Agenda Item 7 CX/NFSDU 13/35/8

Transcription

1 E Agenda Item 7 CX/NFSDU 13/35/8 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES Thirty-fifth Session Bad Soden am Taunus, Germany 4 8 November 2013 PROPOSED DRAFT REVISION OF THE LIST OF FOOD ADDITIVES (Prepared by Switzerland) Background At the 34 th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), the Delegation of Switzerland presented a Proposed Draft Revision of the List of Food Additives (CX/NFSDU 12/34/12) which had been drafted following the proposal made at the 33 rd Session of the CCNFSDU. At its 43 rd Session, the CCFA had examined the Discussion Paper on Food Additive Provisions in the Standard for Infant Formula and Formula for Special Medical Purposes (CX/FA 11/43/5) and recommended the way forward regarding the List of Food Additives Provisions (REP11/FA, para 44). Following the agreement of the CCNFSDU to include in the list of additives the salts of Citric and Phosphoric acid which may be considered as physiological body constituents, and in view of the fact that Sodium citrates (331i, 331iii) and Potassium citrates (332i, 332ii) were already included in the additives section of the Standard, the Committee agreed to forward the provisions of food additives considered as physiological body constituents: INS numbers: 339i, 339ii, 339iii, 340i, 340ii, 340iii to the CCFA for endorsement. The 44 th Session of the CCFA endorsed the list of additives proposed by CCNFSDU (REP12/FA, Appendix IV). In order to find out which of the proposed food additives were technologically justified, Switzerland asked the industry (International Special Dietary Food Industries, ISDI) to clarify which of the additional food additives were really needed and to provide information regarding their use in the production of infant formula. Switzerland then revised the Proposed Draft List of Food Additives in the Standard for Infant Formula and Formula for Special Medical Purposes based on the detailed information provided by ISDI and also inserted three columns ( status, comments and approval status) in the table of food additives including additional information as found in document CX/NFSDU 12/34/12. The Proposed Draft Revision of the List of Food Additives in Infant Formula is also included as Appendix 1 to this document. In light of the above given information and explanations, Switzerland would like to make the following proposals:

2 1. To delete the following food additives from the list: Section A (Infant Formula): Thickeners: INS number 414 Emulsifiers: INS numbers 472a and 473 Acidity regulators: INS number 338 Antioxidants: INS numbers 306, 308 and 309 Section B (Infant Formula as Food for Special Medical Purposes): Thickeners: INS numbers 401, 405, 412, 466 and 414 Emulsifiers: INS number To request to evaluate the following food additives: Section A (Infant Formula): Thickeners: INS number 415 Emulsifiers: INS numbers 472c and 472e Section B: (Infant Formula as Food for Special Medical Purposes): Thickeners: INS numbers 410, 415, 440 and 1450 Emulsifiers: INS number 472c Request for Comments Codex Members and Observers are requested to submit comments on the Proposed Draft Revised List of Food Additives (Appendix I), as well as on the above proposal. Comments should be sent to the following addresses: elisabeth.nellen@bag.admin.ch and codex@bag.admin.ch, with a copy to codex@fao.org and ccnfsdu@bmelv.bund.de by 30 September The Proposed Draft Revised List of Food Additives, including the submitted comments will be considered at the 35 th Session of the CCNFSDU which is due to take place in Bad Soden am Taunus, Germany (4 th - 8 th November 2013). 2

3 APPENDIX 1 FOOD ADDITIVES (INFANT FORMULA (IF)) Request for additional food additives for use in Infant Formula (Section A) and Infant Formula as Food for Special Medical Purposes (Section B) Section A (Infant Formula): INS no. Additive Maximum level in 100 ml of the ready-to-drink product 4 Thickeners 415 Xanthan gum GMP 414 Gum Arabic (acacia) Emulsifiers 472c Citric and glycerol* GMP 0.75 g in powder formula g in liquid formula 2 containing hydrolysed protein or amino acids status Comments Approved in 30 th (1986): ADI NS; infants <12 weeks not mentioned Tox database: threegeneration reproduction study adverse effects attributable to Xanthan gum were not found before ISDI: can be Deletion does not apply to the use of INS 414 as a carrier of nutrient preparations as authorized in CAC/GL th (1973): ADI NS (not limited); infants <12 weeks not mentioned EU (28 countries 1.2 g/l in FSMP) USA (GRAS* for food in general) Australia, Canada, China, EU (28 countries), Malaysia, New Zealand, USA (GRAS for food in general) 1 If more than one of the substances INS 472c, 473 are added the maximum level for each of those substances is lowered with the relative part as present of the other substances. 2 If more than one of the substances INS 472c, 473 are added the maximum level for each of those substances is lowered with the relative part as present of the other substances. 3

