- Environmental law
Overview: POP 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 POP Regulation – german version of the article here. You can find more legal acts here
Artikel31.07.2025
Name of the legal act
Status
Consolidated version dated 17 October 2024Externer Link. Öffnet im neuen Fenster/Tab..Background information
With the last amendment of the Ordinance on the enforcement of sanctions under Community or Union law in the field of Chemical Safety (Chemical Sanctions Ordinance - ChemSanktionsVExterner Link. Öffnet im neuen Fenster/Tab.), violations of POP substance restrictions are again qualified as criminal offenses and further violations as administrative offenses.The POP Regulation is based on the so-called POP or Stockholm ConventionExterner Link. Öffnet im neuen Fenster/Tab. on persistent organic pollutants. This convention is a treaty under international law that is implemented in the EU in a harmonized manner for all Member States through the POP Regulation.
At national level in Germany, the Ordinance on the Separate Collection and Monitoring of Non-Hazardous Waste Containing Persistent Organic Pollutants (POP Waste Monitoring Regulation – POP-Abfall-ÜberwVExterner Link. Öffnet im neuen Fenster/Tab.) must also be observed.
The German Supply Chain Due Diligence Act (LkSG) refers to certain requirements of the POP Regulation under Sec. 2 (3) No. 4 and 5 as relevant environmental concerns (see also the LkSG handout | Module 4 on risk analysis, prioritisation, prevention and remediationExterner Link. Öffnet im neuen Fenster/Tab.).
Scope of application
The POP Regulation sets out detailed requirements regarding the manufacture, placing on the market, use and release of persistent organic pollutants (POPs). It therefore applies in principle to all substances, mixtures and products.Roles
The POP Regulation does not mention any defined roles, but is linked to required and prohibited actions and therefore potentially covers everyone who has anything to do with substances, mixtures and articles.Duties in bullet points
- Prohibition of substances according to Annex I (Art. 3 (1) POP)
- Substance restrictions according to Annex II (Art. 3 (2) POP - Annex II does not yet contain any entries)
- Narrow exceptions from substance prohibitions and restrictions for laboratory-scale or reference standard research and for unintentional trace impurities in substances, mixtures or articles, where provided for in Annexes I and II
- Requirements for the management of stocks with POPs (Art. 5 POP)
- Requirements for the management of waste to prevent POP contamination (Art. 7 POP)
Violations cannot be sanctioned in Germany due to the outdated references. Official orders in individual cases remain possible.
Comprehensive information on POPs can be found on ECHA's topic pageExterner Link. Öffnet im neuen Fenster/Tab. and in the FAQsExterner Link. Öffnet im neuen Fenster/Tab..
Latest news
The annexes to the POP Regulation are constantly being expanded due to their inclusion in international law and the prohibition and restriction decisions made there. A list of substances proposed as POPsExterner Link. Öffnet im neuen Fenster/Tab. is available from the European Chemicals Agency (ECHA).In May 2025, the EU Commission decided to include Dechlorane PlusExterner Link. Öffnet im neuen Fenster/Tab. and UV-328Externer Link. Öffnet im neuen Fenster/Tab. in Annex I of the POPs Regulation.
The Delegated Regulation (EU) 2023/866Externer Link. Öffnet im neuen Fenster/Tab. introduced prohibitions on perfluorooctanoic acid (PFOA), its salts, and PFOA-related compounds, which will be amended shortly. Delegated Regulation (EU) 2023/608Externer Link. Öffnet im neuen Fenster/Tab. introduced prohibitions on perfluorohexane sulfonic acid (PFHxS), its salts, and PFHxS-related compounds. Delegated Regulation (EU) 2024/2570Externer Link. Öffnet im neuen Fenster/Tab. added Methoxychlor to Annex I of the POPs Regulation.
Currently, the EU is planning to propose a restriction on the siloxanes D4, D5, and D6 under the Stockholm Convention; their use has also been further restricted under REACH.
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.
