Health claims on food labels

Health claims and their importance for food start-ups

Food products are no longer just supposed to satisfy hunger or quench thirst; they are also supposed to make us healthier, more beautiful and more efficient. The health aspects of food play an increasingly important role in successful promotion and marketing. The modern consumer eats and drinks health conscious. Understandably, many food start-ups want to take advantage of this trend by creating new products that take greater account of consumers' health needs.

However, high demands are placed on food law at both national and international levels. This also includes the EU Regulation on Health Claims, which came into force in 2007, regulating nutrition and health-related claims in the labeling and presentation of food advertising in all EU member states. The aim of the Health Claims Regulation is to reduce the "uncontrolled growth" of health claims and to create a high level of protection for consumers. So if you want to point out how healthy your products are and don't want to risk a warning, you should definitely take a closer look at the provisions of the Health Claims Regulation.

In the following article, we have therefore summarized, especially for food startups, as well as for manufacturers and retailers of food, what must generally be considered in food advertising with health references in order to ensure legal compliance.

What are health claims in the context of the Health Claims Regulation?
What does the Health Claims Regulation regulate, and when does it apply?
List of permitted health claims
Health claims - What is allowed?
What applies to disease-related information and statements relating to children?
Checklist - Advertising with health claims in EU food law
Legal consequences of violations

Your contact person:

Tobias Bystry

Lawyer

Phone: +49 30 36 41 41 90
E-Mail: kontakt@abd-partner.de

1. What are health claims in the context of the Health Claims Regulation?

"Health Claim" means according to the literal translation Health claim. Art. 2 para. 2 no. 5 of the HCVO defines a "health claim" as follows:

"any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health“

A health claim therefore advertises a health-promoting effect of a food (this also includes dietary supplements), whereby the underlying concept of health also includes mental balance.

In addition to specific health claims, which are assumed when reference is made to certain functions of the body to be promoted, non-specific health claims also fall under the broad category of health claims within the meaning of the HCR (see Art. 10 (3) HCR). A reference to general, non-specific benefits for health or health-related well-being as defined by the HCR can be assumed if benefits of the food (or nutrient) mentioned without stating specific effects on certain bodily functions.

Health-related information includes, for example "Strengthens the body's defenses", "Promotes performance", "For strong bones", "Supports the metabolism" or "Lowers the cholesterol level".

However, contrary to the wording, the scope of the Health Claims Regulation also includes nutrition claims. Nutrition claims are statements or representations on food packaging or in advertising that convey that a product has a special nutritional value, which increases the perceived quality of the food.

A high nutrient content is often advertised, for example "Rich in calcium", "High in protein" or "Source of fiber". Hoewever a low nutrient content can also have a health benefit, for example in the case of fat or sugar (e.g. "Low carbohydrate", "Low carb" or "Reduced fat").

A "claim" within the meaning of the HCR, according to Article 2 (2) No.1, is any statement or depiction,

which is not obligatory under community or national law, including representations by images, graphic elements or symbols in any form; and
which declares, suggests or implies that a food (or food supplement) has particular characteristics.

The term "claim" must therefore be interpreted very broadly. The claim can be made orally or in writing; illustrations are also count as claims. Statements made via the internet, television, radio, etc. can therefore be “claims” within the meaning of the HCR.

Another decisive factor for the existence of a claim within the meaning of the HCR is that statements or representations are made which could give the impression to a reasonably well-informed and reasonably observant and circumspect average consumer that a foodstuff has special characteristics. The question of when a claim falls under the HCR must be answered on a case-by-case basis.

In particular, general advertising exaggerations do not constitute nutrition or health claims. Advertising claims that an energy drink gives you wings, that fruit gum makes children happy or that yoghurt no longer turns you on are not covered by the HCVO. General terms that are traditionally used to indicate a characteristic of a category of food that could have an effect on human health (such as "cough drop") are also excluded. Furthermore, the Federal Court of Justice did not consider the product name "Energy & Vodka" to be a nutritional claim, but rather a descriptive statement that it is a mixed drink consisting of vodka and an energy drink (cf. BGH, judgment of 09.10.2014, I ZR 167/12).

2. What does the Health Claims Regulation regulate, and when does it apply?

The Health Claims Regulation (EU Regulation No. 1924/2006) was enacted by the European legislator back in 2006. The regulation aims to achieve two main objectives:

Firstly, to ensure a high level of protection for consumers. This means that “health promises” are only permitted if they are actually fulfilled.
Secondly, to ensure the free movement of goods by creating equal competitive conditions. Conversely, the regulation also creates legal certainty for companies.

