Biocidal Products Regulation

In practice it has been agreed that the Health and Safety Executive (HSE) will operate as the de facto competent authority and that new Regulations will be made under the Health Safety at Work etc. Act and the European Communies Act - the Biocidal Products Regulations (BPR). 

In 2012, the Biocidal Products Regulation (BPR) came into effect (528/2012/EC) replacing the Biocidal Products Directive (98/8/EC). The BPR deals with marketing and using biocidal products to protect humans, animals, materials, or artieles against harmful organisms (e.g., bacteria) by active substances therein. The BPR not only... 

BRP-Biocideal Product Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. Official Journal of the European Union L167 (55). 27.06.2012. 

Many benzenoid quaternary cationic surfactants possess germicidal, fungicidal, or algicidal activity. Solutions of such compounds, alone or in combination with nonionic surfactants, are used as detergent sanitizers in hospital maintenance. Classified as biocidal products, their labeling is regulated by the U.S. EPA. The 1993 U.S. shipments of cationic surfactants represented 16% of the total sales value of surfactant production. Some of this production is used for the preparation of more highly substituted derivatives (101). 

There is a current control system for certain types of biocidal products (known as non-agricultural pesticides) operated by HSE under the Control of Pesticides Regulations (CoPR). These are antifouling products, insecticides, wood preservatives and surface biocides. Additionally agricultural pesticides are controlled under CoPR but these are administered by the Pesticides Safety Directorate (PSD), an executive agency of the Ministry of Agriculture, Fisheries and Food (MAFF). 

Institute for Health and Consumer Protection (2003) Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances Commission Regulation (EC) No 1488/94 on risk assessment for existing substances Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market... 

The use of DMF in biocidal products was prohibited in the EU according to EU Directive 98/8/EC [15]. However, the directive did not restrict the import of articles treated with DMF into the EU. As a consequence, the European Union made a temporary restriction to place products containing DMF on the market in 2009 (Decision 2009/251/EC). The restriction was on 15 May 2012 made permanent by the EC Regulation 412/2012 amending Annex XVII to EC Regulation 1907/2006 (REACH) [12]. The text in REACH states that articles or any parts thereof in concentrations greater than 0.1 mg/kg shall not be placed on the market. 

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. 

Issue The major implication of this 1st review regulation is that between mid end 2002 to 2006 there will be a gradual removal/phase out of non-identified, non-notified active substances and the biocidal products developed from them. It is impossible to say how many actives/biocidal products will be removed from the market by 2006. It is clear however, that a significant level of biocidal product reformulation may have to take place over the coming years. 

Choice As the second review regulation is enacted we will see the immediate removal of non-identified active substances and the gradual removal of identifi-ed/non-notified active substances (and their formulated biocidal products) from the market. Cost-driven product line rationalisation by the formulators in preparation for authorisation will similarly lead to a reduction in the number of biocidal products. Ultimately there will be less choice for the end-user. Undoubtedly the industries supported by these biocides may be presented with the following potential issues (1) a decrease in functional protection, (2) hygiene decline, resistance/tolerance, (3) process modifications, (4) end-product re-formulation and (5) higher costs. 

On the EU level, biocidal products are mainly regulated by the Biocidal Products Directive (98/8/EG), which came into force in 2000. A biocidal substance or product is defined as Active substances and preparations containing one or more... 

The basis for which regulation that will be applicable is that it is up to the producer to decide whether any substances with a biocidal purpose have been added and whether an approval is needed according to the Biocidal Products Directive. In the case when no biocides are added, REACH will regulate the assessment of the chemicals involved and the amount produced will determine the requirements for testing. In the Biocidal Products Directive on the other hand, there is no lower limit i.e. all chemicals added as biocides shall be tested no matter what amount they are produced. The different requirements on documentation in the Biocidal Products Directive compared to in REACH may have the consequence that some chemicals that are toxic or have other unwanted properties, but only produced in lower amounts can be used in certain products without any evaluation. This will be illustrated with the experiments on anti-fouling paints claimed to function by physical means. 

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