Biocides and BPR Regulation (EU) 528/2012: Compliance and Regulatory Management

What is the BPR Regulation (EU) 528/2012

The Biocidal Products Regulation (BPR), formally Regulation (EU) No. 528/2012, is the European regulatory framework governing the placing on the market and use of biocidal products. It came into force on July 17, 2012, and has been in application since September 1, 2013. It replaced the previous Directive 98/8/EC (Biocidal Products Directive, BPD), introducing a harmonized system at European level for the approval of active substances and the authorization of biocidal products.

The aim of the BPR is to ensure a high level of protection for human health, animal health, and the environment, while ensuring the smooth functioning of the internal market. The regulation applies to biocidal products and the active substances they contain, covering a range of products from disinfectants to preservatives, from pest control to anti-fouling products.

The European Chemicals Agency (ECHA) plays a central role in the BPR, coordinating the scientific evaluation of active substances and providing technical support to the competent authorities of the Member States. The R4BP 3 (Register for Biocidal Products) IT system is the platform used for the submission and management of authorization applications.

The 22 Product Types (PT) of the BPR

The BPR classifies biocidal products into 22 product types (PTs), organized into 4 main groups. Correct identification of the PT is essential for determining the specific regulatory obligations, applicable authorization procedures, and efficacy requirements.

Group 1: Disinfectants (PT 1-5)

• PT 1 — Human hygiene: biocidal products for human hygiene, applied to the skin or scalp (excluding cosmetics and medicines)
• PT 2 — Disinfectants for private areas and public health: products for the disinfection of surfaces, materials, and equipment not used in direct contact with food or feed
• PT 3 — Veterinary hygiene: products for disinfection in the veterinary field (feeding troughs, stables, animal transport vehicles)
• PT 4 — Food and feed sector: products for the disinfection of equipment, surfaces, and pipes in contact with food or feed
• PT 5 — Drinking water: products for the disinfection of drinking water (for both human and animal use)

Group 2: Preservatives (PT 6-13)

• PT 6 — Preservatives for products during storage: preservation of packaged products (excluding food, feed, cosmetics, and medicines)
• PT 7 — Coatings preservatives: preservation of films, coatings, sealants, adhesives
• PT 8 — Wood preservatives: protection of wood against organisms that cause deterioration
• PT 9 — Preservatives for fibers, leather, rubber, and polymerized materials
• PT 10 — Preservatives for building materials: protection of masonry, composite materials
• PT 11 — Preservatives for liquids in cooling and processing systems
• PT 12 — Slimicides: prevention or control of slime on materials, equipment, and structures in industrial processes
• PT 13 — Preservatives for metalworking or cutting fluids

Group 3: Pest Control (PT 14-20)

• PT 14 — Rodenticides: control of mice, rats, and other rodents
• PT 15 — Avicides: control of birds
• PT 16 — Molluscicides, vermicides, and products against other invertebrates
• PT 17 — Piscicides: control of fish
• PT 18 — Insecticides, acaricides and products against other arthropods
• PT 19 — Repellents and attractants: control of harmful organisms by repulsion or attraction
• PT 20 — Control of other vertebrates

Group 4: Other Biocidal Products (PT 21-22)

• PT 21 — Antifouling products: control of the growth and settlement of fouling organisms on boats and aquatic equipment
• PT 22 — Embalming and taxidermy fluids

Approval of Active Substances

The BPR requires that an active substance must be approved at EU level before it can be used in a biocidal product. The approval process follows a rigorous procedure:

• Submission of the dossier — The applicant submits a complete dossier to the competent authority of an evaluating Member State (Competent Authority, CA) via the R4BP 3 system
• Member State evaluation — The evaluating competent authority prepares an evaluation report (Competent Authority Report, CAR) within 365 days
• ECHA evaluation — ECHA's Biocidal Products Committee (BPC) issues an opinion within 270 days
• Commission decision — The European Commission adopts an approval regulation, including the substance in the Union List (Art. 9) with specific conditions

Approved substances are listed in the Union List of approved active substances, which specifies for each substance the authorized product types, the conditions of approval, and the expiry date of the approval (maximum 10 years, renewable). The Review Program manages the evaluation of existing active substances inherited from the previous Directive 98/8/EC.

Authorization of Biocidal Products

Once the active substance has been approved, the biocidal product must be authorized before it can be placed on the market. The BPR provides for several authorization procedures:

National Authorization (Art. 17)

The standard procedure involves submitting an application to the competent authority of the Member State where the product is to be placed on the market. The evaluation includes efficacy, safety for human and animal health, environmental impact, and physicochemical properties.

