The Council for Responsible Nutrition (CRN) appreciates this opportunity to provide comments on issues that have presented significant problems to the members for an extended time. CRN is an association representing over 75 companies that manufacture and/or market dietary supplement products and ingredients. A substantial majority of CRN members manufacture dietary supplement products or ingredients in the United States (U.S.) and export, or attempt to export, these to one or more member states of the European Union (EU). Significant regulatory barriers to this trade have been and continue to be encountered.
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). Recognizing that the U.S. is not a party to intra‐European EU treaties and not subject to its regulations, and the fact that both the U.S. and EU, and EU member states, are subject to the Agreements of the World Trade Organization (WTO), CRN asks only that the ITA take actions to assure that products manufactured in the U.S. are not excluded from EU markets in a manner that violates WTO Agreements.
Two particular areas are of concern to CRN members: (1) health claims on the labels of dietary supplement products (known as food supplements in Europe), and (2) maximum amounts of vitamins and minerals allowed in these products. These issues are addressed separately below.
1. Health claims on labels of dietary supplement 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 US‐made dietary supplement products into the EU. 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 CRN 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 (see Attachment).
CRN notes that the Terms of Reference (TOR) for addressing potential health claims instructs EFSA to take into account the totality of evidence. Further, the TOF instructs EFSA to determine whether a cause‐and‐effect relationship between and 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 adhere to the instructions in the TOR. Thus, 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.
2. Maximum amounts of vitamins and minerals in dietary supplement products.
The European Food Supplements Directive (Directive 2002/46) demands and provides a basis for a risk assessment for maximum amounts of vitamins and minerals permitted in food supplements. This directive was adopted in 2002, and comments to the European Commission on issues related to its implementation were solicited, received, and published in September 2006 (Comments on Discussion Paper http://ec.europa.eu/food/food/labellingnutrition/supplements/resp_discus_paper_amount_vitamins.htm).Yet, no maximum values have been released in draft or final form by the EC. Thus, the Food Supplements Directive, which demands that maximum amounts of vitamins and minerals in food supplements be set primarily on the basis of risk assessment, has not been implemented by the Community. This failure to act during this extended period has allowed 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. Such policies effectively keep higher potency U.S.‐made products out of most of the European market. Further, it is noteworthy that the Codex Vitamin and Mineral Food Supplements Guideline, adopted in 2005 (CAC/GL 55 – 2005), also demands that these maximums be based on risk assessment and specifically prohibits the use of “nutritional need” as the sole basis. The failure by the EC to promulgate maximum levels for vitamins and minerals on the basis of scientific risk assessment has allowed member states, such as France and Germany, to continue their national policies, which apply multiples of the Population Reference Intake when categorizing a product as a food supplement or a medicine. Therefore, continuation of restrictive potency policies for food supplements based on perceived nutritional need and prohibition of the higher potencies that would be feasible under risk assessment violate both European Union agreements and the World Trade Organization agreements that recognize the Codex Alimentarius as the international food standards authority. The net effect is that the ability of U.S. companies to export to Europe is severely hampered by trade standards that violate European and Codex guidelines.
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 the 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.