(CODEX DOCUMENT CX/FA 12/44/7) European Union Competence. European Union Vote.

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1 European Union Comments CODEX COMMITTEE ON FOOD ADDITIVES Forty-fourth Session Hangzhou, China, March 2012 AGENDA ITEM 5 (a) Pending draft and proposed draft food additives provisions and related matters (CODEX DOCUMENT CX/FA 12/44/7) European Union Competence. European Union Vote. GENERAL COMMENTS 1. The EU is of the view that the provisions for food category 16.0 shall not be on the agenda since the discussion on this food category is still ongoing. 2. The EU does not support the heading of the Appendix IIA which states The use of colours in the food categories listed in the table below is ly justified (page 33 of CX/FA 12/44/7). In the EU s view, the fact that one colour is authorised under a specific food category should not be seen as a way of authorising any other food colours in these food categories without verifying that needs, misleading of the consumer and potential intake concerns have been addressed. 1

2 SORBATES (INS ) 2. The 29 th JECFA (1985) assigned a group ADI of 25 mg/kg bw for sorbates. 3. The Codex Class Names and International Numbering System for Food Additives (CAC/GL ) associates the purpose preservative with sorbates. Recommendation 1 Sorbates, INS The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for sorbates in the GSFA. Food EU comments Cat s EU suggests the Dairy-based drinks, flavoured and/or 300 mg/kg Note 42 6 provisions should be limited to flavoured fermented milks and flavoured fermented milks heat treated after fermentation as stated in the Stan on fermented milks fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks) EU opposes No justification Renneted milk (plain) 1,000 mg/kg Note EU does not support. No need of preservatives in the frozen technology. The preservation is adequately provided by the frozen technology itself EU opposes No need The frozen technology provides the adequate preservation In conflict with CS, e.g and Edible ices, including sherbet and sorbet 1,000 mg/kg Note 42 6 Comment No need of preservatives in frozen technology Frozen Fruit 1,000 mg/kg Note 42 6 Comment 1) Freezing provides adequate preservation, no need for chemical preservatives EU supports Candied fruit 1,000 mg/kg Note 42 6 Justification Used in glazed fruit to top Gammon and in cake mix EU does not support. No justification in the ready to eat dessert. For instance fruit compote does not need sorbate. The sugar content plays this role. In fruit based dessert, preservatives can be carried by the fruit but they do not play any role in the final dessert Fruit-based desserts, including fruitflavoured waterbased desserts 1,000 mg/kg Note

3 Recommendation 1 Sorbates, INS The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for sorbates in the GSFA. Food EU comments Cat s EU does not support. EU questions the need for products which are stable after heat treatment and preserved through natural fermentation or acidulants. EU would like to get clarification on the need flagged up in Canada? In conflict with , , , Fermented vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) and seaweed products, excluding fermented soybean products of food categories , , , and ,000 mg/kg Note 42 6 Comment Industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg Only potatoe dough and prefried potatoe slices EU strongly oppose. The Stan on chocolate does not allow sorbate in such products. Technological justification is requested. Should be discontinued EU strongly oppose. The Stan on chocolate does not allow sorbate in such products. Technological justification requested. Should be discontinued EU does not support. Technological justification requested. Should be discontinued Cooked or fried vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds Cocoa mixes (powders) and cocoa mass/cake 2,000 mg/kg Note 42 6 Comment Use should only be in potato dough and prefried potato slices 1,500 mg/kg Note 42 6 Cocoa mixes (syrups) 1,000 mg/kg Note 42 6 Cocoa-based spreads, including fillings 05.4 EU agrees Decorations (e.g., for fine bakery wares), toppings (non-fruit) and sweet sauces 1,500 mg/kg Note ,000 mg/kg Note 42 6 Comment Recommend a level of 1,500 mg/kg. Micro stability of low acid toppings is not achieved at 1,000 mg/kg. 3

4 Recommendation 1 Sorbates, INS The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for sorbates in the GSFA. Food EU comments Cat s 06.2 EU strongly Flours and starches (including 1,000 mg/kg Note 42 6 Comment opposes. Stan soybean powder) No on justification, use.level would result in high wheat flour does intake in a basic foodstuff not authorize preservative in flour. No Technological justification and possible intake concern due to the high consumption of this basic foodstuff 06.5 EU supports Cereal and starch based desserts 1,000 mg/kg Note Collagen based casings with a water activity greater than EU supports but only for food supplements supplied in liquid form changed to 3,000 mg/kg because of the specific gravity of liquid products (would correspond to 2,000 mg/l). No need for food supplement supplied in dried form EU strongly opposes. Stan on fruit juice and nectars does not permit any preservatives in such products. The justification is therefore not pertinent. Discontinuation is requested EU strongly opposes. Stan on fruit juice and nectars does not permit any preservatives in such products. The justification is therefore not pertinent. Discontinuation is requested. (e.g., rice pudding, tapioca pudding) Edible casings (e.g., sausage casings) GMP Note 42 6 Justification For use in collagen based casings with a water activity greater than 0.6 Food supplements 3,000 mg/kg Note 42 6 Comment Only support for use in food supplements supplied in liquid form Vegetable juice 1,000 mg/kg Note 42 6 Justification Adopt based on corresponding levels established for fruit juices and nectars; add notes 91 and 122 for consistency with notes for fruit juices and nectars. Concentrates for vegetable juice 1,000 mg/kg Note 42 6 Justification Adopt based on corresponding levels established for fruit juices and nectars; add notes 91, 122 and 127 for consistency with notes for fruit juices and nectars. 4

