Regulations relating to trans-fat in foodstuffs (No. R. 127 of 2011)

No. R. 127 STAATSKOERANT, 17 FEBRUARIE 2011 GOVERNMENT NOTICES GOEWERMENTSKENNISGEWINGS DEPARTMENT OF HEALTH DEPARTEMENT VAN GESONHEID FOODSTUFFS, COSMETICS AND DISINFECTANTS ACT, 1972 (ACT NO. 54 OF 1972) REGULATIONS RELATING TO TRANS-FAT IN FOODSTUFFS No.34029 3 17 February 2011 The Minister of Health has, in terms of section 15 (1) of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972) made the regulations in the Schedule. SCHEDULE 1. Definitions In these regulations "conjugated linoleic acid (CLA)'' means bacterial metabolites mainly found in products from ruminant animals, e.g. dairy products and beef, that comprise a family of geometric and positional isomers of linoleic acid with two conjugated double bonds, of which there are two major forms, namely cis9, trans11-CLA (c9,t11-CLA) and trans10, cis12-CLA, (t10,c12 CLA); "industrially produced trans-fatty acids" means all the geometrical isomers of monounsaturated fatty acids with one trans double bond, i.e. C14:1, C16:1, C18:1, C20:1, C22:1, and polyunsaturated fatty acids with one or more trans double bonds, i.e. C18:2, C18:3, C20:2, C22:2 having non-conjugated, interrupted by at least one methylene group, carbon-carbon double bonds in the trans configuration and excludes natural trans-fatty acids; 4 No.34029 GOVERNMENT GAZETTE, 17 FEBRUARY 2011 "natural trans-fatty acids" means an unsaturated fatty acid with one or more isolated or non-conjugated double bonds, interrupted by at least one methylene group, in a trans configuration consisting mainly of vaccenic acid (VA) [18:1(n-7)] or conjugated linoleic acid (CLA); "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; "Trans-Fat" has a corresponding meaning as "industrially produced trans-fatty acids"; "vaccenic acid (VA)" means 18:1 trans-11 [18:1(n-7)] and is a geometric and positional isomer of oleic acid with a single double bond and is the precursor of conjugated linoleic acid (CLA). 2. Maximum Trans-Fat content of foodstuffs (1) In line with section 2(1 )(a)(iv) of the Act, the sale, manufacturing and importation of any oils and fats, including emulsions with fat as the continuous phase, either alone or as part of processed foods, which are intended for human consumption or assumed to be intended for human consumption, in the retail trade, catering businesses, restaurants, institutions, bakeries etcetera, of which the content of Trans-Fat exceeds 2 grams per 100 grams of oil or fat, is prohibited. (2) Subject to sub-regulation 2(1) and regulation 4, in cases where Trans-Fat in the end product may be deriving from both partially hydrogenated fat or oil in an ingredient or additive, as well as from ingredients from ruminant animal origin, the Trans-Fat content per individual ingredient at the mixing bowl stage (a) shall be kept on record for the purpose of compliance with these Regulations; and (b) subject to regulation 3, where the claim "Trans-Fat free" is made, the Trans Fat content which shall be declared in the table with nutritional information on the label shall, be the sum of analytical values per individual ingoing ingredient, excluding natural trans-fatty acids. STAATSKOERANT, 17 FEBRUARIE 2011 No.34029 5 3. Trans-Fat free claim Where a claim that a foodstuff is "Trans-Fat free" is made on the !abel or in an advertisement, the content of Trans-Fat shall be less than 1 gram per 1 00 grams of the total fat or oil in the final product. 4. Methodology The methodology to analyse for Trans-Fat content as referred to in Annexure 1 shall be used. 5. Commencement These regulations shall come into operation six (6) months after the date of final publication. A TSOALEDI, MP MINISTI:iR OF HEALTH DATE: 6/2/2011 6 No.34029 GOVERNMENT GAZETTE, 17 FEBRUARY 2011 ANNEXURE 1 METHODOLOGY FOR THE DETERMINATION OF TRANS-FATTY ACIDS IN FOODSTUFFS 1. The preferred method for analyzing the content of trans fatty acids in foodstuffs, other than those from ruminant animals, shall be the latest updated version of AOAC 996.06 or AOCS Ce 1 h-05; or a combination thereof. 2. The preferred GC column shall be at least 100 m in length with a highly polar stationary phase containing at least 70 - 1 00% cyanopropyl silicone. Column performance must match the cis/trans fatty acid methyl esters (FAME} separation criteria specified in AOCS Method Ce 1 h-05. Current recommended columns that meet the above requirements are the CP-Sil 88 (part no. CP7489, Varian, Walnut Creek, CA, USA}, HP-88 (part no. 112 88A7, Agilent/J&W, USA}, SP-2560 (part no. 24056, Sigma-Aidrich/Supelco Inc., Bellefonte, PA, USA}, BPX-70 (part no. 054624, SGE, SGE Inc., Austin Texas, USA). 3. An internal standard shall be used for quantification eg: C11 :0, C13:0, C17:0, C21 :0. 4. The molecular weights of free fatty acids, FAME and tricylglycerols required for calculating the theoretical flame ionization detector correction factor (TCF} relative to a specific internal standard are listed in Table 3 of the following reference: De Vries JW, Kjos L, Groff L, Martin B, Cernohous K, Patel H, Payne M, Leichtweis H, Shay M and Newcomer L. 1999. Studies in improvement of official method 996.06. Journal of AOAC International, 82(5}: 1146-1155. 5. To avoid chromatographic artefacts, it is recommended to adhere to the shelf-life of the specific transesterification reagent used, i.e. hydrogen chloride in methanol, sulphuric acid in methanol or boron trifluoride in methanol (BF3-Me0H). Refer to: Christie WW. 1989. The preparation of derivatives of fatty acids. In: Gas chromatography and lipids. The Oily Press, Bridgwater, UK, pp 64-84; and; Ratnayake WMN and Cruz-Hernandez C. Analysis of trans fatty acids of partially hydrogenated vegetable oils and dairy products. 2009. In: Trans Fatty Acids in Human Nutrition. 2nd Edition. Eds. Destaillats F, Sebedio J-L, Dionisi F, Chardigny J-M. The Oily Press, Bridgewater, UK, pp 1 05-146. 4