Food supplements are considered to be foodstuffs, even if they have some specificities, such as dosage form and are intended to complement or supplement a normal diet. They are not medicinal products and therefore cannot claim prophylactic properties, prevent or cure diseases, nor refer to such properties.
CONCEPTS AND DEFINITIONS
In accordance with Decree-Law no. 118/2015 of 23 june, which amends Decree-Law no. 136/2003, food supplements may only be made available to the final consumer in the form of a pre-packaged product.
They are intended to complement and / or supplement the normal diet and should not be used as a substitute for a varied diet.
They are concentrated sources of certain nutrients or other nutritional or physiological substances, on their own or in combination.
They may contain a wide range of nutrients and other ingredients, namely vitamins, minerals, amino acids, essential fatty acids, fiber and various plants and herbal extracts.
At Community level, only vitamins and minerals that can be incorporated into food supplements, which are discriminated in REG. (EC) no. 1170/2009, of the Commission of 30 November and DIRECTIVE 2002/46/EC of the European Parliament and the council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.
In addition to a list of authorized vitamins and minerals (Annex I), these documents also contain a list of the ways in which nutrients can be incorporated as ingredients in food supplements (Annex II).
Substances other than vitamins and minerals, to be used as food supplement ingredients, must meet the requirements of REG. (UE) No 2015/2283, concerning novel foods and novel food ingredients. It should therefore be possible to establish a significant food consumption history in the European Union before 15 May 1997 (the date of entry into force of that Regulation).
In the absence of any valid reference to the consumption of a particular food or ingredient in this context, it is considered that if a novel food or food ingredient is present and its marketing in the EU depends on a safety assessment carried out by EFSA and subsequent approval by the Commission.
It is the responsibility of the trader to ensure that the ingredients in food supplements are not novel foods. For more information on novel foods, see the DGAV page on this subject [Novel Foods].
In order to better protect consumer safety, the European Commission, at the request of a MS, may decide to include a substance or an ingredient in a list of prohibited substances, restricted substances or a list of substances under Community control, in accordance with the provisions of REG (EC) No. 1925/2006.
However, to date, only the species of Ephedra and Pausinystalia yohimbe have been harmonized: REG. (EU) No. 2015/403 of 11 March, amending Annex III to the Reg. (EC) No. 1925/2006 of the European Parliament and of the Council as regards the species of Ephedra and the Red-bellied Woodpecker [Pausinystalia yohimbe (K. Schum) Pierre ex Beille]. Ephedra species have been included in Part A of Annex III to Regulation (EC) No. 1925/2006 (Prohibited Substances) and Part C of that Annex, Pausinystalia yohimbe.
Products classified as medicinal products for human use as defined in Decree-Law No. 176/2006 of August 30, are not food supplements.
In order to be marketed food supplements shall comply with the specific regulations for this type of products (Decree-Law no. 118/2015)
Designation of the categories of nutrients or substances which characterize the product or a specific reference to their nature.
Recommended daily dose of the product.
Amount of nutrients or substances with a nutritional or physiological effect declared in numerical form and referring to the daily intake recommended by the manufacturer and indicated on the label. Amount of vitamins and minerals also expressed as a percentage of the reference values.
A warning that the indicated daily intake should not be exceeded.
A warning that products should be stored out of the reach of children.
A warning that food supplements should not be used as a substitute for a varied diet.
The labeling of food supplements shall also comply with the provisions of Regulation (EU) No. 1169/2011 in what regards them. For more detailed information on this diploma, see the DGAV portal: Labeling.
In accordance with the provisions of Regulation (EC) No. 178/2002, it is the responsibility of the economic operator to ensure compliance with the requirements of the applicable legislation.
NUTRITION AND HEALTH CLAIMS
In order to know whether the health claim has been authorized and is correctly drafted, please refer to the Commission's statement of claims and, where available, the published regulation and the official Portuguese journal.
To facilitate efficient monitoring of food supplements, Decree-Law no. 118/2015 refers that the manufacturer, distributor or importer must notify the Competent Authority (DGAV) by sending requested documents, in particular a copy of the label.
The DGAV has developed a database - SIPACE - to gather reliable information on agri-food businesses. The updated information, collected in this way, contributes to a better response to the sector by the Administration, so that all operators are encouraged to register, with no costs associated with the process.
This procedure falls within the scope of official control and is therefore intended only for operators based in national territory.