Biocidal products are chemicals intended to destroy, control, or deter harmful organisms. These include products such as disinfectants, repellents, or protective formulations for surfaces that can directly negatively impact human health and the environment. Therefore, the EU regulation on biocidal products (Regulation BPR No. 528/2012) requires that each biocidal product is properly registered before being placed on the market.
When choosing the appropriate registration procedure, the status of active substances in the product is crucial.
When is notification possible?
Notification is a simplified procedure that is possible as long as the active substance in the product has not yet been officially approved at the EU level. This also applies if the substance is under evaluation and there is no available decision on inclusion in the list of approved substances.
In such a case, a company can notify its product to the competent authority and include it in the national register. In Slovenia, this is the Slovenian register of biocidal products. The product can be on the market in the country where the notification was made until the evaluation process of the active substance is completed.
Notification – time and costs
Duration of the process: usually 3–12 months, depending on the country
Costs: approximately 1,000–10,000 €, depending on the country and required documentation.
Conditions: the product must have appropriate efficacy data, safety data sheet, and proper labeling. The active substance must be from an “approved” supplier from the list of suppliers under Article 95 of the BPR Regulation.
!! Important: notification is valid only until the date when the active substance is approved. After this date, the manufacturer must start the authorization process within six months if they wish to continue marketing the product. !!
When is authorization required?
Authorization is a full approval of a biocidal product. This process is required either at the national level or for a unified EU authorization, but the status of active substances is decisive -> if all active substances in the product are already listed on the list of approved active substances, the product must not be placed on the market without proper authorization.
This means:
- the product must have a comprehensive risk assessment (efficacy, impact on humans, impact on the environment),
- must have a prepared IUCLID dossier with studies (official data structure),
- must have a PAR (Product Assessment Report) and SPC (Summary of Product Characteristics).
Authorization – time and costs
Duration of the process: due to the complexity, BPR prescribes a process that should not exceed 2 years, but in practice, it takes about 3–5 years, and in many cases up to 5–7 years if the documentation is incomplete or when additional clarifications or studies are needed.
Costs: very often estimated at around 150,000 € for one country, while EU authorization can cost 200,000–300,000 € or more, depending on the complexity of the product.
|
Criteria |
Notification |
Authorization |
Joining an existing authorization |
|
When is it used |
Active substance is not approved |
Active substance is approved |
Product is identical to an existing authorized biocide |
|
Source of active substance |
Supplier from the list under Article 95 BPR |
Supplier from the list under Article 95 BPR |
Supplier from the list under Article 95 BPR
|
|
Type of procedure |
Simplified |
Full risk assessment |
Adaptation of existing procedure |
|
Duration |
3–12 months |
3–5 years (in practice up to 5–7 years) |
3–6 months |
|
Costs |
1,000–10,000 € |
150,000–300,000 € |
1,000–5,000 € |
|
Scope of documentation |
Basic data on efficacy, safety data sheet, label |
IUCLID dossier, PAR, risk assessment, studies, SPC |
Adaptation of existing authorization, consent of the authorization holder |
|
Important |
Valid only until the active substance is approved |
Mandatory for the market when the active substance is approved |
Consent of the authorization holder and identical use |
What does this mean in practice?
If a product contains active substances that are not yet approved or are still under evaluation, it can only be marketed in the country where national registration is completed. This is a transitional period until the active substances are officially approved. In Slovenia, this registration process is called notification.
When the active substances become approved, it is necessary to start the authorization process within six months from the date of approval of the active substance if you want the product to remain on the market. This applies to cases where the product has already been notified.
If the product has not yet been notified, it can only be placed on the market once the authorization is completed.
If the product contains multiple active substances, each of them must be approved for authorisation to be possible.
Registration of biocides can be complex, but the status of active substances is key. If you understand it, you can correctly choose the appropriate path – notification or authorization – thereby optimizing time and costs for market entry while ensuring the legal and safe use of the product for users and the environment.
If you encounter difficulties, it is advisable to seek professional help, as mistakes in choosing the procedure can cause delays, additional costs, or even a ban on marketing the product.
The image below clearly illustrates when notification is required and when authorization is needed, based on the status of active substances in the product.
If you are unsure about the status of your active substances or the choice of the appropriate procedure, write to us at spela.hudobivnik@bens-consulting.eu and we will advise you on how to ensure the legal, safe, and effective presence of your biocidal product on the market.
bojan.dimic@bens-consulting.eu
Back to posts
