DEPARTMENT OF HEALTH

18 October 2002

FOODSTUFFS, COSMETICS AND DISINFECTANTS ACT, 1972

(ACT No. 54 OF 1972)

REGULATIONS RELATING TO THE FORTIFICATION OF FOODSTUFFS

The Minister for Health intends, in terms of Section 15 (1) 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 comments on the proposed regulations, or any representations they wish to make, to the Director-General: Health, Private Bag X828, Pretoria, 0001 (for the attention of the Director: Nutrition), within three months from the date of publication of this notice.

SCHEDULE

1. DEFINITIONS

In these regulations "the Act" means the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972), and any expression to which a meaning has been assigned in the Act shall bear such meaning and, unless inconsistent with the context -

"authorised health authority" means a local authority or a port official responsible for health matters;

"cereal food vehicle" means the cereal foodstuff that is to be fortified with the prescribed micronutrients as described in these regulations;

"Department" means the national Department of Health;

"electrolytic iron" means elemental iron powder as per specification in the latest edition of Food Chemical Codex;

"enrichment" means the addition of one or more nutrient(s) to a food whether or not it is normally contained in the food with the sole purpose of adding nutritional value to the food;

"food additive" means any substance-

1. which is added to a foodstuff for technological, including organoleptic purposes in the manufacturing, processing, preparation, treatment, packing, packaging, transportation or storage of such foodstuff;
2. the addition of which to a foodstuff results or may reasonably be expected to result in such substance or the by-products thereof becoming a component of or otherwise affecting the characteristics of such foodstuff; and
3. which is not added to foodstuffs for maintaining or improving nutritional qualities or any contaminants;

"food vehicle" means the foodstuff identified to be fortified with the prescribed micronutrients as described in these regulations;

"fortificant" means the micronutrient or micronutrient mix the foodstuff is fortified with;

"fortification" means the addition of one or more nutrient(s) to a food whether or not it is normally contained in the food for the purpose of preventing or correcting a demonstrated deficiency in one or more nutrients in the population or specific population group(s) by the relevant authority;

"main panel" means that part of the label that bears the brand or trade name of the product in greatest prominence or any other part of the label that bears the brand or trade name in equal prominence;

"maize meal" means milled maize products and includes super, special, sifted and unsifted maize meal, but excludes samp, grits and rice;

"maize foodstuffs" mean those maize products that are used to produce maize pap;

"micronutrient" means a natural or synthesised vitamin, mineral, or trace element that is essential for normal growth, development and maintenance of life and of which a deficit will cause characteristic biochemical or physiological changes;

"micronutrient mix" means a blend of vitamins, mineral or trace elements in determinable amounts;

"quality control" means the measures applied and the steps taken by a manufacturer of wheat and maize meal foodstuffs to ensure that the correct procedures are being followed and the set criteria is being met in administering fortificants to food vehicles;

"wheat flour " means all wheat flour with an ash content of more than 0.64% on a moisture free basis;

"wheat foodstuffs" mean wheat products made from wheat flour and meal and that are used to produce bread and similar products.

General provisions

1. Any person who manufactures or imports foodstuffs for sale identified to be food vehicles for mandatory food fortification programmes in South Africa, which have not been fortified in accordance with these regulations, shall be guilty of an offence.
2. Manufacturers and importers of food vehicles may only obtain the micronutrient mix from companies which have registered with the Department of Health.
3. Manufacturers and importers of food vehicles shall keep on record a certificate of micronutrient mix compliance for every batch of micronutrient mix used in the production of every batch of the food vehicles.
4. Any person who manufactures or imports a micronutrient mix for the purpose of these regulations without being registered with the Department of Health shall be guilty of an offence.
5. Manufacturers or importers of micronutrient mixes shall apply to the Director-General for registration of their micronutrient mix specifications including their recommended addition rate by submitting the information specified in Annexure IV.
6. The registration referred to in subsection (1) is valid for one year and such registration may be renewed.
7. The Director–General may require the manufacturers or importers of micronutrient mixes to demonstrate the analytical results for each lot produced when an application is made in terms of regulation 6.
8. Manufacturers and importers of fortificants shall issue a certificate of micronutrient mix compliance as indicated in Annexure II for each batch of premix as analysed by a laboratory accredited with the South African National Accreditation Services (SANAS), qualifying and quantifying the composition of the premix.
9. For the purpose of these regulations, only the results of those laboratories which have accreditation with SANAS for the nutrient and its method as indicated in Annexure I, shall be acceptable.

