New Food Additives Allowed - Cyclamate and Steviolglycoside

An Expert's View about Sugar and Support Services in Thailand

Posted on: 28 Dec 2012

The Thai Food and Drug Administration (FDA) notified the WTO of proposed changes to Thailand’s rules relating to Cyclamate (G/SPS/N/THA/210) and Steviol glycoside (G/SPS/N/THA/211) as food additives.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Voluntary Public - Date: 12/14/2012 GAIN Report Number: TH2138 Thailand Post: Bangkok New Food Additives Allowed - Cyclamate and Steviolglycoside Report Categories: Sanitary/Phytosanitary/Food Safety Approved By: Rey Santella, Agricultural Attaché Prepared By: Sukanya Sirikeratikul, Marketing Specialist Report Highlights: TH2138: On December 3, 2012 the Thai Food and Drug Administration (FDA) notified the WTO of proposed changes to Thailand’s rules relating to Cyclamate (G/SPS/N/THA/210) and Steviol glycoside (G/SPS/N/THA/211) as food additives. U.S. companies exporting these substances and food products containing Cyclamate and Steviol glycoside are encouraged to review the proposed maximum use levels. Under the proposed rules, Cyclamate and Steviol glycoside can be used as food additives (sweeteners or ingredients in processed foods). Thailand’s sweetener imports in 2011 totaled nearly $140 million. Post estimates the market for consumer oriented products containing sweeteners to Thailand could reach $33 million by 2015. General Information: Thailand Proposes to Revise its Rules for Cyclamate and Steviol glycoside as Food Additives. On December 3, 2012 the Thai Food and Drug Administration (FDA) notified the WTO of proposed changes to Thailand’s rules governing the use of Cyclamate and Steviol glycoside as food additives (G/SPS/N/THA/209-211). The decision to revise its standards followed the joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluation, which determined acceptable daily intake (ADI) levels for cyclamic acid, its sodium or calcium salts, and Steviol glycoside. Hence, the Ministry of Public Health issued the following notifications. 1. Ministry of Public Health Notification Regarding Prescribed Prohibited Food to be Produced, Imported or Sold (G/SPS/N/THA/209) The proposal revises and amends Ministry of Public Health Notification (No.292) B.E.2548, which allows cyclamic acid and its sodium or calcium salts and Steviol glycoside as food additives in food products. The regulation will still prohibit the production, import or sale of Stevia, which is known by its scientific name as “Stevia rebaudiana Bertoni.” 2. Ministry of Public Health Notification Regarding Food Additive (No.3): Cyclamate (G/SPS/N/THA/210) This proposal stipulates that the Thai FDA will follow CODEX’s General Standard for Food Additives (GSFA) which establishes quality requirements, standards, and use requirements for cyclamic acid and its sodium or calcium salts in different food types. 3. Ministry of Public Health (No…) B.E…RE: Food Additive (No.4): Steviol glycoside (G/SPS/N/THA/211) This proposal stipulates that the Thai FDA will follow Codex’s General Standard for Food Additives (GSFA) which establishes quality requirements, standards, and use requirements for Steviol glycoside in different food types. Thai FDA’s rules will differ from Codex’s maximum levels in the following categories: - Maximum level is set at 70 mg/kg for products containing milk as a major component (flavored type), either fermented or not (food category code 01.1.2) with the exception of products prohibited under the Ministry of Public Health Notification regarding cow milk and flavored milk; - Maximum level is set at 100 mg/kg for soy milk (food category code 06.8.1); - Maximum level is set at 115 mg/kg for flavored drinks (food category code 14.1.4), except those prohibited under the Ministry of Public Health Notification regarding electrolyte drinks; and - Maximum level is at 1,100 