Biocides and biocidal products

We offer expert advice and assistance for successful authorisation of your biocidal active substances and biocidal products. Our highly qualified staff can support you in the entire process: from safety evaluation of the active substances to identification and generation of missing data, and to communication with authorities and submission of the dossier. 

To obtain authorisation of a biocidal product in the EU it is a requirement in the Biocidal Products Regulation (BPR) that the biocidal active substance in the product is approved for the specific product type. In addition, you must document safety and efficacy of the biocide. Marketing of biocidal products therefore requires extensive knowledge of the harmonised BPR requirements. 

Michael Fink

Tel.: +45 4516 9156
mif@remove-this.dhigroup.remove-this.com

Thit Aarøe Mørck

Tel.: +45 4516 9567
tam@dhigroup.com

We can provide you with the following support:

Strategic advice on authorisation and approval

  • types of application within the BPR regime
  • structuring of possible biocidal product families 
  • data-gap analysis – are any data missing?

Evaluation and documentation of safety

  • risk assessments of human health and the environment
  • assessment of endocrine disrupting properties
  • pre-risk assessments

 

 

Documentation of efficacy

  • identification of required studies
  • evaluation of data

Key documents for application

Communication with the Competent Authority (CA)

Consortia 

Strategic advice on authorisation and approval

The authorisation procedure includes all products in all product-types: wood preservatives, rodenticides, insecticides, disinfectants, preservatives etc. Be aware of different regulatory deadlines for applying dependent on the active substance or product-type combination.

There are several ways to pursue when applying for an authorisation. We can help you to decide which option is the most suitable strategic solution for you.

When you have decided on the type of application, we can help you complete the application and fulfil the requirements.

Authorisation alternatives

National authorisation: The most common type of authorisation. The application is made to the authority of the primary market area.

Mutual recognition: When a biocidal product is authorised in one EU country it is possible to obtain authorisation of the product in another country (or countries) through mutual recognition. 

Same biocidal product application: For a single product, which is either identical to another authorised biocidal product or a product for which an application for authorisation has been submitted.

Union authorisation: A joint EU authorisation of a biocidal product or a biocidal product family for all EU countries. 

Simplified authorisation: For biocidal products that only contain low-risk biocidal active substances, i.e. the product must not contain substances of concern or nanomaterials.

Evaluation and documentation of safety

When placing a biocidal product on the market you must be able to substantiate that the use of the product does not constitute a risk to humans or the environment and that efficacy is consistent with the product claim.

We can help you compile the product dossier that documents safety and efficacy, including retrieval of valid data studies. 

Documentation of efficacy

To obtain approval of a biocidal product you must also document the efficacy of the product against the target organisms of your claim. Depending on the product type and the application type, different efficacy tests are required. 

We have extensive experience in evaluation of efficacy data and can assist you in the process of obtaining sufficient data, including study monitoring and compiling data in the final dossier.

Biocidal product families

Under the BPR you can obtain approval of several biocidal products in one single application and in this way save resources on both time and fees. This requires a large degree of similarity between the biocidal products in the family such as similar uses, same active substances and similar levels of risk and efficacy.

We can help you to determine if your product meets the requirements for approval of a biocidal product family and assist you in the best structural set-up of the family.

Data-gap analysis

Whether you want to submit an application for an active substance approval or a biocidal product authorisation, a large amount of data on the substance or product is required, including efficacy and toxicological data. You may have some of these data already. 

When you have decided on the type of application, we can help you get an overview of what data you need to complete the dossier for a successful application. If you need to produce new data, we can facilitate contact to relevant CROs.

Endocrine disruptors

To obtain authorisation, the application must include an assessment that eliminates possible endocrine disrupting properties of the biocidal active substance or of any non-active constituents in the product. This means that you must be able to document that the substance does not have an adverse effect in an intact organism due to an endocrine disrupting mode of action.

With our profound toxicological expertise, we can assist you in gathering, evaluating and putting together the data and information required to ascertain if the criteria are fulfilled.

No authorisation – no market

There is no way of sidestepping an authorisation if you want to stay on the market.

In this blog entry, biocidal regulatory expert Michael Fink explains why an authorisation application is such a huge task – and gives a couple of tips on where to begin.