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Friends of Freedom Submission for Codex meetings in Bonn,
Germany on
November 1st to 4th, 2004
Addressed to the Canadian Codex Contact office in Health
Canada, relating to the CCNFSDU - Codex Committee for
Nutrition and Foods for Special Dietary Uses, and to CCFL
- Codex Committee for Food Labelling.
To: Canadian delegation for Codex Committee on Nutrition
and Foods for
Special Dietary Uses (NFSDU)
From: The Friends of Freedom, Inc.
Date: Monday, 20 September 2004
THE FRIENDS OF FREEDOM, INC., a mixed stakeholder,
non-partisan, political
and legal action organization dedicated to preserving the
rights of all
Canadians to access substances that promote health through
natural means
that also serves as an umbrella organization advocating on
behalf of
like-minded associated groups across Canada submits the
following comments
on behalf of its 100,000 Canadian members and supporters
and on behalf of
associated groups in response to the request for
stakeholder comments in
preparation for the November committee meeting of the
Codex Committee on
Foods and Nutrition for Special Dietary Uses.
Nothing in this submission should be deemed to express or
imply that
The Friends of Freedom concedes the authority of the
federal government of
Canada to act in this manner as the agent authorized by
Canadian law to
speak on behalf of or vote on behalf of either the
provinces or the citizens
of Canada.
Nothing in this submission should be deemed to express or
imply that The
Friends of Freedom acknowledges or concedes that the
federal government of
Canada acted lawfully in promulgating the regulations
concerning natural
health products contained in Canadian Gazette,Part II,
Volume 137, Number
13.
BACKGROUND AND INTRODUCTION:
THE RELATIONSHIP BETWEEN THE NEW CANADIAN REGULATORY MODEL
AND CODEX:
On 5 June 2003, the Governor General in Council, acting on
the
recommendation of the Minister of Health, published a new
series of
regulations purporting to govern the manufacture, sale,
and licensure of
natural health products in Canadian Gazette, Part II,
Volume 137, Number 13,
pages 1532-1607. Within those regulations were contained
inter alia the
decision to treat natural products as drugs (although
couched in public
relations language as 'the third category,') the decision
to treat Canadians
unequally based on ethnicity by preserving free access for
the few while
denying free access to the many, increasing the cost of
those products that
remain, wiping out the vast majority of small, medium
sized and cottage
producers who created this industry in Canada and who
presently generate an
estimated $ 4.3 billion in retail sales revenue annually,
while transferring control over
these products to 'licensed medical doctors' for purposes
of clinical trials
and control of the marketplace in Canada to large,
principally
foreign-based, transnational pharmaceutical companies.
In promulgating these regulations, the federal government
of Canada and
Health Canada breached a series of promises made by the
federal government
of Canada to its citizenry in pledges made both within and
outside of the
Codex context.
At the Codex Alimentarius Commission, 22nd session, 1997,
the Canadian
delegate said: "Our citizens view access to these products
as a right." And
equally importantly, Canada said at that meeting that
there was no
scientific basis to justify restricting consumer access to
these products.
"The delegation of Canada..expressed objection to the
development of
the guideline [vitamins and minerals] in the framework of
Codex... The development of
international guidelines in this area would negatively
affect the rights of consumers
to use these products and there was no scientific basis
for such restrictions.."
[emphasis added]
Report of the Codex Alimentarius Commission, 22nd Session,
Geneva, 23-24
June 1997
paragraph 110
Outside of Codex but in related pledges, the former
Canadian Minister of
Health promised that access to these products would be
preserved within a
new 'third category' that would not be a drug category.
Similar pledges were
made in the context of a parliamentary review of the
status of natural
health products.
Where Canada sees its new regulations in relation to the
Guidelines for
Vitamin and Mineral Supplements, presently in the final
stages of
preparation at Step 7.
Whether the draft guidelines are finalized as expected or
abandoned, the
Canadian government sees its new regulatory package as
immune to any effect
under international law whether within the WTO
adjudication system or
elsewhere, e.g., within NAFTA.
At Codex, the word food is specifically defined as
excluding "substances
used only as drugs." Through incorporation by reference,
this definition
carries over into the SPS and TBT agreements that form the
basis for WTO
adjudications and define the parameters of Codex authority
as an
international reference standard setting body. Thus Canada
sees itself as
immune from any effect of such vitamin and mineral
guideline. And, Canada
has said as much.
"NHPs are drugs at the level of the Food and Drug Act."
Canadian Gazette, Part II, previously cited, page 1573
"NHPs which,by definition and regulatory authority, are
now a separate
category from foods.
"Therefore, Codex requirements for foods will have no
relevance to NHPs
in Canada."
A Fresh Start, Final Report ONHP Transition Team, Section
7.2 Codex
Alimentarius
Why do we bother? A legitimate question given Canada's
interpretation of the
domestic effect of vitamin and mineral guidelines to be
adopted at Codex:
We at The Friends of Freedom believe that freedom is a
totality. Thus
anything we can do promote and protect the freedom of
others benefits them
and us. This is especially true in the light of efforts
toward globalized
harmonization of regulatory standards
Indeed, Canada has already announced its intention to
aggressively
push for global harmonization of others to its
anti-consumer, anti small and
medium sized enterprises model.
