Food (Flavouring Substances and Flavour Enhancers) Regulations, 2013

I fldgi ( ^I& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2013'02'01 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 01.02.2013 1A w;s úfYI wxl 1795$51 - 2013 fmnrjdß ui 01 jeks isl=rdod - 2013'02'01 No. 1795/51 - FRIDAY, FEBRUARY 01, 2013 EXTRAORDINARY Y%S ,xld m%cd;dka;%sl iudcjd§ ckrcfha .eiÜ m;%h The Gazette of the Democratic Socialist Republic of Sri Lanka (Published by Authority) PART I : SECTION (I) — GENERAL Government Notifications 1A L.D. - B 11/80. FOOD ACT, No. 26 OF 1980 REGULATIONS made by the Minister of Health under Section 32 of the Food Act, No. 26 of 1980 in consultaion with the Food Advisory Committee. MAITHTHRIPALA SIRISENA, Minister of Health. Colombo, 17th January 2013. Regulations 1. These regulations may be cited as the Food (Flavouring Substances and Flavour Enhancers) Regulations 2013 and shall come into force from 01st July 2014. 2. (1) No person shall import, manufacture, store, transport, sell or offer for sale, distribute, use or advertise any flavouring substance or flavour enhancer for use in food unless such flavouring substance or flavour enhancer has been certified to be safe and suitable for use in food by the relevant authority in the country of origin or manufacture. (2) No person shall import, manufacture, store, transport, sell or offer for sale, distribute, use or advertise as an ingredient for the preparation of food any permitted flavouring substance or flavour enhancer (including any permitted flavouring substance or flavour enhancer mixed with any other substance) unless such flavouring substance or flavour enhancer was dispensed in a container bearing a label in accordance with the requirements contained in regulation 9. 3. No person shall use any flavouring preparation containing any flavouring substance specified in Schedule I to these regulations in any article of food. 4. No person shall import, manufacture, store, transport, sell or offer for sale, distribute, use or advertise any flavouring substance which is contained in a solvent other than a solvent specified in Schedule II hereto. 5. The solvents permitted to be used in flavouring substances as referred to in Schedule II hereto other than water, shall conform to the British or United States Pharmacopoeia Standards. 3 – PG 001548 This Gazette Extraordinary can be downloaded from www. documents.gov.lk I fldgi ( ^I& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2013'02'01 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 01.02.2013 2A 6. The following may be used as flavour enhancers in food : (a) Monosodium glutamate - INS 621 (b) Disodium 5’ – guanylate - INS 627 (c) Disodium 5’ – inosinate - INS 631 7. Flavour enhancers – (i) may be added to foods subject to observance of Good Manufacturing Practices (GMP) and where the label carries clearly a declaration as to the particular substance or substances used ; (ii) shall not be added to any food for infants or young children below three years of age; and (iii) shall not be used in the foods specified in Schedule III hereto. 8. (1) Labelling of an article of food containing either a flavouring substance or a flavour enhancer shall be in compliance with the provisions of the Food (Labelling and Advertising) Regulations - 2005 published in Gazette Extraordinary No. 1376/9 of January 19, 2005 as may be amended or replaced subsequently. (2) The label printed on or attached to the package of food containing – (a) a natural flavouring substance as an ingredient, shall include the words ‘‘natural (X) flavour’’. Here (X) shall be the description of the flavour (e.g natural mango flavour, natural chicken flavour); (b) a nature - identical flavouring substance as an ingredient, shall include the words ‘‘nature - identical (X) flavour’’. Here (X) shall be the description of the flavour; (c) an artificial flavouring substance as an ingredient, shall include the words ‘‘artificial (X) flavour’’. Here (X) shall be the description of the flavour ; and (d) any flavour enhancer or enhancers as an ingredient, shall include the words ‘‘flavour enhancer used’’ or ‘‘flavour enhancers used’’ as the case may be, along with the common name or names and the INS number or numbers, as the case may be. (3) The label printed on or attached to the package of food shall not describe any nature - identical flavours in conjunction with any food as ‘‘natural flavours’’. (4) No declaration shall be made on the label printed on or attached to the package of food, of the absence of any single flavour enhancer when the food contains any other flavour enhancer or enhancers. 