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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.
Tel.: +45 4516 9156
mif@dhigroup.com
Tel.: +45 4516 9088
dna@dhigroup.com
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.
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 included in Annex 1.
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.
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.
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.
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.
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 physical-chemical 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.
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.
Read the blog post "No authorisation – no market: Mandatory biocidal regulation puts pressure on industry"
For a full application in compliance with the BPR, several key documents are required for submission:
We have wide experience in all elements of the final application and can provide you with advice, review or completion of documents for a successful application.
For a successful application, good communication with the CA to which you submit your application is essential. During the phase of preparing the final dossier, several questions may arise. The chance of an affirmative and faster evaluation increases when you have clarified as many issues as possible with the CA before submission.
We have contact points with each EU member state authority with whom we have collaborated on various projects and BPR authorisations. These include contacts with the Danish EPA, KemI (Sweden), Ctbg (the Netherlands) and BAuA (Germany).
DHI provided significant support to us in connection with registration of a product under the EU Biocidal Products Regulation. They did the toxicological analysis of our product, and their report was of great help to us in obtaining approval from the Danish Environmental Protection Agency (EPA). DHI also provided considerable assistance in answering extensive questions from the EPA during their evaluation of our application.
Carl G Bechgaard, M.Sc., Managing Director; KRS ApS
If you are a small or medium-sized enterprise (SME) you might consider joining a consortium, which is a cost-efficient way of obtaining authorisation of biocidal products and product families.
In a consortium, you share the costs and benefits related to an authorisation. At the same time, you can still obtain authorisation of own products based on the principle of the biocidal product family concept. In this way you can maintain individual product authorisations independently of a consortium. Both producers, distributors, suppliers and formulators placing biocidal products on the market can participate in consortia.
We have successfully assisted industry clients in obtaining authorisation of biocidal products and biocidal product families through the consortia approach. We also set up and facilitate consortia.
In-situ generated biocidal active substances are active substance generated on site. This includes biocidal processes within all kinds of disinfection and requires documentation of precursors, active substances and by-products.
We have extensive experience in compiling data sets for in-situ generated active substances and in performing risk assessments. We can help you with evaluation of active substances both with regard to the pure active substance and the technical active substance.
DHI functioned as regulatory adviser for the ECA Consortium. This included performance of data gap analysis and preparation of a complete dossier on in-situ generated biocidal active substances containing more than 500 endpoints. Read more.
The ECA Consortium has been very impressed with DHI’s expertise and professionalism. Reports and dossier work were delivered on time with a high quality and within very short deadlines. DHI has been the key contributor in getting members of the ECA Consortium listed as approved biocidal active suppliers.
Peter Madsen, Chairman, ECA Consortium
