FOOD AND AGRICULTURE WORLD HEALTH ORGANIZATION … · type sausages, Canada does not agree with the...

codex alimentarius commissionFOOD AND AGRICULTURE WORLD HEALTHORGANIZATION ORGANIZATIONOF THE UNITED NATIONSJOINT OFFICE: Via delle Terme di Caracalla 00100 Rome Tel.: 39.06.57051 Telex: 625825-625853 FAO I E-mail [email protected] Facsimile:39.06.5705.4593

Agenda Item 7d CX/FAC 01/8February 2001

JOINT FAO/WHO FOOD STANDARDS PROGRAMME

CODEX COMMITTEE ON FOOD ADDITIVES AND CONTAMINANTSThirty-third Session

The Hague, The Netherlands, 12-16 March 2001

COMMENTS ON REVISED TABLE 1, INCLUDING BENZOATES, OF THE CODEX GENERALSTANDARD FOR FOOD ADDITIVES

CANADA

Codex General Standard for Food Additives: Additives with an Acceptable Daily Intake of “Not Specified”(Table 3) (Paragraph 45 and Appendix VI)

1. Canada notes that Processed Eucheuma Seaweed, Gamma Cyclodextrin, Curdlan and SodiumSulfates have temporary “Not Specified” ADIs assigned by JECFA and questions the wisdom of includingsubstances with such status. A temporary ADI is “used by JECFA when data are sufficient to conclude thatuse of the substance is safe over the relatively short period of time required to generate and evaluate furthersafety data, but are insufficient to conclude that use of the substance is safe over a lifetime.” (fromIntroduction, Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on FoodAdditives (JECFA), 1956-1995, ILSI Press, 1996).

Codex General Standard for Food Additives: Draft Food Additive Provisions for Benzoates (Paragraph 48and Appendix IV)

2. With regard to the changes shown in Appendix VI (entitled Draft Revisions for Benzoates....)Canada has no objection to the deletion of benzoates in cheeses, fresh and frozen vegetables, flours andstarches.

3. Canada has no objection to deletion of benzoates from edible ices, including sherbet and sorbet, butrecognizes that benzoates may well be found in such products due to carryover resulting from theirlegitimate use in fruit juices (see 14.1.1.2 and 14.1.2.3) which are components of sherbet and sorbet. In suchcase, their presence in sherbet and sorbet should be in proportion to the amount of fruit juice present insherbet and sorbet, based on the total amount allowed in fruit juices (now 2100 ppm).

4. Canada has no objection to the deletion of benzoates from standardized foods such as beer, wine andspiritous beverages and believes that cider, perry and fruit wine should be included in the deletions. ButCanada believes that provision should be made for the use of benzoates up to 1000 mg/kg in unstandardizedbeverages that are made from all of the above, i.e. so-called “Coolers.” In this regard, a new class ofAlcoholic Beverages (14.2.7 Coolers) is required in the Food Categorization System.

5. Canada questions the need for benzoates in pure dry sugars such as sucrose, fructose, glucose(dextrose), and xylose ( Item 11.1); in brown sugar and maple syrup (Item 11.2); in herbs, spices, andseasonings (Item 12.2); and in vinegars (Item 12.3).

Recommendations of the CCFAC/GSFA Quality Control Working Group (Appendix I)

6. Canada has the following comments on the Quality Control Working Group’s work this year:

7. Allura Red AC, Brilliant Black PN, Brown HT, Carotenoids, Indigotine - Canada does not feel thatcolours in meat marking inks (Categories 08.1.1 and 08.2; also Notes 3 & 4) should be regulated as foodadditives but agrees as a matter of policy that only colours recognized in the GSFA should be employed inthe formulation of such inks. The same comment applies to egg marking inks (Category 10.1).

8. Allura Red AC, Azorubine, Brilliant Black PN, Brown HT, Indigotine - Except for certain specialty-type sausages, Canada does not agree with the general use of colour in edible sausage casings (Category08.4), particularly red colour.

9. Brilliant Black PN - Canada does not agree with the general use of colour on fresh fruit (Category04.1.1.2) and questions the need for Brilliant Black in this regard. Some Note providing restriction orcircumscription is required.

10. Carotenoids - With regard to use of these in Categories 08.3.3 (frozen processed comminuted meat,poultry and game products), 08.4 (edible casings [e.g. sausage casings]), 09.1.2 (fresh molluscs, crustaceans,and echinoderms), 09.2.3 (frozen minced and creamed fish products.....), 09.2.4.3 (fried fish and fishproducts.....), 09.3.1 (fish and fish products....), and 09.3.2 (fish and fish products.....), are these all markingand stamping applications of colour (Note 4)? We note that Note 4 also refers to “decoration.” We reiterateComment (1) above and suggest that if meat and/or egg marking/stamping ink colours are to continue to beregulated under the GSFA, that this caveat be separated in the Note from “decorative” use of colours whichis something else altogether.

11. Dioctyl sodium sulfosuccinate - Canada questions the need for this additive in unripened cheese(Category 01.6.1).

12. Maltol - Maltol is a flavour/flavour enhancer and Canada does not consider this to be a foodadditive. In any case, Canada does not agree to the use of this material in wines (Category 14.2.3) generallyand does not appreciate the exception in Note 93 for natural wines made from Vitis vinifera grapes.

13. Nitrates - Canada questions the need for such high levels of nitrates generally, but in particular, thelevels of 1600 mg/kg as residual NO3 ion in Category 8.2.1.1 (cured [including salted] non-heat processedmeat, poultry and game products in whole pieces or cuts) or the levels of 1250 mg/kg as residual NO3 ion inCategory 8.3.1.1 (cured [including salted] non-heat treated processed comminuted meat, poultry and gameproducts). Even levels of 450 mg/kg (Categories 8.2.1.2 and 8.2.1.3) are considered to be unnecessarilyhigh. In Canada, slow-cured meat products employing sodium or potassium nitrate are made using thenamed salts at no more than 200 mg/kg on a batch input (i.e. not residual) basis prior to any cooking,smoking or fermentation operations. The levels for nitrates appearing in the GSFA for meat products arehigh!

14. Nitrates - The rationale for using nitrates (70 mg/kg) in spirituous beverages containing less than15% alcohol (Category 14.2.6.2) is unclear.

15. Nitrites - Canada considers that levels of 420 mg/kg and 300 mg/kg of nitrite as residual NO2 ion inCategories 08.2.1.1 and 08.2.1.2 are unnecessarily high.

16. Phosphates - Canada questions the need for phosphates in milk and buttermilk (Category 01.1.1),unripened cheese (Category 01.6.1), ripened cheese (Category 01.6.2), butter oil/milkfat/ghee (Category02.1.1), lard/tallow/fish oil and other animal fats (Category 02.1.3), butter and concentrated butter (Category02.2.1.1), infant formula and follow-on formula (Category 13.1), fruit and vegetable juices (Category 14.1.2)

and fruit and vegetable nectars (Category 14.1.3)1.

17. Polyglycerol esters of fatty acids - The need for this emulsifier in spirituous beverages generally isnot evident. Is it used only in cream liqueurs and the like? If so, perhaps a Note is required to qualify itsuse.

18. Phosphates - If an additive is needed in a glaze for use on fresh vegetables, nuts and seeds (Category04.2.1.2), then it need not be regulated on the fresh vegetables, nuts and seeds themselves. It would be betterto regulate it in glazes per se if such a class exists, just as it is in batters (Category 06.6).

19. Propylene Glycol - Why is propylene glycol used on surface-treated fresh fruit (Category 04.1.1.2?Is this the result of its use as a carrier solvent for a fruit and vegetable wax coating preparation?

20. Sorbates - The use of sorbates in standardized chocolate products (i.e. pure chocolate, milkchocolate, etc.) is questioned. Such use is currently not permitted in Canada.

21. Stearoyl-2-lactylates - The level of this additive in breads and rolls (Category 07.1.1) and in finebakery wares (Category 07.2) appears to be excessively high in view of the ADI for this additive. It issuggested that this level be reassessed.

22. Tartrates - If this substance is used in the raw materials used for the manufacture of the finished foodand the raw materials are to constitute the point of regulation, then the specific raw materials upon which the2.62% tartrates are calculated should be identified in the Note.

Revised Table 1 of the Draft GSFA (Appendix II)

23. Canada has the following comments on the GSFA as it stands this year:

24. Allura Red AC, Azorubine, Brilliant Black PN, Brown HT, Curcumin, Indigotine, Ponceau 4R,Quinoline Yellow, Sunset Yellow FCF, Tartrazine - Canada has concerns about the use of broad foodcategories in certain circumstances, particularly when only a few products within that class contain theadditive being regulated (even though a Note may qualify and further restrict the use of the colour). Anexample is in the case where these additives are provided in “fresh fish” (Category 09.1.1) when, accordingto Note 50, their use is confined to fish roe only.

25. Allura Red AC, Azorubine, Brilliant Black PN, Brown HT, Carotenoids, Ponceau 4R, QuinolineYellow, Red 2G, Sunset Yellow FCF, Tartrazine - Canada does not feel that colours in egg marking inks(Category 10.1) should be regulated as food additives but agrees as a matter of policy that only coloursrecognized in the GSFA should be employed in the formulation of such inks. The same comment applies tomeat marking inks (Categories 08.1.1. and 08.2; also Notes 3 & 4).

26. Allura Red AC, Azorubine, Brilliant Black PN, Brown HT, Curcumin, Indigotine, QuinolineYellow, Sunset Yellow FCF, Tartrazine (Category 09.2.1 and Note 95) - Canada believes that a break-out ofsurimi products from the Food Category System is required to handle additives unique to surimi and suchfishery products which often imitate other fishery products. See also (1) above regarding remarks on fishroe.

27. Allura Red AC, Azorubine, Brilliant Black PN, Brown HT, Indigotine, Ponceau 4R, QuinolineYellow, Sunset Yellow FCF, Tartrazine - Canada does not agree with the use in general of colours in cookedfish and fish products (Category 09.2.4.1) or in cooked molluscs, crustaceans or echinoderms (Category09.2.4.2) and believes that at the very least, a footnote explaining/circumscribing such use is required.

28. Various of Allura Red AC, Amaranth, Brilliant Black PN, Brown HT, Carotenoids, Curcumin,

1If phosphates are carried over from “the ingredient” (What ingredient?) and this is a case of legitimate carry-over, then the carry-over additive should not be regulated. After all, it is the carry-over principle that explains andjustifies the presence of the carry-over additive in the final food that is not otherwise allowed to contain it.

Indigotine, Ponceau 4R, Quinoline Yellow, Sunset Yellow FCF, Sunset Yellow FCF, Tartrazine - Canadaquestions the need for colours in various of the following foods: sugars noted under Category 11.1, in infantformula and follow-on formula (Category 13.1), in beer and malt beverages (Category 14.2.1), in cider andperry (Category 14.2.2), and in fruit wine (Category 14.2.4).

29. Aspartame - If the purpose of use of aspartame in beverage whiteners (Category 01.3.2) is tosweeten the beverage in which the whitener is use (i.e. aspartame is functional in the beverage and not in thewhitener), then no entry is needed under Category 01.3.2.

30. Carotenoids - Canada does not see the need for carotenoids in “cream (plain) and the like” (Category01.4).

31. Carotenoids and other colours - Canada reiterates that a sub-class of “coolers” is required in theFood Category System to handle situations like these arising under Categories 14.2.1 (beer and maltbeverages), 14.2.2 (Cider and Perry), 14,2.3.1 (still wine), 14.2.3.3 (fortified wine and liquor wine), 14.2.3.4(Aromatized Wine) and 14.2.4 (fruit wine), where the use of colour, for instance, may be in cooler variantsof these foodstuffs (Note 96). It will be recalled that Canada felt that a listing for “coolers” would be usefulin the context of benzoates. There are many instances of colour use in beer, cider and perry, and wine wherethe use of colours is provided in these classes (e.g. tartrazine is permitted in beer) but there is no qualifyingNote. Either the note has been inadvertently omitted or, if this is not the case, then we can only assume thatthe colours are deliberately provided for in these alcoholic beverages. Canada objects to the use of colours(other than caramel) in beer, cider/perry, and wine but has no objection to their use in cooler variants.

32. Curcumin - See (8) above.

33. Cyclamates - Canada does not agree with the use of cyclamates as food additives and does notbelieve that the ADI can support such use, particularly where beverages are concerned.

34. Ethyl Maltol - This substance is a flavour/flavour enhancer and Canada does not believe it to be afood additive.

35. Maltol - Maltol is a flavour/flavour enhancer and Canada does not consider this to be a foodadditive. In any case, Canada does not agree to the use of this material in wines (Category 14.2.3) generally,in coffee (Category 14.1.5), cider and perry (Category 14.2.2), and fruit wine (Category 14.2.4).

36. Nitrates - Canada questions the need for such high levels of nitrates generally, but in particular, thelevel of 365 mg/kg as residual NO3 ion in Categories 8.2.2, 8.3.1.2, 8.3.1.3, 8.3.2, 8.3.3 and 9.2.5 isconsidered to be unnecessarily high. In Canada, slow-cured meat products employing sodium or potassiumnitrate are made using the named salts at no more than 200 mg/kg on a batch input (i.e. not residual) basisprior to any cooking, smoking or fermentation operations.2 The levels for nitrates appearing in the GSFA formeat products are high.

37. Polyglycerol esters of fatty acids - Canada cannot accept the use of polyglycerol esters of fatty acidsin cream (plain) (Category 01.4), in meat and meat products, including poultry and game (Category 08.0) orin fish and fish products, including molluscs, crustaceans and echinoderms (Category 09.0) without somejustification.

38. Polyglycerol esters of interesterified ricinoleic acid - Canada cannot accept the use of or see the needfor this additive in cream (plain) (Category 01.4), in fats or oils essentially free from water (Category 02.1),in coffee or tea (Category 14.1.5), in beer or malt beverages (Category 14.2.1), in cider and perry (Category14.2.2), in wines (Category 14.2.3), and in fruit wine (Category 14.2.4).

39. Polyoxyethylene stearates, Stearoyl-2-lactylates - Canada cannot accept the use of or see the need forthis additive in fats and oils essentially free from water (Category 02.1).

2Canada does not allow nitrates or nitrites in fish products other than in seal (a mammal) meat.

40. Ponceau 4R, Quinoline Yellow, Sunset Yellow FCF - If an additive is needed in a glaze for use onfresh vegetables, nuts and seeds (Category 04.2.1.2), then it need not be regulated on the fresh vegetables,nuts and seeds themselves. It would be better to regulate it in glazes per se if such a class exists, just as it isin batters (Category 06.6).

41. Ponceau 4R, Quinoline Yellow, Red 2G, Sunset Yellow FCF, Tartrazine - With a few exceptions,Canada does not agree with the use of colours generally in fish, meat and poultry products (Categories 8.1,8.2, 8.3, 8.4, 9.1, 9.2 and 9.4 and most sub-classes thereof). The use of red colour in meats, particularly freshmeat, constitutes fraud in Canada’s view.

42. Sorbates - Canada objects to the use of sorbates (or any preservative) in milk and buttermilk(Category 01.1.1) and in/on fresh and frozen fruit (Categories 04.1.1 and 04.1.2.1), in flours and starches(Category 06.2), in sugars (Category 11.1 and 11.2)(except possibly solutions thereof), and in beer and maltbeverages (Category 14.2.1).

43. Stearoyl-2-lactylates - Canada does not seed the need for this additive in fats and oils essentially freefrom water (Category 02.1).

44. Sucrose esters of fatty acids - Canada does not agree to the use of sucrose esters of fatty acids invegetable oils and fats (Category 02.1.2) or in heat-treated processed meat poultry and game products (wholepieces or cuts or comminuted variants thereof)(Categories 08.2.2 and 08.3.2), in sugars (Category 11.1), ininfant formula and follow-on formula (Category 13.1) and in cider and perry (Category 14.2.2) and fruitwines (Category 14.2.4). What is its purpose in these commodities?

45. Tartrates - Canada notes that tartrates are listed for use in fresh fruit (Category 04.1.1), frozen fruit(Category 04.1.2.1), dried fruit (Category 04.1.2.2), fruit in vinegar, oil and brine (Category 04.1.2.3),canned or bottled (pasteurized) fruit (Category 04.1.2.4), candied fruit (Category 04.1.2.7), fruitpreparations....(Category 04.1.2.8), fruit-based desserts.... (Category 04.1.2.9), fermented fruit products(Category 04.1.2.10), cooked or fried fruit (Category 04.1.2.12), fresh vegetables, and nuts and seeds(Category 04.2.1), frozen vegetables (Category 04.2.2.1), dried vegetables, seaweeds, and nuts and seeds(Category 04.2.2.2), vegetable, and nut and seed purées and spreads (Category 04.2.2.5), fermentedvegetable products (Category 04.2.2.7) and cooked or fried vegetables and seaweeds (Category 04.2.2.8) at1300 mg/kg in each and all of these commodities. What is the purpose of such “across-the-board” use andwhat is the justification for an “across-the-board” use level of 1300 mg/kg?

46. Tocopherols - Canada objects to the use of antioxidants in milk and milk products (e.g. Categories01.1, 01.3, 01.4) and in butter (Category 02.2.1.1). While not permitted in Canada, Canada does appreciatethe need, however, for antioxidants in powdered milks (Category 01.5.1) offered as food in warmer climates.

47. Tocopherols - Canada objects to the use of antioxidants in meat and fish products, particularly infresh meat, poultry and game (comminuted)(Category 08.1.2).

48. Tocopherols - Canada does not allow the use of additives in infant foods (Category 13.1) and objectsto such use. Canada also does not allow antioxidants in beer and malt beverages (Category 14.2.1) or inwines (Category 14.2.3).

Additives Assigned a New ADI by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

49. Canada has the following comments on this Item:

50. Aspartame-acesulfame salt - In Canada, the use of this additive is currently subsumed under theCanadian Food and Drug Regulations for the use of aspartame and acesulfame-potassium. It will also besubsumed in the proposed new Canadian food additive regulations. Consequently, we would consider thatthe individual provisions under the GSFA for the use of aspartame and acesulfame apply to this additive.

Priority List of Additives for Discussion by the 33RD CCFAC (Appendix III)

51. Canada’s comments are as follows:

52. Canada questions the need for several of the priority additives in a number of food categories asfollows:

53. Aluminum Ammonium Sulphate - Food Category 14.2.1 (Beer and malt beverages).

54. Beeswax, White and Yellow - Food Category No. 14.1.4 (Water-based flavoured drinks, including“sport” or “electrolyte” drinks and particulated drinks).

