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Health Claims

In general, health claims are understood to be health-related statements or representations on food products that describe a connection between the food or one of its components and health. In reality, health claims therefore suggest that the food or an ingredient thereof has a particular effect on health (for example: calcium is good for bones, etc.).

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EU-wide Regulations

As the community increasingly labeled food with nutritional and health-related information and advertised it with this information, it was necessary to guarantee consumers a high level of protection and make their choice easier by ensuring that the products on the market are safe and adequately labeled. At the European level, the EU Health Claims Regulation 1924/2007 therefore applies. The introduction of this regulation was intended to create comprehensive harmonization in the field of food law and at the same time offer a high level of consumer protection.

The regulation applies to both food and food supplements as soon as they are placed on the market as food and advertised as such. Food supplements are to be classified as “food” within the meaning of Art. 2 of Directive 2002/46/EC if they are intended to supplement the diet, consist of single or multiple concentrates of a nutrient with a nutrition-specific effect and are placed on the market in dosed form, such as in the form of capsules or other dosage forms. Cosmetics or medicinal products are not covered by this regulation, as they are not considered food.

Scope of application

The Health Claims Regulation applies to all nutrition and health claims made in commercial presentation, labelling (packaging and package inserts), and any type of advertising concerning food products that are supplied as such to final consumers.

It also applies to food products intended for restaurants, hospitals, schools, canteens, and similar catering establishments.

Trademarks, other brand names and fantasy names that can be interpreted as a nutritional or health-related claim and thus give the impression that there is a positive property between the name and health are also covered by the scope of the regulation. Messages contained in brands or names must therefore also be measured against the admissibility criteria of the regulation, i.e. are subject in particular to the prohibition of deception and the other general admissibility conditions of Articles 5-7. If the informative content of the brand or the designation is in accordance with the provisions, i.e. it is not misleading or contrary to any general condition of use with regard to the food products referred to, the brand or designation may be used without an official approval procedure in accordance with Art. 15-18 HCVO, provided that a specific nutritional or health-related application from the lists is also used.

The Regulation applies with restrictions

• to pre-packaged food products (including fresh products such as fruit, vegetables, or bread) offered for sale to the final consumer or mass caterers, and to food products that are either packaged at the point of sale at the purchaser’s request or pre-packaged for immediate sale (in which case Article 7 and Article 10(2)(a) and (b) of the Regulation do not apply – nutrition labelling would accordingly not be mandatory).
• to trademarks, brand names, or fanciful designations used in the labelling, presentation, or advertising of a food product that can be interpreted as a nutrition or health claim (Art. 1(3))

Nutrition-related claims

These refer to claims that state, suggest, or imply that a food product possesses particular positive nutritional properties due to the energy (calorific value) it provides, provides in reduced or increased amounts, or does not provide, and/or due to the nutrients or other substances it contains, contains in reduced or increased amounts, or does not contain.

Example:

• Energy-reduced
• Low fat
• No added sugar
• Light
• High calcium content
• rich in calcium

Health-related claims

These refer to any claim that states, suggests, or implies that a relationship exists between a food category, a food product, or one of its components, on the one hand, and health, on the other.

Example:

• Contains healthy Vitamin C
• Vitamin C to stay fit
• Milk is healthy
• Vitamin E enhances concentration
• Vitamin E is an antioxidant that protects body cells from free radicals.
• Calcium is needed for the maintenance of normal bones and teeth.

Claims regarding the reduction of a disease risk

These refer to any claim that states, suggests, or implies that the consumption of a food category, a food product, or a food component significantly reduces a risk factor for the development of a human disease.

Example:

• Oat beta-glucan has been shown to reduce blood cholesterol levels.
• High cholesterol is one of the risk factors for coronary heart disease.

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Key Provisions of the Regulation

In principle, in addition to general principles, the regulation sets out the conditions under which nutritional and health-related claims about food may be made. The content and requirements for the respective information are sometimes very complex and confusing:

General Principles (Art 3 HCVO)

First, the regulation establishes general principles that must be observed for all information. Accordingly, information (nutritional and/or health-related)

• be false, ambiguous, or misleading;
• raise no doubts about the safety and/or nutritional suitability of other foods. (Here, the prohibition aims at disparaging other, comparable products);
• not encourage or condone excessive consumption of a food product;
• not state or otherwise suggest that a balanced diet cannot generally provide the necessary amount of nutrients;

not influence a consumer’s purchasing decision through alarming indications suggesting a general change in bodily functions, implying that they could personally benefit from it.

