Before a biocidal product can be authorized, you need to ensure that the active substance within the biocidal product has been approved for use under the BPR. Once an active substance is approved, you have approximately two years in which to authorize biocidal products containing that active substance. If your product has more than one active substance, the date of approval of the last active substance sets the 24-month count down.
There are many time-consuming activities when meeting the requirements of the BPR, and different authorization approaches which makes long-term planning essential.
7 steps to biocidal product authorization
1. Establish uses:
It's important to gather product use information early in the process, so you can determine your efficacy data requirements – this can be more time consuming than anticipated as you may be reliant on downstream user input.2. Data gap analysis:
Assess the data currently available. As part of this, establish product usage to help us understand the kinds of efficacy claims or safety considerations that need taking into account.
3. Biocidal product family:If there are multiple products containing the same active substance, it makes sense to submit them as a biocidal product family. A biocidal product family consists of multiple products with different concentrations of the same active substance; the biocidal products within the family will be split into sub-groups known as Meta SPCs. You need to plan your testing strategy by identifying the most appropriate product to use for different tests – i.e., the ‘worst-case’ products. Testing the worst-case product is important as this enables the use of read across to the remaining products within the biocidal product family and limiting the amount of testing required. For example, you would use a product with a high concentration of active substance for any physicochemical or safety testing, but a product with a low concentration for efficacy testing, as the lower the concentration of active substance, the less likely the product is to be efficacious.
4. Outline the testing plan:
The results from the data gap analysis and structuring of the biocidal product family helps define the testing strategy.
5. Testing and dossier preparation:These can run in parallel, as many aspects of dossier preparation can be carried out before test results are available; in addition, some tests take a long time to complete.
6. Risk assessments and summary of product characteristics (SPC):The risk assessment relates to the product use, and requires the creation of possible exposure scenarios, including their risk to human and animal health and the environment. The SPC provides a summary of the product profile, including efficacy and safety information. The SPC needs to be available in multiple languages, so allow time for translation and checking.
7. Dossier finalization and submission:Dossiers are finalized and created in IUCLID, exported and submitted via the R4BP portal.
Testing the worst-case product is important as this enables the use of read across and limiting the amount of testing required
You can find an infographic outlining the Envigo timeline for biocidal product authorization here.
What happens after submission?
What happens after submission depends on the authorization approach you are following. Regardless of the approach, once your dossier has been submitted you need to be ready to act swiftly, as many of the next steps in the evaluation process are time-limited. Below is an example of the steps in the process for mutual recognition in parallel (Article 34 of BPR).
- Pay the invoice: you have 30 days to pay the cost of the submission
- Verification check: within 30 days of your submission, your dossier will be checked to ensure all the required information is included. With national authorization, we’ve found the duration and extent of this step can vary from competent authority to competent authority. If the verification identifies that information is missing, the registrant has 90 days to fill in the gaps
- Evaluation: this should take 365 days, but there is a 180 day ‘stop the clock’ facility that allows you to respond to any additional questions. During this period the evaluating competent authority (eCA) prepares a report to summarise its conclusions
- Draft report: this outlines the initial conclusions on product authorization. You have 30 days to comment on this report – review this carefully to catch and flag-up any possible issues
- Final authorization: For cases where mutual recognition in parallel has been applied, all Member States involved have 90 days to agree on the contents of the SPC file. After 30 days of reaching an agreement, each member State should authorize the biocidal product(s) and final authorisation should be granted
On authorization of a biocidal product, ECHA makes the terms and conditions of the authorization, a summary of the product’s characteristics and the analytical methods used available to the public.
Getting your product through BPR requires long-term planning, insight into the regulatory requirement and a constant focus on reaching your end goal.
For further information on BPR read our 'Forging a path through biocide regulation article.'
About the author
David’s main focus and area of expertise is biocides regulations, including regulatory advice and strategy. The latter often involves preparing documents such as data gap analysis, or setting up and identifying the format of product families.
- Regulatory advice and support
- Biocides regulations
- Regulatory strategy including data gap analysis and product families
- Product authorizations (BPR)
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