Food Supplement Claims: Types and regulatory considerations (Europe)

In recent years, the food supplement industry has made significant progress as consumers increasingly prioritize their overall well-being and seek to enhance their nutritional intake. Food supplements serve as complementary products, designed to supplement the diet, and provide additional nutrients or substances that can help bridge the gap in a person’s nourishment. However, it is important to note that according to their regulatory definition, food supplements are not intended to replace a balanced diet. They come in various forms such as capsules, gummies, powders, tablets, or liquids, and their marketing often includes food supplement claims that highlight and inform consumers about their potential benefits.

What are food supplement claims?

Food supplement claims refer to statements made by marketers to promote the benefits, effects, or characteristics of a specific food supplement product. These claims are aimed at informing consumers about the potential advantages of using the supplement and influencing their purchasing decisions. It is worth mentioning that while we will focus on food supplement claims, it is important to note that regulations regarding nutritional and health claims apply more broadly to food products, including food supplements.

How are food supplement claims categorised?

Food supplement claims can be categorised by their specific focus and regulatory considerations.

The following information is specific to Europe.

Nutritional claims (Europe)

Nutritional claims are statements that declare, suggest, or imply that a food product possesses specific beneficial nutritional properties due to its content of nutrients or other substances, either in increased or reduced proportions, or due to the absence of certain elements. For instance, a supplement might make claims such as being “high in vitamin C,” “salt-free,” or “reduced sugar.” These food supplement claims provide information about the nutritional composition of the product in a way that captures the interest of the target consumers.

The use of nutritional claims follows the principle of the “positive list.” This means that only the nutritional claims listed in the Annex of Regulation (EC) No 1924/2006, or its updated versions, are permitted. For example, a claim like “source of polyphenols” meets the definition of a nutritional claim but is not authorized since it is not included in the list. As a result, among the authorized nutritional claims, the most commonly used ones for food supplements are related to being a “source of” or “high in” a specific vitamin or mineral. Furthermore, the conditions for using these claims are well-defined. To prevent consumer confusion, a food supplement can only carry a nutritional claim if the recommended daily dose of the product, such as two gummies per day, provides a “significant” amount of the nutrient. For vitamins and minerals, a “significant” quantity is defined as “at least 15% of the NRV” (Nutritional Reference Value).

The NRV values for each vitamin and mineral are specified in Regulation CE No 1169/2011.

Health Claims (Europe)

Health claims, as defined by Regulation EC No. 1924/2006, encompass any message that declares, suggests, or implies a connection between a food category, a specific food, or one of its constituents and health. These claims can pertain to various aspects such as growth, development, and bodily functions. However, it is important to note that health claims must not imply that the product is capable of diagnosing, preventing, treating, or curing human diseases. For food supplements there is a list of authorized claims outlined in Regulation EC No. 432/2012 and its updates. Any health claims not included in this list are prohibited for use within the European Union, with the exception of certain “pending claims”.

what are authorised/ pending health claims

What are “authorised” health claims (Europe)?

Authorised health claims must be supported by scientific evidence demonstrating a cause-and-effect relationship between the consumption of the food or ingredient and the claimed health benefit. This scientific assessment is conducted by the European Food Safety Agency (EFSA). Once EFSA publishes its scientific opinion, the European Commission adopts and publishes a Regulation that authorizes the claim and specifies its conditions of use. This rigorous evaluation process ensures that authorized health claims are based on reliable scientific data and provide accurate and truthful information.

Currently, most authorized health claims are related to vitamins or minerals, and they can be used if the recommended daily dose of the food supplement provides at least 15% of the NRV for the respective nutrient. For example, a food supplement that provides at least 15% of the NRV for vitamin C in its recommended daily dosage can bear the authorized health claim “Vitamin C contributes to the normal function of the immune system.” It is important to emphasize that these claims must be associated with the specific ingredient for which the claim has been authorized, rather than the entire finished product. This ensures clarity for the consumer in understanding the responsible ingredient for the claimed health benefit.

Due to the constrained wording of authorized health claims, it can be challenging to differentiate one food supplement from competitors solely based on these claims. However, in addition to an authorized health claim linked to an ingredient, it is possible to use a more general food supplement claim. For example, if the authorized health claim “Iron contributes to the reduction of tiredness and fatigue” is labelled, the food supplement can also use the general claim “vitality” to convey an additional message.