mg/kg for chewing gum (food category code 05.3). The following products are not permitted for use as sweeteners in Thailand: cow milk, flavored milk, jam, jelly and marmalade in sealed container, chocolate and electrolyte drinks. If approved, the new rules will allow for Cyclamate and Steviol glycoside to be used as sweeteners or ingredients in processed foods. Please refer to the various notifications for specific details. Thailand’s sweetener imports in 2011 totaled nearly $140 million. Post estimates the market for consumer oriented products containing sweeteners to Thailand could reach $33 million by 2015. APPENDIX Appendix I: Notification of the Ministry of Public Health (No…) B.E…. Re: Prescribed Prohibited Food to be Produced, Imported, or Sold (Draft) Notification of the Ministry of Public Health (No…) B.E…. RE: Prescribed Prohibited Food to be Produced, Imported, or Sold ----------------------------------- Whereas it is appropriate to revise the Notification of the Ministry of Public Health RE: Prescribed Prohibited Food to be Produced, Imported, or Sold; By virtue of the provisions of Section 5 and Section 6 (8) of the Foods Act B.E.2522 which is an act containing some provisions concerning the limitation of the rights and freedom of a person, which Section 29 combined with Section 33, Section 41, Section 43 and Section 45 of the Constitution of the Kingdom of Thailand prescribes to be permissible by virtue of a legislation, the Minister of Public Health issues a notification as follows: 1. The Notification of the Ministry of Public Health (No. 292) B.E.2548 RE: Prescribed Prohibited Food to be Produced, Imported, or Sold dated 15 November 2005 shall be repealed. 2. The following foods shall be prohibited from being produced, imported or sold: 2.1 Dulcin or also known by its chemical name as para-phenetolcarbamide used as sweetner. 2.2 AF2 or in general name as Furylframide or in chemical name as 2-(2-furyl)-3-(5- nitro-2-furyl) acrylamide if used as food additive 2.3 Potassium bromate if used as food additive 2.4 Food with Dulcin, AF2, Potassium bromated or Cyclamic acid and its salts as food component except Cyclamic acid salt containing Sodium Cyclamate as food component. 2.5 Food with Daminozide or Succinic acid 2,2-dimethylhydrazide 2.6 Stevia or in scientific name as Stevia rebaudiana Bertoni and its products except for production, import or sale of (1) Stevia leaf pursuant to the Notification of the Ministry of Public Health Re: Herbal Tea (2) Steviol glycoside pursuant to the Notification of the Ministry of Public Health Re: Food Additive (No. 4): Steviol glycoside (3) Stevia or its products used for production or such imported or sold for production of Steviol glycoside according to (2) above (4) Stevia or its products produced for export 3. This notification shall come into force as from the day following date of its publication in the Government Gazette. Given on this ………… Appendix II: Notification of the Ministry of Public Health (No…) B.E…. Re: Food Additive (No. 3): Cyclamate (Draft) Notification of the Ministry of Public Health (No…) B.E…. RE: Food Additive (No. 3): Cyclamate ------------------------------------------------------ Whereas it is expedient to allow the use of Cyclamic acid and sodium or calcium salts of Cyclamic acid as food additives where the Joint FAO/WHO Expert Committee on Food Additives or JECFA has assessed and determined Acceptable Daily Intake: ADI; By virtue of the provisions of Section 5 and Section 6(1)(2)(4)(5)(6)(7)(9) and (10) of the Foods Act B.E.2522 which is an act containing some provisions concerning the limitation of the rights and freedom of a person, which Section 29 combined with Section 33, Section 41, Section 43 and Section 45 of the Constitution of the Kingdom of Thailand prescribes to be permissible by virtue of a legislation, the Minister of Public Health issues a notification as follows: 1. The Notification of the Ministry of Public Health No. 113 (B.E.2531) Re: Sodium Cyclamate and Foods containing Sodium Cyclamate dated 7 March 1988 shall be repealed. 