A report on the Codex discussions regarding the Proposed
Draft Guidelines for Vitamin and Mineral Supplements, prepared
by Paul Anthony Taylor.
CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY
USES Twenty-fifth Session. Bruckenforum, Bonn, Germany, 3-7 November
2003.
Monday 3rd November 2003
Agenda item 5. Proposed Draft Guidelines for Vitamin and
Mineral Supplements
The Chairman opened discussions on this agenda item by saying
that for a
long time no progress had been made on this issue, but that
people had
become aware of the need to develop these proposals. He also
stated that he intended to make a major breakthrough on this
occasion, and suggested that the discussions should include
the issue of the maximum values for nutrients.
Title
The first issue to be
discussed by the Committee was that of the title of
the guidelines. (Proposed Draft Guidelines for Vitamin and
Mineral Food
Supplements). Malaysia
proposed to delete the word "food" from the title, and South
Africa supported them on this. The EC (European Commission)
Observer (Mr. Basil Mathioudakis) did not agree to this
however, saying that it was not acceptable. The general
pattern of the debate began to become apparent from this point
onwards, as the Chairman stated that he did not share the
concerns of Malaysia and South Africa, and said that we could
leave the title as it is. In effect (and not for the last time
in these meetings) the Chairman was no longer acting as a
moderator, but as a judge. With regard to this point, it is
notable that the text of the Draft Report that was issued on
the Friday stated the following:
After an exchange of views it was however agreed to retain
the current
title.
As will be seen later, this was by no means the only instance
where the
Draft Report did not reflect what had actually happened.
Preamble
The debate then passed quickly
on to the text of the preamble. South Africa read out their
proposed alterations, which included wording to the effect
that people should "be encouraged to select a healthy diet and
supplement this diet with those nutrients for which the intake
from the diet is insufficient to meet the requirements
necessary for the prevention of
chronic diseases and/or for the promotion of health beyond the
demands of preventing micronutrient deficiencies." The
National Health Federation
supported this, saying that this text merely states what we
know to be true.
The EC Observer however said that food and the prevention of
diseases do not go together. He was supported by the Chairman
in this, who said that drugs are to mitigate and prevent
diseases, and that the role of food supplements is to support
the diet.
CRN talked about the classic nutritional diseases, the
nutrient responsive
diseases, and nutrients used as drugs, and said that this sort
of
categorization should be the way forward. The EC Observer,
however, said that health claims for vitamin and mineral
supplements should be prohibited. The Chairman pointed out
that the situation in the United States was different, and
that the Codex Committee has a certain conflict regarding this
issue. Medical supervision is important in this field, he
said, and we should not talk about the prevention of diseases.
The National Health Federation refuted the Chairman's
statement however.
Tunisia said that most people who have access to a balanced
diet get
sufficient nutrients, and that people should be encouraged to
aim for a
balanced diet. The Chairman then intervened in the discussion,
saying that
he wanted to stick to the preamble as it is, as the Codex
Committee had been discussing this issue for years. Yet again
then, rather than acting as a
moderator the Chairman was playing the role of judge, and the
discussions moved, or rather, were forced, onto the next
paragraph of the Guidelines.
Interestingly however, the Draft Report described this
intervention as
follows:
After some discussion, the Committee agreed to retain the
current text as it resulted from considerable discussion and
consensus at the last session.
Once again, it would appear that the Draft Report did not
accurately reflect what had actually happened.
Scope
South Africa read out their
proposed alterations to this paragraph, and said that the
sentence "It is left to national authorities to decide whether
vitamin and mineral supplements are drugs or foods" should be
deleted. They argued that this sentence creates a potential
barrier to trade, and that the Codex mandate is to remove
existing barriers to trade and to harmonize legislation
globally. South Africa was supported by the USA, who said
that Codex guidelines only apply to foods and that it is not
necessary to reiterate this. After some discussion the
Committee eventually agreed to delete this sentence.
During the discussions on Scope, the Chairman inferred that
the EU wanted to leave the door open for the Draft Guidelines
on Vitamins and Minerals to be extended to other nutrients.