It is worth noting that health claims are not limited to textual messages but can also take visual forms. Food supplement packaging often incorporates visual elements such as images, illustrations, or graphics to communicate potential benefits or effects of the product. However, these visual claims can only be used in conjunction with an authorized health claim to ensure they are not misleading for the consumer. Visual elements may include representations of desired outcomes or symbolic imagery.

What are “pending” health claims (Europe)?

Pending claims refer to claims that are currently on hold and have not yet received official authorization from regulatory authorities. These food supplement claims are predominantly associated with botanicals or plant-based ingredients. The evaluation of pending claims is aimed at determining whether they fulfil the necessary criteria for scientific substantiation, truthfulness, and accuracy. The reason for the “pending” status is that the European Union has yet to reach a consensus on the level of justification required for health claims related to botanical preparations. The main point of contention revolves around whether traditional use alone should be considered sufficient for substantiating such claims. Different Member States hold varying positions on this matter.

Regardless of the country, it is important to note that even if a health claim is on the “pending list,” it cannot be used unless it is adequately justified. It is the responsibility of the marketer to verify this aspect and provide proof, if required by the competent national authorities, that the pending claim being used is sufficiently supported for the intended conditions of use and target population of their product.


Beauty claims (Europe)

Beauty claims made on food supplements refer to the effects of the product on enhancing the appearance of the body or specific body parts. These claims typically focus on promoting physical qualities associated with skin, hair growth, nails, and overall radiance. It is important to note that a beauty claim should not refer to the functioning or physiological aspects of the body; otherwise, it would be considered a health claim and must comply with relevant regulations. Currently, there is no specific regulation governing beauty claims made on food supplements. Instead, a few Member States of the European Union have published guidelines in this regard. The absence of a unified European regulation means that different Member States may have differing positions on beauty claims. As a result, there is no official list of authorized beauty claims.

Determining whether a claim should be classified as a beauty claim or a health claim is the responsibility of the marketer, and this can sometimes be challenging. For example, the claim “Improves skin elasticity” would be considered a beauty claim, while “Improves skin hydration” may be classified as a health claim depending on how the product is presented and the specific regulations of the Member State in which it is marketed.

In the absence of specific regulations, beauty claims must adhere to the general principle of being truthful and not misleading to consumers. In other words, they must be substantiated and justified. However, there is no specific regulatory guideline outlining the type of evidence required to substantiate a beauty claim. Generally, it is understood that such food supplement claims should be supported by evidence obtained from human studies, whether they are clinical trials or consumer studies.

Consumer satisfaction claims (Europe)

food supplement claims, consumer satisfaction

Consumer satisfaction claims are statements made by marketers of food supplements that showcase the satisfaction or positive experiences of consumers who have used the product. These claims aim to emphasize the perceived benefits of the supplement by sharing feedback from individuals who have incorporated it into their daily regimen. The basis for these claims often includes:

-Testimonials and reviews: Marketers may gather and present testimonials or reviews from consumers who have experienced positive outcomes or satisfaction with the supplement.

-Survey results: Data collected from surveys or feedback forms may be used to support the claims of consumer satisfaction.

Consumer satisfaction claims are employed to provide peer validation and establish a sense of trust in the product. They serve as anecdotal evidence of the supplement’s effectiveness and aim to create confidence among potential buyers. However, it is crucial for marketers to ensure that the satisfaction claims they use are backed by objective and verifiable data. It is important to note that testimonials from health professionals cannot be used as part of these claims.

Food supplement claims play a crucial role in informing consumers about the benefits of these products. Regulatory authorities strive to ensure that authorized claims are backed by scientific evidence, while pending claims undergo thorough evaluation to determine their validity. By understanding the different types of claims and their regulatory considerations, food supplement brands can make informed choices when formulating their products and selecting ingredients that align with their objectives and appeal to their target consumers.

The information provided is a general overview and may not cover the specific regulations and requirements of every region or country , even within the EU. Food supplement claims are subject to the regulatory body governing the region in which the product is marketed or sold. It is crucial to consult the relevant regulatory authorities and familiarize yourself with the specific guidelines, regulations, and requirements in your region before making any claims or decisions related to your food supplements and/ or their components.


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