The essentials for understanding regulations

According to the Biocidal Products Regulation (BPR) EU No. 528/2012, a biocidal product is defined as a substance or mixture "intended to destroy, repel or render harmless harmful organisms, to prevent their action or to combat them in any other way by means other than simple physical or mechanical action". Biocidal products are therefore controlled, in order to limit as much as possible the risks they may present for human health, theenvironment and the animal world. There are 4 main groups of biocidal products, subdivided into 22 product types (TP): disinfectants, protection products, pest control products and other biocidal products.

Exporting biocidal products to Europe

To market a biocidal product that contains an active substance (AS) under evaluation by the European Commission, it is necessary to follow the transitional measures specific to the Member State in which you want to export. Each country has its own specific regulatory procedures, the costs of which may vary according to the type of product (TP).

At the end of the evaluation period, two cases are possible. In the first case, the SA/TP couple is not approved at European level and in this case, the biocidal product cannot be marketed. In the second case, the SA/TP couple is approved and, to be able to continue to market your product, you will have to constitute a file of Marketing Authorization (MA) perennial, individually or for example by joining a consortium.

Exporting biocidal products internationally

In order to market biocidal products internationally, you will have to comply with the specific regulations of the country you wish to export to. For example:

• in South Korea: the aim is to meet the requirements of the Korean regulation on biocidal products, the K-BPR, which is similar to the European regulation;
• in North America, particularly in the United States or Canada: you will need to comply with U.S. standards and Good Manufacturing Practices for your entire supply chain. You will also need to build and submit a regulatory file to the Food and Drug Administration (FDA) or the United States Environmental Protection Agency (EPA).