55. Benzoates - 04.2.1.4 (Canned or bottled (pasteurized) fruit), 04.2.2.2 (Dried vegetables, seaweeds,and nuts and seeds), 04.2.2.4 (Canned or bottled (pasteurized) or retort pouch vegetables), 06.2 (Flours andstarches), 11.1 (Sugars), 11.2 (Other sugars and syrups).

56. Brilliant Blue FCF- Food Category 01.6.4 (Processed Cheese), 02.1.3 (Lard, tallow, fish oil, andother animal fats), 02.1.3 (Butter3 and concentrated butter), 02.2.1.2 (Margarine and similar products {e.g.,butter-margarine blends}), 04.1.2.4 (Canned or bottled (pasteurized) fruit),12.5 (Soups and broths), 13.1(Infant formulae and follow-on formulae), 14.2.1 (Beer and malt beverages), 14.2.2 (Cider and perry),14.2.3.4 (Aromatized wine), 14.2.4 (Fruit wine). See also Comments (4), (5), (6), (7) and (8) below.

57. Candelilla Wax - Food Category 14.1.4 (Water-based flavoured drinks, including “sport” or“electrolyte” drinks and particulated drinks).

58. Carmines - Food Category 02.1 (Fat and oils essentially free from water), 02.2 (Fat emulsionsmainly of type water-in-oil), 08.1.2 (Fresh meat, poultry, and game, comminuted), 08.3.1.1 (Cured{including salted} non-heat treated processed comminuted meat, poultry, and game products), 08.3.1.2(Cured {including salted} and dried non-heat treated processed comminuted meat, poultry, and gameproducts), 08.3.1.3 (Fermented non-heat treated processed comminuted meat, poultry, and game products),08.3.2 (Heat treated processed comminuted meat, poultry, and game products), 08.3.3 (Frozen processedcomminuted meat, poultry, and game products), 14.2.1 (Beer and malt beverages), 14.2.2 (Cider and perry),14.2.3.1 (Still wine), 14.2.3.2 (Sparkling and semi-sparkling wines), 14.2.3.3 (Fortified wine and liquorwine), 14.2.3.4 (Aromatized wine), 14.2.4 (Fruit wine).

59. Carnauba Wax - Food Category 4.2.1 (Processed fruit), 12.6 (Sauces and like products),14.1.2.1(Canned or bottled {pasteurized} fruit juice), 14.1.4 (Water-based flavoured drinks, including “sport” or“electrolyte” drinks and particulated drinks).

60. Carotenes, Vegetable - Food Category 02.1 (Fat and oils essentially free from water), 08.1.2 (Freshmeat, poultry, and game, comminuted), 08.3.1.1 (Cured {including salted} non-heat treated processedcomminuted meat, poultry, and game products), 08.3.1.2 (Cured {including salted} and dried non-heattreated processed comminuted meat, poultry, and game products), 08.3.1.3 (Fermented non-heat treatedprocessed comminuted meat, poultry, and game products), 08.3.2 (Heat treated processed comminuted meat,poultry, and game products), 08.3.3 (Frozen processed comminuted meat, poultry, and game products),14.2.2 (Cider and perry), 14.2.3.2 (Sparkling and semi-sparkling wines), 14.2.3.4 (Aromatized wine), 14.2.4(Fruit wine).

61. Chlorophylls, Copper Complexes - Food Category 02.0 (Fat and oils, and fat emulsions {type water-in-oil), 08.0 (Meat and meat products, including poultry and game), 14.2.1 (Beer and malt beverages),14.2.2 (Cider and perry), 14.2.3 (Wines), 14.2.4 (Fruit wine).

3Indeed, Canada may have been the originator of this listing. As explained at previous sessions of the CCFAC

Working Group on Food Additives, the way the current Canadian Food and Drug Regulations are written, all coloursare permitted in butter, when, in fact, only yellow colours such as annatto are actually employed. Canada’s newproposed food additive tables reflect this reality.

62. Diacteyl tartaric acid and fatty acid esters of glycerol - Food Category 01.4 (Cream (plain)), 02.1(Fats or oils essentially free from water), 11.2 (Other sugars and syrups (e.g. brown sugar, maple syrup), 12.3(Vinegars), 14.1.2.2 (Canned or bottled (pasteurized) vegetable juice), 14.1.2.4 (Concentrate (liquid or solid)for vegetable juice), 14.1.5 (Coffee or tea), 14.2.2 (Cider and perry), 14.2.3.4 (Aromatized wines), and 14.2.4(Fruit wine).

63. Grape Skin Extract - Food Category 02.2.1.2 (Margarine and similar products {e.g., butter-margarine blends), 08.1.1 (Fresh meat, poultry, and game, whole pieces or cuts), 08.1.2 (Fresh meat, poultry,and game, comminuted), 08.2 (Processed meat, poultry, and game products in whole pieces or cuts),08.3.1.1 (Cured {including salted} non-heat treated processed comminuted meat, poultry, and gameproducts), 08.3.1.2 (Cured {including salted} and dried non-heat treated processed comminuted meat,poultry, and game products), 08.3.1.3 (Fermented non-heat treated processed comminuted meat, poultry, andgame products), 08.3.2 (Heat treated processed comminuted meat, poultry, and game products), 08.3.3(Frozen processed comminuted meat, poultry, and game products), 14.2.1 (Beer and malt beverages), 14.2.2(Cider and perry), 14.2.3.2 (Sparkling and semi-sparkling wines), 14.2.3.3 (Fortified wine and liquor wine),14.2.3.4 (Aromatized wine), 14.2.4 (Fruit wine).

64. Hydroxybenzoates - 01.6.2 (Ripened cheese), 01.6.4 (Processed cheese), 03.0 (Edible ices, includingsherbet and sorbet), 04.1.1.2 (Surface-treated fruit), 04.1.2.1 (Frozen fruit), 04.1.2.4 (Canned or bottled[Pasteurized] fruit), 04.2.1.2 (Surface-treated fresh vegetables, nuts and seeds), 04.2.2.4 (Canned or bottled[pasteurized] or retort pouch vegetables),04.2.2.5 (Vegetables, and nut and seed purées and spreads [e.g.peanut butter]), 05.1.1 (Cocoa mixes [powders and syrups]), 08.2.1.2, 08.3.1.2 (Various cured4 meatproducts), 08.4 (Edible casings5 [e.g. sausage casings]), 11 1 (Sugars), 11.2 (Other sugars and syrups [e.g.brown sugar, maple syrup]), 14.2.1 (Beer and malt beverages), 14.2.2 (Cider and perry), 14.2.3 (Wines),14.2.3 (Fruit wine), and 14.2.5 (Mead).

65. Mineral Oil - 04.2.2.4 (Canned or bottled [pasteurized] or retort pouch vegetables), 06.2 (Flours andstarches)6, and 10.2.3 (Dried and/or heat-coagulated egg products).

66. Nisin7 - 04.2.2.4 (Canned or bottled [pasteurized] or retort pouch vegetables)

67. Phosphatidic Acid5 - 01.4 (Cream and the like)

68. Riboflavines - 08.0 (Meat and meat products, including poultry, and game), 14.2.1 (Beer and maltbeverages), 14.2.2 (Cider and perry), 14.2.3.1 (Still wine), 14.2.3.2 (Sparkling and semi-sparkling wines),14.2.3.3 (Fortified wine and liquor wine), 14.2.3.4 (Aromatized wine), 14.2.4 (Fruit wine).

69. Sorbitan Esters of Fatty Acids - 14.2.3 (Wines).

70. Sucralose - 06.2 (Flours and starches)

71. Sucroglycerides - 14.2.2 (Cider and perry), 14.2.4 (Fruit wine), 14.2.5. (Mead).

72. Tannic Acid - 02.1.3 (Lard, tallow, fish oil, and other animal fats), 08.2 (Processed meat, poultry,and game products in whole pieces or cuts), 08.3 (Processed, comminuted meat, poultry and game products).

4Our objection is based on the need for benzoates in a product which we assume already contains nitrites or

nitrates as part of the cure.

5We have no objection to use of benzoates on the casings per se pending stuffing with sausage meat.

6Is this use, like Category 06.1, for dust control? If so, Note 98 should be referenced.

7This additive is currently not permitted for use in Canada.

73. Ascorbyl esters - Canada does not permit and objects to the use of ascorbyl esters (ascorbylpalmitate and ascorbyl stearate) in milk and cream powder (Category 01.5.1), in butter oil, anhydrous milkfat and ghee (Category 02.1.1) but can understand the need for such additives when such products are sold ordistributed in warmer climates.

74. Beeswax, White and Yellow - Canada requests justification for 150,000 mg/kg beeswax in chewinggum (Category 05.3) at Step 6. The entry at Step 3 (20,000 mg/kg) is also, in our view, unduly high (Canadapermits a maximum of 0.4% in “confectionery”) but is certainly more moderate than the 15% level. Doesthe 15% use constitute a use in the chewing gum base?

75. Benzoates - Canada does not see a need for the use of benzoates in cured meat products (Categories08.2.1.2, 08.3.1.2 and 08.3.1.2) which presumable already contain a preservative or in meat (Category08.2.28) and fish products (Categories 09.2.4.2, 09.2.5) which already have been subjected to a means ofpreservation like cooking, smoking or drying. Canada understands the need for the use of preservatives likebenzoates in semi-preserved or cold-processed fish products.

76. Benzoates - Canada does not see the rationale in not including the restriction of benzoates to coolersin the case of cider and perry (Category 14.2.2), fruit wine (Category 14.2.4) and mead (Category 14.2.5), aswas done in the case of wines Category (14.2.3) and spirituous beverages (Category 14.2.6). Furthermore,Canada believes that the maximum level of use in all of these cases, and indeed, in beverages allowed tocontain benzoates, should be 1000 mg/kg which over the years has been demonstrated to be more than amplefor preservation needs.

77. Brilliant Blue FCF, Chlorophylls and Carmines, Carotenes - Vegetable, Chlorophylls - CopperComplexes, Grape Skin Extract, Riboflavines - Canada has some concerns about the listing of these colourson surface-treated fresh fruit (Category 04.1.1.2), on surface-treated fresh vegetables, and nuts and seeds(Category 04.2.1.2), on meat and meat products, including poultry and game (Category 08.0), on freshmolluscs, crustaceans and echinoderms (Category 09.1.2), on frozen battered fish, fish fillets and fishproducts, including molluscs, crustaceans and echinoderms (Category 09.2.2), on frozen minced andcreamed fish products, including molluscs, crustaceans and echinoderms (Category 09.2.3), on fried fish andfish products, including molluscs, crustaceans and echinoderms (Category 09.2.4.3), on fish and fishproducts, including molluscs, crustaceans and echinoderms, marinated and/or in jelly (Category 09.3.1), andon fish and fish products, including molluscs, crustaceans and echinoderms, pickled and/or in brine(Category 09.3.2) and related categories wherever Note 16 appears.

78. With a few exceptions, Canada does not agree with the use of colours generally in fruits andvegetables, fish, meat and poultry products (Categories 4.1.1.2, 8.1, 8.2, 8.3, 8.4, 9.1, 9.2 and 9.4 and mostsub-classes thereof). If there are such products that are to be permitted to contain colour, they should becarefully circumscribed. The use of red colour in meats, particularly fresh meat (see, for example, carmine,Category 08.1.2 [Fresh meat, poultry and game, comminuted]), constitutes fraud in Canada’s view.

79. In this instance, according to Note 16, these colourings is permitted “For use in glaze, coatings ordecorations for fruit, vegetables, meat or fish.” In this regard, Canada recommends that the use of thiscolouring be regulated in the glaze, coatings or decorations themselves and not in the specific food categoriessuch as Category 08.0 (Meat and meat products, including poultry and game).

80. Providing for the colour in vegetables, meat and fish products on account of it being used in theglaze is confusing to the reader, despite the Note, and ignores the fact that the glaze really constitutes thecorrect point of regulation.

81. Brilliant Blue FCF, Chlorophylls and Carmines, Carotenes - Vegetable, Chlorophylls - CopperComplexes, Grape Skin Extract, Riboflavines - Canada does not feel that colours in egg marking inks(Category 10.1) should be regulated as food additives, or moreover, should be regulated in final foodstuffs

8See Notes (5) and (10) about the use of additives in glazes.

on account on account of their being used in such inks, but agrees as a matter of policy that only coloursrecognized in the GSFA should be employed in the formulation of such inks. The same comment applies tomeat marking inks (Categories 08.1.1. and 08.2; also Notes 3 & 4).

82. Brilliant Blue FCF, Chlorophylls and Carmines, Carotenes - Vegetable, Chlorophylls - CopperComplexes, Grape Skin Extract, Riboflavines - Canada has concerns about the use of broad food categoriesin certain circumstances, particularly when only a few products within that class contain the additive beingregulated (even though a Note may qualify and further restrict the use of the colour). An example is in thecase where these additives are provided in “fresh fish” (Category 09.1.1) when, according to Note 50, theiruse are confined to fish roe only. Another example is surimi products (Category 09.2.1 and Note 95) andCanada believes that in both these instances, a break-out of these two minor categories is required to handleadditives unique to these two fishery products.

83. Brilliant Blue FCF, Chlorophylls and Carmines, Carotenes - Vegetable, Chlorophylls - CopperComplexes, Grape Skin Extract, Riboflavines - Canada does not agree with the use in general of colours incooked fish and fish products (Category 09.2.4.1) or in cooked molluscs, crustaceans or echinoderms(Category 09.2.4.2) and believes that at the very least, a footnote explaining/circumscribing such use isrequired.

84. Brilliant Blue FCF, Chlorophylls and Carmines, Carotenes - Vegetable, Chlorophylls - CopperComplexes, Grape Skin Extract, Riboflavines - Canada reiterates that a sub-class of “coolers” is required inthe Food Category System to handle situations like these arising under Categories 14.2.1 (beer and maltbeverages), 14.2.2 (Cider and Perry), 14,2.3.1 (still wine), 14.2.3.3 (fortified wine and liquor wine), 14.2.3.4(Aromatized Wine) and 14.2.4 (fruit wine), where the use of colour, for instance, may be in cooler variantsof these foodstuffs (Note 96). It will be recalled that Canada felt that a listing for “coolers” would be usefulin the context of benzoates. There are many instances of colour use in beer, cider and perry, and wine wherethe use of colours is provided in these classes (e.g. tartrazine is permitted in beer) but there is no qualifyingNote. Either the note has been inadvertently omitted or, if this is not the case, then we can only assume thatthe colours are deliberately provided for in these alcoholic beverages. Canada objects to the use of colours(other than caramel) in beer, cider/perry, and wine but has no objection to their use in cooler variants.

85. Diacteyl tartaric and fatty acid esters of glycerol - With regard to the use of these in Fresh meat,poultry and game, whole pieces and cuts (Category 08.1.1), in Frozen processed meat, poultry and gameproducts in whole pieces or cuts (Category 08.2.3), in Frozen processed comminuted meat, poultry and gameproducts (Category 08.3.3), in Fresh fish and fish products, including molluscs, crustaceans and echinoderms(Category 09.1), in Frozen battered fish, fish fillets, and fish products, including molluscs, crustaceans andechinoderms (Category 09.2.2), and in Frozen minced and creamed fish products, including moluscs,crustaceans and echinoderms (Category 09.2.3) and related classes and Note 16, Canada has reservationsabout providing additives in such products by virtue of their use in glazes (or batters). See comments in (4)above re use of colours in such glazes. It would be better to regulate this additive in glazes per se if such aclass exists, just as it is in batters (Category 06.6). If a class for glazes does not exist, we should create it.

86. Diacteyl tartaric and fatty acid esters of glycerol - Note 83 - It is noted that this additive is excludedfrom Dietetic foods intended for special medical purposes including foods for infants and young children(Category 13.3) but nonetheless is permitted in Infant formula and follow-on formula (Category 13.1). Thisseems inconsistent.

87. Mineral Oil - With regard to the listing in Fresh meat poultry and game, comminuted (Category08.1.2) and in Heat-processed comminuted meat, poultry and game products (Category 08.3.2), if the use ofthis additive is a result from carry-over (Note 67), then it need not be regulated (The Carry-over Principleitself explains its presence in such products). In any case, from which ingredients is this additive carriedover?

88. Mineral Oil - Canada believes that this additive should be used sparingly. With regard to the use ofthis substance on Frozen, processed meat, poultry, and game products in whole pieces or cuts (Category08.2.3) or in Frozen, processed comminuted meat, poultry and game products (Category 08.3.3), do the useshere represent use as a “panning agent” (i.e. on surface of handling utensils)? If so, this needs to be further

clarified and specified in Note 3.

89. Mineral Oil - With regard to the use of this additive in Vinegars (Category 9.3) and in Wines(Category 14.2.3), are these uses (Note 99 - “as a float in fermentation fluids”) really “processing aid,” ratherthan food additive, uses?

90. Polysorbates - With regard to their use on Surface-treated fresh fruit (Category 04.1.1.2), see (4)above in connection with such use and for discussion about Note 16.

91. Polysorbates - With regard to their use in Canned or bottled [pasteurized] or retort pouch vegetables(Category 04.2.2.4), this entry show a shortcoming of the system being used to construct this standard. Onlythe use of additives in finished foods is controlled, thus precluding listing them at their proper point-of-regulation, which, in this case, is in flavouring (e.g. dill) oils (Notes 7 and 100). This scheme, although leveland consistent, requires use of extensive footnoting.

92. Sodium aluminum phosphates - If in Frozen battered fish, fish fillets and fish products, includingmolluscs, crustaceans and echinoderms (Category 09.2.2), the use of this additive is restricted to use inbatters and breadings only, then why not control this use through Category 06.6 (Batters (e.g. for breadingsor batters for fish or poultry)? This raises the need for designated “battered” food categories (i.e. other thanbatters/breading themselves) in the first instance.

93. Sorbitan esters of fatty acids - With regard to their use on Surface-treated fresh fruit (Category04.1.1.2), see (4) above in connection with such use and for discussion about Note 16.

