How will the new EU 528/2013 regulation affect biocidal products testing?

by Daniela Romano, PhD, Eurofins BioPharma Product Testing, DanielaRomano@eurofins.com

Since September 1st, 2013, the (EU) No 528/2013 Regulation, concerning placing on-the-market and use of biocidal products, is effectively replacing the previous 98/8/EEC Directive and introducing several novelties, some of which listed below are briefly summarised.

The Union Authorisation at ECHA (European CHemical Agengy) allows companies to apply for authorisation in several Member States simultaneously or for an EU-wide authorisation, in addition to applying for authorisation in a single Member State.

Data sharing for in vivo testing becomes mandatory to avoid unnecessary testing on animals. Therefore, before performing any in vivo tests, companies must send an inquiry to ECHA to find out whether the same test has already been conducted and submitted under EU biocides legislation. If so, companies are required to share the data.

Biocide Product Family (BPF) authorisation allows all products within a BPF to be covered by one authorisation under the Biocidal Products Regulation. A BPF is a group of biocidal products that are used for similar purposes and contain the same active substances. Any variations in the composition of the products must ensure that the level of risk is not increased and that the efficacy of the product is not reduced.

A treated article is any substance, mixture or article that has been treated with, or intentionally incorporates, one or more biocidal products and whose primary function is not as a biocide.

Eurofins has 10 years of experience in supporting companies to meet the regulatory requirements for the registration of biocidal actives and formulated products, providing a complete panel of testing for all product types. The project management is conducted by people cooperating with the European authorities and constantly updated on the news from ECHA. The Biocides Testing BU is comprised of GLP and/or ISO 17025 certified analytical, physical-chemical, efficacy and (eco)toxicological laboratories with experienced personnel dedicated to biocides testing.

For more information, visit www.eurofins.com/biopharm