FABIO MARAZZI

Marazzi & Advisors, Via Evaristo Baschenis, 9, 24122 Bergamo (BG), Italy

Abstract

The use of vitamins, minerals and similar substances in consumer products sold in the EU and US are subject to various regulatory requirements to guarantee the safety of consumers. A comparison between the two regulatory landscapes is provided, as well as a brief review of newly enacted legislation in China.

A clear exception to this rule is provided by EU legislation, which recognizes single Member States the possibility to implement more restrictive requirements, e.g. in the case of dietary supplements in Italy (1).

The EU and US legislation is particularly focused on regulating vitamin-based products – i.e. dietary supplements – and food products to which vitamins are added during the manufacturing and handling process.

Distinguishing between dietary supplements and food products to which vitamins have been added has relevant consequences with regard to applicable legislation: vitamin-added foods are indeed subject to both the specific vitamin-additive legislation as well as normal food laws and regulations; dietary supplements instead are not considered ‘food’, thus being only subject to specific legislation.
EU REGULATORY REGIME 

The EU regulatory regime is based on Directive 2002/46/EC on dietary supplements and on Regulation 1925/2006 on addition of vitamins to foods. Both instruments were enacted with the objective of harmonizing legislation among Member States in the respective su ...