Codex Guidelines for Vitamins and Minerals - Optional or

Mandatory?
By Paul Anthony Taylor

1 Contents
Codex Guidelines for Vitamins and Minerals - Optional or Mandatory? .......................... 1
By Paul Anthony Taylor ............................................................................................... 1
1 Contents................................................................................................................... 1
2 Introduction .............................................................................................................. 1
3 A Brief History of Codex........................................................................................... 2
4 The Relationship between Codex Alimentarius and the WTO.................................. 2
5 Codex is effectively Mandatory for all WTO Members ............................................. 2
6 Codex Texts Used by the WTO to Resolve International Trade Disputes................ 3
7 The WTO does Not Distinguish between Standards and Guidelines.................... 3
8 The Growing Influence of the EU upon Codex......................................................... 4
9 The Likely Acceleration of the Codex Adoption Process.......................................... 4
10 The Codex threat to the Food Supplements Directive legal challenges................... 4
11 Conclusion ............................................................................................................... 6
12 REFERENCES......................................................................................................... 7
13 CONTACT................................................................................................................ 9

2 Introduction
The Codex Alimentarius Guidelines for Vitamin and Mineral Supplements are a joint
attempt by the Food and Agriculture Organization of the United Nations (FAO) and the
World Health Organization (WHO) to formulate one single standard governing the sale
of food supplements that can be applied throughout the global market. Under the guise
of free trade harmonization the Codex Committee on Nutrition and Foods for Special
Dietary Uses (CCNFSDU), are drawing the Guidelines where vitamins and minerals are
defined as foods. This committee meets in Germany once every year, usually in
November.
Although the Guidelines have gone through several revisions over recent years, it is
now becoming increasingly clear that their eventual effect, once completed and
implemented, may be to remove large numbers of the most effective forms of nutrients
from the global market. The Guidelines may set restrictive upper limits on the dosages
of all permitted nutrients; and prohibit the sale of all supplements for curative,
preventative or therapeutic purposes without a doctors prescription. As a result, the
Guidelines would continue to ensure that the sale of curative, preventative and
therapeutic products remains the exclusive province of the pharmaceutical
industry.

As this article will show, the Codex Alimentarius Guidelines for Vitamin and Mineral
Supplements are now without question the most serious of all the various threats
currently facing the global natural products industry.

3 A Brief History of Codex

The Codex Alimentarius Commission was established in 1963 following resolutions
passed at the Eleventh Session of the Conference of the Food and Agriculture
Organization of the United Nations in 1961, and at the Sixteenth World Health Assembly
in 1963. (1). The historical origins of Codex Alimentarius lie in the Codex Alimentarius
Austriacus however, which was a collection of standards and product descriptions for a
wide variety of foods, developed in the Austro-Hungarian Empire between 1897 and
1911. (2). Austria subsequently actively pursued the creation of a regional food code,
the Codex Alimentarius Europaeus, or European Codex Alimentarius, between 1954
and 1958. (3). The Council of the Codex Alimentarius Europaeus then adopted a
resolution in 1961 proposing that its work on food standards be taken over by the FAO
and the WHO. (4).

4 The Relationship between Codex Alimentarius and the

WTO
The WTO replaced the General Agreement on Tariffs and Trade (GATT) on 1 January
1995. The GATT itself had been in existence since 1947, as the organization
overseeing the multilateral trading system. (5). The governments that had signed GATT
were officially known as GATT contracting parties, and upon signing the new WTO
agreements (which include the updated GATT, known as GATT 1994), they officially
became known as WTO Members. Built upon some of the ideas and principles that
underpin the European Union (6), the WTO currently has a total membership of 146
countries. (7). In the mid-1990s Codex Alimentarius signed agreements with the WTO
by which Codex creates trade standards that the WTO uses to resolve international
trade disputes. (8), (9), (10).