5 Recommendation 1 Sorbates, INS The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for sorbates in the GSFA. Food EU comments Cat s EU strongly opposes. Stan on fruit juice and nectars does not permit any preservatives in such products. The justification is therefore not pertinent. Discontinuation is requested. Vegetable nectar 1,000 mg/kg Note 42 6 Justification Adopt based on corresponding levels established for fruit juices and nectars; add notes 91 and 122 for consistency with notes for fruit juices and nectars EU strongly opposes. Stan on fruit juice and nectars does not permit any preservatives in such products. The justification is therefore not pertinent. Discontinuation is requested EU does not support. The high concentration of alcohol does by itself plays the role of preservative Concentrates for vegetable nectar 1,000 mg/kg Note 42 6 Justification Adopt based on corresponding levels established for fruit juices and nectars; add notes 91, 122 and 127 for consistency with notes for fruit juices and nectars. Distilled spirituous beverages containing more than 15% alcohol 600 mg/kg Note 42 6 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s ML seems too high and Unripened cheese 3,000 mg/kg Note 42 6 Comment 1) Industry in Canada has should be indicated a need for sorbates at 3000 aligned with mg/kg. However, in the Codex Codex Standard , standard 221- for Unripened Cheese 2001 including Fresh Cheese there (i.e mg/kg) is a provision for 1000 mg/k 2) Support use level of 3,000 mg/kg which is needed to ML seems too high mg/kg seems sufficient to effect, as authorized by Stan A Justification from Industry in Canada is not substantiated prevent mould growth. Ripened cheese 3,000 mg/kg Note 42 6 Comment 1) Industry in Canada has indicated a need for sorbates at 3000 mg/kg. However, in the Codex Standard A , amended in 2006, Cheese, there is a provision for 1000 mg/kg 2) suggest adding Note 3: surface treatment only 3) ML is 1000 mg/kg in CODEX STAN 283 5

6 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s ML seems too high Processed cheese 3,000 mg/kg Note 42 6 Comment 1) Consistent with the Codex mg/kg seems Standard A-8(b)-1978 for Processed Cheese, also in sufficient to Canada industry has indicated a effect need for sorbates at this level of use. 2) ML 3,000 mg/kg is necessary as anti-moulding 01.7 Only for non heat treated products at a Max Level of 300 mg/kg. The heat treatment provides adequate preservation ML seems high. A ML of 1000 mg/kg should be sufficient EU does not support. No Technological justification ML seems high. A ML of 1000 mg/kg seems sufficient to Dairy-based desserts (e.g., pudding, fruit or flavoured yoghurt) agent for higher ph products 1,000 mg/kg Note 42 6 Comments 1) Not necessary in heat treated products as the heat treatment provides adequate preservation. Add note Only for non-heat treated dairy based desserts 2) ML 1000 mg/kg necessary in dairy based desserts independent of heat treatment; suggest adding a note: use only allowed in heat treated flavoured fermented milk (STAN 243) Dried fruit 2,000 mg/kg Note 42 6 Comment 1) ML seems high. A ML of 1000 mg/kg seems sufficient to 2) Necessary in rehydrated/soft fruit, but not in standard fruit Jams, jellies, marmelades 1,000 mg/kg Note 42 6 Comment 1) In the past, industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg 2) Add note only in lowsugar jams 3) Used at ML of 1000 mg/kg Fruit preparations, including pulp, purees, fruit toppings and coconut milk EU supports Vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds in vinegar, oil, brine, or soybean sauce EU supports Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed purees and spreads (e.g., peanut butter) in all jams. 1,500 mg/kg Note 42 6 Comment 1) ML seems high. A ML of 1000 mg/kg sufficient to 2) This additive s as preservative and the level is necessary to intended technical need. 2,000 mg/kg Note 42 6 Comment Industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg 2,000 mg/kg Note 42 6 Comment Industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg 6

7 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s EU supports Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed pulps and preparations (e.g., vegetable desserts and sauces, candied vegetables) other than food category ,000 mg/kg Note 42 6 Comment Industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg EU opposes. Sorbate should not be allowed in chocolate products conforming with codex stan Technological need requested for other products not conforming with Codex stan EU does not support, ML seems to be high seems sufficient to need EU opposes this provision in dried pasta. Stan clearly excludes pasta. EU propose to add a new footnote to limit the use to noodles only EU opposes for pasta. The Stan on noodles does not apply to pasta either Such a provision should only apply to noodles. Cocoa and chocolate products 1,000 mg/kg Note 42 6 Comment Sorbates are not allowed in standardized cocoa or chocolate products (as per the Codex Standard) Confectionery including hard and soft candy, nougats, etc. other than food categories 05.1, 05.3 and 05.4 Dried pastas and noodles and like products Pre-cooked pastas and noodles and like products 2,000 mg/kg Note 42 6 Comment 1) ML seems high. A ML of 1500 mg/kg seems sufficient to 2) 1500 mg/kg is required for technical application in products 2,000 mg/kg Note 42 6 Justification Consistent with Codex Standard for Noodles Comment No additives are necessary in dried pasta 2,000 mg/kg Note 42 6 Justification Consistent with Codex Standard for Noodles Comment Add note only in noodles 7

