“Codex Bonn Summary”
by James Roza
The 2004 Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) was most auspicious as the collective body of delegates reached consensus on Guidelines for Vitamin and Mineral Food Supplements. The draft standard, now at step eight of the Codex process, will be submitted to the Commission with a view to its adoption as a Codex standard next year.
This event signals closure to a process that began many years ago as CCNFSDU worked towards establishing international guidelines for vitamin and mineral supplements. It has been a long and arduous journey as nations from all over the world worked together to define guidelines for the free trade of supplements across international borders.
This process was complicated by the fact that many nations currently regulate supplements as drugs and only allow RDA potencies. The agreed upon draft standard establishes that vitamin and minerals are food supplements and that maximum safe upper limits must be established using risk analysis. These provisions are significant because it precludes national authorities from categorizing these products as drugs and allows for scientific evaluation to determine safe potencies. Section 3.2 of the Guidelines, Contents of Vitamins and Minerals, states under subsection 3.2.2 that:
Maximum amounts of vitamins and minerals in vitamins and mineral food supplements per daily portion of consumption as recommended by the manufacturer shall be set taking the following criteria into account:
(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking consideration, as appropriate, the varying degrees of sensitivity of different consumer groups;
(b) the daily intake of vitamins and minerals from dietary sources
When the maximum levels are set, due account may be taken of the reference intake values of vitamins and minerals for the population. This provision should not lead to the setting of maximum levels that are solely
Based on recommended nutrient intakes (e.g. Population Reference or Recommended Daily Allowance values
The last sentence of this subsection’s text is most important because it ensures that maximum limits will not be based on RDA’s in disregard of scientific evidence of a nutrient’s safety at higher levels. It was added at this year’s session when interventions to delete the sentence that precedes it did not achieve consensus.
This epochal development sets the stage for science to prevail in establishing the potency limits for which vitamins and minerals can be sold. Although this should allay industry and consumer fears that vitamins and minerals could be disallowed due to potency, vigilance will be required until the risk analysis process is complete. This process will undoubtedly take some time and there are concerns that if the risk analysis is not thorough and transparent; another battle line could be drawn in the process.
Currently, the Food Safety Authority of the European Union is working on maximum safe upper limits as part of their Food Supplement Directive. The Directive applies to all twenty-five nations of the EU and is set to go into effect in August of 2005. It remains to be seen where these limits will be set but if the work done by the Expert Group on Vitamin and Mineral (EVM) of the UK is any barometer; levels for certain nutrients could be lower than potencies considered reasonably acceptable by many experts. Their review set a safe upper limit for B6 at 10mgs. and gave guidance to an upper limit for Niacin at 17mgs. There are concerns that some Codex delegations may attempt to drop this standard into the Codex Guidelines since it would already be the standard for the EU nations. Whether these fears will be realized remain to be seen but it is imperative that industry and consumers monitor this process to avoid unreasonable limits from being set.
Given this caveat, I think its fair to say that the work completed by CCNSFDU this year provides the groundwork for international supplement guidelines that are fair and reasonable. Groups such as the Council for responsible Nutrition (CRN), the National Health Federation (NHF) and the American Holistic Health Association (AHHA) should be recognized for their support in ensuring that health freedoms (in the spirit of DSHEA) are maintained. Much more work still needs to be done the light at the head of the tunnel is becoming discernibly brighter.