Government Notice

Department of Health

No. R.1328

26 September 2003

REGULATIONS RELATING TO FOODSTUFFS FOR INFANTS AND YOUNG CHILDREN

The Minister of Health intends, in terms of section 15 of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), to make the regulations in the Schedule.

Interested persons are invited to submit any substantiated comments or representations on the proposed regulations to the Director-General of Health, Private Bag X828, Pretoria, 0001 (for the attention of the Director: Nutrition), within three months of the date of publication of this notice.

INDEX

1. Definitions

Chapter 1: Labelling, composition, packaging and manufacturing matters

2. General labelling, composition, packaging and other manufacturing requirements
3. Specific labelling and other requirements for infant formula, follow-up and infant or follow-up formula for special dietary or medical purposes
4. Specific labelling requirements and other requirements for complementary food for infants or young children
5. Specific labelling and other requirements for sweetened condensed milk, evaporated milk, skimmed milk powder, full cream milk powder and imitation dairy products
6. Specific labelling and other requirements for feeding bottles, teats and dummies

Chapter 2: Promotion-related matters

7. Sale and promotion of a designated product
8. Gift packs
9. Prohibition of distribution of free and low-cost designated products or samples
10. Prohibition of display of a designated product or printed material
11. Prohibition of donation or distribution of equipment, informational or educational material or other material
12. Provision of sponsorship prohibited
13. Information, education material and other material
14. Health workers
15. Lodging of complaints
16. Repeal
17. Commencement

Annexure A: Sweeteners
Annexure B: Essential Nutrients
Annexure C: Required Nutritional Information
Annexure D: Recommended Dietary Allowances for Infants and Young Children

SCHEDULE

1. Definitions

In these regulations, any expression to which a meaning, has been assigned in the Act, shall bear such meaning, and unless the context otherwise indicates -

"blends" means a blend of cow’s milk, components of cow’s milk, vegetable fats and/or glucose;

"brand name of designated product" means the name given by a manufacturer or distributor to a designated product or range of designated products;

"breastfeeding" means the suckling of the infant or young child on the mother’s breast or the wet nurse’s breast;

"canned foodstuff for infants or young children" means a foodstuff, whether in a ready-to-eat form or in a dry form requiring reconstitution with water only, packed in a hermetically sealed package and intended primarily for use during the infant’s normal weaning period and for the progressive adaptation of infants and young children to ordinary foodstuffs;

"child-care institutions" means the whole or part of a public or private institution, facility, agency, building or place caring for babies, young children and other children, whether part-time or full-time, whether organised for profit or not;

"Codex" means the latest version of the relevant Codex Standards as issued by the Codex Alimentarius Commission of the Joint FAO/WHO Food Standards Programme;

"complaint" means any written information regarding a possible violation of these regulations which comes to the attention of the department or local authority concerned or a written complaint, charge or allegation of a violation of these regulations against any person, group or professional body (including a professional association or society, teaching or training institution, or any other health care or related facility);

"complementary food" means any foodstuff, whether in solid or liquid form, given to an infant as part of the transitional process during which an infant learns to eat food appropriate for his or her developmental stage while continuing to breastfeed or feed with any infant formula or follow-up formula and includes, but is not limited to, canned foodstuffs for infants or young children and processed cereal-based foodstuffs for infants or young children;

"container" means any form of packaging of foodstuffs for sale as a retail unit, including wrappers;

"designated product" means -

1. infant formula;
2. follow-up formula;
3. infant or follow-up formula for special dietary- or medical purposes
4. complementary foods;
5. any other milk product or milk-like product marketed or otherwise represented as suitable for feeding an infant or toddler;
6. any other product marketed or otherwise represented as suitable for feeding an infant up to the age of six months;
7. feeding bottles;
8. teats; or
9. related products such as dummies or feeding cups; whether locally or internationally manufactured;

"Directorate" means the Directorate: Nutrition of the national Department of Health;

"Director-General" means the head of the national Department of Health;

"distributor" means a person, corporation or other entity engaged in the business, whether wholesale or retail, of marketing any designated product and includes any person engaged in the business of providing information or public relations services in relation to any designated product;

"dummy" means an artificial teat for a baby or a toddler to suck, also referred to as a "pacifier";

"feeding bottle" means a device with an artificial teat which is used to feed an infant or a toddler;

"feeding cup" means a cup with a spout, straw, teat or other device marketed or represented as suitable for feeding an infant or a toddler;

"follow-up formula" means a milk or milk-like product formulated industrially and marketed or otherwise represented for an infant or young child from the age of six months onwards;

"gift" means something given free of charge and includes, but is not limited to, a designated product, meals and refreshments, diaries, stationery, calendars, cot tags, stickers, growth charts, prescription pads, tongue depressors or any item of whatever value;

"health claim" means any representation that states, suggests or implies that a relationship exists between a foodstuff or a constituent of such foodstuff and health, and includes a nutrient function claim, other function claim, reduction of disease risk claim, pre-biotic claim and pro-biotic claim as defined in other labelling regulations under the Act;

