MEPs last week proposed amendments to a regulation concerning the placing on the market and use of biocidal products. The draft report submitted by the responsible Parliamentary committee is scheduled for adoption on 3 June.
The purpose of the document is to improve the safety of biocidal products used and placed on the market in the European Union and to simplify authorisation procedures. Directive 98/8/EC established a harmonised regulatory framework for the authorisation and the placing on the market of biocidal products, the mutual recognition of these authorisations within the Community and the establishment at Community level of a positive list of active substances that may be used in biocidal products.
The review of the implementation of the Directive has indicated that for the evaluation of active substances, the simplified procedures provided for in the Directive, notably for low-risk products (Annex IA to the Directive), have no real effect. It has also indicated that the data requirements and data waiving provisions may be unclear or inconsistently applied. In addition, although product authorisation has not yet started, simplification of the procedures concerning the authorisation of biocidal products in Member States may be beneficial in reducing costs and administrative burden for companies and public authorities alike.
The Commission’s impact assessment covers five main issues requiring action:
- Scope: including treated materials in the scope of the Directive would significantly increase the costs to industry. However, although the equal treatment of industry and environmental and human health benefits are difficult to quantify, they are likely to be significant;
- Product authorisation: a combination of the Community authorisation for certain products with the strengthening of the mutual recognition process for other products appears to be the most realistic solution;
- Data sharing: mandatory data sharing at product authorisation and active substance approval stage implies the highest total cost savings to applicants, possibly the highest number of safer products remaining on the market and the highest number of animals saved;
- Data requirements: the best option seems to be a combination of data waiving with the use of existing information and a new approach to low risk biocidal products; Fees charged by MemberStates: a partially harmonised fee structure may encourage the development of more new active substances and the retention of more existing active substances. Another option – specific provisions for SMEs – would make the procedure less costly for SMEs.