5 Codex is effectively Mandatory for all WTO Members

The legal basis for enforcement of the various different Guidelines and Standards created by
Codex comes from the Agreement on the Application of Sanitary and Phytosanitary Measures
(SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement). Both
the SPS Agreement and the TBT Agreement were included among the Multilateral Agreements
on Trade in Goods, annexed to the 1994 Marrakesh Agreement that established the WTO. (11).
Although Codex standards and guidelines are theoretically voluntary, a new status has in
effect been conferred on them by the SPS Agreement, in that any WTO Member adopting them
is presumed to be in full compliance with the SPS Agreement. (12).
The net result of this is that even when a country decides not to use a Codex standard the
measure that it operates in place of that Codex standard remains subject to a range of
conditions set out in detail in Article 5 of the SPS Agreement. (13). The most important of these

conditions is a requirement to take into account risk assessment techniques developed by the
relevant international organizations. (14). As it turns out however these relevant international
organizations actually include Codex itself, and in this respect it is notable that the CCNFSDU
is already considering a document entitled Discussion Paper on the Application of Risk Analysis
Applied to the Work of the CCNFSDU. (15). In other words, in the event of a country choosing
not to implement a Codex standard the measure that it operates in place of that standard still
remains subject to Codex guidelines.
Other conditions affecting measures that countries operate in place of Codex standards include
a requirement to take into account economic factors and the relative cost-effectiveness of
alternative approaches to limiting risks (16); a requirement to take into account the objective of
minimizing negative trade effects (17); and 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 (18).
As such, countries that are members of the WTO are effectively required to implement all Codex
standards by virtue of the fact that they have signed up to the SPS Agreement. It may not be
entirely coincidental therefore that many countries have already begun taking steps to
implement stringent restrictions upon the dosage and availability of vitamins and minerals, in
preparation for the finalisation of the Codex Guidelines for Vitamin and Mineral Supplements.
Indeed, United Nations Resolution 39/85, whereby guidelines were adopted on consumer
protection policies, underscored the significance of Codex in 1985. The guidelines advise 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 the ... Codex Alimentarius". (19).

6 Codex Texts Used by the WTO to Resolve International

Trade Disputes
Whilst it may be technically true for the WTO to say that there is no legal obligation on
Members to apply Codex standards, guidelines and recommendations (20), the reality is that
Codex texts are used by the WTO as a means of resolving international trade disputes (21), and
WTO Members are legally obliged to abide by WTO rulings. Once the Codex Guidelines for
Vitamin and Mineral Food Supplements are completed therefore, all it would take to begin
enacting them globally would be for one of the participating countries to launch, and win, an
international trade dispute. The global adjudicators in such an instance would be the WTO
Dispute Settlement Body (22), some of the hearings for which take the form of closed meetings
held in private. Appeals to Dispute Settlement Body rulings are possible, but they have to be
based on points of law such as legal interpretation they cannot re-examine existing evidence
or examine new issues. (23).

7 The WTO does Not Distinguish between Standards and

Guidelines
Theoretically, there are three levels of acceptance for Codex texts, namely; full acceptance;
acceptance with specified deviations; and free distribution (which means that the country
concerned undertakes that products conforming with a Codex Standard may be distributed
freely within its territorial jurisdiction, while domestically produced products sold within its own
borders remain unaffected). (24). The free distribution option has led many people to
mistakenly believe that Codex does not have the authority to impose anything on a country in

terms of domestically produced products sold into its own internal market. However, because
Codex standards are used by the WTO to resolve international trade disputes, WTO members
can literally have Codex Guidelines and Standards forced upon them, irrespective of
acceptance. Proof of this comes from the Codex Committee on General Principles, who have
stated the following:
The Committee recognized that the current procedures had not been used frequently. They
recalled that Codex standards were a reference in the framework of the WTO Agreements,
irrespective of acceptance. (25).
Furthermore, in response to a request from the 22nd Session of the Codex Alimentarius
Committee for the WTO Committee on Sanitary and Phytosanitary Measures (the SPS
Committee), to clarify how the Committee would differentiate standards, guidelines or
recommendations in relation to the implementation of the SPS Agreement" by WTO Members,
the WTO has informed Codex that the SPS Agreement does not differentiate between
standards and guidelines (26), (20), and that how a Codex text is applied depends upon its
substantive content rather than the category of the text. (20). Clearly then, any distinction
between Standards and Guidelines by the Codex Alimentarius Committee is purely arbitrary.