9. (1) Labelling of a container of a flavouring substance or flavour enhancer shall be in compliance with the provisions of the Food (Labelling and Advertising) Regulations - 2005 published in Gazette Extraordinary No. 1376/9 of January 19, 2005 as may be amended or replaced subsequently. (2) The label printed on or attached to a container – (a) of a natural flavouring substance shall include the words ‘‘natural (here insert description of flavour) flavouring ’’ ; (b) of a nature-identical flavouring substance shall include the words ‘‘nature - identical (here insert description of flavour) flavouring ’’; (c) of an artificial flavouring substance shall include the words ‘‘artificial (here insert description of flavour) flavouring ’’; (d) of a flavouring substance shall not describe any nature - identical flavours as ‘‘natural flavours’’; (e) of any flavouring substance specified in sub-paragraph (a), (b) or (c) of this paragraph shall also state the common name and the INS number, if any, of each other substance present in such flavouring substance, as the case may be ; and I fldgi ( ^I& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2013'02'01 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 01.02.2013 3A (f) of a flavouring substance shall include a statement as ‘‘for food’’ or ‘‘restricted use in food’’ or a more specific reference to its intended food use, as the case may be. 10. In these regulations – ‘‘artificial flavouring substance’’ means a flavouring substance not identified in a natural aromatic raw material or natural flavour concentrate and one that is not prohibited under these regulations and accepted as safe to be used in food, as indicated by one or more of the following and may contain natural flavouring substances or nature-identical flavouring substances :– (a) permitted for use as a flavouring substance by the United States Food and Drug Administration (FDA) as listed in the Code of Federal Register ; (b) ‘generally recognized as safe’ (GRAS) as determined by the independent experts of the Flavour and Extract Manufacturers Association (FEMA); (c) as per the latest list of flavourings accepted by Codex, evaluated by JEFCA (Joint FAO/WHO Expert Committee on Food Additives) to present no safety problems when used as a flavouring substance in food. ‘‘condiment powder or curry powder’’ means the powder obtained by grinding two or more of dry, clean, sound spices such as black pepper, cinnamon, cloves, coriander, cummin seeds, fenugreek, garlic, ginger, mustard, turmeric, nutmeg, curry leaves etc. ‘‘culinary herbs’’ means the fresh or dried leaves of herbaceous plants that are used as a food flavouring (eg. coriander leaves, karapincha, rampe). ‘‘foods for infants or young children below three years of age ’’ means foods that are specifically prepared, manufactured or marketed for infants or young children below three years of age. ‘‘flavour enhancer’’ means any substance when added to food is capable of enhancing or improving the flavour of that food. ‘‘natural aromatic raw material’’ means a substance of vegetable or animal origin, either in its natural form or after processing by physical methods other than heat treatments, possessing flavouring properties. ‘‘natural flavouring concentrate’’ means a concentrated preparation obtained by physical, microbiological or enzymatic process from materials of vegetable or animal origin either in its raw state or after processing by traditional food preparation processes, including drying, roasting and fermentation. ‘‘natural flavouring substance’’ means a single chemical unit obtained by physical, microbiolgical or enzymatic processes from materials of vegetable or animal origin either in its raw state or after processing by traditional food preparation processes including drying, roasting and fermentation and one that is not prohibited under these regulations and accepted as safe to be used in food, as indicated by one or more of the following and may contain natural flavouring concentrate and natural aromatic raw materials, but shall not contain any nature-identical