- Environmental law Overview: Single-use plastics legislation Regulations for the MedTech industry

Name of the legal act

• Ordinance on the composition and labelling of certain single-use plastic products (Single-use plastic labelling ordinance – Einwegkunststoffkennzeichnungsverordnung - EWKKennzVExterner Link. Öffnet im neuen Fenster/Tab.)
• Ordinance banning the placing on the market of certain single-use plastic products and products made of oxo-degradable plastic (Single-Use Plastics Prohibition Ordinance - EWKVerbotsVExterner Link. Öffnet im neuen Fenster/Tab.)
• Single-use Plastics Fund Act (Act Disposable Plastics Fund Act - EWKFondsGExterner Link. Öffnet im neuen Fenster/Tab.)
• Ordinance on the levy rates and points system of the Single-use Plastics Fund (Disposable Plastics Fund Ordinance - EWKFondsVExterner Link. Öffnet im neuen Fenster/Tab.)

Status

• Single-use Labelling Ordinance of 24 June 2021 (BGBl. I p. 2024Externer Link. Öffnet im neuen Fenster/Tab.)
• Single-use Plastics Prohibition Ordinance of 20 January 2021 (BGBl. I p. 95Externer Link. Öffnet im neuen Fenster/Tab.)
• Single-Use Plastics Fund Act of 11 May 2023 (BGBl. 2023 I No. 124Externer Link. Öffnet im neuen Fenster/Tab.)
• Single-use Plastics Fund Ordinance of 11 October 2023 (BGBl. 2023 I No. 274Externer Link. Öffnet im neuen Fenster/Tab.)
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Background information

The EWKKennzV, the EWKVerbotsV and the EWKFondsG as well as the EWKFondsV serve to implement Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (SUP DirectiveExterner Link. Öffnet im neuen Fenster/Tab.).



Scope of application

The EWKKennzV regulates the composition of certain single-use plastic beverage containers and the labelling of certain single-use plastic products on the product itself or on the associated packaging. Compositional and labelling requirements from other legal acts apply in parallel. The EWKVerbotsV applies to the placing on the market of certain single-use plastic products and products made of oxo-degradable plastic, regardless of whether they are considered packaging or not. The EWKFondsG introduces a special levy for placing certain single-use plastic products on the market. This corresponds to a registration and reporting obligation. The levy rates are defined in the EWKFondsV.

Plastic is defined as "a material consisting of a polymer as defined in Art. 3 (5) [REACH] to which additives or other substances may have been added and which may act as the main structural component of end products, with the exception of materials made from natural polymers that have not been chemically modified."

According to Sec. 2 No. 1 EWKVerbotsV, an EWK product is “a product consisting of plastic that is not designed, developed and placed on the market to pass through several product cycles during its lifetime by being returned to a manufacturer or distributor for refilling or reused for the same purpose for which it was manufactured". This means that even a (thin) plastic coating on a product otherwise made of a different material is also sufficient. ATTENTION: Not all EWK products are prohibited, but only those specifically mentioned in Sec. 3 (1) EWKVerbotsV.

Oxo-degradable plastic is a "plastic that contains additives that cause the plastic to break down into microparticles or chemically degrade through oxidation" (Sec. 2 No. 3 EWKVerbotsV).



Roles

In the EWKKennzV and the EWKVerbotsV, no independent roles are defined. The requirements and bans are linked to the placing on the market and therefore affect anyone who wants to place covered products on the market.

In this context, placing on the market only means the first making available on the market in Germany. This does not yet include mere import without any further supply.

Under the EWKFondsG, the producer of the single-use plastic products covered is the obligated party. A producer is either someone who is established in Germany and, as a producer, filler, seller or importer, makes collected products available on the market in Germany for the first time or is not established in Germany and sells relevant products directly to private households or other users in the course of distant sales.



Duties in bullet points

EWKKennzV
• Requirements for the quality of certain EWK beverage containers (Sec. 3 EWKKennzV): Only containers with a filling volume of up to 3.0 liters are covered. From 3 July 2024, closures/lids made entirely or partially of plastic must be fitted in such a way that they remain attached to the container for the intended period of use. This is to be specified by harmonized standards. Exceptions exist for containers made of glass or metal, for metal lids with plastic seals and for containers intended and used for liquid foodstuffs in accordance with Art. 2 (2) lit. (g) of the Regulation (EU) No. 609/2013.
• Labelling obligation on the product or packaging (Sec. 4 EWKKennzV in conjunction with. Implementing Regulation (EU) 2020/215) for:
• Sanitary pads, in particular sanitary towels (incontinence products are not included)
• Tampons and tampon applicators
• Wet wipes (soaked wipes for body and household care) / Note: According to the EU Commission's guidelines (see link below), wet wipes designed, developed and marketed for professional use, such as medical wipes or wipes for nursing care, would not fulfill the criterion of personal or household care. It is therefore considered that these products do not fall within the scope of the Directive.
• Filters intended for use in combination with tobacco products
• Tobacco products with filter
• SUP beverage cups


EWKVerbotsV:

Prohibited SUP products (Sec. 3 (1) EWKVerbotsV):
• Cotton swabs (except medical devices)
• Cutlery, especially forks, knives, spoons and chopsticks
• Plates
• Drinking straws (except medical devices)
• Balloon sticks including holder
• certain to-go food containers made of expanded polystyrene (not films and wrappers)
• Beverage containers/cups and caps/lids made of expanded polystyrene


According to Sec. 3 (2) EWKVerbotsV, ALL products made of oxo-degradable plastic are also prohibited without exception, regardless of whether they are single-use or reusable products.

EWKFondsG and EWKFondsV:
• Obligation to register with the Federal Environment Agency from 1 January 2024 (Sec. 7 EWKFondsG)
• Annual quantity reports from 1 January 2025 (Sec. 11 EWKFondsG)
• Payment of the special levy (Sec. 12 et seq. EWKFondsG)
• Products covered:
• certain to-go food containers
• Films and bag packaging with food contents
• Beverage containers and cups
• Lightweight plastic carrier bags (wall thickness less than 50 microns)
• Wet wipes (note: see above)
• Balloons
• Tobacco products with filter and filter
• Fireworks (from 1 January 2026)


Violations of the registration obligation under the EWKFondsG result in a market ban at all levels. Violations of the applicable requirements constitute administrative offences.

Details on the products covered and existing obligations can be found in the Commission guidelines on single-use plastic articlesExterner Link. Öffnet im neuen Fenster/Tab. and in the BMUV FAQs on EWKKennzVExterner Link. Öffnet im neuen Fenster/Tab., EWKVerbotsVExterner Link. Öffnet im neuen Fenster/Tab. and EWKFondsGExterner Link. Öffnet im neuen Fenster/Tab.. The platform for the EWKFondsG "DIVIDExterner Link. Öffnet im neuen Fenster/Tab." is now online and functional. FAQs and categorisation applications are also available there.



Latest news

There are currently no legislative initiatives at either German or European level that would extend the list of banned products or provide for other changes.



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.