American Holistic Health Association (AHHA) - Codex Guidelines History
Codex Guidelines History

The Codex Draft Guidelines for Vitamin and Mineral Food Supplements (Guidelines) document is on the agenda for finalization by the Codex Alimentarius Commission (CAC) at the July 2005 sesson in Rome. Some may find tracing the history of the drafting of this document enlightening.

Codex committee reports are not available online prior to 1996. However, when Suzan Walter was researching the Guidelines in 2002, Alan Randell of the Codex office in Rome provided general report excerpts indicating that the comments related to food supplements first appeared in the German-hosted Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) session report for 1988. The report did not identify which delegations proposed this work.

The 1988 start is verified by the 1989 CAC Session 18 Report when it mentions that the CCNFSDU had been discussing vitamin and mineral supplement products and the need for controls.

In 1992 the CCNFSDU session report stated that the initial working draft was prepared by Germany.

Important background data: In some countries dietary supplement products are treated as pharmaceutical preparations (drugs), while in others they are "freely available" to the general public. Most countries allowing the public free access to vitamins and mineral supplements (including the U.S.) went on record against developing this type of guideline, as the restrictive controls would be "inconsistent with their national regulations and would unnecessarily restrict consumer access to dietary supplements." Their position that "there was no scientific basis for such restriction" did not withstand the power of those countries which felt "unregulated usage of some supplements might harm the health of consumers." Thus, the CCNFSDU was authorized to proceed to protect the public and remove trade barriers.

Once the project was set in motion, a number of issues became evident. In 1998 the European Union (EU) mentioned at the CCNFSDU session that the EU was drafting a paper dealing with these same issues. The Chair (from Germany) assigned Canada, the U.S. and the EU to study this EU paper and create a CCNFSDU discussion paper on how the EU paper could be used in drafting the Guidelines. It should be noted that the EU paper went on to become the European Union Dietary Supplement Directive, which is extremely restrictive.

The official decision to proceed with developing the Guidelines appears to have been made at the 2000 CCNFSDU session. At this same session the CCNFSDU discussion paper assigned in 1998 (based on the EU directive) became the basis for a significant amount of the content of the Guidelines. This may account for the similarities between the two documents.

From the beginning the most controversial issue was how to determine the maximum amount of a vitamin or mineral to be allowed in a supplement product. Eventually the approaches being considered came down to two: (1) 100% of RDI (Recommended Daily Intake), or (2) upper limits to be based on a combination of risk assessment, including all dietary sources, and safety factors. The latter finally won out in 2003.

The issue of some countries designating dietary supplements as food and some as drugs was eventually addressed by having the Guidelines only apply to those countries using the food designation. Even the name of the document was revised to add the word "Food."

Having positive and negative lists, as the EU Dietary Supplement Directive uses to control which products would be legally allowed, was not incorporated into the Guidelines. Rather, 3.1.1 of the Guidelines states "Vitamin and mineral food supplements should contain vitamins/provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognized by FAO and WHO." Interesting to note that there is no official list of FAO/WHO recognized vitamin and minerals.

The limited role of vitamin and mineral supplements, as defined in the Preamble of the Guidelines, went through challenges throughout the entire process of creating this document. Each attempt was unsuccessful. In 1998 the argument tried was that scientific data indicated that "diet may not be sufficient to meet the requirements for some nutrients of some population subgroups". In 2002 attempts were made to add mention of "prevention to reduce risk of disease." The EU led the objection based on it was not the committee's mandate "to consider the prevention, treatment or cure of diseases." In 2003 the attempt to mention prevention was declined based on the position that the Codex General Guidelines on Claims prohibited this. In 2004 the Chair would not allow the matter to be addressed. The final Preamble states "In cases where the intake from the diet is insufficient or where consumers consider their diet requires supplementation, vitamin and mineral food supplements serve to supplement the daily diet."

