In an answer to a consultation request from the Ministry of the Environment, the Swedish Chemicals Agency (KemI) proposes that Sweden in the main should support the proposal for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products . The regulation will replace the provisions in Directive 98/8/EC (the Biocidal Directive) and contains for example:

• Introduction of a new centralised evaluation system for certain products at the European Chemicals Agency, ECHA;
• Modernisation of existing provisions requiring an authorisation, to a large extent inspired by the recently agreed Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market;
• Adaptation to provisions on chemicals in the Regulation of the European Parliament and the Council (EC) No 1907/2006 (REACH) and the Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP).

KemI is of the opinion that it is necessary for the Member states to discuss [that MS should discuss] further simplifications of the rules, particularly with respect to low risk products and to facilitate for small companies.

 – We consider that Sweden should support a centralised system for authorisation of biocidal products, and that it has to be discussed more in detail which product categories should be covered by such a system. Moreover, it is important that requirements be introduced in the Regulation corresponding to the provisions of the Plant Protection Regulation as regards the application of the substitution principle and phase-out of particularly hazardous substances, says Per Bergman, senior legal adviser with KemI.

The new EC regulation also contains proposals to the effect that articles that have been treated with biocides should be regulated within the EU.

– The resources required for validating authorisations are extensive, both for companies and authorities. We believe it would have been a good thing to simplify the rules more than is now the case in the Commission proposal. At the same time, it is always necessary to weigh the need for simplifications against the need for a sufficiently ambitious assessment of risks, ensuring the protection of human health and the environment, Per Bergman concludes.

Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products