Based on the Biocidal Products Regulation (BPR, Regulation (EU) No. 528/2012), to supply a biocidal product to the EU market, it must be authorised. Biocidal product authorisations ensure that the product, its active substances, composition, and effects are safe for consumers and the environment under the intended conditions of use.
Biocidal products are a broad category, divided into 22 product types, with products of types 3, 4, 14, 18, 19, and 22, related to animal husbandry or transport, considered veterinary biocides. Their authorisation requires extremely precise documentation. The documentation package usually includes a letter of access or a form confirming the supply of the active substance, the product composition, efficacy study protocols, safety data sheets, and draft labels and instructions for use.
Based on the composition of your product and the intended authorisation procedure, INTRA VIRES experts will:
- Check that the labels are not misleading and do not contain statements such as “non-toxic,” “harmless,” “natural,” or “environmentally friendly,” and that the statements on the label are justified and comply with the provisions of the CLP and BPR regulations.
- Evaluate the documentation received and provide comments on any necessary updates or changes.
- Consult on potential manufacturers/suppliers of active substances for veterinary biocidal products.
- Prepare an application for authorisation.
- Mediate communication with the authorities responsible for authorisation throughout the process.
- Will renew or update the product authorisation upon expiry of the old authorisation certificate or submit revised information in case of changes in the product classification, composition, authorisation certificate holder, product claims or other information.
Why are there two authorisation methods?
The procedure for authorising biocidal products depends on whether the active substances in the product are already approved at the EU level.
- If all active substances in the product are approved for use in a specific product type, the product must be authorised under the BPR. This is a single process coordinated by the European Chemicals Agency (ECHA).
- If at least one active substance in the product is still under review, the authorization of biocidal products is carried out under a transitional procedure in accordance with the national legislation of each EU country. In this case, the application is submitted to the national competent authority, which issues biocidal product authorisation certificates after receiving all the necessary information. This authorisation procedure is a temporary measure that will remain in place until the active substance is officially approved at the EU level.
Organisation of efficacy studies for veterinary biocidal products
Every product that claims to have a biocidal (antiviral, antibacterial, fungicidal, etc.) effect must have test protocols to support this claim. The tests are necessary both for the authorisation of the product and for substantiating the claims on the packaging and in advertising content. Depending on the purpose of the product and your needs, INTRA VIRES experts will strategically assess the need for studies, select appropriate laboratories, and ensure that the studies comply with EU requirements.
Authorization change, renewal: when is it necessary?
It is important to note that biocidal product authorization certificates must be renewed when they expire (e.g., every 5 years in Lithuania) or updated before they expire if there are changes to:
- The authorisation holder or manufacturer’s details;
- Claims about effectiveness;
- The composition of the product.
- The classification assigned to the active substance or mixture.
- Instructions for use.
- Labelling information.
For example, if you have conducted additional studies and want to include a claim about the antiviral effect of the product, this data must be submitted to the responsible authorities so that the labelling and authorization can be updated. As the text on the label is part of the authorisation,it cannot be changed independently. A corrections must be documented and agreed upon with the responsible authorities.
Why is it worth contacting experts?
Authorisation certificates for veterinary biocidal products allow you to legally supply products to the EU countries that issued them. Incorrectly assessed requirements or poor-quality documents can not only delay your plans, but also require additional costs. By turning to experts, you will successfully avoid these risks and strategically implement all the necessary stages of product regulation in accordance with current EU legislation or the procedures established by national authorities.
Countries where we provide this service
We work with clients in Lithuania, Latvia, Estonia, and other EU countries (subject to separate agreement).
