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HSE Propose Changes To Biocidal Products Regulations 2001, UK

August 01, 2017

The Health and Safety Executive (HSE) is aiming to make some simple changes to the Biocidal Product Regulations 2001.

HSE is asking current duty holders to view the draft proposal of changes and give their opinions via an online questionnaire.

The draft proposals contain three main amendments from the current regulations which are:

- Keeping biocides on the market after 14 May 2010
- Updating references in the 2001 Regulations
- Adjusting the 2001 Regulations

Keeping biocides on the market after 14 May 2010

The European Commission has confirmed the review of existing active substances will not be completed within the 10-year deadline, which is due to end on 14 May 2010. To overcome this problem, it has been agreed to extend the transitional period by four years during which existing active substances will be reviewed and considered for inclusion in Annex I of the Biocides Directive, and to extend data protection periods by the same period for information submitted under the Biocides Directive.

Updating certain references in the 2001 Regulations

The 2001 Regulations refer to various pieces of legislation that are relevant to the scope or operation of the biocides regime. Since the 2001 Regulations were made, several of these have changed and it is proposed that references are updated accordingly to reflect these changes.

Adjusting the 2001 Regulations

The reference to 'placing on the market' will be redefined to make clear that any act of supply constitutes a 'placing on the market', as does any act of storage other than storage followed by consignment out of the customs territory of the Community or by disposal.

The adjustments will provide clarity in particular about the position when storing and supplying unauthorised products for export outside the European Customs territory.

It is also proposed to amend the reference to importation into Great Britain being an act of 'placing on the market', so that it refers more precisely to importation of a biocidal product, in line with the definition in the Biocides Directive.

Garry Wiles, HSE said "There are no changes to any legal duties or procedures set out by the 2001 Regulations, we are simply proposing some updates and adjustments to make things easier for duty holders."

The changes will only affect those already affected by the existing biocides regime and will not create any additional costs as they do not change any legal duties or procedures established by the 2001 Regulations

The 12-week online consultation will start on the 1 September and will end on 23 November.

To complete the online questionnaire visit here.


1. The 2001 Regulations implement the Biocidal Products Directive 98/8/EC (the Biocides Directive) concerning the harmonisation of the European market for biocidal products. The Biocides Directive established a 10-year review of active substances of biocidal products that were on the European Market when the Biocides Directive came into force on 14 May 2000 (known as 'existing' substances), during which time the biocidal products containing them could remain on the market subject to current national legislation. The European Commission has indicated that the review has fallen behind schedule and will not now be completed on time. It has published a Directive amending the Biocides Directive, to allow existing active substances in the review to stay on the market until 14 May 2014 while the review is being completed. The changes proposed by HSE include amending the relevant dates in the Biocides Regulations in line with these changes.

2. Biocidal products are chemicals or micro-organisms used to control organisms that are harmful to human or animal health and for the control of organisms that can cause damage to natural or manufactured products. Biocides are used in a very wide variety of non-agricultural situations; examples include wood preservatives, insecticides, disinfectants and embalming fluids. They are distinct from 'agricultural pesticides', which are regulated by the Plant Protection Products Directive 91/414/EC, and veterinary medicinal products, which are regulated by the Veterinary Medicines Directive 2002/82/EC.

3. The Health and Safety Executive is the national regulator for workplace health and safety. It aims to prevent death, injury and ill health in Great Britain's workplaces.