8 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s 07.0 Only in prepacked sliced bread and ryebread and partially bake, pre-packed bakery wares intended for retail sale and energy reduced bread intended for retail sale Bakery wares 2,000 mg/kg Note 42 6 Comment 1) industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg 2) Add note Only pre-packed sliced bread and rye bread and partially cooked bakery wares and energy reduced bakery wares 08.2 For surface treatment of dried meat only 08.3 For surface treatment of dried meat only Processed meat, poultry, and game products in whole pieces or cuts Processed comminuted meat, poultry, and game products EU agrees Smoked, dried, fermented, and/or salted fish and fish products, including mollusks, crustaceans, and echinoderms 09.3 EU agrees Semi-preserved fish and fish products, including mollusks, crustaceans, and echinoderms 12.4 Only with a ML of 1000 mg/kg 12.5 EU opposes the proposed ML. Stan , Rev has adopted a ML of 500 mg/kg for sorbate. In addition no justification has been provided. 500 mg/kg seems sufficient to 2,000 mg/kg Note 42 6 Comment 1) Add note for surface treatment of dried meat products 2) Used in Biltong snapsticks 2,000 mg/kg Note 42 6 Comment Add note for surface treatment of dried meat products 2,000 mg/kg Note 42 6 Comment Industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg 2,000 mg/kg Note 42 6 Comment Industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg Mustards 1,500 mg/kg Note 42 6 Comment 1) ML seems high. A ML of 1000 mg/kg seems sufficient to 2) Technological purpose questioned Soups and broths 1,500 mg/kg Note 42 6 Comment 1) Codex Standard for Bouillons and Consommés allows maximum 500 mg/kg 2) ML seems high. A ML of 500 mg/kg seems sufficient to 8

9 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s ML is too high. ML seems high. A ML of 2000 mg/kg seems sufficient to. EU request clarification about the need raised by Canada. In addition, snoek pate should not be covered by but rather sub categories related to fish products Emulsified sauces (e.g., mayonnaise, salad dressing) 3,350 mg/kg Note 42 6 Comment 1) Industry in Canada has indicated a need for use of sorbates in this Category at 3,350 mg/kg 2) ML seems high. A ML of 2000 mg/kg seems sufficient to 3) Used in Snoek pate at 3350 mg/kg ML seems high. A ML of 1000 mg/kg seems sufficient to No justification has been provided ML seems high. A ML of 1000 mg/kg seems sufficient to No justification has been provided The ML of 1000 mg/kg seems to be sufficient to purpose No justification has been provided justifying 2000 mg/kg 13.5 ML seems high. A ML of 1500 mg/kg seems sufficient to Non-emulsified sauces (e.g., ketchup, cheese sauce, cream sauce, brown gravy) 2,000 mg/kg Note 42 6 Comment 1) ML seems high. A ML of 1000 mg/kg seems sufficient to 2) The Additive s as a preservative and the maximum use level of 1000mg/kg is safe and necessary to intended purpose. Mixes for sauces and gravies 2,000 mg/kg Note 42 6 Comment ML seems high. A ML of 1000 mg/kg seems sufficient to Clear sauces (e.g., fish sauce) 2,000 mg/kg Note 42 6 Comment 1) ML seems high. A ML of 1000 mg/kg seems sufficient to 2) The Additive s as a preservative and the maximum use level of 1000 mg/kg is safe and necessary to intended purpose. Dietetic foods (e.g., supplementary foods for dietary use) excluding products of food categories and ,000 mg/kg Note 42 6 ML seems high. A ML of 1500 mg/kg seems sufficient to 9

10 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s EU does not support the Carbonated water-based flavoured drinks 1,000 mg/kg Note 42 6 Comment 1) Industry in Canada has proposed ML indicated a need for use of sorbates in and suggests this Category at 1000 mg/kg that particular 2) ML seems high. A ML of attention 300 mg/kg sufficient to should be paid to this basic foodstuff with regard to 3) Suggest collapsing the subcategories into potential Although 1000 mg/kg is permitted in some countries, intake the current use levels exceedance. A typically do not exceed 500 ML of 300 mg/kg as sorbic acid due to mg/kg should be inadequate solubility and sufficient to sensory concerns at higher use levels.. A high concentration of 1000 ppm may lead to taste issues and potential for precipitation EU does not support the proposed ML and suggests that a particular attention should be paid to this food with regard to potential intake exceedance. A ML of 300 mg/kg should be sufficient to EU does not support the proposed ML. 300 mg/kg should be sufficient to need. In addition, Note 127 should be added. Non-carbonated water-based flavoured drinks, including punches and ades Concentrates (liquid or solid) for water-based flavoured drinks 1,000 mg/kg Note 42 6 Comment 1) Industry in Canada has indicated a need for use of sorbates in this Category at 1000 mg/kg 2) ML seems high. A ML of 300 mg/kg sufficient to 3) Collapse into ,500 mg/kg Note 42 6 Comment 1) ML seems high. A ML of 300 mg/kg sufficient to, add note ) Collapse into If CCFA decides to continue to maintain the subcategories, we suggest including Note 127 (As served to the consumer) in

11 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s Only in liquid tea concentrates and liquid fruit and herbal infusion at 600 mg/kg. Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa 1,000 mg/kg Note 42 6 Comment 1) Set ML to 600 mg/kg. Add note Only in liquid tea concentrates and liquid fruit and herbal infusion concentrates 2) Set ML to 500 mg/kg due to solubility concerns at higher use levels. 3) Add Note 160 (For use in ready-to-drink products and premixes for ready-to-drink products only) The ML seems high. A ML of 200 mg/kg is sufficient to. No justification has been provided for the use at 1000 ppm EU opposes the proposed ML and questions the need of such high ML. At such high concentration undesirable geranium like taste can occur in the wine. This ML should be kept at the minimum necessary for the antiseptic action of sorbic acid. A ML of 200 mg/kg is sufficient to. OIV also recommends the ML of 200 mg/kg ML seems high. A ML of 200 mg/kg is sufficient to Why 1000 ppm is proposed while no justification has been provided for such a high concentration? Cider and perry 1,000 mg/kg Note 42 6 Comment 1) Industry in Canada has indicated that 500 mg/kg is ly sufficient for these foods 2) ML seems high. A ML of 300 mg/kg sufficient to Grape wines 2,000 mg/kg Note 42 6 Comment 1) Industry in Canada has indicated that 500 mg/kg is ly sufficient for these foods 2) ML seems high. A ML of 200 mg/kg sufficient to Wines (other than grape) 1,000 mg/kg Note 42 6 Comment 1) Industry in Canada has indicated that 500 mg/kg is ly sufficient for these foods 2) 200 mg/kg adequate for tech need 11

