New EU Biocide Regulation Enters Into Force

The new Biocidal Products Regulation (BPR) enters into force in the EU today, July 17, 2012. The BPR replaces the Biocidal Products Directive (BPD) that had been the law governing biocides. There will be a transition period for some biocidal products already in the review process, but the new BPR moves much of the responsibility for approving biocides to the European Chemicals Agency (ECHA).  ECHA is also responsible for REACH, the chemicals regulation.

As a regulation, the BPR goes into force in all of the EU immediately.  The previous Directive had to be implemented by individual member state action.

More information on the new Biocidal Products Regulation can be found on ECHA's web site.

ECHA to Begin Authorizing Biocidal Products

The European Union has reached an informal agreement to allow the European Chemicals Agency (ECHA) to being taking responsibility for reviewing and authorizing biocidal products.  The agreement between the European Parliament and the EU Council would give broad powers to ECHA and update the current EU Biocides Directive.

In addition to allowing ECHA to review certain biocides applications at the EU level, companies would also maintain the ability to apply to individual Member States for authorization, after which they would obtain approval in other Member States through a process called mutual recognition.  This is how the process works under the current Directive, and this move to shift some of the responsibility to ECHA is part of the reevaluation of the Biocide process as the Directive is replaced by a Biocidal Products Regulation.  Like REACH, the new regulation would immediately apply across all Member States, whereas the Directive required each MS to pass its own individual implementation legislation.

ECHA's role is limited to only some of the product types of biocides beginning in 2012, and then by 2017 all of the 23 product types will be eligible for authorization at the EU level through ECHA.  The informal agreement also specifically requires that nanoscale active substances in biocidal products be assessed separately from their non nanoscale counterparts.

ECHA Issues 2012 Work Program - Sees Challenges Ahead

The European Chemicals Agency (ECHA) approved its 2012 work program last week and highlighted both its activities and its challenges ahead of the next REACH deadline.  Besides the mid 2013 REACH registration deadline, ECHA will take on an expanding role in the new Biocidal Products Regulation (which will replace the current Directive in 2013). In addition, ECHA will have ramped up activities related to other parts of the expansive REACH regulation, including the Evaluation (the "E") and Authorization (the "A") components, as well as Restrictions (the "missing R").  And of course there is still the continuing evaluation of substance dossiers for high productive volume chemicals submitted in the first registration period that ended on November 30, 2010.

All of this leaves ECHA worried that there may not be enough resources to meet obligations efficiently, both within ECHA and in the Member States.  The current economic situation in most of Europe, which has caused such severe spending cuts (austerity), has led ECHA Executive Director Geert Dancet to openly state his concerns that Member States may not have enough resources to fully conduct their role in chemical evaluation.

The developing Biocidal Products Regulation (BPR) also offers challenges to ECHA as the agency is expected to take on responsibility for authorizing biocides.  Under the current biocides directive this responsibility lies with each Member State.  ECHA would also take on new responsibilities related to the Prior Informed Consent Regulation, which involves identifying hazardous chemicals that could not be exported from Europe unless the country of destination is given sufficient information to assess risk.

During the September 29-30, 2011 meeting of the management board, the mandate of the Executive Director was extended.  According to the chairman, Dr. Thomas Jakl:

"After the first REACH registration deadline was impressively managed by ECHA in 2010, there is no time to rest on our laurels. Challenging further steps of the REACH and CLP implementation lie ahead and the legislator is in the process of entrusting important new regulatory tasks to the Agency. The continuation decision with regard to a selection process for the Executive Director reflects the high satisfaction of the Board with his achievements since 2007."

More information and a link to the work program can be found on the ECHA web site.