ICGMA/GMA Staff Report - Codex Committee on Food Additives March 12 March 16, 2012 Hangzhou (Zhejiang Province), China

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1 ICGMA/GMA Staff Report - Codex Committee on Food Additives March 12 March 16, 2012 Hangzhou (Zhejiang Province), China I. OVERVIEW The 44 th plenary session of the Codex Committee on Food Additives (CCFA) was held in Hangzhou, China from March 12-March 16. Opening remarks were made by Dr Xiaohong Chen, Vice-Minister of Health, on behalf of the Minister of Health of the People s Republic of China. The Vice-Minister informed the Committee that the Chinese Government had given a high priority to food safety and had taken a series of measures to enhance food safety since the entry in force of the Food Safety Law. The measures included improving the legal framework for food safety, performing comprehensive food safety controls, accelerating the development and implementation of national food safety standards, and further increasing active participation in Codex activities. The Vice-Minister emphasized that China, as host country of the CCFA and elected member of the Executive Committee of the Codex Alimentarius Commission, would continue to take an active part in promoting food safety, trade and technical cooperation at the international level. Dr Junshi Chen, Professor of the China National Center for Food Safety Risk Assessment (CFSA), Ministry of Health, chaired the 44 th CCFA plenary session. The Session was attended by: 211 delegates from 51 Member countries; one Member organization; observers from 29 international organizations; FAO and WHO. With support of Codex Trust Fund, nine delegates from seven countries were able to participate in the CCFA Plenary session. The physical working group (pwg) on the General Standard for Food Additives (GSFA) met for two days, on Friday, March 9, AND Saturday, March 10, prior to the plenary. Dr. Dennis Keefe (United States, OFAS) chaired the pwg GSFA session. Additionally, in-session working groups met during lunch on Monday (Endorsement and/or revision of maximum levels for food additives and processing aids in Codex standards), Tuesday morning (International Numbering System) and Tuesday lunch (JECFA priorities). Dr. Paul Brent (Australia) chaired the in-session working group on endorsements, Dr. Behzad Marandi (Iran) chaired the in-session working group on the International Numbering System (INS) while Dr. Matthew Bauder (Canada) chaired the in-session working group on JECFA priorities. GMA s Dr. Maia Jack led the ICGMA delegation.

2 CCFA completed important items of work that will be advanced to the Commission for adoption including: - Food additive provisions of the GSFA at Step 8 and 5/8 (over 150 provisions); - Revisions to Composite Foods category (16) and Emulsified Sauces ( ); - Amendments to the International Numbering System for Food Additives; - Specifications for the Identity and Purity of Food Additives arising from the 74 th JECFA meeting for 22 food additives. 2

3 II. ICGMA priorities The Table below summarizes key ICGMA issues, in the order presented in the Report: Issue ICGMA Support or Intervention Outcome Sorbates ICGMA supported numerous provisions and made interventions when necessary. Sorbates are widely used preservatives in high moisture foods including syrups and toppings. Many frozen, liquid icings are formulated to be ambient-stable so as to be safely stored at room temperature after being whipped and applied to a decorated cake that is displayed in an in-store bakery or retail setting. Formulating a product with high fructose corn syrup is one way to lower the water activity in an ambientstable product. However, when sugar is used in regions where HFCS is not readily available, potassium sorbate is added to prevent yeast/mold and/or bacterial growth. The Committee agreed to forward for adoption the following provisions of interest: Cocoa mixes (syrups) at 1,000 mg/kg as P as chocolate syrups have high water activity and require preservatives to extend shelf-life Confectionery including hard and soft candy at 1,500 mg/kg as P Decorations at 1,000 mg/kg as P Emulsified sauces at 1,000 mg/kg as P Nisin ICGMA supported use of nisin as preservative in only Soups and Broths. Since pasteurization does not kill certain bacterial spores and other thermophilic heat-resistant spores in minimally processed canned foods. Many canned foods cannot be processed under full heat sterilization regimes without destroying their organoleptic and nutritive qualities. Due to JECFA s lack of guidance on how to convert the established ADI from unit/kg bw/d to mg/kg bw/d, the Committee decided to hold any decisions on pending provisions (i.e., , 7.2., , and others at Step 6) until JECFA has had an opportunity to consider safety of proposed uses in relation to the lower ADI. 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 3

