Invitation to comment –
Commission proposal to amend Regulation EU No 528/2012 on making available on the market and use of biocidal products
Background
The EU Biocides Regulation 528/2012 will replace the current Biocidal Products Directive 98/8/EC on 1 September 2013. The Regulation aims to reduce problems with the current Directive, most notably the longer than expected timescales to approve active substances and authorise biocidal products and high compliance costs, especially for SMEs.
Since the Regulation was agreed in late 2011, a number of technical problems have come to light with the text. The European Commission is therefore proposing an amending Regulation to correct these errors as soon as possible after the Regulation takes effect.
The Commission’s proposal can be downloaded from the EU Council website at
Details of the proposed changes
The proposed changes include:
(i)Corrections to terminology where this has been applied incorrectly or the intention of certain provisions is not completely clear. For example, a correction is being proposed to reflect the fact that the terms ‘persistent, bioaccumulative and toxic’ (PBT) and ‘very persistent and very bioaccumulative’ (vPvB) can only be applied to individual substances, not to biocidal products (which are normally mixtures of substances).
(ii)Corrections to some cross-references between Articles within the Regulation which are currently incorrect.
(iii)Corrections to provisions setting out administrative procedures, for example, in relation to payment of fees, to ensure that workflows for processing applications will operate correctly.
(iv)Corrections to transitional arrangements to ensure that transitional periods, application processing deadlines and phase-out provisions for old stock are consistent and do not introduce unintended restrictions on products during transitional periods.
(v)Corrections to new provisions intended to ensure that alternative suppliers of active substances for use in biocidal products have contributed to the cost of supporting those active substances through the Regulation’s review process.
HSE’s position on the Commission’s proposal
HSE believes the corrections are technically correct and are necessary to ensure that the Regulation meets its policy intention, and fully supports the Commission’s proposal; many of the amendments were suggested by HSE. HSE intends to resist attempts to seek policy changes to the Regulation. We believe further policy changes at this stage would be inappropriate, since the Regulation has only recently been agreed following a lengthy negotiation.
Impact on businesses
The proposal contains only technical changes and clarifications and does not alter duties on businesses. As such, our initial estimate is that there will be no impact on businesses.
Progress
Preliminary negotiations on the Commission’s proposal commenced on 2 July with a short meeting of the Council Environment Working Group when there was widespread support for the draft Regulation in principle and recognition of the need for the Council to act swiftly. A further meeting took place on 25 July where discussions began on the text of the proposal.
Negotiations are expected to resume in October. Negotiations are not expected to be contentious and the Commission has tentatively stated that it hopes the proposal will be adopted by the end of 2013. If this happens, the amending Regulation would be published in the Official Journal of the European Union and would enter into force around the middle of 2014.
HSE would like to have your comments on the Commission proposal before substantive negotiations begin in October.
How you can comment
You are invited to let us have your comments on the Commission’s proposal, either in general terms or on specific issues, or both, by 30 September, so we can take them into account before negotiations resume in October as anticipated.
Comments can be madein any one of three ways:
- by e-mail ;
- by posting on the discussion forum of the HSE biocides web community ( or
- by post to
Garry Wiles
Health and Safety Executive
GSW Rose Court
2 Southwark Bridge
London
SE1 9HS