94. Sucralose - Canada is concerned and wonders about the need for some of the seemingly high levelsof sucralose enables in this item, e.g. Fruit-based spreads [e.g. chutney] excluding products of Food Category04.1.2.5 (Category 04.1.2.6; 800 mg/kg), Fruit-based desserts, including fruit-flavoured, water-based desserts(Category 04.1.2.9; 1250 mg/kg), Vegetable, nut and seed purées and spreads (e.g. peanut butter)(Category04.2.2.5; 1500 mg/kg), Cocoa products and chocolate products including imitations and chocolate substitutes(Category 05.1; 1500 mg/kg), Confectionery including hard and soft candy, nougat, etc., other than foodcategories 05.1, 05.3 and 05.4 (Category 05.2; 1500 mg/kg), Chewing gum (Category 05.3; 5000 mg/kg),and Cereal and starch-based desserts (Category 06.5; 1250 mg/kg). Also, Canada is concerned about the useof this additive in Bread and ordinary bakery wares (Category 07.1; 750 mg/kg) which are frequentlyconsumed across population age/sex sub-groups and which are high intake staple items of the diet.

Canadian Comments on Proposals for the Use of Caramel II (150b) as a Colour in Food

95. In the proposed new Canadian regulations, caramel II (150b) will be listed as per the followingTable. Those food groups/categories that are italicized represent Codex Food Categorization System classeswhich Canada will be adopting. Those in ordinary type are Canadian food classes for which we did not finda Codex equivalent and which we considered necessary to regulate food additives in Canada. We have notconverted these to an approimate Codex Class, feeling that it would be better for those constructing theGSFA to do the conversion in order to maintain consistency with other nations’ input. Canada supports theinclusion of caramel II (150b) in the GSFA in a manner that would accommodate the uses in this table.

INS No. Additive Food Group/Category Maximum Level of Use

150b

150c

150d

Caramel Class II(E150b)Caramel Class III (E150c)Caramel Class IV (E150d)

Dairy-based desserts; Dairy-baseddrinks, flavoured and/orfermented

Good manufacturing practice

Edible ices Good manufacturing practiceJams, Jellies, Marmalades; Fruit-based spreads


Dehydrated potato products Good manufacturing practice

Pickles and relishes Good manufacturing practiceConfectionery; Cake decorations;Icings


Rice products; Pastas and noodles Good manufacturing practiceBreakfast cereals Good manufacturing practiceBakery wares Good manufacturing practiceBatter and breading Good manufacturing practiceMeat product extenders Good manufacturing practiceMarinades, rubs, glazes, andshake-on seasonings externallyapplied to meat products


Simulated meat Good manufacturing practiceSmoked fish; Lobster Paste;Caviar; Kamaboko- or surimi-type products


Table syrup Good manufacturing practiceFlavours; Seasonings Good manufacturing practiceVinegars Good manufacturing practiceSoups and broths Good manufacturing practiceCondiments; Dressings; Gravy;Sauces


Concentrates (liquid or solid) forfruit juice; Water-based flavoureddrinks


Spirituous beverages; Beer andmalt beverages; Wines; Cider andperry; Liqueurs and spirituouscordials


Snack foods Good manufacturing practiceMincemeat Good manufacturing practiceDesserts, toppings and fillings Good manufacturing practice

CHINA

C=: Recommended Change to the Appendix II of draft GSFA Table 1A=: Recommended Addition to the Appendix II of the draft GSFA Table 1D=: Recommended DeletionNew Text is in Bold font

Table 1 Recommendations of Provisions for the Use of Additives Listed in Table 1 of the DraftGSFA and Contained in Appendix III

Additive Max Level Food Cat.Code Food/Food Category inwhich Used

Notes

A GMP Soybean productsA GMP 7.2.1 Cakes, cookies and

piesA

Aluminum Ammonium Sulfate硫酸铝铵

GMP 15.1 Snacks-potato, cereal,flour or starch based

Note1&4

D Brilliant Blue FCF亮蓝

300 mg/kg 08.0 Meat and meat products,including poultry andgame

Note 2

Additive Max Level Food Cat.Code Food/Food Category inwhich Used

Notes

D 300 mg/kg 09.1.1 Fresh fishD 500 mg/kg 09.1.2 Fresh mollusks,

crustaceans andechinoderms

D 500 mg/kg 09.2 Frozen fish and fishproducts

D 500 mg/kg 09.3 Cooked and/or fried fishand fish products

D GMP 10.1 Fresh eggsD 50 mg/kg 13.1 Infant formula and

follow-on formulaD 50 mg/kg 13.2 Weaning foods for

infants and growingchildren

D Carmines胭脂虫红

GMP 10.1 Fresh eggs Note 2

C 500 mg/kg 01.7 Dairy-based dessertsC

Chlorophylls, CopperComplexe叶绿素

500 mg/kg 03.0 Edible ices, includingsherbet and sorbet

Note 1

C Grape Skin Extract葡萄皮提取物

1000mg/kg

03.0 Edible ices, includingsherbet and sorbet

Note 1

A 5000mg/kg

10.1 Fresh egg (shelled) Note 3

C

Mineral Oil矿物油

5000mg/kg

05.0 Confectionery Note 1

A 200 mg/kg Beverage of VegetableProtein origin

A 500 mg/kg 8.0 Meat and meatproducts

Note1&4

C

Nisin(乳酸链球菌素)

500 mg/kg 1.0 Dairy products Note 1C Phosphate

磷酸盐5000mg/kg

06.4.2 Pre-cooked or driedpastas and noodles andlike products

Note 1

D 1000 mg/kg 11.1 White and semi-whitesugar

D

Benzoate苯甲酸盐

200 mg/kg 14.1.1.2 Table waters and Sodawaters

Note 2

Note 1: C or A is proposed based on technical necessity in food processing and no health concern with theamount recommended.Note 2: D is proposed because there is no sufficient justification on the technical necessity and may result inexcessive exposure.Note 3: For surface treatment only (for maintaining freshness of egg).Note 4: No suitable Food Category Code could be allocated.

Table 2 Comments on the GSFA Working Group Recommendation (Appendix I)

Additive Max Level Food Cat.No. Food/Food Categoryin which Used

Notes

C Aspartame GMP All kinds of foods Note 1D Carotenoids 100 mg/kg 08.1.1 fresh meat, poultry and

game, whole pieces orcuts

Note 2

Additive Max Level Food Cat.No. Food/Food Categoryin which Used

Notes

D 100 mg/kg 08.1.2 Fresh meat, poultryand game,comminuted

D 100 mg/kg 09.1.2 Fresh mollusks,crustaceans andechinoderms

D 150 mg/kg 08.1 Fresh meat, poultryand game

C

Nitrates

500 mg/kg(1600mg/kg)

08.2.1.1 Cured (includingsalted) non-heattreated processedmeat, poultry andgame products inwhole pieces or cuts

Note 3

C 5000mg/kg(880mg/kg)

01.2 fermented andrenneted milk products(plain)

C 5000mg/kg(880mg/kg)

01.5.2 milk and creampowder analogues

C

Phosphates

GMP(530mg/kg)

04.1.2.5 jams, jellies andmarmelades

Note 1

C Saccharin 5000mg/kg(500mg/kg)

04.1.2.7 Candied fruit Note 1

Note 1: C is proposed based on technical necessity in food processing and no health concern with theamount recommended.Note 2: D is proposed because there is no sufficient justification on the technical necessity and may result inexcessive exposure.Note 3:Considering nitrates is a precursor of nitrosamine which is regarded as a carcinogen, therefore alower use level is recommended.

Table 3 Proposals for the use of additives listed in Table 3 in the food categories listed in the Annex to Table3

INS Food Additives FoodCategoryCode

Food/Food Category permitted tobe applied

Maximum Level(mg/kg)

260 Acetic acid 12.2 Complex of spices andcondiments

GMP

1422 Acetylated distarch adipate All kinds of foods GMP1401 Acid treated starch 12.2 Seasoning powder 2500406 Agar All kinds of foods GMP400 Alginic Acid All kinds of foods GMP1100 Alpha-Amylase(Bacillus

subtilis)06.2 Starch GMP

1100 Alpha-Amylase(Carbohydrase)(Basillus

06.2 Starch GMP




licheniforimis)510 Ammonium Carbonate All kinds of foods GMP

06.4 Pastas and noodles 200300 Ascorbic acid14.1.5 Tea beverage 500

162 Beet red All kinds of foods GMP06.4 Pastas and noodles 200302 Calcium Ascorbate12.2 Soup powder 1000

All kinds of foods used as abulking agent

GMP170(i) Calcium Carbonate

06.2 used as a flour treatment agent 30 (in flour)509 Calcium Chloride 04.2..2.6 Bean curd GMP282 Calcium Propionate 06.4 Pastas and noodles 250150a Caramel Color, Class I 12.2 Seasoning powder GMP407 Carrageenan All kinds of foods GMP330 Citric Acid All kinds of foods GMP1400 Dextrins, White and

yellow, Roasted Stach12.2 Soup powder 10000

627 Disodium Guanylate, 5'- All kinds of foods GMP631 Disodium Inosinate, 5'- All kinds of foods GMP635 Disodium Ribonucleotide,

5'-All kinds of foods GMP

1412 Distarch Phosphate 06.4 Pastas and noodles 20009.2 Frozen fish 1000315 Erythorbic Acid12.8 Yeast and the like products (used

in brewing industry)40

297 Fumaric Acid 6.4 Pastas and noodles 600418 Gellan gum All kinds of foods GMP

09.1 Fresh fish and fish products,including mollusks, crustaceansand echninoderms

100575 Glucono Delta-lactone

12.8 yeast and like products GMP06.2 Wheat flour 780 GODF1102 Glucose Oxidase

(Aspergillus niger.var.) 12.8 Yeast and the like products (usedin brewing industry)

80 mg/L

412 Guar gum All kinds of foods GMP414 Gum Arabic All kinds of foods GMP464 Hydroxypropyl starch 12.2 Soup powder 3000630 Inosinci Acid, 5'- All kinds of foods GMP270 Lactic Acid All kinds of foods GMP504(I) Magnesium Carbonate 06.2 Wheat flour 1500 (面粉中)296 Malic Acid, D,L- All kinds of foods GMP621 Monosodium Glutamate All kinds of foods GMP1404 Oxidized Starch 12.2 Seasoning powder 25000440 Pectins (Amidated and

Non-amidated)All kinds of foods GMP

1413 Phosphated DistarchPhosphate

06.4 Pastas and noodles 200

1200 Polydextroses 12.2 Seasoning and condiments GMP402 Potassium Alginate All kinds of foods GMP501(I) Potassium Carbonate 06.4 Pastas and noodles GMP508 Potassium Chloride 12.1 Salt 350551 Silicon Dioxide

(amorphous)




10.2.2 Egg powder 1500011.1 White sugar 1500012.2 Soup powder 1500014.1.5 Instant coffee 15000

401 Sodium Alginate All kinds of foods GMP06.4 Pastas and noodles 200301 Sodium Ascorbate12.8 Yeast and the like products (used

in brewing industry)40

500 (I) Sodium Carbonate 06.4 Pastas and noodles GMP466 Sodium Carboxymethyl

Cellulose06.4 Instant noodles 50000

331 (I) Sodium Dihydrogen Citrate All kinds of foods GMP500(ii)

Sodium HydrogenCarbonate

All kinds of foods GMP

325 Sodium Lactate 06.4 Pastas and noodles 240009.2 Processed fish and fish products 500420 Sorbitol (including sorbitol

syrup) 11.1 Sugar GMP1450 Starch Sodium Octenyl

succinate01.2 Fermented and Renneted Milk

ProductsGMP

332(ii)

Tripotassium Citrate All kinds of foods GMP

331 (I) Trisodium Citrate All kinds of foods GMP06.2 Pastas and noodles 1000002.1 Fats and oils 10000

415 Xanthan Gum

09.2 Processed fish and fish products

INDIA

96. We have gone through the revised Table-1 of the Draft GSFA (Appendix-II) and found that more orless the format of the Draft Table-1 is the same as in CL 1999/15-FAC. Nevertheless, on perusal of RevisedTable-1 under Sulphites on page 74 & 75 of 86, we find that Food Category No.11.1 is not included in theDraft. This category covers ‘White and semi-white sugar (sucrose or saccharose), fructose, glucose(dextrose), xylose, sugar solutions and syrups, also (partially) inverted sugars, incl. Molasses, treacle, andsugar toppings’ as can be seen under Sucrose esters of fatty acids cat. No.11.1. Since the above items havesulphites, as such cat. No.11.1 as per draft GSFA Table-1 of 99, page 151 of 167 be also included in theRevised Table-1 under Sulphites.

INDONESIA

97. Aluminium Ammonium Sulfate (INS 523)Its function as :a. Acidity regulator in baking powder with maximum level of use is GMPb. Firming agent in pickled cucumber in glass with maximum level of use is GMPFunction as raising agent and stabilizer until now has not been regulated.

98. Carmines (INS 120)Its function as color in flavored yogurt And products heat treated after fermentation, with maximumlevel of use 20 mg/kg flavoring substances as a result of carry over.

99. Brilliant Blue FCF (INS 133)Its function as color in :

a. edible ices and ice mixes with maximum level of use 100 mg/kg in the final product (total amount ofcolor 300 mg/kg)

b. canned green peas with maximum level of use 100 mg/kg, singly or in combination with other colorsc. canned nature processed peas with maximum level of use 200 mg/kg singly or in combination with

other colorsd. pickled cucumbers in glass with maximum level of use 300 mg/kg singly or in combination with

other colorse. jams and jellies; canned apples sauces with maximum level of use 200 mg/kg singly or in

combination with other colorsf. other food with maximum level of use 100 mg/kg singly or in combination with other colors

100. Chlorophylls copper complexes (INS 141i)Its function as color in :a. edible ices and ices mixes with maximum level of use 100 mg/kg in the final productsb. pickled cucumber in glass with maximum level of use 300 mg/kg singly or in combination with

other colorsc. processed cheese preparation with maximum level of use is GMP

101. Diacetyl tartaric and fatty acid esters of glicerol (INS 472e)Its function as emulsifier, stabilizer and thickener in :a. edible ices and ices mixes with maximum level of use 10 g/kg or in combination with other

emulsifier, stabilizer and thickenersb. margarine 10 g/kg singly or in combination with other emulsifiers

102. Ethyl p-hydroxy benzoate (INS 214)Its function as preservative in jams and jellies with maximum level of use 1 g/kg singly or incombination with benzoates, sorbic acid and pottasium sorbate

103. Metyhl p-hydroxy benzoate (INS 218)Its function as preservative in :a. jam and jellies with maximum level of use 1 g/kg singly or in combination with benzoates, sorbic

acid and pottasium sorbateb. pickled cucumbers in glass; soy sauce with maximum level of use 250 mg/kgc. dry coffee extract, with maximum level of use 450 mg/kgd. tomato paste; fruit juice with maximum level of use 1 g/kge. other unstandardized food, except unstandardized preparation of :

- meat- fish- poultrywith maximum level of use 1 g/kg

104. Propyl p-hydroxy benzoate (INS 216)Its function same with metyhl p-hydroxy benzoate

105. Nisin (INS 234)Its function as preservative in processed cheese preparation; with maximum level of use 12.5 mg/kg

106. Phosphatidic acid ammonium salts (INS 442)Its function as emulsifier ion cocoa powder and dry cocoa sugar mixture with maximum level of use 7g/kg (total emulsifier 15 g/kg)

107. Polysorbate 60 (INS 435)Its function as emulsifier, stabilizer and thickener in :a. edible ices and ice mixes with maximum level of use 10 g/kg singly or combination with other

emulsifier, stabilizer and thickenerb. cake, cake mixes with maximum level of use 5 g/kg on a dry weight basis, if polisorbat 65 is also

used the total must not exceed 5 g/kg on a dry weight basis

c. chocolate with maximum level of use 5 g/kg of finished cake icing, if polysorbate 80 or sorbitanmonostearate, either singly or in combination as also used, the total must not exceed 5 g/kg offinished cake icing

108. Polysorbate 65 (INS 436)Its function as emulsifier, stabilizer and thickener in :a. edible ices and ice mixes with maximum level of use 10 g/kg singly or in combination with other

emulsifier, stabilizer and thickenersb. cake with maximum level of use 3 g/kg on a dry weight basis, if polysorbate 60 is also used the total

must not exceed 5 g/kg dry weightc. beverage base or mix with maximum level of use 500 mg/kg beverage if sorbitan monostearate is

also used, the total must not exceed 500 mg/kg beveraged. breath freshener product in candy, tablet or gum form with maximum level of use 200 mg/kge. flavoured milk with maximum level of use 5 g/kgf. margarine with maximum level of use 10 g/kgg. chocolate with maximum level of use 10 g/kg singly or in combination with other emulsifier (total

emulsifier 15 g/kg)

109. Polysorbate 80 (INS 433)Its function as emulsifier, stabilzer and thickeners in :a. edible ices and ice mixes 10 g/kg, singly or in combination with other emulsifier, stabilizer and

thickenersb. cake icing 5 g/kg of the finished cake icing, if polysorbate 60 or sorbitan monostearate, either singly

in combination is used, the total must not exceed 5 g/kg of the finished cake icingc. beverage base or mix with maximum level of use 500 mg/kg beverage if sorbitan monostearate is

also used, the total must not exceed 500 mg/kg beveraged. breath freshener products in candy tablet or gum form with maximum level of use 100 mg/kge. cream with maximum level of use 1 g/kgf. pickled cucumber in glass with maximum level of used 500 mg/kg singly or in combination with

other sulubilizing and disversing agentsFunction as antifoaming agent, adjuvants, foaming agent, flour treatment agent until now has not beenregulated

110. RiboflavinIts function as color in :a. pickled cucumber in glass with maximum level of use 300 mg/kg singly or in combination with

other colorsb. cheese;processed cheeses preparation with maximum level of use is GMPc. edible ices and ices mixes with maximum level of use 50 mg/kg in the final products

111. Sodium aluminium phosphate (INS 541)Its function as emulsifier, stabilizer and thickeners in :Processed cheese preparation with maximum level of use 9 g/kg, singly or in combination with otheremulsifier, stabilizer and thickeners