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General Conditions (Art 5 HCVO)

In addition to the general principles, the regulation sets out general conditions for nutritional and health-related claims. Accordingly, nutritional and health-related claims may only be used if

• the stated effect is generally accepted and scientifically proven;
• the substance referred to is present (or absent) in the product in a sufficient quantity to achieve the claimed effect;
• – where applicable – the substance in question is in a form that is available to the body (according to nutrition experts, this term is defined by the percentage absorption of a respective nutrient into the body, taking into account the amount and speed of absorption). The bioavailability criterion is dependent on various food factors and therefore only applies facultatively in some cases, i.e. “where applicable”, because information that indicates a reduced content of a nutrient, as is the case, for example, in Art. 5 Para. 1 lit b (ii), cannot naturally meet this requirement.
• the usual amount of product consumed is suitable for achieving the stated effect;
• the specific requirements (see further below) are met;
• the claim refers to the food product as consumed.

In addition, the use of nutritional and health-related claims is only permitted if an average consumer can be expected to understand the positive effect stated. Therefore, attention must be paid to ensuring that the formulation is consumer-friendly.

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Nutrition Labelling (Art 7 HCVO)

The general principles and general conditions to be observed are ultimately accompanied by labeling provisions as a prerequisite. Accordingly, food that contains both nutritional and health-related information must contain mandatory nutritional labeling.

The regulation refers here in general to Regulation (EU) No. 1169/2011 (https://eur-lex.europa.eu/legal-content/DE/TXT/HTML/?uri=CELEX:02011R1169-20180101&from=EN). Accordingly, according to Art. 30 Para. 1 of this regulation, the calorific value, the amounts of fat, saturated fatty acids, carbohydrates, sugar, protein and salt must be stated.

In addition, for substances that are the subject of a nutritional or health-related claim and do not appear in the nutritional labeling, the respective amounts must be stated in the same field of vision in the immediate vicinity of this nutritional labeling. For food supplements, the special requirements of Art. 8 of Directive 2002/46/EC apply to labeling (https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:02002L0046-20220930&from=EN).

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Specific Conditions for Nutrition-Related Claims (Art 8 and 9 HCVO)

Art 8 of the Regulation stipulates that nutrition-related claims are only permissible if they are enshrined in a circumscribed form in the Annex to the Regulation and also generally comply with the requirements of the Regulation (see above, general principles and conditions, labelling obligation).

The list in the appendix is a self-contained structure. Accordingly, information that is not listed therein may no longer be used. The aforementioned annex embodies the idea of harmonization, especially since the individual member states had different provisions for nutrition-related information before the regulation came into force.

Even if this information is considered directly applicable and is regarded as higher-ranking law, it is only “specifications.” The nutrition-related information should therefore be contained in the annex in terms of meaning, but does not have to correspond to the exact wording of the claim stated there. The understanding of an average consumer should be used for this relaxed application. It is therefore permissible to use synonyms, provided that the consumer can recognize a connection with the information and the formulation in the annex. For example, instead of “source of fiber”, the wording “rich in fiber” can also be used.

The list in the appendix can be expanded or adapted by the authority after carrying out a procedure specified in the regulation. This ensures that the information corresponds to the latest state of technology and science.

A comparison of nutrition-related claims with other food products is only permissible if it is made between food products of the same category and taking into account a range of food products within that category (Art 9 Regulation).

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Specific Conditions for Health-Related Claims (Art 10 et seq. HCVO)

Health-related claims are prohibited if they do not meet the general requirements (see above) and the specific requirements (see below) of this regulation. In addition, health-related claims must be included in the list of approved claims (in accordance with Articles 13 and 14).

Such claims may therefore only be made if the labelling or, if such labelling is absent, the presentation of the food products and the food advertising bear the following additional information:

• an indication of the importance of a varied and balanced diet and a healthy lifestyle
• information on the amount of the food product and the consumption pattern required to achieve the claimed positive effect.

For example, it must be stated whether it is assumed that the stated effect is achieved if the food is consumed only once a day or several times throughout the day. Also, the reference must not encourage excessive consumption of a food or portray it favorably. In cases where this cannot be achieved, the health-related claim should be waived.

• where appropriate, an indication for persons who should avoid consuming this food product, and
• an appropriate warning for products that could pose a health risk if consumed in excessive amounts.

