CODEX PROPOSAL FOR READY TO
USE THERAPEUTIC FOODS
International Regulation for foods used in
CMAM contexts
Alison Fleet
UNICEF Supply Division, 1 July 2015
WHAT IS THE CODEX ALIMENTARIUS?
UNICEF
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Mission: Codex aims to set regulation to ensure safe, good
foods for International trade
Committees and Subcommittees
Codex Alimentarius consists of numerous committees that are
responsible for the work of establishing guidelines or standards.
UNICEF is working with:
CCNFSDU (Codex Committee for Nutrition and
Foods for Special dietary uses) &
CCFH (Codex Committee for Food Hygiene)
UNICEF
Codex Proposal for Ready to use Therapeutic Foods
THE CODEX PROCESS
Proposal by a
country
Plenary
reaches
consensus
for each step
Committee
plenary
consider
Codex
Guideline,
Standard or
Code
Plenary
reach a
consensus
Progress in
steps
Work begins
(EWG)
Safety of
global supply
of RUTF
Smooth
importing and
exporting
building
regulatory
capacity
Assist
manufacturers
Resolution of
disputes (trade
and safety)
UNICEF
Purpose of Codex for RUTF
UPDATE : CCFH
CCFH
16th- 19th
November
2014
Electronic
working
group
• Request that RUF for acute
malnutrition are included in the
ongoing codex work on a Code of
Hygienic practice for Low Moisture
Foods.
• The committee agreed to include the
foods as an example in the Code, and
UNICEF SD are now part of the
electronic working group of the
committee. This work will cover the
microbiological specification only.
UPDATE : CCNFSDU
Proposal
presented
CCNFSDU
16th- 19th
November 2014
Redraft proposal
for CCNFSDU
November 23rd27th November
2015
• UNICEF SD presented a ‘discussion paper’
on a proposal for a commodity codex
standard for RUF in acute malnutrition on
26th of November 2014 at the Codex
Committee for Nutrition and Foods for
Special Dietary Uses (CCNFSDU).
• After much debate, the committee agreed
that the document should be redrafted to
address country member’s comments
Codex standard
for RUF will not
change the lack
of regulation in
many countries
(EU)
RUF is not widely
consumed and has Regulatory status
is unclear:
trade low value
Medicine or Food?
(EU)
Focus should Medicines are
outside the scope
be on
of Codex.. (Nigeria
affordable
 examples of recipes
and India)
culturally
for RUF developed for appropriate
Vietnam, Bangladesh,
foods
Ethiopia, and Pakistan
Guideline to encompass local,
that incorporate local
endogenous foods – as
ingredients
nutrition is a cultural
sustainability
phenomenon. (Senegal,
Bangladesh, Tanzania,
Nigeria, Rwanda
EVIDENCE
UNICEF
Cochrane 2013
Evidence
 The recent Cochrane review published in 2013 concluded that
there is a lack of evidence to demonstrate superiority of RUTF
over flour porridge as an intervention for SAM.
 This review was based on just 3 trials, all done in one country
(Malawi)
 The argument was made that flour porridge is more akin to
indigenous foods, and much cheaper and therefore
preferable
 The citation of this review hindered the acceptance of RUTF
as a superior product in the treatment of SAM, that needed a
standard or guideline
UNICEF
Regulation
 The doses of micronutrients are high because many of
these children have had a very bland, low diversity diet
for a long time, leading to many nutrient deficiencies.
The basis for the formulation is that the children need
all nutrients to be fortified for a short period of time, in
order to address multiple nutrient deficiencies.
 The high dose of micronutrients will mean that many
countries will have difficulty categorizing RUTF as a
food, as the regulatory systems for high dose nutrient
products are often classified as drugs.
UNICEF
STRATEGY FOR THE REDRAFTING
 Focus on relevance of a guideline for current and future
products
 Limit work to RUTF, inclusion of RUSF too politically
sensitive
 Explore the possibility of an additional annex to the
Foods for Special Medical Purposes with FAO (not
recommended by WHO)
 Include relevant research that supports the use of a
finished product in the treatment of SAM
 Keep in communication with those countries with
concerns, and lobby groups
UNICEF
STRATEGY FOR NEXT CCNFSDU
MEETING
 Gain support from EU, American and African
Union delegations
 Collaborate closely with Sengal as the main
contact for the African nations
 Run side sessions to educate attending
delegates for the CCNFSDU meeting in
Germany
UNICEF
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WHAT CAN SUPPLIERS DO TO
ASSIST?
 Contact your national Codex contact point
and CCNFSDU representative
 Express your support and justification for
wanting a guideline developed
UNICEF
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