EU to amend regulation on biocide approvals

The European Commission’s environment department will propose changes to the 2012 regulation on biocide approvals in April. It aims to clarify and improve the legislative text after errors and inconsistencies were found by experts.

Speaking at a seminar on the new regulation held by law firm Steptoe & Johnson LLP, an official said he hoped the amendments would be adopted quickly by member states and MEPs before the law takes effect in September.

One of the changes aims to clarify that a ban on biocides containing substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) also applies to mixtures.

A commission note for member state authorities, seen by ENDS, proposes article 19 should now state that a biocidal product cannot not be placed on the market if it "constitutes or contains a substance that meets the criteria for being PBT or vPvB”.

There are three exceptions to this ban, with one being that it must not result in a "disproportionate negative impact" to society.

Another change involves giving member state authorities up to three years to approve biocides, as opposed to up two years from the date of application in the existing regulation. This is because more time may be needed to resolve potential disagreements between countries over mutual recognition.

The European Biocidal Product Forum, a group that is part of chemicals industry association CEFIC, said it was satisfied with most changes except for an amendment that would extend mandatory information sharing from ecotoxicological data to “environmental fate and behaviour studies”.

This change would make it too easy for competitors to launch new products without having to conduct the research themselves, the group says.

Separately, the commission is also planning to further extend the deadline for evaluating the safety of biocides put on the market before May 2000. The deadline, initially set for 2010, has already been extended by three years. The department might ask for another ten years because about 200 substances still need to be evaluated.

Next week, the EU executive also plans to publish guidelines on fees that member states can charge for handling requests for approval at national level.

It is also trying to address the European Chemicals Agency’s recent warning that it might not get sufficient funding to process all requests for approval made at EU level.