"health establishment" means the whole or part of a public or private institution, facility, agency, building or place, whether organised for profit or not, that is operated or designed to provide inpatient or outpatient treatment, diagnostic or therapeutic interventions, nursing or rehabilitative, palliative, preventative or other health services, and includes child-care institutions and pharmacies;

"health professional" means a health worker with a professional degree, diploma, certificate or licence, such as a medical practitioner, nurse or midwife, or other person registered with a statutory council;

"health worker" means a person providing or in training to provide health care services in a health establishment, whether professional or non-professional, including a health care provider or a voluntary unpaid worker;

"hermetically sealed package" means an unopened package which forms an airtight closure, is impervious to liquid and which cannot be opened without breaking or damaging such package or the seal, adhesive label or other part thereof or attachment thereto;

"imitation dairy product" means a foodstuff such as tea or coffee creamer, blend or sweetened condensed milk with vegetable oils;

"infant" means a person under the age of 12 months;

"infant formula" means a foodstuff specially manufactured to meet an infant’s nutritional requirements consisting of the milk of cows or other animals and/or on other constituents of animal, including fish, or plant origin, in liquid or powder form;

"infant or follow-up formula for special dietary or medical purposes" means infant or follow-up formula which is processed and/or formulated for special dietary uses and which is presented for the dietary management of infants and toddlers, and which is used only under medical supervision such as metabolic disorders namely phenylketonuria, maple syrup disease and galactosaemia.

"manufacturer" means a person, corporation or other entity engaged in the business of manufacturing a designated product whether directly, through an agent, or through a person controlled by or under an agreement with it;

"marketing" means promoting, distributing, selling, or advertising a designated product and includes product public relations and information services, including the use of professional service representatives, health workers such as mother craft nurses, or any person acting on behalf of a manufacturer or distributor, and "market" has a corresponding meaning;

"marketing personnel" means personnel, including health workers, who are involved in the marketing of a designated product;

"maternal nutritional supplement" means a substance in capsule, tablet, soft gel, liquid or powder form which is marketed or otherwise represented as being beneficial if taken by pregnant and lactating mothers in addition to or as part of their normal diet;

"medical dispensary" means a room in a health establishment where medicines are prepared and provided;

"negative claim" means a declaration or implication made on a label, in an advertisement or in any other manner that a foodstuff alone possesses specific characteristics or properties when in fact similar foodstuffs possess the same characteristics or properties;

"non-profit organization" means a trust, company or other association of persons –

1. established for a public purpose; and
2. the income and property of which are not distributable to its members or office-bearers except as reasonable compensation for services rendered;

"nutrition claim" means any representation which states, suggests or implies that a food has particular nutritional properties, including but not limited to the energy value and to the content of protein, fat, carbohydrate, vitamins and minerals, and includes nutrient content claims, glycaemic index claims or nutrient comparative claims as defined under other labelling regulations under the Act;

"pack-shot" means any representation of a designated product, including photographs, graphics or line drawings;

"pharmacy" means a place in or from which any service specially pertaining to the scope of practice of a pharmacist is provided, but does not include a medical dispensary;

"processed cereal-based foodstuff for infants or young children" means a foodstuff intended to supplement the diet of infants or young children, which has been prepared primarily from one or more milled cereal products such as wheat, barley, rice, oats, rye, maize, millet, sorghum or buckwheat, which products shall constitute at least 25% of the final mixture on a dry weight basis, and may also contain legumes (pulses), starchy roots (such as arrowroot, yam, or cassava) or starchy stems or oils seeds in smaller proportions, and the term shall include -

1. products consisting of cereals which are or have to be prepared for consumption with milk or other appropriate nutritious liquids;
2. cereals with an added high-protein food which are or have to be prepared for consumption with water or other protein-free liquids;
3. pasta, which is a foodstuff prepared from milled cereal products, which is to be used after cooking in boiling water or other appropriate liquids;
4. rusks and biscuits, which are cereal-based foodstuffs produced by baking, which may be used either directly or, after pulverisation, with the addition of water or milk or other suitable liquid, and milk biscuits consisting mainly of cereals and containing milk solids;
5. enzyme-treated flours of cereals, which are flours prepared with enzymes, the starch content of which has been transformed into dextrin, maltodextrin, maltose and glucose; and
6. simple or composite cooked flours of cereals, which are foodstuffs that have been cooked in a way that distinguishes them as follows:

1. partially cooked flours requiring a second short cooking before use;
2. cooked flours, for immediate use, as such not requiring any further cooking before use; and
3. dextrinised flours, the starch content of which has in part been transformed into dextrin by heat treatment;

"promote" means to employ a method of directly or indirectly encouraging a person to purchase or use a designated product, and includes but is not limited to point-of-sale advertising, giving of samples, special sales, free supplies, donations, free gifts, whether related or unrelated to purchases, free utensils or articles, prizes, carrier bags with pack-shots or product logos, prizes or special displays at retail outlets, discount coupons, premiums, special sales, loss-leaders, tie-in sales, rebates and other give-aways;