   Special provisions

   Fortification standards

10. (a)The final, minimum levels of fortificants in the fortified foodstuff shall be not less than the levels shown in Columns III, IV and V of the table below:

    TABLE I: FORTIFIED FOOD VEHICLE STANDARDS

    Fortificant	Unit	Wheat foodstuffs	Maize foodstuffs	Unsifted maize meal
    Vitamin A	IU/kg	5400.00	6400.00	6400.00
    Thiamin	Mg/kg	3.60	3.85	3.85
    Riboflavin	Mg/kg	2.00	1.85	1.85
    Niacin	Mg/kg	31.00	28.50	28.50
    Folic acid	Mg/kg	1.50	1.50	1.50
    Pyridoxine	Mg/kg	3.20	3.20	3.20
    Iron	Mg/kg	43.00	37.00	14.00
    Zinc	Mg/kg	20.00	18.50	18.50

    (b)The following micronutrient mix composition shall be used:

TABLE II: FORTIFICATION MICRONUTRIENT MIX SPECIFICATION

Fortificants	Wheaten flour (g/kg)	Maize meal (g/kg)	Unsifted Maize meal (g/kg)
Vitamin A Palmitate, 250 000 IU/g	119.04 g	138.88 g	138.88 g
< SIZE=1> Thiamin Mononitrate	12.34 g	13.93 g	13.93 g
Riboflavin	8.90 g	8.50 g	8.50 g
Nicotinamide	118.40 g	125.00 g	125.00 g
Folic acid	7.15 g	7.15 g	7.15 g
Pyridoxine HCL	16.24 g	19.32 g	19.32 g
Electrolytic iron	178.57 g	178.57 g	89.28 g
Zinc oxide (min. 80% activity)	93.40 g	93.40 g	93.40 g
Calcium carbonate (min. 40% activity), As carrier	To complete 1000 g	To complete 1000 g	To complete 1000 g

The dosage of 200g of micronutrient mix per ton of wheat or maize foodstuffs is necessary to cover the minimum fortification levels.

(c)The quality standard for fortificants, independently or mixed with a diluent shall be the Food Grade Standard in accordance with the standards as determined in the latest edition of Food Chemicals Codex (FCC).

(d)The fortification standards referred to in paragraph (c) shall be the minimum levels in the dry wheat flour, dry maize meal when analysed at the point of manufacturing or importation and include the micronutrient levels naturally present;

Labelling

11. In addition to the Regulations Governing the Advertising and Labelling of Foodstuffs made under the Act, all food vehicles shall be labelled as follows:
    1. The claim "enrich with" or "enriched" may only be used in addition to the word "fortified" on one label in cases where a nutrient other than the fortificants is added to a food vehicle;
    2. The claim "Fortified for better health" and the logo to that effect are reserved for food vehicles which have been identified in the mandatory food fortification programme by the Director-General and may be displayed on the label or in advertising material;
    3. The words "Manufactured with fortified wheat flour for better health" and a logo to that effect may be displayed, in the case of non-prepacked bread and similar products, at the point of sale on a notice displayed in the direct vicinity of where the bread is displayed, on the shelf and within clear sight of the consumer;
    4. The micronutrient mix shall be indicated in the list of ingredients either as "fortificant mix" or listed individually by the name of the vitamin or mineral compound;
    5. The nutritional information shall be printed by the manufacturer in the following format on the back or side panel of food vehicles in letters at least 1 mm in height for small/lower-case letters:

* South African Prudent Dietary Goals
** RDA = Recommended Dietary Allowance for persons 10 years and older

Repeal

12. The Regulations on the Enrichment of Maize Meal, promulgated under Government notice No. R 2839 of 21 December 1979 are hereby repealed.

