Biocide Directive

Substances to be evaluated in accordance with the biocide directive as per a comparable process since 2003 are not dealt with here. 

Comments and Proposals concerning Efficacy Data Requirements in the context of EU Biocides Directive (98/8/EC), CEFIC report, 1996/09, pp. 28. 

Directive 98/8/EC [4-18], known as the Biocide Directive , concerns the authorization and placing on the market of biocidal products. 

Article 3 of the biocidal Directive states that no biocidal product which is not authorized in accordance with Directive 98/8/EC [4-18] is allowed to be placed on the market. 

The list will be decreased as a result of the implementation of new directives, such as the European Biocide Directive that will be fuUy implemented by 2010. The use of biocides in paper production is often further limited by national health authorities, e.g. FDA (USA) and BfR (Europe) for food packaging paper, as well as green label lists such as White Swan. A list of substances used to control microbiological growth on a paper machine is given below ... 

Also such materials, even though these are typically of non-toxic nature, must be registered both in Europe (European biocide directive) and the USA, limiting the list of products commercially available. 

The European Economic Union has begun to publish standardized tests for disinfection these are promulgated by the Standard European Commission 216 and will become part of the European Biocides Directive. A pan-European test will replace the corresponding national tests after publication in the Official Journal of the European Community. 

The production of alkylphenols exceeds 450,000 t/yr on a worldwide basis. Alkylphenols of greatest commercial importance have alkyl groups ranging in size from one to twelve carbons. The direct use of alkylphenols is limited to a few minor appUcations such as epoxy-curing catalysts and biocides. The vast majority of alkylphenols are used to synthesize derivatives which have appUcations ranging from surfactants to pharmaceuticals. The four principal markets are nonionic surfactants, phenoUc resins, polymer additives, and agrochemicals. 

Monofunctional, cyclohexylamine is used as a polyamide polymerization chain terminator to control polymer molecular weight. 3,3,5-Trimethylcyclohexylamines ate usehil fuel additives, corrosion inhibitors, and biocides (50). Dicyclohexylamine has direct uses as a solvent for cephalosporin antibiotic production, as a corrosion inhibitor, and as a fuel oil additive, in addition to serving as an organic intermediate. Cycloahphatic tertiary amines are used as urethane catalysts (72). Dimethylcyclohexylarnine (DMCHA) is marketed by Air Products as POLYCAT 8 for pour-in-place rigid insulating foam. Methyldicyclohexylamine is POLYCAT 12 used for flexible slabstock and molded foam. DM CHA is also sold as a fuel oil additive, which acts as an antioxidant. StericaHy hindered secondary cycloahphatic amines, specifically dicyclohexylamine, effectively catalyze polycarbonate polymerization (73). 

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). 

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. 

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. 

There will be a long transitional period (the Directive foresees 10 years) before the Regulations come fully into effect. During the transition period existing national rules will contine to apply - that means CoPR will continue until all biocidal active substances have been reviewed under the biocides programme. 

The Directive, and implementing Regulations require that risk assessments are carried out on biocidal active substances and the products containing them. This requires the submission, and in many cases the generation of data and industry has to provide this. 

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... 

It does have a number of draw backs. It has poor thermal stability (a property common to most formaldehyde release biocides) and, in some instances, may cause blackening of metalworking fluid concentrates if heated above 50°C for a period of time. Recently, this active ingredient was placed on Annex 1 of the Dangerous Substances Directive having been identified as a potential skin sensitiser. This means that formulations containing efficacious levels of this class of triazine in them would have to be labelled with R43 - may cause sensitisation by skin contact. This is unacceptable to many UK customers. As this material is only bactericidal, it needs to be co-formulated with a fungicide to provide complete protection for a product. 

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. 

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