New Biocides Regulation Enters Into Force in EU

2 Sep 2013 --- A new Regulation on biocidal products applying from 1st September will significantly increase the safety and simplify the authorisation procedure of biocides used and placed on the market in the EU. Biocides are chemicals used to suppress harmful organisms such as pests and germs (i.e. moulds and bacteria), including insect repellents, disinfectants and industrial chemicals like anti-fouling paints for ships and material preservatives.

The new Regulation is a major breakthrough for the internal market with the possibility to request an EU-wide authorisation for biocidal products, which will allow industry to directly place their products on the entire EU market. The total cost savings for the industry, to be achieved through this simplified and more efficient product authorisation, data sharing and data requirements are estimated to be € 2.7 billion over a period of 10 years.

Environment Commissioner Janez Potocnik said: "This Regulation is another step towards ensuring that only safe, authorised products are made available throughout the EU. The simplification of authorisation procedures will bring significant economic benefits to companies while ensuring a high level of environmental protection for citizens."

The new provisions also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A dedicated IT platform (the Register for Biocidal Products) currently used for submitting applications and recording decisions, will now also be used for disseminating information to the public.

The new Regulation was also the first piece of legislation to integrate the new Commission definition on nanomaterials.

The European Chemicals Agency (ECHA) will provide scientific and technical back-up to the Commission and the Member States under this new Regulation. The agency's tasks include, among others, delivering opinions on the approval of active substances and the Union authorisation of biocidal products. The total number of opinions to be delivered by ECHA is expected to grow from 80 in 2014 to 300 in 2020.

Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products was adopted in 1998. According to the Directive, Member States had to transpose the rules before 14 May 2000 into national law. The Biocidal Product Directive aims to harmonise the European market for biocidal products and their active substances. At the same time it aims to provide a high level of protection for humans, animals and the environment.

The new Regulation on Biocidal products (EU) No 528/2012 was adopted on 22 May 2012, and applies from 1st September 2013. It repeals and replaces the former Directive.

Since its adoption, numerous implementing measures have been adopted by the European Commission to enable a proper application of the Regulation.