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Revision of the Biocidal Products Directive (98/8/EC)

Government department lead

HSE, but many departments have an interest including Defra, DH, Scottish Executive and the Welsh Government. BIS have a strong interest in the regulatory simplification agenda.


Regulation (EU) No 528/2012 of theropean Parliament and of the Council of 22 May 2012 concerning the making available and use of biocidal products (“the Biocides Regulation”) was published in the Official Journal on 27 June 2012 and entered into force on 17 July 2012. It took effect in Member States on 1 September 2013.

Main provisions

The Biocides Regulation revises and replaces the current regulatory framework for the marketing and use of biocidal products contained in the Biocidal Products Directive 98/8/EC. It aims to improve the functioning of the internal market in biocidal products in five key policy areas:

without reducing the high level of protection provided by the regime for human and animal health and the environment.

Latest Developments and next steps

The Biocides Regulation acts directly in Member States, and so does not require transposition. However, new domestic legislation has been put in place to specify enforcement measures and penalties in relation to breaches of the Regulation, appoint competent authorities and provide a system of fees and charges by which the costs of operating the biocides system in the UK can continue to be recovered. This is contained in:

The new domestic legislation revokes the legislation transposing the now replaced Biocidal Products Directive (the Biocidal Products Regulations 2001, and four amending Regulations in 2003, 2005, 2007 and 2010). Similar measures have been put in place in Northern Ireland.


Updated 2017-09-11