Commencement

13. These regulations shall come into operation 6 months after the date of final publication.

ME TSHABALALA-MSIMANG
MINISTER OF HEALTH

ANNEXURE I

METHODS OF ANALYSIS FOR FORTIFICANTS

TABLE III: TEST METHODS FOR FORTIFICANTS IN MICRONUTRIENT MIXES

ANNEXURE I (continues)

TABLE IV: TEST METHODS FOR FORTIFICANTS IN MAIZE MEALS

ANNEXURE I (continues)

TABLE V TEST METHODS FOR FORTIFICANTS IN WHEAT FLOURS

These methods shall be agreed to by the micronutrient mix seller and buyer before it is sold and shall be recorded. These methods shall be used for monitoring and law enforcement purposes.

ANNEXURE II

QUALITY CONTROL PRINCIPLES

1. Manufacturers of wheat flours and maize meals

   Manufacturers of wheat flours and maize meals shall:

   1. keep monthly records of the amount of micronutrient mix used every month. These records shall correspond with the monthly production records;
   2. ensure that micronutrient mixes are stored under the conditions laid down by the manufacturer;
   3. ensure that strict stock rotation procedures are adhered to in order to prevent old stock losing potency and to comply with the shelf life expiry date;
   4. ensure that all critical stages of the manufacturing process are monitored to ensure that the correct dosage levels are maintained through the following measures:
      1. Checking of micronutrient mix feeders at least once a day to ensure that they are delivering the correct dosage levels;
      2. Performing visual checks at least twice per shift to ensure that micronutrient mix is being used and that no blockages have occurred and keeping record of this;
      3. Performing two-hourly spot checks to ensure that the product has been dosed correctly by determining one of the components of the micronutrient mix according to the appropriate analytical method.
2. Manufacturers or suppliers of the micronutrient mixes

   Manufacturers or suppliers of the micronutrient mixes shall:

   1. keep monthly records of the quantities of micronutrient mixes sold to wheat flour and maize meal manufacturers as well as a list of the names and addresses of the aforesaid purchasers;
   2. ensure that the qualitative and quantitative testing for each fortificant in every batch of micronutrient mix are done according to the methods described in Annexure II;
   3. ensure that each batch of micronutrient mix for the various vehicles comply with the fortification standards described in table II of regulation 10(b);
   4. submit one 500 g sample micronutrient mix every six months for each food vehicle to a laboratory that has accreditation for the prescribed methods of analysis from the South African National Accreditation Services (SANAS), keep it on record and submit a copy of the report to the Director-General; and
   5. bear the costs of the analysis mentioned in paragraph 2.4.

ANNEXURE III

CERTIFICATE OF MICRONUTRIENT MIX COMPLIANCE

(This certificate is not transferable from one lot to another)

1. Company Name:
2. Company address (Postal):
3. Company street address:
4. Company Tel. No.
5. Company Fax No.
6. E-mail address:
7. DECLARATION:

It is hereby certified that (lot number/batch) _________ micronutrient mix, complies qualitatively and quantitatively with the following composition/specification:

MICRONUTRIENT MIX SPECIFICATION FOR FORTIFICATION PURPOSES

ANNEXURE III (continued)

Analysis Result for this batch:

Micronutrient mix for ____ (wheat flour/ maize meal/ unsifted maize meal)

ANNEXURE IV

REGISTRATION FORM FOR MICRONUTRIENT MIX MANUFACTURERS/IMPORTERS/SUPPLIERS

1. Company Name:
2. Company address (Postal):
3. Company street address:
4. Company Tel. No.
5. Company Fax No.
6. E-mail address:
7. Names of: (Print please)
   1. Managing Director:
   2. QA Manager:
   3. Production Manager:
8. Activities/facilities:
   Are you:

   	Yes	No
   A co-packer?
   A manufacturer?
   A packer?
   A distributor?
   An importer?

9. Do you have a Quality Control Laboratory?
10. Of those ingredients used in the manufacturing of micronutrient mixes, indicate which ingredients are:

    Self manufactured by your company in South Africa:

    ___________________________________________________

    Imported from the mother company elsewhere in the world:

    ___________________________________________________

    Acquired from outside the borders of South Africa:

    ___________________________________________________

    Acquired in South Africa:

    ___________________________________________________

    How long has the company been in the business of manufacturing/selling micronutrient mixes?

    ___________________(number) years

11. Has the Company been inspected by the Inspectorate Medicines Administration?Yes/No
12. If, yes mention the date of the last inspection: