What is Biocidal Product Authorisation?
Biocidal product authorisation refers to the legal approval required for the placing on the market and use of biocidal products. The aim of biocidal product authorisation is to ensure that only products which are effective and pose no unacceptable risks to human health, animal health, or the environment are placed on the market and used within the EU.
Navigating the regulatory landscape of biocidal product authorisation under the EU Biocidal Products Regulation (BPR) [Regulation (EU) No 528/2012] requires expertise and strategic planning.
Our Biocidal Product Authorisation Service ensures that your products comply with EU regulations and obtain the necessary approvals for market entry.
Who Needs a Biocidal Product Authorisation?
- Manufacturers of biocidal products
- Importers & representatives placing biocides on the EU market
- Companies with biocidal-treated articles
Biocidal Product Authorisation Procedures
Under the EU Biocidal Products Regulation, different authorisation routes exist to ensure that biocidal products are safe and effective before being placed on the market. The appropriate authorisation type depends on factors such as the intended use, the number of Member States involved, and whether the product meets certain criteria. The following authorisation types may apply:
- National Authorisation (NA) – Approval granted for marketing a biocidal product in a specific EU Member State.
- Mutual Recognition (MRP & RUP) – Extension of an existing national authorisation to other Member States.
- Union Authorisation (UA) – A single application grants approval for marketing across the entire EU.
- Simplified Authorisation – For biocidal products meeting specific low-risk criteria (e.g. no substances of concern, sufficient efficacy, etc.).
Biocidal Product Authorisation Process
The authorisation process differs depending on the type and scope of the authorisation. The table below summarizes the main pathways:
Authorisation Type | Process | Focus Area | Validity |
National Authorisation (NA) | The applicant submits a comprehensive dossier to the competent authority of an individual EU Member State. The authority assesses the product’s compliance with BPR requirements. If approved, the authorisation is valid only in that Member State. | National market access; local risk-benefit assessment. | Valid only in the Member State where authorisation was granted. |
Mutual Recognition – MRP & RUP | The applicant submits the national authorisation and assessment report to other Member States. • MRP (Mutual Recognition in Parallel): done at the same time as national evaluation. • MRS (Mutual Recognition in Sequence): done after national approval. | Facilitating access to multiple Member States based on existing authorisation. | Valid in all Member States that accept the mutual recognition. |
Union Authorisation (UA) | A single application is submitted via ECHA. The evaluating competent authority prepares an assessment report which is reviewed by ECHA and approved by the European Commission. Covers defined product types and uses across the EU. | Centralised authorisation for full EU market access. | Valid in all EU/EEA Member States simultaneously. |
Simplified Authorisation | Applies to products that meet specific low-risk criteria (e.g. no substances of concern, sufficient efficacy, low toxicity). The dossier is evaluated by a single Member State. | Facilitating market access for low-risk products. | Valid in the issuing Member State; can be extended via mutual recognition to other countries. |
Authorise Your Biocidal Products with Chemleg Experts
Our Biocidal Product Authorisation Services within the EU include:
- Regulatory Strategy & Planning – The most appropriate authorisation route (NA, MRP/MRS, UA, or SA) is selected based on product type, use pattern, and active substance status.
- Dossier Preparation & Submission – A complete dossier is compiled in accordance with Annex II and III of the BPR, including technical, toxicological, ecotoxicological, and efficacy data, and submitted via R4BP 3.
- Active Substance Compliance – The active substance must be approved and the supplier must be listed on the Article 95 list.
- Risk & Efficacy Assessment – All required studies and expert evaluations are conducted to assess human health, environmental risks, and product efficacy, in line with ECHA guidance.
- Label & SDS Compliance – Product labels and Safety Data Sheets must comply with EU BPR as well as CLP and REACH requirements.
• Authority Communication & Follow-Up – Communication with ECHA and national competent authorities is managed throughout the process, ensuring timely responses to requests and compliance with post-authorisation obligations.
Why Choose Us?
- Expert Regulatory Knowledge – Years of hands-on experience with BPR compliance
- End-to-End Support – From initial strategy to final authorisation
- Time & Cost Efficiency – Minimising delays and avoiding unnecessary costs
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Frequently Asked Questions
Why is biocidal product authorisation required?
As per the regulation, biocidal products must be authorised before being placed on the market to ensure they pose no unacceptable risk to human, animal, or environmental health.
Can a product be authorised without active substance approval?
No, all active substances used in biocidal products must be approved before the product can be authorised.
Can I authorise my biocidal product myself?
While it is legally possible to authorise your biocidal product independently, the process demands extensive technical documentation, regulatory knowledge, and effective project management. Engaging professional consultancy can offer a strategic advantage and ensure compliance.
