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LEGAL ANALYSIS OF SUPPLEMENT
INTERNATIONAL TRADE AND MARKETING ISSUES

by SIDLEY AUSTIN LLP, Washington, DC.

At CRN's request, attorneys at Sidley Austin who specialize in international trade issues have developed detailed legal analyses of the implications of certain regulatory and policy activities for international trade. These opinions are provided in the links below in order to help increase awareness and understanding by regulatory authorities and the industry of the international implications of certain regulatory and policy actions, with respect to the SPS and TBT World Trade Organization Agreements.

  1. WTO Analysis of EU Health Claims Regulation
    The EU health claims regulation, if applied, would appear to violate several obligations under the WTO Agreement on Technical Barriers to Trade (TBT Agreement).  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 and the European Food Safety Authority that  we anticipate would violate the EU's obligation under Articles 2.2 and 5.1.2 of the TBT Agreement.

    • Full text--English only

  2. WTO Analysis of RDA-Based Maximum Levels for Vitamin and Mineral Food Supplements
    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.  Now six years later, many countries continue RDA-based limits for vitamin and mineral supplements.  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--TBT Agreement and the Sanitary and Phytosanitary (SPS) Agreement--would seem to overtly prohibit these practices for products introduced into international trade:

    SPS:  Specifically, SPS Articles 2.2, 5.1, and 5.2 demand  that standards be based on risk assessment maintained with sufficient scientific evidence; Articles 2.3 and 5.5 prohibit application of regulations that are more burdensome than applied to other similar products.

    TBT:  Article 2.2 prohibits regulations by the importing country that are more trade-restrictive than necessary to protect consumer  health; Article 2.1 prohibits trade restrictions that are less favorable to  imported products than accorded to domestically produces similar products.

    The analysis on RDA-based maximums is available in both English and Spanish:

    • Full text English

    • En Español