Biocidal products are an extremely broad group of products, divided into 22 types. This category includes products designed to destroy or control harmful organisms: bacteria, viruses, fungi, insects, rodents, etc. They are used both in the home and in industry.
Depending on their purpose and composition, biocidal products can pose various risks to human health and/or the environment. On the other hand, biocidal products are classified according to the requirements applicable to chemical substances and mixtures, and are therefore subject to multi-layered regulatory requirements.
Biocidal products are regulated under the BPR ((EU) No. 528/2012) and CLP ((EC) No. 1272/2008) regulations, and certain products may also be subject to additional legislation, such as the Detergents Regulation (EC) No. 648/2004 applies to surface disinfectants and laundry disinfectants.
In order to legally and smoothly supply biocides to the EU market, it is critically important to properly assess the requirements applicable to a specific product. INTRA VIRES experts will not only provide clear conclusions, but also prepare a specific action plan that will help you avoid costly mistakes and smoothly authorise, notify, and label your products.
Frequently asked questions and topics we advise on:
- Does a biocidal product need to be authorised separately in each country?
- How long are biocidal product authorisation certificates valid?
- What efficacy studies are required to authorise a biocidal product?
- Who are the possible suppliers of active substances for my product?
- Which laboratory can perform efficacy studies?
- Can you prepare a safety data sheet for a biocidal product?
- Where can I find a list of authorized biocidal products?
- How long does the authorisation process take, and what documents are required?
- What is the applicable amount of the state fee?
- Is it necessary to generate a UFI code and notify the mixture to ECHA?
- Do biocidal products need to be notified in the IS AIVIKS system?
Organization of biocidal product efficacy testing
Every product that claims to have a biocidal effect (e.g., antiviral, antibacterial) must have studies to support this claim. Studies are necessary both for product authorisation and to substantiate its effect. Taking into account the product documentation 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. We also advise on what additional studies or data may be required, depending on the intended use of the product.
Why is it worth contacting experts?
The regulation of biocidal products is dynamic and complex. An inappropriate strategy, low-quality documentation, or failure to meet requirements can delay the product’s entry into the market, increase costs, and lead to legal liability. Consultations on the regulation of biocidal products will help you avoid these risks and properly assess the applicable requirements. We will also share best practices that will help you get your product on the right shelf.
Countries where we offer this service
Depending on the composition of the biocidal product, it will be regulated either by EU legislation or by the national requirements of the country to which you wish to supply the product. We advise clients in Lithuania, Latvia, Estonia, and other EU countries (subject to separate agreement).