4 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 highlighted 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 Committee Deliberations: JECFA Secretariat informed the Committee that the ADI for nisin was derived in units/kg b.w. based on a publication of 1949, in which the unit of antibiotic activity was defined as the amount that would just inhibit the growth of the test organism, Streptococcus agalactae, in 1 ml of broth (test Ai). The specific activity being 1300 units/mg of nisin preparation. This is not identical with the currently used IUs, defined as the amount of nisin required to inhibit one cell of Streptococcus agalactae in 1 ml of broth (with pure nisin having an activity of about IU/mg). The Committee further noted that the risk assessment conducted by JECFA was based on studies conducted with nisin preparations and the ADI derived was based on the activity of the preparation, and using a study by Tramer and Fowler, 1964, as the pivotal study. To what extent the preparation used had the same purity level as preparations used today was unclear. 4

5 Hence, the specific activity might have been lower, should the preparation used in the earlier studies have been of a lower purity. It was also noted that the specifications prepared by the 71 st JECFA considered nisin and nisin preparation as synonyms. Phosphates ICGMA supported numerous provisions and made interventions when necessary. In most cases, phosphates were being used as buffering agents. Outstanding provisions of interest included: Edible Oils and Fats - Phosphoric acid use in Edible Oils and Fats ( and ) as antioxidant/chelator to prevent metal-catalyzed oxidative breakdown of the oil JECFA Secretariat indicated that it was not feasible at this point to (i) verify the calculation of the ADI for nisin, (ii) clarify the basis of the ADI for nisin, and (iii) provide the calculation to convert the ADI to mg nisin/kg b.w. without the necessary data package. ELC and Japan indicated they had the necessary information. Thus, the Committee has included nisin on the JECFA priority list. The Committee agreed to endorse for adoption most provisions of interest. For standardized oils and fats, since the Codex Commodity Standards did not have any provisions for phosphoric acid, these provisions were discontinued. For fresh meat, use of phosphates was opposed by Brazil, Israel, and EU, in spite of the technological justification provided. The Committee decided to discontinue this provision as well. Confectionery (Phosphates typically used as buffering agents to prevent protein coagulation and grittiness; also used as anticaking agents.) Cocoa-based spreads at 880 mg/kg as P Cocoa mixes and cocoa mass/cakes and Cocoa and chocolate products per Codex 5

6 Commodity standards at 1,100 mg/kg as P Hard/Soft candy at 2,200 mg/kg as P Chewing gum at 44 g/kg as P Decorations at 1,500 mg/kg as P Bakery Bakery ware at 9,300 mg/kg as P Fresh Meat Fresh meat, poultry and game, comminuted [Sodium or potassium phosphates (e.g., trisodium polyphosphate, sodium tripolyphosphate, sodium phosphate) to adjust ph on the surface of carcasses, primal/subs and on trim- all for the purpose of killing E. coli.] Sauces Sauces at 2,200 mg/kg as P Aspartame- Acesulfame Potassium Steviol Glycoside Vegetable Juice/Nectars and Concentrates , , , at 1,000 mg/kg as P / Fruit Nectar/Concentrates in step Water-based flavored drinks (Note 161) 5.3. Chewing gum (Note 161) ICGMA supported numerous provisions for which there was a technological justification. The Committee agreed to endorse the provision for fruit nectars and concentrates. However, decisions on provisions associated with Note 161 (subject to national legislation) were deferred until after the Committee had the opportunity to discuss Note 161 during the Plenary. To be consistent with previous decision on provisions with associated Note 161, the Committee agreed to HOLD all outstanding 6

