Is your product a biocide?
Biocidal products contain biocidal active substances that are used to destroy or inactivate harmful organisms e.g. viruses, molds, bacteria, insects, ticks and rodents.
Chementors is your reliable partner to make biocidal product registration for you!
Are you exporting biocides to Europe?
Import of biocides is regulated in the EU by BPR (Biocidal Products Regulation, (EU) No 528/2012).
According to the Regulation biocidal products need an authorisation.
The products can contain only active substances which are either already approved for use or which are under evaluation. Suppliers of the active substances have to be included in the Article 95 list of compliant suppliers.
Certainly, Chementors can help you with all the different applications needed according to BPR and all other biocides related issues and problems. Furthermore, if you are interested in applying for authorisation together with other companies, we will assist you with the negotiations and the management of the consortium.
Allow us to take care of all mandatory challenges, as choosing the right strategy will save your money.
Biocidal Product Regulation
Biocidal products are used to destroy or make inactive harmful organisms. Efficacy of the products is based on the biocidal active substance(s) contained in the products. These substances can be harmful also to humans, animals and the environment. Disinfectants, preservatives, pesticides (e.g. insecticides and rodenticides) and antifouling paints used on boats and ships are examples of biocidal products.
The aim of the Biocidal Products Regulation (BPR) is to protect humans, animals and the environment against adverse effects of biocides, and the harmonisation of regulation of biocides in Europe. Active substances and biocidal products on the EU market have to be compliant: actives approved and products authorised by national or EU authorities for use in specified product types (22 product types).
Biocidal active substances which are included in the European Commission’s Review Programme can be manufactured and used in biocidal products during their evaluation period according to transitional rules. If the active substance was not included in the Review Programme it has to be approved before using in biocidal products.
How can we help with biocidal product registration?
We can assist you with all problems and questions regarding Biocidal Products Regulation. Let us help you with active substance or product authorisation dossier compilation and submission, Article 95 inclusion application, and consortium management. Our specialists have up-to-date information on interpretation of the BPR. We can help your company to find the most cost-effective way to reach compliance.
Our headquarters is in Finland with excellent connections to the European Chemicals Agency (ECHA) and national authorities. We have substantial experience in all aspects of biocides including active substance approval and product authorisation. Please contact our specialists and we will find the best and most cost-effective solution for your company!
Companies manufacturing biocidal products and selling them in the EU can use in their products only actives from compliant suppliers, regardless of the status of the evaluation process for the active. The supplier of the active has to be included on ECHA’s Article 95 list. This applies also to actives and products imported into the EU.
Biocidal Product Registration
To begin with, all biocidal products need authorisation. Companies can apply for authorisation after the European Commission has decided to approve the active substance contained in the product. The prospective applicant should remember that preparation of the product dossier takes time, especially if there is need for new tests or data. The application dossier needs the Letter of Access (LoA) of the active substance.
Two authorisation options are available: National and Union authorisation. National authorisation entitles the company to sell the product in the member state where the authorisation was granted. You can also extend your market by applying for mutual recognition in other member states. Union authorisation gives permission to sell the product in all EU member states.
You can apply the Authorisation for a single product or for a product family. If the company’s product portfolio contains many similar products, the family approach can be more cost-effective.
NOTICE! EU member states can have their own legislation for biocides which is applied during the transitional period.
It is possible to apply for the product or product family authorisation with other companies as a product consortium.