A great deal of discussion has and continues to take place within the natural products industry on this subject. Arguably, there appears to be no single and categorical obligation for governments to adopt Codex standards and guidelines.
However, the preamble to the SPS Agreement (to which all WTO Members are signatories) specifically mentions Codex and states that WTO Members (and hence all SPS signatories) desire: “To further the use of harmonized sanitary and phytosanitary measures between Members on the basis of international standards, guidelines and recommendations developed by the relevant international organizations, including the Codex Alimentarius Commission.”
In fact, Article 3.1 of the Agreement goes even further than this to state: “To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist.”
The key word here, from a legal point of view, would appear to be the word, “shall,” which could perhaps be said to make the Guidelines for Vitamin and Mineral Food Supplements mandatory for all WTO member countries.
This is where possible future legal battles may arise on the international trade level in order to sort out “voluntary” from “mandatory” legal interpretation. On one side the natural health industries, practitioners and consumers and on the other side Codex, the WTO and our own government who‟s main interests may or may not be influenced more by international relations and trade pressure.
But, what about Countries that choose to continue to ignore Codex?
Even if a country decided not to follow Codex guidelines and standards, the
standards that the refraining country does employ in place of Codex standards
remains subject to a wide range of conditions as set out in detail in Article 5 of the
Sanitary and Phytosanitary Measures (SPS Agreement).
In relation to dietary supplements, one of the most important of these conditions
would appear to be a requirement to take into account risk-assessment techniques
developed by “the relevant international organizations.”
And you should also note that guidelines on risk analysis are already under
discussion at meetings of the Codex Committee on Nutrition and Foods for Special
Dietary Uses. Unfortunately, the committee has already indicated that this work will
be concentrating upon “the development of methodological aspects for over dosage
Other conditions that would blunt deviating “standards” utilized by non-conforming
countries in place of Codex standards include;
- A requirement to take into account economic factors as well as the relative cost-effectiveness of alternative approaches to limiting risks.
- A requirement to take into account the objective of minimizing negative trade effects
- A requirement to avoid arbitrary or unjustifiable distinctions in the levels of risk protection that it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade
Again, the resultant impact of signing onto earlier trade agreements is that, even if a country decided not to follow a Codex standard within its own borders, they would remain subject to a wide range of conditions set out in detail in Article 5 of the Sanitary and Phytosanitary Measures (SPS Agreement) and thereby made to comply. Therefore, countries that are members of the WTO are effectively required to implement all Codex standards by virtue of the fact that they have signed the SPS Agreement.
It may not be entirely coincidental that many countries have already begun taking
steps to implement stringent restrictions upon the dosage levels and availability of a
number of vitamins and minerals, including the United States and Canada, in
preparation for the finalization of the Codex Guidelines for Vitamin and Mineral
Additionally, what can be said, promoted or advertised as mental or physiological
benefit from such substances are already being restricted within the borders of the
United States by the FDA who issued “cease and desist” letters to more than 40
supplement manufacturers and distributors last January.
Indeed, the significance of Codex was underscored in 1985 by United Nations
Resolution 39/85, whereby guidelines were adopted on consumer protection policies.
One could also argue that countries were already expected to adopt Codex guidelines and standards before either the WTO or the SPS Agreement came into existence on the grounds that a United Nations General Assembly resolution in 1985 gave rise to the United Nations “Guidelines for Consumer Protection.”
These guidelines stated that "Governments should take into account the need of all consumers for food security and should support and, as far as possible, adopt standards from ...Codex Alimentarius.” Although it could also be said that the use of the word “should” in this text, as opposed to the word “shall,” could arguably be said to amount to something less than a mandatory requirement; nevertheless, the United Nations Guidelines for Consumer Protection were later expanded in 1999 and the reference to Codex was retained.
More recent developments might make the issue of “adoption” somewhat academic however, as the Codex Alimentarius Commission has recently deleted the notification and acceptance procedures from the Codex Procedural Manual. Prior to this, there had been three levels of acceptance procedures for Codex texts, and countries were, theoretically, supposed to inform the Codex Alimentarius Commission of which level of acceptance they would be applying to each individual Codex standard within its territorial jurisdiction. This is no longer an option.
Consequently, while these notification and acceptance procedures had effectively been ignored already by governments for many years, the fact that they have now been abolished provides further substantiation that in light of the SPS Agreement, compliance with Codex standards and guidelines is effectively assumed to be mandatory.
Finally, it should be noted that the text of the Codex Guidelines for Vitamin and Mineral Food Supplements specifically states in paragraph 1.2 that "These Guidelines do apply in those jurisdictions where products defined in 2.1 [i.e. vitamin and mineral food supplements] are regulated as foods."
As such, given that the United States regulates dietary supplements as foods, notwithstanding the popularity and apparent protections under DSHEA, it seems quite clear that the guidelines will indeed apply in the U.S.
In the Next Issue: Codex Alimentarius - Part Six: Final Summary