There are more than 30,000 biocidal products in Germany alone. They are used to control pests, such as insects or rats, but also against bacteria or fungi.

As a means to control different organisms, biocidal products are potentially dangerous for humans, animals and the environment. In order to achieve the necessary level of safety for consumers and the environment and to be able to guarantee the required effectiveness of the corresponding products, the Biocide Regulation (Regulation (EU) No. 528/2012) was introduced to regulate the marketing and use of biocidal products. In principle, only biocidal products approved after official testing may be marketed and/or used.

The authorisation process for biocidal products is a two-stage process that first requires the authorisation of the biocidal active ingredient and then regulates the authorisation of the biocidal product.
 

Biocides regulation – National approval and recognition within the EU

If a biocidal product is to be placed on the market in one member state of the EU, an authorisationin this country is sufficient. To this end, the company applies for authorisation in the relevant member state. The competent authority of the member state has 365 days to evaluate the application and to take a decision concerning the authorisation. If the company wishes to place a biocidal product on the market in several countries, it can apply for mutual recognition for the authorisationof the product.

Biocides regulation – EU-wide authorisation

The Biocidal Products Regulation (BPR) provides for the possibility to have certain biocidal products authorisedat the EU level. In this way, companies can place their biocidal products on the market across the European Union without having to obtain specific national authorisations.

Biocide Regulation - Simplified authorisation

The simplified authorisation procedure is intended to promote the use of biocidal products that do less harm to human and animal health and the environment. Under certain conditions, a corresponding application can be submitted to ECHA. Once the simplified authorisation has been granted, the respective biocidal product may be placed on the market in other EU member states without the need for mutual recognition.