The Council for Responsible Nutrition (CRN), Washington, D.C., recently submitted comments to the International Trade Administration (ITA) concerning regulatory cooperation between the U.S. and the European Union (EU) that could help eliminate or reduce unnecessary divergences in standards that impede U.S. exports.

In written comments, John Hathcock, PhD, senior vice president, Scientific & International Affairs, CRN, acknowledged that CRN members continue to encounter significant regulatory barriers to trade of dietary supplement products or ingredients, but pulled up short of calling for harmonization of standards.

“CRN does not expect, nor necessarily desire, the U.S. Government, and the International Trade Administration (ITA) in particular, to take actions to eliminate differences in the relevant regulations between the U.S. and EU. Instead, CRN requests that the U.S. Government take action to reduce or eliminate non-tariff barriers to trade in these products. In these efforts, it should be recognized that standards do not necessarily need to be ‘harmonized’ but, instead, the EU and its member states should only impose import standards that are no more restrictive than necessary to achieve legitimate goals (in this case, to protect public health).”

Dr. Hathcock went on to request that ITA assure products manufactured in the U.S. are not excluded from EU markets in violation of World Trade Organization (WTO) agreements.

CRN highlighted two areas of particular concern to its members: health claims on labels of dietary supplement products (known as food supplements in Europe), and maximum amounts of vitamins and minerals allowed in these products.

“CRN members are concerned that the advisory opinions provided to the European Commission (EC) by the European Food Safety Authority (EFSA), if implemented in a legally binding manner by the EC or any of the EU member states, could create unjustified technical barriers to the import of U.S.-made dietary supplement products into the EU,” CRN said. “While the texts of the EU Health Claims Regulation, itself, does not appear to violate the WTO agreements as such, it is the expected application of the EFSA opinions that we anticipate will violate the EU’s obligations of Articles 2.2 and 5.1.2 of the WTO Technical Barriers to Trade (TBT) Agreement by imposing requirements more restrictive than needed to protect the public health.”

According to CRN, the Terms of Reference (TOR) for addressing potential health claims instructs EFSA to take into account the totality of evidence and to determine if a cause-and-effect relationship between a food or ingredient and a health effect has been established. “During its implementation of these instructions, EFSA has routinely denied the existence of a causal relationship unless demonstrated in randomized, controlled clinical trials (RCTs). In effect, EFSA is not genuinely considering the totality of scientific evidence, and thus not adhering to the instructions in the TOR. [Therefore], if the EC implements regulations congruent with the EFSA opinions it will be imposing requirements more restrictive than necessary to adequately perform the legitimate objectives of protecting and informing the public.”

As for the maximum amounts of vitamins and minerals in dietary supplement products, the European Food Supplements Directive (Directive 2002/46) provides a basis for a risk assessment.

However, the EC has not released maximum values in draft or final form, allowing individual EU member states to continue their previous regulatory policies, “most of which are excessively restrictive by setting maximums based on Population Reference Intakes (called Recommended Dietary Allowances or RDAs in the U.S.),” CRN noted. “Such policies effectively keep higher potency U.S.-made products out of most of the European market.”

“If and when the EC releases draft or final maximums based on risk assessment as demanded by the Food Supplement Directive, CRN will comment to U.S. Government authorities and provide our evaluation of whether these values represent arbitrarily restrictive risk assessment and are more restrictive than necessary to protect the health of consumers. If such excessive restriction is present and is implemented in a legally binding manner, it would represent a violation of the WTO agreements,” CRN said.