Biocidal product

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). 

EC Directive concerning the placing of biocidal products on the market... 

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. 

A proposal for a European Parliament and Council Directive concerning the placing of biocidal products on the market was adopted on 16 February 1998, numbered 98/8/EC and published in the Official Journal on 24 April 1998 (reference L 123 pp 1-62). 

HARMONISATION OF THE MARKET FOR BIOCIDAL PRODUCTS - A HIGH LEVEL OF PROTECTION FOR HUMANS AND THE ENVIRONMENT... 

The Directive will operate by listing all active substances which can be used in biocidal products in a list (annex I to the Directive) and requiring that only those active substances listed can be used in biocidal products. Member states will then authorise biocidal products to a set of common principles (annex V of the Directive) with a system of mutual recognition of authorisations. 

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). 

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). 

The Directive (article 25) allows for full cost recovery and HSE s proposals are that this will be collected in two ways by fees and by a general industry charge (GIC). A fee will be charged to directly identifiable customers e.g. those who apply for authorisation of a biocidal product whilst the GIC will be payable by all with biocidal products on the market. It will cover the costs of work such as monitoring, specific biocides research work etc. it is likely to start on 14 May 2000. 

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... 

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. 

Mainly comprised of plant protection products and biocidal products, pesticides are designed to influence fundamental processes in living organisms. They may have the potential to kill or control harmful organisms such as pests, but can also cause unwanted adverse effects on non-target organisms, human health and the environment (EC 2007). Both the hazards and benefits of pesticides are well documented in published literature and have been reviewed most recently by Cooper and Dobson (2007). 

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. 

Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of oiganisms that cause damage to natural or manufactured products. Although they are beneficial they can pose risks to humans, animals and the environment in a variety of ways due to their intrinsic properties and associated use patterns and therefore a comprehensive evaluation of the hazard and the risk and recommendations for safe use of such substances are required. In February... 

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. 

This directive is concerned with the authorisation and the placing on the market of biocidal products. It attempts to establish a list of active substances that may be used in biocidal products within the EC. In order to assess which substances should be included in the list, a system of registration, authorisation and periodic evaluation is legislated with this Directive. Once approved, active substances will be incorporated into Annex I of the directive. The system of registration is created for active substances, which pose a low riskfor humans, animals and the environment and will be incorporated in Annex lA. In Annex I B so called basic substances such as are listed. For products of higher concern, usually not an active substance, an authorisation system is established, that includes the formulation of dossiers on these products which need to be submitted to the respective national authority. In Annex I B... 

Disinfectants and general biocidal products (i.e. human hygiene products, drinking water disinfectants)... 

Other biocidal products (i.e. antifouling products) Authorisations that have been given have to be mutually recognised by all EU Member States. 

Directive 98/8/EC [10] of the European Parliament and of the Council concerning the placing of biocidal products on the market. 

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