"proprietary product" means a designated product which is explicitly associated with a particular manufacturer or distributor;

"related products" means products or devices that may interfere with breastfeeding, such as dummies or feeding cups;

"retail outlet" means a pharmacy, shop, supermarket, medical hall or other premises used by, for example, a distributor, agent or importer;

"sample" means a single or small quantity of a designated product provided at no cost;

"scientific research material" means health-related research published in peer-reviewed, reputable and credible scientific journals;

"serving", in relation to a foodstuff, means a reasonable quantity of food suitable for consumption as a single meal by infants or young children;

"sponsorship" means any financial assistance to a person, group or activity alone or with others and "sponsor" has a corresponding meaning;

"sugar" means the sugars listed in Annexure A under the heading "Sugars";

"teat" means a device resembling a female nipple for an infant or toddler to suck or which is used to feed food from a bottle, cup or other feeding device;

"tie-in sales" means the sale of any designated product that is linked to the purchase of any other product including a designated product;

"toddler" means a child from the age of 12 months up to the age of 24 months (two years);

"the Act" means the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972);

"worker in a health establishment" means a person providing or in training to provide services in a health establishment, whether professional or non-professional, including a voluntary unpaid worker;

"young children" means persons from the age of 12 months up to the age of three (3) years.

Chapter 1: Labelling, composition, packaging and manufacturing matters

2. General labelling, composition, packaging and other manufacturing matters

(1) The requirements specified in regulations 2, 3, 4, 5 and 6 of these regulations are supplementary to the other labelling and packaging requirements laid down by the Act.

(2) No person shall offer for sale or sell any –

1. infant formula;
2. follow-up formula;
3. infant or follow-up formula for special dietary or medical purposes;
4. complementary food;
5. any other milk product or milk-like product marketed or otherwise represented as suitable for feeding an infant or toddler; or
6. any other product marketed or otherwise represented as suitable for feeding an infant up to the age of six months,

that is not packed in a hermetically sealed package.

(3) Subject to the provisions of subregulations (17) and (18), the products referred to in subregulation (2) and the components of such products shall not have been treated by ionizing radiation;

(4) The label of a product referred to in subregulation (2) shall -

1. not show any photograph, drawing or graphic representation other than –

1. for illustrating the method for preparation of infant formula, follow-up formula or infant or follow-up formula for special dietary or medical purposes as indicated in regulation 3(1)(b), or for complementary food for infants or young children;
2. for illustrating the sterilisation of equipment and utensils in the case of infant formula, follow-up formula and infant or follow-up formula for special dietary or medical purposes as indicated in regulation 3(1)(c);
3. the ingredients or composition of a complementary food for infants or young children; and
4. the logo of the manufacturer or distributor;

2. not contain any information relating to the nutritional content or other properties of human milk;
3. not contain words that such a product is suitable for all infants;
4. be written in English, except for the -

1. instructions on preparation and use referred to in regulation 3(1)(b)(ii);
2. sterilisation of equipment referred to in regulation 3(1)(c); and
3. directions for storage referred to in regulation 3(1)(d),

which shall be in three official languages of which English is one;

5. indicate in the middle or at the bottom on the front panel of such label the age of the infant or young child for which such product is suitable.

(5) No nutrition claim or health claim shall be permitted with regard to nutrients or food constituents that are required as a part of the essential composition of a foodstuff for infants or young children as determined in –

1. Codex; or
2. Annexure B.

(6) Subject to the provision of subregulation (5), any nutrition claim or health claim which a manufacturer or distributor intends to make shall be subject to the written approval of the Director-General prior to market appearance.

(7) The written request by a manufacturer or distributor for written approval referred to in subregulation (6) shall contain conclusive proof of the efficacy and functionality of the nutrient or food constituent in the specific foodstuff in peer-reviewed clinical studies that have been published in credible, reputable scientific journals, complete copies of which shall be submitted with such written request.

(8) (a) In order to ensure that a nutrition claim or health claim made by a manufacturer or distributor prior to the promulgation of these regulations is valid and scientifically correct, such manufacturer or distributor shall apply, within a period of 12 months after the promulgation of these regulations, for written approval for the nutrition or health claim from the Director-General.

(b) A manufacturer or distributor referred to in paragraph (a) who does not obtain written approval within the period referred to in paragraph (a) shall be in contravention of these regulations.

(9) The nutritional value of a foodstuff for the purpose of nutrition information on a label shall be done according to the methods of analysis and sampling as stipulated in Codex and other relevant regulations under the Act.

(10) The essential composition and optional ingredients of any foodstuff for infants or young children including permitted additives shall be in accordance with Codex.

(11) Any foodstuff for infants or young children shall be -

1. free from residues of hormones;
2. free from antibiotics as determined by means of agreed methods of analysis; and
3. practically free from other contaminants, especially other pharmacologically active substances.

(12) Any foodstuff for infants or young children shall be prepared under good manufacturing practices so that residues of those pesticides which may be required in the production, storage or processing of the raw materials or the finished food ingredient do not remain or, if technically unavoidable, are reduced to a minimum.