112. Sucroglycerides (INS 474)Its function as emulsifiers, stabilizers and thickeners in :a. margarine with maximum level of use 10 g/kgb. edible ices and ice mixes with maximum level of use 10 g/kg, singly or in combination with other

emulsifiers, stabilizers and thickeners

113. Benzoic Acid (INS 210)Its function as preservative in :a. soy sauce with maximum level of use 600 mg/kgb. soft drink with maximum level of use 600 mg/kgc. pickled of cucumbers in glass with maximum of use 1 g/kg, singly or in combination with potassium

and sodium salt of benzoic acid and potassium sorbate

d. margarine with maximum level of use 1 g/kg, singly or in combination with their salts or sorbic acidand their salts and sulphites but sulphites not to exceed 500 mg/kg

e. other foods with maximum level of use 1 g/kg

114. Potassium benzoate (INS 212)Its function preservative in :a. pickled of cucumber in glass with maximum level of use 1 g/kg, singly or in combination with

benzoic acid, sodium benzoate and potassium sorbateb. cheeses with maximum level of use 1 g/kg, singly or in combination with their saltsc. margarine with maximum level of use 1 g/kg, singly or in combination with the acid, sorbic acid and

their saltsd. dried apricots with maximum level of use 500 mg/kg, singly or in combination with their saltse. jams and jellies with maximum level of use 1 g/kg, singly or in combination with potassium sorbate

and salts of benzoic acidf. marmalade with maximum level of use 500 mg/kg, singly or in combination with potassium sorbateg. concentrated pineapple juice with maximum level of use 1 g/kg, singly or in combination with the

acid, sorbic acid and their salts and sulphites, but sulphites not to exceed 500 mg/kgh. syrup, tomato salts with maximum level of use 1 g/kgi. wine, fruit wine and other alcoholic beverage with maximum level of use 200 mg/kgj. other unstandardized food, (except unstandardized preparation) of :

- meat- fish- poultry

115. Calcium Benzoate (INS 213)Its function as preservative in :a. concentrated pineapple juice with maximum level of use 1 g/kg, singly or in combination with the

acid, sorbic acid and their salts and sulphites but sulphite not to exceed 500 mg/kgb. tomatoes sauce, syrup, concentrated fruit juice with maximum level of use 1 g/kgc. wine, fruit wine and other alcoholic beverage with maximum level of use 200 mg/kg

116. Sodium Benzoate (INS 211)Its function as preservative in :a. see potassium benzoateb. jams and jellies with maximum level of use 1 g/kg, singly or in combination with sorbic acid and

potassium salt or ester p-hydroxy benzoic acidc. soy sauce with maximum level of use 600 mg/kgd. soft drink with maximum level of use 600 mg/kge. tomato sauce with maximum level of use 1 g/kgf. other foods with maximum level of use 1 g/kg

117. Ascorbyl palmitate (INS 304)Its function as antioxidant in :a. edible fat and oil, with maximum level of use 500 mg/kg, singly or in combination with ascorbyl

stearateb. margarine, with maximum level of use 200 mg/kg, singly or in combination with ascorbyl stearatec. edible arachis oil; edible coconut oil and other oils with maximum level of use 200 mg/kg, singly or

in combination with ascorbyl stearated. infants formula with maximum level of use 10 mg/l of the ready to drink producte. canned baby foods; processed cereal, based food for infants and children, with maximum level of use

200 mg/kg fat

118. Ascorbyl Stearate (INS 305)Its function as antioxidant in :a. edible fat and oil with maximum level of use 500 mg/kg or in combination with ascorbyl palnitateb. margarine with maximum level of use 200 mg/kg, singly or in combination with ascorbyl palmitate

edible arachis oil;edible coconut oil and other oils with maximum level of use 200 mg/kg, singly or incombination with ascorbyl palmitate

UNITED STATES

Revised Table 1 of the Draft GSFA

119. Several high-intensity sweeteners in food category 11.4 (Table- top sweeteners, including thosecontaining high-intensity sweeteners) are listed in the revised Table 1 of the GSFA. Table-top sweetenerscontaining high intensity sweeteners are sold to the consumer as a composite food that generally containsantioxidants (e.g., ascorbyl esters), bulking agents (e.g., maltodextrin) and anticaking agents (e.g.,polydimethylsiloxane).

120. Table-top sweeteners are not eaten as is, but rather are added by the consumer to other food products(e.g., breakfast cereals, fruit, beverages). The use of a mg/kg limitation for high intensity sweeteners intable-top products couild lead to confusion in the marketplace because a mg/kg limitation could beinterpreted on an as-is basis. On an as-consumed basis the concentration of high intensity sweeteners intable-top sweeteners varies widely depending on the type of food to which the product is added (e.g., addedto a beverage, sprinkled on fruit) or the preference of the consumer. Therefore, the use of high-intensitysweeteners in table-top sweeteners should only be limited by good manufacturing practices (GMP) becausetable-top sweeteners are not consumed on an as-is basis. Moreover, the use of high-intensity sweetenersunder GMP is self-limiting and there is no evidence that these self-limiting levels would result in exceedingthe ADI assigned by JECFA.

121. The USA recommends that the CCFAC not establish numeric limits for the use of high intensitysweeteners in table-top sweeteners. The USA recommends that the CCFAC endorse GMP limitations for theuse of high intensity sweeteners in food category 11.4.

Provisions for the use of additives listed in Appendix III to CL 2000/33-FAC

Aluminum Ammonium Sulfate (INS 523)

122. The use of aluminum ammonium sulfate in Beer and Malt Beverages (14.2.1) should be deleted.The USA reported the use of aluminum ammonium sulfate as a processing aid, in beer and malt beveragesand not as a food additive.

Brilliant Blue FCF (INS 133)

123. In principle, the USA supports inclusion of “brilliant blue FCF” in the GSFA but notes that to ensurethe safe use of brilliant blue FCF in food, the USA requires batch certification of brilliant blue FCF as FD&CBlue No. 1.

Brilliant Blue FCF (INS 133), Carmines (INS 120), Carotenes, Vegetable (INS 160aii), Chlorophylls,Copper Complexes (INS 141i, 141ii), Grape Skin Extract (INS 163ii)

124. In the USA, colors are generally not permitted in raw, uncooked meat or poultry products (foodcategory 8.1). Colors are however, permitted for limited use as “stamping inks” for marking raw, uncookedmeat or poultry products.

Proposals for the use of Caramel Color II (INS 150b) as a color in food

125. The 55th Session of the JECFA assigned Caramel Color II an ADI of 0-160 mg/kg bw. The 29th

JECFA assigned Caramel Color I (INS 150a) an ADI not specified, and assigned Caramel Color III (INS150c) and Caramel Color IV (INS 150d) each an ADI of 200 mg/kg bw. The 23rd Session of the CodexAlimentarius Commission (CAC) adopted Caramel Color I as part of Table 3 of the GSFA. Provisions forthe use of Caramel Colors III and IV were endorsed by the 23rd CAC for use in specific food categories and

are listed in Tables 1 and 2 of the GSFA. In the USA, all of the caramel colors are approved color additivesfor use in foods generally with a limitation of GMP. The USA therefore recommends that the CCFACconsider including Caramel Color II in Tables 1 and 2 of the GSFA at levels not to exceed GMP.

Proposals for the use of additives listed in Table 3 in the food categories listed in the Annex to Table 3

126. The USA proposes the following editorial changes to the food categories listed in the Annex toTable 3 (ALINORM 99/12A, App. III).

1. Delete the following sub-categories because they are redundant in light of the hierarchical nature ofthe food category system and the listing of the supra-food category:

a) 04.1.1.2 (Surface-treated fresh fruit) and 04.1.1.3 (Peeled or cut fresh fruit). These sub-categoriesare superseded by the listing of food category 04.1.1 (Fresh fruit) in the Annex to Table 3.

b) 04.2.1.2 (Surface-treated fresh vegetables, and nuts and seeds) and 04.2.1.3 (Peeled, cut or shreddedfresh vegetables, and nuts and seeds). The listing of food category 04.2.1 (Fresh vegetables, nuts andseeds) supersedes these sub-categories in the Annex to Table 3.

These food category names have also been revised to reflect changes in the food category systemagreed to by the 32nd CCFAC (ALINORM 01/12, para. 36).

2. Update the list of food categories to reflect the changes in the food category system agreed to by the32nd CCFAC (ALINORM 01/12, App. VIII) by replacing food category 06.4 (Pastas and noodlesand like products (e.g., rice paper, rice vermicelli) (Only dried products) with the subcategories06.4.1 (Fresh pastas and noodles and like products) and 06.4.2 (Pre-cooked or dried pastas andnoodles and like products (Only dried products)).

These food category (06.4.1 & 06.4.2) descriptors reflect the changes agreed to by the 32nd CCFAC(ALINORM 01/12, para. 36).

3. Replace the sub-categories 08.1.1 (Fresh meat, poultry and game, whole pieces or cuts) and 08.1.2(Fresh meat, poultry and game, comminuted) with the supra-food category 08.1 (Fresh meat poultryand game). Food category 08.1 exclusively contains the sub-categories 08.1.1 and 08.1.2.

4. Correct the typographical error for the food category “Canned or bottled (pasteurized) fruit juice,”which should be 14.1.2.1 instead of 14.12.1.

127. For clarity, a list of food categories appearing in the Annex to Table 3 that incorporates thesechanges is appended. The proposed deletions are indicated by strikeout and the proposed additions andchanges are indicated in bold.

128. Table 3 includes INS 1420 as “starch acetate” (ALINORM 99/12A, App. III). According to theSummary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)1954-1997 (First through Forty-ninth Meetings), FAO/WHO, 1999, INS 1420 is listed as “starch acetate(esterified with acetic anhydride or 7.5% max. vinyl acetate). According to the Codex INS (Sects. 3 & 4 ofthe Codex Alimentarius, Vol. 1A, 1995), INS 1420 is “starch acetate esterified with acetic anhydride” andINS 1421 is “starch acetate esterified with vinyl acetate.” Based on this information, it appears that JECFAhas included the substance identified as INS 1421 in the Codex INS under its evaluation of “starch acetate”(INS 1420). The USA recommends that the JECFA Secretariat be asked to clarify the ADI status of INS1421. If the JECFA Secretariat’s response indicates that the JECFA evaluated both starch acetates (INS1420 and 1421) when assigning an ADI, then the current listing of INS 1420 (starch acetate) in Table 3should be amended to include the esterification agent agent i.e., INS 1420 (starch acetate esterified withacetic anhydride) and add INS 1421 (starch acetate esterified with vinyl acetate) to the table. Consequently,any entries in Tables 1 and 2 of the draft GSFA for the use of the current INS 1420 (starch acetate) in thefood categories listed in the Annex to Table 3 should be corrected to reflect the changes in Table 3.

Food Categories or Individual Food Items Excluded from the General Conditions of Table Three

129. The use of additives listed in Table Three in the following foods is governed by the provisions inTables One and Two.

Cat. No. Food Category01.1.1 Milk and buttermilk01.2 Fermented and renneted milk products (plain) excluding food category 01.1.2 (dairybased

drinks)01.4.1 Pasteurized cream01.4.2 Sterilized, UHT, whipping or whipped, and reduced fatcreams02.1 Fats and oils essentially free from water02.2.1.1Butter and concentrated butter (Only butter)04.1.1 Fresh fruit04.1.1.2Surface treated fresh fruit04.1.1.3Peeled or cut fresh fruit04.2.1 Fresh vegetables, and nuts and seeds04.2.1.2Surface-treated fresh vegetables, and nuts and seeds04.2.1.3Peeled, cut or shredded vegetables, and nuts and seeds04.2.2.1 Frozen vegetables06.1 Whole, broken or flaked grain, including rice06.2 Flours and starches06.4 Pastas and noodles and like products (e,g, rice paper, rice vermicelli) (Only dried

products)06.4.1 Fresh pastas and noodles and like products06.4.2 Pre-cooked or dried pastas and noodles and like products (Only dried products)08.1 Fresh meat, poultry and game08.1.1 Fresh meat, poultry and game, whole pieces or cuts08.1.2 Fresh meat, poultry and game, comminuted09.1 Fresh fish and fish products, including mollusks, crustaceans and echinoderms09.2 Processed fish and fish products, including mollusks, crustaceans and echinoderms10.1 Fresh eggs10.2.1 Liquid egg products10.2.2 Frozen egg products11.1 White and semi-white sugar (sucrose or saccharose), fructose, glucose (dextrose), xylose;

sugar solutions and syrups, also (partially) inverted sugars, including molasses, treacle andsugar toppings

11.2 Other sugars and syrups (e.g., brown sugar and maple syrup)11.3 Honey12.1 Salt12.2 Herbs, spices, seasoning (including salt substitutes) and condiments (e.g., seasoning for

instant noodles) (Only herbs and salt substitutes)12.8 Yeast13.1 Infant formulae and follow-on formulae13.2 Weaning foods for infants and growing children14.1.1.1Natural mineral waters and source waters (Only natural mineral waters)14.1.2.1Canned or bottled (pasteurized) fruit juice14.1.2.3Concentrates (liquid and solid) for fruit juice914.1.3.1Canned or bottled (pasteurized) fruit nectar14.1.3.3Concentrates (liquid and solid) for fruit nectar14.1.5 Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages,

excluding cocoa

9 The addition of food categories 14.1.2.3, 14.1.3.1, and 14.1.3.3 was adopted by the 23rd Session of the CAC,(ALINORM 99/37, para. 111)

14.2.3 Wines

ASSOCIATION DES AMIDONNERIES DE CEREALES DE LÚNION EUROPEENNE (AAC)

ANNEX 5 PROPOSED DRAFT ADDITIONS TO TABLES 1 AND 2 OF THE GSFA AACCOMMENTS REGARDING THE CHEMICALLY MODIFIED STARCHES

130. All modified starches have an ADI non specified and are listed in table 3 of thegeneral standard on food additives of the CCFAC “Additives permitted for use in food ingeneral unless otherwise specified in accordance with GMP”. The annex to table 3 limits orexcludes some food categories from the general conditions.

131. Therefore by the provisions of annex 3, the chemically modified starches are excludedfor use in certain foods (battered fish, and certain weaning foods for young children) wherethey have a long tradition of use, and technological justification. That’s why the exceptions tothe annex of table 3 of the GSFA are re-incorporated to tables 1 and 2. This is found in annex5 of document ALINORM 01/12.

Reminder, the following are modified starches :

ACTYLATED DISTARCH ADIPATE 1422ACTYLATED DISTARCH PHOSPHATE 1414ACID TREATED STARCH 1401ALKALINE TREATED STARCH 1402BLEACHED STARCH 1403DEXTRINE WHITE AND YELLOW,ROASTED STARCH 1400DISTARCH PHOSPHATE 1412ENZYME TREATED STARCH 1405HYDROXPROPYL DISTARCH PHOSPHATE 1442HYDROXPROPYL STARCH 1440MONOSTARCH PHOSPHATE 1410OXIDIZED STARCH 1404PHOSPHATED DISTARCH PHOSPHATE 1413STARCH ACETATE 1420STARCH SODIUM OCTENYL SUCCINATE 1450

In the EU the following starches are not considered as food additives :

ACID TREATED STARCH 1401ALKALINE TREATED STARCH 1402BLEACHED STARCH 1403DEXTRIN WHITE AND YELLOW, ROASTED STARCH 1400ENZYME TREATED STARCH 1405

132. The reason for this is because they are minor treated starches and enjoy the samespectrum of use as NATIVE and PHYSICALLY MODIFIED STARCHES.

133. In tables 1 and 2 there is therefore no reason to impose limits of inclusion for example10000mg/kg for the starches 1400,1401,1402,1403,and 1405 which are granted native starchstatus in Europe.

The other modified starches:

134. All modified starches are used for their specific technological functions. Thefollowing modified starches 1404,1410,1412,1413,1414,1420,1422,1440,1442,1450, are foodadditives with an ADI non-specified as granted by JECFA. Their use is defined according toGMP (table 3 of GSFA). The choice of a type of starch ultimately depends on the desiredproperty in the foodstuff : texture, viscosity, and palatability at the best price possible.

135. The AAC/UFE notes in the proposed draft additions to table 1 and 2, inclusionslimited to 10000 or 25000 ppm. There is no reason to have restrictions other than GMP. Theabove modified starches have horizontal approval throughout the EU. They are listed onAnnex 1 of Council Directive 95/2/EC as generally permitted additives. As such they may beadded to all foodstuffs following the quantum statis principle unless otherwise specifiedwithin the Directive. The use of these modified starches is restricted in weaning foods, whereall modified starches are limited to 5% inclusion, with the exception of the hydroxypropylstarches (1440 and 1442) which are not authorised. Note the reference text in Europe isDirective 95/2 relative to additives other than colours and sweeteners annexes 1-5 and 6 thirdpart.

136. Due to the fact that they have similar generic functions as bulking agent, emulsifier,stabiliser, thickeners etc. the AAC/UFE cannot see any reasons for discrepancies in the proposedconditions of use. We therefore, as the AAC/UFE, request that the conditions of use for all themodified starches be identical.

EUROPEAN CHEMICAL INDUSTRY COUNCIL (CEFIC)

137. We have been informed that the International Sweeteners Association (ISA) is seeking clarificationthat sweeteners can be used in foods for which they are not listed in the draft General Standard for FoodAdditives. This allows us to modify our proposal for INS 950 Acesulfame K. Below please find our newproposal, and we would like to ask you to replace our former submission by this new proposal.

Proposals for additional listings for INS 950 Acesulfame K

138. The following categories are proposed for addition. These proposals are based on legislation inmember states of the Codex Alimentarius. Some are made to clarify the applicability of Acesulfame K semi-finished products not intended for consumption.

01.5 Milk powder and cream powder: GMP

139. This listing would replace the present limitation to category 01.5.1

140. Reason: Powdered dairy and dairy-analogue prepapations used in coffee and tea instead of milk orcream fall in this category. The can be pre-sweetened. As the dosage is in the discretion of the user/consumerand will be made on the basis of personal taste preferences GMP listing is proposed. Present approvals are,i.a.: dry bases for instant beverages (GMP, Taiwan) and dry bases for instant beverages and dairy-analogueproducts (GMP, USA)

01.6.5 Cheese analogues: GMP

141. This proposal is equivalent to the listing in category 01.6.1 (unripened cheese).Reason: In several countries approvals for dairy products include analogues provided they are adequatelylabelled.

06.1 Whole, broken, or flaked grain, including rice: 300 mg/kg

142. Reason: Approval for mixed congee in The People´s Republic of China, also covered by approvalsfor "other foods" in Japan and Korea granted in 2000.

06.4.2 Pre-cooked or dried pastas and noodles: 1000 mg/kg

143. Reason: Approvals for flour paste in Japan and Korea granted in 2000.

14.1.2.3 Concentrate for fruit juice: 3000 mg/kg

144. This proposal corresponds to the listing in category 14.1.2.1 (canned or bottled fruit juice) with a uselevel of 600 mg/kg.

145. Reason: In many countries additives approved for the ready-to-use product can also be added toconcentrates and pre-blends at levels corresponding to those approved for the ready-to-use product. Listingin this category will clarify that concentrates containing Acesulfame K can be placed on the market ininternational trade. The proposed level corresponds to a dilution factor of 5 before consumption.