2. Cyclamate shall be considered as food additives. 3. Cyclamate shall refer to Cyclamic acid (Cyclohexylsulfamic acid [INS No. 952(i)]) and sodium or calcium salts of Cyclamic acid such as Sodium Cyclamate (Sodium cyclohexylsulfamate or Sodium cyclohexanesulfamate [CAS: 139-05-9, INS No. 952(iv)]) or Calcium Cyclamate (Calcium cyclohexylsulfamate or Calcium cyclohexanesulfamate [CAS: 139-06-0, INS No. 952(ii)]). 4. Production or import for sale of Cyclamate shall be in compliance with the Notification of the Ministry of Public Health (No.281) B.E.2547 RE: Food Additives dated 18 August 2004 except the observance of Clause 4 and Clause 6, this Notification shall be applicable. 5. Sodium Cyclamate shall bear quality or standard as follows: Chemical name: Sodium cyclohexylsulfamate or Sodium cyclohexanesulfamate [CAS: 139-05-9, INS No. 952(iv)] Formula: Sodium Cyclamate: C6H12NNaO3S, molecular weight 201.22 Properties: colorless crystal powder or white crystal Specification: Quantity not less than 98% and not exceeding 101% of dried weight - Sodium; pass the test - Crystallization: test by using 10 ml. of solution 10 parts in 100 added with Hydrochloric acid 1 ml, mix them well and then added with Barium chloride 1 ml to get clear solution and when being added with Sodium nitrite 1 ml, it will become white crystal. - Weigh loss when dried: not exceeding 1.0% (105 degree Celsius, 1 hour) - Purity: Cyclohexylamine not exceeding 10 mg/kg and Dicyclohexylamine not exceeding 1 mg/kg Limit of foreign substance : Lead not exceeding 1 mg/kg Packing and storage: kept in sealed container Quality or standard: referred to JECFA Monograph (2004) or if such quality or standard is amended, as per the latest version 6. Calcium Cyclamate shall bear quality or standard as follows: Chemical name: Calcium cyclohexylsulfamate หรอ Calcium cyclohexanesulfamate [CAS: 139-06-0, INS No. 952(ii)] Formula: Calcium Cyclamate: C12H24CaN2O6S22H2O molecular weight 432.57 Properties: Colorless crystal power or white crystal, approximately 30 times sweet compared with sucrose Specification: Quantity not less than 98% and not exceeding 101% of dried weight - Calcium; pass the test - Crystallization: test by using 10 ml. of solution 10 parts in 100 added with Hydrochloric acid 1 ml, mix them well and then added with Barium chloride 1 ml to get clear solution and when being added with Sodium nitrite 1 ml, it will become white crystal - Weigh loss when dried: not less than 6.0% and not exceeding 9.0% - Purity: Cyclohexylamine not exceeding 10 mg/kg and Dicyclohexylamine not exceeding 1 mg/kg Limit of foreign substance : Lead not exceeding 1 mg/kg Packing and storage: kept in closed container Quality or standard: referred to JECFA Monograph (2004) or if such quality or standard is amended, as per the latest version 7. The use of Cyclamate as sugar substitute shall be subject to the requirements based on food types and its quantity as specified in the schedule attached to this Notification only. 8. This notification shall come into force as from the day following date of its publication in the Government Gazette. Given on this ………… Schedule of Requirements for use of Cyclamate attached to the Notification of the Ministry of Public Health (No…) B.E…RE: Food Additive (No.3): Cyclamate No. Name and Food Food Type Maximum quantity allowed (mg/kg) functions in the category except specific quantity specified food code 1. Cyclamate 01.1.2 Drinks containing milk as major component, 250 calculated in Cyclamic acid (INS Other names: either in fluid or powder form, either fermented or 952) - Cyclamic acid, not but excluding flavored milk INS 952 (i) 01.7 Sweets containing milk as major component 250 calculated in