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Pharma Newsletters >> Eurofins BioPharma Services Newsletter 23 - June 2019 >> Eurofins provides one-stop solution for biocidal products authorisation

Eurofins provides one-stop solution for biocidal products authorisation

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by Daniela Romano, PhD, Eurofins BioPharma Product Testing Italy

Biocidal Products are substances or mixtures used to “control” any harmful organism by other means than just physical or mechanical action. Some examples are antimicrobials, anti-fouling, preservatives, rodenticides, insecticides, and repellents. Since they are widely used in households, hospitals, industry, and institutional areas, and they might be harmful towards humans and the environment, their marketing is highly regulated.

Biocidal Product authorisation is disciplined by the European Regulation (EU) 528/2012. It is quite a long and complex path, that usually requires the collaboration between a consultancy team and a number of analytical laboratories (chemical, microbiological for antimicrobials and preservatives, toxicological, and eco-toxicological).

Eurofins BioPharma Product Testing Italy provides clients with a ONE STOP SOLUTION for Biocidal Products Authorisations. Eurofins’ consultancy team creates the best testing strategies that enables clients to save time and resources. The chemical laboratory manages all chemical physical analyses. The microbiological laboratory takes care of all efficacy testing on antimicrobials and preservatives.

The toxicological laboratory performs all the in vitro toxicological tests with the eco-toxicological lab to support requests of aquatic testing or biodegradability. And the project management team ensures the project meets its timelines and works in close cooperation with the consultancy team who, as study monitor, revises data and corrects the strategy when necessary.

Once all analytical data are collected, the consultancy team can prepare the human health and environmental risk assessment, the product authorisation report, and the IUCLID dossier.

In addition to the preparation of dossiers for biocidal products, the consultancy team constantly monitors the developments of the regulatory issues, assuring an exhaustive fulfillment of clients’ designated obligations as a producer.

Antimicrobials and preservatives have further support due to the presence in the consultancy team of a CEN/TC 216 Expert and CEN/TC216/WG3 Convenor who can provide clients with the best advice on how to address the product efficacy.

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