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Suplementos alimentares e diatéticos: Um serviço tudo incluído

Dietary supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form and intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or support specific physiological functions.

Supplements do not have curative properties, but they can support the human health by optimizing the nutritional status or contributing to well-being by providing nutrients and substances with physiological activity for the normal development and maintenance of good health in the body. There are many types of supplements on the market, varying according to need. The main substances include milk enzymes, mineral salts, vitamins, fatty acids, proteins, plant extracts and fibres.

Consumers worldwide are turning to dietary supplements and food supplements as one part of their personal goal to lead healthier and more active lives. With increasing number of consumers focused on improving their health regime, the demand for vitamins and supplements is on a rise.

Dietary supplements & food supplements legislation

In the EU, food supplements are regulated as foods. The objective of the Harmonized rules under DIRECTIVE NO. 2002/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements is protect consumers against potential health risks and to ensure that they are not provided with misleading information.

In order to assure the food supplements’ safety, the Directive establish a harmonized list of vitamins and minerals, and permitted sources:

  • Annex I: list of vitamins and minerals that may be added for nutritional purposes in food supplements.
  • Annex II: list of permitted sources (vitamin and mineral substances) from which those vitamins and minerals may be manufactured.

The list has been amended by the following Regulations and Directive to include additional substances:

  • Commission Regulation (EU) no. 2017/1203 of 5 July 2017 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards organic silicon (monomethylsilanetriol) and calcium phosphoryl oligosaccharides (POs-Ca®) added to foods and used in the manufacture of food supplements.
  • Commission Regulation (EU) no. 2015/414 of 12 March 2015 amending Directive 2002/46/EC of the European Parliament and of the Council as regards (6S)-5- methyltetrahydrofolic acid, glucosamine salt used in the manufacture of food supplements.
  • Commission Regulation (EU) no. 119/2014 of 7 February 2014 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods
  • Commission Regulation (EU) no. 1161/2011 of 14 November 2011 amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Commission Regulation (EC) No 953/2009 as regards the lists of mineral substances that can be added to foods.
  • Commission Regulation (EC) no. 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements.
  • Commission Directive no. 2006/37/EC of 30 March 2006 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards the inclusion of certain substances.

How Mérieux NutriSciences can support you?

Thanks to specialized laboratories, a GMP pharmaceutical division and a global network of experts at Mérieux NutriSciences, we have expanded our expertise in the dietary supplements and food supplements sector. We are able to offer a complete service to support companies in ensuring dietary supplements quality, safety and efficacy.

Safety and quality of food supplement products

In 2020, and according to the RASFF data monitored and analysed with Mérieux NutriSciences’ solution: Safety HUD, 211 events were notified along the year. Among them, composition was the main root cause and led to 86 (-44% compared to 2019) notified events.

EFSA milestones

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