The intended use of the Guidelines would appear to be optional, based on the 2003 CCNFSDU session report that included replacing all uses of shall with should as "the text was not a standard." Twice at the 2004 CCNFSDU session it was stated from the podium that the Guidelines were optional. No mention was made to the delegates that Codex Alimentarius agreements with the World Trade Organization (WTO) would allow the WTO to use any Codex document (standard or guideline) as a mandatory trade standard to resolve international trade disputes.


If you wish further exploration into the history of the development of the Guidelines, you can review actual Codex reports AND reports from participants. Links to these are available below.


LINKS TO OFFICIAL CODEX REPORTS:

CAC = Codex Alimentarius Commission
CCNFSDU = Codex Committee on Nutrition and Foods for Special Dietary Uses

1987
CAC Session 17
Paragraph 454: The former Codex Committee on Foods for Special Dietary Uses was renamed as Codex Committee for Nutrition and Special Dietary Uses - "in order to take into account the extended terms of reference as approved by the 15th Session of the Commission."
No mention of Vitamins and Minerals

1988
CCNFSDU session

According to Alan Randell of Codex office in Rome - The process started in 1988 when "Several delegations" at the Codex Committee on Nutrition and Foods for Special Dietary Uses proposed work in the area of food supplements as part of an overall review of the work of Codex in the area of nutrition.

1989
CAC Session 18
Vitamin and Mineral Supplements at paragraphs 369 through 371
"The Commission was informed that the Committee had considered the need for standardization of these products (para 37, ALINORM 89/26). However, the Committee had doubts as to whether vitamin or mineral supplements would fall within the terms of reference of the Commission and had requested the Commission to consider this matter. The Chairman of the Committee indicated that in some countries these products were considered foods, while in others they were considered to be pharmaceutical preparations. Furthermore, depending on composition and other factors, these products could be either regarded as foods or pharmaceuticals. In any case they were nutrient preparations serving a special dietary purpose." "Opinion was divided concerning the need to develop Codex standards for these products. Some delegations considered that trade in these products was considerable and that Codex standards or guidelines should be developed to control them. Other delegations were of the opinion that there was no need, at this time, to work in this area. The point was made that a clear definition should be developed as to which products were foods and which products were to be considered pharmaceuticals." "The Commission agreed that the Secretariat should send a circular to governments seeking their views on whether or not work on vitamin and mineral supplements should be undertaken and to provide appropriate information so that distinction could be made between products which are foods and those which are pharmaceuticals or medicines. The Codex Committee on Nutrition and Foods for Special Dietary Uses was requested to consider information received and advise the Commission accordingly, without initiating the standardization of the products."

According to Alan Randell of Codex office in Rome - In 1989 the Codex Commission asked for more consultation between Member countries before agreeing to undertake the work. Identified the problem of defining supplements as "food" (i.e., falling within the Codex mandate) or as pharmaceuticals.

1991
CCNFSDU session

According to Alan Randell of Codex office in Rome - In 1991 following a Circular Letter to Members, the Committee agreed to undertake work on guidelines for vitamin and mineral supplements, support ranging from a non-committal "not opposed" (Denmark) to "strong" (USA). The Commission later in the year approved the new work.

1991
CAC Session 19
Vitamin and Mineral Supplements at paragraphs 272 through 274
"The Commission recalled its earlier decision to seek the views of governments on whether or not work on vitamin and mineral supplements should be undertaken within the Codex System, and to provide appropriate information so that distinction could be made between products which are foods and those which are pharmaceutical or medicines." "The Commission noted that the comments received in response to this request had been discussed at the 17th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses. Most of the comments stressed the need to clearly distinguish between foods and drugs, and there was a general support for the development of guidelines. Several delegations at the present Session expressed support for the development of the document in view of the increasing international trade in these products and their free availability to the general public. Two delegations proposed that the Guidelines be further developed to cover other supplements such as amino acids, fatty acids. One delegation expressed concern over the implications of the Guidelines in those countries where these products are considered medicines." "The Commission noted the general support for a document on this subject and agreed that work on the Guidelines should continue. The Commission noted that a paper on vitamin and mineral supplements would be presented at the next session of the Codex Committee on Nutrition and Foods for Special Dietary Uses."

