STANDARDS, LEGISLATION,
REGULATION AND REGISTRATION OF
HOME FORTIFICATION PRODUCTS
Jonathan Siekmann, PhD
Technical Advisor, Multi-Nutrient Supplements
Initiative (MSI)
Secretariat, Home Fortification Technical Advisory
Group (HF-TAG)
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Introduction
• Several international regulations are relevant for the
classification of and communication around home
fortification products (MNP and SQ-LNS)
• For home fortification programs at scale it will be
important to understand the applicable international and
national regulations
• While complying with relevant regulations, aim to ensure
maximum and sustained access to information on the
purpose and appropriate use of home fortification
products
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Example from European Union
• Food supplements: foodstuffs to supplement the normal
diet and which are concentrated sources of nutrients
…marketed in dose form…such as capsules, pastilles,
tablets, pills and other similar forms, sachets of powder,
ampoules of liquids, drop dispensing bottles…designed to
be taken in and measured small unit quantities;
• Nutrients means the following substances:
(i) vitamins, (ii) minerals.
EC Directive 2002/46
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Example from United Kingdom
(England)
• Food supplements: food sold in dose form…to
supplement the normal diet…a concentrated source of a
vitamin or mineral or other substance with a nutritional or
physiological effect, alone or in combination.
• Food supplements are not required to demonstrate their
efficacy before marketing, nor are they subject to prior
approval unless they are genetically modified or are
“novel”. It is the responsibility of the manufacturer,
importer or distributor to ensure that their product
complies with the necessary legislation.
THE FOOD SUPPLEMENTS REGULATIONS 2007 No. 330
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Overview
Pharmaceuticals/
Medicines
Food
Food Supplements/
Dietary Supplements
Legislation
(e.g.)
EC Directive 2001/83
(EU)
Medicine Act (UK)
EC Directive 2002/178
(EU)
Food Safety Act (UK)
EC Directive 2002/46
and 2006/37 (EU)
Food Supplement
Regulation (England)
Standards
Pharmacopoeia
Codex Alimentarius
Pharmacopoeia
Regulations
Registration
Manufacturing
Labeling
Advertisement
Manufacturing
Labeling
Safety
List of Allowed Vitamins
and Minerals and their
forms
Manufacturing
Labeling
Registration
MUST
NOT NECESSARY
NOT NECESSARY
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Registration
Important to register home fortification products (MNP or
SQ-LNS) in country
• For MNP: pharmaceutical? nutritional supplement?
food?
• For SQ-LNS: food? nutritional supplement?
Potential challenges
• If pharmaceutical, only medical staff can handle; storage
and handling conditions more stringent; higher costs
• Need to be able to accommodate the home fortification
product within national categories of products
• Might need to create new national standard for this
category of products if one does not exist
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MNP Registration Category:
Home Fortification Global Assessment 2011
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SQ-LNS Registration Category:
Home Fortification Global Assessment 2011
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Relevant regulations and standards
International
• International Code of Marketing of Breast-milk
Substitutes (BMS) and subsequent World Health
Assembly resolutions
• Codex Alimentarius standards and guidelines for
nutrition and health claims and labeling
National
• National laws, regulations and other measures
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The Code
& Subsequent WHA Resolutions
1. The International Code of Marketing of Breast-milk
Substitutes (the Code)
• Ensuring the appropriate marketing of breast-milk
substitutes, teats and feeding bottles.
• These products should not be advertised or promoted.
2. Subsequent relevant World Health Assembly (WHA)
resolutions:
• Same status as the Code
• Clarify or strengthen the Code
• Also provides guidance on the marketing of
complementary foods.
