Regulatory Aspects of Food Fortification

Ramesh V Bhat

Independent International ConsultantCentre for Science Society and Culture

M 11, Kakateeyanagar, Habshiguda,Hyderabad- 500 007

rameshvbhat@yahoo.com

Codex definition of food fortification• “The addition of one or more essential

nutrients to a food, whether or not it is normally contained in the food, for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups”.

• Fortification differs from enrichment, which is the process of restoring the nutrients to a food removed during refinement or production.

Food fortification needs to be controlled by legislation

Adherence to legislation will ensure -

- Objectives of a food-fortification programme are achieved

- Levels of micronutrients are controlled within safe and acceptable limits

- Consumers are protected against inadequately packaged or labeled foods, nutritionally poor or unsafe foods

Principles considered when developing legislation for food

fortification

• Fortification should always be in the best interests of the selected population

• There should be input from interested parties in the development of the law and regulations

• Fortification must be supported by appropriate food safety and quality standards

Law dealing with fortification should• Set out what is required or prohibited by the law, including

setting the standards that must be met by fortified food• Allow flexibility (making it easy to change regulations to

reflect changes in circumstances or population health status)

• Allow for food fortification generally, rather than prescribing fortification of specific items with specific nutrients (this is

because a country may wish to change a fortification vehicle or nutrient in response to changes in health status)

• Contain enforcement provisions, including adequate inspection and sampling powers to allow the safety and efficacy of fortified food to be monitored and enforcement action to be taken

• Set out penalties for non-compliance with regulatory requirements

Law dealing with fortification should (contd)

Support non-regulatory policy approaches to micronutrient deficiencies, such as

• promotion of locally-grown/traditional nutrient-rich foods

• preventive supplementation programmes for high risk groups

• national nutrition plans and policies• health promotion initiatives and creation of

physical environments that support good nutrition

Codex standards relevant to food fortification

• Codex General Principles for the Addition of Essential Nutrients to Foods(GL9-1987)

• Codex General Standard for the Labelling of Prepackaged Foods [Codex Stan1-1985 (Rev. 1-1991)

• Codex General Standard for the Labelling and Claims for Pre-packaged Foods for Special Dietary Uses (Codex Stan 146-1985)

• Codex General Guidelines on Claims (CAC/GL 1-1979 Rev. 1-1991)

• Codex Guidelines on Nutritional Labelling (CAC/GL 2-1985)• Recommended International Code of Practice: General Principles of

Food Hygiene [CAC/RCP 1 (Rev. 2-1985)

• Guidelines on the Application of the Hazard Analysis Critical Control Point (HACCP) System (CAC/ GL 18-1993)

Comprehensive food fortification legislations: example of FIJI

• Legislation which allows, or requires flour fortification

• Standards for flour composition, fortificant composition, fortificant level, packaging and labelling

• Flour fortification with respect to Nutritional or health claims regulated

• Regimes for imported/exported fortified foods

European Fortified Food Regulation• The Fortified Foods Regulation will set out rules

for the addition of vitamins, minerals and other nutrients to foods, and include a 'positive list' of fortifying substances, as well as minimum and maximum levels

• The regulation has been deemed necessary since different member states currently operate their own restrictions, which creates an obstacle for the free movement of goods within the bloc.

Reason for FFR in Europe

• The fortification of food be done in a way that is safe and transparent

• Food manufacturers throughout the EU will now be able to work under the same, clear, science-based rules

• Unless there are regulations in place, there is the risk of over-consumption of certain nutrients

Time frame for European FFR• The EU fortification regulations will apply from six

months after its publication in the Official Journal of the European Communities.

• Foods not in compliance will still be able to be marketed in the EU for three years, however, as long as they have been labelled or made their market entry before the regulation comes into force.

• There is also a seven-year transitional period with respect to vitamins and minerals not on the EU list, as long as they were already used in foods prior to the regulation and dossiers supporting their use are submitted to the Commission within three years.

