According to the Biocidal Products Regulation (BPR) (EU) No. 528/2012, biocides may only be placed on the market and used after they have been authorised. Biocidal product authorisation certificates ensure that products and their active substances have been assessed for their effects on human and animal health and the environment under the intended conditions of use.
The category of biocidal products is divided into 22 product types. It includes products such as various surface disinfectants, insect repellents, wood preservatives, rodenticides, swimming pool disinfectants, and many other products. Different types of biocides are subject to specific requirements, so each biocidal product must be individually evaluated and authorised.
The authorisation of biocides requires specific documentation. Typically, the documentation package includes a letter of access or a form confirming the supply of the active substance, the composition of the product, efficacy test reports, safety data sheets, and draft labels and instructions for use.
After evaluating the composition of the products and following the established procedure for the authorisation of biocidal products, 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 documents required for the authorisation of biocides and provide comments on any necessary updates or changes.
- We will consult on possible manufacturers/suppliers of active substances for biocidal products.
- Prepare an application for biocidal product authorization.
- Mediate communication with the authorities responsible for authorisation throughout the process.
- Will renew or update the product authorisation upon expiry of the authorisation certificate and in case of changes in the product classification, composition, authorisation certificate holder, efficacy claims or other information.
Why are there two authorisation methods?
There are two different ways to get a biocidal product authorized. Which way to go in a specific case depends on whether the active substances in the product are already approved at the EU level or are still in the review program.
- The procedure set out in the BPR Regulation is followed in cases where all active substances in the biocidal product are already approved for the product type to be authorized. Biocidal product authorization certificates are issued following an evaluation 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 transitional arrangements in accordance with the national legislation of each EU country. In this case, an application is submitted to the national competent authority, which issues a biocidal product authorization certificate after receiving all the necessary information. This authorization procedure is a transitional measure that will remain in force until the active substance is officially approved at EU level.
Regulation (EU) No. 528/2012 entered into force in 2012. However, the extremely wide variety of biocidal products and the complexity of their evaluation process led to the decision on a transitional period so that products containing active substances that have not yet been evaluated could remain on the market. Each year, uniform EU authorisation of biocidal products applies to an increasing variety of active substances, while the possibility of authorising products at the national level is gradually decreasing.
The authorisation of biocidal products at the national level during the transitional period has several advantages: the authorization process is faster, the state fees are significantly lower, and the requirements for the documentation to be submitted are less stringent and more flexible. It is important to note that this decision is temporary and that, once the last active substance assigned to this product type has been approved, biocidal products will only be authorised under the BPR.
If an application under the BPR is not submitted after all active substances in the product have been approved, then:
- Biocidal products may no longer be placed on the market 180 days after the approval date.
- Existing stocks of products must be used within 365 days of the approval date of the active substance.
Treated articles: what is important to note?
Not all products related to biocides require authorisation. If a product is treated with biocidal substances, it is considered a treated article.
Treated articles are chemical substances and mixtures that have been deliberately treated with biocidal products to protect the article or give it biocidal properties. Treated articles include products such as paints containing preservatives (mixture), socks woven with silver fibres to prevent odour (article containing a biocidal product), etc. Such products do not require authorisation, but they can only be placed on the market if the active substance used is approved for a specific purpose at EU level.
The treated product must:
- Be clearly labelled, indicating which biocidal substance it contains.
- Have accurate statements describing its safety and effectiveness;
- Comply with the information formats set out in Article 58 of the BPR.
Organization of efficacy testing for biocidal products
Every product that claims to have a biocidal (antiviral, antibacterial, mycidal, fungicidal, etc.) effect must have test protocols to support this claim. Tests are necessary both for product authorization and to substantiate 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 testing, select the appropriate laboratories, and ensure that the tests comply with EU requirements.
Biocidal product authorization: modification and renewal
Existing biocidal product authorisation certificates must be renewed when they expire (e.g., every 5 years in Lithuania). Certificates may also need to be revised before their expiry date if there has been a change in essential information:
- The authorisation holder or the product manufacturer.
- The composition of the product.
- The classification of the active substance.
- Instructions for use.
- The type of product.
- Claims regarding effectiveness.
- 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 biocidal authorisation can be updated. The text on the label is part of the authorisation, so it cannot be changed independently – all corrections must be documented and agreed with the responsible authorities.
Why is it worth contacting experts?
The authorisation of biocidal products or other transitional procedures is a necessary step before supplying biocidal products to the markets of European Union countries. If the requirements are not properly understood and implemented, or if low-quality documents are submitted, this may not only delay plans but also lead to additional costs. By consulting experts, you will successfully avoid these risks and strategically implement all the necessary product regulation stages in accordance with the relevant EU legislation or the procedures established by national authorities.
Countries where we provide this service
The authorisation of biocidal products, including applicable procedures, document requirements, and fees is regulated by EU regulations and/or national legislation. After submitting the application and all necessary documents, the competent national authority will conduct an assessment and issue a biocidal product authorisation certificate or other form of approval within 1-12 months. We help prepare and submit authorisation documents, coordinate the process from start to finish in Lithuania, Latvia, Estonia, and other EU countries (under a separate agreement).
