide common principles for the evaluation and authorisation of biocidal products to ensure a harmonised approach by Member States. The European Parliament and of the Council of the European Union adopted the Directive 98/8/EC concerning the placing of biocidal products on the market (BPD)² on the 16th of February 1998. Full text of Directive 98/8/EC:
EU-Richtlinie 98/8/EG (422 KB)
EU Directive 98/8/EC (, 379 KB)
The implementation of the Biocidal Product Directive is now coming into effect within EU countries.
Within the framework of the BPD several processes are taking place: Identification, notification and subsequent review regulation. The first review guideline regulated the first phase of the review program and established the identification and notification of existing biocidal substances by March 2002. The second review guideline came into force in November 2003 with the exhaustive list of 580 identified and 360 notified existing biocidal substances. This will now regulate the dossier submission and review of notified biocidal substances between 2004 and 2008. Identified but un-notified biocides shall be banned by 01/09/06. Biocides that were not listed are no longer to be used in biocidal products.
At present there is debate, mostly dominated by consideration of the discrimination criteria separating biocidal and non-biocidal products. This debate was instigated by the definition given in article 2, paragraph 1, the labelled and intended use of a product, defined by the manufacturer, determines if a product is a pharmaceutical, cosmetic or biocidal product. This definition is based mostly on the use of the biocide incorporated into the product. According to the 2nd Review Regulation 44 (EU Regulation 2032/2003) antifouling biocides have been notified³. Full text of the 2nd Review Regulation:
EU-Verordnung 2032/2003 (535 KB)
In the past, several European countries like the Sweden, United Kingdom, The Netherlands and Switzerland established registration and authorisation procedures for biocidal products including antifouling paints. In other European countries including Germany antifouling products could be marketed without registration, apart from selected dangerous substances already regulated by the EU. The marketing and the use of dangerous substances is regulated by the EU Directive 76/769/ECC¹.
As these differences between countries constitute barriers, not only to trade in biocidal products but also to trade in products treated with biocides, thereby affecting the functioning of the EU market, the Commission proposed the development of a common framework of biocide regulations. These relate not only to the market placement and use of biocidal products but also establish a higher degree of protection for humans, animals and the environment. To achieve this it was necessary to provide common principles for the evaluation and authorisation of biocidal products to ensure a harmonised approach by Member States. The European Parliament and of the Council of the European Union adopted the Directive 98/8/EC concerning the placing of biocidal products on the market (BPD)² on the 16th of February 1998. Full text of Directive 98/8/EC:
EU-Richtlinie 98/8/EG (422 KB)
EU Directive 98/8/EC (, 379 KB)
The implementation of the Biocidal Product Directive is now coming into effect within EU countries.
Within the framework of the BPD several processes are taking place: Identification, notification and subsequent review regulation. The first review guideline regulated the first phase of the review program and established the identification and notification of existing biocidal substances by March 2002. The second review guideline came into force in November 2003 with the exhaustive list of 580 identified and 360 notified existing biocidal substances. This will now regulate the dossier submission and review of notified biocidal substances between 2004 and 2008. Identified but un-notified biocides shall be banned by 01/09/06. Biocides that were not listed are no longer to be used in biocidal products.
At present there is debate, mostly dominated by consideration of the discrimination criteria separating biocidal and non-biocidal products. This debate was instigated by the definition given in article 2, paragraph 1, the labelled and intended use of a product, defined by the manufacturer, determines if a product is a pharmaceutical, cosmetic or biocidal product. This definition is based mostly on the use of the biocide incorporated into the product. According to the 2nd Review Regulation 44 (EU Regulation 2032/2003) antifouling biocides have been notified³. Full text of the 2nd Review Regulation:
EU-Verordnung 2032/2003 (535 KB)