The 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... 

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and of the 20,000 formulated biocidal products containing them currently marketed in the EU may eventually be withdrawn as a result of the implementation of the Biocidal Products Directive.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 Biocidal Products Directive and the Mineral Processing Industry Possible Issues and Implications... 

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. 

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. 

Doc-Biocides-2002/01 Version 08.01.2008, Guidance document agreed between the Commission services and the competent authorities of the Member States for the Biocidal Products Directive 98/8/EC and for the Medicinal Products for Human Use Directive 2001/83/EC and the Veterinary Medicinal Products Directive 2001/82/EC Borderline between Directive 98/8/EC concerning the placing on the market of biocidal products, Directive 2001/83/EC concerning medicinal products for human use and Directive 2001/82/EC concerning veterinary medicinal products. 

The Biocidal Products Directive aims to harmonise the authorisation and marketing of biocidal products and provide a high level of protection for humans and the environment across Europe. 

Biocidal Products (Directive 98/8EEC). The HSE is the competent authority for authorisations of non-agricultural pesticides. Under the biocidal products directive, and COPR in England and Wales, the competent authority evaluates risk to human health and the environment on data provided by companies in support of approval applications. 

CCB and CCP are similar in many respeets to CCA except for the fact that the arsenic is replaced by boron in CCB and by phosphate in CCP. Most commonly used in Europe, both formulations were developed in part to address concerns about the toxicity of the arsenic in CCA. CCB and CCP are less efficacious than CCA and in the absence of arsenic the fixation processes are compromised. The systems still contain significant levels of chromium, which faces significant regulatory pressure from the Biocidal Products Directive in Europe. In the longer term the future for preservative formulations containing chromium is questionable. 

Biocide active substances or products are generally exempt from REACH evaluation and authorization procedures because they are regulated in the EU under the Biocidal Products Directive (BPD) (EC 1998). This Directive has an established process for evaluation of active substances (for listing in Annex I of the BPD), followed by national approvals of the formulated biocidal products containing them. However,... 

In the EU, antibacterial plastics could be classified as Biocidal Products rmder the Biocidal Products Directive (BPD) and the cost of registration could be as much as 200,000. 

The Biocidal Products Directive has begun in Europe Directive 98/8/EC of the European Parliament of 16th February 1998 concerning the placing of biocidal products on the market. ... 

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