Biocidal products have to be registered at the competent authorities before they can be placed on the market.
There are two possible procedures to register a biocidal product, namely:
- Notification
- Authorization
What are the differences between these procedures?
PROCEDURE SELECTION
It all starts with your formulation and especially with the active substances! In order to be able to choose the appropriate registration procedure, we must first check which active substances we have in the formulation and what is the approval status of these active substances.
What are the possible scenarios?
The active substance may be under evaluation or already approved. The approval status of active substances directly affects the registration process:
- If the active substance is still in the evaluation phase, then you can only submit an application for notification of the biocidal product. This counts as a transitional period.
- If the active substance is already approved, you can submit an application for authorization. In the case of mixtures containing two or more active substances, you can apply for authorization only when all active substances in your product have been approved.
REQUIRED DOCUMENTATION
- For notification, the required documentation differs significantly based on country. Some countries only require appropriate safety data sheets and product labels. Some other countries, however, require a much more extensive dossier, which usually also includes efficacy trials, declarations of compliance with Article 95 of the BPR regulation, information on composition and packaging, and a completed application form.
- For authorization, the documentation requirements are uniform for all countries in the EU and include a very extensive dossier together with all declarations of conformity and access, studies (efficacy, physico-chemical properties, stability, toxicity and analytical methods), risk assessments for the environment, health human and endocrine properties. All these documents must be combined into a IUCLID dossier and drafts of the product assessment report PAR and the summary of product characteristics SPC must also be provided.
PROCEDURE DURATION
- In the case of notification in different EU member states, the procedures last from a few weeks to a year. The average duration of the procedure is around 4 months. You can find more about the duration of this type of registration in different countries on the following blog post.
- In the case of authorization, the duration of the procedure is defined by the regulation and should not exceed 2 years. In practice, unfortunately, the procedures take much longer. On average, somewhere around 4 years. In exceptional cases, if the documentation is inadequate, the duration of the authorization process can even exceed 7 YEARS! Ouch!
COSTS
- Notification costs vary significantly based on country. From 0 € to few 1,000 €. On average, the cost is around 1,000 €.
- In the case of authorization, the total cost for one such authorization of a biocidal product is approximately 150,000 € for an individual country or ca. 300,000 € for the entire EU. Costs between countries are much more comparable.
If you need help with biocidal products registrations or have any other questions related to biocidal products, safety data sheets or PCN notification, you can contact me at tim.bencik@bens-consulting.eu.
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