(Copy) Notification of Food and Drug Administration Re : Prescription of quality or standards of single food additives

Transcription

1 (Copy) Notification of Food and Drug Administration Re : Prescription of quality or standards of single food additives By the virtue of provision clause 4(2) of the Notification of the Ministry of Public Health (No.281) B.E (2004) Re : Food Additives dated 18 August B.E.2547 which issued by the virtue of provisions of Section 5 and 6 (1)(2)(4)(5)(6)(7)(9) and (10) of the Food Act B.E.2522 (1979), in which contain provisions in relation to the restriction of Rights and Liberties of the Persons, in respect of which Section 29 and in conjunction with Section 35, Section 39, Section 48 and Section 50 of the Constitution of the Kingdom of Thailand so permit by the virtue of provisions of law : the Food and Drug Administration according to an approval of the Food Committee in the Meeting 2/2548 on the 13 th May B.E.2548(2005) issues the Notification as follows : Clause 1 Single Food Additives mean food addtives which the Food and Drug Administration permits to use by an approval of the Food Commiittee. Clause 2 Food additives in Clause 1 shall have quality or standards as follows: (1) Succinic acid Chemical name : Succinic Acid or Butanedioic Acid [INS: 363, CAS : ] Formula : C 4 H 6 O 4 Molecular weigth Characteristic : white powder or crystal or no colour, soluble in water alcohol and glycerine Specification : C 4 H 6 O 4 content between 99.0 to 100.5% - Residue on ignition not more than 0.025% - Melting point between o C - Lead not more 2 mg/kg Packaging and storage : Keep in tightly sealed container

2 Quality or Standards : refer to Food Chemical Codex Monograph Fifth (2) Glycine Chemical name : Glycine or Aminoacetic Acid or Glycocoll [INS: 640, CAS : ] Formula : C 2 H 5 NO 2 Molecular weigth Characteristics : white powder, well soluble in water, less soluble in alcohol and ether Specification : C 2 H 5 NO 2 content between 98.5 to 101.5% (on dry basis) - Loss on drying not more than 0.2% - Residue on ignition not more than 0.1% - Lead not more 5 mg/kg Packaging and storage : keep in tightly sealed container Quality or Standrads : refer to Food Chemical Codex Monograph Fifth Edition 2004 or If there are amendments, (3) Disodium Succinate Chemical name : Disodium Succinate or Disodium 1,4-butanedioate Formula : C 4 H 4 Na 2 O 4.nH 2 O (n=6 or 0) Molecular weigth of hexahydrate = Anhydrous = Characteristic : white or no colour crystalline or powder, no odour and has specific taste. There are hexahydrate and Anhydrous type

3 Specification : C 4 H 4 Na 2 O 4 content between 98.0 to 101.0% (on dry basis) - Sulfate (calculated as SO 4 ) not more than 0.019% - ph ( dilute 1 g of Disodium Succinate in 20 ml of water) - readily oxidizable substances pass the test - Loss on drying Hexahydrate type between % (at 120 o C for 2 hours) Anhydrous type not more than 2.0 (at 120 o C for 2 hours) Heavy metals (calculated as Lead) not more 20 µg/g Arsenic ( calculated as As 2 O 3 ) not more 4 µg/kg Packaging and storage : keep in tightly sealed container Quality or Standards : refer to Japaneses Specifications and Standards for Food Additives, Seventh Edition 2000 or if there are any amendments, Qaulity or Standards shall comply with that specify in the latest edition. (4) DL-Alanine Chemical name : DL-Alanine or DL-2-Aminopropaonic acid [ CAS : ] Formula : C 3 H 7 NO 2 Molecular weigth Characteristic : white powder, well soluble in water, partly soluble in alcohol Specification : C 3 H 7 NO 2 content between 98.5 to 101.5%(on dry basis)

4 - Loss on drying not more than 0.3% - Residue on ignition not more than 0.2% - Lead not more 5 mg/kg Packaging and storage : keep in tightly sealed container Quality or Standrads : refer to Food Chemical Codex Monograph Fifth Qaulity or Standards shall comply with that (5) Starter Culture Name of Starter Culture are as follows: - Aspergillus oryzae - Aspergillus sojae - Chrysosporium merdarium - Fusarium solani - Geotrichum candidum - Penicillium camemberti (or alpum) - Penicillium caseicolum - Penicillium chrysogenum -Penicillium cyclopium - Penicillium nalgiovense - Penicillium roqueforti Formula : - Molecular weigth - Characteristics : moulds that not producing aflatoxin or other hazardous toxins, may be liquid or powder which are produced under good fermentation process control ; may be mixture of many cultures or mix with other substances, which not harm to health, to assist dispersion, prevention of agglomeration and aid in processing.