(13) Any foodstuff for infants or young children shall -

1. be prepared and handled in accordance with Codex; and
2. comply with any microbiological criteria determined in Codex.

(14) The name and address of the manufacturer shall appear on the label of a designated product in accordance with other labelling requirements laid down by the Act, and, in the case of an imported foods stuff, such label shall contain the contact details of the South African distributor.

(15) The label of a designated product shall not refer to, promote or advertise another designated product.

(16) No toys or any other form of gifts or tokens may be inserted or sold with the product referred to in subregulation (2).

(17) The addition of honey or maple syrup as a component in a foodstuff for infants or young children will be permitted: Provided that -

1. such honey has been irradiated according to existing legislation;
2. such honey or maple syrup complies with Codex microbiological standards; and
3. prove is on record that such honey or maple syrup is free from Botulism toxins.

(18) The addition of herbs and spices as a component in a foodstuff for infants or young children will be permitted: Provided that such herbs and spices has been irradiated according to current legislation.

3. Specific labelling and other requirements for infant formula, follow-up formula and infant or follow-up formula for special dietary or medical purposes

(1) A manufacturer or distributor shall not offer for sale or sell infant formula, follow-up formula or infant or follow-up formula for special dietary or medical purposes if the container or label affixed to such formula -

1. does not have the following clear, conspicuous and easily readable messages: "Breastfeeding provides the best food for your baby and reduces the risk of diarrhoea and illnesses" and "Before you decide to use this product, consult your doctor or health worker for advice", which shall be -

1. on the top of the front label or main panel;
2. in bold letters at least 5 mm high for a container of 500 g or smaller and shall increase proportionately with the size of the container;
3. framed with a solid black line at least 1 mm thick;
4. be in three official languages of which English is one; and
5. repeated on the leaflet referred to in subregulation (6);

2. does not provide instructions for the proper preparation and use -

1. which shall be in graphic representation which shall depict the use of the scoops referred to in subregulation (2), feeding cups and feeding bottles; and
2. which shall be in at least three official languages of which English is one;

3. does not provide instructions for the proper sterilisation of equipment and utensils and the proper preparation and use which shall -

1. be in graphic representation and in colour coding which shall depict the use of the enclosed scoops referred to in subregulation (2), feeding cups and feeding bottles;
2. be in at least three official languages of which English is one;
3. indicate that potable, previously boiled water should be used;
4. indicate that only the enclosed scoop(s) should be used; and
5. indicate that any formula left in the feeding cup or feeding bottle after a feed should not be given to the infant;

4. does not provide instructions for the proper storage and keeping before and after the package has been opened in at least three official languages of which English is one;
5. includes the terms "maternalised", "humanized" or similar expression;
6. does not include a warning preceded by the words "Important Notice" against the health hazards of improper preparation and use and must be in three official languages of which English is one;
7. does not include the words "Warning – follow instructions exactly. Prepare feeding cups or feeding bottles as directed. Incorrect preparation can make your baby ill" and must be in three official languages of which English is one;
8. does not include the words "Warning: Do not add salt" on the main panel in capital letters at least 3 mm height if the formula contains the maximum concentration of NaCl as determined in Codex;
9. does not contain a message on the importance of regular clinic visits for growth monitoring; or
10. does not contain a warning that the infant must be held while feeding.

(2) A package of infant formula, follow-up formula or infant or follow-up formula for special dietary or medical purposes in a powdered form shall contain two scoops (one blue scoop for the water and one red scoop for the formula) to enable the use of such formula in accordance with the directions contained on the label on the container.

(3) In the case of infant formula or infant formula for special dietary or medical purposes, the container or label shall indicate the monthly quantity necessary to feed an infant during the first six months of its life.

(4) In the case of infant formula or follow-up formula, the container or label shall contain the words "It is recommended that infants over the age of six months should be offered appropriate complementary foods in addition to the infant formula or follow-up formula".

(5) A manufacturer or distributor shall not offer for sale or sell follow-up formula or follow-up formula for special dietary and medical purposes if the container or label affixed to it does not include a warning that the foodstuff is not intended for infant under six months of age and that early introduction of this foodstuff may have health hazards for the infant, that shall be –

1. in three official languages of which English is one;
2. in letters at least 4 mm high; and
3. repeated in the leaflet referred to in subregulation (6).

(6) A manufacturer or distributor shall not offer for sale or sell infant formula, follow-up formula or infant or follow-up formula for special dietary or medical purposes if it does not include an information leaflet inserted between the label or container and the hermetically sealed package that include the following nutritional information -

1. an indication of the mass or volume of a serving of the ready-to-eat product, if not given elsewhere on the label;
2. the required nutritional information in the format of Annexure C;
3. the amount of each vitamin and mineral referred to in Annexure B contained in the product; and
4. what percentage of the Recommended Dietary Allowance determined in Annexure D of the vitamins and minerals determined in Annexure B and protein are present in a single serving;

(7) The nutritional information referred to in subregulation (6) may also be indicated by a manufacturer or distributor on the label of a product referred to in subregulation (1).

