18 March, 2020

Legislation on food supplements: which regulation is applied

In 2002 a harmonized regulatory system was created in Europe that enshrined the legislation on food supplements in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of law of the member states in regard to food supplements, which came into force on 12 July 2002. This Directive is important within food supplements legislation, since in an initial phase it establishes the specific rules for one part of the nutrients: vitamins and minerals, leaving for a subsequent phase the specific rules for nutrients other than vitamins or minerals or other substances with a nutritional or physiological effect used as ingredients of Food Supplements. In addition it regulates the procedure to be followed within that legislation on food supplements for notifying these products, the mandatory information that must be shown on the labelling, the addition of vitamins and minerals and their permitted forms in supplements, etc. Also approved in Europe were two very important regulations in the legislation on food supplements:

• Regulation (EU) 1169/2011 of 25 October on food information provided for consumers, which has the purpose of pursuing a high level of protection for consumer health and of ensuring consumers’ right to information so that they can take decisions in an informed manner.

This rule establishes the basis for ensuring a high level of consumer protection in regard to food information, taking into account the differences between what consumers want and their need for information.

• Regulation (EC) 1924/2006 of 20 December on nutritional declarations and those on health claims in foods has the goal of ensuring an efficient operation of the internal market and of providing a high level of consumer protection. It is applied to nutritional declarations and those on health claims contained in the food labelling or advertising.

This rule harmonizes the legal, regulatory or administrative provisions of the member states relative to the nutritional declarations and to health claims in order to ensure the efficient operation of the market while providing a high level of consumer protection. Through Royal Decree 1275/2003 of 10 October on food supplements, Directive 2002/46/EC was incorporated into the Spanish legal system, but it was repealed and a new one drafted, Royal Decree 1487/2009 of 26 September, which regulated food supplements consisting of concentrated sources of nutrients. Its purpose is to regulate any food products consisting of concentrated sources of nutrients presented as a complement to a normal diet.

This Royal Decree only establishes the specific rules for the vitamins and minerals utilized as ingredients in food supplements, with regulation of specific rules on other nutrients and ingredients in food supplements left for a later phase and also establishing the composition and labelling requirements applicable to food supplements sold as food products and presented as such.

This legislation on food supplements is applied to businesses that produce, process, package, store, distribute, import and sell food supplements. This Royal Decree is important because it contains all the necessary information for a food supplement to display correct and legal labelling, establishing the enforceability of notifying these products before or simultaneously to their being placed on the market. As legislation on food supplements, we should also take into account the regulation that governs the Food Safety Registry.

Royal Decree 191/2011 of 18 February on the General Health Registry for Food Businesses and Foodstuffs, which has the purpose of making it mandatory to enter them in the Register of businesses involved in the food chain, which means that any business established in Spain that operates with food supplements must have the corresponding registration in Code 26. At LegaleGo Sport Nutrition we provide the best advisory service on food supplements legislation so that our clients can operate within this market with ease and peace of mind. It is important in each case and product that the regulations be applied in order to comply with all legal requirements.