Cyclamic acid - Calcium C yclamate, INS 952 02.4 Sweets containing fat as major component 250 calculated in Cyclamic acid (ii) - 03.0 Ice cream 250 calculated in Cyclamic acid Sodium Cyclamate, INS 04.1.2.4 Fruits processed by canning 1000 calculated in Cyclamic acid 952 (iv) 04.1.2.6 Products with fruits as major component used for 2000 calculated in Cyclamic acid Function: baked product not including those under section - sweetener 04.1.2.5 04.1.2.8 Transformed fruits ready for cooking 250 calculated in Cyclamic acid 04.1.2.9 Sweets containing fruits as major component 250 calculated in Cyclamic acid 04.2.2.6 Vegetables, seaweed, nuts and crushed kernels 250 calculated in Cyclamic acid 05.1.3 Products made of cocoa used for paste or filling 500 calculated in Cyclamic acid of baked product not including chocolate 05.1.4 Cocoa and chocolate not including chocolate 500 calculated in Cyclamic acid 05.1.5 Chocolate-like products 500 calculated in Cyclamic acid 05.2 Candy, nougat and marzipan 500 calculated in Cyclamic acid for candy or small pastille with very sweet flavor or mint-flavored fresh breath pill acceptable up to 2,500 mg/kg 05.3 Chewing gum 3000 calculated in Cyclamic acid 05.4 Products used for decorating sweets 500 calculated in Cyclamic acid 06.5 Sweets containing cereals and starch as major 250 calculated in Cyclamic acid component 07.2 Pastry (sweet, salty, special flavor) and mixes 1600 calculated in Cyclamic acid for products used for special nutrition purpose 10.4 Sweets containing egg as major component 250 calculated in Cyclamic acid 11.4 Sugar and syrup used for topping or decorating 500 calculated in Cyclamic acid purpose used for pancake topping syrup or maple syrup only 11.6 Sweetener Proper amount calculated in Cyclamic acid 12.6.1 Emulsion sauce 500 calculated in Cyclamic acid 12.7 Salad and sandwich spreads 500 calculated in Cyclamic acid 13.3 Medical food 400 calculated in Cyclamic acid 13.4 Foods for weight controlled person 400 calculated in Cyclamic acid 13.5 Foods of special nutrition purpose 400 calculated in Cyclamic acid 13.6 Dietary supplement 1250 calculated in Cyclamic acid 14.1.3.1 Nectar fruit juice 400 calculated in Cyclamic acid 14.1.3.2 Nectar vegetable juice 400 calculated in Cyclamic acid 14.1.3.3 Concentrate nectar fruit juice 400 calculated in Cyclamic acid in condition directly sold to the consumer 14.1.3.4 Concentrate nectar vegetable juice 400 calculated in Cyclamic acid in condition directly sold to the consumer 14.1.4 Flavored drinks not including electrolyte drinks 350 calculated in Cyclamic acid in condition directly sold to the consumer 14.2.7 Flavored alcohol drinks 250 calculated in Cyclamic acid Appendix III: Notification of the Ministry of Public Health (No…) B.E…. Re: Food Additive (No. 4): Steviol glycosides (Draft) Notification of the Ministry of Public Health (No…) B.E…. RE: Food Additive (No. 4): Steviol glycosides ------------------------------------------------------ Whereas it is appropriate to allow the use of Steviol glycosides consisting of Stevioside, Rebaudioside A, Rebaudioside B, Rebaudioside C, Rebaudioside D, Rebaudioside F, Dulcoside A, Rubusoside and Steviolbioside as food additives where the Joint FAO/WHO Expert Committee on Food Additives or JECFA has assessed and determined Acceptable Daily Intake: ADI; By virtue of the provisions of Section 5 and Section 6(1)(2)(4)(5)(6)(7)(9) and (10) of the Foods Act B.E.2522 which is an act containing some provisions concerning the limitation of the rights and freedom of a person, which Section 29 combined with Section 33, Section 41, Section 43 and Section 45 of the Constitution of the Kingdom of Thailand prescribes to be permissible by virtue of a legislation, the Minister of Public Health issues a notification as follows: 1. The Notification of the Ministry of Public Health (No. 262) B.E.2545 RE: Stevioside and Food containing Stevioside dated 26 September 2002 shall be repealed. 