5. Claim Requirements

General Foods
EU

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

Within the European Union (EU), regulations regarding nutrition and health claims are established to ensure that consumers are not misled by false or exaggerated claims about food products. The regulation governing nutrition and health claims in the EU is regulation (EC) 1924/2006 [1]. It aims to harmonize rules across member states to protect consumers and facilitate the free movement of goods within the EU. 

5.1.1 Types & Definitions

Nutrition claims denote the presence of significant nutrients within the final food product. They encompass content claims and comparative claims, highlighting specific nutritional attributes. 

Health Claims pertain to the authorized health benefits linked to the nutritional content of the final product. These approved health claims span general functions claims, claims associated with mitigating disease risk, and claims relevant to the growth and development of children.

5.1.2 List of Prohibited Claims

In the EU, nutrition and health claims are regulated to ensure accuracy and prevent misleading information. Prohibited claims include:

• Claims that are false, ambiguous, or misleading.
• Statements that cast doubt on the safety or nutritional adequacy of other foods.
• Encouragement of excessive consumption of a food.
• Implications that a balanced diet cannot provide sufficient nutrients.
• References to bodily function changes that may exploit consumer fears.

Additionally, nutrient content claims contradicting established profile criteria are not allowed. For instance, a food high in sugar cannot claim to be low in fat. 

Foods making nutrition or health claims must comply with established EU nutrient profiles. These profiles set criteria for the maximum levels of certain nutrients, such as sugar, fat, and salt, to ensure that foods bearing claims are consistent with a balanced diet. Other prohibited claims include those implying foods can prevent, treat, or cure diseases, suggesting foods have medicinal properties or are substitutes for medical treatment, making misleading claims lacking scientific evidence, and unfairly denigrating competing products. These regulations aim to ensure consumers have accurate information for making informed choices.

5.2 Nutritional Claims

5.2.1 Permitted Claims

Permitted nutritional claims are those that meet specific criteria outlined in Regulation (EC) No 1924/2006 [1]. These claims must accurately represent the nutritional composition of the food product and must not be false, misleading, or ambiguous. Some examples of permitted nutritional claims include:

• "Low fat": A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 3 g of fat per 100 g for solids or 1,5 g of fat per 100 ml for liquids.
• "High fiber": A claim that a food is high in fiber, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 6 g of fiber per 100 g or at least 3 g of fiber per 100 kcal.
• “Low sugars": A claim that a food is low in sugars, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 5 g of sugars per 100 g for solids or 2,5 g of sugars per 100 ml for liquids.

Nutrition claims are only permitted if they are listed in Annex 1 of Regulation 1924/2006 lastly amended by Regulation 1047/2012 [2]. Currently, there are 30 nutrition claims permitted.

Nutritional claims are voluntary. However, nutritional labeling is compulsory where a claim is made.

The nutrient must appear in the nutrition table or in the same field of vision as the nutrition information.

5.2.2 Nutritional Claim Registration

(a) For nutritional claims that are already permitted for use: No need for registration before use.

(b) For nutritional claims that are not currently permitted for use: Only the positive list applies, there is no possibility to apply for new nutritional claims.

5.3 Health Claims

5.3.1 Permitted Claims

There are four main types of health claims in the EU:

• General, nonspecific health claims. These types of claims refer to health or well-being (Article 10) [1]. They must be supported by a related specific Article 13 or 14 health claim close to the general claim or suitably signposted, for example, with an asterisk.
• Health claims other than those referring to the reduction of disease risk (Article 13) [1]. These can relate to the growth, development, and functions of the body; to psychological and behavioral functions; or to slimming or weight control. (However, claims that refer to the rate or amount of weight loss are not allowed). Article 13 function claims are based on “generally accepted scientific data” whereas Article 13 claims are based on newly developed scientific data.
• Reduction of disease risk claims (Article 14 1a) [4]. These claims should also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
• Children’s growth and development (Article 14 1b)5 [1]. These claims are supported by scientific studies in children. There are 12 authorized health claims for children’s growth and development. Food products for children cannot bear adult claims.

A health claim draws the consumers' attention to the health benefits associated with a nutrient claim.

A public EU Register of Health Claims [4] lists all authorized and non-authorized health claims.

5.3.2 Health Claim Registration

(a) For health claims that are already permitted for use:

No need for registration before use.

