- Environmental law Overview: Biocide Regulation Regulations for the MedTech industry

Name of the legal act

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Status

Consolidated version of 11 June 2024.Externer Link. Öffnet im neuen Fenster/Tab.

Background information

National implementation and sanction provisions are contained in the following legal acts:

• Ordinance on the Notification and Supply of Biocidal Products and on the Implementation of Regulation (EU) No. 528/2012 (Biocide Law Implementation Ordinance - ChemBiozidDVExterner Link. Öffnet im neuen Fenster/Tab.)
• Act on Protection against Hazardous Substances (Chemicals Act - ChemGExterner Link. Öffnet im neuen Fenster/Tab.)
• Ordinance on the Enforcement of Sanctions under Community or Union Legislation in the Field of Chemical Safety (Chemical Sanctions Ordinance - ChemSanktionsVExterner Link. Öffnet im neuen Fenster/Tab.)
• Ordinance on Prohibitions and Restrictions on the Marketing and Distribution of Certain Substances, Mixtures and Products under the Chemicals Act - in particular Sect. 15a to 15h (Hazardous Substances Ordinance – GefStoffVExterner Link. Öffnet im neuen Fenster/Tab.)

Biocidal products in accordance with the Biocidal Products Regulation are subject to market surveillance in accordance with Regulation (EU) 2019/1020 and the supplementary provisions of the Act on Market Surveillance and Ensuring Product Compliance (Market Surveillance Act - MüGExterner Link. Öffnet im neuen Fenster/Tab.).

Supplementary and accompanying legal actsExterner Link. Öffnet im neuen Fenster/Tab. are available on the website of the European Chemicals Agency (ECHA).

Scope of application

The Biocidal Products Regulation applies to biocidal products and treated articles. Annex V contains a list of the types of biocidal products and their description.

The term "biocidal product" is defined in Art. 3 (1) lit. (a) of the Biocidal Products Regulation as "any substance or mixture, in the form in which it is supplied to the user, and which consists of, contains, or generates one or more active substances, and is intended to destroy, deter, neutralize, prevent the action of, or otherwise control harmful organisms by means other than mere physical or mechanical action" and also "any substance or mixture produced from substances or mixtures that are not themselves covered by the first part, but are intended to destroy, deter, neutralize, prevent the action of, or otherwise control harmful organisms by means other than mere physical or mechanical action".

A treated article with a primary biocidal function is considered a biocidal product. A dominant claim of a biocidal function may already be sufficient (e.g. antibacterial effect).

The following are also covered:

• Substances or mixtures with a biocidal function produced on site (in-situ)
• Products that only indirectly affect the target harmful organisms, provided that they contain one or more active substances that cause a chemical or biological effect as part of a causal chain intended to induce an inhibitory effect on the harmful organisms in question. (see ECJ judgment of 1 March 2012, Case C-420/10, "Söll").

However, there are exceptions from the Biocidal Products Regulation for medical devices, medicinal products for human use and veterinary medicinal products. According to the European Commission´s Implementing Decision (EU) 2016/904, products with an exclusively biocidal function and no specific medical purpose are biocidal products and not medical devices or medicinal products (e.g. hand sanitisers).

Special case: ethylene oxide

• Before the MDR came into force, products specifically intended for the sterilization of medical devices fell within the scope of the Biocidal Products Regulation. However, following the entry into force of the MDR, products for sterilization are also considered medical devices in accordance with Art. 2 No. 1 subparagraph 2 MDR, provided that they are specifically intended by the manufacturer for the sterilization of medical devices, accessories and products without an intended medical purpose that are listed in Annex XVI BPR.
• Ethylene oxide is a substance used in the manufacturing process to sterilize medical devices that are subsequently placed on the market in a sterile state. This use of ethylene oxide therefore falls under the MDR and no longer within the scope of the Biocidal Products Regulation. By Implementing Decision (EU) 2025/1074 of 2 June 2025, ethylene oxide was not approved due to the lack of independent areas of use falling within the scope of the Biocidal Products Regulation.
• The requirements for the use of ethylene oxide under the MDR for sterilization purposes are now summarized in Medical Device Coordination Group Document MDCG 2024-13 “Regulatory status of ethylene oxide (EtO) intended for the sterilization of medical devices” (October 2024)