Mutual Recognition (Articles 33-34)

A product authorized in one Member State can obtain recognition in other Member States through mutual recognition, either sequentially (Art. 33) or in parallel (Art. 34). This avoids duplication of assessments and speeds up access to European markets.

Union Authorization (Art. 41-46)

For certain types of products (PT 1, 2, 3, 4, 5, 18, and 19, with progressive extension to other PTs), it is possible to obtain a single authorization valid throughout the EU, issued by the European Commission on the advice of ECHA. This procedure ensures uniform conditions of use in all Member States.

Simplified Authorization (Art. 25-28)

For low-risk biocidal products containing only active substances included in Annex I of the BPR (low-risk active substances), a simplified procedure is provided. Products authorized under the simplified procedure can be placed on the market in all Member States without the need for mutual recognition.

Article 95 List and Access to Data

Article 95 of the BPR introduces a mechanism for data protection and fair sharing of costs. As of September 1, 2015, a biocidal product can only be placed on the market if the active substance/supplier combination is included in the Article 95 list for the relevant product type.

This means that:

• The supplier of the active substance must be included in the Article 95 list, or must have a Letter of Access from a supplier included in the list
• The person placing the product on the market must be able to demonstrate that the supply chain of the active substance is linked to a supplier on the Article 95 list
• ECHA publishes and regularly updates the Article 95 list on its website

kemXpro monitors the Article 95 list and automatically verifies that the suppliers of the biocidal active substances in your formulations are correctly listed.

SDS requirements for biocidal products

Biocidal products are subject to specific Safety Data Sheet (SDS) requirements. In addition to the standard requirements of the REACH Regulation (Annex II), SDSs for biocidal products must include:

• Biocidal product authorization number in Section 1
• Product type(s) (PT) and specific intended use as a biocide
• Active substance(s) with specific concentration and CAS/EC number
• Reference to the BPR in Section 15 (regulatory information)
• Authorization conditions relevant to safe use

kemXpro automatically generates compliant SDSs for biocidal products, integrating BPR information with CLP classification and REACH requirements.

CLP Classification of Biocidal Products

Biocidal products must be classified, labeled, and packaged in accordance with CLP Regulation (EC) 1272/2008. The CLP classification of biocides has specific features:

• Harmonized classification of active substances: many biocidal active substances have a harmonized classification in Annex VI of the CLP
• Efficacy data: toxicological data generated for BPR evaluation may influence CLP classification
• Specific labeling: in addition to CLP labeling, biocidal products must display specific information required by Art. 69 of the BPR (authorization number, identity of active substances, instructions for use, etc.)
• PCN notification: biocidal products classified as hazardous must be notified to poison centers in accordance with Regulation (EU) 2017/542 (Annex VIII of the CLP)

Treated articles: Obligations under Article 58 of the BPR

Article 58 of the BPR regulates treated articles, i.e., any substance, mixture, or article treated with or intentionally containing one or more biocidal products. The obligations include:

• Mandatory labeling when the manufacturer claims biocidal properties of the treated article (e.g., "antibacterial," "antifungal")
• Mandatory labeling when required by the conditions of approval of the active substance for the protection of human or animal health or the environment
• Information obligation: the consumer has the right to receive information on the biocidal treatment within 45 days of request
• Treated articles may only be placed on the market if the active substances used are approved for the relevant product type or are included in the review program

Biocidal management with kemXpro

kemXpro offers an integrated platform for biocide compliance management, linking BPR obligations with SDS management, CLP classification, and PCN notification:

• SDS generation for biocidal products — Compliant SDSs with automatic integration of BPR information (authorization number, PT, active substances, conditions of use)
• Automated CLP classification — Classification calculation according to CLP criteria, taking into account the harmonized classifications of biocidal active substances
• PCN notification — Generation and submission of notifications to ECHA poison centers for biocidal products classified as hazardous
• REACH monitoring for active substances — Verification of REACH compliance of active substances present in biocidal formulations
• Article 95 list monitoring — Automatic verification that active substance suppliers are correctly included in the Article 95 list
• Document management — Centralized storage of authorizations, SDSs, labels, dossiers, and regulatory correspondence

Transition from Directive 98/8/EC to BPR

The transition from the old Directive 98/8/EC to the BPR Regulation has brought about significant changes. Products authorized under the Directive benefited from transitional measures that allowed them to remain on the market during the review process for active substances. The Review Program, governed by Delegated Regulation (EU) No. 1062/2014, establishes the timetable and procedures for the systematic evaluation of all existing active substance/product type combinations. Substances that have not yet been evaluated remain subject to national legislation until their evaluation under the review program is completed.