From September 2013 the Regulation (EC) 528/2012 (BPR) concerning the placing on the market of biocidal products and their use entered into force. Its purpose is to protect humans and animals from harmful organisms (i.e., bacteria, crawling and flying insects, etc.) dwelling their habitats, and to maintain an high level of protection for themselves and the environment.
Before authorizing the marketing of biocidal products in the Member States, the relevant active substances have to be approved at European Union level. In the case of active substances belonging to the review program, the related biocidal products can remain on the market waiting for their approval.
The deadline for the systemic review of the existing active substances, combined with the pertinent product types, was extended to 2024, but at the end of 2016 opinions from ECHA Biocidal Products Committee have to be finalized for active substances contained in products such as insecticides, anti-foulings, rodenticides and others.
After approval of the active substances, the companies, who wish their products to be authorized or remain authorized, have to submit a dossier containing the required information.
The experimental data obtained from the studies requested by the BPR, along with other collected information, have to be such to carry out a proper risk assessment and to make a decision about the product authorization. The information requirements are at 2 levels: the Core Data Set (CDS), mandatory and common for all product types, and the Additional Data Set (ADS) specific for product type. CDS and ADS consist of chemical-physical properties, efficacy evaluation, environmental fate and behavior tests, ecotoxicological studies and others.
In this scenario Biotecnologie BT is placed, with its wide variety of tests performed according to standardized methods and in compliance with the Good Laboratory Practice (GLP).
Efficacy evaluation through customized laboratory tests and simulated use trials on several target organisms, to support label claims, are also part of Biotecnologie BT core business.
Our over ten-year experience on studies in support of the xenobiotic registration dossier, together with our high qualified technical team, are offered to the clients who have to fulfill all the Authorities’ requirements.