What is the nutrition and health claims regulation?

December 3, 2025 •

4 min read

The European Union's Regulation (EC) No 1924/2006, which came into application in 2007, established harmonized rules to ensure food claims are clear, accurate, and based on sound scientific evidence. This legislation defines precisely what is the nutrition and health claims regulation and how it is implemented to protect consumer health and prevent misleading information in the food market.

Quick Summary

The regulation governs nutrition and health claims on EU food products to ensure scientific substantiation, clarity, and fair competition. It specifies categories of claims, authorization procedures involving EFSA, and restrictions on misleading information, impacting both consumer choices and manufacturer marketing strategies.

Key Points

Consumer Protection: The core purpose is to prevent misleading claims on food labels and advertising, empowering consumers to make informed purchasing decisions.
Scientific Basis: All claims, especially health claims, must be substantiated by robust scientific evidence and evaluated by authorities like EFSA.
Two Main Categories: The regulation distinguishes between 'nutrition claims' (e.g., 'low fat') and 'health claims' (e.g., 'calcium for bones'), each with specific rules.
Authorization Process: New or specific health claims require a formal application and evaluation, leading to inclusion on an authorized list.
Clear Restrictions: The rules prohibit claims that are false, misleading, or that attribute medicinal properties to a food.
Fair Competition: By creating harmonized rules, the regulation ensures all food businesses operate under the same conditions, fostering a level playing field.

The Purpose of the Regulation

At its core, the nutrition and health claims regulation, primarily Regulation (EC) No 1924/2006 in the EU, aims to protect consumers from false, ambiguous, or misleading information on food labels and advertising. By regulating the claims made, the legislation helps consumers make informed choices based on credible, scientifically backed evidence. For manufacturers, it creates a level playing field by setting clear, harmonized conditions for using claims across the market, fostering fair competition. This regulatory framework addresses the information asymmetry that exists between food producers and consumers, building trust and safeguarding public health.

Types of Claims Covered

The regulation categorizes claims into two main types: nutrition claims and health claims. Each type has specific requirements that must be met before use.

Nutrition Claims

These claims indicate a food's beneficial nutritional properties related to energy or nutrient content. Examples include: “low fat,” “high fibre,” or “sugar-free.” Such claims require the food to meet specific compositional criteria; for example, a “low fat” claim on a solid food means it has no more than 3g of fat per 100g.

Health Claims

Health claims suggest a relationship between a food or its components and health. These are more strictly regulated, often requiring scientific substantiation and approval, frequently involving the European Food Safety Authority (EFSA). Health claims are divided into:

Function Claims (Article 13): Relate to normal body functions, psychological aspects, or weight control. Example: “Calcium is needed for the maintenance of normal bones”.
Risk Reduction Claims (Article 14): State that a food significantly reduces a disease risk factor. Example: “Plant stanol esters have been shown to reduce blood cholesterol. Blood cholesterol is a risk factor in the development of coronary heart disease”.
Claims for Children's Development (Article 14): Address growth and development specifically in children. Example: “Vitamin D is needed for normal growth and development of bone in children”.

The Authorization Process

Authorizing a health claim is a detailed process. Manufacturers submit scientific evidence to national authorities, which then forward it to EFSA for scientific assessment. EFSA evaluates the data to confirm the link between the food component and the claimed health benefit. The European Commission makes the final authorization decision based on EFSA's opinion and other factors. Approved claims are added to an official list, though proprietary claims can have a five-year data protection period.

Key Restrictions on Claims

The regulation prohibits claims that are false, ambiguous, misleading, or that:

Raise doubts about other foods' safety or nutritional value.
Promote excessive consumption.
Suggest health is compromised by not eating the food.
Refer to weight loss rates or amounts.
Cite individual health professionals' recommendations.
Attribute the ability to prevent, treat, or cure diseases.

General health claims like “good for you” must be supported by a specific, authorized claim. Claims on products like sports supplements must be well-substantiated and not misleading to athletes.

A Comparison of Regulatory Approaches

Comparing the EU and Australia/New Zealand (FSANZ) systems reveals different regulatory models.


Feature	EU Regulation (EC) No 1924/2006	Australia/New Zealand (FSANZ Standard 1.2.7)
Core Principle	Claims must be scientifically substantiated and often require pre-market authorization.	Claims need scientific evidence and follow a tiered system.
Claim Tiers	Function Claims: Based on accepted science (Article 13). Risk Reduction Claims: Require authorization (Article 14).	General Level: Self-substantiated, notify FSANZ. High Level: Link to serious disease, need FSANZ approval.
Approval Body	European Commission (EC) final decision, with EFSA scientific input.	FSANZ approves high-level claims and is notified of general-level claims.
Prohibited Claims	No disease prevention/treatment claims. Restrictions on weight loss and implying necessity.	No claims on alcohol or infant formula. High-level claims must refer to a disease biomarker.
Mandatory Labeling Info	Must state the importance of a varied diet.	Foods with health claims must meet Nutrient Profiling Scoring Criteria.

Impact on Consumers and Manufacturers

The regulation enhances consumer confidence by providing credible information, reducing exposure to misleading marketing, and facilitating informed dietary choices. For manufacturers, while authorization can be complex and costly, successful claims offer a competitive edge and boost product reputation. This encourages innovation and research into beneficial food properties. The clear process supports fair competition. Navigating varied global regulations remains a challenge, though harmonization efforts help.

For more detailed regulatory guidance, manufacturers can consult the European Food Safety Authority (EFSA) website.

Conclusion

The nutrition and health claims regulation is essential for building consumer trust and protecting public health. It mandates scientific backing for marketing messages, ensuring claims are credible and based on evidence. Oversight by bodies like EFSA confirms accuracy and promotes healthy diets. Ultimately, the regulation empowers consumers and drives responsible innovation in the food industry.

Frequently Asked Questions

The primary EU regulation is Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.

A nutrition claim refers to the beneficial nutritional content of a food (e.g., 'high fibre'), while a health claim suggests a relationship between a food and a health benefit (e.g., 'calcium helps build strong bones').

The European Food Safety Authority (EFSA) is responsible for conducting the scientific assessment of health claim applications to verify they are backed by solid scientific evidence.

No. While most specific health claims require pre-market authorization, certain 'function claims' (Article 13) based on generally accepted science do not need individual submission if they are on the authorized list and comply with the conditions of use.

No, it is strictly forbidden to market food products with claims that they can prevent, treat, or cure a human disease.

The label must include a statement about the importance of a varied and balanced diet, the quantity of food needed for the beneficial effect, and, where appropriate, a warning for excessive consumption.

'On hold' claims, particularly for botanicals, are claims submitted for approval before the European Claims Register was established. They may be used under certain conditions if they have generally accepted scientific advice to support them and are not misleading.