EcoMundo's toxicologists and regulatory affairs specialists will take care of all or part of your compliance procedures regarding biocidal products and active substances.
Thanks to its expert knowledge of regulations and experience in the way in which institutions operate, EcoMundo will optimize your regulatory strategy and help you reduce your registration costs.
Our experts are aware of the challenges involved in the compliance procedure. They will come up with solutions to your problems, and remain attentive to your concerns on a daily basis.
Successfully market your biocidal products internationally and optimise the costs associated with their compliance.
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Market your biocidal products successfully in Europe and optimise compliance costs.
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Reduce costs related to government fees and testing by joining a Biocides consortium.
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According to the Biocidal Products Regulation (BPR) EU No. 528/2012, a biocidal product is defined as a substance or mixture "with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action".
Biocidal products are therefore quite controlled, in order to limit as much as possible the risks they may present for human health, the environment and the animal world. There are 4 main groups of biocidal products, subdivided into 22 product types (PTs): disinfectants, protection products, pest control products and other biocidal products.
To market a biocidal product containing an active substance (AS) under evaluation, it is necessary to follow the transitional measures specific to the Member State to which you wish to export. Each country has its own specific regulatory procedures, the costs of which may vary depending on the product type (PT).
At the end of the evaluation period, two cases are possible. In the first case, the AS/PT combination is not approved at European level and the biocidal product can no longer be marketed. In the second case, the AS/PT combination is approved and, in order to continue to market your product, you will have to compile a permanent Marketing Authorisation (MA) dossier, either individually or by joining a consortium.
To market biocidal products internationally, you will need to comply with the specific regulations of the country to which you wish to export. For example: