Masterarbeit

Should the European Union introduce 'nutrivigilance' for food supplements and dietary foods for special medical purposes?

Hella Witt (2012)

Language: English

The aim of this thesis is to describe the legal provisions and the conditions that have to be considered, when deciding on the introduction of nutrivigilance for food supplements and dietary foods for special medical purposes in small dose units, such as tablets and capsules.
Food supplements and dietary foods for special medical purposes (FSMP) can be concentrated sources of vitamins, minerals and other substances with a nutritional or physiological effect. They are usually promoted for their health benefits and may be marketed with nutrition or health claims. Certain food supplements can be used for the reduction of a risk factor for a disease. Thus these products may share the property of reducing a disease risk with medicinal products. FSMP are a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision.

While pharmacovigilance is mandatory to monitor the safety of medicinal products, a term such as nutrivigilance is not used in food law. The principles guiding food law and the general provisions ensuring food safety in the European Union are described in the first part of this thesis. Then the specific requirements applicable for food supplements and FSMP are specified.

Potential adverse effects and other health concerns that may be associated with the use of food supplements or FSMP are discussed. The potential effects of the use of high quantities of food substances with a nutritional or physiological effect, vulnerable sub-groups of the population, substances not included in approved Union lists, consumers understanding of health claims, and novel food ingredients will be considered as factors that may have an impact on the safety of food supplements and FSMP.

The principles of hazard analysis and critical control points (HACCP) are applied by food business operators to ensure the production of safe foods. Their appropriateness for controlling hazards caused by the composition, manufacturing and use of food supplements and FSMP are examined. Food alerts notified to the European rapid alert system for food and feed (RASFF) indicate that only few cases are reported by consumers. Risks identified in connection with food supplements and FSMP were in the majority detected through official controls.

In 2009 a nutrivigilance system was implemented in France for the monitoring of new foods, food supplements, foods containing additives for nutritional or physiological purposes and food products intended for special uses. Similar food products are monitored in the USA.

It is finally examined, for which factors that may have an impact on the safety of food supplements and FSMP nutrivigilance may be beneficial to enhance food safety.

Pages: 58,
Annexes: pages: 3