8 The Growing Influence of the EU upon Codex

The EU is the single most powerful influence upon the Codex discussions. A recent European
Council document has acknowledged the increased legal relevance that the various Codex
Alimentarius standards, guidelines and recommendations have acquired by virtue of the
reference made to the Codex Alimentarius in the WTO Agreements and the presumption of
conformity which is conferred on relevant national measures when they are based on such
standards, guidelines or recommendations adopted by the Codex Alimentarius Commission.
(27). Similarly, this document also acknowledges that one of the objects of the Codex
Alimentarius Commission is to harmonise worldwide health standards. (28).
It now appears increasingly likely that EU health policy will gradually become the blueprint for
global health policy. The growing similarities between the text of the EU Food Supplements
Directive (29) and the Codex Draft Guidelines for Vitamin and Mineral Supplements (30), for
example, are no coincidence. Mr. Basil Mathioudakis, who was responsible for drafting the text
of the EU Food Supplements Directive, is the head of the European Commission delegation at
Codex, and will now be representing all 25 EU Member States at the next Codex meeting in
Bonn in November 2004 (due to the 10 new countries who joined the EU on 1st May 2004).
Moreover, the EU will shortly have full membership status at Codex. (31). The net result of this
is that Mr. Mathioudakis, on behalf of the EU Commission, will now be entitled to wield a
number of votes at Codex equal to the number of its Member States that are present at the time
the vote is taken. (32). Furthermore, whenever Mr. Mathioudakis exercises his right to vote, the
Member States will not be entitled to exercise theirs. (33). As such, the EU Member States are
now virtually powerless to oppose the EU Commission at Codex; especially so given the fact
that the majority of the guidelines being drawn up are either already law, or about to become
law, in their own countries.

9 The Likely Acceleration of the Codex Adoption Process

Although formal votes are rarely taken at Codex, both the FAO and the EU are now in
favour of a majority of two-thirds being sufficient in future for a Codex text to be
adopted. (34). Democratically of course, since the EU, with its soon-to-be population of
4

450 million people (35), is allowed 25 votes at Codex, then the United States of
America, with its population of over 280 million people (36), should proportionately be
given at least 15 votes.
Under the present system however, the United States is allowed one vote, which
means that the EU is now in an extremely powerful position.
In fact, at the next Codex meeting it is very likely that the EU will be able to wield a
block vote consisting of almost one half of all the countries likely to attend.
As such, only another 12 more votes would be needed over and above the EUs 25
votes to reach a two-thirds majority. (37). Because only one country, South Africa, is
actively opposing these restrictive proposals for the world-wide availability of vitamin
and mineral supplements, the global future for natural health care now lies at a critical
juncture.
Furthermore, both the FOA and the EU have recently stated their desire to accelerate
the work of Codex (38), and have agreed that the present 8-step procedure be
simplified to a 5-step procedure. (39). Nevertheless, it should be borne in mind that in
order to achieve an adoption on 5 steps it may not even be necessary to modify the
existing procedures, as these already provide for an accelerated adoption. (40), (41).
The Codex Alimentarius Commission can authorise, for example, on the basis of a twothirds majority of votes cast, the omission of Steps 6 and 7, whenever such an action is
recommended by the relevant Codex Committee. (42).

10 The Codex threat to the Food Supplements Directive legal

challenges
The Food Supplements Directive (29) was passed by the EU Parliament on 13th March 2002,
and entered into law in EU Member States on 1st August 2003.
Its text and intent are remarkably similar to that of the Codex Draft Guidelines for Vitamin and
Mineral Supplements (30), as its effect, when it becomes fully implemented on 1st August 2005,
will be to
1. remove large numbers of the most effective forms of nutrients from the EU market;
2. set restrictive upper limits on the dosages of all nutrients permitted in the EU;
3. prevent the sale of all supplements for curative, preventative or therapeutic purposes
within the EU without a doctors prescription.
Two legal challenges to the validity of this Directive have now been launched by groups from
the UK; one by the Alliance for Natural Health (43) in conjunction with Nutri Link Ltd. (44), and
the other by the Health Food Manufacturers Association (45) in conjunction with the National
Association of Health Stores (46). Both of these challenges have recently been referred to the
European Court of Justice (ECJ), following a High Court hearing that took place in London on
30th January 2004. The judge at the hearing, Mr Justice Richards, ruled that there was an
arguable case that the Food Supplements Directive was unlawful; that a reference to the ECJ
was plainly appropriate; and that it should be made as soon as possible. (47).