12 Recommendation 3 Sorbates, INS The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for sorbates in the GSFA. s ML seems high. A ML of 200 mg/kg seems sufficient to Mead 1,000 mg/kg Note 42 6 Comment ML seems high. A ML of 200 mg/kg seems sufficient to ML seems high. A ML of 200 mg/kg seems sufficient to Aromatized alcoholic beverages (e.g., beer, wine and spirituous cooler-type beverages, low alcoholic refreshers) 500 mg/kg Note 42 6 Comment 1) Industry in Canada has indicated a need for use of sorbates in this Category at 500 mg/kg 2) Level of 200 mg/kg adequate HYDROXYBENZOATES, PARA- (INS 214, 218) 4. The 17 th JECFA (1973) assigned a group ADI of 10 mg/kg bw for para-hydroxybenzoates. The Codex Class Names and International Numbering System for Food Additives (CAC/GL ) associates the purpose preservative with para-hydroxybenzoates. Recommendation 1 Hydroxybenzoates, para-, INS 214, 218 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for para-hydroxybenzoates in the GSFA. Food EU comments Cat EU opposes Processed cheese 300 mg/kg Note 27 6 Para hydropxy benzoate is not allowed in Stan A8(b) on processed cheese. Such a provision should be considered first by the CCMMP 01.7 EU does not support Dairy-based desserts (e.g., pudding, fruit or flavoured 120 mg/kg Note 27 6 Comment Only allowed in Not yoghurt) flavoured fermented milks heat treated after authorised in fermentation per the CODEX STAN 243. amendment in 2008 to Stan on fermented milk products (Alinorm 08/31/11) EU does not support Not authorised by Stan on dairy fat spreads 02.3 EU opposes. Not authorised by Stan on fat spreads and blended spreads Fat spreads, dairy fat spreads and blended spreads Fat emulsions mainly of type oil-in-water, including mixed and/or flavoured products based on fat emulsions 300 mg/kg Note mg/kg Note

13 Recommendation 1 Hydroxybenzoates, para-, INS 214, 218 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for para-hydroxybenzoates in the GSFA. Food EU comments Cat 03.0 EU opposes. No Edible ices, including sherbet and sorbet 1000 mg/kg Note 27 6 Comment No need of preservatives and antioxidants in frozen need of technology. preservatives & antioxidant in the frozen technology EU agrees Fruit in vinegar, oil, or brine 800 mg/kg Note EU does not support. Technological need requested Fruit-based spreads (e.g., chutney) excluding products of food category mg/kg Note EU does not support EU does not support. Technological need requested. The efficacy at such low level is also questioned EU does not support. Basic foodstuff. The efficacy at such low level is also questioned EU does not support and question the need in such product that are preserved through natural fermentation or by acidulants EU does not support. Not authorised under Stan Fruit-based desserts, including fruit-flavoured water-based desserts Surface-treated fresh vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweeds, and nuts and seeds Peeled, cut or shredded fresh vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweeds, and nuts and seeds Fermented vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) and seaweed products, excluding fermented soybean products of food categories , , , and Cocoa mixes (powders) and cocoa mass/cake 800 mg/kg Note mg/kg Note 27 6 Comment Request need, seems too low for efficacy 12 mg/kg Note 27 6 Comment Request need, seems too low for efficacy 300 mg/kg Note mg/kg Note EU does not support. Not authorised under Stan ML is too high. Max 300 mg/kg Cocoa-based spreads, including fillings Confectionery including hard and soft candy, nougats, etc. other than food categories 05.1, 05.3 and mg/kg Note mg/kg Note 27 6 Comment 1000 mg/kg is sufficient for technical application in products 13

14 Recommendation 1 Hydroxybenzoates, para-, INS 214, 218 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for para-hydroxybenzoates in the GSFA. Food EU comments Cat 11.4 EU strongly oppose No need. Other sugars and syrups (e.g., xylose, maple syrup, sugar toppings) 100 mg/kg Note EU does not support and suggests discontinuation similarly to sorbate, following the same rational. Why is preservative required in a product that has a minimum 5% acetic acid? EU oppose in coffee No need in beer EU opposes. This substance is not authorised by the OIV (Organisation internationale du vin et de la vigne). No justification has been provided and OIV itself questions the need EU does not support EU agree but questions the need for such a high maximum limit Vinegars 100 mg/kg Note 27 6 Comment Preservative not required in products with minimum 5% acetic acid. Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa 450 mg/kg Notes 27 & Beer and malt beverages 200 mg/kg Note 27 6 Grape wines 50 mg/kg Note 27 6 Wines (other than grape) 200 mg/kg Note 27 6 Aromatized alcoholic beverages (e.g., beer, wine and spirituous cooler-type beverages, low alcoholic refreshers) 1000 mg/kg Note 27 6 Recommendation 2 Hydroxybenzoates, para-, INS 214, 218 The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for para-hydroxybenzoates in the GSFA. Food EU comments Cat EU opposes. No Jams, jellies, marmelades 1000 mg/kg Note 27 6 Comments Except for low-sugar justification. Not jams, there is no authorised by justification to add p- Stan hydroxybenzoate as the on marmalades. sugar ensures the preservative 1 Note 160: For use in ready-to-drink products and pre-mixes for ready-to-drink products only. 14