(b) For nutritional claims that are not currently permitted for use:

The authorization procedure for individual applications of new health claims under Article 14(1)(a) and 14(1)(b) of Regulation (EC) No 1924/2006 [1] involves several steps, including the submission of a dossier containing scientific evidence to support the proposed health claim. The Commission's implementing rules, established by Commission Regulation (EC) No 353/2008 [5], inform applicants what their application should include. More guidance on the definition and classification of the scientific data for the assessment of a health claim is available on the EFSA website [6].

1. Preparation of the Application Dossier: Compile a comprehensive dossier containing all relevant scientific evidence supporting the health claim. Include detailed information on the food or ingredient, the proposed claim, and its intended use.
2. Submission of the Application: Submit the application dossier to the relevant authority in the EU member state where the product will be marketed. Applications may be submitted electronically or in hard copy, depending on the preference of the regulatory authority.
3. Validation of the Application: The regulatory authority reviews the submitted dossier to ensure that all required information and documentation are included. If the application is incomplete, the applicant may be requested to provide additional information or clarification.
4. Evaluation by the European Food Safety Authority (EFSA): Upon validation, the application is forwarded to the EFSA for scientific evaluation. EFSA assesses the scientific evidence provided in the dossier to determine if the proposed health claim is substantiated and meets the criteria outlined in the regulation. EFSA may request additional data or clarification from the applicant during the evaluation process.
5. Decision by the European Commission: Following EFSA's evaluation, the European Commission reviews the assessment and decides whether to authorize the health claim. If the claim is authorized, it is added to the EU Register of nutrition and health claims made on foods, and the applicant is notified of the decision.

Costs and Timeline

• The cost of the authorization procedure varies depending on factors such as the complexity of the application and any additional data required.  
• Applicants are responsible for covering the costs associated with preparing and submitting the application, as well as any fees charged by regulatory authorities. 
• The timeline for approval can vary significantly, ranging from several months to over a year, depending on the completeness of the application, the complexity of the scientific evidence, and the workload of regulatory authorities.

Overall, the authorization procedure for individual health claim applications involves a rigorous scientific assessment to ensure that only substantiated and accurate claims are authorized for use in the EU market.

5.4 Other Notes or Requirements for Claims

Food business operators are responsible for ensuring that any claims made on their products comply with EU regulations. This includes conducting necessary assessments and keeping documentation to support the claims made.

A trademark, brand name, or fancy name appearing in the labeling, presentation, or advertising of food which may be construed as a nutrition or health claim may be used without undergoing the authorization procedures provided for in this Regulation, provided that it is accompanied by a related nutrition or health claim in that labeling, presentation or advertising which complies with the provisions of this Regulation.

Conditions for use in making claims

Article 10 of the regulation (EC) 1924/2006 [1] states that when making a health claim there are certain conditions and additional statements that would be required on the pack:

1. A statement referring to a varied and balanced diet for a healthy lifestyle
2. Quantity of food required for the claimed benefit
3. Warning for those to whom it presents a health risk
4. Statement for those who should avoid the foods

‘On Hold’ - Botanical/Substance Claims

In the UK, the “On Hold Claims register” [7] outlines the botanical claims that are currently on hold as these claims have not yet been validated. However, on-hold claims may be used while they are still under consideration, subject to the transition measures. This means that they must comply with Articles 3, 5, 6, 7 & 10 of the Regulation (EC) 1924/2006 as well as other relevant national legislation. Note that claims must be scientifically substantiated and an individual using a claim must be able to justify its use.

5.5 References

1. Regulation (EC) 1924/2006 on nutrition and health claims made on food

EUR-Lex - 02006R1924-20141213 - EN - EUR-Lex (europa.eu)

2. Regulation (EU) 1047/2012 Amending Regulation (EC) 1924/2006 with regards to the list of nutrition claims

Regulation - 1047/2012 - EN - EUR-Lex (europa.eu)

3. COMMISSION IMPLEMENTING DECISION of 24 January 2013adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council

Implementing decision - 2013/63 - EN - EUR-Lex (europa.eu)

4. EU Register of Health Claims

Food and Feed Information Portal Database | FIP (europa.eu)

5. COMMISSION REGULATION (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council

Regulation - 353/2008 - EN - EUR-Lex (europa.eu)

6. EFSA Application Procedures 

Application procedures | EFSA (europa.eu)

7. On Hold Claims register 

Article-13.1-on-hold-health-claims.ods (live.com)