Biocidal active substances and biocidal products

We offer expert advice and assistance in obtaining approval for biocidal active substances and biocidal products. We can guide you through the entire process: from the safety assessment of active substances and the identification and generation of missing data to communication with authorities and dossier submission.

To obtain approval for biocidal products in the EU, the Biocidal Products Regulation (BPR) requires that the product's biocidal active substance be approved for the specific product type. Furthermore, it must be documented that the product is both safe and effective.

Consequently, marketing biocidal products in the EU requires thorough knowledge of the Biocidal Products Regulation and the harmonized requirements for documenting safety and product efficacy.

Strategic advice on applications and approvals

Authorization covers all products across all product types: wood preservatives, rodenticides, insecticides, disinfectants, preservatives, and more. Please note that there are different deadlines for applying for authorization, depending on the active substance and product type.

There are several different options for applying for authorization. We can help you assess which option represents the best strategic solution.

In addition to assisting with the choice of application route, we can also help prepare the application and meet the application requirements.

Safety assessment and documentation

When marketing a biocidal product, you must be able to document that the product's use poses no risk to either human health or the environment.

We can assist you in compiling the dossier and documenting safety and claimed effects, including sourcing valid data studies.

Documentation of efficacy

To obtain approval for a biocidal product, you must also be able to document that the product delivers its claimed effect. Testing requirements vary depending on the product and the type of application.

Drawing on our extensive experience in data evaluation, we can assist in obtaining the necessary data, including overseeing studies and compiling the data into the final dossier.

Endocrine-disrupting substances

To obtain authorisation, the application must include an assessment ruling out endocrine-disrupting properties in the biocidal active substance and the non-active components of the product. The assessment must demonstrate that the substance does not adversely affect intact organisms due to an endocrine-disrupting effect.

Leveraging our extensive toxicological expertise, we can assist in gathering, evaluating, and compiling data to demonstrate that the product does not contain endocrine-disrupting substances.

No authorisation – no market

In this blog post, our regulatory expert Michael Fink explains why meeting the requirements for biocides is such a major undertaking - and offers a few tips on how to approach it.

Read the blog: "No authorisation - no market"

Families of biocidal products

Under the Biocidal Products Regulation, it is possible to obtain approval for multiple biocidal products in a single application, thereby saving both time and money. However, this requires a very high degree of similarity between the individual biocidal products within the product family - such as identical uses, the same active substances, and comparable levels of risk and efficacy.

We can help determine whether your products meet the requirements for approval as a family of biocidal products and assist in structuring the product family in the most effective way.

Data gaps

Applications for the approval of both an active substance and a biocidal product require a wide range of data, including physicochemical data and data regarding the claimed efficacy.

We can help you assess which data you already have and identify any data gaps that need to be filled for a complete application. If additional data is required, we can facilitate contact with established contract research organizations (CROs).

Application documents

An application must include a range of documents to meet the requirements of the Biocidal Products Regulation:

• IUCLID dossier containing all submitted test data,
• draft Product Assessment Report (PAR) and Competent Authority Report (CAR) – including an overview of all submitted data and risk assessments regarding human health and impacts on animals and the environment,
• Summary of Product Characteristics (SPC): an overview of product characteristics (must be prepared in a specific SPC format),
• famil overview (for product authorizations), and
• other documents

We have in-depth knowledge of every stage of the application process and can assist you with advice, assessment of application drafts, and the finalization of application documents.

Communication with authorities

You are more likely to experience a positive and smoother approval process if you maintain good communication with the biocides authorities throughout the application process. This allows you to clarify any questions or uncertainties before submitting the application.

We have numerous personal contacts within EU authorities, established through collaborations on biocides applications and projects. In addition to contacts at the Danish Environmental Protection Agency, we have connections with all national biocides authorities across the EU.

Consortia

The EU Biocidal Products Regulation allows for the formation of consortia to obtain authorization for biocidal products or biocidal product families. This is a good option for SMEs, for example.

By participating in a consortium, you benefit from obtaining a joint authorization for a biocidal product family. At the same time, individual consortium members have the opportunity to obtain authorization for their own products under the regulation concerning the authorization of same biocidal products. In this way, the consortium shares the high costs of authorization while allowing members to maintain individual product authorizations independently of the consortium.

Manufacturers, formulators, distributors/suppliers, and importers can all participate in consortia.

In-situ generated biocidal active substances

In-situ generated biocidal active substances are active substances that are "generated on-site." This encompasses processes across all types of disinfection and requires documentation regarding precursors, active substances, and the final product.

We have extensive experience in gathering data for in-situ generated biocidal active substances, including conducting risk assessments based on the data. We also assist in evaluating substances - both pure active substances and technical-grade active substances.