The Biocidal Products Regulation (EU) No. 528/2012 (BPR)
Biocidal active substances are the active ingredients of biocidal products. The approval of the active substance always depends on the combination of an active substance with a specific product type (PT) that describes the use.
We would be pleased to advise you on the status of your biocidal active substance and on the approval process (here).
Regulation (EU) No 528/2012 also regulates the authorisation of biocidal products: Authorised biocidal products may only contain active substances that are already listed on the Union list of approved biocidal active substances. For biocidal products with so-called existing active substances that are under review, country-specific transitional regulations apply.
What does this mean for you? We will be happy to assist you with the registration or preparation of an application for authorisation of your biocidal product and we take on the associated dossier preparation work.
Since September 2015, the supplier of the active substance or the manufacturer of the biocidal product must be registered on the so-called Article 95 list for biocidal active substances. This also applies to manufacturers or distributors who registered their biocidal product before 1 September 2015. Make sure that you have the necessary proof of compliance with the provisions of Art. 95(2)! We are happy to advise you on this issue (here).
For all topics concerning the Biocidal Products Regulation, we offer training courses tailored to your needs. Our experts can provide you with the necessary background knowledge and give insight into the steps involved in preparing a dossier.