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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 RegistrationManufacturing

LabelingAdvertisement

ManufacturingLabelingSafety

List of Allowed Vitamins and Minerals and their

formsManufacturing

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

1.1. The International Code of Marketing of Breast-milk The International Code of Marketing of Breast-milk

Substitutes (Substitutes (the Codethe 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) World Health Assembly (WHA)

resolutionsresolutions:

• 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

Main Concern: Misleading or Unsubstantiated Health Claims

Support your baby’s Support your baby’s natural immune systemnatural immune system

Support your baby’s Support your baby’s natural immune systemnatural immune system

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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

Claim Definitions (CODEX)

NUTRITION CLAIM: States, suggests or implies that a food has beneficial nutritional propertiesbeneficial nutritional properties.

Nutrient content claim:Nutrient content claim: ““contains ironcontains iron””; ; ““micronutrient fortifiedmicronutrient fortified””;;

““contains essential fatty acidscontains essential fatty acids””; ; “enriched”; “fortified”;“enriched”; “fortified”;

Nutrient content claim:Nutrient content claim: ““contains ironcontains iron””; ; ““micronutrient fortifiedmicronutrient fortified””;;

““contains essential fatty acidscontains essential fatty acids””; ; “enriched”; “fortified”;“enriched”; “fortified”;

Nutrient comparative claim:Nutrient comparative claim:““reduced fat compared to Xreduced fat compared to X””; ; ““less sodium less sodium

than Ythan Y””; ; ““fewer micronutrients than Xfewer micronutrients than X””; ; ““increased micronutrient content compared increased micronutrient content compared

to Yto Y””; ; ““more iron than Xmore iron than X””

Nutrient comparative claim:Nutrient comparative claim:““reduced fat compared to Xreduced fat compared to X””; ; ““less sodium less sodium

than Ythan Y””; ; ““fewer micronutrients than Xfewer micronutrients than X””; ; ““increased micronutrient content compared increased micronutrient content compared

to Yto Y””; ; ““more iron than Xmore iron than X””

Level of a nutrient in a

food

Level of a nutrient in a

food

Compares the nutrient levels of two or more

foods.

Compares the nutrient levels of two or more

foods.

Claim Definitions (CODEX)HEALTH CLAIM: any representation that states, suggests, or implies that a relationship exists relationship exists between a food or a constituent of that food and healthfood and health.

Nutrient function claimsNutrient function claims"Vitamin A is important for the maintenance of "Vitamin A is important for the maintenance of good vision and normal growth.good vision and normal growth. Food X is a Food X is a

source of/ high in nutrient Asource of/ high in nutrient A ""

Nutrient function claimsNutrient function claims"Vitamin A is important for the maintenance of "Vitamin A is important for the maintenance of good vision and normal growth.good vision and normal growth. Food X is a Food X is a

source of/ high in nutrient Asource of/ high in nutrient A ""

Other function claims Other function claims ““Omega 3 fatty acids are vital for brain development Omega 3 fatty acids are vital for brain development in children thereby enhancing intelligence. Product X in children thereby enhancing intelligence. Product X

contains Y EPA+DHAcontains Y EPA+DHA””

Other function claims Other function claims ““Omega 3 fatty acids are vital for brain development Omega 3 fatty acids are vital for brain development in children thereby enhancing intelligence. Product X in children thereby enhancing intelligence. Product X

contains Y EPA+DHAcontains Y EPA+DHA””

Reduction of disease riskReduction of disease risk““Iron may treat and prevent anaemia”Iron may treat and prevent anaemia”

Reduction of disease riskReduction of disease risk““Iron may treat and prevent anaemia”Iron may treat and prevent anaemia”

Describes the physiological role of the nutrient in growth, development and normal

functions of the body.

Describes the physiological role of the nutrient in growth, development and normal

functions of the body.

Specific beneficial effects of the consumption of foods or their constituents, in the context

of the total diet on normal functions or biological activities of the body

Specific beneficial effects of the consumption of foods or their constituents, in the context

of the total diet on normal functions or biological activities of the body

Relating the consumption of a food or food constituent, in the context of the total diet, to

the reduced risk of developing a disease or health-related condition

Relating the consumption of a food or food constituent, in the context of the total diet, to

the reduced risk of developing a disease or health-related condition

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Common Claims Prohibited for Complementary Foods

High in calcium High in calcium High in calcium High in calcium Good source of Good source of iron and zinciron and zinc

Good source of Good source of iron and zinciron and zinc

Aids in your Aids in your baby's healthy baby's healthy

growth and growth and developmentdevelopment

Aids in your Aids in your baby's healthy baby's healthy

growth and growth and developmentdevelopment

Contains Contains vitamins for vitamins for

healthy growthhealthy growth

Contains Contains vitamins for vitamins for

healthy growthhealthy growthWith DHAWith DHAWith DHAWith DHA

8 Vitamins8 VitaminsCalciumCalcium

IronIron

8 Vitamins8 VitaminsCalciumCalcium

IronIron

Prohibited health and nutrition claims

What is ‘Inappropriate Promotion’?

• 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

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“

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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.

25Final Sachet Design

Final Box 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