15 NISIN (INS 234) 5. The 12 th JECFA (1968) assigned an ADI of 33,000 U/kg bw for nisin. 6. The Codex Class Names and International Numbering System for Food Additives (CAC/GL ) associates the purpose preservative with nisin. 7. Nisin preparation is the commercially-available form of nisin. At the 68 th JECFA (2007), the name of the additive nisin was changed to nisin preparation to clarify that the preparation also includes sodium chloride and several different types of nisin (WHO TRS 947 (2007) pp ). At the 71 st JECFA it was decided to keep the name Nisin. The composition of nisin has in principle not been changed since it was evaluated in The previous specifications clearly gave the information that the product consists of a mixture of different types of nisin and that it contains sodium chloride). One gram of nisin preparation contains 1,000,000 International Units (IU) of nisin (see specifications in JECFA Monographs 4 (2007)). Available information indicates that a typical nisin preparation contains 2.5 % nisin. As there is μg nisin per IU, nisin preparation also contains μg nisin per IU (i.e., (2.5 g nisin/100 g nisin preparation) x (1 g nisin preparation/1,000,000 IU)). The JECFA ADI of 33,000 IU/kg bw refers to nisin (WHO TRS 430 (1969), pp ). Therefore, to compare this ADI with the use levels in the GSFA, which are reported as nisin, the ADI should be converted to the mg/kg bw basis. The GSFA (Note 28) provides this calculation: (33,000 IU nisin/kg bw) x (0.025 μg nisin/iu) x (1 mg/1 000 μg) = mg/kg bw. Therefore, both the JECFA ADI and use levels in the GSFA are on the nisin reporting basis.the JECFA ADI is given as units/kg bw instead of (as usual) mg/kg bw. JECFA has not given a guidance on how unit/kg bw could be converted to mg/kg bw. 8. Since the JECFA ADI and the use levels in the GSFA are on the nisin reporting basis, it is proposed that the current Note 28 be revised to clarify this: Revised Note 28: As Nisin. Nisin preparation (as defined in the JECFA specifications monograph for Nisin Preparation ) typically contains 2.5 percent nisin. The maximum use level as nisin can be converted to a maximum use level for nisin preparation by dividing by The ADI of 33,000 IU nisin/kg bw is equivalent to mg/kg bw [(33,000 IU nisin/kg bw) x (0.025 µg nisin /IU) x (1 mg/1 000 µg)]. EU comment: JECFA should provide a guidance on how unit/kg bw could be converted to mg/kg bw. The EFSA's scientific opinion on Nisin (The EFSA Journal (2006) 314, 1-16) states: JECFA allocated an ADI in 1969 (JECFA, 1969). However there was a mistake in the units used and the US Food and Drug Administration (FDA) subsequently calculated the equivalent dose of 4.9 mg /kg bw. Using a safety factor of 100, an Acceptable Daily Intake (ADI) of mg/kg bw/day was established. This corresponds to 2.9 mg/person/day (FDA 1988, Federal Register, Nisin preparation: Affirmation of GRAS status as a direct human food ingredient. 21 CFR Part 184, Fed. Reg. 53: ). The EU would like to highlight that the Scientific Committee for Food established an ADI of 0.13 mg pure nisin/kg bw and this ADI was reconfirmed by EFSA in

16 Recommendation 1 Nisin, INS 234 The ewg of the 41 st CCFA recommended discontinuation of the following food additive provisions for nisin in the GSFA Technological need is questioned - pasteurization is sufficient to reach the purpose The ML is too high. A child could reach the ADI of mg/kg bw by consuming 25 g of milk and dairy-based drinks. This is not an extreme amount and also repetitive daily exposure is likely to occur. Milk and dairy-based drinks 500 mg/kg Note Comment Should not be discontinued approved in milk products in certain Middle eastern countries at GMP and in China at 500 mg/kg as salt Not authorised under Stan A , rev 2003 on cream and prepared cream. EU agrees in clotted cream at 10 mg/kg pure nisin. Such proposal should be first discussed by CCMMP followed by an exposure assessment performed by JECFA EU can agree at 12.5 mg/kg of pure nisin EU can agree at 12.5 mg/kg of pure nisin 01.7 Dairy-based desserts (e.g., pudding, fruit or flavoured yoghurt) Cream (plain) and the like 500 mg/kg Note 28 3 Comment 1) There is no need. 2) Permitted in at 10 mg/kg as nisin in ANZ, EU and other countries. Ripened cheese 500 mg/kg Note 28 3 Comment The level of 12.5 mg/kg is ly adequate. With a ML of 500 mg/kg, a child who would eat a portion of 25 g would reach the ADI Processed cheese 500 mg/kg Note 28 3 Comment The ML is far too high. Level of 12.5 mg/kg is ly 500 mg/kg Note 28 3 adequate 2 Note 28: ADI conversion: if a typical preparation contains μg/u, then the ADI of U/kg bw becomes: [( U/kg bw) x (0.025 μg/u) x (1 mg/1 000 μg)] = mg/kg bw. 16

