- Environmental law Overview: Green Claims Regulations for the MedTech industry

This factsheet provides an overview of relevant legal topics in the area of advertising with ESG statements ("environmental, social, governance"). As there is no uniform legal framework for this, but rather requirements from various national and European legal acts must be taken into account, these are presented here in an overview.

Draft of the Green Claims Directive presented

IMPORTANT: The legislative process for the adoption of the Green Claims Directive has been delayed and it is currently unclear whether the directive will be adopted.

On 20.06.2025, it was announced that the EU Commission intends to withdraw its legislative proposal for a Green Claims Directive. This would have meant that there would have been no further regulation of green claims at European level in the foreseeable future and that the competition law approach against inappropriate green claims, which was recently tightened further by the EmpCo Directive (Directive (EU) 2024/825), would have remained in place (see below). However, the Commission made it clear on 24.06.2025 that it still supports the draft Directive. In the meantime, however, Italy has withdrawn its support for the directive, making a majority in the Council appear questionable.

The EU Commission has now presented the draftExterner Link. Öffnet im neuen Fenster/Tab. for a Green Claims Directive. This is intended to create uniform EU-wide standards for substantiation and advertising with green claims. As a result of the new draft, the possibilities for advertising with green claims, which are becoming increasingly important in practice, will be noticeably restricted in future.

The new legal framework is intended to regulate voluntary environmental advertising claims made by traders to consumers. The draft contains detailed requirements for substantiating green advertising claims. It must also be stated whether the claim relates to the business, the entire product or only part of the product. The required assessment must be carried out on a scientific basis and must demonstrate that the advertised environmental impacts are significant over the lifetime of the product. Compensation for greenhouse gas emissions must also be distinguished from the respective emissions themselves, and it must be indicated whether such compensation is achieved through reduction or removal of emissions. Green claims may only be used if the statements they contain have been substantiated in accordance with the methodology outlined above and if these claims are significant.

The creation of new environmental labels should be restricted.

Another new requirement is that advertising claims relating to an end product must contain information on how the consumer should use the product in order to achieve the advertised environmental performance.
The specific information on a green claim must be published together with it, for example by providing a link or a QR code.
As a minimum, the following must be stated:

• Environmental aspects, environmental impact or environmental performance that are the subject of advertising,
• the relevant European standards or, where applicable, relevant international standards,
• the studies or calculations for determining and monitoring the relevant environmental aspects, including their results, as well as explanations of their scope, assumptions and limitations, unless they are business secrets,
• a brief explanation of how the advertised improvements will be achieved,
• a specific certificate of conformity to substantiate the claim (see below) and the contact details of the issuer of the certificate,
• for explicit climate-related environmental claims that rely on offsetting greenhouse gas emissions, information on the extent to which they rely on offsetting and whether this relates to reducing or removing emissions; and
• a comprehensible summary of the assessment in at least one of the official languages of the member state where the claim is used.

Brand new and central to the directive are the rules on the verification and certification of environmental claims. Before a green claim may be used, it must, according to the directive, be verified by an independent third party, the verifier. The same applies to the use of an environmental label.

If the result of the verification is positive, a special certificate of conformity is to be issued, confirming that the requirements of the directive have been met.

In the event of violations, severe sanctions are foreseen. These include, among other things, the confiscation of corresponding revenues, temporary exclusion from public procurement, and fines, the maximum amount of which is to be at least 4 per cent of the annual turnover in the affected member states.

The draft is currently in the ordinary legislative procedureExterner Link. Öffnet im neuen Fenster/Tab. and is being discussed in the institutions based on a legislative resolution of the European Parliament from 12 March 2024 in the new legislative term. With the establishment of its general orientationExterner Link. Öffnet im neuen Fenster/Tab. on 17 June 2024, the Council has paved the way for the trilogues (negotiations between the European Parliament, the European Council, and the European Commission).

Proposal for a Directive amending the UCP Directive and the Consumer Rights Directive

On 6 March 2024, Directive (EU) 2024/825 amending Directives 2005/29/EC and 2011/83/EU was published, aimed at strengthening consumers for the ecological transition through better protection against unfair practices and improved information (commonly referred to as the EmpCo Directive in practice). These regulations will be applicable from 27September 2026.

In the context of the misleading conduct provision, ecological and social characteristics, as well as circularity aspects such as durability, reparability, and recyclability of the product, will be included as essential characteristics. Furthermore, an environmental claim about a future environmental performance will be considered misleading if it is made without clear, objective, publicly accessible, and verifiable commitments and goals set out in a detailed implementation plan.

The so-called blacklist of business practices that are always considered unfair is to be expanded to include the following offences in particular:

• Making a general environmental claim where the trader cannot provide evidence of the recognized environmental excellence to which the claim relates; and
• making an environmental claim about the whole product or business activity when it only relates to a particular aspect of the product or to a particular activity of the trader, and.
• making a statement based on the compensation of greenhouse gas emissions, suggesting that a product has neutral, reduced, or positive impacts on the environment in terms of greenhouse gas emissions, will be affected by this provision. Just this last point alone is likely to render a significant portion of the currently common green claims about greenhouse gas emissions obsolete.

Finally, the pre-contractual information obligations towards consumers are to include information on the durability and reparability of products be extended. by means of a so-called harmonized communication or harmonized labelling. The European Commission will establish uniform templates for mandatory information on statutory warranties and commercial durability guarantees by 27 September 2025.

Also with regard to competition law, therefore, in future when using green claims greater caution will be required.

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.