4 INS no. Additive Maximum level in 100 ml of the ready-to-drink product Sucrose esters 12 mg in formula 3 of s* containing hydrolysed protein or amino acids status Comments Approved in 49 th (1997) :ADI specified at 0-30 mg/kg bw; infants <12 weeks not mentioned Japan, EU (28 countries) 472e Tartaric and glycerol GMP (China) 0.5 g 61 st (2003) ADI specified at 0-50 mg/kg bw (2003); infants <12 weeks not mentioned 1998 Australia, New Zealand, USA (GRAS for food in general) 472a Acetic and glycerol Acidity Regulators 338 Phosphoric acid 0.1 g expressed as P 2 O 5 singly or in combination and within the limits for sodium, potassium and phosphorus in Section (e) in all types of infant formula Antioxidants 306 Vitamin E concentrate GMP (USA) 17 th (1973): ADI NS (not limited); infants <12 weeks not mentioned 1 mg in all types of infant formula singly or in combination Protect oxidation from 15 th (1971): suitable chemical compound for baby food (not specifically mentioned); attention to Ca:P ratio MTDI: 70 mg/kg bw as P (combined for all P sources) Not supported by ISDI: can be Not supported by ISDI: can be Is equivalent to specification INS 307b, therefore INS 306 can be If more than one of the substances INS 472c, 473 are added the maximum level for each of those substances is lowered with the relative part as present of the other substances. 4

5 INS no. Additive Maximum level in 100 ml of the ready-to-drink product Gamma tocopherol 308 Delta tocopherol 1 mg in all types of infant formula singly or in combination 1 mg in all types of infant formula singly or in combination Protect oxidation Protect oxidation from from status Comments Approved in It is not used in infant formulas, therefore can be. It is not used in infant formulas, therefore can be. Thickeners 401 Sodium alginate 405 Propane 1,2- diolalginate 410 Carob bean gum (Locust bean gum) Section B (Infant Formula as Food for Special Medical Purposes): INS no. Substance Maximum level in 100 ml of the ready-to- drink product 4 Status Comments Approved in 100 mg Not supported by ISDI: can be 20 mg Not supported by ISDI: can be 0.5 g 412 Guar gum 1 g Not supported by ISDI: can be 414 Gum Arabic (acacia) GMP Not supported by ISDI: can be. Deletion does not apply to the use of INS 414 as a carrier of nutrient preparations as authorized in CAC/GL Xanthan gum 0.12 g 30 th (1986), not specified 4 Except for the functional class 4.4 Antioxidants where the maximum level is expressed in mg/kg fat EU 1.2 g/l in FSMP, USA (GRAS for food in general)

6 440 Pectins 1 g 25 th (1981), not specified 466 Sodium carboxymethyl cellulose 1450 Starch sodium octenyl succinate Emulsifiers Mono- and diglycerides 472c Citric and glycerol 473 Sucrose esters of s g Not supported by ISDI: can be 2 g. 26 th (1982), not specified g Not supported by ISDI: can be 0.75 g in powder 17 th (1973), formula not limited 0.9 g in liquid formula containing partially hydrolysed protein, peptides or amino acids 12 mg in formula containing hydrolysed protein, peptides or amino acids * Generally recognised as safe (GRAS) 49 th (1997) :ADI specified at 0-30 mg/kg bw; infants <12 weeks not mentioned Brazil, EU (28 countries in FSMP), Indonesia, USA (GRAS for food in general) EU 20g/L in FSMP, USA exempt IF protein hydrolysate Australia, Canada, China, EU (28 countries), Malaysia, New Zealand, USA (GRAS for food in general) Japan, EU (28 countries) 5 If emulsifiers are used in combination, the combined levels should be within the levels listed and be proportionately reduced, and with the minimum amount necessary to achieve the intended technical effect. 6