Introduction
The Health Claims Regulation (EC) No 1924/2006 forms the central legal basis for the use of nutrition and health claims on food in the European Union. The aim of this regulation is to strengthen consumer protection and ensure a uniform application of health-related claims in all EU member states. The Health Claims Regulation governs under what conditions manufacturers can make certain claims about the benefits or effects of their food products. The regulation distinguishes between nutritional claims, such as “rich in vitamin C,” and health claims that establish a link between the consumption of a food product and a health benefit. A central element of the regulation is the requirement that all claims must be based on solid scientific evidence to prevent consumer deception. This ensures that consumers throughout the EU receive reliable and comparable information.
Regulatory Scope
The regulatory scope of the Health Claims Regulation extends to all food products, including dietary supplements, marketed in the EU. The regulation applies to all claims that establish a link between a food product or one of its components and health. This includes statements about the significance of nutrients such as vitamin C, calcium, or dietary fibers for health. Products like herbs, spices, or plant extracts, often used in dietary supplements, are also covered by the regulations of the Health Claims Regulation. It is crucial that health-related claims are only permissible if they are based on generally accepted scientific data and can be understood by the average consumer. This ensures that claims on food products are transparent and comprehensible, enabling consumers to make informed health decisions.
ECJ Ruling of 04/30/2025 – Case No. C-386/23
On April 30, 2025, the European Court of Justice (ECJ) made a landmark ruling regarding the application of the Health Claims Regulation to botanicals (Case No. C-386/23). According to this, health claims for botanicals are only permissible under strict conditions. The relevant articles of the Health Claims Regulation outline which claims and statements on products are permissible and how they are to be legally assessed.
The Health Claims Regulation (HCVO) has been in force across the European Union since 2007. Its aim is to protect consumers from misleading advertising with alleged health effects of food products and dietary supplements. According to the regulation, manufacturers can only make health claims that have been approved by the European Commission, according to the law firm MTR Legal Rechtsanwälte, which advises on, among other things, food law.
Positive List for Health Claims
Permissible health claims are published in so-called positive lists. However, for many so-called botanicals, such as plant substances like herbs, extracts, or plant components often used in dietary supplements, the situation is unclear. Although numerous applications for approval have been submitted, a large portion has not yet been approved or rejected by the EU Commission. They are in a legal state of limbo. The assessment of the underlying substances, ingredients, and nutrients is crucial for the approval of health claims, as the properties of a nutrient or other ingredients must be scientifically proven and assessed. The ECJ has provided more clarity with its ruling from April 30, 2025.
The point of contention in the underlying case was the advertising of a German company for a dietary supplement containing saffron and melon juice extract. Promises of effects such as “mood-enhancing,” “reducing stress,” or “contributing to relaxation” were made on the packaging and in online advertising. Such claims fall under the term health claims according to the European Health Claims Regulation. The issue is that the underlying substances had not yet been evaluated by the EU Commission, and no timely application had been filed.
Violation of the Health Claims Regulation
A competition association saw this as a clear violation and filed for an injunction. The case ultimately reached the Federal Court of Justice (BGH), which referred a preliminary question to the ECJ regarding the interpretation of the regulation. In assessing such cases, compliance with the relevant rule and the EU-wide regulations of the Health Claims Regulation is of paramount importance. For manufacturers, clear guidelines and support in implementing the provisions are particularly important.
The ECJ sided with the consumer protection advocates and found that advertising with the health claims was impermissible. Health claims for botanicals are only allowed if they have either already been approved by the European Commission and are thus on the positive list, or if a proper, timely application according to Article 28 has been submitted and the conditions of the transitional provision are met. These conditions were not fulfilled, the ECJ clarified.
Caution with General Statements
The European Court of Justice further clarified that even generally made statements like “for more well-being” or “good for the mood” count as health claims within the meaning of the Health Claims Regulation. Such statements are only permissible if they are directly connected to an already approved specific claim – a so-called linking requirement. An example of a permissible statement would be: “Calcium contributes to the maintenance of normal bones,” while an impermissible statement might be: “This product cures bone diseases.”
The fact that many health claims for botanicals have not yet been conclusively evaluated does not change this according to the ECJ. It cannot be in the interest of consumer protection for manufacturers to freely use health claims in the meantime. The impact of such statements on consumers can be significant, as examples of statements like “Fiber promotes bowel function” or “low-fat – for a conscious diet” show. The inactivity of the Commission in evaluating plant substances should not be to the detriment of consumers.
ECJ Confirms Strict Requirements
With the ruling, the ECJ confirms the strict requirements for health-related advertising for food products and dietary supplements. This provides legal certainty in the previously unresolved area of botanical claims.
For the entire food and dietary supplement industry, the ruling can have far-reaching consequences, as many manufacturers advertise with promises of effects of plant-based ingredients. The decision by the ECJ shows that there may be a lack of legal basis for this. Manufacturers should review their advertising claims for compliance with the Health Claims Regulation. Only health claims that are on the positive list or for which a valid transitional application exists are permissible. The health benefits and advantages that products with demonstrably positive properties offer are central – both for consumers and manufacturers.
Violations of the HCVO can not only lead to conflicts with the authorities but also to warnings and compensation claims. Therefore, advertising measures should be checked for their legal admissibility and advertising strategies possibly revised. However, there are opportunities for manufacturers to legally advertise with health claims within the scope of the legal regulations.
MTR Legal Rechtsanwälte advise on the Health Claims Regulation and other topics of food law.
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