Biocides and Pesticides

Biocides

Biocidal products must either be approved according to the rules of the EU Biocidal Products Regulation (Regulation (EU) No. 528/2012) or according to the old national approval systems if the active substance in the product has not yet been fully assessed by the EU.
If you have an old national approval, the product must be approved again according to the rules in the Biocidal Products Regulation as soon as the active substance has been fully assessed in the EU. The EU's decision on approval / non-approval of an active substance is published well in advance, typically two years before the substance's actual "approval date". As a company, you therefore have plenty of time to prepare your application for product approval. However, this is also necessary in many cases, as the data requirements according to the BPR are quite extensive. It may, for example, be necessary to initiate new physico-chemical tests of the product, new efficacy tests, etc. The most important advice is therefore to start the preparatory work well in advance of the deadline.

Marketing of biodiesel

Part of the preparatory work also includes considering which markets you want to market your biocidal product in. The individual countries charge a fee for processing applications for product approval. These are typically quite large amounts. It is therefore important to include this when you need to get an overview of the total costs. In Denmark it is (primarily) The Environmental Protection Agency, which approves the biocide products. However, through an approval in Denmark, it is possible to apply for approval in other countries (mutual recognition), thereby saving both time and money.

22 biocidal product types

For the majority of the 22 biocidal product types, it is also possible to apply for an actual EU approval, which gives access to marketing throughout the EU and in the EEA countries. However, this form of application is significantly more expensive and more extensive compared to a national approval. Finally, it is advantageous to apply for approval of a biocidal family if you have several products that are similar to each other and contain the same active substances.

Article

In the EU, biocides are divided into four main groups with a total of 22 different product types. This means that an active substance may be approved in one product type and not in another, or may still be under assessment in a third product type. It is only legal to use active substances that are either approved or under assessment in the product type in which the product is to be used. In addition, the supplier of the active substance must be listed on the Article 95 list, which is the EU's list of approved suppliers of active substances.

The regulations in this area and the process for approving biocidal products can seem confusing. It can therefore be an advantage to get help from a consultant. Mediator has helped many Danish companies with biocidal and pesticide applications. We are happy to help you too.