"... Canada will need to ensure that its NHP status is
secure within
international agreements..other countries which regulate
their NHPs as foods or pharmaceuticals will engage in
trade within these parameters."
A Fresh Start, cited above, Section 7.2
Being pragmatic, the announced framework for discussion at
Codex NFSDU:
Under the Codex committee system, a committee chair has
wide latitude to
control the scope of discussion and to determine when
consensus has been
reached. We understand that chairman Grossklaus has
announced his intention
to keep the discussion of the draft guideline strictly
focused on brackets,
that is undecided porticos of the text.
Accordingly, our discussion focuses on those areas.
DRAFT GUIDELINES FOR VITAMINS AND MINERAL SUPPLEMENTS at
Step 7:
Paragraph 3.1.2
The sources of vitamins and minerals may be from either
[natural] or
synthetic sources....
Recommendation:
We recommend removal of the brackets and addition of the
bracketed material
to the text so that the phrase reads:
"may be from either natural or synthetic sources.."
Rationale:
Canada in its new regulations supports the maintenance of
natural
sources for vitamins and minerals. (See page 1570 and page
1575, Canadian
Gazette, Part II, previously cited.)
In this instance, Canada's stated view is the correct one.
For some
consumers the distinction between natural and synthetic
sources is a vital
one due to allergy, past toxic chemical exposure and
bioavailability issues.
In addition, Canada cannot keep its pledge to protect
Chinese herbal
practitioners and their sources of supply, if it does not
support creation
of an international guideline that recognizes the value of
natural sources
should the guideline later be expanded to include herbal
and botanical
products.
Paragraph 3.2
"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 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 value of vitamins and minerals for the
population.]
Recommendation:
We recommend deleting the bracketed language.
Rationale:
Actual diets consumed, as opposed to theoretical diets
postulated (based
on extrapolations from out of date studies of limited
populations), differ
widely based on a variety of factors. In fact, total diet
studies. the
scientific basis for actual diet consumption
determinations are in their
infancy in terms of real world application. See, for
example, Food Safety
Consultation, GEMS/Food, Total Diet Studies, Report of the
2nd International
Workshop on Total Diet Studies, 4-15 February 2002. [N.B.;
We are aware that
the focus of this report is on non nutritive substances
within foods.
Nevertheless, the point remains that these studies have
not been done widely
nor on a global scale. Much work needs to be done to apply
these studies to:
nutritional aspects of foods consumed coupled with
determination of the
specific needs of individuals and groups.] .
Canada has represented itself to the world as a proponent
of science
based rules and risk assessment based on sound science. It
would be highly
inappropriate for Canada to use a back door approach to
setting ULs on a
non-scientific basis as a method for avoiding its consumer
protection and
fair trade obligations as a Codex member and as a member
of the WTO and as a
signatory to various regional trade integration and
bilateral trade
agreements.
PROPOSED DRAFT RECOMMENDATIONS ON THE SCIENTIFIC BASIS OF
HEALTH CLAIMS, at
Step 4:
Since the proposed standard is at a very early stage, our
comments are
general.
Recommendation One:
We recommend that Canada recommend that NFSDU seek a WTO
opinion on the
ramification and effects of this standard in general.
Rationale:
In the past delegates to committees that have not obtained
expert
guidance at an early stage have wasted much time worrying
on the record,
during meetings, about the legal effect of guidelines.
Delegates who are
uncertain about the application of a standard tend to
resist standard
development.
Recommendation Two:
Since we presume from the language of the text as proposed
so far, that
its primary application is intended to fall under the TBT
and that its
primary goal is to prevent fraud in claims, we propose the
following
framework for discussion:
-That fraud be understood to mean the knowing
misrepresentation of a
material fact and/or the representation as fact of a thing
not true based on a
reckless disregard for the consequences of that
misrepresentation
- That it be clearly understood that fraud can come in
many forms as for
example, in a representation that a food is safe based on
extrapolation of data from consumption patterns studies in
1940 transmuted into an RDA and then preserved as an RDI.
And that such pseudoscientific representation can be very
fraudulent
compared to,for example, centuries of reporting of safe
traditional usage.
The framework for presentation of claims should include:
Claims based on well designed clinical studies, claims
based on reports of
decades and/or centuries of safe usage, that traditional
claims encompass
all forms of traditional usage whether Western or Asia or
other and that
accumulated documented cases of individual reports be
deemed an appropriate
basis for claims. The framework could include transition
language so that as
better data becomes available, regulatory authorities
could phase out
certain bases for claims.
What should not be done here would be to formulate a
pseudo-precautionary principle that allows regulators to
avoid the time limitations on precautionary measures
contained in current international agreements.
