The placing of biocidal products on the European Union market is governed by one of the most demanding regulatory frameworks within the chemical sector: Regulation (EU) No 528/2012, commonly referred to as the BPR (Biocidal Products Regulation). This Regulation establishes the conditions under which a biocidal product may be authorised and legally placed on the European market, ensuring a high level of protection for human health, animal health, and the environment.
Registering a new biocidal product is not a simple administrative procedure. It involves a comprehensive assessment of the active substance, the formulated product, its efficacy, its risks, and its intended use. An incomplete or incorrect approach may lead to delays, requests for additional information, or even refusal of authorisation.
This article provides a structured overview of the key requirements for registering a new biocidal product under Regulation (EU) 528/2012, the main steps of the process, and the most common mistakes to avoid.
What Is A Biocidal Product Under The BPR
Before initiating any procedure, it is essential to confirm that the product falls within the legal definition of a biocidal product.
According to Regulation (EU) 528/2012, a biocidal product is any substance or mixture, in the form in which it is supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on harmful organisms by chemical or biological means.
The BPR classifies biocidal products into 22 Product Types (PTs), grouped into four main categories:
- Disinfectants
- Preservatives
- Pest control
- Other specialised biocidal products
Correctly identifying the Product Type (PT) is one of the first critical steps, as it determines data requirements, the type of evaluation, and the competent authority involved.
Regulatory Framework Applicable To Biocidal Product Registration
Regulation (EU) 528/2012 governs:
- Approval of active substances
- Authorisation of biocidal products
- Placing on the market and use of biocidal products
- Obligations of manufacturers, importers, and authorisation holders
One of the fundamental principles of the BPR is that no biocidal product may be placed on the EU market unless it has been authorised beforehand, except in very specific and transitional cases.
The Regulation applies directly in all Member States, although authorisation may be managed at national level, through mutual recognition, or via a Union authorisation.
Active Substance: The First Major Requirement
A biocidal product may only be authorised if all its active substances are approved for the corresponding Product Type.
Approved Active Substances
The active substance must be:
- Included in the list of approved active substances
- Specifically approved for the relevant PT
- Within the validity period of approval
If the active substance is not approved, the product cannot be authorised, unless a full active substance approval dossier is submitted, which involves a lengthy and costly process.
Review Programme
Many active substances are still included in the Review Programme, which allows, under certain conditions, the temporary placing on the market of products while the substance is being evaluated.
This situation requires close regulatory attention, as timelines and conditions may change.
Types Of Authorisation For Biocidal Products
The BPR provides for different authorisation routes:
National Authorisation
- Granted by the competent authority of a Member State
- Valid only in that country
This route is commonly used as a first step for new products.
Mutual Recognition
Allows extension of a national authorisation to other Member States:
- In parallel (simultaneous application)
- In sequence (after obtaining a national authorisation)
Union Authorisation
- A single authorisation valid throughout the EU
- Managed by ECHA
- Requires a particularly robust dossier
Not all Product Types are eligible for this route.
Authorisation Dossier: What Information Is Required
The dossier for a biocidal product is extensive and highly technical. It includes, among other elements:
Identity And Composition
- Qualitative and quantitative composition
- Chemical identity of the substances
- Relevant impurities
- Manufacturing method
Efficacy Assessment
Efficacy must be demonstrated in accordance with recognised European standards (for example, EN standards for disinfectants).
Studies must:
- Be representative of the intended use
- Justify concentrations and contact times
- Support the product claims
Human Health Risk Assessment
This includes assessment of:
- Exposure of professional and non-professional users
- Acute and chronic toxicity
- Risks via inhalation, dermal contact, or accidental ingestion
Environmental Risk Assessment
The impact of the product must be assessed for:
- Water
- Soil
- Air
- Non-target organisms
This section is often one of the most complex parts of the dossier.
Classification, Labelling, And Safety Data Sheets
The product must comply with:
- CLP Regulation (EC) No 1272/2008
- BPR-specific labelling requirements
- An up-to-date Safety Data Sheet
Evaluation Process In Biocidal Product Registration
Once the dossier has been submitted:
- The competent authority evaluates the documentation
- Requests for clarification or additional data may be issued
- A decision is taken to grant authorisation, grant authorisation with conditions, or refuse authorisation
The process may take several months or years, depending on the complexity of the product and the quality of the dossier.
Obligations After Authorisation
Authorisation is not the end of the process. The authorisation holder must:
- Strictly comply with the conditions of authorisation
- Keep documentation up to date
- Notify changes in composition or use
- Renew the authorisation before its expiry
- Comply with pharmacovigilance/biocidovigilance obligations
Common Mistakes In Biocidal Product Registration
Some of the most frequent mistakes include:
- Incorrect selection of the Product Type (PT)
- Underestimating the complexity of the dossier
- Efficacy studies not aligned with EN standards
- Lack of consistency between claims, labelling, and the dossier
- Failure to anticipate environmental requirements
These errors often result in significant delays and additional costs.
The Role Of SHAPYPRO In BPR Compliance
In a regulatory environment as demanding as the BPR, specialised technical support is essential.
SHAPYPRO supports companies through:
- Interpretation of Regulation (EU) 528/2012
- Definition of regulatory strategy
- Review of efficacy studies
- Technical support in proficiency testing programmes
- Preparation and review of technical documentation
This approach enables companies to address biocidal product registration with greater confidence, efficiency, and regulatory alignment.
Conclusion: Key Points In Biocidal Product Registration
Registering a new biocidal product under Regulation (EU) 528/2012 is a complex process that requires planning, technical expertise, and a thorough understanding of the regulatory framework. From active substance approval to final product authorisation, each stage demands scientific rigour and documentary consistency.
Companies that approach this process in a structured and proactive manner are better positioned to place their products on the European market in a legal, safe, and sustainable way.