Impact of trade agreements on food fortification proposals

• A well-designed fortification programme should be defensible in the unlikely event that it is challenged on trade grounds.

• Various food fortification programmes have been established around the world, and none has been challenged on trade grounds.

• Fortification programmes are prima facie defensible as necessary to protect human health under article XX(b) of GATT. Where a country has a clear rationale and evidential basis for its fortification regime, a good argument exists that the conditions of article XX(b) are met

• The existence of widespread national and international standards for fortification minimizes the possibility of challenges under the TBT Agreement.

The regulation must meet a two-stage test

• The country must show that the health measure is necessary

• That it is effective and that no less restrictive trade measures were available to achieve the same public health purpose; and

• If the measure is proven necessary, the country must show that it does not constitute a ‘disguised restriction on international trade’ or ‘arbitrary or unjustifiable discrimination’

The Agreement on Technical Barriers to Trade (TBT Agreement)

• The TBT Agreement focuses on technical regulations, including matters like product composition, labelling & packaging.

• Thus, it is perhaps the WTO agreement most relevant to food fortification issues.

• WTO members must base any domestic technical regulations and standards on existing international standards, or international standards whose completion is imminent, unless to do so would be ineffective or inappropriate due to differences in things like climate, geography, or technology

Indian Regulations on fortification

• Prevention of Adulteration Rules, 1955

Rules pertaining to packaging and labelling , restriction on use of anticaking agents, notice of addition, admixture or deficiency in food

• Definitions and standards of quality as per Rule 5 details in Appendix B

Iodized salt

• Rule 62. Provides for provision of using crystal modifiers and anti-caking agent in common salt, iodised salt and iron fortified salt in quantity not exceeding 10 mg/ kg singly or in combination expressed as ferrocyanide at the same time

• Restricting on use of anticaking agents in other foods

Iodized salt (A. 15.01.) • Crystalline solid, white / pale/ pink / light grey in color,

free form contamination with clay, grit and other extraneous adulterants and impurities.

• Shall conform to the following standards -

– Moisture : Not > 6.0 % by weight , Not < 96.0 % by weight (NaCl) on dry basis

– Matter insoluble : Not more than 1.0 % by weight in water on dry basis

– Matter soluble in water other than sodium chloride: Not more than 3.0 % by weight on dry basis

Iodized salt (A.15.01 contd)Iodine content at :-

– (a) Manufactures‘ level : Not less than 30 parts per million on dry weight basis.

– (b) Distribution channel including retail level : Not less than 15 parts per million on dry weight basis

- Provided that table iodised salt may contain permitted anticaking agent as provided in rule 62 of these rules.

- Provided further that the total matter insoluble in water in such cases shall not exceed 2.2 per cent and sodium chloride content on dry basis shall no be less than 97.0 % by weight

Specification for Potassium iodate A. 15.01.01 POTASSIUM IODATE - a crystralline powder, white in colour, free

from impurities, shall conform to the following standards :-

• Potassium iodate (as KIO3) % by wt. not < 99.8• Solubility. Soluble in 30 parts of water• Iodide (as I) % by wt, not more than 0.002• Sulphate (as SO4) % by wt. not more than 0.002• Bromate, bromide, chlorate & chloride, % by wt, not > than

0.01• Matter insoluble in water, % by wt. not > 0.10• Loss on drying, % by wt. not > 0.1• PH (5 % solution) Neutral• Heavy metal (as Pb) ppm, not > 10• Arsenic (as As) ppm, not > 3• Iron (as Fe) ppm, not > 3

Iron fortified common salt

Rule 42 form of labels– Every container or package of edible common salt or

iodised salt or iron fortified common salt containing permitted anticaking agent shall bear the following label –

‘EDIBLE COMMON SALT OR IODISED SALT OR IRON FORTIFIED COMMON SALT CONTAINS PERMITTED ANTICAKING AGENT’