However, because of the strength of the EU block-vote at Codex it is possible that discussions
regarding the Codex Draft Guidelines for Vitamin and Mineral Supplements might even be
completed at this years CCNFSDU meeting in November. Such an outcome could have grave
implications for the legal challenges to the EU Food Supplements Directive, because if the
Codex Guidelines were agreed before the legal challenge was completed, the UK lawyers
would in essence be arguing for the European Court of Justice to overturn legislation that was
fully in line with a newly agreed global standard.
Nevertheless, the legal challenges currently being mounted against the EU Food Supplements
Directive are unquestionably crucial to the future of health freedom in the EU. Their eventual
success could buy valuable time for the growing European health freedom movement, as well
as strike a blow against the text of what is in effect a EU blueprint for the global regulation of
supplements. However, it should not be forgotten that from the regulatory perspective Codex is
the trump card. Even if the legal challenges to the Food Supplements Directive are successful,
for example, the Codex proposals could still be implemented as the global standard, thus
effectively overruling any short-term victory for health freedom in the EU.

11 Conclusion
As a result of the SPS Agreement, Codex texts, guidelines and standards are effectively
mandatory for all WTO Members. Also, because the WTO do not distinguish between guidelines
and standards, and the fact that the WTO uses Codex texts to resolve international trade
disputes, a finalised Codex text would have the ability to override the dietary supplement laws of
all countries - including the United States and its hard-fought victory in passing DSHEA.
Moreover, although the Codex Guidelines for Vitamin and Mineral Food Supplements are
currently at step 5 of an 8-step finalisation process, the EU and the FAO have both
recently stated their desire to accelerate the work of Codex such that the adoption of
Codex texts could henceforth be achieved in 5 steps.
However, and as previously stated, in order to achieve an adoption in 5 steps it may not even
be necessary to modify the existing procedures, as these already provide for an accelerated
adoption. As a result of the stranglehold that the EU are beginning to exert upon the Codex
Alimentarius discussions this outcome therefore remains a very real possibility for the next
CCNFSDU meetings in November 2004.
In summary the EU is now the single strongest influence at Codex meetings, and the EU Food
Supplements Directive is essentially the blueprint for the Codex Guidelines for Vitamin and
Mineral Supplements. Unless serious changes are made to the way in which Codex operates
therefore, it would not be unreasonable to expect that other EU health-related legislation, such
as restrictive regulations on nutrition and health claims, will become the blueprints for still further
standards to be enacted on a globally harmonised basis. In the event of this the planetary
effects upon natural health, and by implication public health, would be both profound and
disastrous.

12 REFERENCES
1. Understanding Codex Alimentarius. Food and Agriculture Organisation of the United
Nations. World Health Organization. 2000. p. 11.
2. Ibid. p. 6.
3. Ibid. p. 7.
4. Ibid. p. 7.
5. World Trade Organization http://www.wto.org/english/thewto_e/gattmem_e.htm
6. The man who built the WTO: an interview with Peter Sutherland.
http://www.opendemocracy.net/debates/article-6-28-1674.jsp
7. World Trade Organization http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm
8. SPS Agreement. World Trade Organization. URUGUAY ROUND AGREEMENT: Agreement
on the Application of Sanitary and Phytosanitary Measure.
http://www.wto.org/english/docs_e/legal_e/15sps_01_e.htm
9. TBT Agreement. World Trade Organization. URUGUAY ROUND AGREEMENT: Agreement
on Technical Barriers to Trade. http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm
10. Understanding Codex Alimentarius. Food and Agriculture Organisation of the United
Nations. World Health Organization. 2000. pp. 24-25.
11. Ibid. p. 24.
12. World Trade Organization
http://www.wto.org/english/thewto_e/whatis_e/eol/e/wto03/wto3_26.htm#note7
13. Ibid.
14. World Trade Organization. The WTO Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement).
http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm Article 5; paragraph 1.
15. Codex Committee on Nutrition and Foods for Special Dietary Uses. Agenda for Twenty-fifth
Session, held at "Brckenforum Bonn", Friedrich-Breuer-Strasse 17, Bonn, Germany, on 3
7 November 2003. http://www.codexalimentarius.net/ccnfsdu25/nf03_01e.htm
16. World Trade Organization. The WTO Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS Agreement).
http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm. Article 5; paragraph 3.
17. Ibid. Article 5; paragraph 4.
18. Ibid. Article 5; paragraph 5.
19. United Nations Food and Agriculture Organization (FAO).
http://www.fao.org/news/1999/codex-e.htm
20. World Trade Organization. http://docsonline.wto.org/gen_search.asp?searchmode=simple
SIMPLE SEARCH for document number 98-1071.
21. Understanding Codex Alimentarius. Food and Agriculture Organisation of the United
Nations. World Health Organization. 2000. p. 25.
22. World Trade Organization. http://www.wto.org/english/tratop_e/dispu_e/dispu_e.htm

