Regulation (EU) No 528/2012 harmonises the rules in the European Union (EU) concerning the sale and use of biocidal products1, while ensuring high levels of protection of human and animal health, and of the environment.
KEY POINTS
Active substance approval
In order to be allowed to be sold in the EU, all biocidal products require an authorisation. The active substances that they contain must be approved or included in Annex I to the regulation.
The evaluation of biocidal active substances is carried out at the EU level. For each active substance that needs to be evaluated, an interested company (or group of companies) submits an application to an ‘evaluating’ EU Member State. The evaluating Member State is responsible for producing an assessment report, which is peer-reviewed by the other Member State representatives within the Biocidal Products Committee of the European Chemicals Agency (ECHA). The Biocidal Products Committee prepares an opinion of the agency, which is the basis for the European Commission’s decision to approve (or not approve) the substance.
Active substances that meet the exclusion criteria are not approved. These are substances that are:
the risks from exposure to the substance are negligible;
the substance is essential in preventing or controlling a serious danger to human health, animal health or the environment; or
non-approval would cause a disproportionate negative effect on society when compared to the effects caused by the use of the active substance.
The risks associated with nanomaterial biocides6 must be specifically assessed.
The approval of an active substance is granted for a period not exceeding 10 years.
Approved active substances are listed on the ECHA website.
Product authorisation
Once an active substance is approved, companies must apply for permission to place their products on the market in one of the following ways.
By submitting a request for EU authorisation to the ECHA, if the company is interested in marketing it in the entire EU. If the product is deemed safe following the assessment by a competent evaluating authority of a Member State and the granting of an authorisation by the Commission, it can be sold directly throughout the EU without the need to obtain specific national authorisation. A guidance document has been adopted by the Commission to further explain the eligibility criteria for the EU authorisation procedure for products.
By submitting a request for national authorisation, or for national authorisation by mutual recognition procedure in parallel, if the product is to be sold in one or several Member States. If an authorisation is granted, companies wishing to place the same product on the market of other additional Member States can apply for the principle of mutual recognition of the authorisation of the product in these other Member States.
There is also a simplified authorisation procedure for the least harmful products that meet specific conditions (contain no substances of concern, no nanomaterials or are sufficiently effective and their handling does not require the use of personal protective equipment).
By way of exception, biocidal products containing active substances that were already on the market in May 2000 and that are included in the work programme for the examination of existing biocidal active substances can be made available on the market and used in accordance with the national laws of each Member State, pending the final decision on the approval of the active substance(s) they contain.
Data sharing
To minimise costs and the use of animal testing, the regulation requires the sharing of data on approved substances and products authorised in the EU. The agency has set up an information system (register for biocidal products) that contains all the information on applications, assessments and authorisations or approvals.
Treated articles
The regulation covers articles that have been treated with or incorporate a biocidal product (such as furniture and paints). Treated articles can only be treated with active substances that have been approved in the EU and must be labelled following specific rules.
Delegated and implementing acts
The European Commission has adopted many delegated and implementing acts in relation to Regulation (EC) No 528/2012.
Of particular note are:
Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products, as last amended by Delegated Regulation (EU) 2022/825;
Delegated Regulation (EU) 2017/2100, setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council;
Delegated Regulation (EU) No 492/2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition;
Implementing Regulation (EU) No 354/2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council;
Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (as last amended by Implementing Regulation (EU) 2016/1802);
Implementing Regulation (EU) No 564/2013 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (as last amended by Implementing Regulation (EU) 2025/1490).
Biocidal products. Products such as household disinfectants, insecticides and other chemicals used to suppress pests (parasites, fungi, bacteria, etc.) or to protect materials. As their properties can pose risks to humans, animals and the environment, they are regulated at the EU level.
Endocrine disruptors. Chemicals that under certain conditions can affect the hormonal system of humans and animals.
Persistent. These are chemicals that persist in the environment (i.e. do not break down) and thus may damage human health. The pesticide DDT is an example.
Bioaccumulative. The accumulation of a substance such as a chemical in an organism. Bioaccumulation occurs when this substance is absorbed faster by the organism than it is eliminated.
Toxic. Substances that may harm health if inhaled, ingested or absorbed through the skin, or that may harm the environment.
Nanomaterial biocide. A biocide produced using a nanomaterial. Nanomaterials are chemical substances or materials that are manufactured and used on a very small scale. Nanomaterials have unique and more pronounced characteristics compared to the same material without nanoscale features (source: ECHAs).
MAIN DOCUMENT
Regulation (EU) No 528/2012 of the European Parliament and of the Council of concerning the making available on the market and use of biocidal products (OJ L 167, , pp. 1–123).
Successive amendments to Regulation (EU) No 528/2012 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Communication from the Commission – Guidance document on the definition of ‘similar conditions of use across the Union’ in accordance with Article 42(2) of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ C, C/2025/3004, ).
Delegated Regulation (EU) No 492/2014 of supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition (OJ L 139, , pp. 1–6).
Implementing Regulation (EU) No 88/2014 of specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 32, , pp. 3–5).
Implementing Regulation (EU) No 564/2013 of on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, , pp. 17–25).
Implementing Regulation (EU) No 414/2013 of specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, , pp. 4–6).
Implementing Regulation (EU) No 354/2013 of on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, , pp. 4–13).
Directive 2010/63/EU of the European Parliament and of the Council of on the protection of animals used for scientific purposes (OJ L 276, , pp. 33–79).