Backed by growing awareness around health and fitness among consumers, and the continued growth in popularity of related products more generally, the EU food supplements market is expected to more than double in size to €27 billion by 2027. Meanwhile, innovators in the food supplement and cosmetic sectors continue to develop liquids, gels, capsules, syrups and sachets containing ingredients such as collagen, hyaluronic acid, specific vitamin/mineral mixtures and various botanical extracts with claimed benefits such as glowing skin, fewer wrinkles or glossier hair.

As compelling as these offerings are for consumers pursuing ‘beauty from within’, manufacturers of these types of products need to chart a path through a number of different EU rules and regulations when deciding what claims to make relating to their products. We break down the main pieces of legislation to be aware of.

Foods not cosmetics

EU food law provides a very broad definition of food as any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Therefore, products that are intended to be ingested by consumers, as opposed to being applied to an external part of the body (per the definition of a cosmetic product under EU law), are regulated under EU food legislation.

Regulation 1169/2011 on food information for consumers

Regulation 1169/2011 on food information for consumers (the FIC Regulation) is the omnibus labelling and food information law in the EU. It sets out various detailed requirements relating to ingredients, allergens, nutrients declarations, dates of minimum durability, etc. that need to be complied with.

In terms of claims or information provided about the product at a general level, Article 7(1)(b) of the FIC Regulation provides that food information (which is defined very broadly as what is communicated to the final consumer via the label or any other means) shall not be misleading “by attributing to the food effects or properties which it does not possess”.

The Food Supplements Directive

Specific regulations relating to food supplements are provided for under the Food Supplements Directive (Directive 2002/46/EC). It contains a harmonized definition of a food supplement, sets out some additional specific labelling requirements for these types of products and provides for a notification system where food supplements can be reported to competent authorities before they are placed on the market.

In terms of claims or information provided about food supplements specifically, labelling, presentation and advertising of food supplements must not:

• Attribute to food supplements the property of preventing, treating or curing a human disease (Article 6), or

• Include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general (Article 7)

The Health Claims Regulation

A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health. In the EU, these types of claim must be validated by the European Food Safety Authority (EFSA) and listed in a register maintained at EU level which includes the wording of claims and the conditions applying to them.

The treatment of claims relating to appearance under the Health Claims Regulation (1924/2006) need to be assessed carefully on a case-by case basis. A key question is whether or not the claim being made about the food product relates to a function of the body and a beneficial physiological effect. If it does, then the claim is a health claim requiring pre-approval by EFSA. In order to avoid making an unauthorised health claim, businesses therefore need to ensure that no claim relating to a function of the body resulting in a beneficial physiological effect is being made, and that the causal relationship being highlighted is one between the product and physical appearance, not a function of the body. This can be particularly important in claims being made about the appearance versus functions of the skin for example.

Advertising standards

Businesses should also be aware of general advertising standards. In Ireland, these are set out in the Advertising Standards Authority of Ireland's 'Code of Standards for Advertising and Marketing Communications in Ireland' (ASAI Code). Section 8 of the ASAI Code relates to the advertisement of food and non-alcoholic beverages and specifically refers to the provisions of the FIC Regulation and the Health Claims Regulation.

Although, primarily considered under the umbrella of food legislation, product claims relating to appearance should also take note of Section 11 of the ASAI Code, which deals specifically with health and beauty and provides that claims regarding health and beauty products should be backed by substantiation and, where relevant, should include the results of reputable trials on human subjects.

Conclusion

Given the innovative nature of these types of food products, the wording and context of claims to accompany them need to be carefully considered with reference to various pieces of legislation and regulatory codes. This assessment should always be carried out on an individual basis. However, the following points should be helpful in guiding that exercise:

• If a product is intended to be, or reasonably expected to be ingested by humans, it is a ‘food’ under EU law and is regulated under EU food legislation.

• Businesses should be careful to ensure that no unauthorised health claims are being made about a product. If necessary, they should be ready to justify the position that the claim is not a health claim and falls outside the scope of the Health Claims Regulation.

• Health claims aside, there is also a more general requirement not to mislead consumers under the FIC Regulation. Businesses still need to be in a position to present evidence in support of any claims or other information being provided to consumers in relation to a product.

• Under the Supplements Directive, care should also be taken to avoid presenting the product as preventing, treating or curing a human disease or suggesting that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.

• Outside of food-specific legislation, claims regarding health and beauty products should also be evidence-based in order to comply with relevant advertising standards.

For expert guidance on these matters, contact a member of our Food & Beverage or Product Regulation & Consumer Law team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.