The EC Observer replied by saying that they did not want this,
but that if the Scope was defined too rigidly some products
might be taken out of the Guidelines by the addition of other
nutrients, thus claiming that they were not vitamin and
mineral supplements. As a result of this, the Committee added
the following sentence to the Guidelines:
Food Supplements containing vitamins and/or minerals as
well as other
ingredients should also be in conformity with the specific
rules on vitamins and minerals laid down in these Guidelines.
Definitions
Following a short tea-break,
the Chairman stated that there was consensus
that the Committee wanted to draw up guidelines, and the
discussions
eventually moved on to the issue of definitions.
The New Zealand delegation wanted to delete the square
brackets around the following:
They serve to supplement the daily diet with these
nutrients in cases when the intake from food is insufficient
or where the consumers consider their diet requires
supplementation.
The delegations of Thailand and India both supported this.
The EC Observer however stated that the definition is wrong,
and that it was necessary to come to a decision. He also
complained that the discussion could easily take up the rest
of the allotted time.
The word "dose" was discussed, and the USA stated that this
word can imply a drug use rather than a food use, adding that
they are unaware of what a "significant amount of energy"
means. (The term "a significant amount of energy" was
originally contained in the draft definitions, but was
eventually deleted by the Committee).
Malaysia wanted to add wording to the effect that supplements
should not be used to replace a balanced diet, but the
Chairman said that this was
mentioned in the preamble.
The EC Observer wanted to add the words "measured small unit
quantities" to the definition, so that vitamins and minerals
could not be added to a drink and taken in large doses. South
Africa stated however that they could not support the EU on
this, and said that if this wording was to stay it should be
defined properly. Nigeria was of the opinion that "measured
small unit quantities" made the definition too long. India
agreed with this, saying that the existing definition serves
the purpose. The EC Observer was not happy with this however,
and asked whether a can of Coca-Cola containing vitamins and
minerals is a food supplement. "This is what we want to
avoid," he said. Germany said that the concept of "measured
small unit quantities" should be included in the definition.
France also supported this proposal.
The USA said that they would be willing to consider other
language, but that the burden of the language should be on the
EU, since they were the ones proposing the language!
After some further discussion the Chairman eventually said
that "small unit
quantities" should be put into square brackets.
Composition
The USA proposed the
following:
The sources of vitamins and minerals may be from either
natural sources or synthetic sources... IADSA and the UK
both supported the USA regarding this suggestion. The EC
Observer was not happy with this however, and asked if acerola
was going to be used as a source whether it would be labeled
as a source of acerola or vitamin C. He also wanted to know
what "natural or synthetic" means. CRN were of the opinion
that the source would be acerola and that the vitamin C
content would be listed in brackets. The EC Observer replied
that vitamin C can either be extracted from natural sources or
it can be one of the natural constituents, adding that the
words "natural or synthetic sources" should go in square
brackets. The Chairman then told the Committee that the USA
proposal re: "natural or synthetic sources" should go into
square brackets, and the discussion moved on to the next
sentence of the Guidelines.
The USA proposed to delete the following sentence, on the
grounds that the issue of safety was addressed in the section
on Contents.
The use of individual vitamins and minerals in supplements
can be [limited] for reasons of health protection and consumer
safety, taking into account regional or national peculiarities
concerning the supply situation of the population.
This was put to the Committee by the Chairman, and as a result
was removed from the Guidelines.
With regard to the reference to the FAO and WHO in 3.1.2, the
EC Observer asked whether this is referring to a specific FAO/WHO
document:
The sources of vitamins and minerals may be from either
[natural or
synthetic sources] and should be based on consideration such
as safety and bio-availability. In addition, purity criteria
should take into account
FAO/WHO standards, or if FAO/WHO standards are not available,
international Pharmacopoeias or recognized international
standards. In the absence of criteria from these sources
national legislation may be used.
In his answer the Chairman invited the EU to propose a list
for this section
of the Guidelines. The USA however stated that they could not
see how having a list would help. Although this was not
clarified, one was left wondering whether this was the first
mention of a possible "positive list", along the lines of the
EU Food Supplements Directive.
