Background information about the EU Biocides Regulation 528/2012 (EU BPR)
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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (the EU Biocides Regulation) was published in the Official Journal of the European Union on 27 June 2012 and came into force 20 days later (17 July 2012). However, it applies in Member States from 1 September 2013.
The EU Biocides Regulation repeals and replaces the Biocidal Products Directive 98/8/EC (the BPD), with the overall aim to simplify and streamline existing EU requirements without reducing the level of protection to health and the environment. The UK’s Biocidal Products Regulations 2001 (and the Northern Ireland equivalent) which implemented the BPD are also revoked from 1st September, and new UK implementing regulations were brought in to :
- enable the EU Regulation to be enforced in the UK;
- appoint a UK competent authority;
- set maximum penalties for non-compliance; and
- recover through a fees system the costs of services HSE provides from those who benefit from them.
Transitional arrangements were also required to enable parts of legacy systems (BPD and the Control of Pesticides Regulations 1986) to remain in place until affected products are fully brought under the new EU Regulation.
The new EU Biocides Regulation retains the basic structure of the BPD – a two-step procedure for approving active substances at EU level and authorising biocidal products in Member States. The review programme of active substances begun under the BPD will also continue under the new Regulation.
However, the Regulation will introduce some changes that will affect some businesses marketing biocidal products and producing active substances. These include:
- a new option for companies to apply for a single authorisation of a biocidal product across the whole of the European Union. Companies wishing to do this will need to apply to the European Chemicals Agency (ECHA), which will now play a role in the biocides system. ECHA will also manage applications for active substance approvals under the new Regulation.
- new provisions on alternative suppliers of active substances (i.e. someone other than the company supporting the active substance in the EU review programme), meaning that if you are making a biocidal product available on the EU market the supplier of the active substance must have access to the data that ‘supported’ it through the EU review programme. ECHA will maintain a database of such suppliers.
In addition, new provisions on treated articles mean that if you are importing an article into the EU that is treated with a biocide, you will have to ensure that the active substance that was used is approved under the Regulation. If you make biocidal claims for the article, it may have to carry a label with information about the biocide that was used.
The EU Commission has published various amendments to the legal text of the EU BPR to addresses a number of aspects of the regulation and to give further clarification. They have also published various implementing and delegated regulations that further specify the requirement and procedures of the EU BPR. Details of the various regulations that have been published to amend the EU BPR and the various implementing and delegated regulations can be found in the legislation section of the ECHA website.