What are they?
Biocidal products are substances or mixtures intended to control harmful organisms through chemical or biological action. They are used, for example, to disinfect, preserve materials, control insects, mites or rodents, repel organisms, or protect certain materials.
Biocidal products are not the same as plant protection products, although both fall within the broader field of pesticides. Plant protection products are mainly used to protect plants and plant products against harmful organisms, whereas biocidal products have other uses, such as disinfection, pest control, preservation of materials or treatment of certain systems.
The main regulatory framework in the European Union is Regulation (EU) No 528/2012, concerning the making available on the market and use of biocidal products (Biocidal Products Regulation, BPR). The Regulation establishes the conditions for the approval of active substances and the authorisation of biocidal products, with the aim of ensuring a high level of protection of human and animal health and the environment.
Biocidal products may contain active substances with hazardous properties for human health or the environment. Depending on their composition and the conditions of exposure, they may present risks such as acute toxicity, irritation or sensitisation, effects on specific target organs, reproductive toxicity, carcinogenicity, mutagenicity or hazards to the environment. Therefore, the fact that a biocidal product is authorised does not mean that it is harmless or that it can be used without preventive measures.
The assessment of active substances includes exclusion and substitution criteria. As a general principle, active substances that are carcinogenic, mutagenic or toxic for reproduction in categories 1A or 1B, endocrine disruptors, or persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances are not approved, although the Regulation provides for certain exceptions. Some active substances are also considered candidates for substitution, for which a comparative assessment with less hazardous alternatives must be carried out.
The Regulation establishes 22 product types (PTs), grouped into four main groups:
Group 1. Disinfectants
- PT 1. Human hygiene.
- PT 2. Disinfectants and algaecides not intended for direct application to humans or animals.
- PT 3. Veterinary hygiene.
- PT 4. Food and feed area.
- PT 5. Drinking water.
Group 2. Preservatives
- PT 6. Preservatives for products during storage.
- PT 7. Film preservatives.
- PT 8. Wood preservatives.
- PT 9. Fibre, leather, rubber and polymerised materials preservatives.
- PT 10. Construction material preservatives.
- PT 11. Preservatives for liquid-cooling and processing systems.
- PT 12. Slimicides.
- PT 13. Working or cutting fluid preservatives.
Group 3. Pest control
- PT 14. Rodenticides.
- PT 15. Avicides.
- PT 16. Molluscicides, vermicides and products to control other invertebrates.
- PT 17. Piscicides.
- PT 18. Insecticides, acaricides and products to control other arthropods.
- PT 19. Repellents and attractants.
- PT 20. Control of other vertebrates.
Group 4. Other biocidal products
- PT 21. Antifouling products.
- PT 22. Embalming and taxidermist fluids.
The classification by product type is important because the approval of an active substance is granted for a specific product type, and the authorisation of each biocidal product establishes the uses and conditions under which it may be used.
There are also treated articles, which are materials or articles to which biocidal products have been incorporated or which have been treated with them. Where these articles have biocidal properties or contain certain active substances, they may be subject to specific information and labelling requirements established by the Biocidal Products Regulation.
What should be done?
Check that the product is authorised and that it is used for the authorised purpose
As a general rule, a biocidal product cannot be placed on the market or used without the corresponding authorisation. Authorisation may be national, granted by the European Union, or obtained through other procedures provided for in the Regulation, such as mutual recognition or the simplified procedure. Certain transitional situations are provided for by the legislation, so the relevant official registers should be consulted.
Before using a biocidal product at work, check that:
- the product is authorised;
- the authorisation number corresponds to the product;
- the product type (PT) is appropriate;
- the intended use is included in the authorisation;
- the user category corresponds to the person carrying out the treatment;
- the doses, application methods, frequency, waiting periods, ventilation requirements and other conditions established in the authorisation and on the label are respected;
- the necessary information on hazards and preventive measures is available.
In Spain, the Official Register of Biocidal Products of the Ministry of Health can be consulted to search for authorised products, their registration or authorisation number, product type, user category, composition and other information.
The ECHA database can also be consulted. It contains information on authorised biocidal products in the European Union and allows searches by product, product type, active substance, authorisation number and authorisation status.
Prioritise elimination and substitution of the risk
The use of a biocidal product must be included in the workplace risk assessment. Royal Decree 374/2001 requires risks arising from the presence or use of hazardous chemical agents to be assessed, taking into account their properties, the quantities used, the type and duration of exposure, working conditions and possible accidental exposures.
Prevention should prioritise:
- Eliminating the use of the biocidal product whenever possible.
- Replacing it with another product or procedure presenting a lower risk, where technically possible.
- Reducing the quantities used and the number of people exposed.
- Using procedures and equipment that prevent or reduce the release of the product.
- Applying collective protective measures, particularly at the source of the risk.
- Using personal protective equipment where the measures above are not sufficient.
Royal Decree 374/2001 expressly establishes that substitution with another agent or process that is not hazardous, or is less hazardous, should be the preferred option whenever possible.
Substitution is particularly important when the biocidal product contains an active substance that is a candidate for substitution or has properties of particular concern. The Biocidal Products Regulation requires a comparative assessment of such substances against other biocidal products or non-chemical control methods.