2. Steviol glycosides shall be considered as food additives. 3. Steviol glycosides shall refer to pure extracts from Stevia rebaudiana Bertoni consisting of Stevioside, Rebaudioside A, Rebaudioside B, Rebaudioside C, Rebaudioside D, Rebaudioside F, Dulcoside A, Rubusoside and Steviolbioside. 4. Production or import for sale of Steviol glycosides shall be in compliance with the Notification of the Ministry of Public Health (No.281) B.E.2547 RE: Food Additives dated 18 August 2004 except the observance of Clause 4 and Clause 6, this Notification shall be applicable. 5. Steviol glycosides shall bear quality or standard as follows: Chemical name: Stevioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid or β- D-glucopyranosyl ester [CAS : 57817-89-7, INS No. 960] Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β-Dglucopyranosyl-β-D- glucopyranosyl)oxy] kaur-16-en-18-oic acid or β-D-glucopyranosyl ester [CAS: 58543-16-1, INS No. 960] Formula: Stevioside: C38H60O18 molecular weight 804.88 Rebaudioside A: C44H70O23 molecular weight 967.03 Properties: white or pale yellow powder, odorless or unique odor, 200-300 times sweeter than sugar Specification: contain total substances in Steviol glycosides group not less than 95% of dried weight - water soluble - pH 4.5-7.0 of solution 1 part in 100 - non-soluble items: passed the test - purity: Ash not exceeding 1% Weight loss when dried: not exceeding 6.0% Residue solvent not exceeding 200 mg/kg (methanol) or not exceeding 5000 mg/kg (ethanol) Limits for foreign substance: arsenic not exceeding 1 mg/kg and lead not exceeding 1 mg/kg Packing and storage: kept in sealed container Quality or standard: referred to JECFA Monograph (2010) or if such quality or standard is amended, as per the latest version 6. The use of Steviol glycosides as sweetener shall be subject to the requirements based on food types and its quantity as specified in the schedule attached to this Notification only. 7. The food producer or importer permitted under the Notification of the Ministry of Public Health (No.262) B.E. 2545 Re: Stevioside and Foods containing Stevioside dated 26 September 2002 shall properly register food recipe according to this Notification and the Notification of the Ministry of Public Health (No. 281) B.E.2547 RE: Food Additives dated 18 August 2004 within 1 year from the date this Notification has come into force. Foods containing Stevioside used as food for weight controlled person according to the Notification of the Ministry of Public Health No. 121 (B.E.2536) RE: Foods for Weight Controlled Person dated 23 May 1989 shall be revised as to their details to be in compliance with this Notification within 1 year from the date this Notification has come into force. 8. This notification shall come into force as from the day following date of its publication in the Government Gazette. Given on this ………… Schedule of Requirements for the use of Steviol glycosides attached to the Notification of the Ministry of Public Health (No…) B.E…RE: Food Additive (No.4): Steviol glycosides No. Name and Food Food Type Maximum quantity allowed (mg/kg) except functions in category specific quantity specified the food code 1. Steviol 01.1.2 Drinks containing milk as major component, either 70 calculated in Steviol (INS glycosides in fluid or powder form (flavored), either used for flavoring agent only 960) Other name: fermented or not but excluding flavored milk Steviol 01.5.2 Milk-like and cream power-like products 330 calculated in Steviol glycosides used for flavoring agent only Function: 01.7 Sweets containing milk as major component 330 calculated in Steviol - Sweetener 02.4 Sweets containing fat as major component 330 calculated in Steviol 03.0 Ice cream 270 calculated in Steviol 04.1.2.3 Fruits in vinegar, oil, or brine 100 calculated in Steviol 04.1.2.4 Fruits