The Biocidal Products (Amendment) Regulations 2010

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Biocidal Products Regulations 2001 (S.I. 2001/880) (“the 2001 Regulations”) to make further provision as regards Great Britain for the implementation of Directive 98/8/EC of the European Parliament and Council (OJ No. L123, 24.4.98, p.1.) concerning the placing of biocidal products on the market.

These Regulations—

(a) implement Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods (“the Amending Directive”);

(b) update references and make minor corrections in the 2001 Regulations; and

(c) take account of developments that require further amendment to the 2001 Regulations.

The main changes made by these Regulations are as follows.

Regulation 3 amends the definitions of “new active substance” and “placing on the market” and substitutes the “fifth” for the “second” review regulation.

Regulation 4 corrects a cross reference.

Regulation 5 amends time periods.

Regulation 6 extends the data protection periods for active substances from 14th May 2010 to 14th May 2014.

Regulation 7 extends the data protection periods for biocidal products from 14th May 2010 to 14th May 2014.

Regulation 8 adds the Medical Devices Regulations 2002, the Plant Protection Products Regulations 2005 and the Plant Protection Products (Scotland) Regulations 2005 to Schedule 2 and removes the Medical Devices Regulations 1994 and the Plant Protection Products Regulations 1995.

Regulation 9 clarifies that a biocidal product can only remain on the UK market under its existing national authorisation if all the active substances within it are existing active substances and changes specific time periods.

A full regulatory impact assessment has not been produced for this instrument as no impact on the private or voluntary sectors is foreseen. A copy of the transposition note in relation to the implementation of the Amending Directive can be obtained from the Health and Safety Executive, International Branch, Redgrave Court, Merton Road, Bootle, Merseyside L20 7HS. Copies of these documents have been placed in the Library of each House of Parliament.