1992
CCNFSDU session

According to Alan Randell of Codex office in Rome - In 1992 the initial working draft was prepared by Germany and circulated for comment.

1993
CAC Session 20
Vitamin and Mineral Supplements at paragraphs 293 through 294
"The Commission noted that the Committee, at its 18th Session, had considered the Guidelines for Dietary Supplements with Special Reference to Vitamins and Minerals. The Guidelines would be further considered by the Committee taking into account recent research information on vitamins and minerals and the fact that more and more supplementary products were available on the market." "The Observer of AOAC informed the Commission that an AOAC Manual containing methods of sampling and analysis of vitamins and minerals for use for nutrition labelling purposes would be available in September."

1995
CAC Session 21
No mention of Vitamin and Mineral Supplements

1996
CCNFSDU Session

Report for Proposed Draft Guidelines for Dietary Supplements -- Agenda Item 7
Paragraphs 42 through 62
Status of Guidelines document
Lead U.S. Delegate Dr. Elizabeth A. Yetley
The U.S., United Kingdom and Japan were against developing the guidelines as the provisions therein were inconsistent with their national regulations and would unnecessarily restrict consumer access to dietary supplements. Others felt a need to regulate these "widely traded products." Canada emphasized the importance of applying risk assessment methodology if setting maximum levels of intake. The Netherlands was for a safety based approach in setting upper limits. There was agreement to concentrate on safety considerations based on scientific evidence and to change from "Dietary Supplements" to "Vitamin and Mineral Supplements." Added that guidelines would not apply where supplements were designated as drugs. Between a "positive list" and "no limitations should be set except on the basis of safety", decided to include only vitamins/provitamins and those minerals which were recognized as essential on a scientific basis.

1997
CAC Session 22
Proposed Draft Guidelines for Vitamin and Mineral Supplements
Paragraphs 110 through 112
"The Delegations of Canada and the United States, supported by Australia and Japan, expressed their objection to the development of the Guidelines in the framework of Codex as this matter should be left to national authorities to regulate, in view of the wide differences between countries concerning the regulatory status and consumption habits of vitamin and mineral supplements. The development of international guidelines in this area would negatively affect the right of consumers to use these products, and there was no scientific basis for such restriction. It was also pointed out that many sections of the text were in square brackets and there may not be sufficient consensus at this stage to advance it to Step 6." "Several delegations pointed out that these products were traded internationally and their unregulated development posed a problem to control authorities, it was therefore essential that work on this issue should continue within the Committee on Nutrition and Foods for Special Dietary Uses."

1997
CCNFSDU session

According to Alan Randell of Codex office in Rome - In 1997 the Proposed Draft Guidelines submitted to the 22nd Session of the Codex Commission for consideration and approval (Step 5) and the Commission returned it to the Committee for re-drafting due to lack of consensus on the content of the guidelines.

1998
CCNFSDU Session

Report for Proposed Draft Guidelines for Vitamin and Mineral Supplements -- Agenda Item 5
Paragraphs 41 through 48
Document not provided
Lead U.S. Delegate Dr. Elizabeth A. Yetley
Strong opinions that guidelines needed to be developed as "unregulated usage of some supplements might harm the health of consumers." "Moreover, since national legislation could not always address the problems and trade barriers already existed, it was essential to provide an international reference in the framework of the Codex and to ensure fair trade practices." Canada (supported by the U.S.) "strongly objected to further elaboration of the guidelines as this would interfere with the trade of products which could benefit certain consumers, as recent scientific data[10] indicate that diet may not be sufficient to meet the requirements for some nutrients of some population subgroups; in addition, many consumers felt that the consumption of vitamin and minerals was a "right", and products which were safe and presented no health risk should be freely available. The Delegation stressed that, since the attitude and perception of consumers greatly differed from one country to another, the regulation of supplements should be left to national authorities." Debate on upper limits included an approach combining risk assessment, considering all dietary sources, and safety factors. The EU proposed that a paper on dietary supplements being developed by the EU could serve to revolve several unresolved issues. A discussion paper on several issues, to be based on the EU paper, was assigned to Canada, the U.S. and the EU.