All this information must be part of the labeling. If such labeling is missing, it must be part of the presentation of the food and food advertising. If a health-related claim is used in general advertising for a food (such as meat, dairy products, etc.) that does not refer to a specific product, then these mandatory references must appear in the advertising and presentation of this food.

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Note:

Presentation: This refers in particular to the shape, appearance, packaging, the manner of its arrangement, and the environment in which it is offered for sale.

Non-specific (health-related) information that promises a beneficial effect on health and general well-being is only permitted if it is accompanied by a specific statement contained in the list according to Art. 13 or Art. 14. The background to this provision is that such information has a blanket character with a general formulation. It is therefore a so-called “combination solution.”

Examples of non-specific health claims include:

• Milk is healthy
• Contains healthy Vitamin C
• Fitness rolls

Health claims (Art 12) are in any case impermissible if they:

• create the impression that health could be impaired by not consuming the food product;
• refer to the duration and extent of weight loss;
• refer to recommendations from individual doctors or representatives of medical professions and associations not mentioned in Art 11.

Other health claims than those referring to the reduction of a disease risk, and other than those referring to the development and health of children (Art 13 HCVO)

On the basis of these provisions, the Commission has drawn up a Community list of health-related claims together with the necessary conditions governing their use (the so-called Art. 13 list). The health-related (other) information listed in the aforementioned list may therefore be used. This is information that

• describe the importance of a nutrient or other substance for growth, development, and bodily functions (e.g., “calcium is important for bones”),
• psychological or behavioural functions (e.g., “Vitamin E increases concentration”), or
• the slimming or weight-control properties of the food product, or the reduction of hunger, or an increased feeling of satiety, or a reduced energy intake through the consumption of the food product (before the Regulation, a total ban applied to such slimming advertisements) (e.g., “contains carnitine, which supports the weight-reducing effect”).
  It was only through the judgment of the ECJ of 15.7.2004, C-239/02, Douwe Egberts NV/Westrom Pharma NV/FICS-World BVBA, that a general ban on such advertising was regarded as contrary to Community law. Accordingly, the use of such information is permitted, provided that the consumer is not misled),

describe or refer to.

These aforementioned references therefore do not require an explicit authorisation procedure (see below), but must instead comply with the above-mentioned content requirements for inclusion in the so-called Art 13 list (https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:02012R0432-20210517&from=EN) (currently the latest valid version), as well as provide scientific proof and meet the requirements of consumer understanding.

However, additions to this list can be requested by anyone using a simplified approval procedure (Art. 18), provided that this desired information is based on new scientific evidence. However, this does not include information on the development and health of children, which are approved according to the procedure of Articles 15, 16, 17 and 19 (individual approval procedure) (see below). The aforementioned list can also be changed on the initiative of the Commission or at the request of a Member State, taking into account the regulatory procedure in accordance with Art. 25 Para. 3 of the regulation. The aforementioned simplified approval procedure (which anyone can initiate) corresponds in its basic structure to the stricter individual approval procedure (see below for information according to Art. 14 of the regulation) according to Art. 15 – 17 HCVO. The most significant difference in the shortened decision-making process is that the Commission has exclusive decision-making power. While in the case of individual approval according to Art. 15 ff, the application is decided in the regulatory procedure with control according to Art. 2, here the Commission makes its decision alone within 2 months after a positive opinion from the EFSA (European Food Safety Authority).

Information on the reduction of a disease risk and information on the development and health of children (Art. 14 HCVO)

The regulation also governs the approval procedure for health claims regarding the reduction of diseases and also information on the development and health of children.

These are claims in which a food is advertised as either reducing certain disease risks or having positive effects on the development and health of children.

Example: “Regular consumption of vitamin E reduces the risk of developing arteriosclerosis.”

For this information, the regulation provides for individual approval procedures according to Articles 15 ff of the regulation. Approval of this information therefore does not take place via (automatic) inclusion in the Community list according to Article 13 Para. 3 of the regulation, as is the case with other health-related information. In addition to the approval requirement, this information must of course also comply with the general principles and conditions (see above).

Claims regarding the reduction of a disease risk may therefore only be made if an approval procedure for inclusion in a list has been initiated and approved for their use.

In addition to the Art. 13 list, there are therefore also lists of approved information relating to the reduction of disease risks. These are based on Regulations No. 1226/2014 and No. 1228/2014. Link to Regulation 1228/2014: https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:32014R1228&from=DE.

