Food Supplements

Food supplements are defined as foodstuff which are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect. They are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses) to be included in the normal diet

The European Union regulates Food Supplements through the Directive 2002/46/EC. However, they are considered foodstuff and therefore several additional European legislations will apply, on top of specific national laws. Due to the complexity of the applicable legislative frameworks, guidance of professional regulatory advice is critical.

How we support you in placing food supplements on the European market

1

We analyse the formula of your products, identifying restricted and banned ingredients at both a European and national level

2

We assess the necessary documentation for your type of product

3

We review and propose strategies to compile a complete Food Supplement Information File

4

We check the compliance of your labels and packaging towards the/both EU and national requirements

5

We submit the pre-market authorization at a national level

EU Legislation on Food Supplements

Food Supplements are regulated in Europe as foodstuff, falling under the EU General Food Law (Regulation (EC)No 178/2002) for safety requirements and Regulation (EU) No 1169/2011, on the provision of food information to consumers (FIC). In addition to these general rules, specific requirements are set out by the Food Supplements Directive 2002/46/EC. which establishes harmonised lists of the vitamins and minerals-substances used in the manufacture of food supplements- and the labelling requirements for these products.

Besides harmonized rules, national legislation may apply, including additional restrictions and requirements for the use of substances other than vitamins or minerals, and the maximum and minimum level of vitamins and minerals allowed. Food supplement may be subject to national registration as a pre-market authorization.

Labelling of Food Supplements

Providing information to consumers has become the driving force to improve the European citizens’ right to choose, which has an impact on the mandatory elements of a food supplements product’s packaging.

Harmonized legislation protects the consumer from potential health risks, while granting the option of an informed decision making towards the choice of a specific product. Below are some of the major/main elements of a (compliant) food supplements’ label:

  • Brand and commercial name of the product
  • Ingredient list in descendant order of weight
  • Warnings and precautions
  • Intended dose
  • Explicit mention of the nature of the product
  • Expiry date
  • Manufacturer name and address
  • Health claims: for each ingredient, a claim has been approved (Regulation (EC) 1924/2006)
  • Vitamin/mineral values
  • QUID (Quantitative Ingredient Declaration) when a specific ingredient is included in the name of the product or stated as a claim

Additional elements, such as the notification number, may apply depending on the country.

Food Supplement Ingredients

Vitamins and minerals are microelements indispensable to countless body functions, such as brain performance, blood pressure or digestion.

Using food supplements is a complementary way to raise our levels of those elements, normally obtained through a healthy diet. Citizens are becoming health-focused costumers, which heavily influences the food industry’s importance in last decades.

Regulatory-wise, the EU Commission, supported by EFSA1, establishes maximum limits for vitamins and minerals in food supplements for different population groups, to ensure a correct daily intake that will not pose a risk of adverse health effects.

Annex I to the Directive 2002/46/EC frames the regulatory threshold, however, each EU Member State has the power to impose a stricter approachof any element, reducing the maximum levels

Additional vitamins and minerals may be considered for inclusion in the list following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by the European Food Safety Authority

Annex II to the above Directive contains a list of permitted sources for these vitamins and elements, which cannot be changed by the Member States.

Ingredients not included in any of the above-mentioned groups are classified as “other substances”.

Their use can be restricted or banned by the European Union following Regulation  1925/2006, in case scientific research finds an adverse effect on human health. If this is the case, they would be part of Annex III of the mentioned Regulation, listing them for public reference.

The absence of a specific restriction at a EU level, substances may be governed by national legislation in EU Member States.

Food additives specifically are regulated by Regulation EC 1333/2008, as they are recognized as not essential yet important ingredients in the food industry. They are also subject to national regulations, if applicable.

1 EFSA: European Food Safety Agency

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