Reply from:
Santina Scalzo
Manager, Codex Program Services
Office of Ron Burke, Codex Contact Point for Canada
Hi Trueman:
This is further to our conversation on draft proposals
that are currently
being developed for consideration at the upcoming Codex
Committee on
Nutrition and Foods for Special Dietary Uses. I have to
admit that based
on our conversation I needed some time to track all the
documents that are
currently out for stakeholder consultation as I wasn't
sure if your
interest is strictly with the CCNFSDU and/or the Codex
Committee on Food
Labelling (CCFL) as well.
I have summarized below what is currently out for comments
for both of
these Committees, in an effort to provide clarity for you
to be able to
pull together your organization's comments. Please note
anytime you submit
comments on any draft texts out for review, our job in the
Codex office is
to ensure it is dispersed to the appropriate technical
expert/Head delegate
for that Committee who has the responsibility to review
and consider all
comments received in the development of a Canadian
position. In the case
of CCNFSDU Health Canada has the lead and the Head
delegate is Christina
Zehaluk. In the case of CCFL, the Canadian Food Inspection
Agency has the
lead and the Head delegate is Greg Orriss. Of course when
there are
cross-issues both CFIA and HC will be involved in the
development of
Canadian positions.
As regards CCNFSDU, the following documents were
circulated in May for
comments by August 13:
1. CL 2004/20-NFSDU:
- Proposed Draft Revised Standard for Infant Formula [and
Formulas for
Special Medical Purposes intended for Infants]
- Section B: Formulas for Special Medical Purposes
intended for Infants.
2. CL 2004/21-NFSDU:
Comments on the Advisory List(s) of Mineral Salts and
Vitamin Compounds for
the Use in Foods for Infants and Children (CAC/GL 10-1979
(amended 1983,
1991)).
These three proposals were circulated in early July for
comments by August
16th:
3. CX/NFSDU 04/3-Add.1:
Agenda Item 3: Proposals for a Definition and Methods of
Analysis for
Dietary Fibre Content - Prepared by a drafting group led
by France and
Sweden
Regarding agenda item 3 above, "Part B Containing
Provisions on Dietary
Fibre" of the "Guidelines for the Use of Nutrition Claims:
Draft Table of
Conditions for Nutrient Contents" is also on the CCNFSDU
agenda. Comments
were requested on this through the distribution of the
report of the last
session (25th) of the CCNFSDU in November 2003 (ref:
Alinorm 04/27/26, CL
2003/42-NFSDU, Appendix II).
4.CX/NFSDU 04/9:
Agenda Item 8: Proposed Draft Recommendations on the
Scientific Basis of
Health Claims (at Step 3) - Prepared by France
5. CX/NFSDU 04/11:
Agenda Item 10: Discussion Paper on Definition for Trans
Fatty Acids -
Prepared by Malaysia and Denmark.
Most recently, the following was circulated for comments
by early
September:
6. CL 2004/36_GEN:
This Circular Letter is a compilation of draft standards
and texts that
were reviewed and adopted at Step 5 of the Codex process
by the 27th
Session Codex Alimentarius Commission (held in July 2004)
with the
understanding that the CCNFSDU would do a review and take
into
consideration written comments submitted to the
Commission. Therefore, the
following three CCNFSDU issues were circulated for review
and comments:
- Draft Guidelines for Vitamin and Mineral Supplements
(ref: Alinorm
04/27/26; para. 61; Appendix IV)
- Draft Standard for Infant Formula (Section A) (ref:
Alinorm 04/27/26;
para. 100; Appendix V), and
- Draft Revised Standard for Processed Cereal-Based Foods
for Infants and
Young Children (ref: Alinorm 04/27/26; para. 130; Appendix
VI)
All of the above issues are on the agenda for the upcoming
CCNFSDU and it
would be appreciated if you could provide us with your
comments by
September 20th, 2004 at the latest. For your convenience I
have attached a
copy of the provisional agenda.
If you wish to attend the CCNFSDU as an observer with the
Canadian
delegation, you need to advise our office. An invitation
to the meeting
including a list of hotels and a registration form was
also circulated to
our stakeholders on July 22nd. I will resend you a copy of
the e-mail and
attachments. Please fill out the registration form and
return it to our
Codex Canada mailbox: codex_canada@hc-sc.gc.ca.
As regards the CCFL, the report of the 32nd Session (Alinorm
04/27/22; CL
2004/22-FL) was circulated in May and comments were
requested on the
following issues for consideration at the next CCFL
session to take place
in Malaysia (May 2005):
1. Proposed Draft Amendment to the Guidelines for the
Production,
Processing, Labelling and Marketing of Organically
Produced Foods:
Proposed Draft Revised Annex 2 - Permitted Substances (para.
76, Appendix
VIII).
2. Proposed Draft Amendment to the General Standard for
the Labelling of
Prepackaged Foods: Quantitative Declaration of Ingredients
(para. 109,
Appendix VII).
3. Proposed Draft Guidelines for the Labelling of Foods
and Food
Ingredients Obtained through Certain Techniques of Genetic
Modification/Genetic Engineering: Labelling Provisions (para.
93, Appendix
VI).
Comments are requested by November 1, 2004.
Best regards,
Santina Scalzo
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