Food Supplement Legislation in the EU

Before selling nutraceuticals to different countries, enterprises shall understand corresponding regulations and supervision framework in the target country. When it comes to product classification from the legal perspective, a nutraceutical product can be regarded as regular food or subject to a specialized food category. In different places, the specialized food category is named health food in China, health functional food in South Korea, health protection food in Vietnam, etc. The counterpart in the EU is food supplement.

As food supplement in the EU is regulated as food, despite following specialized regulations for food supplement, these products shall also conform with general regulations for all kinds of food, including aspects such as product recall, additives, labeling, claims, hygiene, contaminants, GMO, etc.

Definition

According to Directive 2002/46/EC on the Approximation of the Laws of the Member States Relating to Food Supplements¹, food supplement is supervised as foodstuffs, with the purpose to supplement the normal diet. Such products are concentrated sources of the following substances, alone or in combination:

Nutrients, which refer to vitamins and minerals
Other substances with nutritional or physiological effect, such as amino acids, essential fatty acids, fibre, as well as various plants and herbal extracts.

Regarding the dose form, food supplements are in forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

Please note that, the addition of nutrients or other substances to fortify a food is regulated under Regulation (EC) 1925/2006². This kind of fortified food does not fall within the definition of food supplement³. Read more differences between the fortified food and food supplement here⁴.

EU Framework and Management Mechanism

In the EU, the European Commission is responsible for developing and implementing laws. General principles and requirements for food are supervised by the General Food Law Regulation (Regulation (EC) 178/2002)⁵. As per this General Food Law Regulation, the European Food Safety Authority (EFSA) will be responsible for scientific advice and support.

When it comes to the food supplement sector, Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements¹ is the major reference legislation in the EU level. It stipulates some basic requirements for food supplements, including harmonized definition, allowed nutrients lists, labeling requirements, etc. Member States will ensure that food supplements can only be marketed within the EU after these products comply with the rules laid down in this Directive. Some Member States may adopt a notification procedure⁶ to supervise such products.

For non-harmonized requirements not stipulated in Directive 2002/46/EC, enterprises need to conform with corresponding national law, if any, in the target Member State. For example, in the absence of harmonized maximum levels for certain vitamins and minerals, some Member States⁷ already have their own maximum levels and other related restrictions in place. It is worth mentioning that EU is now preparing to launch an initiative to regulate the maximum and minimum level for specific vitamins and minerals when being added to food supplements⁸.

Ingredient management

Annex I of Directive 2002/46/EC lays down a list of vitamins and minerals which may be used in the manufacture of food supplement (e.g., vitamin A). Annex II details a list of substances authorized as the sources of the vitamins and minerals listed in Annex I (e.g., retinol, a permitted source of vitamin A, is listed in Annex II). For enterprises that want to market new substances as the source of nutrients listed in Annex I³, they can submit applications to the European Commission. Upon the request from the Commission, EFSA will conduct an assessment and issue the scientific opinion. Based on the scientific opinion from EFSA, the Commission may update the list. Submission of requests for inclusion of vitamins and minerals as well as their sources in the Annexes, and the use of substances other than vitamins and minerals in food supplement can be check here⁹.

Moreover, as per EFSA³, the use of ingredients other than vitamins and minerals (e.g., botanicals) in the manufacture of food supplements may also be authorized under other specific legislation depending on the nature of the substance (e.g., novel foods, substances for the fortification of food and foods for specific groups). Please note that ingredients outside the above situations may still be used under Member States’ national rules³. In addition, the use of food additives shall conform with Regulation (EC) No 1333/2008 on Food Additives¹⁰. On the other hand, please note that Regulation (EC) No 1925/2006² contains a short list of substances whose use in foods is prohibited, restricted or under scrutiny.

Mandatory labeling

Regulation (EU) No 1169/2011 on the provision of food information to consumers¹¹ is the fundamental labeling regulation for food products in the EU, which establishes the general principle and requirements governing food labeling. As per Regulation (EU) No 1169/2011, mandatory labeling items for food supplement include:

Name of the food
List of ingredients
An indication of ingredient or processing aid causing allergy or intolerance
Quantity of certain ingredients or categories of ingredients
Net quantity of the food
Date of minimum durability “best before” or the “use by” date
Any special storage conditions and/or conditions of use
Name or business name and address of the responsible food business operator
Country of origin or place of provenance
Instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions
[Nutrition declaration. According to Regulation (EU) No 1169/2011 on the provision of food information to consumers¹¹, provisions for nutrition declaration prescribed in this Regulation do not apply to food supplement.]