1999
CAC Session 23
No mention of Vitamin and Mineral Supplements

2000
CCNFSDU Session

Report for Proposed Draft Guidelines for Vitamin and Mineral Supplements -- Agenda Item 5
Paragraphs 36 through 57
Status of Guidelines document
Lead U.S. Delegate Dr. Elizabeth A. Yetley
The discussion paper assigned in 1998 to Canada, the U.S. and the EU was introduced by the U.S. First, the discussion addressed whether or not to proceed with the elaboration of the Guidelines. Canada, India and Kenya strongly objected. The U.S. stressed the importance of consumer choice and access to vitamin and mineral supplements. Malaysia and others felt it was necessary to regulate products in the marketplace that sometimes had a very high dosage of vitamins and minerals in order to avoid misleading consumers. The decision was to proceed. Then each section of the Guidelines was addressed in conjunction with the Discussion paper. It was agreed that "supplements should contain substances of nutritive value proven by scientific data, instead of indispensability in Section 3.1.1." "Section 3.1.2 was amended to reflect that criteria such as safety and bioavailability were essential in the selection of sources..." No consensus on minimum and maximum levels. Extensive debate, also, on the declaration of vitamins and minerals. Some supported reference to the biologically active part of vitamins and minerals as bioavailability was referenced as one of the criteria in Section 3 while other delegations indicated that the meaning of this wording was not clear enough. As a compromise it was agreed to amend the former Section 8.3 as proposed by the Observer of the EC and including the references to amounts of vitamins and minerals by units of weight, the amount per portion of the product and the percentage of the NRV mentioned and retained it in square brackets.

2001
CAC Session 24
No mention of Vitamin and Mineral Supplements

2001
CCNFSDU Session

Report for Proposed Draft Guidelines for Vitamin and Mineral Supplements -- Agenda Item 4
Paragraphs 18 through 40
Status of Guidelines document on page 41 in Appendix II
Lead U.S. Delegate Dr. Elizabeth A. Yetley
Noted that "the current Guidelines contained some prescriptive text that could be more relevant to a standard." Option to extend scope of Guidelines to cover herbs was not accepted, as this matter is to be left to national authorities to decide. Section 3. Composition was amended to make less prescriptive, plus stated that the status of vitamins and minerals should be recognized by FAO/WHO. Lower limits of 15%, 25% and 33% were discussed. Upper limits continue to be between 100% of recommended daily intake vs. risk assessment and considering all sources of the nutrients.

2002
CCNFSDU Session

Report for Proposed Draft Guidelines for Vitamin and Mineral Supplements -- Agenda Item 6
Paragraphs 87 through 100
Status of Guidelines document on page 56 in Appendix IV
Lead U.S. Delegate Dr. Elizabeth A. Yetley
Chair stressed the importance of a risk-based approach and the work of FAO and WHO on establishment of safe upper limits. Added "food" to title to clarify that the products were foods at request of EU. South Africa and National Health Federation supported revising Preamble to include reference to prevention to reduce risk of disease. EU and others objected to as not mandate of committee "to consider the prevention, treatment or cure of diseases." No progress on criteria for upper limits.

