European Union Regulation for Chemical Disinfectants, Antiseptics and Preservatives

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Chapter: Pharmaceutical Microbiology : Chemical Disinfectants, Antiseptics And Preservatives

Regulation of biocides continues to develop within the EU and many other countries wherein guidance is defined for both manufacturers and users. Specific guidance documents agreed between the EU Commission services and the competent authorities of the Member States include, importantly, the Biocidal Products Directive 98/8/EC and the related directives.


EUROPEAN UNION REGULATION

 

Regulation of biocides continues to develop within the EU and many other countries wherein guidance is defined for both manufacturers and users. Specific guidance documents agreed between the EU Commission services and the competent authorities of the Member States include, importantly, the Biocidal Products Directive 98/8/EC and the related directives: Medicinal Products for Human Use Directive 2001/83/EC and the Veterinary Medicinal Products Directive 2001/82/EC. Additionally, ‘agricultural pesticides’, are regulated by the Plant Protection Products Directive 91/414/EC.

 

The term ‘biocidal product’ (98/8/EC) encompasses active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.

 

The European Commission has proposed a new Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products. The proposed European Regulation will, over a period of time, revise and replace the current regulatory framework for the marketing and use of biocidal products contained in the Biocidal Products Directive (BPD) 98/8/EC (as amended). The BPD is currently transposed into domestic UK law by the Biocidal Products Regulations (BPR) 2001 ([SI 2001/880] as amended). The UK Government Health and Safety Executive (HSE) engages in negotiations with all 27 Member States of the EU, the European Commission and the European Parliament in the development of a new directly-acting EU law. The new draft regulation which is scheduled to come into effect on 1 January 2013 proposes several important changes to the current approach to dealing with biocides, including:

 

• Extending the scope of the regime to cover treated articles and materials containing biocides

• Adopting a Community authorization scheme for certain types of products

• Requiring mandatory data-sharing of some animal testing data

• Reducing the burden of data collection requirements

• Harmonizing fee structures across member states

 

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