1. Definition
According to Directive 2002/46/EC on the Approximation of the Laws of the Member States Relating to Food Supplements, 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.
2. Competent authority
Competent authority | Reponsibility |
European Commission (EC) | Developing and implementing laws, authorizing the use of a substance in food/food supplement, etc. |
European Food Safety Authority (EFSA) | Evaluating product safety, providing scientific advice and support, etc. |
Member States |
|
3. Management mechanism
Enterprises shall comply with the EU level legislation first. For non-harmonized requirements, 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 States already have their own maximum levels and other related restrictions in place. Some Member States may adopt a notification procedure to supervise food supplements.
Key legislation in EU level include:
Regulation (EU) No 1169/2011 on the provision of food information to consumers
Regulation (EC) No 1924/2006 on nutrition and health claims made on foods
…
4. 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)
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)
Ingredients outside the above situations may still be used under Member States’ national rules
The use of food additives shall conform with Regulation (EC) No 1333/2008 on Food Additives
Regulation (EC) No 1925/2006 contains a list of substances whose use in foods is prohibited, restricted or under scrutiny.
5. Mandatory 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
Besides this Regulation, Directive (EC) 2011/91 requires the labeling of lot indication and Directive 2002/46/EC 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
Details regarding labeling requirements can be found at ChemLinked's Food Check tool.
6. Nutrition and health claim
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 foods. In this case, it is mandatory to make nutrition labeling of products.
Permitted nutrition and health claims are listed below.
Definition and explanation | A list of detailed claims | |
Nutrition claim | Nutrition claims include content claim and comparative claim. 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
2. The nutrients or other substances it
Examples include: low energy, energy-reduced, energy free; source of fiber, high fiber | Annex of Regulation (EC) No 1924/2006 |
Health claim | 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:
|
|
Read more at Food Supplement Legislation in the EU.
*Global Food Compliance Service
We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.
Covered Countries
China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.
Our Services
Food Ingredient Review
Label Review
Product Registration
Regulatory Consultation
Monitoring, Training and customized report
Please feel free to contact us via food@chemlinked.com if you need any help.