By Dr. Géza Katona, LL.M., Katona & Partners Law Firm
Introduction
Health claims on foods and dietary supplements are crucial to consumers, shaping purchasing decisions and perceptions of product benefits. However, such claims are strictly regulated under European Union law to ensure that marketing communications are truthful, scientifically substantiated, and not misleading. This article provides an overview of the legal framework governing health claims in the EU, with a focus on Hungary, and highlights key risks for manufacturers and distributors.
1. Types of Health Claims
Health claims related to foods and dietary supplements generally fall into two categories under Regulation (EC) No 1924/2006:
- Functional claims: These describe the role of a nutrient or substance in growth, development, and normal body functions. Examples include “contributes to normal immune system function” or “supports metabolism.” Such claims describe scientifically proven physiological effects on the body’s normal functioning.
- Risk reduction claims: These refer to claims that a food or its constituents significantly reduce a risk factor in the development of a disease. For example, “improves vision” or “promotes cognitive development.” These claims suggest a relationship between the product and a lowered risk of a specific disease.
The distinction is important as risk reduction claims are subject to particularly rigorous scientific and regulatory scrutiny.
2. Authorized Health Claims — What Is Permitted?
Only health claims that have been evaluated and authorized at the EU level can be used legally in marketing and labeling. This authorization is published in official EU regulations and their annexes, such as Commission Regulation (EU) No 432/2012, which contains a list of approved health claims.
For a claim to be authorized:
- The substance (e.g., vitamin, mineral, or other nutrient) must have a proven beneficial physiological effect, supported by generally accepted scientific evidence.
- The product must contain the substance in a sufficient quantity and bioavailable form to exert the claimed effect.
- The wording and conditions for use of the claim must comply precisely with the authorized text.
Manufacturers must ensure that their products meet these conditions before making any authorized claim.
3. New and ‘On Hold’ Claims — A Risky Landscape
Many health claims, especially those concerning botanical ingredients and plant extracts, remain under review or ‘on hold.’ These claims were submitted by EU Member States during the initial claim evaluation process and have not yet received final authorization.
Using ‘on hold’ claims is risky:
- Such claims have not been fully evaluated and authorized by the European Food Safety Authority (EFSA) and the European Commission.
- Application of these claims is only permitted under the full responsibility of the manufacturer or marketer.
- Scientific evidence supporting these claims often does not meet the stringent standards applied to authorized claims.
Consequently, their use can lead to regulatory sanctions, fines, and reputational damage.
A notable example is the 2013 decision by the Hungarian Competition Authority (GVH), which fined a company for using unapproved health claims related to a turmeric dietary supplement. Despite scientific studies cited by the company, the lack of authorization resulted in significant penalties.
4. Prohibited Claims and Sources
Claims not included in the EU’s authorized list or explicitly rejected by regulatory authorities cannot be legally used in product marketing or labeling.
This prohibition extends to:
- References to scientific literature, medical professionals, or professional associations if the underlying claim itself is unauthorized.
- Any assertion implying disease prevention or treatment, which is strictly forbidden under food law and would classify the product as a medicinal product.
Manufacturers must avoid relying on unapproved sources or ‘grey area’ claims that have not been rigorously vetted.
5. Specific Challenges with Herbs and Botanical Extracts
Unlike vitamins and minerals, the regulation of health claims for herbs, botanicals, and their extracts is less harmonized across the EU.
- There is no comprehensive EU-wide authorized list of health claims for botanical substances.
- Safety assessments and approved health effects for these ingredients remain inconsistent.
This regulatory gap creates significant uncertainty for producers of botanical dietary supplements, who remain legally liable for their marketing claims.
In Hungary, it is explicitly prohibited to attribute disease prevention or healing effects to such products.
Accordingly, communications about botanical supplements must be extremely cautious, relying only on generally accepted scientific facts that are non-product-specific.
Conclusion
Navigating the complex regulatory landscape of health claims on foods and dietary supplements requires thorough understanding and strict compliance with EU and national laws. Authorized health claims provide a valuable tool to build consumer trust and competitive advantage, while unauthorized or ‘on hold’ claims pose significant legal and reputational risks.
Manufacturers and distributors must:
- Verify that any health claim used is explicitly authorized by the EU.
- Ensure products contain sufficient quantities of active substances in bioavailable forms.
- Avoid claims implying disease treatment or prevention.
- Exercise caution with botanical ingredients, given the current regulatory uncertainties.
Failure to adhere to these principles may lead to substantial fines, product recalls, and damage to brand credibility.
About the Author
Dr. Géza Katona, LL.M., is an attorney at law specializing in food law and regulatory compliance at Katona & Partners Law Firm, Budapest. The firm assists clients in navigating complex EU legal frameworks to ensure lawful and effective product communication.
Contact Information
Katona & Partners Law Firm
H-106 Budapest, Tündérfürt utca 4.
Tel.: +36 1 225 25 30
Mobile: +36 70 344 0388
Email: g.katona@katonalaw.com
Website: www.katonalaw.com