Therefore, the Health Claims Regulation applies to nutrition and health claims made in commercial communications in the labeling and presentation or advertising of foods and food supplements (Art. 1 para. 2 HCR) and regulates the admissibility of such claims. According to Art. 1 (3) HCR, the Regulation also applies to trademarks, other brand names and fanciful names that can be interpreted as nutrition or health claims. Furthermore, the Regulation also applies to statements relating to the reduction of disease risks and those related to children.

Attention: The Health Claims Regulation only regulates the voluntary area of health-related advertising for food. The regulation does not apply to any information that must be provided on food products by law (e.g., under the Food Labeling Regulation). Manufacturers and retailers only have to comply with the Health Claims Regulation if they want to provide their food with an additional positive advertising message that refers to its particular health benefits.

Furthermore, health claims must be distinguished, in particular, from promises of healing. If manufacturers advertise that their product can cure or prevent diseases or other ailments, they are suppliers of remedies and no longer (only) of food or food supplements. In such cases, the Health Claims Regulation does not apply. In Germany, particular attention must then be paid to the Health Services and Products Advertising Act.

3. List of permitted health claims

The European Commission has tasked the European Food Safety Authority (EFSA) with examining what is behind the advertising slogans and which of the health claims are actually true. On this basis, the EU Commission drew up a list of permitted health claims. On the one hand, the list is intended to simplify the control of the claims used and, on the other, to prevent companies from creating a non-transparent, broad field of health claims with more and more new claims, which harbors the risk of arbitrary use and misleading consumers. Health claims are therefore only permitted following prior substantive examination and subsequent inclusion in approval lists. Only claims from these lists are permitted. The statements should always contain the wording specified in the list, but are also permissible if they have the same meaning as the standardized wording (see Recital 9 HCR). Additionally, companies are free to apply for approval of further claims through a regulatory procedure.

>A partial list of permitted health claims can be found in the Annex to the EU Authorization Regulation No. 432/2012 . The list can also be found on the Website of the EU Commission. According to Art. 20 para. 1 HCR, the Commission is obliged to establish and maintain a EU register of nutrition and health claims made on foods. As Regulation No. 432/2012 has since been extended and amended by various legal acts, it is therefore important to always refer to the latest version of the EU database in order to determine the authorization of a health claim with legal certainty. Only the EU Commission's register contains a complete list of all authorized health claims from all initiative and amending regulations, as well as the conditions for their use. The register also includes a list of rejected health claims and the reasons for their rejection.

According to the list, the following statements, among others, are permissible:

"Magnesium contributes to the reduction of tiredness and fatigue."
"Iron has a function in cell division.";
"Vitamin C increases iron absorption.";
"Water contributes to the maintenance of normal physical and cognitive functions."
"Zinc contributes to the maintenance of normal nails." and
"Sugar-free chewing gum helps to maintain tooth mineralization."

However, all statements are subject to further conditions, which can also be found in the annex to the regulation or the EU database. For example, the above statement on water is only permitted if the consumer is also informed that at least 2.0 liters of water should be consumed daily in order to achieve the stated effect.

4. Health claims - what is allowed?

a) General requirements

In general, the use of nutrition and health claims for foods is only permitted in accordance with Art. 5 HCR if:

the stated effect is generally recognized and scientifically proven
the named substance is present (or absent) in the product in sufficient quantity to achieve the claimed effect
the named substance is present in a form that is available to the body
the usual consumption quantity of the product is suitable for achieving the stated effect
the claim refers to the ready-to-eat food.

These requirements must be met cumulatively for a nutrition and health claim.

According to Art. 3 HVCO, the nutrition and health claims used must not, in particular:

be false, ambiguous or misleading;
raise doubts about the safety and/or nutritional suitability of other foods;
encourage excessive consumption of a food or present it favorably;
explain, suggest or even indirectly imply that a balanced and varied diet generally cannot provide the required amounts of nutrients.
refer to changes in bodily functions that could cause anxiety or benefit the consumer, through a textual statement or through representations in the form of images, graphic elements or symbolic representations

Important: Compliance with the aforementioned conditions alone does not automatically mean that the health claims are permitted. The regulation as a whole is to be regarded as a prohibition subject to authorization. Nutrition claims must be explicitly permitted according to an annex of the HCR. Health claims must be included in the EU Commission's list of authorized claims (more on this below).

b) Nutrient profiles

According to Art. 4 of the HCVO, the Commission is to define specific nutrient profiles for food (categories), compliance with which is to constitute a further admissibility requirement for nutrition and health claims. Only if a food complies with its nutrient profile may health or nutrition claims be made at all (apart from a few exceptions, see below). Nutrient profiles are intended to prevent "unhealthy" foods from being advertised with such claims, thereby giving the impression that they have a higher nutritional value than is actually the case. Due to the current the lack of adoption of relevant nutritional profiles however, when using claims according to the HCVO, these are not (yet) to be observed (as of January 2024).

