EU harmonisation ideals marred by business pragmatism

By Shane Starling

- Last updated on GMT

Related tags: Member states, European union

European Union harmonising Directives and regulations that give
companies the right and power to trade their wares in any Member
State are rarely utilised because companies fear a commercial
backlash, according to a European regulatory expert.

Patrick Coppens, secretary general of Belgium-based European Responsible Nutrition Alliance (ERNA), a trade group that represents food supplements manufacturers and other health product makers, said companies were reluctant to challenge member states that restricted free trade by ignoring pan-bloc regulations. Regulations such as those relating to health claims, food supplements, botanical products and functional foods had been enacted in recent years and were at various stages of implementation. These sought in part to provide regulatory harmony and facilitate free trade across the 27-member bloc. Uneasy alliance ​ But member states that may not have fully implemented EU directives, or continue to operate a system whereby local and EU regulations exist in an uneasy alliance, may block the trade of products or ingredients leaving companies with a choice to withdraw from the market, alter their products or take the matter up with the European Commission. "Few companies take it up with the EC,"​ Coppens said. "Companies are reluctant to exercise the right to the free movement of goods for many pragmatic reasons. If they decide to challenge they may face a backlash from the member state that might do their overall business more harm than good."​ Those that did challenge a rogue member state faced a lengthy and costly procedure that may end up in the European Court of Justice (ECJ) and take 3-5 years before a decision is reached. This was another disincentive to act because shelf-life was typically considerably less than this time-frame and so "the commercial moment"​ may be lost by the time a verdict was delivered. "Yet challenges made to those member states on the grounds of restricting free trade are generally successful so it shows the regulations are enforceable." ​ The recent garlic case in which the ECJ ruled that Germany could not classify garlic supplements as medicines, was a good example of a free-trade victory, he said. "Other nutrients" ​ Some of the EU's harmonisation issues arise out of grey areas that exist in and around the regulations and Directives that are in place. One such area is the addition of certain nutrients widely used throughout the EU but which are not included in either the herbal or food supplements Directives. As part of an ongoing series that has included carotenoids and vitamins and minerals, ERNA has released fact sheets on four nutrients that are awaiting official classification by EU regulators, and which in the mean time are governed on a state-by-state basis. ERNA gathered experts in L-carnitine, conjugated linoleic acid, coenzymeQ10 and polyunsaturated fatty acids to produce the fact sheets, intended to assist regulators, scientists, industry and consumers seeking further comprehensive information about the nutrients. The nutrients have not been included in the Food Supplements Directive positive list because that list only includes vitamins and minerals. An EC working group is considering the addition of "other nutrients"​ to the list although it is not certain when its conclusions are likely to be handed down. "In the light of the expansion of the EU Food Supplement Directive to substances other than vitamins and minerals, we have selected substances that are widely used because of their health benefits and collated the vast amount of information available into a clear and manageable format,"​ Coppens said. "Our fact sheets clearly demonstrate the usefulness of supplementing the diet with these substances".​ The fact sheets are freely available in printed and electronic form by contacting ERNA​.

Related topics: Regulation & Policy, Suppliers

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