Biocidal product directive

This paper outlines the content of the Biocidal Products Directive and explains how it will be implemented in the UK. It covers what industry will have to do in compliance, what is currently happening in Europe and gives an estimated timetable for all the activities. 

In conclusion the Biocidal Products Directive will have the following effects ... 

Biocides are by their nature intrinsically toxic, in this respect any adventitious release to the environment requires an assessment of the relative risk posed. The 5th Environmental Action Plan of the EU is committed to a substantial reduction in the use of biocides. In particular, the Biocidal Products Directive (98/08/EC) is concerned with controlling biocidal products in the market place. Compliance with this directive is required from all member states by 14th May 2000. In this context, a strategy to control the release of biocides is timely, if continued protection is to be afforded to industry and consumer alike. One approach to controlling the release of biocide is to encapsulate in an inert inorganic framework, prior to incorporation in the coating.1... 

The use of biocides is in Europe controlled and regulated by the EU Biocidal Products Directive [15]. Registration of a biocide is expensive and only a few active biocide substances will in the future be available for the leather industry in the EU. The directive will include a list of active substances that are permitted to use by the leather industry (a so-called positive list). Many eco-labels and RSL does already today include restrictions of the use of some biocides. 

European Commission (1998) Directive 98/8/EC of the European Parliament and of the Council of February 1998 concerning the placing of biocidal products on the market (Biocidal Products Directive)... 

Substances notified under the DSD (392) are considered as having been registered. Similarly, substances used only as active substances for plant protection products, which are covered by the Plant Protection Products Directive (a. 13), or for biocidal products, which are covered by the Biocidal Products Directive (a. 14) are counted as registered under REACH. 

The requirements of Directive 98/8/EC (the Biocidal Products Directive) are briefly outlined and the possible effects of the implementation of this Directive on the market for biocides and development of biocides are considered. The general time-frame for the Directive is indicated and a list of the dossier requirements for the common core data set for active substances is included together with a list of the data required to be submitted under section VI on the toxicological profile for man and animals. 4 refs. 

CEFIC has estimated that more than 60% of the 2,000 biocidal active ingredients and of the 20,000 formulated biocidal products containing them currently marketed in the EU may eventually be withdrawn as a result of the implementation of the Biocidal Products Directive. Avecia believes the BPD is likely to restrict new product development and increase the costs of notifying and listing active substances, meaning that research on new actives will be difficult to justify. Avecia Protection Hygiene develops and produces antimicrobials for more than 25 applications in industrial preservation, disinfection, plastics, textiles and personal care, and it continues to develop new products. 

The new Biocidal Products Directive is examined, which closes the gap in European legislation for products such as disinfectants and anti-foulants where there has not, until now, been a Europe-wide standard. The basic goals of the directive are to simplify and harmonise Europe s regulatory framework for biocides, and to remove trade barriers within the EU, and to improve the protection of both human health and the environment. The new directive must be enforced as national legislation in all member countries by 14 May 2000. Details are given of products defined within the directive, and ways in which the directive will be put into practice in the UK are discussed. The implications of the legislation on the industry in terms of time and money spent on testing for each active substance involved are examined. 

Within the EU, experimental human toxicity smdies must not be conducted specifically for the purpose of hazard assessment of biocides according to the EU Biocidal Product Directive (EC 1998), or pesticides according to the EU Plant Protection Product Directive (EC 1991). 

The Biocidal Products Directive and the Mineral Processing Industry Possible Issues and Implications... 

Directive 98/8/EC, the so-called Biocidal Products Directive (BPD) was integrated into each Member State National legislation for May 14th 2000. Within the Annexes of this directive several biocidal product types are identified that are relevant either directly or indirectly to mineral processing or to the use of mineral slurries. This legislation will have an increasingly significant impact on the active substance producers, the biocidal product formulators and the end-user industries they serve. Some of the more important consequences/issues for the industry include ... 

Products registered under the Plant Protection Directive [6] or Biocidal Products Directive [7] are deemed registered under REACH. 

EC (1998) Biocidal Products Directive. Official Journal of the European Communities, L123 (24 April 1998), 1-63. 

The BPD introduced a European scheme for authorisation of biocidal products. The Directive was closely based on an earlier authorisation directive dealing with plant protection products (agricultural pesticides). The context within which the Commission views biocidal products can be seen from the fact that the Directive was originally, in early drafts, called the Non-Agricultural Pesticides Directive . It is therefore not surprising that the Biocidal Products Directive introduces an onerous authorisation scheme that aligns with a previously stated EC requirement to reduce the number of pesticides on the EU market. The Directive came into force on 14 May 1998 and had to be implemented in all Member States within 2 years. Many Member States, including the UK, were late. 

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