4. Specific labelling and other requirements for complementary food for infants or young children

(1) A manufacturer or distributor shall not offer for sale or sell complementary food for infants or young children if the container or label affixed to such product does not -

1. provide instructions for proper preparation and use;
2. provide instructions for proper storage before and after the package has been opened;
3. include a warning preceded by the expression "Important notice" against the health hazards of improper preparation and use;
4. include a warning that such foodstuff is not intended for infants under six months of age and that early introduction of such foodstuff may have health hazards for infants, that shall be -

1. on the front label or main panel;
2. in capital letters at least 3 mm high for a container of 50 g or smaller and shall increase proportionately with the size of such container; and
3. repeated in the leaflet referred to in subregulation (2);

5. include the expression "Warning: Do not add salt" on the main panel in capital letters at least 3 mm height if such product contains the maximum concentration of NaCl as determined in Codex;
6. contain the expression "home prepared foods are equally beneficial for infants from six months and young children";
7. include an indication of the mass or volume of a serving;
8. include the required nutritional information in the format of Annexure C and any other micronutrient which is present in such foodstuff: Provided that -

1. such micronutrient is present in amounts of more than 5% per single serving; and
2. such micronutrient shall be one of the micronutrients listed in Annexure B; or

9. include the relevant nutrition information where a health claim or nutrition claim referred to in regulation 2(6) is made,

(2) Not withstanding the provisions of subregulation (1), the label or container of a processed cereal based foodstuffs for infants or young children shall –

1. state that water, expressed breastmilk, milk or formula may be used for diluting or mixing where such foodstuff contains more than 15% protein; and
2. contain the expression: "Expressed breastmilk, milk or a formula, but no water, shall be used for dilution of mixing in accordance with medical advice" where such foodstuff contains less than 15% protein and the quality thereof is less than 70% of that of casein.

(3) The nutritional information referred to in subregulation (1)(h) may also be indicated by a manufacturer or distributor on a leaflet attached to a foodstuff referred to in subregulation (1) if the label space is not sufficient.

5. Specific labelling and other requirements of sweetened condensed milk, evaporated milk, skimmed milk powder, full cream milk powder and imitation dairy products

The labels of sweetened condensed milk, evaporated milk, skimmed milk powder, full cream milk powder and imitation dairy products shall be marked with the following words "Not for baby feeding", which shall be -

1. on the front label or main panel;
2. in three official languages of which English is one;
3. in capital letters at least 3 mm high; and
4. framed with a solid black line at least 1 mm thick.

6. Specific labelling and other requirements of feeding bottles, teats and dummies

(1) A label, package or container of a feeding bottle or teat shall include -

1. a statement on the superiority of breastmilk for feeding infants which shall be -

1. on the front label or main panel;
2. in capital letters at least 3 mm high for a label of 70 cm² and shall increase proportionately with the size of the label; and
3. framed with a solid black line at least 1 mm thick;

2. a statement that feeding with a cup is safer than bottle feeding and such statement shall be in bold letters at least 3 mm high;
3. instructions for proper cleaning and sterilisation of feeding bottles and teats which shall be in three official languages of which English is one;
4. a warning on the potential health hazards of using a feeding bottle especially if it is not properly sterilised which shall be in three official languages of which English is one;
5. a warning on the negative impact of bottle-feeding and the need to follow preparation instructions carefully to ensure that an infant does not fall ill which shall be in bold letters at least 3 mm high; and
6. the name and address of the manufacturer or distributor of the product or the local agent.

(2) A label, package or container of a feeding bottle or teat shall not show any photograph, drawing or graphic representation other than -

1. for illustrating the cleaning sterilisation and as referred to in subregulation (1)(c); and
2. the logo of the manufacturer or distributor.

(3) The information referred to in subregulation (1) shall be written in English, except for the sterilisation of equipment referred to in subregulation (1)(c), which shall be in three official languages of which English is one.

(4) The label on a dummy shall -

1. have a notice that the use of such a dummy can interfere with breastfeeding, which shall be:

1. on the front label or main panel;
2. in bold letters at least 3 mm high; and
3. framed with a solid black line at least 1 mm thick; and

2. have instructions for proper cleaning and sterilization of such a dummy which shall be in three official languages of which English is one;
3. have a warning on the potential health hazards of using a dummy especially if it is not properly sterilized;
4. not show any photograph, drawing or graphic representation other than -

1. for illustrating the cleaning and sterilisation referred to in paragraph (b); and
2. the logo of the manufacturer or distributor; and

5. be written in English, except for the sterilisation of equipment referred to in paragraph (b) which shall be in three official languages of which English is one.

(5) The label, package or container of a feeding bottle, teat or dummy shall not contain any words or images that create the impression that such feeding bottle, teat or dummy is manufactured in accordance with the recommendation of a medical or dental practitioner, or another person registered under the Health Professions Act, 1974 (Act No. 56 of 1974), or the Allied Health Professions Act, 1982 (Act No. 63 of 1982).