However, Article 4(3) of the HCR also establishes an inherent nutrient profile and prohibits health claims for alcoholic beverages with an alcohol content of more than 1.2% by volume. In addition, for beverages with an alcohol content of more than 1.2% by volume, only nutrition claims are permitted, whichs refers to a low alcohol content or a reduction in the alcohol content or a reduction in the calorific value are permitted (relative ban on nutrition claims).

c) Special conditions for nutrition claims

According to Article 8 (1) HVCO, nutrition claims may only be made if

they are included in the list in the annex to the regulation and
comply with the general conditions set out in the regulation (see above).

In addition to the list of permitted health claims, there is also a list of permitted nutrition claims. This list in the Annex to the HCR must be observed (in addition to the general conditions) for nutrition claims. The list does not provide any explicit wording for nutrition claims, but regulates the material scope of admissibility for certain statements. Any claims that are identical to the respective heading (e.g. "low-fat", "sugar-free" or "low-sodium") or have the same meaning according to consumer understanding must comply with the specified criteria.

For nutrition claims, the Health Claims Regulation provides, among other things, the following:

Products labeled as "energy-reduced" must contain at least 30% less energy than comparable foods.
The term light has the same meaning as "reduced", i.e. at least 30% less energy or nutrient content.
The claim "low-fat" is only permitted if the product contains less than 1.5 g fat per 100 g or 100 ml.

These and other nutritional claims such as "high protein content", "high vitamin C content" are binding definitions for 24 different nutritional values listed in the annex to the regulation.

d) Specific conditions for health claims

The so-called prohibition principle with reservation of permission applies to health claims. According to this principle, health claims are generally prohibited unless they comply with

the general principles regulated in Art. 3 to 7 HCR (see above) and
the specific requirements for health claims laid down in Art. 10 to 19 HCR and
the list of authorized claims in accordance with Articles 13 and 14 of the HCR.

The catalog of the specific labeling requrements in Art. 10 para. 2 HCR is a separate admissibility condition for health claims. Accordingly, it is required that the labeling or advertising on food contains the following information:

an reference to the importance of a varied and balanced diet and a healthy lifestyle,
information on the quantity of the food and the consumption pattern, which are required to achieve the claimed beneficial effect,
if applicable, a notice to persons who should avoid consuming this food and
an appropriate warning for products that could pose a health risk if consumed in excess.

The labeling requirements must be fulfilled cumulatively; violations lead to the inadmissibility of the health claim.

It should also be noted that health claims can change because, for example, research discovers new effects of foods or disproves previously believed ones.

Furthermore, it is also important to note that according to Art. 10 para. 3 HCR, references to general, non-specific benefits of a nutrient or food for health or health-related well-being are only permissible if they are accompanied by one of the specific health claims contained in the lists according to Art. 13 or Art. 14 HCR. The completeness of the lists is no longer a prerequisite for the application of the provision according tot he case lae oft he German Federal Court of Justice. For non-specific health claims, the information requirements of Art. 10 para. 2 HCR also apply. This means that such claims are inadmissible if they are not linked to the mandatory information.

Many German courts have already dealt with the problem of health-related advertising claims and have had to decide which promises are permissible and which are not. For example, the following advertising claims, which were often used until recently, were deemed inadmissible:

Detox:"Detox" is a non-permissible health-related advertising claim for a herbal tea. The term "detox" is understood by consumers in the sense of a detoxifying effect. Such an effect is neither proven nor permitted as a health claim (cf. BGH, decision from 06.12.2017 - I ZR 167/16).

Digestible: Beer, wine and liqueurs may not be advertised with the statement "digestible". For alcoholic beverages with an alcohol content of more than 1.2% by volume, such a health-related statement is generally not permitted (cf. BGH, judgment of. May 17, 2018 - I ZR 252/16 - Wholesome beer; OLG Düsseldorf, judgment of 23.03.2010 - I-20 U 183/09; ECJ, Judgment of. 6. 9. 2012 - C-544/10 - Deutsches Weintor eG/Land Rheinland-Pfalz).
Probiotic: The health claim "probiotic yoghurts have a positive effect on the immune system" is not permitted. This health claim was not even included on the European Commission's list of permitted health claims (OLG Celle, judgment of. September 4, 2018 - 13 U 37/18).