17 Recommendation 1 Nisin, INS 234 The ewg of the 41 st CCFA recommended discontinuation of the following food additive provisions for nisin in the GSFA No justification. Sterilisation processed in ad hoc hygienic conditions is sufficient to prevent micro organism growth. Not authorised by the Stan for certain canned vegetables as revised by Alinorm 09:32/27 (24th session of CCPFV). Such proposal should be first examined by CCPFV Canned or bottled (pasteurized) or retort pouch vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds GMP Note 28 6 Comment 1) There is no need 2) Nisin controls outgrowth of heat resistant bacterial spores. Many of these vegetable products cannot be processed under full heat sterilization regimes without destroying their organoleptic and nutritive qualities 07.2 EU opposes. Wide consumption. A child could reach the ADI by consumption of 50 g of fine bakery wares Not authorised under Stan , rev 2001 on bouillons and consommés. Fine bakery wares (sweet, salty, savoury) and mixes Ready-to-eat soups and broths, including canned, bottled, and frozen 250 mg/kg Note 28 6 Comment Suggest revision; 6.25 mg/kg as nisin required to produce desired preservative effect. Use permitted in several countries at 6.25 mg/kg. GMP Note 28 6 Comment Used in minimally processed, refrigerated soups to prevent spoilage of products that cannot be processed under full heat sterilization regimes without destroying their organoleptic and nutritive qualities. EU COMMENTS : EU SUPPORTS THE RECOMMENDATION 1 EXCEPT PROVISIONS AND Recommendation 2 Nisin, INS 234 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for nisin in the GSFA Only in mascarpone An authorisation in the broad category of unripened cheese should be first discussed by CCMMP followed by an exposure assessment performed by JECFA Unripened cheese 12.5 mg/kg Note 28 6 Comment Broadly used in the manufacturing of cheese: inhibits spore germination and growth of clostridium, bacillus or listeria. For the latter, no alternative method allowed to reach the same level of safety 17

18 Recommendation 3 Nisin, INS 234 The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for nisin in the GSFA EU strongly opposes the ML. Processed cheese 250 mg/kg Note 28 6 Comment 1) The ML is far too The ML is far too high. Level of 12.5 mg/kg is ly high and should adequate stick to the value of 2) National legislation 12.5 mg/kg for pure exists for use as an nisin adopted under antimicrobial in Stan A8(b)-1978 on processed cheese The pasteurized process cheese spreads (including those need of such level containing fruits, vegetables or meats) at should be a level of 250 mg/kg considered first by the CCMMP. A child could reach the ADI by consuming 50 g of processed cheese mg/kg should be sufficient to purpose 08.0 EU strongly oppose the use of Nisin in basic foodstuffs like meat and meat products. The low numerical ADI of Nisin (0.825mg/kg) should easily lead to intake concern. The ML is far too high. A child would exceed the ADI by consuming 25 g of meat/meat products Nisin is allocated a numerical ADI. Therefore, a numerical maximum level is required. EU support a numerical ML of 6.25 mg/l Meat and meat products, including poultry and game ASCORBYL ESTERS (INS 304, 305) 500 mg/kg Note 28 3 Comment 1) More information needed on the use of nisin in the general Category 8.0 Meat and meat products because the adoption of the provision would allow the use of a preservative in fresh meat products. 2) Revise to subcategory provisions , 08.2 and 08.3 Liquid egg products GMP Note The 17 th JECFA (1973) assigned a group ADI of 1.25 mg/kg bw for ascorbyl esters. 10. The Codex Class Names and International Numbering System for Food Additives (CAC/GL ) associates the purpose antioxidant with ascorbyl esters. 18

19 Recommendation 1 Ascorbyl Esters, INS 304, 305 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for ascorbyl esters in the GSFA EU agrees but the ML should be lowered (50g are sufficient to reach the ADI). 304 Unripened cheese 500 mg/kg Note EU supports only in noodles. No justification in pasta. Note 153 to be added Pre-cooked pastas and noodles and like products PROPYL GALLATE (INS 310) 20 mg/kg Note 10 Adopted Recommendation 2 Ascorbyl Esters, INS 304, 305 The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for ascorbyl esters in the GSFA EU opposes. No Pre-cooked pastas and noodles and like products 500 mg/kg Note 10 3 Comment 1) Consistent with the Standard (Instant Noodles) as need in pasta. antioxidants at a In addition the maximum level of 500 ML is far too mg/kg singly or in high (A child combination as ascorbyl reaches the ADI by consuming stearate. 2) Only in noodle but not in pre-cooked pasta only 50 g of 3) Do not support only in noodle as fried, pre- food). cooked pasta may have tech need for antioxidant 11. The 46 th JECFA (1996) assigned an ADI of 1.4 mg/kg bw for propyl gallate. 12. The Codex Class Names and International Numbering System for Food Additives (CAC/GL ) associates the purpose antioxidant with propyl gallate. Recommendation 1 Propyl Gallate, INS 310 The ewg of the 41 st CCFA recommended revocation of the following food additive provision for propyl gallate in the GSFA. Food Cat Food Category Max Level Comments Step Justification provided to ewg Pre-cooked pastas and noodles and like products Adopted Justification 100 mg/kg Notes 15 4 & Consequential effect of recommendation to adopt provision in food category at Step 3. 3 Note 10: As ascorbyl stearate. 4 Note 15: Fat or oil basis. 5 Note 130: Singly or in combination: butylated hydroxyanisole (INS 320), butylated hydroxytoluene (INS 321), tertiary butylated hydroxyquinone (INS 319), and propyl gallate (INS 310). 19

