- Environmental law Overview: Packaging Act (VerpackG) Regulations for the MedTech industry

Name of the legal act

Act on the Placing on the Market, Return and High-Quality Recovery of Packaging (Packaging Act - VerpackGExterner Link. Öffnet im neuen Fenster/Tab.).

Status

Packaging Act of 5 July 2017 (BGBl. I p. 2234Externer Link. Öffnet im neuen Fenster/Tab.), which last was amended by Art. 62 of the Act of 25.10.2023 (BGBl. 2023 I No. 294Externer Link. Öffnet im neuen Fenster/Tab.).

Background information

The VerpackG serves to implement Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste (consolidated version of 4 July 2018Externer Link. Öffnet im neuen Fenster/Tab.).

Scope of application

The VerpackG applies to all packaging, regardless of the packaging material and the packaged products. Packaging within the meaning of the VerpackG is always a unit consisting of goods and packaging, as the VerpackG does not impose any direct requirements on mere packaging materials. According to Sec. 3 (1) VerpackG, a distinction must be made between sales, service, dispatch, outer and transport packaging. Details: Topic paper by the Central Agency Packaging Register (ZSVR) “Demarcation between packaging and non-packaging (as of October 2022)Externer Link. Öffnet im neuen Fenster/Tab.”

If packaging is present, it must be classified as either system participation-required or non-system participation-required, as the existing obligations depend on this classification. According to Sec. 3 (8) VerpackG, packaging subject to system participation requirements refers to 'sales and outer packaging filled with goods that typically become waste after use by private end consumers. Due to the standardised approach, the specific source of waste generation is not relevant; instead, it depends on a Germany-wide overall market analysis of all packaging for the in question For this purpose, the ZSVR has published the catalog of system participation-obligated packagingExterner Link. Öffnet im neuen Fenster/Tab.. Accordingly, packaging in the 'Health' sector (see product group sheet 18-000Externer Link. Öffnet im neuen Fenster/Tab.) is subject to system participation obligations.

Roles

The central role is played by the producer within the meaning of Sec. 3 (14) VerpackG. This is „the distributor who first markets packaging commercially available on the German market. The producer is also considered to be the one who commercially imports packaging into the scope of this law.“ The first distributor is always considered to be the one who first markets packaged goods (and usually not the manufacturer of packaging materials). For imports, it depends on who assumes legal responsibility for the packaged goods at the border crossing (usually assessed based on contractual terms, particularly the place of performance or INCOTERMs).

According to Sec. 3 (12) VerpackG, a distributor is anyone who places packaging on the market on a commercial basis, regardless of the distribution method or level of trade."

Placing on the market is any supply to third parties in Germany, whether in return for payment or free of charge, with the aim of distribution, consumption or use. The supply of packaging filled on behalf of a third party to this third party is not deemed to be placing on the market if the packaging is labelled exclusively with the name or trademark of the third party or both" (in particular in the case of trademarks and production by extended workbenches).

New obligations have now also been added for operators of electronic marketplaces (Sec. 3 (14b) VerpackG) and fulfilment service providers (Sec. 3 (14c) VerpackG).

Duties in bullet points

• Substance restrictions (Sec. 5 (1) VerpackG)
• Ban on lightweight plastic carrier bags (Sec. 5 (2) VerpackG)
• Requirements for the use of certain abbreviations/numbers for voluntary material labelling (Sec. 6 in conjunction with Annex 5 VerpackG)
• Obligation to register (Sec. 9 VerpackG - since 1 July 2022 for producers of all types of packaging)
• System participation obligation (Sec. 7 VerpackG)

• Data reporting (Sec. 10 VerpackG)
• Declaration of completeness (Sec. 11 VerpackG)

• Own take-back obligations + organizational, financing, information, documentation, evidence obligations with regard to packaging not subject to system participation (Sec. 15 VerpackG)
• From 1 January 2025, requirements for minimum recyclate content in single-use plastic beverage bottles primarily of polyethylene terephthalate made (PET) (Sec. 30a VerpackG)
• Mandatory deposit for single-use beverage bottles (Sec. 31 VerpackG)

Violations of substance restrictions, registration and system participation obligations lead to a traffic ban at all levels. Other violations are regularly administrative offenses.

Latest news

On 22 January 2025, Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC was published and entered into force on 11 February 2025. It applies as of 12 August 2026 and until then, VerpackG has to be amended accordingly (detailed information can be found in the 'VerpackVO' information sheet).

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.