5. What applies to disease-related statements and statements relating to children?

As already mentioned, the provisions of the Health Claims Regulation also apply to claims relating to the reduction of disease risks and to those with child reference.

With the so-called "Risk Reduction Claims" (e.g. "the risk of colds is reduced") are claims according to which the food or an ingredient has a beneficial effect. Risk factor for the development of a disease in humans clearly lowers. Such claims are only permitted if they have been approved in a special Community list following an official approval procedure. Risk reduction claims must be applied for by the manufacturers who wish to use them, submitting scientific data on their truthfulness. The EFSA checks whether the statements are scientifically correct and proposes acceptance or rejection of the health claims to the EU Commission. Lists of the claims permitted to date can be found in the EU Regulation No. 1226/2014 and EU Regulation No. 1228/2014.

For example, the following disease-related statement is permissible:

"The use of unsaturated fatty acids instead of saturated fatty acids in the diet has been shown to lower/reduce blood cholesterol levels. A high cholesterol level is one of the risk factors for coronary heart disease."

This information may only be used for fats and oils.

In addition to the requirement to obtain authorization for the claims, the use of disease-reducing claims must comply with additional labeling requirements in accordance with Art. 14 (2) HCR.

For claims relating to children's development and health (e.g. claims "Lernstark" and "Mit Eisen ... zur Unterstützung der Konzentrationsfähigkeit" for a children's juice), express approval is also required as part of the individual authorization procedure (see above).

6. Checklist - advertising with health claims in EU food law

Simplified, the following checklist can be used to check whether a claim can be used or not:

Is the product to be advertised a foodstuff?
Does the food comply with the nutritional profile? (Due to the lack of adoption of relevant nutrient profiles so far, this point is not yet relevant for the use of claims under the HCR)
Is the claim related to health, nutrition, disease-related, or about children's development and health?
Is the health claim permitted in specific cases?

For nutrition claims: does the claim comply with the annex of the regulation?
For health claims: is the claim on the Community list and does it comply with its requirements?

If these points are answered in the affirmative, the most important hurdles of the Health Claims Regulation have been overcome and the claim may be used if it also complies with the other provisions of the regulation, which should generally be the case with the "common" claims on foods.

7. Legal consequences of violations

Inadmissible health or nutrition claims are not only a violation of the Health Claims Regulation, but also an infringement of the German competition law, as it is a market conduct regulation (cf. BGH, judgment of. 26.2.2014 - I ZR 178/12).

The rules of the market are set out in Act Against Unfair Competition (UWG). The UWG regulates the market behavior of competitors to ensure a free and fair market. According to Section 3a UWG, unfair competition occurs if a statutory provision that regulates market behavior to protect the interests of market participants is not observed. In the event of a breach of the Health Claims Regulation, competitors as well as certain associations and institutions (see Section 8 (3) UWG) therefore have a right for injunctive relief against the manufacturer and/or the retailer who advertises their products with the unlawful health or nutrition claims. Legal enforcement typically begins with a cease-and-desist letter under competition law and, in the event that the required cease-and-desist declaration is not provided, then proceeds with the help of the courts.

The risk for food manufacturers and distributors of being warned or even receiving a preliminary injunction for a competition violation against the Health Claims Regulation is very high, especially in times of booming online trade. Online retailers who either adopt the product manufacturer's advertising claim or wish to advertise the product with their own claim must also note that the advertiser has the burden of presentation and proof for a health-promoting property of a product if this is not listed in the HCR.

Retailers should therefore be careful with health claims and and have the product advertising checked in advance by a specialized competition lawyer. This can usually prevent cost-intensive warnings, injunctions and lawsuits.

If a c&d letter has already been issued, it is advisable not to sign the attached cease-and-desist declaration in the specified form without checking it, as it is often too broadly formulated. So signing it could lead to far-reaching consequences, particularly high contractual penalties. Claims for payment should also not be fulfilled without being checked by a specialized lawyer for competition law. In many cases, where c&d letters are issued by lawyers, the amounts in dispute are often exessively high. In such cases, it is often possible to achieve a reduction in the costs demanded through a settlement.

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