– or Every container or package of iron fortified common salt shall bear the following label -

IRON FORTIFIED COMMON SALT

Iron fortified common salt

Rule 57 Poisonous metals specifies-

• No article of food like iron fortified common salt contain more than 1 ppm by weight of lead and in any foods other metals like tin 250 ppm, zinc 50 ppm, methyl mercury 0.25 ppm

Iron fortified common salt

Rule 62 restriction on use of anticaking agents provides that

• calcium, potassium or sodium ferrocyanide may be used as crystal modifiers and anti-caking agent in common salt, iodised salt and iron fortified salt in quantity not exceeding 10 mg/ kg singly or in combination expressed as ferrocyanide

Iron fortified common salt (A.15.02 )A crystalline solid white /pale/ pink / light grey in colour, free form visible contamination

with clay and other extraneous adulterants and impurities, conform to the following standards –

– Moisture : Not > 5.0 % by weight.– Water insoluble matter: Not > 1.0 % on dry weight basis.– Chloride content; Not < 96.5 % by weight (as NaCl) on dry weight basis.– Matter insoluble in dilute hydrochloric acid : Not > 0.3 % by weight on dry

weight basis, (to be determined by the method specified in IS 253-1970)– Matter soluble in water other than sodium chloride weight basis: Not > 2.5

% on dry– Iron content (as Fe): 850-1100 parts per million, Phosphorous as inorganic

(PO4): 1500-2000 ppm, Sulphate (as SO4): Not > 1.1 % by weight, Magnesium as : Not > 0.10 % by weight (Mg) water soluble

– PH value of 5 % solution in water : 2 to 3.5.– Provided than Iron Fortified Common Salt may contain permitted anticaking

agent as provided in rules 62 of these rules and in such a case the total matter insoluble in water shall not exceed 2.2 per cent on dry weight basis].

Fortified Atta (A 18.01.01 ) Otained by adding one or more of the following materials to atta -

• (a) Calcium carbonate (preparated chalk popularly known as Creta

preparata).• (b) Iron.• (c) Thiamine.• (d) Riboflavin, and• (e) Niacin.• The calcium carbonate powder, if added for fortification, shall be

in such amount that 100 parts by weight of fortified atta shall contain not less than 0.30 and not more than 0.35 parts by weight of calcium carbonate. It shall be free from rodent hair and excreta.

Fortified Maida (A18.02.01 )

The product obtained by adding one or more ot the following materials to maida, namely:-

• (a) Calcium carbonate (preparated chalk popularly known as creta

• preparata),• (b) Iron,• (c) Thiamine,• (d) Riboflavin, and• (e) Niacin.• The calcium carbonate powder, if added for

fortification, shall be in such amount that 100 parts by weight of fortified maida shall contain not less than 0.30 and not more than 0.35 parts by weight of calcium carbonate. It shall he free from Rodent hair and excreta.

Vanaspati• VANASPATI means any refined edible vegetable

oil or oils, subjected to a process of hydrogenation in any form. Shall be prepared by hydrogenation from groundnut oil, cottonseed oil and sesame oil or mixture thereof or any other harmless oils allowed by the Government for the purpose.

• Shall contain not < 25 I.U. of synthetic Vitamin 'A' per gram at the time of packing and shall show a positive test for Vitamin A when tested by Antiomony trichloride (Carr-Price) reagent (as per I.S. 5886 - 1970]

Rule 43. Notice of addition, admixture or deficiency in food

• Every advertisement and every price or trade list or label for an article of food which contains an addition, admixture or deficiency shall describe the food as containing such addition, admixture or deficiency and shall also specify the nature and quantity of such addition, admixture or deficiency. No such advertisement or label attached to the container of the food shall contain any words which might imply that the food is pure.

• for the purpose of this rule VITAMINS IN FOOD not be deemed as an admixture or an addition.

