Authorization of biocidal products in Europe
After active substance approval, each biocidal product containing that substance must gain authorization. There are multiple routes for biocidal product authorization in Europe:
- National authorization: this clears a product for sale in a single EU/EEA country
- National authorization with mutual recognition:
- in parallel: where a product authorization submission is made to multiple EU/EEA countries at the same time
- in sequence: where once a product receives authorization in one EU/EEA country, you can apply for this to be recognized by other countries
- Union authorization: this allows the biocidal product access to all EU/EEA countries
Each of these routes has different complexities and timelines. However, depending on your product, additional routes with a simplified administrative burden may be available:
- Simplified authorization is appropriate for biocidal products that meet all the criteria specified in Article 25 of the BPR. For example, the active substance must be listed within Annex I of the BPR and the product must not contain substances of concern
- Same biocidal product authorization is possible if you can show that your product is the same as one already on the market
By grouping products together as a biocidal product family, you can apply for authorization of multiple biocidal products within one submission (all products must contain the same active substance, but they can appear at different concentrations).
As your partner, Covance can help you navigate the administrative and technical burden of biocidal product authorization.
- Vast experience submitting biocidal product authorizations across Europe
- Proactive engagement with regulators enhances the efficiency and cost effectiveness of the authorization process
- Established record of biocidal product authorizations for multiple product families following national and union authorization approaches
Finding the best way through BPR product authorization can be complex and time consuming
There are many considerations as you plan the best way to get your biocidal products authorized. What is the optimum route to take and what are the implications on time to market? Can you simplify applications by using the product family approach? How many products and different uses can be grouped under the same authorization without slowing the process? What safety and efficacy endpoints have you got data for and what is missing? How can you fill those data gaps? How can you keep up with the administrative and technical requirements of the submission process?
A strategic, proactive approach helps achieve BPR product authorization success
Our goal is to ensure a smooth, efficient and straightforward authorization of your product. This is achieved by combining excellence in data analysis with regulatory insight and expertise and a focus on detail. Whether you are using our own world-leading testing laboratories for data generation or providing your own data, we can help plot your route. Starting with a strategic review of your plans, we can advise on the most suitable authorization route and evaluating member state (where appropriate). To smooth the authorization journey, we always conduct pre-submission meetings with the regulator to understand specific requirements and resolve potential problems early.
Services Covance undertake for BPR product authorization include:
- Evaluation of product type and uses
- Data gap analysis
- Identifying testing strategies for missing endpoints, taking into consideration the use of read-across where possible
- Defining and structuring product families
- Biocidal efficacy testing
- A full range of physicochemical properties testing, including storage stability studies
- Preparation of ED assessments for both active substances and co-formulants
- IUCLID dossier preparation
- Preparation of dPAR including human health and environmental exposure modeling
- Identifying substances of concern
- Summary of Product Characteristics preparation
- R4BP support and submission
Your advocate, managing your submission through evaluation
After dossier submission to R4BP, many time-sensitive administrative steps follow. Our team manages all administrative and project management requirements of authorization which can differ depending on the route you take. Technical questions are also common, so our regulatory scientists are skilled at advocating for your products and defending the scientific basis for each submission.