20 EU COMMENTS : EU SUPPORTS THE RECOMMENDATION Recommendation 2 Propyl Gallate, INS 310 The ewg of the 41 st CCFA recommended adoption of the following food additive provision for propyl gallate in the GSFA. Food Cat EU comments EU opposes the use of propyl gallate in pre-cooked pastas as there is no justification to use this food additive. EU takes note that propyl gallate is authorised at 200 ppm in Stan for instant noodles The footnote 153 should be added (For use in instant noodles only.) Pre-cooked 200 mg/kg Notes 15 & pastas and 130 noodles and like products 3 Justification Consistent with Codex STAN (Instant Noodles): provision for the use of propyl gallate as an antioxidant at a maximum level of 200 mg/kg singly or in combination with TBHQ, BHA, or BHT. Comment No justification for use in precooked pastas. Recommendation 3 Propyl Gallate, INS 310 The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for propyl gallate in the GSFA. Food EU comments Cat 12.5 Propyl gallate is not Soups and broths 200 mg/kg Notes 15 & Justification Consistent with Codex STAN ly (Bouillons and Consommes): provision for the use of propyl gallate as an antioxidant at a necessary in all maximum level of 200 mg/kg singly or in soup, its combination with antioxidant TBHQ, BHA, or BHT. is only Comment needed in powdered and dehydrated products This additive is not ly necessary in all soups, its antioxidant is only needed in powdered and dehydrated products covered by category EU supports Mixes for soups and broths 200 mg/kg Notes 15 & 130 Adopted PHOSPHATES (INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451i-ii, 452i-v, 542) 13. The 29 th JECFA (1985) assigned a group MTDI (maximum tolerable daily intake) of 70 mg/kg bw, as phosphorus, for phosphates. 14. The Codex Class Names and International Numbering System for Food Additives (CAC/GL ) associates the purposes acidity regulator, sequestrant, emulsifier, texturizing agent, stabilizer, and moisture-retention agent with phosphates. Recommendation 1 Phosphates, INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451iii, 452i-v, 542 The ewg of the 41 st CCFA recommended discontinuation of the following food additive provision for phosphates in the GSFA. Justification provided to ewg Food Category Max Level Comments Step EU supports Fresh Fish GMP Note 33 6 Comment Not needed in fresh fish (only necessary when fish is frozen to prevent drip loss) 20

21 EU COMMENTS : EU SUPPORTS THE RECOMMENDATION 1 6 Comment Recommendation 2 Phosphates, INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451i-ii, 452i-v, 542 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for phosphates in the GSFA. Food EU comments Cat EU supports Dairy-based drinks, 1,320 mg/kg Notes 33 & flavoured and/or fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks) mg/kg necessary to stabilize the protein matrix in whey-based products EU supports Condensed milk (plain) 880 mg/kg Notes 33, 34 7, & ML is too high. 13g/kg should be sufficient to need Beverage whiteners 22,000 mg/kg Notes 33 & EU supports Milk powder and 4,400 mg/kg Notes 33 & 6 cream powder (plain) EU supports except the ML. Such a value should be lowered due to intake concern. A child could reach the ADI by consuming 100 g of processed cheese. 9 g/kg should be sufficient to reach the effect. This value has been adopted by Stan 8(b)-1978 on processed cheese. Processed cheese 14,050 mg/kg Note EU supports. However the ML should be lowered due to intake concern. A child could reach the ADI by consuming 106 g of cheese analogues EU strongly opposes this provision because CX STAN for edible fats and oils not covered by individual standards prohibits the use of phosphates in vegetable oils. In addition Stan for named vegetable oils clearly states that no food additives are permitted in virgin or cold pressed oils covers virgin olive oil, peanut oil for instance as well as cold pressed oils. EU questions the use of footnote 88 (carry over from the ingredient) and wonders from which ingredient the phosphates would come Cheese analogues 13,200 mg/kg Note 33 6 Vegetable oils and fats 220 mg/kg Notes 33 & Note 88: Carryover from the ingredient. 7 Note 34: Anhydrous basis. 21

22 Recommendation 2 Phosphates, INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451i-ii, 452i-v, 542 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for phosphates in the GSFA. Food EU comments Cat EU opposes. Not authorized in Stan for named animal fats.. A need for phosphates in simple oils and fat is not recognised. EU questions the use of footnote 88 (carry over from the ingredient) and wonders from which ingredient the phosphates would come Lard, tallow, fish oil, and other animal fats 220 mg/kg Notes 33 & EU does not support. Technological need is requested EU does not support. Technological need is requested EU does not support. Technological need is requested EU does not support and questions the need, as phosphates are primarily used as waterretention EU does not support. Technological need is requested Only for processed potato products EU does not support. Should exclude chocolate covered by Stan Fruit in vinegar, oil, or brine Dried vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweeds, and nuts and seeds Vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds in vinegar, oil, brine, or soybean sauce Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed purees and spreads (e.g., peanut butter) Vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweed, and nut and seed pulps and preparations (e.g., vegetable desserts and sauces, candied vegetables) other than food category Cooked or fried vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds Cocoa-based spreads, including fillings 2,200 mg/kg Note ,000 mg/kg Notes 33 & ,200 mg/kg Note ,200 mg/kg Notes 33 & 76 2,200 mg/kg Notes ,200 mg/kg Notes 33 & 76 2,200 mg/kg Notes 33 & Comment Only for processed potato products 6 8 Note 76: Use in potatoes only. 22

23 Recommendation 2 Phosphates, INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451i-ii, 452i-v, 542 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for phosphates in the GSFA. Food EU comments Cat 05.3 EU supports Chewing gum 44,000 mg/kg Note 33 6 Comment The use of phosphates in chewing gum does not raise safety concerns as phosphates are part of the nutrient source of Phosphorous to human bodies. Phosphates play an important role in a wide range of chewing gum and they are also specifically used with calcium in specialized chewing gum EU questions the need for Flours 11,900 mg/kg Note 33 6 Comment 1) Revise ML to 2500 such high ML. The ML mg/kg (except in selfraising flour) should be lowered to 2.5 2) Used as raising g/kg (except in self raising agent in self raising flour) flour, and various cakes 06.6 EU supports Batters (e.g., for 5,600 mg/kg Note 33 3 breading or batters for fish or poultry) EU supports Heat-treated processed meat, poultry, and game products in whole pieces or cuts 3,100 mg/kg Note EU does not support EU questions the need of phosphates in these marinated or pickled containing fish Only for mollusk and crustaceans Fish and fish products, including mollusks, crustaceans, and echinoderms, marinated and/or in jelly Fish and fish products, including mollusks, crustaceans, and echinoderms, pickled and/or in brine EU does not support Salmon substitutes, caviar, and other fish roe products 2,200 mg/kg Note ,200 mg/kg Note ,200 mg/kg Note EU does not support Preserved eggs, 1,000 mg/kg Note 33 6 including alkaline, salted, and canned eggs EU supports Salt Substitutes 4,400 mg/kg Note EU supports Seasonings and 4,400 mg/kg Note EU does not support. Clarification on the need of phosphate as acidity regulator should be welcomed EU supports Ready-to-eat soups and broths, including canned, bottled, and frozen condiments Mustards 1,320 mg/kg Note ,320 mg/kg Note