(6) Any action, motion or benefits with regard to the feeding or sucking on a feeding bottle, dummy or teat or the physical properties of such feeding bottle, dummy or teat shall not in any form or manner be compared to the action, motion or benefits of suckling on a human breast or the physical properties of such human breast.

Chapter 2: Promotion-related matters

7. Sale and promotion of a designated product

(1) No person shall sell, advertise or assist in the sale or advertisement of a designated product in a health establishment.

(2) Notwithstanding the provisions of subregulation (1), a pharmacy may sell a designated product in a health establishment.

(3) No person shall undertake or participate, in a health establishment or elsewhere, for example a shop, in any promotional practice or device in respect of -

1. infant formula;
2. follow-up formula;
3. infant or follow-up formula for special dietary or medical purposes
4. any other milk product or milk-like product marketed or otherwise represented as suitable for feeding an infant or toddler;
5. any other product marketed or otherwise represented as suitable for feeding an infant up to the age of six months;
6. feeding bottles;
7. teats; or
8. related products such as dummies or feeding cups, whether locally or internationally manufactured.

(4) A person may undertake or participate in a promotional practice or device in respect of a complementary foods: Provided that such promotional practice -

1. does not take place in a health establishment ; and
2. complies with the requirements determined in subregulations (5) and (6).

(5) A promotional practice or device, excluding T-shirts, caps and towels, in respect of a complementary food referred to in subregulation (4) shall -

1. in the case of written material contain -

1. the appropriate age;
2. a warning that such food is not intended for infant under six months of age and that early introduction of such food may have health hazards for the infant; and
3. the expression "home prepared foods are equally beneficial for infants from six months or young children",

which shall be in bold letters at least 4 mm high for a page of A4 size or smaller and shall increase proportionately with the size of such material;

2. in the case of audio or visual material -

1. contain -

27. the appropriate age;
54. a warning that such food is not intended for infant under six months of age and that early introduction of such food may have health hazards for the infant; and
81. the expression "home prepared foods are equally beneficial for infants from six months and young children"

2. which shall be –

27. in the same voice and/or speed as used in the rest of the material;
54. of sufficient duration to be clearly understood; and
81. clear and conspicuous.

(6) A promotional practice or device in respect of a complementary food referred to in subregulation (4) shall not -

1. contain, include, refer to or provide any nutrition claim or health claim unless the manufacturer or distributor of such food complies with the requirements indicated in regulation 2(6);
2. contain, include, refer to or provide a negative claim;
3. contain, include, refer to or provide any information related to the nutritional content or other properties of human milk;
4. contain, include, refer to or provide the words "fortified" or a fortification logo;
5. contain, include, refer to or provide toys or any other forms of gifts or tokens; or
6. create an association with -

1. infant formula;
2. follow-up formula; or
3. infant or follow-up formula for special dietary or medical purposes;

(7) A promotional practices or devices referred to in subregulations (3), (4), (5) and (6) include but are not limited to -

1. sale devices such as rebates, special display to promote sales, tie-in sales, grant of rewards, discount coupons, prizes and gifts;
2. direct or indirect contact between marketing personnel and members of the public in furtherance of or for the purpose of promoting the business of the marketing personnel with regard to a designated product and for purposes of these regulations "indirect contact" includes television and radio, telephone or internet help lines and mother and baby clubs;
3. the distribution of any information, educational material or other material on feeding of infants and toddlers except in accordance with regulations 11 and 13 of these regulations;
4. electronic communications including web sites, internet and email except in accordance with regulations 11 and 13 of these regulations;
5. promotional items such as T-shirts, caps and towels that refer to a designated product or to a brand name of a designated product as far as promotion to the general public is concerned;
6. promotional items such as T-shirts, caps and towels that refer to a designated product, to a brand name of a designated product or to a manufacturer as far as promotion within a health establishment is concerned;
7. outdoor advertisements such as billboards; and
8. practices that create an association in any manner, whether written, visual or audio, between a manufacturer and -

1. breastfeeding;
2. infant formula;
3. follow-up formula;
4. infant or follow-up formula for special dietary or medical purposes;
5. any other milk product or milk-like product marketed or otherwise represented as suitable for feeding an infant or toddler;
6. any other product marketed or otherwise represented as suitable for feeding an infant up to the age of six months;
7. feeding bottles;
8. teats; or
9. related products such as dummies or feeding cups, whether locally or internationally manufactured.

(8) The name or label of a maternal nutritional supplement shall not be used to promote or create an association with a designated product, breastfeeding or breastmilk.

8. Gift packs

(1) Marketing personnel may donate gift packs to health establishments for distribution to families, mothers of new-born infants or pregnant mothers: Provided that such gift packs shall not -

1. contain designated products or other items such as tokens, information or educational material, advertisements or images of artificial feeding on the packaging or labels of other products which are intended to induce the use of a designated product;
2. contain the name or logo of a manufacturer or a brand name of a designated product; or
3. be donated directly by marketing personnel to such families, mother of new-born infants or pregnant mothers.

