Biocides are chemical or microbiological active substances that are used to destroy, deter or render harmless harmful organisms such as bacteria, viruses, insects or rodents. The EU Biocidal Products Regulation (BPR, Regulation (EU) No. 528/2012) regulates the authorization and distribution of such products within the EU. BPR covers, for example, disinfectants, insect repellents, wood preservatives and pest control products.

Treated goods, such as antibacterial textiles or coated surfaces, may also fall under the regulation. The aim of the BPR is to protect human health and the environment while ensuring a functioning internal market.

Yes - before a biocidal product can be marketed or used in the EU, it must be authorized in accordance with the BPR. The prerequisite is that the active substance it contains has already been approved or is currently in the official review program.

Depending on the product type and area of application, there are different authorization procedures - from national authorization to mutual recognition to Union authorization. Choosing the right route is crucial in terms of effort, time and costs.

The Article 95 list is an overview maintained by the ECHA of all companies that are authorized as suppliers for a specific biocidal active substance or have corresponding rights.

Only those who are on this list - or who use a supplier listed there - may legally place biocidal products on the market. The aim of this regulation is to distribute the costs for active substance data fairly and to prevent illicit trade.

Anyone who does not comply with Article 95 risks legal consequences and a ban on the sale of their products.

The authorization procedure begins with the decision as to which authorization route is most suitable. A comprehensive dossier is then compiled containing all relevant data on the efficacy, safety, environmental impact and use of the product. Depending on the procedure, a national authority or the ECHA examines the dossier.

Depending on the complexity, the process can take several months to years. Good planning, complete documentation and experienced support are crucial for a swift and successful authorization.

The active substance approval refers to the pure biocidal active substance, e.g. ethanol or permethrin. It ensures that this active substance is basically usable from a health and environmental point of view. Only once an active substance has been approved (or is in the review program) can a specific biocidal product containing this active substance be authorized.

The product authorization then evaluates the specific composition, application and safety of the finished product. Both procedures are legally separate, but coordinated with each other.

If the approval of an active substance expires and is not renewed or if an active substance is rejected, no product containing this substance may be marketed or used. In such cases, transitional periods apply during which stocks still have to be sold off or withdrawn.

Companies must react at an early stage, for example by switching to alternative active substances or applying for an extension in good time. We help you to keep an eye on such deadlines and take the appropriate measures.

We take care of the entire process for you - from strategic advice and dossier preparation to communication with the authorities. Thanks to our standardized approach, we can work efficiently and reliably without compromising on individual requirements.

Our clients benefit from fixed contact persons, many years of experience and a clearly structured project process. This gives you peace of mind and saves you valuable time and resources - regardless of whether you are a manufacturer, importer or distributor.