Bringing food supplements to market in Latin America and Europe: a regulatory overview
It is fair to say that bringing food supplements to market in the regions of Latin America and in Europe involves diverse and diverging challenges. The European Union (EU), with the formation of the EU Food Supplement Directive, appears to be predominantly harmonised in this area, whereas Latin America, a region formed of more than 30 countries and five times the size of the EU, has little harmonisation in place today for food supplements. While the two certainly present diverse challenges, however, they also show some similar regulatory trends and legislative developments, that companies entering these regions must be aware of to optimise business strategies.
DEGREES OF HARMONISATION
In Europe, the 2002 EU Food Supplement Directive (Directive 2002/46/EC) created a partial harmonisation of the regulatory framework among its 27 Member States. But there is still a lot of confusion regarding which regulations are EU-wide and which are market-specific.
- harmonised the definition of food supplements
- introduced specific rules on vitamins, minerals and their forms that can be used in food supplements
- harmonised labelling provisions specific to food supplements
- introduced an optional requirement for Member States to adopt a notification procedure, and
- harmonised the criteria for the setting of maximum levels of vitamins and minerals.
However, no harmonised rules have been adopted regarding maximum levels of vitamins and minerals used in food supplements, or in terms of the use of ingredients other than vitamins and minerals for nutritional/physiological purposes (including botanicals). These non-harmonised areas are therefore subject to potential national rules and practices, which across 27 Member States, can prove chal ...