14.1.2.4 Concentrate for vegetable juice: 3000 mg/kg

146. This proposal corresponds to the listing in category 14.1.2.2 (canned or bottled vegetable juice) witha use level of 600 mg/kg.


14.1.3.3 Concentrate for fruit nectar: 2500 mg/kg

148. This proposal corresponds to the listing in category in category 14.1.3.1 (canned or bottled fruitnectar) with a use level of 500 mg/kg.


14.1.3.4 Concentrate for vegetable nectar: 2500 mg/kg

150. This proposal corresponds to the listing in category 14.1.3.2 (canned or bottled vegetable nectar)with a use level of 500 mg/kg.


16.0 Composite foods: 350 mg/kg

152. Reason: Approvals for "other foods" in Japan and Korea granted in 2000.

EUROPEAN COMMUNITY

General Comments

153. The European Community attempts to minimise the use of food additives to those that aretechnologically necessary and to limit their use to an as low as possible level.

154. Accordingly the European Community is of the opinion that the Draft General Standard on FoodAdditives (GSFA) generally allows too many additives in too many food products. In our opinion the CodexCommittee for Food Additives and Contaminants should make a close scrutiny of the Draft General Standardon Food Additives (GSFA) and should

− re-examine which additives are technologically necessary in the individual foodstuffs (to this end a tablewhich is arranged according to foodstuff groups should be discussed),

− question levels which are very high (see examples in specific comments on the priority list),− compare the standards accepted by the Codex Commodity Committees to those in the draft GSFA in

order to avoid contradictions. In this respect we await receipt of the “discussion paper on therelationship between Codex Commodity Standards and the further development of the GSFA” announcedby the Codex secretariat under agenda item 7.

155. We are aware that differences exist in the production processes and storage conditions employedaround the world. The same phenomenon can be observed when it comes to food patterns and the taste andcolour preferences of individual countries. These differences must be taken into account when evaluating thetechnological need for food additives in the Draft General Standard on Food Additives (GSFA).

156. On the other hand we do not understand the reasoning behind the procedure described on page 2 ofCircular Letter 2000/33 and point 4 ii/iii. According to this procedure, two levels are proposed if a new entryis higher10 and only one level (the higher one) is proposed if the new level is less (or equal to) the use levelfor an entry already listed in the draft GSFA.

157. We suggest that instead of automatically adopting the highest reported use level of each additive asthe maximum use level, the lowest reported use level should be adopted by the Codex Committee on FoodAdditives and Contaminants. This has been discussed in great length at earlier sessions of the Committee.

158. If the principle for setting levels of use in Codex had been chosen to be the lowest level, thepossibilities of exceeding the ADI would had been reduced. If a Member State, in submitting properdocumentation, can justify a need for higher use levels, this should be taken into account. If properdocumentation can not be provided, the entry is to be deleted from the GSFA. This approach will ensure thatadditives are only used in applications where the technological need is justified and in quantities that are notexceeding the amounts sufficient to fulfil this need.

Allocation – Composite Food – Carry-over

159. Codex employs a system for categorising foodstuffs consisting of 16 food groups. As a general rule,any foodstuff should be allocated to one of these groups. To our understanding it is supposed to be designedin order to ensure easy and consistent understanding of which additives are allowed in different groups offoodstuffs. However, there are no guidelines given in any Codex document, this means there is a possibilityfor misunderstandings in the allocation of a specific foodstuff. During the discussion of some of the entriesin the GSFA, the European Community has discussed the matter of allocation into a food group, andidentified a need for guidance. In the interest of clarity, we would like to suggest the following text as a basisfor a guideline to the GSFA e.g. as an appendix.

Proposal for a guideline text on allocation:

160. If a composite foodstuff can not be allocated to one of the food groups from 1 to 15, it should notautomatically be categorised as a foodstuff of group 16. A composite foodstuff in most cases consists ofingredients or parts that individually can be placed in the food categories 1 to 15. This can be illustrated bythe following examples:

10 (e.g., Adipate has two entries listed for use in food category 02.4, one at Step 6 (10,000 mg/kg) and one at Step 3(30,000 mg/kg)

• Pizza is made up of a bread-part belonging to group 7.2 (bread and ordinary bakery wares) and toppingingredients belonging to different groups such as ripened cheese (1.6.2.1), vegetable preparations(4.2.2.6), heat-treated processed meat (8.2.2) depending on the recipe.

• Beer coolers are made from beverages belonging to group 14.1.4, (water-based flavoured drinks) andgroup 14.2.1, (beer and malt beverages).

161. The composite foodstuff may thus contain proportional quantities of the food additives allowed inthe constituent ingredients.

162. The carry-over principle illustrated by these examples can generally be applied to any compositefoodstuff. As a result a food additive may be permitted in one or several of the ingredients of the compositefoodstuff. The amount of residue tolerated will be that of the respective amount authorised in the individualingredients. Separate listings for the additives that may be carried over into composite food would thereforebe redundant. One important exception of this general rule would be infant formulae, follow-on formulae andweaning foods.

163. If these guidelines were followed, the food category 16.0 should for example not include casseroles,meat pies and minced meat. This is because all the ingredients of these composite foodstuffs would beregulated in accordance with the food additive approvals in the food categories 1 to 15. As a consequence ofthis proposal, it is suggested that all the products assigned to group 16.0 be re-evaluated. As a result of thisexercise, group 16.0 should contain fewer but more precise entries.

164. Moreover notes such as note 12 “Carryover from flavouring substances” would probable becomeredundant.

Additives in unprocessed or fresh food

165. The European Community is of the opinion that unprocessed foods or fresh food such as:

• Fresh fruit and vegetables (food categories 04.1.1 and 04.2.1)• Frozen fruit and vegetables (food categories 04.1.2.1 and 04.2.2.1)• Flours and starches (food category 06.2)• Fresh meat and fish (food categories 08.1 and 09.1)• Fresh eggs (food category 10.1)

should not contain additives.

166. This is because the use of additives in these products will in many cases mislead the consumers onthe quality of the foodstuff. Any exemption should be justified as a technical necessity. The CodexCommittee on Food Additives and Contaminants has already accepted some exemptions following properdocumentation. However, the technological need for the majority of the suggested additives in the GSFA forunprocessed foods or fresh food seems unjustified and should be deleted, if documentation is not presentedto the Committee.

Additives in infant formulae, follow-on formulae, and weaning foods

167. Infant formulae, follow-on formulae, and weaning foods are full-meal foodstuffs in the sense thatthey constitute most if not all the nutrition provided to an infant. For this reason it is imperative that this foodonly contains additives that are technologically justified or even indispensable. If considered necessary theyshould only be authorised in the minimal amounts necessary to obtain the desired effect.

168. In particular the European Community does not support the use of colouring agents or sweeteners ininfant formulae, follow-on formulae and weaning foods.Use of colouring agents

169. According to the draft GSFA, colours are proposed for a significant number of food groups. In somecases the use of colours can mislead consumers and many consumers find colours superfluous as additives infood. For this reason the European Community believes that colours should be used in a restrictive manner.

170. In Directive 94/36/EC of the European Community it is stipulated that the use level of all colourswith low numerical ADIs for a given foodstuff is the total sum of all colours with low numerical ADIsemployed. The Codex Committee on Food Additives and Contaminants (CCFAC) was notified on thisprovision in Community legislation at an earlier stage. We suggest that a similar provision be incorporated inthe GSFA using the document’s note system. The European Community believes that the Committee - byimplementing such a provision - would lay the foundation for a more cautious use of colours in foodstuffs.

171. In particular we would like to avoid any colouring in (grape)wine, unprocessed food and infantformulae, follow-on formulae and weaning foods.

Preservatives

172. Draft General Standard on Food Additives (GSFA) allows the use of preservatives in a broad varietyof foodstuffs. Moreover some of the levels proposed are quite high. This is especially true if it is taken intoaccount that there is no provision that excludes the use of similar preservatives like sorbates, benzoates andp-hydroxybenzoates in the same product. A provision that limits the use of several preservatives withoverlapping technological effects in the same product is recommended.

173. The use of preservatives in fresh or unprocessed food is misleading to consumers since a foodstuffcan not both be fresh or unprocessed and at the same time preserved.Hence the use of e.g. p-hydroxybenzoates in surface-treated fresh fruit (04.1.1.2), peeled or cut fresh fruit(04.1.1.3), surface-treated fresh vegetables (04.2.1.2), peeled, cut or shredded vegetables (04.2.1.2) shouldnot be allowed.

Use of Additives with quantitative/numerical ADI under GMP

174. The European Community considers that additives having a quantitative/numerical acceptable dailyintake (ADI) should not be allowed to be used according to Good Manufacturing Practice (GMP) in theGSFA. When additives are used according to GMP it is not possible to conduct reliable intake-studies inorder to evaluate whether or not the ADI has been exceeded. For this reason the European Communitysuggests that the GMP status for all additives having a quantitative ADI is re-evaluated.

Annex to Table 3 GSFA

175. The Annex to Table 3 lays down a list of foodstuffs that are considered to be basic foodstuffsconsumed regularly by all age groups or especially by infants. Yeast (category 12.8) is currently included inthe Annex. However, in yeast many additives listed in Table 3 are commonly used, such as ascorbic acid,carbon dioxide, nitrogen, and nitrous oxide. As yeast is merely an ingredient in bread, not a basic foodstuff,we would like to propose that yeast is removed from the Annex to Table 3.

Wine (category 14.2.3)

176. We think that any use of food additives in wine should be in line with the OIV norms. Additives notneeded for wine making should be removed from the GSFA and the maximum use levels should be in linewith the need expressed by OIV.

Pastas and noodles (category 6.4)

177. The European Community would like to question the technological need for the many additives indry and fresh pasta. In the European Community, where the highest amount of pasta products is consumedper capita in the world, the use of additives is forbidden in dry pasta and the use of additives in fresh pasta is

very restricted. This is because all technological and sensorial needs can be fulfilled by using naturalingredients, while very few additives are required in fresh pasta and in the fillings of filled pasta.

Request for Comments on the Draft Revised Codex General Standard for Food Additives (GSFA)Priority List (appendix III)

178. The 32nd CCFAC agreed that the USA should select additives for discussion by the 33rd CCFAC.Appendix III lists all of the Group V1 additives. The Committee’s ad hoc GSFA working group intends todiscuss provisions in the revised Table 1 for all of the Group V additives as well as provisions for the use ofbenzoates.

179. The European Community has examined the substances listed on the priority list (Appendix III) ofthe draft Codex General Standard for Food Additives (GSFA) (CL 2000/33 – FAC) and would like to makethe following specific remarks. More general remarks will be made in a separate document.

Aluminum Ammonium Sulphate

INS/E: 523Function: Firming Agent, Raising Agent, Stabilizer

180. The tolerable weekly intake of aluminium is 7 mg/kg bodyweight equal to approximately 60 mg/dayaluminium (originating from all sources) for an adult. The use of aluminium ammonium sulphate accordingto Good Manufacturing Practice in common foodstuffs such as flours and starches (06.2) and beer and maltbeverages (14.2.1) is not in accordance with the limitation of the daily intake. Moreover it is noteworthy thatthe provisional tolerable daily intake of aluminium will be exceeded with the ingestion of 30 grams of egg-based dessert (10.4) or composite food (16.0) containing the proposed levels. Furthermore the technologicalneed for this additive does not seem justified in applications as vegetables and seaweeds in vinegar(04.2.2.3), vegetable preparations (04.2.2.6), cooked and fried fish (09.2.4) and beer and malt beverages(14.2.1).

181. On the contrary the European Community finds that the technological need is documented in thecase of use of up to 30 mg/kg aluminium ammonium sulphate in egg white-products in order to re-establishthe whipping ability of pasteurised egg white. A higher use level appears technologically unjustified.

Ascorbyl Esters

Ascorbyl Palmitate: Ins/E 304 (Fatty acid esters of ascorbic acid)Ascorbyl Stearate: Ins/E 305 (Fatty acid esters of ascorbic acid)

182. The ADI assigned to Ascorbyl Esters by JECFA is 1.25 mg/kg. Considering this, the EuropeanCommunity cannot accept the proposed use of the additive in infant formulae and follow-on formulae (13.1)at 10000 mg/kg. An infant of 4 kg would then only be able to consume 0.5 grams of formula before the ADIis exceeded. The use level of 50 mg/kg is closer to the amount used for this application within theCommunity (10 mg/kg). Due to the previously mentioned reasons it is also suggested to lower the use levelin weaning foods (13.2) from 1000 mg/kg to 100 mg/kg.

183. The use of Ascorbyl Esters in table-top sweeteners (11.4), salt (12.1) and yeast (12.8) seemstechnologically unjustified. These uses should be deleted.

184. The technological need for Ascorbyl Esters in pre-cooked dries pastas and noodles (GMP) andvegetable oils and fats has to be justified.

Beeswax, White and Yellow

INS/E: 901Function: Bulking Agent, Glazing Agent, Release Agent, Stabilizer

185. It is not clear why the use of beeswax for fine bakery wares has been limited to 500 mg/kg whileCandelilla Wax and Carnauba Wax can be used according to GMP.

Benzoates

Benzoic Acid INS/E: 210; Sodium Benzoate INS/E: 211;Potassium Benzoate INS/E: 212; Calcium Benzoate INS/E: 213,Function: Preservative

186. Generally the draft Codex standard allows the use of preservatives in a broad variety of foodstuffs.Moreover some of the levels proposed are quite high. This is especially true if it is taken into account thatthere is no provision that excludes the use of similar preservatives like sorbates, benzoates and p-hydroxybenzoates in the same product. A provision that limits the use of several preservatives withoverlapping technological effects in the same product is recommended (see also general comments).

01.2.12 Fermented milks (plain), heat treated after fermentation

187. Note 12 reads “Carryover from flavouring substances”. Therefore the listing is not compatible with“plain” milk and therefore the listing should be deleted.

02.2.1.2 Margarine and similar products (e.g., butter-margarine blends) and 02.2.2 Emulsionscontaining less than 80% fat (e.g., minarine)

188. From a technological point of view the use of benzoates in products that have a low water activityand are generally kept in a refrigerator is of questionable value and should be justified.

04.1.2.4 Canned or bottled (pasteurised) fruit

189. It is considered that adequate pasteurisation of these products in sealed containers is sufficient toensure an acceptable shelf life. Consequently we consider it necessary to thoroughly review this listing,especially its technical necessity. Moreover these proposals are not in line with the Codex Draft Standardsfor Fruit and Vegetable Juices and nectars according to which antioxidants and preservatives may only beused in accordance with national legislation.

04.2.2.4 Canned or bottled (pasteurised) or retort pouch vegetables

190. Benzoates are not allowed according to European Community legislation in canned or bottled(pasteurised) or retort pouch vegetables. It is considered that adequate pasteurisation or of these products insealed containers or pouches is sufficient to ensure an acceptable shelf life. Consequently we consider itnecessary to thoroughly review this listing, especially its technical necessity.

06.2 Flours and starches

191. There is no technical need to use benzoates in flours and starches. We consider that this listing is amistake. It should be deleted.

06.4.2 pre-cooked or dried pastas and 07.0 bakery wares

192. The low water activity of pre-cooked or dried pastas (06.4.2) and bakery wares (07.0) has apreserving effect towards bacteria eliminating the need for benzoates. Since pasta and bakery wares areconsumed daily in significant quantities there is a possibility of exceeding ADI (5 mg/kg) when preservativesare used at 1000 mg/kg in these kind of foods. Consequently we consider it necessary to reconsider thetechnical necessity of the use in pre-cooked or dried pastas and bakery wares.

07.2 Fine bakery wares

193. There is no technological need to use benzoates in fine bakery wares. The use in ingredients shouldcovered by the carry over concept (see general comments).

08.3.1.2 Cured (including salted) and dried non-heat treated processed comminuted meat, poultry, andgame products

194. For these products preservative treatment is necessary on the surface only. This should be doneaccording to Good Manufacturing Practice (GMP).

11.2 Other sugars and syrups (e.g. brown sugar, maple syrup)

195. There is no technical need for the use of benzoates in sugar and other products with a low content offree water. We consider that this listing is a mistake. It should be deleted.

12.5 Soups and broths

196. The use of benzoates in soups and broths should be limited to those that cannot be adequatelypreserved with other methods. For this reason dried products and those that are heat-treated during thecanning procedure should be excluded.

14.1.1.2 Table waters and soda waters

197. There is no technical need for the use of benzoates. We consider that this listing is a mistake. Itshould be deleted.

14.1.2.1 Canned or bottled pasteurised fruit juice, 14.1.2.2 canned or bottled pasteurised vegetablejuice, 14.1.3.1 canned or bottled pasteurised fruit nectar and 14.1.3.2 canned or bottled pasteurisedvegetable nectar

198. It is considered that adequate pasteurisation of these products in sealed containers is sufficient toensure an acceptable shelf life. Consequently we consider it necessary to thoroughly review this listing,especially its technical necessity. Moreover these proposals are not in line with the Codex Draft Standardsfor Fruit and Vegetable Juices and Nectars according to which antioxidants and preservatives may only beused in accordance with national legislation.

14.1.4 Water based flavored drinks, including “sport” or “electrolyte” drinks and pasteurised drinks

199. The proposed level of 1000 mg is too high. Consequently we consider it necessary to thoroughlyreview the level proposed, especially its technical necessity.

14.2.1 Beer and malt beverages

200. The use of benzoates is technically necessary only in alcohol-free beer delivered in kegs and its useshould be limited to them. The level of 200 mg/kg in alcohol free beer is acceptable.

14.2.5 Mead

201. The use of benzoates in mead seems unjustified since the low pH value and the alcohol content ofthe product inhibits the growth of bacteria. Therefore it is suggested to delete the application of benzoates inmead.

16.0 Composite foods (e.g., casseroles, meat pies, mincemeat) - foods that could not be placed incategories 01 – 15

202. It seems unnecessary to allow the use of 1000 mg/kg of p-hydroxybenzoic acid in all compositeproducts. Consequently we consider it necessary to thoroughly review the level proposed and to identifymore precisely in which foodstuffs of this group preservatives are technically indispensable.

Brilliant Blue FCFBrilliant Blue FCF INS/E: 133Function: Colour

203. Generally the use of Brilliant Blue FCF is proposed for a too large variety of products. It should beconsidered that colours could also deceive the consumer.

