In the EU, "food supplements" are concentrated sources of nutrients or other substances with a nutritional or physiological effect, aiming to supplement the normal diet. They are marketed in many shapes and sizes and they come in dose form, such as tablets, capsules, liquids etc. Safety and Efficacy of Food Supplements are evaluated by the European Food Safety Authority (EFSA), (more) an entity set up in January 2002 as an independent source of scientific advice that produces opinions which then are used by the European Commission to adopt legislation.

Since 2002, the EU has created a legal and regulatory framework for these products with the Food Supplements Directive 2002/46/EC. EC legislation includes the following:

• general requirements for food safety, responsibilities for producers and obligations for traceability, information provision and recall of harmful products (Regulation (EC) No 178/2002)2
• preparation and hygiene of foodstuffs based on the principles of Hazard Analysis and Critical Control Points (HACCP) (Regulation (EC) 852/2004)3
• food labeling with the aim of adequately informing the consumer about the composition, properties and use of foodstuffs (Regulation (EU) 1169/2011)4
• use of nutrition and health claims, which must be authorized before they can be used (Regulation (EC) 1924/2006)5
• conditions for the use of additives (Regulation (EC) 1333/2008)6
• maximum levels for residues and contaminants (Regulation (EC) 369/2005 - Regulation (EC) 1881/2006)7,8
• approval of novel foods and food ingredients not on the European market before 15 May 1997 (Regulation (EU) 2015/2283)9

With this Regulation the EU outlined the general principles and requirements of the Food Law. The food supplements safety for human health was adopted as the leading principle in the field of food supplements. The Directive 2002/46/EC partially harmonized the rules for placing on the market of food supplements including the label information. This Directive is applied to all food supplements of any composition that are marketed as foods and presented as foods, reaching to the end user only in prepackaged and prelabeled dose form.

The Directive calls for the establishment of harmonized minimum and maximum dosage amounts; however, this has yet to be done and remains a competence of EU member states. Also, substances other than vitamins and minerals are not directly covered by the directive, and rules regulating these substances are still governed by individual EU member states. In the next Table 2.2.1. is presented a List of competent authorities of the Member States within the meaning of Article 4(6) of Directive 2002/46 on food supplements.

Table 2.2.1 List of competent authorities of the Member States Prepared by: Health and Food Safety Directorate-General Unit E1 - Last revision: February 2019

List of competent authorities of the Member States responsible for: Nutrition, food composition and information

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In Art. 5 of the Directive2002/46/EC are set requirements to the maximal and minimal amounts of vitamins and minerals in food supplements based on scientific evidence concerning health safety.

Vitamins and minerals may be ingested from a variety of foods that are eaten as part of the daily diet. They can be naturally present in foods or added to them both for technological or nutritional purposes. Innovation in the food sector tends to take increasingly into account the relationship between diet and health and may lead to an increase of the percentage of foodstuffs fortified with vitamins and minerals on the market. The amounts contributed by these various sources have to be taken into account when setting maximum levels.

On the other hand, is obvious that vitamins and minerals used in food supplements or added to foods should result in a minimum amount being present. Otherwise, the presence of too small amount would not offer any benefit to consumers, namely to supplement the normal diet in the case of food supplements, and would be misleading.

Council Directive 90/496/EEC on nutrition labeling requires that in order that vitamins or minerals may be declared in nutrition labeling they have to be present in a significant amount, which, as a rule, is the amount in 100 g or 100 ml of the food representing 15% of the recommended allowance specified in the Annex to Directive 90/496/EEC. The same amount has to be present if a nutrition claim is made that the food is a "source" of a vitamin or a mineral, according to the proposed Regulation on nutrition and health claims made on foods, expected to be adopted in September/October 2006. The proposed Regulation on the addition of vitamins and minerals to foodstuffs foresees that, in order to guarantee consumers of the presence of vitamins and minerals in fortified foods in at least a meaningful amount, their addition shall result in the presence of at least a significant amount where this is defined according to the Annex to Directive 90/496/EEC on nutrition labeling. However, this provision allows discretion to set minimum amounts that are different from that significant amount for specific foods or categories of foods.

While the use of significant amounts as minimum amounts may be considered generally acceptable for fortified foods, some argue that it would not be adequate for food supplements. Food supplements are by definition concentrated sources of nutrients. Therefore, some argue that these products should be providing minimum amounts of those nutrients, per recommended daily consumption dose, higher than the abovementioned significant amounts. In the next Table 2.2.2. is offered a Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs where are presented Examples of existing models for the setting of Maximum amounts of vitamins and minerals in foods.

Table 2.2.2. Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs. Health and Consumer Protection Directorate-General June 2006.

This paper identifies the issues to be considered in the setting of maximum and minimum amounts of vitamins and minerals in foods.
It also describes the use of different theoretical models to assess the safety of the (voluntary) addition of vitamins and minerals to foods.

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Additionally, regulations regarding vitamins and minerals were issued: Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods and Commission Regulation (EC) No 1170/2009 and Regulation (EC) No 1925/2006 of the European Parliament as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements.

The Food Supplements Directive (FSD) Directive 2002/46/EC, establishes a definition for food supplements, establishes a list of allowable vitamins and minerals, and sets labeling requirements.

Currently the European Community is concerned about food products, including nutritional supplements present in the market aiming to offer to its citizen's reliable protection of their health.

• Quality and post-marketing control of nutritional supplements cannot be neglected, and it is necessary to set more precise quality and safety criteria in future strategies associated with those products.
• Guidance on safety evaluation of sources of nutrients
• Quality assurance and full traceability of ingredients are essential to ensure consumer safety.