The Green Claims Directive – New rules regarding environmental claims

The EU Commission adopted a proposal for a Directive on Green Claims in 2023, which is expected to be finally adopted in mid-2025. The proposal aims, among other things, to make green claims reliable, comparable and verifiable across the EU, and to protect consumers from greenwashing. The directive introduces stricter requirements as to how companies substantiate and communicate voluntary green claims to consumers. As many companies in the life science sector use environment and sustainability statements — such as claims about eco-friendly production of pharmaceuticals, ”green” medical devices and biodegradable diagnostic tests — the new directive will impact the life sciences industry and its marketing. In this article, we summarise some of the key points of the proposed directive that companies in the life sciences sector should be aware of.

Background

It has been found that many environmental claims made by companies were unreliable and consumer trust in them was extremely low. For example, it has been found that 53% of green claims give vague, misleading or unfounded information. With a proposed new law on green claims, the EU addresses “greenwashing”, a practice where consumers risk being misled, as companies may have given a false impression of their environmental impacts or benefits. Against that background, the upcoming Green Claims Directive proposes the imposition of specific and binding rules on how claims must be substantiated, verified and presented.

Substantiation requirements

According to the directive, all green claims — including statements like “climate neutral”, “sustainable production” and “biodegradable materials” — must be verifiable and based on scientific evidence. This means that companies must conduct an evaluation to substantiate their environmental claims. The assessment should, among other things, demonstrate that the environmental aspects covered by a claim are significant throughout the lifecycle of the products and should specify whether a claim applies to the whole or certain parts of a product. For example:

• A biotech company promoting a “sustainable fermentation process” must demonstrate the full environmental lifecycle benefits, not only in manufacturing but also in sourcing raw materials and waste management.
• A medical device manufacturer marketing a “low-carbon footprint” instrument must substantiate the claim through lifecycle assessments covering material extraction, production, usage and end-of-life disposal.

Moreover, companies must make evidence supporting claims easily accessible to consumers — for instance by using QR codes on packaging linking to detailed sustainability reports.

The proposal includes already existing trademarks, meaning that trademarks consisting of claims that could be considered as an environmental claim (for example, a green leaf) may be covered by the act. However, many are hoping for an exception for already registered trademarks, but this is not yet clear.

Verification requirement

A major shift is the mandatory third-party pre-verification of environmental claims. No marketing materials using green claims may be published without prior certification from an accredited body. If the body determines that the claim meets the requirements of the directive, a certificate of conformity is issued. The effect of the certificate is that companies are allowed to use the claim in commercial communication to consumers throughout the internal market, and the claim in question cannot be challenged by competent authorities in other member states.

The cost of verification will vary depending on claim complexity:

• The cost to verify a simple claim, e.g., regarding materials used in production, is estimated at EUR 500.
• A full lifecycle-based claim for the environmental footprint of one product could cost up to EUR 8,000.
• A claim regarding an entire organisation’s environmental footprint could cost EUR 54,000.

As a result, companies must plan for additional costs and timelines in the go-to-market process. This requirement has faced criticism as it risks leading to increased costs, long processing times and increased administration for companies, which may discourage companies from communicating their sustainability initiatives – a phenomenon known as “green hushing”. Despite the criticism, the EU Council has chosen to retain the requirement for prior approval but proposes a simplified process for certain types of environmental claims.

Penalties

Non-compliance could result in severe consequences, such as:

• Fines up to 4% of the company’s annual turnover in the Member State concerned.
• Temporary exclusion from public procurement.

The EU Council has expressed concern about the proposed sanctions and believes that they may be too severe and difficult to enforce. Instead of imposing fixed fines, the EU Council has suggested that Member States should be allowed to decide for themselves which sanctions to apply and how to enforce them. This issue is still under discussion, and it remains to be seen which solution will be adopted in the final directive. The final rules on penalties are thus still under discussion, but Member States are expected to be allowed some flexibility in setting national sanctions.

Key steps for life science companies

In light of the upcoming rules, businesses should start preparing by:

• Mapping all environmental claims in marketing materials.
• Collecting scientific evidence for each claim, including full lifecycle analyses where necessary.
• Budgeting for verification costs and incorporating extra time into project planning.

Conclusion

The Green Claims Directive will change the way environmental claims are used in marketing in the EU. Companies that act early to align with the new rules will be better positioned to maintain compliance, strengthen brand trust, and differentiate themselves in an increasingly sustainability-focused market.