The European Commission grants the authorisation of biocidal products

The Biocidal Products Regulation

The Biocidal Products Regulation applies. What to do ?

The biocidal products regulation (BPR) – or more precisely, the Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products – aims to ensure a better functioning of the biocidal market and to protect people, animals and the environment. The regulation applies since the 1st of September 2013. You are affected by this regulation if you are a manufacturer, importer, or professional user of biocidal products.

The biocidal products regulation provides that all biocidal products are authorised by their individual deadline. Only after authorisation they are allowed to be placed on the market. The deadline depends on the successful approval of the active substances contained in the product. After the approval announcement by the European Commission the application dossier for the biocidal product can be submitted.

By changing the definition of biocidal products in-situ active substances are now subject to the Biocidal Products Regulation, which were not previously covered by the Biocides Directive. Both, substances that are generated in-situ from corresponding devices, as well as precursors that generate in-situ agents are considered as biocidal products and therefore require an authorisation. Thus, users of these systems are now subject to obligations under the new regulation, which were previously not affected.

Another important change of the Biocidal Products Regulation concerns substances, mixtures or articles treated with biocidal products or where biocidal products have been added. Such goods may be marketed only if the active substances are approved - from the respective suppliers. Furthermore, certain information and labeling requirements result.

It is important to know: If a treated article has a primary biocidal function, that means the biocidal product is added not only to protect the treated article itself, it is considered as a biocidal product that has to be authorised accordingly. The differentiation between treated article and biocidal product is not always clear and may depend on individual decisions.

Prosacon provides expert consulting services for REACH and the Biocidal Products Regulation to be implemented by industry and commerce. Our website gives you an overview of our services and how to contact us.

We at Prosacon support you with:
  • Development of suitable and efficient implementation strategies
  • Portfolio analysis
  • Dossier creation for your application for a biocidal product authorisation
  • Dossier creation for your application of approval of an active substance
  • Support in the communication with competent authorities within your piocidal products authorisation
Target groups:
  • Manufacturers / importers of biocidal active substances
  • Manufacturers / formulators of biocidal products
  • Users of biocidal products
  • Purchasers of drugs or other substances fully formulated biocidal
  • Producers to process the drugs or other substances to produce biocidal
  • Seller of biocidal products
  • Users of biocidal products
  • The product safety experts, the regulatory issues have been discussed and implemented for biocidal function called carrier