New regulation on biocidal products to be applied from 1 Sep 2013

30 August 2013 14:00  [Source: ICIS news]

LONDON (ICIS)--A new regulation on the authorisation of biocidal products will be applied from 1 September 2013 that will improve human health and environmental protection, the European Commission said on Friday.

The regulation, which was first adopted on 22 May 2012, “will significantly increase the safety and simplify the authorisation procedure of biocides used and placed on the market in the EU,” it added.

From 1 September onwards, industry can apply for the approval of an active biocidal substance as well as authorisation for a biocidal product containing an approved active substance through the European Chemicals Agency (ECHA).

The regulation will introduce new ways to authorise the biocidal products, the Commission said. In addition to applying for authorisation in a single member state, companies can apply for authorisation in several member states simultaneously or for an EU-wide authorisation.

The Commission estimated the industry could save €2.7bn ($3.6bn) over a period of 10 years through this simplified and more efficient product authorisation process.

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."

One other aim of the regulation is to avoid unnecessary testing on animals by making data sharing compulsory and encouraging a more flexible approach to testing.

Before carrying out any tests on animals, companies will need to send an inquiry to ECHA to find out whether the same test or study has already been conducted and submitted. If such information exists, companies are required to share the data.

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

The ECHA will provide scientific and technical back-up to the Commission and the member states under this new regulation.

The Commission said the ECHA 's tasks include 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, the Commission added.

ECHA's executive director Geert Dancet said: "ECHA has been working hard over the last year to get the essential elements in place to allow this important new regulation to enter into operation.

“In preparing, we have been very mindful of the many small and medium-sized enterprises in Europe who will need to apply this new law. We are and will continue to provide material that will help all companies to comply."

Biocides are chemicals used to suppress harmful organisms such as pests and germs, including insect repellents, disinfectants and industrial chemicals like anti-fouling paints for ships and material preservatives, according to the Commission.

($1 = €0.76)


By: Franco Capaldo
+44 (0)20 8652 3214



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