24 Recommendation 2 Phosphates, INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451i-ii, 452i-v, 542 The ewg of the 41 st CCFA recommended adoption of the following food additive provisions for phosphates in the GSFA. Food EU comments Cat EU questions the proposed Mixes for soups and 6,600 mg/kg Note 33 6 Comment ML. The ML should be broths Revise ML to lowered to 1.3 g/kg which mg/kg; is tech needed for dry soups that are is sufficient to high in fat, protein, dairy (cream/creamer/whey) content and reconstituted by the addition of milk and water. Product is cooked up and fat must remain stable after EU does not support. EU questions the use of footnote 88 (carry over from the ingredient) and wonders from which ingredient the phosphates would come EU does not support. The need is requested. In addition EU questions the use of footnote 88 (carry over from the ingredient) and wonders from which ingredient the phosphates would come Beer and malt beverages Wines (other than grape) 440 mg/kg Notes 33 & mg/kg Notes 33 & 88 cooking 6 Question use of note 88 6 Recommendation 3 Phosphates, INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451i-ii, 452i-v, 542 The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for phosphates in the GSFA Only in UHT and sterilised milk. In Milk and buttermilk (plain) 1,500 mg/kg Notes 33 & 88 3 Comment 1) In the past, industry in addition the ML Canada has indicated that the use of monoammonium should be lowered phosphate in uncultured to 400 mg/kg buttermilk at 270 ppm which is sufficient expressed as phosphorus is to ly sufficient.. EU questions the use 2) Only in UHT and sterilised milk. In addition the ML should be lowered to 400 mg/kg which of footnote 88 is sufficient to. (carry over from 3) Question use of note 88 the ingredient) and 4) support ML of 1500 mg/kg wonders from for UHT goat milk to stabilize which ingredient calcium due to higher the phosphates temperatures would come 01.4 ML seems excessive. A value of 1100 mg /kg has been proposed by the Alinorm 08/31/11 appendix V for creams and prepared creams Cream (plain) and the like 2,200 mg/kg Notes 33 & 88 6 Comment 1) A value of 1100 mg /kg (as P) has been proposed by the ALINORM 08/31/11 Appendix V for creams and prepared creams 2) Used to stabilize prepared cream in products such as chocolate mousse. 3) ML of 2000 mg/kg as phosphate (880 mg/kd as phosphorus) in CODEX STAN 288 for Cream 24

25 Recommendation 3 Phosphates, INS 338, 339i-iii, 340i-iii, 341i-iii, 342i-ii, 343i-ii, 450i-iii, 450v-vii, 451i-ii, 452i-v, 542 The ewg of the 41 st CCFA recommended further discussion of the following food additive provisions for phosphates in the GSFA ML seems excessive. Around Unripened cheese 10,000 mg/kg Note 33 6 Comment 1) 1000 mg/kg (as P) seems 1000 mg/kg seems sufficient to (Stan sufficient to ;STAN ). 2) Reduce maximum level to 3500 mg/kg, as referenced in (Stan 273- the Codex Standard ; stan 275- (2001) for Unripened Cheese. 1973) ML seems excessive. A ML of 1500 mg/kg seems sufficient to EU does not support EU suggests that the need is evaluated by the CCMMP 02.4 A ML of 1500 mg/kg seems sufficient to 03.0 EU opposes, the ML is far too high. A ML of 500 mg/kg seems sufficient to EU does not support. No need EU does not support. No need EU does not support. Dairy-based desserts (e.g., pudding, fruit or flavoured yoghurt) Liquid whey and whey products, excluding whey cheeses Fat-based desserts excluding dairybased dessert products of food category 01.7 Edible ices, including sherbet and sorbet 10,500 mg/kg Note 33 3 Comment 1) A ML of 1500 mg/kg (as P) seems sufficient to 2) Used to stabilize prepared cream (chocolate mousse) 3) Add note stating a level of 1000 mg/kg as phosphorus for flavoured fermented milks (CODEX STAN 243) 880 mg/kg Note 33 6 Comment 1) Industry in Canada has indicated a need for use of calcium phosphate, tribasic, in liquid whey, as a carrier for benzoyl peroxide but at lower levels than that proposed here. 2) ML of 1320 necessary to stabilize higher protein liquid whey used for further processing into whey protein concentrates 7,000 mg/kg Note 33 6 Comment A ML of 1500 mg/kg (as P) seems sufficient to 12,000 mg/kg Note 33 6 Comment 1) A ML of 500 mg/kg (as P) seems sufficient to 2) Recommends reducing the maximum value to 7500 Frozen fruit 200 mg/kg Note 33 6 Comment 1) Technological need is not recognized in such products 2) Maximum level be raised to 350 mg/kg, as such a limit is needed to get proper water activation and stabilize the colour throughout the shelf-life of such foods. Dried fruit 10 mg/kg Note 33 6 Comment 1) Technological need is not recognized in such products 2) Maximum level be raised to 500 mg/kg, as such a limit is needed to get proper water activation and stabilize the colour throughout the shelf-life Canned or bottled (pasteurized) fruit of such foods. 200 mg/kg Note 33 6 Comment Questions the need. 25

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