204. For instance the use of Brilliant Blue FCF in lard, tallow, fish oil (02.1.3), butter and concentratedbutter (02.2.1.1), margarine (02.2.1.2) and bread and bakery wares (07.1) has a bleaching effect on thenatural yellow colour of these foodstuffs. The resulting white colour serves no purpose in enhancing thesafety or nutritional value of the foodstuffs. Consequently, these uses should be deleted.

205. Moreover the use in cocoa products and chocolate products (05.1) can be questioned and the levelsproposed for soups and broths (12.5 - 300 mg/kg) and for smoked, fish (09.2.5 – 500 mg) are too high.

206. Consequently we consider it necessary to thoroughly review this listing, especially in relation totechnological need.

CANDELILLA WAXINS/E: 902Function: Bulking Agent, Carrier Solvent, Glazing Agent, Release Agent

[No specific comment]

CARMINESINS/E: 120Function: Colour

207. JECFA has set ADI for carmines of 0-5 mg/kg bodyweight. In view of this ADI the use of Carminesis proposed for too many products. The use of Carmines in the following products should be technologicallyjustified at the same time it should be demonstrated that the consumer is not mislead: unripened cheese(1.6.1), total ripened cheese (1.6.2.1), fats and oils (2.1), fat emulsions mainly of type water-in-oil (2.2),surface-treated fresh fruit (04.1.1.2), surface-treated fresh vegetables (04.2.1.2), cocoa products andchocolate products (05.1), bread and ordinary bakery ware (07.1), fresh meat (08.1), fresh eggs (10.1),canned or bottled fruit juice (14.1.2.1), canned or bottled fruit nectar (14.1.3.1), beer and malt beverages(14.2.1), still wine (14.2.3.1). Alternatively these uses have to be deleted.

208. Consequently we consider it necessary to thoroughly review this listing, especially its technicalnecessity.

CARNAUBA WAXINS/E: 903Function: Anticaking Agent, Adjuvant, Bulking Agent, Carrier Solvent, Glazing Agent, Release Agent

209. The Codex Standards proposes the use of Candelilla Wax in processed fruit (04.1.2), unripenedcheese (01.6.1 6), total ripened cheese, includes rind (01.6.2.1), fat emulsions mainly of type water-in-oil(02.2), sauces and like products (12.6), for canned or bottled pasteurised fruits (14.1.2.1) as well as for fruitjuices and water-based flavoured drinks (14.1.4). This should be justified.

CAROTENES, VEGETABLECarotenes, Natural Extracts, (Vegetable) INS: 160a ii, E 160aFunction: Colour

210. Generally the use of Carotenes is proposed for too many products. It should be considered thatcolours could also deceive the consumer. Especially the proposed use in canned or bottled (pasteurised) fruitand vegetable juices and nectars (14.1.2.1 – 14.1.3.4) should be justified. The use in many other products e.g.cocoa products and chocolate products including imitations and chocolate substitutes (05.1), fresh eggs

(10.1) or wine in general (14.2.3) seems to be not only unjustified but rather intended to deceive theconsumer. Consequently we consider it necessary to thoroughly review this listing and to especially questionthe necessity.

CASTOR OILCastor Oil INS: 1503Function: Anticaking Agent, Carrier Solvent, Glazing Agent, Release Agent

211. The Codex Standards proposes the use of Castor Oil in cocoa products and chocolate productsincluding imitations and chocolate substitutes, confectionery including hard and soft candy, nougat, etc.,chewing gum, decorations (e.g., for fine bakery wares), toppings (non-fruit) and sweet sauces, foodsupplements, water-based flavoured drinks, including "sport" or "electrolyte" drinks and particulated drinks.This should be justified.

CHLOROPHYLLS, COPPER COMPLEXESChlorophylls, Copper Complex INS/E: 141iChlorophyllin Copper Complex, Sodium and Potassium Salts INS/E: 141iiFunction: Colour

212. We refer to the comments on the use of colours in our separate document.

DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROLDiacetyltartaric and Fatty Acid Esters of GlycerolINS/E: 472eFunction: Emulsifier, Sequestrant, Stabilizer

213. The Codex Standards proposes the use Diacetyltartaric and Fatty Acid Esters of Glycerol in a greatvariety of foodstuffs according to GMP. The technological need for Diacetyltartaric and Fatty Acid Esters ofGlycerol in buttermilk (01.1.1.2), fermented milk products (01.2.1.2), other sugars and syrups (11.2) andcoffee substitutes, tea, herbal infusions etc. (14.1.5) has to be justified.

GRAPE SKIN EXTRACTINS: 163ii (E 163 Anthocyanins)Function: Colour

214. We refer to the comments on the use of colours in our separate document.

HYDROXYBENZOATES, p-Ethyl p-hydroxybenzoate INS/E: 214, Propyl p-hydroxybenzoate INS/E: 216,Methyl p-hydroxybenzoate INS/E: 218Function: Preservative

215. Generally the draft Codex standard allows the use of preservatives in a broad variety of foodstuffs.Moreover some of the levels proposed are quite high. This is especially true if it is taken into account thatthere is no provision that excludes the use of similar preservatives like sorbates, benzoates and p-hydroxybenzoates in the same product. A provision that limits the use of several preservatives withoverlapping technological effects in the same product is recommended.

216. The use of preservatives in fresh or unprocessed food is misleading to consumers since a foodstuffcan not both be fresh or unprocessed and at the same time preserved.Hence the use of p-hydroxybenzoate in e.g. surface-treated fresh fruit (04.1.1.2), peeled or cut fresh fruit(04.1.1.3), surface-treated fresh vegetables (04.2.1.2), peeled, cut or shredded vegetables (04.2.1.2) should beomitted from the GSFA.

217. We refer to the comments on the use of additives in unprocessed food in our separate document.04.1.2.1 Frozen fruit

218. The low water activity of frozen fruit ensures preservation. For this reason this entry should bedeleted.

04.1.2.4 Canned or bottled (pasteurised) fruit

219. European Community legislation does not allow the use of p-hydroxybenzoates in liquid fruit. It isconsidered that adequate pasteurisation of these products in sealed containers is sufficient to ensure anacceptable shelf life. Consequently we consider it necessary to thoroughly review this listing, especially itstechnical necessity. Moreover these proposals are not in line with the Codex Draft Standards for Fruit andVegetable Juices and Nectars according to which antioxidants and preservatives may only be used inaccordance with national legislation.

04.2.2.4 Canned or bottled (pasteurised) or retort pouch vegetables

220. The use of p-hydroxybenzoic acid in canned or bottled (pasteurised) or retort pouch vegetables is notallowed according to European Community legislation. It is considered that adequate pasteurisation of theseproducts in sealed containers or pouches is sufficient to ensure an acceptable shelf life. Consequently weconsider it necessary to thoroughly review this listing, especially its technical necessity.Moreover these proposals are not in line with the Codex Draft Standards for Fruit and Vegetable Juices andNectars according to which antioxidants and preservatives may only be used in accordance with nationallegislation.

05.1.1 Cocoa mixes (powders and syrups)

221. The low water activity of cocoa mixes ensures preservation of the product. For this reason this entryshould be deleted.

05.3 Chewing gum

222. The low water activity of chewing gum ensures preservation of the product. For this reason this entryshould be deleted.

08.3.1.2 Cured (including salted) and dried non-heat treated processed comminuted meat, poultry, andgame products

223. For these products preservative treatment is necessary on the surface only. This should be doneaccording to GMP.

11.2 Other sugars and syrups (e.g. brown sugar, maple syrup)

224. There is no technical need for the use of p-hydroxybenzoates in sugar and other products with a lowcontent of free water. We consider that this listing is a mistake. It should be deleted.

12.5 Soups and broths

225. The use of p-hydroxybenzoic acid in soups and broths should be limited to those that cannot beadequately preserved with other methods. For this reason dried products and those that are heat-treated in thecanning procedure should be excluded.

14.1.2. Fruit and vegetable juices to 14.1.3.4 Concentrate (liquid or solid) for vegetable nectar

226. According to European Community legislation p-Hydroxybenzoates are not allowed in fruit orvegetable juices, nectars or concentrates to prepare them. In particular for pasteurised products it isconsidered that adequate heat treatment or of these products in sealed containers is sufficient to ensure anacceptable shelf life. Consequently we consider it necessary to thoroughly review this listing, especially itstechnical necessity.

14.1.4 Water based flavored drinks, including “sport” or “electrolyte” drinks and pasteurised drinks

227. The proposed level of 1000 mg is too high. Consequently we consider it necessary to thoroughlyreview the level proposed, especially its technical necessity.

14.2.1 Beer and malt beverages

228. The use of preservatives is technically necessary only in alcohol-free beer delivered in kegs and itsuse should be limited to them. The proposed level of 1000/kg mg is quite high.

15.1 Snacks - potato, cereal, flour or starch based (from roots and tubers, pulses and legumes) and15.2 Processed nuts, including covered nuts and nut mixtures (with e.g., dried fruit)

229. The low water activity of these products ensures preservation. For this reason this two entries shouldbe deleted.

16.0 Composite foods (e.g., casseroles, meat pies, mincemeat) - foods that could not be placed incategories 01 – 15

230. It seems unnecessary to allow the use of 1000 mg/kg of p-hydroxybenzoic acid in all compositeproducts. Consequently we consider it necessary to thoroughly review the level proposed and to identifymore precisely in which foodstuffs of this group preservatives are technically indispensable.

Mineral OilINS: 905aFunction: Adjuvant, Antioxidant, Glazing Agent, Humectant, Release Agent

231. It is questionable whether the use of Mineral Oil is truly justified in all suggested products. Thetechnological need for mineral oil in fresh meat in vegetables and seaweeds in vinegar, oil, brine, or soysauce (04.2.2.3) or the use in canned or bottled (pasteurised) or retort pouch vegetables (04.2.2.4), whole,broken, or flaked grain, including rice (06.1), flours and starches (6.2), fresh meat (08.1.2), dried and/or heatcoagulated egg products (10.2.3), vinegars (12.3), sauces and like products (12.6), yeast and like products(12.8) and wines (14.2.3) seems unjustified. For this reason these entries should be deleted.

NISININS/E: 234Function: Preservative

232. In the European Community there is generally a cautious use of this antibiotic preservative infoodstuffs. For this reason the technological need for nisin is only recognised in three food groups. In ripenedcheese (01.6.1) and processed cheese (01.6.4) nisin is allowed at 12.5 mg/kg, in clotted cream andmascarpone at 10 mg/kg and in semolina and tapioca puddings is allowed at 3 mg/kg.

233. When comparing the applications for nisin within the Community to the suggestions of the GSFA asignificant number of these suggestions seem unjustified. Furthermore the suggested use levels at 250 mg/kgin processed cheese (01.6.4) and fine bakery wares (07.2) are high. The ADI assigned to nisin by JECFA is33.000 IU. For an adult this means that ADI is exceeded after 200 grams of processed cheese or fine bakeryware.

234. The use of nisin at GMP in canned vegetables (04.2.2.4) and ready-to-eat soups and broths (12.5.1)not only seems technologically unnecessary since the products can be pasteurised, but also not recommendedconsidering the low ADI of nisin.

235. Consequently we consider it necessary to thoroughly review this listing, especially its technicalnecessity.

Phosphatidic Acid, Ammonium SaltIns/E: 442Function: Emulsifier, Stabilizer

236. The levels of 5000 mg/kg in dairy-based desserts (0.1.7) and 7500 mg/kg in edible ices (03.0) areunnecessary high. The use of phosphatidic acid in dairy-based drinks (01.1.2), cream (plain – 01.4) and breadand rolls (07.1.1) at GMP seems technologically unjustified and should be deleted. Consequently weconsider it necessary to thoroughly review the levels proposed.

POLYSORBATESPolyoxyethylene (20) Sorbitan Monolaurate INS/E: 432Polyoxyethylene (20) Sorbitan Monooleate INS/E: 433Polyoxyethylene (20) Sorbitan Monopalmitate INS/E: 434Polyoxyethylene (20) Sorbitan Monostearate INS/E: 435Polyoxyethylene (20) Sorbitan Tristearate INS/E: 436

Function: Antifoaming Agent, Adjuvant, Emulsifier, Foaming Agent, Flour Treatment Agent, Stabilizer

237. Polysorbates are in the GSFA proposed for a broad variety of foodstuffs at high use levels when it isconsidered that the ADI assigned to polysorbates by JECFA is 25 mg/kg. For example the proposed use levelof polysorbates in processed meat (08.2) is 10000 mg/kg which means that after consuming 150 g ofprocessed meat an adult consumer will have exceeded the ADI.

238. In order to avoid ADI concerns the suggested use of Polysorbates must reviewed. The technologicalneed for polysorbates in the following products seems unjustified: unripened cheese (01.6.1), fat emulsionsmainly of type water-in-oil (02.2), surface-treated fresh fruit (04.1.1.2), cocoa mixes (05.1.1), batters (06.6),bakery ware (07.0), processed meat (08.2), processed comminuted meat (08.3), edible casings (08.4), salt(12.1), herbs, spices, seasonings (12.2), non-emulsified sauce (12.6.2), clear sauces (12.6.4), yeast and likeproducts (12.8), carbonated drinks (14.1.4.1), non-carbonated drinks (14.1.4.2).

RIBOFLAVINESRiboflavin 5'-Phosphate, Sodium INS/E: 101i Riboflavin 5'-Phosphate INS/E: 101iiFunction: Colour

239. The technical need for using colour in foodstuffs like surface-treated fresh fruit (04.1.1.2), surface-treated fresh vegetable (04.2.1.2), meat and meat products (08.0), other sugars (11.2), fruit juice and nectar(14.1.2.1, 14.1.2.2, 14.1.3.1), vegetable nectar (14.1.3.2, 14.1.3.4) seems unjustified and should be deleted.

SHELLACINS/E: 904Function: Bulking Agent, Glazing Agent, Release Agent

240. The use of shellac in cocoa products and chocolate products including (05.1) imitations andchocolate substitutes should be limited to “For use in chocolate only” Consequently the listing should befollowed by this note.

SODIUM ALUMINIUM PHOSPHATESE 541Sodium Aluminium Phosphate-Acidic INS: 541iSodium Aluminium Phosphate-Basic INS: 541iiFunction: Acidity Regulator, Emulsifier, Raising Agent, Stabilizer, Thickener

241. The tolerable weekly intake of aluminium is 7 mg/kg bodyweight equal to approximately 70 mg/dayaluminium (originating from all sources) for an adult. Given the low tolerable weekly intake of aluminiumand considering that other aluminium compounds are also suggested for use as additives (AluminiumAmmonium Sulphate, Aluminium Silicate, Calcium Aluminium Silicate) the number of suggested applica-

tions for sodium aluminium phosphates seems exaggerated and the use levels far too high. If 45000 mg/kgsodium aluminium phosphate is allowed in flours and starches (06.2) the tolerable weekly intake will beexceeded for an adult consumer after the indigestion of 55 grams of flour or starch.

242. It is difficult to believe that sodium aluminium phosphates when used as an acidity regulator,stabiliser or thickener can not be substituted by other additives to obtain the same technological effects.

243. The European Community allows sodium aluminium phosphates as an emulsifier and rising agent.However, the application is limited to a few products that are not consumed in significant quantities.Furthermore the maximum use level allowed is 1000 mg/kg. It is suggested that the Committee employ thesame type of precautionary measures.

244. Consequently we consider it necessary to thoroughly review the entire listing of Sodium AluminiumPhosphates, especially its technical necessity.

SORBITAN ESTERS OF FATTY ACIDSSorbitan Monostearate INS/E: 491, Sorbitan Tristearate INS/E: 492, Sorbitan Monolaurate INS/E: 493Sorbitan Monooleate INSE: 494,Sorbitan Monopalmitate INSE: 495

Function: Emulsifier, Stabilizer

245. Generally the use of sorbitan esters of fatty acids is proposed for a large variety of products and in anumber of the suggested applications for sorbitan esters of fatty acids the additive seems to be technicallyirrelevant. Examples are: surface-treated fresh fruit (04.1.1.2), fruit preparations (04.1.2.8), dried vegetables(04.2.2.2), non-emulsified sauces (12.6.2), water-based flavoured drinks (14.1.4) and wines (14.2.3).

246. It has to be kept in mind that sorbitan esters of fatty acids have been assigned an ADI of 25 mg/kg.This means that a child vastly exceeds the ADI after consuming a can (0.33 litre) of water-based flavoureddrink (14.1.4).

247. Consequently we also consider the following levels as too high: 1200 mg/kg for edible ices,including sherbet and sorbet (03.0), 20.000 mg/kg for confectionery (05.0) and 5000 mg/kg for coffee, coffeesubstitutes, tea, herbal infusions etc. (14.1.5).

248. For that reason a significant number of entries should be lowered in level or be deleted from thetable in order to avoid ADI concerns. Apart from those mentioned above we suggest that that the followingentries are also discussed in this light: dairy-based drinks (01.1.2), fruit fillings (04.1.2.11), ordinary bakeryware (07.1), edible casings (08.4), egg products (10.2) and mixes for soups and broths (12.5.2).

249. For emulsified sauces (e.g. mayonnaise, salad dressing – 12.6.1) the European Community wouldprefer the first level listed (5000 mg/kg).

SUCRALOSESucralose INS: 955Function: Sweetener

250. There is no technical need to use Sucralose in whole and broken, or flaked grain, including rice(06.1) flours and starches (06.2). We consider that these listing are mistakes and should be deleted.

SUCROGLYCERIDESSucroglycerides INS: 474Function: Emulsifier, Stabilizer, Thickener

251. The technical necessity for this additive in fine bakery wares (07.2) should be justified.

TANNIC ACID (TANNINS, FOOD GRADE)INS: 181Function: Colour

252. The JECFA evaluation with the result ADI “not specified” is only valid for “use as a filtering aidwhere the application of good manufacturing practice ensures that it is removed from food after use.” To ourunderstanding it is not valid for the use of tannic acid as a colouring agent. The listing should therefore bedeleted.

EUROPEAN FEDERATION OF FOOD ADDITIVES AND FOOD ENZYMES INDUSTRIES (ELC)

253. ELC, in particular ELC member EPA (European Association of Polyol producers) would like tocomment on the listing of the food categories concerning the different polyols including Lactitol, Maltitoland Maltitol Syrup, Mannitol and Xylitol.

254. Attached you will find detailed comments for each polyol concerned. EPA requests the addition ofthe food categories that are in bold and the deletion of the food category with a strikethrough. Theseamendments would ensure the use of polyols in almost the same food categories. This would be inaccordance with the legislation in the European Union which allows all polyols to be used in the same foodcategories.

LACTITOL INS 966Food Cat. No. Food Category 01.2.1.2 Fermented milks (plain), heat-treated after fermentation01.2.2 Renneted milk06.4.2 Pre-cooked or dried pastas and noodles and like products08.1.1 Fresh meat, poultry, and game, whole pieces or cuts08.1.2 Fresh meat, poultry, and game, comminuted09.1 Fresh fish and fish products, including mollusks,

crustaceans, and echinoderms09.2.1 Frozen fish, fish fillets, and fish products, including

mollusks, crustaceans, and echinoderms09.2.2 Frozen battered fish, fish fillets, and fish products,

including mollusks, crustaceans, and echinoderms09.2.3 Frozen minced and creamed fish products, including

mollusks, crustaceans, and echinoderms09.2.4.1 Cooked fish and fish products09.2.4.2 Cooked mollusks, crustaceans, and echinoderms09.2.4.3 Fried fish and fish products, including mollusks,

crustaceans, and echinoderms09.2.5 Smoked, dried, fermented, and/or salted fish and fish

products, including mollusks, crustaceans, and echinoderms11.2 Other sugars and syrups (e.g., brown sugar, maple syrup)12.2 Herbs, spices, seasonings (including salt substitutes), and

condiments (e.g., seasoning for instant noodles)13.1 Infant formulae and follow-on formulae13.2 Weaning foods for infants and growing children

MALTITOL AND MALTITOL SYRUP INS 965Food Cat. No. Food Category 01.2.1.2 Fermented milks (plain), heat-treated after fermentation01.2.2 Renneted milk02.2.1.1 Butter and concentrated butter04.1.1.2 Surface-treated fresh fruit04.2.1.2 Surface-treated fresh vegetables, and nuts and seeds

06.4.3 Pre-cooked or dried pastas and noodles and like products08.1.1 Fresh meat, poultry, and game, whole pieces or cuts08.1.2 Fresh meat, poultry, and game, comminuted09.1 Fresh fish and fish products, including mollusks,






products, including mollusks, crustaceans, and echinoderms10.2.2 Frozen egg products11.2 Other sugars and syrups (e.g., brown sugar, maple syrup)12.3 Herbs, spices, seasonings (including salt substitutes), and


MANNITOL INS 421Food Cat. No. Food Category 01.2.1.2 Fermented milks (plain), heat-treated after fermentation01.2.2 Renneted milk02.2.1.2 Butter and concentrated butter04.1.1.2 Surface-treated fresh fruit04.2.1.2 Surface-treated fresh vegetables, and nuts and seeds06.4.4 Pre-cooked or dried pastas and noodles and like products08.1.1 Fresh meat, poultry, and game, whole pieces or cuts08.1.2 Fresh meat, poultry, and game, comminuted09.1 Fresh fish and fish products, including mollusks,








XYLITOL INS 967Food Cat. No. Food Category

01.2.1.2 Fermented milks (plain), heat-treated after fermentation01.2.2 Renneted milk02.2.1.3 Butter and concentrated butter04.1.1.2 Surface-treated fresh fruit04.2.1.2 Surface-treated fresh vegetables, and nuts and seeds06.4.5 Pre-cooked or dried pastas and noodles and like products08.1.1 Fresh meat, poultry, and game, whole pieces or cuts08.1.2 Fresh meat, poultry, and game, comminuted09.1 Fresh fish and fish products, including mollusks,








INTERNATIONAL FEDERATION OF FRUIT JUICE PRODUCERS (IFU)

255. As you know, the Codex ad hoc task force on Fruit and Vegetable Juices is considering the adoptionof new standards for fruit and vegetable juices and nectars.(Ref. CL2000/01-FJ Point 4 and CL2000/02-FJPoint 4). The first meeting of the task force was held in Brasilia, Brazil September 18-22, 2000.

256. In the draft standard for fruit juices and nectars, the task force will address the issue of additives forfruit juices. IFU has compared Table 1 of the Draft GSFA to the draft Codex fruit juice standard. Seeattached IFU Annex 1.

257. You will see by the comparison, that the Revised Codex GSFA Table 1 allows the addition of manyadditives not allowed in the draft Codex juice and nectar standard. The draft Codex juice and nectar standardwas initiated as a proposal of the IFU, with widespread industry consensus on additives to be allowed in fruitjuices. Because consumers expect fruit and vegetable juices to possess attributes of purity and contain onlynatural ingredients, a main objective of the Codex standard is to limit the use of additives in standardisedjuice and nectar products except when technically necessary. In standardised juice products (as opposed todiluted juice drinks), there is no technical need for most of the additives listed in Table 1.

258. Further, the product definitions in GFSA sections 14.1.2 (Fruit and Vegetable Juices) and 14.1.3(Fruit and Vegetable Nectars) do not conform to the product definitions in the proposed standards for fruitjuices.

259. IFU urges the harmonisation of the CCFAC work and the work in progress currently before theCodex ad hoc task force on Fruit and Vegetable Juices. IFU requests that CCFAC adapt Table 1 on this basisby removing additives not present in the draft juice standard and add the additives allowed by the draft juicestandard which are not included in Table 1.

260. To the extent that the vertical commodity standard for fruit juices and nectars precludes or limitsadditives allowed by the horizontal additive standards, an ambiguity will exist.

261. Such ambiguity will cause trading partners, as well as consumers, to not realise the benefits ofharmonisation and coherent international standards designed to facilitate trade.

INTERNATIONAL FEDERATION OF MARGARINE ASSOCIATIONS (IFMA)

262. In January 2000 our secretariat forwarded comments about the revised Table 1 of the GSFA, basedupon the needs of our industry and the current EC legislation in force ( see enclosure ADD0003).

263. Although we realise that some progress was made by the Codex Quality Control Group after thelatest CCFAC meeting, we still would like to refer to the same comments for the remaining problems:

General comments- Provisions in the GSFA should be aligned with European legislation in force since many years.- Classification of the fats and oils category should be revised after clarification of the meaning of the

subcategories and in particular of 02.3 " emulsions other than food category 02.2, including mixed and/ or flavoured products based on emulsions ".

Specific comments- Ascorbyl esters should be allowed GMP in conformity with EU legislation.

GSFA indicates 400 ppm ( previously 500 ppm) in 2.1.2. and 2.1.3., 500 ppm in 2.2.. We would liketo know the reason for restriction.

- Carotenoïds : use levels have been modified according to IFMA - IMACE proposal,- Curcumin : same comments as previously in ADD0003,- Diacetyl tartaric and fatty acid esters of glycerol : use levels have been modified according to IFMA -

IMACE proposal,- Phosphates : although use levels of phosphates in 2.2.1.2., 2.2.2., 2.3. were harmonised as suggested

by IFMA - IMACE, the present level (1.100 ppm ) is insufficient and should be raised to 5.000 ppm,- Tocopherols : same comments as previously, in ADD0003.

1. General Remarks

264. Comments forwarded by IMACE to the secretariat of CCFAC are based on the comparison of TableOne of GSFA with European legislation in force and with the proposed Codex Standard for Fat Spreads.

265. In the European Council and Parliament Directive EC 95/2, Annex I concerns a list of food additivesgenerally permitted GMP for use in foodstuffs not referred to in Art.2 (3). (Non emulsified oils and fats forcold applications). The Proposed Codex Fat Spreads Standard equally allows the use of many of theseadditives on a GMP basis. It is important for our industry that the provisions in the draft GSFA be alignedwith those previously indicated in order that it be possible for the European margarine industry to continuemanufacturing their products to existing specifications and avoid expensive reformulations.

266. Additives of Table One of GSFA falling under this category are:

260-263,270,301-305, 306-309, 322, 325-327, 330-333, 335-337, 338-341, 400-404, 406-418, 440, 471,472a-472e, 500, 500iii, 575, 938, 941,942, 1400-1405, 1410-1414, 1420-1422, 1440, 1442, 1450.

267. In Table One of GFSA many of these additives (the missing additives should be added) are foreseenfor use in a subcategory of Group 02 (Fats and Oils).

268. As an example, 472a in Table One of GSFA has a GMP provision in subcategory 02.1.3 (lard,tallow, fish oil and other animal fats) . But, 472a can also be used in vegetable oils and even in emulsionsaccording to the European legislation. We believe that in these cases the whole category 2 should be referredto in the Table One of GSFA (subject to approval of the dairy sector) at GMP level. This would enable themanufacturers to add these additives to the fats and oils or to the emulsions.

269. The classification into categories is certainly an important tool in the setting up of Table One ofGSFA. It is, however, not always clear to IMACE which products belong to which subcategory. We wouldlike to obtain some guidance from CCFAC especially for subcategory 02.3 “emulsions other than foodcategory 02.2, including mixed and for flavoured products based on fat emulsions” , as we alreadymentioned in our letter to the Chairman of CCFAC dated 5 February 1998.

2. Specific remarks

304, 305 Ascorbyl esters

270. Should be allowed GMP in conformity with EU legislation and Codex Fat Spreads Standard Draft.GSFA indicates 500 ppm, which could be an acceptable level. We would like to have some clarificationsregarding the two different allocations (80 ppm and 500 ppm) for the same subgroup 02.3.

160 a i,f, e Carotenoids

271. We understand that the GSFA differentiates between vegetable carotenoids and syntheticcarotenoids, although the EU legislation regarding colouring matters makes no such difference and allowscarotenoids at GMP level in 02.1.2, 02.1.3,02.2.1, 02.2.2.For the sake of consistency, however, the same amount (and in any case not less) should be allowed for fatsand oils, as for the emulsions, made with fats and oils. We therefore suggest the level of 1000 ppm in 02.1,02.2.1.2,02.2.2., 02.3.

100 Curcumin

272. As already mentioned in our letter to the Chairman of CCFAC dated 4th February 1998 our sectorneeds the use of Curcumin in 02.1.2 (in fats only) and 02.1.3 (the fats only), 02.2.1 and 02.2.2. at GMP level(according to the Colour Directive). The levels indicated in the present draft GSFA are inconsistent, 5 ppm inthe fats and oils, GMP in butter (made with milkfat) and 10 ppm in margarine. We therefore would like tohave the level of GMP for the entire group 02.

472e Diacetyltartaric and fatty acid esters of glycerol

273. As already mentioned under point 1 of my letter, our manufacturers use this emulsifier at GMP level,according to European legislation and according to the Codex Draft Fat Spreads Standard. We do, however,believe that our sector does not need more than 10.000 ppm, as level mentioned in Table One of GSFA for02.2. But, we ask for consistency of levels within group 02. The same level (10.000 ppm) should bementioned for 02.3 and a higher level (and not a lower as is presentlythe case) for the oils, which are diluted in the emulsion.

338-343, 450-452 Phosphates

274. IMACE would like harmonisation of the use levels of phosphates according to the EuropeanDirective on Miscellaneous Additives 95/2: 5000 ppm in 02.2.1.2, 02.2.2., 02.3. The draft Standard on FatSpreads quotes a GMP level for these products.

306, 307, 308, 309 Tocopherols

275. 308 and 309 are missing in Table one of the Draft GSFA.For reasons of consistency with the European Directive 95/2, which empowers industry to use thesesubstances GMP in all products of Group 02, except in non-emulsified oils and fats for cold applications,IMACE would request a GMP level in 02.1.2, 02.2.1.2, 02.2.2, 02.3.

276. The present provisions in Table one of GSFA would allow for a higher level (500 ppm) in the finalproduct than in the oils (300 ppm), which is illogical.

INTERNATIONAL PECTIN PRODUCERS ASSOCIATION (IPPC)

277. In the draft GSFA, Table one, in the entry for pectin, there are entries for 01.2.1.1 fermented milks(plain) not heat treated, with pectin at GMP, and 01.2.1.2 fermented milks (plain) heat treated, with pectin at10000mg/kg.

278. IPPA would suggest in the interests of simplicity that these entries should be combined with a limitof GMP. There is no obvious reason for a numerical limit in only the heat-treated case, the products wherepectin is most necessary as a stabiliser for the protein dispersion.

279. A similar arguement should be applied also to 01.4.1 (pasteurised cream) at GMP, and 01.4.2(sterilized, UHT, whipping of whipped, and reduced fat creams) at 5000mg/kg. The latter are more likely torequire a stabiliser, and all should be at GMP.

INTERNATIONAL SOFT DRINK COUNCIL (ISDC)

280. ISDC commends the Quality Control Working Group for the job it has done in reviewing theadditives and their recommended use levels. We are in agreement with the recommendations with theexception of the recommendation for phosphates for Food Category 14.1.1.2 Table Waters and Soda Waters.We recommend the level should be 1000 mg/kg based on phosphates (instead of 890 mg/kg) due to theuncertainty factor when considering the chain length of the polyphosphates.

281. Table 1 continues to be very confusing due to the listing of many additives with an ADI "NotSpecified" or "Not Limited" both in Table 1 and in Table 3. The reason for this is understood only by themost discerning reader and follower of the development of the GSFA. Many of the listings in Table 1 are forGMP levels which seem to us to be unnecessary since Table 3 additives are permitted in foods in general atGMP levels. When some food categories are listed in Table 1 for food additives that have an ADI "NotSpecified" or "Not Limited" and other food categories are not listed even though the additive is permitted inthat food at GMP levels , it creates much confusion and misunderstandings. As an example, acetic acid,glacial (INS 260) has an ADI "Not Limited" and is included in Table 3 for use in food in general at GMPlevels, yet Table 1 has only a few food categories listed which makes it appear that these are the only foodcategories that can use this additive. Therefore, we repeat our request for a clear subtitle for Table 1 asfollows:

Table One - Additives Permitted for Use Under Specified Conditions in Certain Food Categories orIndividual Food Items [Those food additives with an ADI "Not Specified" or "Not Limited" are Listedin Table Three and are permitted for use in food in general in accordance with Good ManufacturingPractice, unless otherwise specified in Table One.]

282. Because of the confusion between Tables 1 and 3 in the treatment of additives with an ADI "NotSpecified" or "Not Limited", we continue to request that the ADI of each additive be included in Table 1along with the INS number. In this way the user of the GSFA when looking at Table 1 and noting the ADIwould know that the additive is permitted in food in general at GMP levels (and would look for thisconfirmation in Table 3), but any limitations on the use of the additive would be listed in Table 1.

283. We continue to note the inconsistencies in Table 1 regarding the treatment of additives with anumerical ADI and their use levels. We wish to remind CCFAC that at the 1999 meeting of theCommission, Caramel Color III and Caramel Color IV were adopted at Step 8 at GMP levels in all foods.This adoption came as a result of a recommendation from the 31st CCFAC in 1999. We therefore requestthat CCFAC reconfirm the GMP levels for Caramel Color III and Caramel Color IV and delete fromTable 1 the numerical limits in Food Category 14.1.4 for the following reasons:

1) The Preamble to the GSFA doe not prohibit food additives with a numerical ADI from beingapproved in the GSFA at GMP levels.

2) Good Manufacturing Practice (GMP) means that the additive must present no hazard to publichealth and must not be used to mislead consumers. Therefore, this means that consumer safety isincorporated into the meaning of GMP.

3) The ADI's for these two additives are very high (each of them have an ADI of 200 mg/kgbw/day), and therefore, could be considered to be equal to an ADI "Not Specified" or "Not Limited."

4) These two additives have a long history of safe use throughout the world, and the majority ofcountries worldwide permit these two additives at GMP levels. If countries have to change to a numericallimit, it would be very disruptive in the food regulation with no public health benefit.

284. There are still a number of additives in food category 14.1.4 Water-based flavored drinks, including"sport" or "electrolyte" drinks and particulated drinks which could be collapsed to just the main categorywithout having further details for subcategories 14.1.4.1 Carbonated drinks, 14.1.4.2 Non-carbonatedincluding punches and aides, and 14.1.4.3 Concentrates (liquid or solid) for drinks. Logically it makes nosense to subdivide this food category for the sake of permitting a higher level in concentrates when a finishedfood level in category 14.1.4 would take care of the need for a higher level in the concentrate.

INTERNATIONAL SWEETENERS ASSOCIATION (ISA)

Appendix I (Recommendations of the quality control working group)

285. PROPOSALS for additional listings for INS 950 Acesulfame K, INS 951 Aspartame, INS 955Sucralose and for the new Aspartame-Acesulfame salt (attachments I, 2, 3, 4))

Appendix III (Priority List of Additives for discussion by the 33rd CCFAC)

286. Appendix III lists Group V additives, including the high intensity sweetener sucralose. Thegroupings were established according to the number of comments received by the CCFAC.

PROPOSAL: The ISA believes that it would be more logical to discuss all high intense sweeteners at thesame CCFAC meeting, preferably the 33rd.

Table 2, Food category 11.0

287. PROPOSAL : The ISA would like to endorse the proposal made by the CEFS (EuropeanCommittee of Sugar Producers) amending the category 11.0 (attachment 5).

Table-top sweeteners, including those containing high-intensity sweeteners (current category 11.4.(CEFS 11.6.))

288. The ISA has four comments to this category: (attachment 6)

3.1.1. PROPOSAL : It is essential that all high-intensity sweeteners may be used in table-topsweeteners at GMP

289. Reasons are as follows:

A. sweeteners are particularly self-limiting in this application;B. table-top sweeteners being sold to the ultimate consumers, it is the latter who determine the amountactually consumed; additionally “use levels” refer to the food as consumed and table-top sweeteners are onlyconsumed in conjunction with another food (coffee etc.) and as the use level is at discretion of the final user,it does not make sense to define numerical use levels in table-top formulations.C. among the existing real intake data (see Renwick A. “Intake of sweeteners”) there is no evidence ofexceeding the ADI.

3.1.2. PROPOSAL : It is important to list all substances necessary in the production of table-toppreparations at GMP

290. The production of table–top sweeteners requires a series of foods such as sugars and starches and/oradditives as excipients, carriers and preservatives, depending on the form of the products: tablets, powder orliquid.

3.1.3. Excipients and additives: PROPOSAL : We have prepared a comprehensive list of ingredients forthe category: “Table-top sweeteners, including those containing high intensity sweeteners” .

3.1.4. Definition or description: given that table-top sweeteners are considered as a food category, adefinition – to be added in a footnote – might be:

291. PROPOSED DEFINITION : “Table-top sweeteners are preparations of sweeteners, intended forsale to the ultimate consumer, which may contain foodstuffs and food ingredients such as sugars,maltodextrin etc., and functional additives (as per Table 3 and as listed for additives of Table 1) in orderto facilitate storage, sales, standardization, dilution or dissolution”.

Use of sugars and sweeteners:

292. PROPOSAL: We would like it to be clarified that, according to the reverse carry-over principle,laid down in the Preamble of the Draft CGSFA, under 4.2., sweeteners can be mixed with foods for whichsweeteners are not listed in the GSFA, if such products are intended as intermediate products in themanufacture of final foods for which sweeteners are approved; and providing such intermediate productsare labelled accordingly.

Proposals for additional listings for INS 950 Acesulfame K

293. The following categories are proposed for addition. These proposals are based on legislation inmember states of the Codex Alimentarius. Some are made to clarify the applicability of Acesulfame K semi-finished products not intended for consumption.

01.5 Milk powder and cream powder: GMP

294. This listing would replace the present limitation to category 01.5.1

295. Reason: Powdered dairy and dairy-analogue prepapations used in coffee and tea instead of milk orcream fall in this category. The can be pre-sweetened. As the dosage is in the discretion of the user/consumerand will be made on the basis of personal taste preferences GMP listing is proposed. Present approvals are,i.a.: dry bases for instant beverages (GMP, Taiwan) and dry bases for instant beverages and dairy-analogueproducts (GMP, USA)

01.6.5 Cheese analogues: GMP

296. This proposal is equivalent to the listing in category 01.6.1 (unripened cheese).

297. Reason: In several countries approvals for dairy products include analogues provided they areadequately labelled.

06.1 Whole, broken, or flaked grain, including rice: 300 mg/kg

298. Reason: Approval for mixed congee in The People´s Republic of China, also covered by approvalsfor "other foods" in Japan and Korea granted in 2000.

06.4.2 Pre-cooked or dried pastas and noodles: 1000 mg/kg

299. Reason: Approvals for flour paste in Japan and Korea granted in 2000.

14.1.2.3 Concentrate for fruit juice: 3000 mg/kg

300. This proposal corresponds to the listing in category 14.1.2.1 (canned or bottled fruit juice) with a uselevel of 600 mg/kg.


14.1.2.4 Concentrate for vegetable juice: 3000 mg/kg

302. This proposal corresponds to the listing in category 14.1.2.2 (canned or bottled vegetable juice) witha use level of 600 mg/kg.


14.1.3.3 Concentrate for fruit nectar: 2500 mg/kg

304. This proposal corresponds to the listing in category in category 14.1.3.1 (canned or bottled fruitnectar) with a use level of 500 mg/kg.


14.1.3.4 Concentrate for vegetable nectar: 2500 mg/kg

306. This proposal corresponds to the listing in category 14.1.3.2 (canned or bottled vegetable nectar)with a use level of 500 mg/kg.


16.0 Composite foods: 350 mg/kg

308. Reason: Approvals for "other foods" in Japan and Korea granted in 2000.

PROPOSALS FOR ADDITIONAL LISTINGS FOR INS 951 ASPARTAME

309. To include aspartame at GMP in the following categories in Table 2 (according to permissions in atleast two Codex countries, i.e. Japan and USA):

9.4 Fully preserved fish12.3 Vinegars15.1 Snacks

15.2 Processed nuts

Justification of Revised Proposed Levels for INS 955

310. Sucralose has now been approved in over 40 countries around the world and it should be notedthat in several countries (USA, South Africa, Hong Kong) sucralose has broad category approval with GMP

status. An approval permitting the usage of sucralose GMP, provides food technologists with full flexibilitywhen developing new products.

311. When reviewing the proposed categories and usage levels for sucralose, consideration was taken ofthe levels at which sucralose is already approved for use in the above mentioned countries and the levelssubmitted by the CIAA to the European Commission.

312. The aim of reviewing the original list was therefore to bring the Codex categories and levels in linewith those levels permitted in countries that have already approved sucralose. This includes a numberof reductions in levels as well as a few increases. For example, the levels for “fermented milk” and “jams,jellies & marmalades” were increased to make them consistent with the levels permitted in Japan. Similarly,the level for “dried fruit” was increased to 1500 mg/kg to cover the category “preserve fruit” for China. Insome cases (frozen fruit, fruit fillings and desserts) the levels were increased slightly to bring them in linewith the levels proposed by the CIAA to the European Commission.

313. In the same way, the usage levels for some beverages i.e. fruit and vegetable juice and nectar, wereincreased slightly following a request from the soft drink trade association UNESDA, that sucralose shouldbe permitted in soft drinks up to a level of 300 mg/kg. The level for sugar based confectionery was alsoincreased to 2400 mg/kg to cover usage levels in products such as breath mints where high levels ofsweeteners are required to mask the bitter taste of the flavours.

314. Sucralose has also been added to three additional categories, “beverage whiteners”, “cream” and“food supplements” for which the other HIS sweeteners are already included.

315. Where appropriate, the levels have been reduced in a number of categories to bring them in linewith typical usage levels currently permitted and available. This includes the major categories for sucraloseusage i.e. carbonated and non-carbonated drinks which were reduced by 50% to a level of 300mg/kg. Othercategories where the levels were reduced include chewing gum, fruit and vegetables in vinegar oil or brine,fruit based spread, fruit based desserts, cocoa and chocolate products, cereal and starch based desserts, semi-preserved fish and fish products, mustards, soups and broths, sauces, salads and sandwich spreads, dieteticformulae for slimming purposes, ready to eat savouries and some alcoholic beverages.

316. In addition two categories where sucralose is not used have been deleted (cooked and fried fruit andvegetables).

CategoryNo.

Category ProposedLevel

Recomed

Levelmg/kg

1.1.2 Dairy based drinks, flavoured and/or fermented (eg chocolatemilk, cocoa, eggnog

300 300

1.2.1 Fermented milk (plain) 250 400

1.3.2 Beverage Whiteners GMP

1.4 Cream (plain) and the like GMP

1.7 Dairy based desserts (eg ice cream, ice milk, pudding, fruit offlavoured yoghurt)

400 400

2.4 Fat based desserts excluding dairy based desserts products offood category 1.7

250 400

3.0 Edible ices, including sherbet and sorbet 400 320

4.1.2.1 Frozen fruit 150 4004.1.2.2 Dried fruit 150 1500

4.1.2.3 Fruit in vinegar, oil or brine 450 1804.1.2.4 Canned or bottled (pasteurised) fruit 450 4004.1.2.5 Jams, jellies, marmalades 450 10004.1.2.6 Fruit-based spread (chutney)excluding products in 4.1.2.5 800 4004.1.2.7 Candied fruit 800 8004.1.2.8 Fruit preparations, including pulp and fruit toppings 450 4004.1.2.9 Fruit based desserts including fruit flavoured water-based

desserts1250 400

4.1.2.10 Fermented fruit products 150 1504.1.2.11 Fruit fillings for pastries 250 4004.1.2.12 Cooked or fried fruit 150 DELETE4.2.2.1 Frozen vegetables 150 1504.2.2.2 Dried vegetables 150 1504.2.2.3 Vegetables in vinegar, oil or brine 450 2504.2.2.4 Canned or bottled (pasteurised) vegetables 150 1504.2.2.5 Vegetable, and nut & seed purees and spread (peanut butter) 1500 15004.2.2.6 Vegetable and nut & seed pulps and preparations (vegetable

desserts and sauces, candied vegetables) other than 4.2.2.5500 500

4.2.2.7 Fermented vegetables 150 1504.2.2.8 Cooked or fried vegetables 150 DELETE

5.1 Cocoa products and chocolate products including imitationsand chocolate substitutes

1500 800

5.2 Sugar based confectionery, including hard and soft candy,nougats etc other than food categories 5.1, 5.3 & 5.4

1500 2400

5.3 Chewing gum 5000 30005.4 Decorations (eg for fine bakery wares), toppings (non-fruit) and

sweet sauces1000 1000

6.3 Breakfast cereals including rolled oats 1000 10006.5 Cereal and starch based desserts (eg rice pudding, tapioca

pudding)1250 400

7.1 Bread and ordinary bakery wares 750 7007.2 Fine bakery wares 700-800 700

9.3 Semi-preserved fish and fish products 450 120

9.4 Fully preserved, including canned or fermented fish & fishproducts

120

10.4 Egg based desserts eg custard 250 400

11.2 Other sugars and syrups (eg brown sugar, maple syrup) 1500 150011.4 Table top sweeteners including those containing HIS GMP GMP

12.2 Herbs, spices, seasonings (including salt substitutes) andcondiments

400 400

12.4 Mustards 400 14012.5 Soups & broths 1250 4512.6 Sauces and like products (mayonnaise, salad dressing, soy

sauce, ketchup, cheese sauce, brown gravy etc.1250 450

12.7 Salads and sandwich spreads excluding cocoa- and nut-basedproducts

1250 450

13.3 Dietetic foods intended for special medical purposes including 400 400

those for infants and young children13.4 Dietetic formulae for slimming purposes and weight reduction 1250 32013.5 Dietetic foods (eg supplementary foods for dietary use)

excluding products for categories 13.1-13.4800 800

13.6 Food supplements 2400

14.1.2.1 Canned or bottled (pasteurised) fruit juice 250 30014.1.2.2 Canned or bottled (pasteurised) vegetable juice 250 30014.1.2.3 Concentrates (liquid or solid) for fruit juice 1250 150014.1.2.4 Concentrates (liquid or solid) for vegetable juice 1250 1500

14.1.3.1 Canned or bottles (pasteurised) fruit nectar 250 30014.1.3.2 Canned or bottled (pasteurised) vegetable nectar 30014.1.3.3 Concentrates (liquid or solid) for fruit nectar 1250 150014.1.3.4 Concentrates (liquid or solid) for vegetable nectar 1250 1500

14.1.4.1 Carbonated drinks 600 30014.1.4.2 Non-carbonated, including punches and ades 600 30014.1.4.3 Concentrates (liquid or solid) for drinks 1250 1500

14.1.5 Coffee, coffee infusion (excluding flavoured coffees), teas andother hot cereal beverages excluding cocoa

250 300

14.2.1 Beer and malt beverages 700 25014.2.2 Cider and perry 700 25014.2.3 Wines 700 25014.2.4 Fruit wines 700 25014.2.5 Mead 700 70014.2.6 Spiritous beverages 700 700

15.0 Ready to eat savouries 1000 400Aspartame-acesulfame salt

Technological justification and Proposal

317. Aspartame-acesulfame salt technologically outperforms blends of single sweeteners in a number ofways:� It dissolves significantly more rapidly than an equimolar blend of aspartame and acesulfame-K. Instant

powder products such as desserts, toppings, powder beverage mixes and some pharmaceuticals thusperform better during reconstitution by the consumer. Similarly, table-top sweeteners dissolve faster,especially in cold beverages.

� In instant powder products it provides the consumer a fixed ratio of sweeteners and thus guaranteeing abalanced sweetness throughout the dissolution process whereas a blend does not, because acesulfame-Kdissolves faster than aspartame.

� In contrast to both blends of aspartame and acesulfame-K and to aspartame alone, the aspartame-acesulfame salt is not hygroscopic. It is thus much easier to store and to use in food manufacture,especially during the preparation of powder mixes. The latter can be problematical, especially at times ofhigh relative humidity. Use of the salt eases product handling and poses less stringent demands onpackaging. The consumer receives a product that is less likely to be subject to caking. The latter defect isparticularly irksome where containers are intended for multiple use by the consumer, and the repeatedopening and closing of packaging allows ingress of atmospheric moisture and product deterioration.

� The product has superior powder-flow properties to those of a blend of aspartame and acesulfame-K.Aspartame and acesulfame-K have different crystal shapes, which do not lend themselves to thepreparation of homogeneous, stable mixtures. Thus the use of blends can lead to inhomogeneities in

powder products which the consumer may experience as variation in taste quality and/or sweetness level.Use of the salt assists in preparing products which are more uniform and acceptable to the consumer.

� It disperses easily in difficult applications, such as sugar-free hard candy and sugar-free chocolate,where a blend of sweeteners is difficult to employ. Superior product quality results.

� Surprisingly, it’s the only sweetener that boosts the sweetness of chewing gum and gives the gum avery long-lasting quality without recourse to encapsulation of the sweetener, for example with polymercoatings. The consumer experiences an improved product quality at potentially lower costs.

� Aspartame-acesulfame salt is more stable in certain applications than aspartame alone. This means thatit can be used in applications where aspartame has either required encapsulation for protection or hasbeen substituted by sweeteners of inferior taste such as saccharin. The consumer benefits from productsof improved taste and prolonged shelf life.

� The potassium contained in acesulfame-K is eliminated when the aspartame-acesulfame salt is made, asis the moisture contained in aspartame. The salt thus represents a more concentrated source ofsweetness, and comprises two pure sweeteners together, without the functionless presence of potassiumor water. A modest weight saving of about 11% results.

Regulatory status

318. The salt has been assessed by the US-FDA on September 30, 1998 and the Canadian HealthProtection Branch (June 3, 1999), who both consider the product to be regulated under the existingregulations for aspartame and acesulfame-K.

319. The EC Scientific Committee on Food at its 120th meeting (Brussels, 8-9 March 2000) concludedas follows: Considering that a) the salt represents an alternative source of aspartame and acesulfame ions tothe two already permitted sources (E951 and E950), b) potential exposure is the same with an equivalentblend of aspartame and acesulfame-K, c) the use of this substance raises no additional safety considerationsthe Committee regards as acceptable the use of aspartame-acesulfame salt as an additive.It should be ensured that consumption of this substance is taken into account when estimating intakes ofaspartame and acesulfame-K in relation to the ADIs for these substances.

320. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 55th meeting(Geneva, 6-15 June 2000) concluded as follows: Aspartame and acesulfame moieties are covered by theADIs established previously for aspartame (0-40 mg/kg bw) and acesulfame-K (0-15 mg/kg bw).

Proposal

321. Formally aspartame-acesulfame salt is a new compound and therefore it has to be incorporated in thevarious legislations. However as it also is merely a new form of combining two well-known, permittedsweeteners, it is proposed to regulate the salt by adding the following footnote to these two sweeteners,aspartame and acesulfame-K.

322. 'Maximum dosage levels for the salt of aspartame and acesulfame should be derived from themaximum dosage levels for its constituents parts aspartame (E 951) and acesulfame-K (E 950). Themaximum dosage levels for aspartame (E 951) and acesulfame-K (E 950) shall not be exceeded by their usein combination with the salt of aspartame and acesulfame.'

323. The alternative, a positive list for aspartame-acesulfame salt, would be very confusing for those foodmanufacturers that would like to use the salt together with aspartame or acesulfame-K.

Table-top sweeteners, including those containing high-intensity sweeteners (Food Category 11.4,according to CEFS proposal 11.6) (proposed changes are in bold/italics)

Additive Max. Level

INS 414 ACACIA GUM (GUM ARABIC) GMPINS 950 Acesulfame Potassium GMPINS 956 Alitame GMPINS 304,305 Ascorbyl Esters GMP

INS 951 AspartameGMP

INS 210-213 BenzoatesGMP

INS 578 Calcium gluconate GMPINS 341 Calcium orthophosphate GMPINS 552 Calcium silicate GMPINS 407 CARRAGEENAN GMPINS 466 Carboxymethylcellulose sodium GMPINS 460i Cellulose, microcrystalline GMPINS 460ii Cellulose GMP

INS 330 Citric acid GMP 468 Croscarmellose sodium GMPINS 952 Cyclamates

GMPINS 385-386 EDTAs GMPINS 127 Erythrosine

GMPINS 297 Fumaric acid GMPINS 418 Gellangum GMPINS 575 Glucono-delta-lactone GMPINS 422 Glycerol GMPINS 640 Glycine GMPINS 214,216,218

Hydroxybenzoates, p- GMPINS 464 Hydroxypropylmethylcellulose GMPINS 132 Indigotine GMPINS 953 Isomalt GMPINS 966 Lactitol GMPINS 641 L-Leucine GMP

INS 470b Magnesium salts of myristic, palmitic andStearic acids GMP

INS 553b Magnesium silicate GMPINS 296 Malic acid GMPINS 965 Maltitol GMPINS 421 Mannitol GMPINS 471 Mono- and diglycerides of fatty acids GMPINS 621 Monosodium glutamate GMP INS 338; 339i-iii; 340i-iii; 341i-iii; 342i-ii; 343ii-iii; 450i,iii,v,vi; 451i,ii; 452i,ii,iv,v;542 Phosphates GMPINS 1200 Polydextrose GMPINS 900a Polydimethylsiloxane GMPINS 1201 Polyvinylpyrrolidone GMPINS 1202 POLYVINYLPYRROLIDONE, INSOLUBLE GMPINS 124 Ponceau 4R GMPINS 1520 Polypylene Glycol GMP

INS 336 Potassium tartrates GMP INS 501 Potassium carbonates GMP

INS 577 Potassium gluconate GMPINS 954 Saccharin

GMPINS 551 Silicon dioxide GMPINS 500 Sodium carbonates GMPINS 331 Sodium citrates GMPINS 576 Sodium gluconate GMPINS 219 Sodium methyl p-hydroxybenzoate GMPINS 217 Sodium propyl p-hydroxybenzoate GMP

INS 200-203 Sorbates GMPINS 420 Sorbitol GMPINS 955 Sucralose GMPINS 110 Sunset Yellow FCF GMPINS 334-337 Tartrates GMPINS 334 TARTARIC ACID GMPINS 102 Tartrazine GMPINS 957 Thaumatin GMPINS 415 Xanthan gum GMPINS 967 Xylitol GMP

CEFS Proposal for new subcategories for the category 11.0(CEFS letter dated September 12, 2000)

11.0 Sweeteners, including honey11.1

11.1.1

11.1.2

11.1.3

11.1.3.1

11.1.3.2

11.1.4

11.1.5

11.2

11.3

11.4

11.5

11.6

Products of the Codex Standard for Sugars

White sugar, dextrose anhydrous, dextrose monohydrate, fructose

Powdered sugar, powdered dextrose

Soft white sugar, soft brown sugar, glucose syrup, dried glucose syrup, raw cane sugar

Dried glucose syrup used to manufacture sugar confectionery

Glucose syrup used to manufacture sugar confectionery

Lactose

Plantation or mill white sugar

Brown sugar excluding products of food category 11.1.3

Sugar solutions and syrups, also (partially) inverted, including treacle and molasses,excluding products of food category 11.1.3

Other sugars and syrups (e.g. xylose, maple syrup, sugar toppings)

Honey

Table-top sweeteners, including those containing high-intensity sweeteners

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