Mandatory/Voluntary fortification• voluntary approach enables fortification

• mandatory regimes require it

• Infant foods and weaning foods are usually fortified by the manufacturers mainly to conform to the specification

• Fortification of processed foods with vitamins, minerals and even amino acids is often resorted to as part of sales promotion

Example of voluntary fortificationWorld food programme Fortified biscuits;India

• Required shelf-life: minimum 9 months.• Proposed recipe for required finished product:• Wheat Flour: 60-67.5% • Sugar: 20% • Vegetable oil: 7.5-10% • Soya flour: 5-10% • Leavening agent (sod. Bicarb & Ammon.

Bicarb.) as required  • Vitamin premix: as required • Mineral premix: as required • Vanilla flavor: as required (no other flavor

accepted)

Quality control procedures followed• The ingredients used for the manufacture of micronutrient

fortified biscuits, shall conform to the standards laid down under the Prevention of Food Adulteration Act, 1954

• The finished product shall have the nutritional value and Vitamin

content/levels as indicated in specifications

• Biscuits shall be processed, according to the product specifications provided in specification

• Micro nutrient fortified biscuits shall be of rectangular shape, of approximate dimensions L 5.5 cm/W 3.5 cm, H 0.7 cm , 12 pcs of each in a pack of 75 gms at the time of delivery, shall be dry, in good and sound condition, fit for human consumption and free from bad smell, infestation and any poisonous or deleterious substances in amounts hazardous to health.

Example of Quality control of mandatory programme

It has been found in certain states of India that only 40 to 80 per cent of iodised salts conform to the standards. The reasons for this include

• infiltration and mixing up of non-fortified common salt,

• poor packing conditions• want of an adequate number of covered railway

wagons• adulteration of potassium iodate with lime, • use of substandard salt• the use of non-food-grade potassium iodate

Iodised salt- Quality control• In order to maintain the quality of iodised salt,

necessary standards have been laid down under the Prevention of Food Adulteration Act, (i.e. 30 ppm at the manufacturing level and 15 ppm at the consumer level)

• At the manufacturing level, quality control is checked by the Salt Commissioner’s Organisation (Government of India)

• At the consumer level, quality control is maintained by the State Health Departments, under the PFA rule

Need for purity standards

An imminent need has been felt to lay down purity/quality standards for raw materials such as salt (98 % purity), food grade potassium iodate (for iodine fortification) and for food grade ferrous sulphate and stabilizers-cum-absorption promoters such as sodium hexametaphosphate (for iron fortification)

Food Safety And Standards Act 2006

• A BILL to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto was enacted by Parliament

Legislations to be replaced with the new Act on implementation

• Prevention of Food Adulteration Act, 1954 (37 of 1954).

• The Fruit Products Order, 1955. • The Meat Food Products Order, 1973. • The Vegetable Oil Products (Control) Order, 1947. • The Edible Oils Packaging (Regulation) Order, 1998. • The Solvent Extracted Oil, De oiled Meal, and Edible

Flour (Control) Order, 1967. • The Milk and Milk Products Order, 1992. • Any other, issued under the Essential Commodities

Act, 1955 (10 of 1955) for food

Food safety and standards act

• Clause 98 provides that notwithstanding the repeal of the enactment and orders specified in the Second Schedule the standards, safety requirements and other provisions of the Acts, rules, regulations and orders listed in that Schedule shall continue to be in force and operate till new standards are specified under the Bill or rules and regulations made there under.

Biofortification• Develop varieties of staple foods high in iron, zinc and

provitamin A

• The golden rice evolved through genetic engineering to produce beta carotene as a complementary intervention to combat vitamin A deficiency among the rice eating populations

• The most important hurdle of any Genetically Modified Food is completion of food safety assessment.

• Only a full fledged toxicological and allergy assessment study in animals and a clinical trial in humans will provide the answer to the possible role of allergens.

• Regulatory regimens need to be in place and implementation procedures need to be evolved