- Environmental law
Overview: F-Gas Regulation Regulations for the MedTech industry
The MedTech industry is directly or indirectly affected by numerous environmental regulations. With our information service on environmental law, BVMed provides an overview of the most important national (Germany) and European legal acts as well as the resulting obligations. This article focuses on the F-Gas Regulation – german version of the article here. You can find more legal acts here
Artikel31.07.2025
Name of the legal act
Status
Version of 20 February 2024Externer Link. Öffnet im neuen Fenster/Tab..Background information
The previously applicable Regulation (EU) No. 517/2014 was generally repealed by the new Regulation with effect from 11 March 2024, although specific transitional periods still exist. The main contents of the new regulation are further restrictions on use and market bans, export restrictions and additions to existing regulations.National implementation and sanction provisions are contained in the following legal acts:
- Act on Protection against Hazardous Substances (Chemicals Act – ChemGExterner Link. Öffnet im neuen Fenster/Tab.)
- Ordinance on the Protection of the Climate from Changes Caused by the Emissions of Certain Fluorinated Greenhouse Gases (Chemicals Climate Protection Ordinance - ChemKlimaschutzVExterner Link. Öffnet im neuen Fenster/Tab.)
- Ordinance on the enforcement of sanctions under Community or Union regulations in the field of chemical safety (Chemical Sanctions Ordinance – ChemSanktionsVExterner Link. Öffnet im neuen Fenster/Tab.)
Scope of application
The F-Gas Regulation contains- Rules and measures for the limitation of emissions, use, recovery and destruction of fluorinated greenhouse gases
- Requirements for the placing on the market of certain products and equipment that contain or require fluorinated greenhouse gases for their functioning
- Requirements for certain uses of fluorinated greenhouse gases
- Quantity limits for the placing on the market of hydrofluorocarbons
The fluorinated greenhouse gases covered by the F-Gas Regulation are listed in Annex I of the F-Gas Regulation and include partially fluorinated hydrocarbons, perfluorinated hydrocarbons, sulphur hexafluoride and other greenhouse gases that also contain fluorine. The term includes mixtures containing one of these substances.
Roles
On the one hand, the F-Gas Regulation affects operators of systems that contain fluorinated greenhouse gases. On the other hand, the F-Gas Regulation is linked to the placing on the market of fluorinated greenhouse gases/mixtures and certain products. According to Art. 3 No. 6 of the F-Gas Regulation, placing on the market covers " the customs release for free circulation in the Union or the supplying or making available to another person within the Union, for the first time, for payment or free of charge, or the use of substances produced, or of products or equipment manufactured, for own use."Duties in bullet points
- Avoidance of emissions (Art. 4 et seq.)
- Restrictions on the placing on the market of certain products (Art. 11 in conjunction with Annex IV) - supplementary requirements and prohibitions in Sec. 12i ChemG
- Labelling and information for certain products/facilities (Art. 12)
- Restrictions on use (Art. 13)
- Quotas for the placing on the market of hydrofluorocarbons (Art. 14 et seq.) - supplementary requirements and prohibitions in Sect. 12j ChemG
- Trade controls (Art. 22 et seq.)
- Reporting (Art. 26)
Further information on the F-Gas Regulation is available on the EU Commission's topic portalExterner Link. Öffnet im neuen Fenster/Tab. and on the Federal Environment Agency's topic portalExterner Link. Öffnet im neuen Fenster/Tab..
Violations of the regulations are partly criminal offences and partly administrative offences.
Latest news
Against the background of the new EU regulation, the national transposition and implementing acts will now also have to be revised in a timely manner. In this context, two relevant draft bills are available since 23 July 2025: Draft billExterner Link. Öffnet im neuen Fenster/Tab. for a Fifth Act Amending the Chemicals Act and draft billExterner Link. Öffnet im neuen Fenster/Tab. for a regulation implementing Regulation (EU) 2024/573 on fluorinated greenhouse gases and strengthening the circular economy with partially fluorinated hydrocarbons. In addition, numerous new implementing acts or at least amendments to existing requirements will be required at EU level, which are now gradually being processed.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.