processed by canning 330 calculated in Steviol 04.1.2.6 Products with fruits as major component used for 330 calculated in Steviol baked product not including those under section 04.1.2.5 04.1.2.7 Fruits preserved in syrup 40 calculated in Steviol 04.1.2.8 Transformed fruits ready for cooking 330 calculated in Steviol 04.1.2.9 Sweets containing fruit as major component 350 calculated in Steviol 04.1.2.10 Fermented fruits 115 calculated in Steviol 04.1.2.11 Fillings for pastry made from fruits 330 calculated in Steviol 04.1.2.12 Ready cooked fruits 40 calculated in Steviol 04.2.2.2 Vegetables, seaweed, nuts and kernels in dried 40 calculated in Steviol condition 04.2.2.3 Vegetables, seaweed in vinegar, oil, brine, or soy 330 calculated in Steviol sauce 04.2.2.4 Vegetables, seaweed processed by canning 70 calculated in Steviol 04.2.2.5 Vegetables, seaweed, nuts and kernels crushed or 330 calculated in Steviol used for making pastry 04.2.2.6 Vegetables, seaweed, nuts and crushed kernels 165 calculated in Steviol 04.2.2.7 Fermented vegetables, seaweed 200 calculated in Steviol 04.2.2.8 Cooked or fried vegetables, seaweed 40 calculated in Steviol 05.2 Candy, nougat and marzipan 700 calculated in Steviol 05.3 Chewing gum 1100 calculated in Steviol 06.3 Cereals for breakfast 350 calculated in Steviol 06.5 Sweets containing cereal and starch as major 165 calculated in Steviol component 06.8.1 Soy milk 100 calculated in Steviol 08.3.2 Minced meat cooked by heat 100 calculated in Steviol used for brine for sausage production only 09.3.1 Aquatic animals and their products, fermented in 100 calculated in Steviol vinegar or wine and probably immersed in gelatin used for products of sour and sweet taste only 09.3.2 Aquatic animals and their products, fermented in 165 calculated in Steviol brine 09.3.3 Caviar and caviar substitutes 100 calculated in Steviol 09.4 Aquatic animals and their products treated by 100 calculated in Steviol comprehensive food preservation processes 10.4 Sweets containing egg as major component 330 calculated in Steviol 11.6 Sweetener Appropriate amount Calculated in Steviol 12.2.2 Seasoning 30 calculated in Steviol 12.4 Mustard 130 calculated in Steviol 12.5 Soup 50 calculated in Steviol 12.6.1 Emulsion sauce 350 calculated in Steviol 12.6.2 Non-emulsion sauce 350 calculated in Steviol 12.6.3 Concentrate sauce and gravy 350 calculated in Steviol. Used for baking only. 12.6.4 Clear sauce 350 calculated in Steviol 12.7 Salad and sandwich spreads 115 calculated in Steviol 12.9.2.1 Seasoning products made from soy protein 30 calculated in Steviol digestion under fermentation 12.9.2.2 Seasoning products made from soy protein 165 calculated in Steviol digestion under non-fermentation 12.9.2.3 Seasoning products made from soy protein 165 calculated in Steviol digestion in addition those under 12.9.2.1 and 12.9.2.2 13.3 Medical food 350 calculated in Steviol 13.4 Foods for weight controlled person 270 calculated in Steviol 13.5 Foods of specific nutrition purpose 660 calculated in Steviol This amount applies to products in solid form (e.g. food for weight controlled person to be consumed or partially consumed instead of regular foods) For product in liquid form, allowable up to 600 mg/kg, calculated in Steviol 13.6 Dietary supplements 2500 calculated in Steviol used for chewing dietary supplement only 14.1.3 Nectar vegetable and fruit juice 200 calculated in Steviol 14.1.4 Flavored drinks not including electrolyte drinks 115 calculated in Steviol 14.1.5 Tea, coffee, coffee substitute, herbal tea and hot 200 calculated in Steviol used for ready-to-eat drinks from cereals not including cocoa products and component for preparing ready- to-eat products 14.2.7 Flavored alcohol drinks 200 calculated in Steviol 15.0 Snacks 170 calculated in Steviol End of the report.
Posted: 28 December 2012

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