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Special case: ethanol

• Ethanol is listed as a biocidal active substance in the EU work program and has been submitted for approval under the Biocidal Products Regulation. Due to its specific hazardous properties, ethanol has been identified as a substance that may need to be replaced; the corresponding public consultation ended on 30 April 2025.
• Due to the properties of the substance, a more harmonized classification of ethanol is intended. However, due to studies on dermal toxicity that are still pending, the submission of the corresponding proposal is not expected until 31 December 2026. The submission of the proposal will be followed by further procedure in accordance with Regulation (EC) No. 1272/2008 (CLP) and a supplementary public consultation.
• The procedure for the approval of active substances under the Biocidal Products Regulation will continue independently of any further classification in accordance with the CLP Regulation. The further decision-making process is expected to be completed at the level of the Biocidal Products Committee (BPC) of the European Chemicals Agency before the end of 2025; the subsequent decision by the Commission is expected in 2026 at the earliest.

Roles

The relevant actor regarding the placing on the market of biocidal products in the EU is the (potential) authorisation holder. According to Art. 3 (1) lit. (p) of the Biocidal Products Regulation, this refers to the person established in the European Union who is responsible for placing a biocidal product on the market in a particular Member State or in the European Union and who is named in the authorisation or who must apply for the authorization. Placing on the market in the given context refers to the first making available of a biocidal product or a treated article on the market.

Duties in bullet points

• Approval of active substances (Art. 4 et seq. of the Biocidal Products Regulation - transitional provisions, especially in Art. 90) - Information from ECHAExterner Link. Öffnet im neuen Fenster/Tab.
• Authorization of biocidal products - national authorization or Union authorization possible (Art. 17 et seq. - transitional provisions, especially in Art. 89 for active substances subject to the work programme) - Information from the ECHA
• Requirements for placing treated articles on the market (Art. 58) - Information from ECHA
• Classification, packaging and labelling (Art. 69)
• Safety data sheets according to REACH (Art. 70)
• Requirements for advertising (Art. 72)
• Information on poison centers under the CLP Regulation (Art. 73)

Subject to any transitional provisions, biocidal products may only be placed on the market and used if the active substances they contain are authorized and the biocidal product itself is authorized. In addition, at least one actor in the respective supply chain must be listed in accordance with Art. 95; exceptions may apply in individual cases.

National process requirements may apply during transitional provisions (e.g. in Germany according to ChemBiozidDVExterner Link. Öffnet im neuen Fenster/Tab.).

Treated goods may only be placed on the market if the biocidal products used for treatment contain only authorized active substances or active substances that are still marketable and usable due to transitional provisions (Art. 94 of the Biocidal Products Regulation). If biocidal properties are advertised, additional labelling requirements apply (Art. 58 of the Biocidal Products Regulation).
Violations of the provisions of the Biocidal Products Regulation are generally administrative offences.

Comprehensive information on the Biocidal Products Regulation can be found on the ECHA's topic pageExterner Link. Öffnet im neuen Fenster/Tab., the FAQsExterner Link. Öffnet im neuen Fenster/Tab. and in the comprehensive guidance documentsExterner Link. Öffnet im neuen Fenster/Tab.. Information is also available at the German helpdeskExterner Link. Öffnet im neuen Fenster/Tab..

Latest news

No imminent legal changes expected. Continuous further development of active substance authorizations and deadlines for product approvals must still be observed. However, the Biocidal Products Regulation is due for revision. The Commission is currently expected to adopt a proposal to this effect in spring 2027.

Continuous development regarding active ingredient approvals and deadlines for product approvals must still be observed regardless of this.

European enforcement projectsExterner Link. Öffnet im neuen Fenster/Tab. on the Biocidal Products Regulation have been running with different focuses since 2020

Imprint

© Bundesverband Medizintechnologie e.V. (BVMed), the German MedTech Association, in cooperation with the law firm "Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH" („Produktkanzlei“).

This overview does not replace an individual case assessment.