Health claim denial: what food manufacturers must do in 2026

Key data

If your company manufactures, distributes or markets food in the European Union and uses —or planned to use— a health claim that is not linked to disease risk reduction or child development and health, you must act now. Regulation (EU) 2026/1118, published on May 27, 2026 and in force since May 26, formally denies authorization of that claim.

The European Commission evaluated the available scientific evidence and concluded that the claim in question does not meet the requirements of Regulation (EC) 1924/2006, the framework regulation governing all nutrition and health claims in the EU. The consequence is direct: the claim cannot appear on any commercial medium.

What does this regulation establish?

Regulation (EU) 2026/1118 denies authorization of a health claim in food of a general type, that is, one that does not fall into either of the two special protected categories:

• Claims relating to disease risk reduction
• Claims relating to child development and health

The applicable legal framework is Regulation (EC) 1924/2006, which establishes that any health claim must be supported by solid scientific evidence and receive express authorization from the European Commission before it can be used. When the evidence is insufficient or does not meet the criteria, the Commission issues a denial regulation, as in this case.

The denial means that the claim cannot appear on any of the following media:

• Food product labeling
• Advertising (digital, print, audiovisual)
• Commercial presentation of the product (packaging, displays, product sheets)

Economic and operational impact

The impact is not only legal: it is operational and economic. Affected companies must bear real costs resulting from compliance:

• Packaging redesign: Removing the claim from labeling involves modifying graphic designs, approving new print tests and managing current container stock.
• Marketing materials update: Catalogs, product sheets, websites, social media and any advertising medium must be reviewed and corrected.
• Possible reformulations: In some cases, if the claim was central to the product positioning, it may be necessary to reconsider the product communication strategy.
• Risk of sanctions: Non-compliance may result in administrative sanctions whose amount depends on the national regulations of each EU Member State.

The concrete cost varies depending on the volume of affected products, the number of markets in which the company operates and the amount of materials that need to be updated. There is no single figure set by the regulation, but the risk of sanctions adds urgency to adaptation.

Who does it affect?

• Food manufacturers that include the denied claim on their labels or packaging.
• Distributors that market products with that claim in their materials or platforms.
• Marketers and retailers that present the product with that claim in physical or digital stores.
• Marketing and communications departments of food companies that use the claim in advertising campaigns.
• Labeling and regulatory managers (Regulatory Affairs) of any food sector company with presence in the EU.
• Legal advisors and labeling consultants that manage regulatory compliance of their food sector clients.

Practical example

Imagine a Spanish company that manufactures energy bars and has been using a general type health claim on its packaging for two years —for example, linked to wellness or performance— that is not related to disease risk reduction or child health.

From May 26, 2026, that claim is prohibited by Regulation (EU) 2026/1118. The company must:

1. Remove from the market or correctly label existing stock with that claim.
2. Commission packaging redesign to eliminate the prohibited mention.
3. Update its website, product sheets on marketplaces and any advertising material where it appears.
4. Verify that no distributor or retailer continues to present the product with that claim.

If it does not act and an inspection by the competent authority detects non-compliance, the company is exposed to administrative sanctions according to Spanish food safety regulations, the amount of which depends on the severity of the infraction.

What should companies do now?

1. Identify if you use the denied claim: Review all your food products and check if any health claim on the label is not linked to disease risk reduction or child health.
2. Remove the claim from labeling: Start the packaging redesign process to eliminate the prohibited mention in all formats and EU markets.
3. Update marketing and advertising materials: Review websites, catalogs, product sheets, social media and any medium where the claim appears.
4. Communicate with your distribution network: Inform distributors and retailers to remove or correct any commercial presentation that includes the denied claim.
5. Document the adaptation process: Keep evidence of actions taken and dates, in case of a subsequent inspection.
6. Consult a food labeling specialist: If you have doubts about whether your claim is affected, an advisor in food regulation can confirm the scope before incurring unnecessary costs or, worse, sanctions.

Official source

View complete regulation in official source

Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R1118