- Environmental law Overview: Circular Economy Act (KrWG) Regulations for the MedTech industry

Name of the legal act

Act on the promotion of the circular economy and safeguarding the environmentally sound management of waste
(Kreislaufwirtschaftsgesetz - KrWGExterner Link. Öffnet im neuen Fenster/Tab.).

Status

Circular Economy Act of 24 February 2012 (BGBl. I p. 212Externer Link. Öffnet im neuen Fenster/Tab.), which was last amended by Art. 5 of the Act of 2 March 2023 (BGBl. I No. 56Externer Link. Öffnet im neuen Fenster/Tab.).

Background information

The KrWG is supplemented by the following ordinances, among others:

• Waste Management Officer Ordinance (AbfBeauftrVExterner Link. Öffnet im neuen Fenster/Tab.),
• Waste Catalogue Ordinance (AVV)Externer Link. Öffnet im neuen Fenster/Tab.,
• End-of-Life Vehicles Ordinance (AltfahrzeugVExterner Link. Öffnet im neuen Fenster/Tab.),
• Waste Wood Ordinance (AltholzVExterner Link. Öffnet im neuen Fenster/Tab.),
• Waste Oil Ordinance (AltölVExterner Link. Öffnet im neuen Fenster/Tab.),
• Biowaste Ordinance (BioAbfVExterner Link. Öffnet im neuen Fenster/Tab.),
• Landfill Ordinance (DepVExterner Link. Öffnet im neuen Fenster/Tab.),
• Ordinance on Specialized Waste Management Companies (EfbVExterner Link. Öffnet im neuen Fenster/Tab.),
• Commercial Waste Ordinance (GewAbfVExterner Link. Öffnet im neuen Fenster/Tab.),
• Sewage Sludge Ordinance (AbfKlärVExterner Link. Öffnet im neuen Fenster/Tab.),
• Verification Ordinance (NachwVExterner Link. Öffnet im neuen Fenster/Tab.),
• PCB/PCT Waste Ordinance (PCBAbfallVExterner Link. Öffnet im neuen Fenster/Tab.),
• Transport Autorisation Ordinance (TgVExterner Link. Öffnet im neuen Fenster/Tab.),
• Offsetting Ordinance (VersatzVExterner Link. Öffnet im neuen Fenster/Tab.),
• Packaging Act (VerpackGExterner Link. Öffnet im neuen Fenster/Tab.).

In addition, there are waste laws in the individual Länder that contain implementing provisions for the KrWG and may also supplement it. Finally, there are also waste regulations at the municipal level that specify further details.

NOTE: This information sheet cannot cover the complex interrelationships of overall waste regulation but merely provides an overview of some key aspects of the KrWG.

Scope of application

The purpose of the KrWG is to promote the circular economy in order to conserve natural resources and to ensure the protection of people and the environment in the generation and management of waste. Accordingly, it contains requirements for the prevention, recovery and disposal of waste as well as for other waste management measures. Sec. 2 (2) KrWG contains exceptions to the scope of application, but none specifically for medical devices.

Determining whether an item is considered waste within the meaning of the KrWG is, on one hand, a key decision for the applicability of waste law regulations, but on the other hand, it can be extremely complex and must be determined individually for each case, based on all the specific circumstances. According to Sec. 3 (1) KrWG, waste is "any material or object which the holder discards [Sec. 3 (2) KrWG], intends to discard [Sec. 3 (3) KrWG] or is required to discard [Sec. 3 (4) KrWG]. Waste for recovery is waste that is to be recovered; waste that is not recovered is waste for disposal." For determining the hazardousness of waste under the KrWG, the AVV (Abfallverzeichnis-Verordnung) is particularly relevant. In addition to determining the waste characteristics according to the definition mentioned, the provisions on by-products (Sec. 4) and the end of waste status (Sec. 5) should also be considered to obtain a complete picture. All of the mentioned areas are heavily influenced by case law from national and European courts, which is often inconsistent and highly case-specific.

NOTE: Materials obtained from waste in a recycling process are again subject to the applicable requirements of chemicals and product law (Sec. 7a) when they are used or placed on the market from the end of their waste status. This means, for example, that all substance restrictions from the REACH Regulation and the RoHS Directive must be complied with.

Roles

The producer is central to the regulation alongside the holder of waste. A waste producer is "any natural or legal person who, 1. through their activity, generates waste (primary producer), or 2. who carries out pre-treatments, mixtures, or other treatments that result in a change in the nature or composition of the waste (secondary producer)." A waste holder is "any natural or legal person who has actual control over the waste."

Duties in bullet points

• Basic obligations of the circular economy - recovery before disposal (Sec. 7 KrWG)
• Separate collection and treatment (Sec. 9 KrWG and GewAbfV)
• Prohibition of mixing and treatment of hazardous waste (Sec. 9a KrWG)
• Disposal requirements (Sec. 15 et seq. KrWG)
• Product responsibility (Sec. 23 et seq. KrWG): The requirements for product responsibility in the KrWG are framed in a programmatic manner and are not directly enforceable on their own. Nevertheless, the KrWG establishes comprehensive requirements for product design in terms of waste prevention (e.g. durability, reparability, resource efficiency, use of secondary materials, reusability). At the same time, it also outlines numerous requirements for product responsibility (e.g. labelling requirements, information obligations, take-back, financial security for collection/recycling/disposal, duty of care prohibiting the destruction of new goods). However, all of these topics are not directly applicable to specific products from the KrWG itself; they require specification by law or ordinance (on the basis of the KrWG).
• Requirements for the voluntary take-back of waste (Sec.26 and 26a KrWG)
• Verification obligations for hazardous waste (Sec. 50 KrWG and NachwV)
• Waste Management Officer (Sec. 59 et seq. KrWG and AbfBeauftrV)

Violations are regularly administrative offences.

Latest news

In light of the EU Green DealExterner Link. Öffnet im neuen Fenster/Tab. and the Circular Economy Action PlanExterner Link. Öffnet im neuen Fenster/Tab. adopted under it, all areas of waste regulation are subject to evaluation and revision processes. The EU's goal is to comprehensively strengthen the circular economy in order to reduce the use of primary resources in favour of secondary materials. Given that the KrWG contains comprehensive programmatic guidelines in this area, it is expected that existing waste regulations in the implementing and enforcement laws will be refined, and new requirements will be introduced, even for products that were not previously covered by specific legislation.

The National Circular Economy Strategy (NKWSExterner Link. Öffnet im neuen Fenster/Tab.) was adopted in Germany in December 2024 - a summary of political strategies in the areas of circular economy, resource conservation, and environmental and climate protection. The med-tech sector is mentioned as part of an illustrative list of products that use plastics. Overall, the NKWS strongly aligns with goals and demands known from the EU Green Deal, and it is unlikely to trigger many national regulations, as many of the areas addressed are already or will be regulated at the EU level.

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.