Food, Drugs and Chemical Substances (Food Labelling, Additives and Standards) (Amendment) Regulations, 2012 (L.N. No. 62 of 2012)

Legal Notice No. 62 THE FOOD, DRUGS AND CHEMICAL SUBSTANCES ACT Cap. 254) IN EXERCISE of the powers conferred by section 28 of the Food, Drugs and Chemical Substances Act, the Minister for Public Health and Sanitation makes the following Regulations:— THE FOOD, DRUGS AND CHEMICAL SUBSTANCES (FOOD LABELLING, ADDITIVES AND STANDARDS) (AMENDMENT) REGULATIONS, 2012. Citation 1. These Regulations may be cited as the Food, Drugs and Chemical Substances (Food Labelling, Additives and Standards) (Amendment) Regulations, 2012. Sub. Leg. 2. The Food, Drugs and Chemical Substances (Food Labelling, Additives and Standards) Regulations (in these Regulations referred to as “the principal Regulations”) are amended in regulation 2 by inserting the following new definitions in their proper alphabetical sequence— “food bio-fortification” means addition of nutrients through a process of genetic manipulation to mitigate the dietary deficiency in a food article; “food enrichment” means addition of nutrients to replace nutrients lost during processing or addition of nutrients to enhance existing nutrients in a food article; “food fortification” means addition of nutrients to bridge the dietary deficiency in a food article; “Minister” means the Minister for the time being responsible for matters related to public health and sanitation. 3. Regulation 249 of the principal Regulations is amended by renumbering the existing provision as paragraph (1) and inserting the following new paragraph— (2) Packaged wheat flour shall be fortified and conform to the food requirements specified herebelow: Nutrient Fortification Compound Recommended factory average (mg/kg) Regulatory requirements (mg/kg) Vitamin A Vitamin A plam.SD 2 ± 1 0.5 3.0 Thiamine (Vitamin B1) Thiamin Mononitrate 10± 5 5.0 15 Riboflavin (Vitamin B2) Riboflavin 6± 3 2.5 9 Niacin (VitaminB3 ) Niacinamide 60±15 40 75 Folates Folic acid 1.5±1.0 0.5 2.5 Pyrodoxine (Vitamin B6) Pyrodoxine 6.5±3.5 3.0 10 Cabalamine (Vitamin B12) Vitamin B120.1% WS 0.015±0.005 0.005 0.025 Iron NaFe EDTA 40±10 30 50 Total iron 50±10 40 60 Zinc oxide 40±10 30 50 4. Regulation 253 of the principal Regulations is amended— (a) by deleting the expression “15” appearing in paragraph (1) and substituting therefor the expression “13.5”. (b) by inserting the following new paragraph immediately after paragraph (2)— (3) Packaged dry milled maize products shall be fortified and conform to the requirements specified herebelow— Nutrient Fortification Compound Recommended factory average (mg/kg) Regulatory requirements (mg/kg) Vitamin A Vitamin A plam.SD 0.5 ± 0.02 0.2 1.0 Thiamine (Vitamin B1) Thiamin Mononitrate 4.0± 2.0 1.5 6.0 Riboflavin (Vitamin B2) Riboflavin 3.5± 2.0 1.5 5 Niacin (VitaminB3 ) Niacinamide 25±5 15 30 Folates Folic acid 1.5±1.0 0.5 2.5 Pyrodoxine (Vitamin B6) Pyrodoxine 5.0±2.5 2.0 7.5 Cabalamine (Vitamin B12) Vitamin B120.1% WS 0.005±0.002 0.002 0.010 Iron NaFe EDTA 10±5 5 15 Total iron 20±5 15 30 Zinc Zinc oxide 30±10 20 40 (4) The Minister may, from time to time, amend paragraph (3). 5. Regulation 258 of the principal Regulations is amended— (a) by re numbering the existing provision as paragraph (1) and (b) by inserting the following new paragraph— (2) vegetable fats and oils shall be fortified with Vitamin A in accordance with the Kenya Standard for Edible Fats and oils KS326-2:2009. 6. The principal Regulations are amended by inserting the following new Regulations immediately after Regulation 318— 319. Where no specifications are set out in any part of these regulations for the fortification of any food articles, but specifications have been established by the joint Food and Agricultural Organisation and World Health Organization Codex Alimentarius Commission the Specifications of the Codex Alimentarius Commision shall apply. 320. Labeling of fortified products shall be done in accordance with the relevant Kenyan Standard relating to nutrition. Dated the 4th June, 2012. BETH MUGO, Minister for Public Health and Sanitation.