Contents
Japan was of the opinion that
a minimum level of 15% for each vitamin and mineral contained
in a supplement is too low. The USA however said that a
logical basis for setting a percentage value should be
employed, and
reminded the Committee that it was not possible to include
more than 15% to 33% of the recommended daily intake of
calcium and magnesium in a capsule as it would be overly
large. Malaysia supported the USA on this, as did South Africa
and the Philippines. Thailand however said that the minimum
should be at least 33%. The Chairman stated that the majority
of comments wanted to maintain the 15% minimum, adding that
the issue as to what is a significant amount still needed to
be clarified to the Labeling Committee.
The EC Observer said that 3.2.1 contained a reference to the
RDA, and that the Committee needed to know which RDAs would be
used, since the FAO/WHO recommendations did not include all
nutrients.
When the discussion eventually passed on to the issue of
maximum levels
(3.2.2), the Chairman stated that the vast majority wanted
upper limits to
be based on risk assessment.
Delegations in favor of scientific-based risk assessment
included the EU,
South Africa, USA and Switzerland. Delegations in favor of the
maximum
level of each vitamin and/or mineral contained in a supplement
not being
allowed to exceed RDA levels included Norway, Malaysia and
Thailand.
The National Health Federation said that 3.2.2 (b)
the daily intake of vitamins and minerals from other
dietary sources.
should be deleted, because it was not necessary to take the
daily intake of
vitamins and minerals from other dietary sources into account
when setting the maximum levels that can be contained in a
supplement. The Chairman replied by saying that this would be
counter-productive.
The USA wanted to delete the following:
When the maximum levels are set, due account should be
taken to the
reference intake values of vitamins and minerals for the
population.
The EC Observer stated however that he could not support this.
A number of delegations however supported the USA on this,
including
Tunisia, IADSA, New Zealand, Philippines, South Africa and the
National
Health Federation. CRN also supported this, but said that if
it must be kept then the RDA could be used as a floor so that
the risk assessment could not deliver a level below the RDA.
In addition to the EC Observer, other delegations who wanted
account to be taken of the reference intake values of vitamins
and minerals when the maximum levels are set included Norway
and Italy.
It was eventually agreed to retain this sentence in square
brackets.
Tuesday 4th November 2003
At the beginning of day two,
the Chairman proposed that the Committee should deal with the
items in square brackets first.
Labeling
With regard to the name of the
product, the EC Observer proposed the
following:
The name of the product shall be food supplement with an
indication of the categories of nutrients or of the individual
vitamin(s) and/or mineral(s) contained in the product as the
case may be.
IADSA however wanted "The labeling of the product", and were
supported by South Africa on this. The EC Observer replied
that this would be grammatically incorrect. The National
Health Federation supported IADSA and South Africa. IADSA then
suggested that "The specified name of the product..." would be
better. The National Health Federation then proposed "shall be
identified as a food supplement", and suggested the use of
square brackets. The Chairman however stated that he did not
want the use of square brackets, and accepted the proposal of
the EC Observer.
The Draft Report however wrote this up as follows:
The Committee deleted the square brackets in section 5.2,
agreed that the name of the product should be "food
supplements" for consistency with the rest of the text, and
reworded the sentence for clarification purposes.
Once again, it would appear that the Draft Report did not
accurately reflect what had actually happened.
With regard to 5.3, the Committee decided upon the following
text:
The amount of the vitamins and minerals present in the
product shall be
declared in the labeling in numerical form. The units to be
used shall be
units of weight.
(Interestingly however, when the Draft Report was distributed
on the Friday the word "shall" had been replaced by the word
"should". (Errors of this sort are somewhat commonplace in the
Draft Report).
When the discussion passed on to 5.4, the USA suggested the
following:
The amounts of the vitamins and minerals present in the
product declared shall be those amounts per portion of the
product recommended on the labeling for single use and if
different the amounts per day.
The EC Observer disagreed with the USA however, saying that in
the EU they had decided that consumers would be confused by
this.
The text displayed on the screen at the front of the meeting
then became:
The amounts of the vitamins and minerals declared shall be
those per portion of the product as recommended for daily
consumption on the labeling and if different the amounts per
single use.
The EC Observer was still unhappy however, and said that EU
consumers would not understand this!
The National Health Federation made a couple of interventions
in support of the US proposal, saying that it was safer.
After some discussion it was agreed to retain the square
brackets in section 5.4, as the Committee were unable to agree
upon whether the declaration of vitamin or minerals should be
the amount per portion of the product recommended for daily
consumption or the amount per single use.
When the discussion turned to 5.5, and the issue of nutrient
reference
values, the Chairman suggested that an electronic working
group should be set up, and that one of the tasks of this
working group should be to set new nutrient reference values.
The USA was in agreement with this proposal, and noted the
inadequacy of the current nutrient reference values, saying
that they need to be updated. The EC Observer asked whether
the working group would be setting population recommended
daily intakes or population reference values, and the Chairman
confirmed that it would be the latter. CRN meanwhile said that
a guide as to what would be a reasonable amount was necessary,
and quoted 100mg of vitamin C as an example!
The Chairman said that the Committee should be talking about
nutrient
reference values as defined in the Helsinki Consultation
(1988), and that
values for different age groups should be set.
The National Health Federation then informed the Chairman that
they would like to take part in this electronic working group,
and the Codex
Secretariat offered to send out a Circular Letter to ask for
proposals for
additional or revised nutrient reference values for labeling
purposes.
5.7 had originally read as follows:
The label must contain a warning statement [if the product
contains a
significant amount of a nutrient with respect to the toxicity
level.]
The USA and South Africa both wanted to delete this, and were
supported by CRN and the National Health Federation.
Switzerland however wanted the following:
Where appropriate and as determined by risk assessment the
label should advise consumers not to exceed the maximum
one-day dose.
The EC Observer meanwhile, proposed:
The label must contain a warning statement not to exceed the
stated
recommended daily dose [if the product contains a significant
amount of a
nutrient with respect to the toxicity level.]
Germany, Slovenia and Denmark supported the EC Observer's
proposal, and the Chairman stated that the EC Observer's
proposal was reasonable if consumers want to do something good
for their health. This then became the wording that was
displayed on the screen at the front of the hall.
Following a short coffee break it was announced that South
Africa had spoken to the Chairman, and had agreed to chair the
electronic working group looking into the issue of nutrient
reference values.
Once discussion resumed on the matter of labeling, Austria
said that the
warning statement should begin with:
"The label must..."
The head of the National Health Federation delegation then
intervened,
complaining that the Chairman was fashioning the document
according to what the EU wants. "What the EU wants, the EU
gets," he said, adding that the Committee did not have a
consensus and so some things needed to remain in brackets.
The delegation from Kenya however wanted the word "shall", as
opposed to the word "must". There then followed a great deal
of disagreement amongst the delegations over this point, and
much discussion ensued as to whether the guidelines were
recommendations or mandatory. Eventually however, the
following was agreed:
The label shall contain advice to the consumer not to
exceed the maximum one-day amount.
The Committee then passed on to section 5.8, which had
formerly read as
follows:
The label must contain a statement: supplements can not be
used for the replacement of meals on long-term basis.
The EC Observer wanted to replace this with the following:
The label must contain a statement that supplements can not
be used for the replacement of a varied diet.
The USA meanwhile proposed:
The label should not state or imply that supplements can be
used for the
replacement of meals or a varied diet.
China however wanted to use "replacement of meals or drugs",
and New Zealand
wanted to delete this section entirely, but were prepared to
support the USA if this were not possible. After much
discussion the USA proposal was eventually accepted by the
Committee.
When it came to section 5.9, which had originally stated that
all labels
should bear a statement that the supplement should be taken on
an advice of a nutritionist, a dietician or a medical doctor,
the South African
delegation said that they wanted to delete this. The
Philippines and
Malaysian delegations meanwhile wanted to keep this statement.
The Chairman however stated that we are not speaking about
drugs here, and it was accordingly agreed to delete this
section.
At this point all of the items that were originally contained
in brackets
had now been dealt with, and the Committee proceeded to
discuss some of the other issues relating to these Guidelines.
