Term and definition of biocidal products
Biocidal products are substances or mixtures intended to destroy, render harmless, prevent the effects of, or otherwise combat harmful organisms by means other than mere physical or mechanical action. The legal basis for the classification, placing on the market and use of biocidal products in the European Union is Regulation (EU) No. 528/2012 (Biocidal Products Regulation – BPR), which has been in force since 1 September 2013.
Biocidal products cover a wide range of products, including disinfectants, pest control agents, wood preservatives, preservatives, and many other substance classes.
Regulatory framework: The Biocidal Products Regulation (BPR)
Objectives and scope
The Biocidal Products Regulation (EU) No. 528/2012 governs the placing on the market and use of biocidal products in the EU internal market. The Regulation aims to ensure both the protection of humans, animals, and the environment from the risks that may arise from the use of these products, and to guarantee a functioning European market for biocidal products.
The regulations cover
- Finished biocidal products and treated articles,
- the manufacturing and distribution chain,
- as well as the use of these products.
Products already falling under specific provisions of other EU legislation, such as pharmaceuticals or plant protection products, are not covered.
Definitions and distinctions
Biocidal product
According to Article 3 paragraph 1(a) of the BPR, a biocidal product is any substance or mixture containing or generating one or more active substances, intended to destroy, deter, render harmless, or control harmful organisms by chemical or biological means.
Harmful organism
A harmful organism is any living being, including harmful microorganisms, that adversely affects the health of humans, animals, or natural or manufactured objects/energy.
Active substance
An active substance within the meaning of the BPR is any substance or microorganism, including viruses or fungi, that exerts an effect on harmful organisms.
Product types
The BPR classifies biocidal products into four main groups with a total of 22 product types (see Annex V of the Regulation):
- Disinfectants,
- Preservatives,
- Pest control products,
- Other biocidal products (e.g. antifouling products).
Each product type is subject to specific authorisation requirements and restrictions on use.
Authorisation and approval procedures
Approval of active substances
Before a biocidal product may be authorised, the active substance it contains must first be approved at EU level. Approval is granted following a comprehensive assessment by the European Chemicals Agency (ECHA), which in particular considers the effects on the health of humans and animals and on the environment.
Authorisation of biocidal products
National authorisation
The authorisation of a biocidal product is generally carried out at national level by the competent authority of the respective Member State. Extensive application documentation must be submitted, including data on efficacy, physicochemical properties, toxicological and ecotoxicological risks, and proposals for conditions of use.
Union authorisation
Alternatively, it is possible to obtain EU-wide (Union) authorisation for a biocidal product, if the product is to be made available and used in all Member States. Union authorisation is granted centrally by the European Commission.
Mutual recognition
A biocidal product authorised in one Member State may, upon application, also be recognised in other Member States, provided there are no specific national objections.
Requirements for products and labelling
Biocidal products may only be placed on the market or used if they are duly authorised. They must
- have the stated efficacy,
- cause no unacceptable risks to humans, animals, or the environment,
- be correctly labelled and packaged.
Labelling is subject to strict requirements (Art. 69 BPR) and must, among other things, include the identity of all active substances, intended uses, risk warnings, and conditions of use.
Obligations and responsibilities of market participants
Manufacturers and importers
Manufacturers and importers are obliged to place only authorised products on the market and to ensure compliance with all regulatory requirements. This includes notifications to authorities, regular monitoring, and the immediate reporting of incidents to the competent bodies.
Users and distributors
Users and distributors must observe the provisions of the Biocidal Products Regulation. Applications may only be carried out in accordance with the authorisation and specified conditions of use. Violations may lead to extensive market surveillance measures or recalls.
Notification obligations
Market participants are required to report certain data, including
- Sales and usage data,
- Adverse effects,
- Recalls and other safety-related incidents.
Special provisions: Treated articles
Treated articles are products, substances or mixtures that have been treated with or contain one or more biocidal products. They are subject to special labelling requirements and restrictions if the active substance used in the article is not approved in the EU (Art. 58 BPR).
Supervision and sanctions
Market surveillance is carried out at national level by the competent authorities. Sanctions for violations range from withdrawal or prohibition of placing on the market to substantial fines and criminal sanctions.
Relationship to other legal regulations
Biocidal products are subject to further overarching regulations, in particular
- the CLP Regulation (Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures),
- the REACH Regulation (Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals).
In many cases, a biocidal product must comply with these regulations at the same time.
