Revision of biocides legislation at EU level
On 12 June 2009 the EU Commission adopted a proposal for a revision of the Biocidal Products Directive 98/8/EC (BP Directive) in the form of a regulation, which has the advantage that transposition into the national legislation of individual Member States will not be necessary. Meanwhile, after its first reading by the European Parliament, a more recent draft version (of 21 June 2011) has been made available to the bodies involved. Many details of the first proposal have been modified or removed, while others are still being negotiated between Parliament, the Commission and the Council.
Important elements of the revision affect the scope of the Directive, modifications of the “low-risk” approach, product authorisation, data sharing and fees. The scope of the Directive will be extended to cover imported treated articles or materials and active substances generated in situ. An important change is the involvement of ECHA for a variety of coordinating and data management tasks. It is for example intended that ECHA should act, on behalf of the EU Commission, as a centralised agency for the authorisation of biocidal products (“Union authorisation”).
Notably the approach to low-risk biocidal products is to be changed by introducing “simplified authorisation procedure” requirements for biocidal products containing active substances which have been included in an Annex to the BP Regulation on the basis of certain exclusion criteria. In order to be included onto the list, these active substances do not have to go through the standard procedure of detailed risk assessment. In the future, active substances will no longer be candidates for comparative risk assessment but shall be designated as candidates for substitution; detailed criteria have been developed for this purpose. The exclusion criteria applicable to inclusions onto the “Union list” (the former Annex I of the BP Directive) have been extended (e. g. endocrine disruptors, active substances with PBT and vPvB properties) but at the same time restricted through certain exceptions. The rules on comparative risk assessment will be transferred to the product level.
Procedures for mutual recognition of authorisations are to be strengthened in order to support the harmonisation of the European market. Taking into account demographic divergences of authorisations (by way of mutual recognition) or divergences between Member States will be difficult also in the future. Frame formulations are to be authorised under one procedure together with the products within the respective frame formulation.
In terms of consumer protection and its enhancement, the provisions and labelling requirements for articles or materials treated with biocidal products are a welcome improvement. However, other than in the revision of the Plant Protection Products Directive, the precautionary principle is still implemented less in the present revision, as are concrete regulations about applying biocides which may lead to their more effective and reduced use. Improved data protection and the obligatory sharing of studies on vertebrates are welcome advancements. Further elements of the draft include a more flexible and tiered approach to the data requirements.