During the last 15 years, Food Compliance Int. has successfully registered thousands of food products for manufacturers worldwide. We provide full support in placing food product on the market in the EU, including a complete assessment of the composition and labeling of the food for compliance in the EU law and the Member States of prior notification, the first placing on the market in the EU and subsequently in the rest of the EU, benefiting from the mutual recognition principle
Directive 2002/46 allows Member States to establish a notification procedure for the placing on the market of food supplements. Most Member States have implemented such procedure, in practice often resembling a pre-market authorization.
Before the first placing on the market of a food supplement, compliance of the composition and labelling in the EU law and the national Member State of first notification should be ensured. Directive 2002/46/EC lists the vitamins and minerals, as well as the forms of these nutrients, that may be used in the manufacture of food supplements.The use of other substances (such as aminoacids, essential fatty acids, fibre and various plants and herbal extracts), maximum and minimum levels of vitamins and minerals, purity criteria or tolerance margins remain subject to the national rules of the Member States.
The Member State where a food supplement is first placed on the market should be chosen strategically. Not only should the product comply with the national rules of this Member State, other factors should be taken into account, such as the length of the notification procedure and the issuing of a registration letter, which facilitates subsequent notification in other Member States on the basis of mutual recognition,
Foods to which vitamins and minerals have been added are regulated under Regulation 1925/2006 and are subject to a notification requirement in 18 of the 28 Member States. The notification procedures for fortified foods are similar to those for food supplements.
As with food supplements, Regulation 1925/2006 has harmonized the use of vitamins and minerals by establishing positive lists of nutrients and their forms. The addition of other substances with a nutritional or physiological effect remains subject to regulations of the Member States.
Therefore, before placing a fortified food on the market in the EU, it should be ensured that the composition and labelling of the product complies with EU law and the national laws of the Member State where it is first placed on the market,
Not all foods for particular nutritional uses are subject to a national notification procedure. Directive 2009/39 and its various implementing Acts establish a notification requirement for infant formulae and follow-on formulae and those PARNUTS which are not listed in the Annex of Directive 2009/39, such as foods for people intolerant to gluten. It further allows Member States to have a notification procedure for foods for special medical purposes. Foods for sports people are subject to a notification in some Member States.