5 Specification : content is between 85.0 to 115.0%of the number of declared unit - Lead not more 5 mg/kg - Coliform not more than 30 colonies per gram - Salmonella not detected in 25 grams Packaging and storage : keep in tightly sealed container Quality or Standards : refer to Food Chemical Codex Monograph Fifth Qaulity or Standards shall comply with that (6) Maltodextrin Name of chemical : Maltodextrin [CAS : ] Formula - Molecular weigth - Characteristics : concentrated saccharide polymers which obtained from partly hydrolyzation of flour White powder or flake, no taste, well soluble in water. Specification : reducing sugar content less than 20.0%(calculated as equivalent dextrose) - Residual ignition not more than 0.5% - Total protein not more than 0.5% or not more than 1.0% for maltodextrin produced from flour with high amylose content - Total solid powdered or flaked maltodextrin not less than 90.0% liquid maltodextrin not less than 50.0% - Sulfurdioxide not more than %

6 - Lead not more 0.5 mg/kg Packaging and storage : keep in tightly sealed container Quality or Standards : refer to Food Chemical Codex Monograph Fifth Qaulity or Standards shall comply with that (7) Powder yeast from Saccharomyces or Torula Name of yeast culture : Dried Yeast or Brewer s Yeast or Torula Yeast Formula : - Molecular weigth - Characteristics : appearance as powder flake or light brown colour piece and have odour of yeast ; produced from yeast culture, type Saccharomyces cerevisiae or Saccharomyces fragillis or Torula utilis which are dried and are not add other substances. Specification : Total protein content not less than 45.0% - Folic Acid not more than 0.04 mg/g - Loss on drying not more than 7% - Total ash not more than 8.0% - Lead not more 1 mg/kg - Total Count not more than 7500 colonies/g - Coliform not more than 10 colonies/g - Salmonella not detected in 25 g Packaging and storage : Keep in tightly sealed container Quality or Standards : refer to Food Chemical Codex Monograph Fifth Qaulity or Standards shall comply with that (8) Other Yeasts

7 Name of Yeast cultures : other Yeasts are as follows : - Candida utilis - Candida versatilis - Debaryomyces hansenii - Kluyveromyces lactis - Kluyveromyces marxianus - Saccharomyces unisporus - Saccharomyces exiguus - Zygosaccharomyces rouxii Formula : - Molecular weigth - Characteristics : yeast that not producing hazardous toxins and safe for food producing, may be liquid or powder which are produced under good fermentation process control ; may be mixture of many cultures or mix with other substances, which not harm to health, to assist dispersion, prevention of agglomeration and aid in processing. Specification : content between %of number of declared units - Lead not more than 5 mg/kg - Coliform not more than 30 colonies/g - Salmonella not detected in 25 g Packaging and storage : Keep in tightly sealed container Quality or Standrads : refer to Food Chemical Codex Monograph Fifth (9) Lactic Acid Bacteria

8 Name of Bacteria are as follows : - Bifidobacterium bifidum - Lactobacillus acidophilus - Lactobacillus brevis - Lactobacillus bulgaricus - Lactobacillus casei - Lactobacillus casei subsp. Shirota - Lactobacillus delbruekii - Lactobacillus delbruekii subsp. bulgaricus - Lactobacillus delbruekii subsp. delbruekii - Lactobacillus delbruekii subsp. Lactis - Lactobacillus kefiri - Lactobacillus paracasei - Lactobacillus paracasei subsp. paracasei - Lactobacillus lactis - Lactobacillus lactis subsp.cremoris - Lactobacillus lactis subsp.lactis - Streptococcus lactis - Streptococcus thermophilus Formula : - Molecular weight Characteristics : Colonies are sphere or rather long rod; positive gram stain, non -spore producing, non-catalase producing, metabolize sugar to lactic acid; may be in form of liquid or powder which are produced under good fermentation process control ; may be mixture of many cultures or mix with other substances, which not harm to health, to assist dispersion, prevention of agglomeration and aid in processing. Specification : content between %of number of declared

9 units - Lead not more than 5 mg/kg - Coliform not more than 30 colonies/g - Salmonella not detected in 25 g Packaging and storage : Keep in tightly sealed container Quality or Standrads : refer to Food Chemical Codex Monograph Fifth (10) Oxidised Polyethylene Name of Chemical : oxidised polyethylene Formula :- Molecular weight 1,200 Characteristics : polymer substance which obtained from oxidation of Polyehylene Specification : - - ph (calculated as mg of potassium hydroxide) not more than 70 mg/kg - Lead not more than 2 mg/kg - Chromium not more than 5 mg/kg Quality or Standard : refer to Commission Directive96/77/EC of 2 December 1996 or If there are any amendments, (11) Enzyme Transglutaminase from Streptoverticillium mobaraense var. Name of Chemical: Enzyme Transglutaminase from Streptoverticillium mobaraense var. Formula - Molecular weight -

10 Characteristics : may be in form of liquid, semi liquid or solid; produced from fermentation of microorganism variety Streptoverticillium mobaraense var. under good fermentation process control; may have mixture of cells, part of cells or liquid in cells as well as may mix with solvent, preservatives or antioxidants or other non harzadous substances, soluble in water but nonsoluble in alcohol, chloroform or ether with good manufacturing practice. Specification : content is between 85.0%-115.0% of the declared efficiency of enzyme. - Lead not more than 5 mg/kg - Coliform not more than 30 colonies/g - Salmonella not detected in 25 g Packaging and Storage :Keep in tigthly sealed containers. Quality or Standrads : refer to Food Chemical Codex Monograph Fifth Notify on 2 4 th June B.E (2005) Signed Pakdee Pothisiri (Mr.Pakdee Pothisiri) Secretary General of Food and Drug Administration

11 Certified true copy Jirarat Tesasilp (Miss Jirarat Tesasilp) Food and Drug Officer level 6 Note: This English version of the notification is translated to meet the need of the non-thai speaking people. In case of any discrepancy between the Thai original and the English translation, the former will take priority.