Besides this Regulation, Directive (EC) 2011/91¹² requires the labeling of lot indication¹³ and Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements¹ adds additional labeling items as below:

Names of the categories of nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances
Portion of the product recommended for daily consumption
A warning not to exceed the stated recommended daily dose
A statement to the effect that food supplements should not be used as a substitute for a varied diet
A statement to the effect that the products should be stored out of the reach of young children
Amount of the nutrients or substances with nutritional or physiological effect present in the product

Finally, enterprises shall pay attention that the labeling, presentation and advertising of food supplement, including:

Not attribute to food supplements the property of preventing, treating or curing human disease, or indicate to such properties
Not state or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general

Check more labeling requirements at the EU Food Labeling Information System¹³ and Food Labeling Rules¹⁴.

Nutrition and Health Claims

Claims are not mandatory in the EU. However, if enterprises choose to use nutrition or/and health claims, they shall comply with the provisions of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods¹⁵. In this case, it is mandatory to make nutrition labeling of products, which contains nutrition and/or health claim. Besides, this Regulation also prescribe some non-compliant situations. For example, the use of nutrition and health claims shall not:

Be false, ambiguous or misleading
Give rise to doubt about the safety and/or the nutritional adequacy of other foods
Encourage or condone excess consumption of a food
State, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general
Make statements that incite fear on the part of consumers

Permitted nutrition and health claims as well as their use requirements are listed below. Notably, regular food can also be attached with such claims as long as meeting relevant requirements.

Table 1: A Summary of requirements for nutrition claims

Explanation of the term

Nutrition claims include content claim and comparative claim.¹⁶ It refers to any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to

1. The energy (calorific value) it

Provides
Provides at a reduced or increased rate or
Does not provide

2. The nutrients or other substances it

Contains
Contains in reduced or increased proportions or
Does not contain

Examples include: low energy, energy-reduced, energy free; source of fiber, high fiber

Use condition

Product shall comply with the official definition
The product shall comply with the conditions for making the nutritional claim
The nutritional claim is listed in Annex of Regulation (EC) No 1924/2006¹⁵

List

Annex of Regulation (EC) No 1924/2006¹⁵

Table 2: A Summary of requirements for health claims

Explanation of the term	Health claim refers to any claim that states, suggests or implies that a relationship exists between a food category, a food, or one of its constituents and health. It can be roughly divided into 3 types: The so-called “Function Health Claims”: Article 13 “Health claims other than those referring to the reduction of disease risk and to children's development and health”, including those: ✔ Relating to the growth, development and functions of the body (e.g., “Protein contributes to a growth in muscle mass”) ✔ Referring to psychological and behavioural functions (e.g., “Thiamine contributes to normal psychological function”) ✔ On slimming or weight-control (e.g., “Glucomannan in the context of an energy restricted diet contributes to weight loss”) The so-called “Risk Reduction Claims”: Article 14 1 (a) Reduction of disease risk claims. For example: "Plant stanol esters have been shown to reduce blood cholesterol. Blood cholesterol is a risk factor in the development of coronary heart disease." Health claims referring to children's development and health, as stipulated in Article 14 1 (b). For example: "Vitamin D is needed for the normal growth and development of bone in children."
Use condition	The use of health claims shall comply with general and specific regulations in the Regulation. Notably, the health claim shall be authorized and included in the list of authorized claims. Besides, health claim can only be permitted when it is displayed together with the information regulated in Clause 2 of Article 10, including a statement indicating the importance of a balanced diet and healthy lifestyle, etc. National authorities monitor the use¹⁸ of claims through inspections and legislation.
List	Regulation (EC) No 983/2009¹⁹ on the authorization and refusal of authorization of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health Regulation (EU) No 432/2012²⁰ establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health EU Register of Health Claims²¹ (including non-authorized health claims)
How to apply for new claims	The submission procedure of application, needed materials and EFSA’s guidance can be found at: Regulation (EC) No 1924/2006 on nutrition and health claims made on foods¹⁵ Regulation (EC) No 353/2008 establishing implementing rules for applications for authorization of health claims²² EFSA’s general scientific guidance for stakeholders on health claim applications (Revision 1)²³ EFSA’s scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)²⁴ The rough application procedure: Enterprises submit application to authority in Member State²⁵➡EFSA conducts evaluation and releases scientific opinion➡The Commission gives the decision based on all considerations

Others

Key regulations¹⁶ that are not mentioned above but are also important include: