CRN shares legal analyses of potential WTO violations related to EU health claims

CRN shares legal analyses of potential WTO violations related to EU health claims

The analysis details how the European Union (EU) Health Claims Regulation, if implemented, would violate several obligations under the WTO Agreement.

Potential actions of regulatory authorities and some governments could violate agreements under the World Trade Organization (WTO), says the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, following release of two documents commissioned by the association from law firm Sidley Austin LLP.

The association commissioned attorneys specializing in international trade law to develop detailed legal analyses for two separate, and troubling, issues related to: 1) WTO Analysis of EU Health Claims Regulation; and 2) WTO Analysis of RDA-Based Maximum Levels for Vitamin and Mineral Food Supplements.

The Sidley Austin analysis on health claims was originally provided to CRN in May and the maximums analysis in August; the association is now publicly sharing these documents to urge regulators to consider the potential implications, which will be discussed at a session during the CRN-International (CRN-I) scientific symposium, “Nutrition Issues in Codex: Health Claims, Nutrient Reference Values and WTO Agreements,” taking place in Germany on November 11.

The first analysis—WTO Analysis of EU Health Claims Regulation—details how the European Union (EU) Health Claims Regulation—if implemented, would violate several obligations under the WTO Agreement on Technical Barriers to Trade (TBT).  In particular, while the text of the EU health claims regulation itself does not appear to violate the TBT Agreement as such, it is the application of that regulation by the European Commission on the basis of several of the European Food Safety Authority recommendations that is anticipated to violate the EU’s obligations under the WTO agreement because it is more trade restrictive than necessary to achieve the EU’s objective of preventing misleading health claims.  The legal analysis is available on CRN-I’s website in English. 

The second analysis—WTO Analysis of RDA-Based Maximum Levels for Vitamin and Mineral Food Supplementsexplains that the Codex Vitamin and Mineral Food Supplement Guideline, finalized in 2005, specifies that maximum levels of these nutrients in food supplements should be based primarily on risk assessment, and not on the RDAs.  However, many countries still impose RDA-based limits for vitamin and mineral supplements and have not yet updated regulations that may have been in effect prior to the Codex guideline. Other countries regulate these supplements as “drugs” in the mistaken belief that this practice will exempt them from the Codex guideline.  In contrast, both relevant WTO Agreements—the TBT Agreement and the Sanitary and Phytosanitary (SPS) Agreement—overtly require risk assessment as the basis for restrictions on international trade, and thus prohibit these practices.

The analysis on RDA-based maximums is available in both English and Spanish on the CRN-I website.

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement manufacturers and ingredient suppliers.  In addition to complying with a host of federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control and safety, our 75+ manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as CRN’s Code of Ethics. Visit

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