The essentials for understanding the regulations

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".
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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.

Exporting biocidal products to Europe

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).
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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.

Exporting biocidal products internationally

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:

• In South Korea, you will need to meet the requirements of the Korean regulation on biocidal products, the K-BPR, which operates quite closely to the European regulation.
• In North America, especially in the US or Canada, you will need to comply with US standards and Good Manufacturing Practices (GMPs) for your entire supply chain. You will also need to build and submit a regulatory dossier to the Food and Drug Administration (FDA) or the United States Environmental Protection Agency (EPA).