The team at Food Compliance Int. has reviewed thousands of food supplements adjusting their composition and labeling for EU compliance. Our thorough analysis include proposals for reformulation and adjustments in case of multiple jurisdictions and languages. In addition to product review we have successfully represented individual firms as well as industry associations before national authorities, the European Commission, opening EU markets to their products, annulling restrictions on the use of botanicals, or unjustified low levels of vitamin and minerals

Food supplements
+ fortified foods

Food supplements

In the EU, food supplements are regulated under Directive 2002/46/EC. 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 amino acids, essential fatty acids, fiber and various plants and herbal extracts), maximum and minimum levels of vitamins and minerals, purity criteria or tolerance margins remain subject to the national laws of the EU countries and Articles 34-36 of the Treaty (free movement of goods).

A recent initiative by Belgium, France and Italy seeks to harmonize the legislation of the EU countries on botanicals permitted in food supplements. The so-called BELFRIT list is the first step towards harmonization of the use of other substances throughout the EU.


Fortified foods are regulated under Regulation (EC) No 1925/2006. As with food supplements, Regulation 1925/2006 has harmonized the use of vitamins and minerals by establishing positive lists of nutrients and their forms. Vitamins and minerals may not be added to unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish, and beverages containing more than 1,2 % by volume of alcohol, with some exceptions.

As it is the case with food supplements, the addition of other substances with a nutritional or physiological effect remains subject to national laws of the Member States and Articles 34-36 of the Treaty on the Functioning of the European Union (free movement of goods). The Union Registry on the addition of vitamins and minerals and of certain other substances to foods lists the vitamins and minerals which may be added to foods, but is still silent as to the use of other substances.

Around 75% of our clients are manufacturers or distributors of food supplements, and we consider our expertise in this sphere unrivaled in the EU.

Around 75% of our clients are manufacturers or distributors of food supplements, and we consider our expertise in this sphere unrivaled in the EU.

Success Stories

We advised the world’s number one online food supplement store in their expansion in the EU with their own line of products. We analyzed composition and labelling of their products, classified them and placed them on several EU countries
We assisted the Spanish food supplement industry in ensuring the Spanish authorities implemented the mutual recognition principle in favour of herbal food supplements marketed in other EU countries
We advised one of the world’s leading food supplement distributors in their strategy to sell their products in the EU. We suggested changes to their formulas and labels for EU compliance and successfully used mutual recognition to place them in several EU markets.

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