Packaging
With regard to 4.3, which had
stated that vitamin and mineral supplements
should be distributed in child-resistant packaging, the EC
Observer proposed to delete this, and wanted a statement to
the effect that the products should be stored out of the reach
of young children, such as:
The label must contain a statement to the effect that the
product must be
stored out of the reach of young children.
The Chairman commented that it is true that vitamins are often
consumed by children as if they were colorful sweets (!!), and
went on to say that
child-resistant packaging is often difficult for the elderly
to open.
Poland and Bulgaria both supported the EC Observer on their
proposed
amendment. This was then agreed by the Committee, and became
section 5.9, whilst the original section 4.3 was deleted.
Contents of Vitamins and
Minerals
The Committee then turned its
attention to 3.2.3, and the South African
delegation stated that they would be in favor of:
For vitamins and minerals with a narrow safety margin
between the
recommended daily intake and the adverse effect level,
different maximum limits for the daily dose may be established
at the national level, if the national authority can show
scientifically that a level lower than that established by
Codex is appropriate.
The EC Observer however suggested taking out section 3.2.3,
and this was duly done.
Advancement from Step 4 to
Step 5
The Chairman then proposed to
advance the Proposed Draft Guidelines for adoption at Step 5,
and this was agreed by the Committee.
Analysis and Comment
One of
the most interesting aspects of these Codex meetings was that
the 15 EU member states generally only entered into the debate
when the EC
Observer, Basil Mathioudakis, was in need of support to defend
his position. Mr Mathioudakis is now a major contributor to
the Codex Committee discussions, and he manages to exert a
tremendous amount of influence both over the drafting of the
Codex Guidelines and the meetings themselves. Interestingly,
the delegate from IACFO (International Association of Consumer
Food Organizations), during the discussions that took place on
the Friday regarding the Draft Report, actually asked the
Chairman for clarification of the EU's status at Codex, given
that Basil Mathioudakis had been described as the EC
'Observer'. Following the Chairman's reply, Italy stated that
at the beginning of the week the EU countries had decided that
Mr Mathioudakis would speak for them. Upon further questioning
from the IAFCO delegate, the Chairman then stated that the EU
would have full membership status at Codex "within 24 hours".
It was also announced by the Chairman that from this year
onwards the official Codex Report will not name individual
countries who were in favor of the motions being passed, and
will instead only name those countries who were against the
motions being passed and who had asked for their opposition to
be mentioned in the official report.
A number of books, booklets and leaflets were left out on
trestle tables
this year for the delegates to take away. Many of these had
somewhat
patronizing titles, such as "Understanding Codex
Alimentarius" and
"Consumers: Are you concerned about the quality and safety
of your food". It was no coincidence that this was the
first year in which consumers were allowed to attend the
meetings as observers, and several people commented to me that
these publications were clearly a (somewhat clumsy) attempt by
the Codex Committee to address the negative image that it has
amongst consumers.
One of the most obvious ways in which the Codex process could
be made more transparent would be if an official written
record of everything that was said at the meetings was made
available to the public, similar to the way in which Hansard
records everything that is said in the British Parliament. The
lack of this (along with the lack of a transparent voting
procedure where real votes are cast and then made public
afterwards) are major failings that the Committee seems to be
in no hurry to address.
Germany, incidentally, had by far the largest delegation at
these meetings,
with a total of 22 members. Almost without exception the
German delegation all appeared to be keeping copious notes on
everything that was said and done. Germany also had a further
6 Secretariat representatives present at these meetings, who
were from the German Ministry for Consumers, Nutrition and
Agriculture. The United States, by way of a comparison, had a
total of 10 delegates, not all of whom were present for the
entire week. The UK, meanwhile, had only one delegate (from
the Food Standards Agency), who left following the conclusion
of Wednesday's discussions.
Finally, this report would not be complete without a few words
concerning the 'victory' that some have been proclaiming
following the conclusion of the discussions over the Draft
Guidelines for Vitamin and Mineral Supplements. Although it is
of course true to say that things would have been very much
worse had the Committee agreed to recommend RDA levels only,
it by no means follows that just because scientific risk
assessment will be used we can assume that the safe upper
limits will be set at reasonable levels. Scientific risk
assessment was used by the EU Scientific Committee on Food (SCF),
for example, when they were setting the tolerable upper intake
levels in connection with the EU Food Supplements Directive.