Always consult the label and the Safety Data Sheet
The label must provide essential information about the product, including:
- identity and concentration of the active substances;
- authorisation number;
- authorisation holder;
- formulation type;
- authorised uses;
- instructions for use, frequency and dosage;
- possible adverse effects and first-aid measures;
- storage conditions;
- instructions for disposal;
- batch number and expiry date;
- waiting periods and, where applicable, ventilation periods and conditions for re-entry into treated areas;
- precautions during use and transport;
- authorised user category or categories;
- specific hazards to the environment, where applicable.
The label must not mislead users about the risks of the product and must not contain expressions such as “low-risk biocidal product”, “non-toxic”, “harmless” or similar expressions.
Biocidal products must also comply, where applicable, with the classification, labelling and packaging requirements established by the CLP Regulation. The current consolidated version of the CLP Regulation should be consulted.
Safety Data Sheets (SDSs) provide information on hazards, preventive measures, first aid, storage, exposure control, disposal and action in the event of an accident. The Biocidal Products Regulation establishes that SDSs for active substances and biocidal products must be prepared and made available in accordance with REACH where applicable.
The employer must have the information necessary to carry out the risk assessment. Workers must receive the information and training necessary to use products safely and to understand the applicable risks and preventive measures.
Pay particular attention to exposure during application
Risks depend not only on the intrinsic hazard of the biocidal product but also on how it is used. Particular attention should be paid to operations that may result in higher exposure, such as:
- spraying or fogging;
- applications in enclosed spaces;
- preparation and dilution of concentrates;
- transfer operations;
- cleaning of equipment;
- maintenance of application equipment;
- removal of waste and containers;
- handling surfaces or materials that have recently been treated;
- spills or accidents.
The assessment must also consider maintenance, repair and cleaning tasks that may result in significant exposure, even when these are not part of the routine application of the product.
Preventive measures must be adapted to the specific product and application. It should not be assumed that a measure such as wearing gloves or a respirator is sufficient on its own: elimination, substitution and collective protective measures identified in the risk assessment must be applied first.
Take reproductive health and the gender perspective into account
The risk assessment should consider possible differences in exposure and health effects between women and men. The INSST indicates that a gender-sensitive risk assessment should take into account possible biological differences in the severity of the effects of chemical agents, as well as possible differences in exposure arising from the organisation and distribution of tasks.
Particular attention should be paid to possible effects on fertility and reproductive function, both in women and men. Law 31/1995 establishes that the assessment must take into account risk factors that may affect reproductive function and fertility or the development of offspring.
Special attention should also be paid to pregnancy, recent childbirth and breastfeeding where the product or activity may pose a risk. The assessment must determine the nature, degree and duration of exposure and, where a risk exists, the necessary measures must be adopted to prevent exposure.
The gender perspective should not be limited to maternity protection. It should be incorporated into the overall risk assessment, avoiding the assumption that women and men perform the same tasks or are exposed in the same way.
In the event of non-compliance
If an unauthorised product, use other than the authorised use, incorrect labelling, lack of safety information or any other situation that may put workers’ health at risk is identified, it should be reported to the employer and to the workers’ legal representatives or trade union representatives, where applicable.
Where necessary, the situation may be brought to the attention of the competent authority responsible for health, public health or occupational safety and health, depending on the nature of the non-compliance.
In Spain, responsibilities and powers relating to biocidal products are distributed among different public administrations. The Ministry of Health maintains the Official Register of Biocidal Products and provides information on authorisation and control procedures.
Guidance and reference sources
• INSST. Technical Guide for the assessment and prevention of risks related to chemical agents present in workplaces. 2022 edition. Provides criteria for assessing and preventing risks arising from the presence and use of chemical agents at work.
• INSST. Frequently Asked Technical Questions on Gender. Includes criteria for incorporating the gender perspective into risk assessment, particularly in relation to chemical agents, reproductive health, pregnancy and breastfeeding.
• ECHA. Information on biocidal products. Provides information on authorised biocidal products in the European Union and their authorisation conditions.
• ECHA. Biocidal active substances. Allows users to check the approval status of active substances and their relationship with the different product types.
• Ministry of Health. Official Register of Biocidal Products. Allows users to check products registered or authorised in Spain, their composition, uses and user categories.
Legislation
• Regulation (EU) No 528/2012, concerning the making available on the market and use of biocidal products (Biocidal Products Regulation, BPR). Consolidated text in force as of 15 June 2026.
• Regulation (EC) No 1272/2008 (CLP), on classification, labelling and packaging of substances and mixtures. Consult the current consolidated version.
• Regulation (EC) No 1907/2006 (REACH), concerning the registration, evaluation, authorisation and restriction of chemicals. Consolidated text updated in 2026.
• Law 31/1995 of 8 November, on Occupational Risk Prevention. Consolidated text with last update published on 9 April 2026.
• Law 31/1995 on Occupational Risk Prevention — BOE.
• Royal Decree 374/2001 of 6 April, on the protection of the health and safety of workers against risks related to chemical agents at work. Current consolidated text.
• Royal Decree 830/2010 of 25 June, establishing the regulatory framework for training and qualifications required to carry out treatments with biocidal products. Consolidated text.
Last updated: August 2026.