(2) In a health establishment information and educational material in gift packs shall comply with the provisions in regulation 13.

9. Prohibition of distribution of free or low-cost designated products or samples

(1) No person, manufacturer or distributor shall distribute free, or at low cost, supplies or samples of a designated product to any person in a health establishment or elsewhere, including a shop.

(2) Nothwithstanding the provisions of subregulation (1), a person, manufacturer or distributor may distribute free, or at low cost, supplies or samples of a designated product to hospices, orphanages or places of safety.

(3) No worker in a health establishment shall accept or give to any other person free or at low cost, supplies or samples of a designated product.

(4) Research involving the use of a designated product in a human subject shall be subject to the written approval of a properly constituted committee for research on human subjects.

(5) A health establishment referred to in subregulation (1) shall procure all designated products it requires through the normal procurement channels.

10. Prohibition of display of a designated product or printed material

No person shall display or permit to be displayed in a health establishment a designated product or printed material that bears the name or any other description of a designated product or the company name or logo.

11. Prohibition of donation or distribution of equipment, informational or educational material or other material

(1) No manufacturer or distributor shall directly or indirectly donate, or pay for or distribute any equipment, informational or educational material or other material to -

1. a health establishment taking care of infants, young children, pregnant mothers or mother of infants and young children; or
2. a unit taking care of infants, young children, pregnant mothers or mother of infants and young children in health establishment,

unless such donation, payment or distribution is with the prior written approval of the head of the provincial department of health concerned.

(2) No person, manufacturer or distributor shall donate, pay for or distribute within or to -

1. a health establishment taking care of infants, young children, pregnant mothers or mother of infants and young children; or
2. a unit taking care of infants, young children, pregnant mothers or mother of infants and young children in health establishment,

equipment, informational or educational material or any other material (including the structure of a health establishment) that bears the name, logo, graphic, trademark or any other description of such manufacturer or distributor, or the brand name of a designated product.

(3) A person, manufacturer or distributor may provide informational or educational material or any other material about a designated product to a health professional: Provided that such information or material is restricted to current scientific and factual matters reflected in total and not selected parts that can be used in a misleading way, that relate to the technical aspects and methods for the uses of the designated product.

(4) Subject to the provisions of subregulations (1), (2) and (3) a person, manufacturer or distributor may donate or distribute informational or educational material subject to the written approval of such health establishment: Provided that such informational or educational material complies with the provisions in regulation 13.

12. Provision of sponsorships prohibited

(1) No manufacturer or distributor shall directly or indirectly -

1. provide research grant or any other financial assistance to a health worker or health establishment relating to infant or young child health or nutrition; or
2. sponsor the attendance of a health worker at a conference, seminar or any health related professional meeting relating to infant or young child health or nutrition,

without the prior written approval of the head of the provincial department of health concerned.

(2) No manufacturer shall directly or indirectly offer a gift in cash or in kind to a worker in a health establishment.

(3) No worker in a health establishment shall accept a gift in cash or in kind from a manufacturer or distributor.

13. Information, educational material or other material

(1) Any information, educational material or other material, excluding scientific research material whether written, audio or visual on infant and young children feeding containing 600 words or less made available in the country by any person shall state the following:

1. the superiority of breastmilk and breastfeeding;
2. the value of exclusive breastfeeding for six months followed by sustained breastfeeding for two years and beyond; and
3. the negative effect on breastfeeding and infant health of introducing partial artificial feeding.

(2) Any information, educational material or other material excluding scientific research material whether written, audio or visual on infant and young children feeding containing more than 600 words made available in the country by any person shall clearly explain the following:

1. the superiority and benefits of breastmilk and breastfeeding;
2. the value of exclusive breastfeeding for six months followed by sustained breastfeeding for two years and beyond;
3. how to initiate and maintain exclusive and sustained breastfeeding
4. (d) how and why the introduction of artificial feeding or early introduction of complementary foods interferes with breastfeeding;
5. why it is difficult to return to breastfeeding after a period of artificial feeding even if this is limited to a few feeds per day;

(3) Notwithstanding the provisions of subregulations (1) and (2), any information, educational material or other material about the use of infant formula, follow-up formula or infant or follow-up formula for special dietary or medical purposes whether written, audio or visual made available in the country by any person shall clearly explain the following:

1. the proper preparation and use of such formula, including the cleaning and sterilisation of feeding utensils;
2. the social and financial implications of its use including –

1. in the case of infant formula or infant formula for special dietary or medical purposes for infants up to six months, how many tins will be needed for the first six months and how much will such tins cost;
2. in the case of follow-up formula or follow-up formula for special dietary or medical purposes for infants six months and older, how many tins will be needed from six months to two years and how much will such tins cost;
3. the need for an adequate supply of good quality water;
4. the equipment needed to sterilise the feeding bottles, teats or utensils;
5. the need for an adequate supply of fuel for sterilisation (boiling water) or other sterilisation solutions; and
6. the method and process of formula mixing;

3. the health hazards of inappropriate foodstuffs and feeding methods and in particular the health hazards of unnecessary or improper use of infant formula, special formula or follow-up formula; and
4. how to feed an infant with a cup.

