- Environmental law
Overview: Packaging 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 Packaging 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 22 January 2025Externer Link. Öffnet im neuen Fenster/Tab..Background information
The Packaging Regulation was published in the Official Journal of the EU on 22 January 2025 and entered into force on 11 February 2025. The date of application is scheduled for 12 August 2025. However, it should also be noted that there will be longer transitional periods for specific obligations, which in many cases will last several years.The German Packaging Act must be adapted to the changes until 12 August 2025. Although the basic structures of extended producer responsibility (registration, system participation and data reporting) will be retained, they may be extended to other types of packaging.
Scope of application
The Packaging Regulation applies to all packaging, regardless of the material used, and to all packaging waste, regardless of whether the waste is generated or used in industry, other manufacturing, retail or distribution businesses, administration, the service sector, or households. In terms of content, there should be no change compared to the previous legal framework.The Packaging Regulation does not contain any general exceptions from the scope of application. However, in some areas, duty-specific exceptions are provided, particularly for contact-sensitive packaging (Art. 3 No. 10 PPWR) for medical devices, IVDs, medicinal products (human and animal) and certain speciality foods. This particularly applies to the requirements for recyclability (Art. 6 (11) PPWR), the minimum recyclate content (Art. 7 (4) and (5) PPWR) and packaging labelling (Art. 12 (11) PPWR). Still, it should be noted that not all packaging for medical devices is exempt, meaning that a specific case-by-case examination is required to determine which packaging is exempt from individual obligations and to what extent.
Roles
Compared to the VerpackG, the Packaging Regulation introduces several new roles and amends existing definitions.The central definition for all sustainability, labelling and conformity assessment obligations is the manufacturer in accordance with Art. 3 No. 14 PPWR. Therefore, a manufacturer is any "any natural or legal person that manufactures packaging or a packaged product". It should be noted that the Packaging Regulation does not provide any differentiating criterion for defining which of the two actors mentioned in the definition is ultimately to be regarded as the manufacturer. This will have to be clarified by interpretation guidelines and possible changes to the wording of the Packaging Regulation. In the case of orders for own-brand packaging, the client is in any case to be regarded as the manufacturer.
This must be distinguished from the producer in accordance with Art. 3 No. 15 PPWR. In summary, a producer is always the person who supplies packaging in a specific Member State for the first time. The producer is primarily responsible for fulfilling the extended producer responsibility.
The importer according to Art. 3 No. 17 PPWR will also be subject to extensive inspection obligations in the area of sustainability and labeling obligations in the future.
The distributor will also be made more liable in accordance with Art. 3 No. 18 PPWR.
Duties in bullet points
Sustainability and labelling obligations (producer responsibility):- Substance restrictions (Art. 5)
- Recyclability (Art. 6)
- Minimum recycled content in plastic packaging (Art. 7)
- Compostability (Art. 9)
- Minimisation of packaging (Art. 10)
- Prohibition of excessive packaging (Art. 24)
- Restriction of certain packaging formats (Art. 25)
- Reusability and refilling (Art. 11 and Art. 26 et seq.)
- Labelling (Art. 12)
- Conformity assessment, including technical documentation and EU Declaration of Conformity (Art. 35 et seq.)
Obligations of economic operators:
- Manufacturer obligations (Art. 15)
- Obligations of suppliers (Art. 16)
- Importer obligations (Art. 18)
- Distributor obligations (Art. 19)
Extended producer responsibility - (Art. 44 et seq.)
In addition to this brief summary, the Packaging Regulation contains numerous detailed obligations that must be observed in individual cases.
Latest news
Since the Packaging Regulation came into force, there have been numerous discussions about the scope of individual obligations, with the reusability obligations under Art. 29 being the focus of attention. In addition, several lawsuits for the annulment of the Packaging Regulation or individual parts of it are already pending before European courts. The outcome of these proceedings is naturally open. Concrete legislative developments to amend the Packaging Regulation or to implement it in Germany are currently not discernible.For the time being, however, there is no indication that existing or newly introduced labelling requirements in other member states will be repealed or suspended in anticipation of the Packaging Regulation.
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.
