Letter to the Editor: EU/Codex

Letter to the Editor: EU/Codex

Recent legislation enacted by the European Parliament will have seriousimplications for any American company selling supplements abroad. The FoodsSupplement Directive (Directive 2002/46/EC) was signed into law on July 12,2002, for the express purpose of harmonizing vitamin and mineral regulationsbetween European Union (EU) nations. This legislation will apply to each membernation that currently comprises the union, as well as 13 countries that haveapplied for admission. In addition, it will undoubtedly be accepted by thosenations (Norway, Iceland, Switzerland and Liechtenstein) that form the EuropeanFree Trade Association.

This Directive has within its provisions the establishment of a positive listthat will eliminate some 300 nutrients currently on the market in the UnitedKingdom and in Europe. This is a draconian approach to regulate which vitaminsand minerals are acceptable for vitamin and mineral supplements. Boron, Vanadiumand Sulfur are conspicuously absent from the list as are all forms of mineralyeasts and amino acid chelates. Vitamins don't fare any better. For example, thelist precludes all forms of Niacin, other than Nicotinamide and Nicotinic Acid.This effectively removes other forms of Niacin, such as Nicotinamide AdenineDinucleotide (NADH) and Inositol Hexanicotinate from the market. The onlyrecourse to prevent these omissions is the submission of dossiers that willaffirm the safety of each nutrient in question. The industry has 36 months fromthe date of the Directive's enactment to submit these dossiers for review. Uponsubmission, the nutrients will remain on the market until a final decision isrendered. Provided the dossiers meet the criteria set by the EU, they then wouldbe added permanently to the list. It is, therefore, vitally important thatAmerican companies trading in Europe work with ingredient manufacturers toensure that the EU's requirements are fulfilled or risk losing a substantialnumber of safe ingredients.

Another onerous aspect of the Directive involves the creation of a maximumsafe Upper Limit (UL) for vitamins and minerals. This would limit the potenciesof nutrients sold in dietary supplements. Expert groups in the U.K. and Europewill work collaboratively to render a decision by later this year. Earlierindications suggest that Vitamins B6 and Niacin, for example, will be held tolevels that are considerably less than what is generally regarded as safe andmay instead be set on an arbitrary multiple of the RDA. This would directlyimpact many American products currently on the European market. It is imperativethat a UL only be established when a safety issue has clearly been identifiedusing sound scientific principles. Since there is still time to affect theoutcome, it behooves U.S. companies to support the efforts of activist groups,such as Consumers Health Choice UK, who are working to ensure that science andreason prevails.

As this scenario plays out in Europe, it is important to note that as anindustry, we are faced with similar challenges at home in the form of CodexAlimentarius. Later this year, the Codex Committee on Nutrition and Foods forSpecial Dietary Uses (CCNFSDU) will meet in Berlin to discuss many of the sameissues that could ultimately impact our own domestic market. Therefore, it wouldbe prudent for all our industry members to remain vigilant as these issuesunfold or face the same untenable situations at home.

James Roza
EU Sub-Committee Chair
AHPA/NNFA International Committee