Link to Regulation 1226/2014: https://eur-lex.europa.eu/legal-content/DE/TXT/PDF/?uri=CELEX:32014R1226&from=DE

In addition to this (approval procedure) and the general requirements, the labeling or, if there is none, the presentation of the food and the food advertising must contain a statement that the disease mentioned in the claim depends on several factors and that a change in one of these factors may or may not have a positive effect.

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Authorisation Procedure

The individual approval procedure is divided into three sections:

• the application (Art. 15),
• the EFSA (European Food Safety Authority) – assessment of the subject of the application and opinion (Art. 16) and
• the claims approval by the Commission within the framework of the committee procedure (Art. 17).

Since March 29, 2021, the application for individual approval has been submitted exclusively electronically via the new E-Submission platform (ESFC) on the basis of the EU Transparency Regulation. Only the approval of the use of a health-related claim may be requested in each application form. Furthermore, it is only permissible to present the connection between a precisely defined health effect per advertised food or food category or a nutrient or substance.

References to general, non-specific benefits of the nutrient or food for health in general or health-related well-being are in accordance with Article 10 Para. 3 of the HCVO only permitted if they are accompanied by a specific health-related claim contained in one of the lists according to Article 13 or 14 (see above).

The applicant has the legal remedy of an action for annulment within the meaning of Art. 263 TFEU (ex-Art. 230 Para. 4 EC Treaty) before the Court of First Instance (EuG) against the Commission’s decision (i.e. in the event of rejection or if disproportionate requirements are set). The period for bringing an action laid down in Union law is two months and can be extended by a further 10 days in accordance with the provisions of the Rules of Procedure of the Court of First Instance.

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EU Register (Art 20 HCVO)

The Commission maintains a Community register. This is intended to provide an overview of all approved and rejected health and nutrition-related claims. It therefore contains information regarding

• approved nutrition claims,
• approved health claims according to Art. 13 and Art. 14,
• rejected claims,
• health claims with “On Hold status”

Link to the register: https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=register.home

General Information on the Use/Formulation of Claims under the HCVO

First step

If it is planned to provide a product with a nutritional and/or health-related claim, it is recommended to first consult the existing Community register and the lists. For the list of permitted nutrition-related information, see above under point 2.2.3.

Health-related statements approved according to the register can be used at any time, taking into account the conditions of use or possible restrictions for the respective product. However, the general principles and conditions, as well as the labeling obligation, must always be taken into account.

It should also be noted that the use of non-approved information is generally prohibited. In addition, all (approved) health-related statements may only be made for those foods, food categories or nutrients for which they were originally approved and in no case for products that contain them.

Example:

The following health-related claim would therefore be inadmissible: “Product X contributes to the maintenance of teeth.” In this sense, the following would be permissible: “Product X contains vitamin D and calcium, which contribute to the maintenance of normal teeth.”

Inadmissible: “A glass of orange juice contributes to the reduction of tiredness and fatigue”. Permissible: “The vitamin C in a glass of orange juice contributes to the reduction of tiredness and fatigue.” (Teufer, GRUR-Prax 2012, 476/477 according to OLG Bamberg).

If the claim you are looking for is neither approved, rejected or cannot be found in the overall database, then this claim has apparently not yet been submitted for approval by anyone. Such claims may then not be used. However, if you have comprehensive scientific studies that prove the effect, then this information can be submitted via the approval procedure.

Formulation

If information has already been approved, the formulation for this can be found in the second table column of the Community list.

This formulation should express the scientifically proven effect of a food or a specific nutrient on the health of a person.

The question is whether a deviation from this explicit formulation is permissible. In recital 9 of Regulation 432/2012 (regarding the Art. 13 list), the legislator states that the regulation is intended to ensure that health-related information is truthful, clear, reliable and helpful to the consumer. The formulation and presentation of the information must be assessed against this background. Legal experts conclude from this paragraph that a certain flexibility of the individual information is probably permissible. This is as long as this improves the comprehensibility for the average consumer. In any case, attention must be paid to the various consumer target groups as well as to linguistic and cultural differences. Ultimately, what is decisive is that the formulation in terms of content is the same as that of the Community register.

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Legal Advice / Legal Representation

We would be happy to support you in all legal matters relating to the Health Claims Regulation. As part of the free initial consultation, we would be happy to discuss the ideal approach for your legal questions with you.

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