(4) Notwithstanding the provisions of subregulations (1) and (2), any information, educational material or other material about the use of complementary food whether written, audio or visual made available in the country by any person shall contain the following:

1. clear instructions for the proper preparation and use including cleaning of feeding utensils;
2. a warning that such complementary food is not intended for an infant under six months of age and that early introduction of such complementary food may have health hazards for such infant; and
3. a statement that home prepared foods are equally sufficient for an infant from six months and young children.

(5) The statements and explanations in the information, educational material or other material referred to in subregulations (1), (2), (3) and (4) that are written, shall be:

1. in the same font type and letter size as the rest of the material; and
2. clear and conspicuous.

(6) The statements and explanations in the information, educational material or other material referred to in subregulations (1), (2), (3) and (4) that are audio or visual, shall be:

1. in the same voice and speed as used in the rest of the material;
2. of sufficient duration to be clearly understood; and
3. clear and conspicuous.

(7) Information, educational materials or other materials referred to in subregulations (1), (2), (3) and (4) shall:

1. not use any pictures or text, for example animals, story-book characters or other images associated with infants and young children, that encourage the use of infant formula, follow-up formula or infant or follow-up formula for special dietary or medical purposes or that discourage breastfeeding;
2. contain only correct and current information;
3. be in at least three official languages of which English is one, except for magazines, newspapers, books, television programmes and radio programmes that will be in the language of publication or broadcasting;
4. not give the impression or create the belief that a designated product is equivalent to, comparable with, or superior to breastmilk or to breastfeeding;
5. bear the date of publication and printing; and
6. not make any reference to any proprietary product or contain the name or logo of any manufacturer or distributor of a designated product except by way of indicating a copyright.

(8) A health worker may, subject to the requirements determined in subregulations (1), (2), (3) and (4) when necessary for the purpose of giving nutrition support or feeding advice to a mother, family member or care giver of an infant or young child that needs to be fed with a designated product -

1. demonstrate feeding of or with a designated product;
2. demonstrate the use of a designated product; or
3. give information including lectures:

Provided that such health workers shall not be employed or paid for (partly or fully) by a manufacturer or distributor.

14. Health workers

(1) Heads of health establishments and national, provincial and local authorities shall take measures to promote, support and protect breastfeeding and to promote these regulations, and shall give information and advice to health workers regarding their responsibilities, in particular ensuring that health workers are familiar with all of the information specified in these regulations.

(2) A health worker shall promote, support and protect breastfeeding.

(3) A health worker shall work to eliminate practices such as prelacteal feeds, that directly or indirectly retard the initiation and continuation of exclusive breastfeeding for six months and sustained breastfeeding for two years and beyond.

(4) A health worker shall submit a written report to the head of his or her workplace, of any offer he or she receives for a sample or gift or other benefit from a manufacturer or distributor or any other contravention of the provisions of the regulations.

15. Lodging of complaints

(1) Any person, group, body or institution may submit a written complaint to the local authority concerned.

(2) Notwithstanding the provisions of subregulation (1), any person, body or institution may submit a written complaint to the Directorate.

16. Repeal

Government Notice No. R. 1130 of 8 June 1984, as amended by Government Notices Nos. R. 2542 of 15 November 1985 and R. 1256 of 15 July 1994, is hereby repealed.

17. Commencement

(1) The provision of Chapter 1 of these regulations shall come into operation 12 months after the promulgation of these regulations; and

(2) The provisions of Chapter 2 of these regulations shall come into operation on the date of promulgation of these regulations.

MINISTER OF HEALTH

ANNEXURE A

Sugars

Corn syrup
Deionised, deflavoured fruit concentrates and juices
Dextrose
Dextrose syrup
Fructose
Fructose syrup
Glucose
Glucose syrup
Invert sugar
Lactose
Maltose
Maltose syrup
Sucrose
Sucrose syrup
Xylose

• Vitamin A
• Vitamin D
• Vitamin E
• Ascorbic acid (Vitamin C)
• Thiamine (Vitamin B1)
• Riboflavin (Vitamin B2)
• Niacin, niacin equivalents’
• Vitamin B6
• Folic acid
• Pantothenic acid
• Folic acid
• Vitamin B12
• Vitamin K1
• Biotin (Vitamin H)

Minerals

• Sodium (Na)
• Potassium (K)
• Chloride (Cl)
• Calcium (Ca)
• Phosphorus (P)
• Magnesium (Mg)
• Iron (Fe)
• Iodine (I)
• Copper (Cu)
• Zinc (Zn)
• Manganese (Mn)
• Selenium (Se)

Choline

ANNEXURE C

Required Nutritional Information

Part A:

Format for mandatory nutritional information where no health claim or nutrition claim is made

Typical nutritional information:

Quantified single serving size expressed in grams or millilitres, whatever is appropriate