As a result of their 'scientific' risk assessment, the SCF
recommended that the tolerable upper intake level for niacin
should be set at only 10mg, an amount which is just over half
of the EU RDA for vitamin B3. Similarly with their evaluation
of vitamin B6, the SCF relied strongly upon a Dalton & Dalton
study from 1987 that has been largely discredited by most
acknowledged experts in the field of nutritional science.
Based upon this study, the SCF set a tolerable upper intake
level of only 25mg for vitamin B6.
To make matters worse, the preamble to the EU Food Supplements
Directive states that: When maximum levels are set,
therefore, account should be taken of the upper safe levels of
the vitamins and minerals, as established by scientific risk
assessment based on generally acceptable scientific data, and
of intakes of those nutrients from the normal diet. Due
account should also be taken of reference intake amounts when
setting maximum levels.
Clearly then, the text of the Food Supplements Directive
strongly indicates
that when setting the maximum levels a further amount will be
deducted to
account for dietary intake. Given the influence that the EU
now clearly has
upon the Codex Alimentarius Committee, it is unthinkable that
a similar
process will not be used when setting the upper safe levels
for the
Guidelines for Vitamin and Mineral Supplements. Indeed, most
of the text for this is already in place.
Consider the following, which now forms part of the Codex
text, as agreed this year:
3.2.2 Maximum amounts of vitamins and minerals in vitamin
and mineral 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 into
consideration, as appropriate, the varying degrees of
sensitivity of
different consumer groups;
(b) the daily intake of vitamins and minerals from other
dietary sources.
[When the maximum levels are set, due account should be taken
to the
reference intake values of vitamins and minerals for the
population.]
Bearing the above in mind, proclaiming 'victory' following the
agreement of Codex to utilize 'scientific' risk assessment in
the setting of the upper
safe levels seems both premature and naive.
These growing similarities, and others, between the text of
the EU Food
Supplements Directive and the Codex Draft Guidelines for
Vitamin and Mineral Supplements are no coincidence. Basil
Mathioudakis (the EC Observer), who drafted the text of the EU
Food Supplements Directive, will now be representing 25 EU
countries at the next Codex meeting in Bonn in November 2004.
Clearly the long-held fear that the EU will eventually win the
vote at Codex over the vitamin and mineral issue, through
being able to outvote all of the other countries, could soon
become a reality. This therefore raises the grim possibility
that discussions regarding the Codex Draft Guidelines for
Vitamin and Mineral Supplements could even be concluded at
next year's meeting. This eventuality could have grave
implications for the legal challenge to the EU Food
Supplements Directive, because if the Codex Guidelines are
agreed before the legal challenge is complete the UK lawyers
would in essence be arguing for the European Court of Justice
to overturn legislation that is fully in line with a newly
agreed global standard.
In summary then, Codex is the trump card. Even if the legal
challenge to the Food Supplements Directive is successful the
Codex proposals could still be implemented globally,
effectively overruling any short-term victory for health
freedom in Europe. Proof of this comes from recent research by
the American Holistic Health Association, which confirms that
implementation of the Codex Guidelines for Vitamin and Mineral
Food Supplements is not optional.
Clearly then, the next couple of years are going to be crucial
ones for the
future of natural healthcare and freedom of choice.
Paul Anthony Taylor, from the United Kingdom was welcomed as
an NHF Advisory Board member November 2003.
Paul
Anthony Taylor's background is in the music industry, working
as a
musician, arranger and producer. In recent years however he
has been
spending an increasingly large amount of time campaigning for
health
freedom. He became interested in natural health after falling
ill with
Myalgic Enchephalomyelitis in 1991, and subsequently made a
full recovery via the use of high-dose nutritional
supplements. As a result of this he has been campaigning for
over 10 years against the global moves to restrict consumer
access to these safe and effective health-promoting
substances. He lives in the UK and can be contacted by e-mail
at
paulandpolly@btinternet.com