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National laws, regulations and
other measures
• Over 80 countries have implemented the Code
• National laws govern advertising and promotion of foods
for IYC, including
• Information and educational materials on infant and
young children not coming from health professionals
• Labeling of relevant products
• WHA 63.23 calls on Governments to ensure that nutrition
and health claims shall not be made for foods for infants
and young children unless specifically allowed under
Codex or National Legislation
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Main Concern: Misleading or Unsubstantiated
Health Claims
Support your baby’s
natural immune system
The Code and WHA resolutions:
relevance to home fortification
MNP
• Not food or breast milk substitute so clearly outside the
scope of the Code and subsequent WHA resolutions
• Except where interpreted by National legislation
SQ-LNS
• Not a breast milk substitute (if used from age 6+ months)
• Studies show it does not displace or negatively impact
breast milk intake
• Complementary food for older infants and young children
• If classified as a food, it comes under the scope of the
Code and subsequent WHA resolutions
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WHA Resolution 63.23
Article 1 (4) - May 2010
Calls on governments:
• To end inappropriate promotion of food for
infants and young children and
• To ensure that nutrition and health claims
shall not be permitted for foods for
infants and young children,
• Except where specifically provided for, in:
• Relevant Codex Alimentarius standards OR
• National legislation
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Codex
GUIDELINES FOR
USE OF
NUTRITION AND
HEALTH CLAIMS
Shown: page 1 of 8
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Claim Definitions (CODEX)
NUTRITION CLAIM: States, suggests or implies that a food
has beneficial nutritional properties.
Nutrient content claim:
“contains iron”; “micronutrient fortified”;
“contains essential fatty acids”;
“enriched”; “fortified”;
Level of a
nutrient in a food
Nutrient comparative claim:
“reduced fat compared to X”; “less sodium
than Y”; “fewer micronutrients than X”;
Compares the“increased micronutrient content compared
nutrient levels of
to Y”;
two or more
“more iron than X”
foods.
Claim Definitions (CODEX)
HEALTH CLAIM: any representation that states,
the physiological
role of the nutrientexists
suggests, orDescribes
implies
that a relationship
growth, development and normal functions of
between a infood
or a constituent
of that food and
the body.
health.
Nutrient function claims
"Vitamin A is important for the maintenance of
beneficial
effects ofgrowth.
the consumption
goodSpecific
vision
and normal
Food of
X is a
foods or their constituents, in the context of the
source of/ high in nutrient A "
total diet on normal functions or biological
activities of the body
Other function claims
“Omega 3 fatty acids are vital for brain development
in children Relating
therebythe
enhancing
intelligence.
Product X
consumption
of a food or food
contains
EPA+DHA”
constituent,
in theYcontext
of the total diet, to
the reduced risk of developing a disease or
health-related condition
Reduction of disease risk
“Iron may treat and prevent anaemia”
Common Claims Prohibited for
Complementary Foods
High in calcium
Good source of
iron and zinc
8 Vitamins
Calcium
Iron
Aids in your
baby's healthy
growth and
development
Contains
vitamins for
healthy growth
With DHA
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Prohibited
health and
nutrition claims
What is ‘Inappropriate Promotion’?
WHA Resolution 63.23
"to end inappropriate promotion of food for infants and young children and to
ensure that nutrition and health claims shall not be permitted for foods for
infants and young children, except where specifically provided for, in relevant
Codex Alimentarius standards or national legislation“
• Are all claims inappropriate?
• Claims on breast milk substitutes are always
inappropriate
• Promotion for use before 6 months is always
inappropriate
• SQ-LNS≠ breastmilk substitutes – but if classified as
food, claims not allowed unless permitted in national
legislation
Example from Zambia
• Design for labeling and packaging developed in the
preparatory phase of pilot study
• Formative research findings shaped design
• Consultation with the National Fortification Alliance,
partners & government representatives to develop
Zambia-specific packaging
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Initially proposed package design
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Revisions to initial design
• Law-enforcers as guardians of the Code, who were not
included in initial discussions, learned of proposed
packaging design
• Purpose of MNP misunderstood
• Forced to change design in final stages
IMPORTANT: Early engagement & active dialogue with all
relevant groups throughout the package design process to
prevent misunderstandings & ensure compliance with
national legislation.
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Final Box
Design
Final Sachet Design
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Latest developments (2012) …WHA 65.6
• Adopts the Comprehensive Implementation Plan on
Maternal, Infant and Young Child Nutrition
• Requested that the Director-General “provide
clarification and guidance on the inappropriate promotion
of foods for infants and young children cited in resolution
WHA63.23, taking into consideration the ongoing work of
the Codex Alimentarius Commission.”
• WHO currently setting up a technical advisory group to
look at the above
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Conclusion
• For labeling, marketing, manufacture and registration of
MNP and SQ-LNS
• Important to consider national laws, the Code, and
subsequent WHA resolutions
• Aim to ensure that target beneficiaries have maximum
and sustained access to information on the purpose and
appropriate use of home fortification products
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THANK YOU FOR YOUR ATTENTION
jsiekmann@gainhealth.org
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