flavouring substance or artificial flavouring substance :– (a) permitted for use as a flavouring substance by the United States Food and Drug Administration (FDA) as listed in the Code of Federal Register ; (b) ‘generally recognized as safe’ (GRAS) as determined by the independent experts of the Flavour and Extract Manufacturers Association (FEMA) ; (c) as per the latest list of flavourings accepted by Codex, evaluated by JEFCA (Joint FAO/WHO Expert Committee on Food Additives) to present no safety problems when used as a flavouring substance in food. I fldgi ( ^I& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2013'02'01 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 01.02.2013 4A ‘‘nature-identical flavouring substance’’ means any flavouring substance chemically isolated from aromatic raw materials or obtained synthetically, and are chemically identical to substances present in natural products meant for human consumption either processed or not and one that is not prohibited under these regulations and accepted as safe to be used in food, as indicated by one or more of the following and may contain natural flavouring substances natural flavouring concentrate and natural aromatic raw materiasls, but shall not contain any artificial flavouring substance :– (a) permitted for use as a flavouring substance by the United States Food and Drug Administration (FDA) as listed in the Code of Federal Register ; (b) ‘generally recognized as safe’ (GRAS) as determined by the independent experts of the Flavour and Extract Manufacturers Association (FEMA) ; (c) as per the latest list of flavourings accepted by Codex, evaluated by JEFCA (Joint FAO/WHO Expert Committee on Food Additives) to present no safety problems when used as a flavouring substance in food. Regulation 3 SCHEDULE - I Flavouring substances prohibited to be used in food (1) Aloin (2) Berberine (3) Beta-Azarone and cinnamyl anthracillate (4) Cade oil (5) Calamus oil (6) Cocaine (7) Coumarin (8) Diethylene glycol (9) Diethylene glycol monoethyl ether (10) Estragole (11) Eugenyl methyl ether (12) Hypericine (13) Nitrobenzene (14) Pyroligenous acid (15) Saffrole and Isosaffrole (16) Santonin (17) Sasafras oil (18) Thujone, Isothujone, ( & β thujone) (19) Tonka bean (Dipteryl adorat) (20) Any other flavouring substance that is injurious or likely to be injurious to health. 8 I fldgi ( ^I& fPoh - YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha w;s úfYI .eiÜ m;%h - 2013'02'01 PART I : SEC. (I) - GAZETTE EXTRAORDINARY OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA - 01.02.2013 5A Regulation 4 and 5 SCHEDULE II Permitted Solvents The following solvents are permitted to be used in flavouring substances : 1. Diacetin (glycerine diacetate, glyceryl diacetate, glycerol diacetate) 2. Diethyl ether 3. Ethyl acetate 4. Ethyl alcohol 5. Glycerol 6. Isopropyl alcohol 7. Propylene glycol 8. Triacetin (glycerine triacetate, glyceryl triacetate, glycerol triacetate) 9. Water Regulation 7 (iii) SCHEDULE III Foods in which flavour enhancers are prohibited 1. Milk and Milk Products 2. Ice cream and frozen desserts 3. Fats and oils 4. Margarine and Fat Spreads 5. Fresh, surface treated, peeled or cut fruits and vegetables 6. Mushrooms and their products 7. Fruit wines 8. All fruit and vegetable products except fruit powders, vegetable powders, instant fruit and vegetable chutney mix (dry) 9. Vinegar 10. Food grains, pulses, oil seeds and ground/powdered food grains 11. Whole, broken or flaked grains, including rice 12. Edible flours and starches 13. Sago 14. Pastas and noodles (only dried products) 15. Malt based foods and milk based foods 16. Bakery Products 17. Fresh meat, poultry and game, whole pieces or cuts or comminuted 18. Fresh fish and molluscs, crustaceans and echinoderms 19. White sugar, brown sugar and sucrose, fructose, glucose (dextrose), xylose, sugar solutions and syrups, also (partially) inverted sugars, jaggery, treacle, sugar toppings, other sugars and syrups, bee honey 20. Sugar confectionery 21. Ice - candies 22. Culinary herbs, spices, condiment powder and curry powder except special curry mixtures and flavouring mixtures in sachets 23. Black tea, green tea, coffee, herbal extracts and cereal beverages 24. Baking powder 25. Cocoa butter and Cocoa products 02–585 PRINTED AT THE DEPARTMENT OF GOVERNMENT PRINTING, SRI LANKA.