23. World Trade Organization.

http://www.wto.org/english/thewto_e/whatis_e/tif_e/disp1_e.htm#appeals
24. General Principles of the Codex Alimentarius. 4.A.i/ii/iii.
http://www.fao.org/DOCREP/005/Y2200E/y2200e05.htm#TopOfPage
25. Report of the Thirteenth Session of the Codex Committee on General Principles, held in
Paris from 7 to 11 September 1998. Item 6.2; paragraph 43. Revision of the Acceptance
Procedure (CX/GP 98/8).
http://www.fao.org/docrep/meeting/005/W9809E/w9809e08.htm#bm08.2
26. World Trade Organization. http://docsonline.wto.org/gen_search.asp?searchmode=simple
SIMPLE SEARCH for document number 98-0462.
27. COUNCIL DECISION of 17 November 2003 on the accession of the European Community
to the Codex Alimentarius Commission (2003/822/EC). http://europa.eu.int/eurlex/pri/en/oj/dat/2003/l_309/l_30920031126en00140021.pdf Preamble; paragraph 2.
28. Ibid. Preamble; paragraph 1.
29. http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_183/l_18320020712en00510057.pdf
30. Codex Committee on Nutrition and Foods for Special Dietary Uses. 25th Session.
Bruckenforum, Bonn, Germany 3-7 November 2003. ALINORM04/26.
ftp://ftp.fao.org/codex/alinorm04/al04_26e.pdf
31. COUNCIL DECISION of 17 November 2003 on the accession of the European Community
to the Codex Alimentarius Commission (2003/822/EC). http://europa.eu.int/eurlex/pri/en/oj/dat/2003/l_309/l_30920031126en00140021.pdf
32. Codex Alimentarius Commission. Procedural Manual. Thirteenth Edition. Rules of Procedure
of the Codex Alimentarius Commission. Rule II (3) - Member Organizations. p. 6.
ftp://ftp.fao.org/codex/PM/Manual13e.pdf
33. Ibid.
34. European Community Comments on the Joint FAO/WHO Evaluation of Codex Alimentarius
and other FAO and WHO work on Food Standards. (Codex Circular Letter CL 2003/8-CAC).
p. 9. http://europa.eu.int/comm/food/fs/ifsi/eupositions/cac/cac_ec-comments_cl20038_en.pdf
35. http://europa.eu.int/comm/eurostat/Public/datashop/printproduct/EN?catalogue=Eurostat&product=3-09012004-EN-BP-EN&mode=download
36. http://www.census.gov/main/www/cen2000.html
37. Forty eight countries attended the Codex Committee on Nutrition and Foods for Special
Dietary Uses 25th Session, held at the Bruckenforum, Bonn, Germany, from 3-7 November
2003. ALINORM04/26. See ftp://ftp.fao.org/codex/alinorm04/al04_26e.pdf These forty eight
countries included three of the new EU countries (Hungary, Poland and Slovenia). If the
other seven new EU countries attend the next meeting in November 2004 (and assuming
that every country that attended last year also attends) there will be fifty five countries
attending in total. A two thirds majority would therefore consist of thirty seven votes. The EU
will have twenty five votes.
38. European Community Comments on the Joint FAO/WHO Evaluation of Codex Alimentarius
and other FAO and WHO work on Food Standards. (Codex Circular Letter CL 2003/8-CAC).
p. 1. http://europa.eu.int/comm/food/fs/ifsi/eupositions/cac/cac_ec-comments_cl20038_en.pdf

39. Ibid. p. 8.
40. Ibid. p. 9.
41. Codex Alimentarius Commission. Procedural Manual. Thirteenth Edition. Part 2: Uniform
Accelerated Procedure for the Elaboration of Codex Standards and Related Texts. pp. 2223. ftp://ftp.fao.org/codex/PM/Manual13e.pdf
42. Ibid. Procedures for the Elaboration of Codex Standards and Related Texts. p. 22.
43. http://www.alliance-natural-health.org/
44. http://www.autismfile.com/nutrilink.htm
45. http://www.hfma.co.uk/
46. http://www.nahs.co.uk/
47. BBC News. http://news.bbc.co.uk/2/hi/health/3445503.stm

13 CONTACT
Paul Anthony Taylor
paulandpolly@btinternet.com