2003
CAC Session 26
No mention of CCNFSDU

2003
CCNFSDU Session

Report for Proposed Draft Guidelines for Vitamin and Mineral Supplements -- Agenda Item 5
Paragraphs 36 through 61
Status of Guidelines document on page 44 Appendix IV
Lead U.S. Delegate Dr. Elizabeth A. Yetley
Efforts to block addition of "food" to title unsuccessful. South Africa tried to get preventive role of vitamins and minerals added to Preamble. This was declined based on position that General Guidelines on Claims prohibited. Efforts to remove reference to whether countries referred to vitamins and minerals as food or drugs were unsuccessful. Sentence states Guidelines to be applied to foods. EC successfully proposed to add provisions so that food supplements containing vitamins and mineral were also subject to Guidelines. Specified that the purpose of products "is to supplement the intake of vitamins and/or minerals from the normal diet." Minimum amount set at 15%. Upper limits were finally resolved on "the basis of scientific risk assessment." Rather then child-resistant packages, labelling is to specify that "the product should be stored out of reach of young children." Name of product should be "food supplements." Each place shall appeared, it was replaced with should as "the text was not a standard." Need for a "warning statement" was replaced with "advice to the consumer not to exceed the maximum one-day amount." A requirement that "supplements should be taken on the advice of a nutritionist, a dietician or a medical" was removed.

2004
CAC Session 27
No mention of CCNFSDU

2004
CCNFSDU Session

Report for Proposed Draft Guidelines for Vitamin and Mineral Food Supplements -- Agenda Item 4
Paragraphs 23 through 35
Status of Guidelines document on page 42 in Appendix II
Lead U.S. Delegate Dr. Barbara O. Schneeman
Chair commented again about prior agreement to refer to vitamin and mineral "food" supplements in title and relevant parts of document. Quantity reference ended up "to be taken in measured small-unit quantities" and added a footnote to clarify reference is to physical forms of vitamin and mineral supplements. Finalized "selection should be based on considerations of safety and bioavailability." Recalled that agreed earlier to "limit guidelines to vitamin and minerals for which the Recommended Daily Intake was established by FAO/WHO." Agreed to advance the Draft Guidelines for adoption at Step 8 by 28th Session of the Codex Alimentarius Commission.


LINKS TO REPORTS FROM PARTICIPANTS:

Since official Codex session reports do not include everything that happens, it is interesting to review reports from participants at these sessions.

2004
Suzan Walter (AHHA president) - Guidelines Completed. Now What?

Scott Tips - A Meeting of Two

Paul Anthony Taylor - The Controversy Continues

Sepp Hasslberger - Codex Nutrition Committee: Supplement Guidelines Final

James Roza - Codex Bonn Summary

Carolyn Dean, M.D., N.D. - Codex Overview and Report on Bonn, 2004


2003
Suzan Walter - Important News from Bonn

Scott Tips - Rearranging the Deck Chairs on the Titanic

Antoinette Booyzen - South Africa CCNFSDU Report 2003

Paul Anthony Taylor - Codex 2003--The EU tightens its grip

Council for Responsible Medicine - Codex Committee Backs Science-Based Safety Standards for Vitamin and Mineral Supplements--Breaks Eight-Year Stalemate

Josef Hasslberger - South Africa breaks ranks at Codex Nutrition Committee

Dr. Wong Ang Peng - Hypocrisy! Hypocrisy! Hypocrisy!


2002
Suzan Walter - AHHA Attends Berlin Codex Session--What did we learn?

Scott Tips - Report From The Eastern Front: Author finds much to mistrust at recent Codex session in Berlin

Susan Negus - 2002 Report

Anthony Rees - Victory from Within Codex


2001
Scot Tips - Codex Gets One Step Closer To Control

Susan Negus - 2001 Report


2000
Scott Tips - Breathe Easier--Codex Adjourns



If you know of additional online participant reports, please e-mail the report's URL to our webmaster at codexinfo@ahha.org, so that we can expand this list. Thank you.




This website (codexinfo.org) was restructured in June 2005. This specific page was last updated June, 2005.


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