Summary and outlook
Biocidal products are a particularly regulated product group with numerous requirements in terms of authorisation, labelling, distribution, and use. The aim of the comprehensive European legal framework is to provide a balanced level of protection for humans, animals, and the environment, while ensuring the availability of effective biocidal products. The continuously evolving legal situation requires ongoing monitoring and adaptation in manufacturing, distribution, and use.
Frequently asked questions
What legal requirements apply to the placing on the market of biocidal products in the European Union?
The rules of Regulation (EU) No. 528/2012 on the making available on the market and use of biocidal products (Biocidal Products Regulation, BPR) apply to the placing on the market of biocidal products within the European Union. A key legal requirement is that a biocidal product must obtain either a national authorisation from an EU Member State or a Union authorisation under the BPR prior to being placed on the market for the first time. In addition, all active substances contained in the product must have been approved for the relevant product type or be under review. Comprehensive dossiers must be submitted for authorisation applications, in particular with information on efficacy, safety for humans, animals and the environment, shelf life and labelling requirements. There are also specific requirements for labelling, packaging, traceability, and, if applicable, advertising claims. Companies are also required to report all significant changes retrospectively and are subject to periodic reporting obligations to the competent authorities.
Who is responsible for the legal authorisation and supervision of biocidal products?
Responsibility for the authorisation and supervision of biocidal products in the EU initially lies with the national authorities of the respective Member States (in Germany, for example, the Federal Institute for Occupational Safety and Health, BAuA). For Union authorisations, the European Chemicals Agency (ECHA), in cooperation with the European Commission and the competent authorities of the Member States, is the lead authority. As part of market surveillance, the competent authorities regularly check whether biocidal products are lawfully authorised and labelled in accordance with the applicable regulations, and whether advertising and distribution comply with statutory requirements. Violations are subject to corresponding sanctions.
What obligations arise for manufacturers and distributors of biocidal products under the Biocidal Products Regulation?
Manufacturers and distributors of biocidal products are legally obliged to place on the market only authorised or registered active substances and products. They must ensure that products are appropriately labelled, particularly regarding active substances, warnings, instructions for use, and restrictions on use. Furthermore, preparation of a safety data sheet in the official language of the Member State where the product is placed on the market is mandatory. There is a duty to report serious incidents arising from use. Product advertising that makes false or misleading statements regarding risks, efficacy, or possible treatments is prohibited under Art. 72 BPR. Any changes in the product or manufacturing process must be reported to authorities immediately.
What does the active substance approval procedure within the meaning of the Biocidal Products Regulation entail?
The active substance approval procedure is a central element of the Biocidal Products Regulation. It requires that any active substance in a biocidal product must first be approved at European level before the product itself can be authorised. Comprehensive scientific data on efficacy, toxicity, environmental properties, and exposure scenarios must be submitted for approval. Evaluation is carried out by a rapporteur Member State, followed by risk assessment by ECHA. Only once the active substance has been approved for the relevant product type can a corresponding biocidal product be submitted for authorisation.
How must biocidal products be labelled and what legal information is mandatory?
The labelling of biocidal products is comprehensive and subject to strict legal requirements under Art. 69 BPR. Among other things, the product name, authorisation number, name and address of the authorisation holder, type and concentration of included active substances, as well as all relevant hazard statements, safety instructions, and user restrictions must be provided. Additional information includes instructions on risks to humans, animals and the environment and clear directions for the safe and appropriate use in the authorised areas of application. Misleading statements such as “harmless”, “non-toxic”, “natural”, or similar unfounded claims that could trivialise the product’s risks are not permitted.
What sanctions are imposed for breaches of biocidal law?
In the event of unlawful placing on the market or violations of the provisions of the Biocidal Products Regulation, varying levels of sanctions may apply, depending on the severity and relevant national laws. In Germany, the Chemicals Act (ChemG) in particular governs criminal and administrative offences in connection with unauthorised placing on the market, failure to observe notification and labelling requirements, incorrect advertising, and incorrect information to authorities. Sanctions can range from fines of up to tens of thousands of euros and bans on distribution to criminal penalties, for example if breaches of regulations create risks for humans or the environment.
In which cases is an exemption from the authorisation requirement for biocidal products possible?
Biocidal law provides for exemptions from the authorisation requirement in certain narrowly defined situations. For example, Article 55 BPR allows, in emergency situations, exemptions for the temporary provision of non-approved active substances or products, for instance in the event of novel pests or infectious diseases when there are no suitable alternatives. Temporary exemptions are granted at national level, are time-limited, and require subsequent assessment of the risk by the relevant authorities. Outside such exemptions, products may not lawfully be placed on the market without authorisation.