7 ICGMA interventions included arguments based primarily on: (i) the list of food categories for which use of sweeteners were agreed to be technologically justified by CCFA; (ii) the WHO FAS 60 Report Table 4 (p. 207, cations/2009/ _eng.pdf); (iii) use of other sweeteners in relevant GSFA and Codex commodity standards; (iv) products containing these sweeteners are already in global trade. Caramel IV Caramel IV use in Decorations (5.4.) based on technological need. Horizontal There was only enough time for discussion approach of acidity regulators during the pwg. to GSFA ICGMA provided in-depth comments Use of during the ewg and made numerous acidity interventions during the pwg based on regulators examples/input provided by ICGMA (AR), member companies, member trades (e.g., emulsifiers FCPC), AND by a number of vertical (E)/stabiliz trades (e.g., ISEO, AMI, USDEC, etc.) es (S)/thicken ers (T) Aluminium- Containing Food Additives ICGMA provided in-depth comments during the electronic WG regarding appropriate conversion factors for Aluminium-containing food additives. steviol provisions. Of interest: 5.2., , , , and 7.2. The Committee agreed to forward for adoption caramel IV in decoration at 50,000 mg/kg. Due to ICGMA interventions, pending provisions in some categories (e.g., edible oils and fats, fresh meats, peeled fruits/vegetables, surfacetreated fresh vegetables, etc.) which would ve otherwise been slated for discontinuation were retained and will be considered on a case-bycase basis. Regarding Herbs and Spices, ICGMA clarified that typically anticaking agents and antioxidants are used in these products and that AR, E/S/T are not needed. The Committee only considered discontinuance/revocation of those provisions under Recommendation 7 of the CX/FA 12/44/10. The Committee agreed to circulate all outstanding provisions under Recommendations 4-6 (adoption, further discussion, new) for further input. 7

8 Composite Foods Although the U.S. (chair of electronic working group) prepared an elaborate Discussion Draft on this topic for the Plenary discussion, EU agreed to the following compromise to the Plenary: - maintain FC 16.0 but delete descriptor and leave title as foods that do not fit into FC delete all outstanding provisions for FC agree to consider provisions on case-by-case basis in future years - develop an appropriate title/descriptor to reflect adopted provisions. In future CCFA meetings, composite foods provisions will be considered on a case-by-case basis. Current descriptor reads: 16.0 Prepared foods These foods are not included in the other food categories (01-15) and should be considered on a case-by-case basis. Prepared foods are mixtures of multiple components (e.g., meat, sauce, grain, cheese, vegetables); the components are included in other food categories. Prepared foods require minimal preparation by the consumer (e.g., heating, thawing, rehydrating). Provisions for additives will be listed in this food category in the GSFA only if the additive is needed: (i) solely to have a technological function in the prepared food as sold to the consumer; or (ii) at a use level that has an intentional technological function in the prepared food that exceeds the use level that can be accounted for by carry-over from the individual components. FOOD CATEGORY Emulsified sauces and dips (e.g., mayonnaise, salad dressing, onion dip) Sauces, gravies, dressings, and dips based, at least in part, on a fat- or oil-in water emulsion. Examples include: salad dressing (e.g., French, Italian, Greek, ranch style), fatbased sandwich spreads (e.g., mayonnaise with mustard), salad cream, fatty sauces and snack dips (e.g., bacon and cheddar dip, onion dip). Note 161 Subject to national legislation of the importing country aimed in particular at consistency with Section 3.2 Many country delegations wanted Note 161 deleted. However, the Chair decided that this was not an option but rather entertained the possibility of establishing another ewg to address the use of Note 161 for sweeteners and find an alternative approach. After a prolonged discussion, ICGMA intervention indicated that Note 161 was being used for additives that have been evaluated by JECFA and deemed safe for identified uses. Additionally, if an ewg is to discuss how to replace Note 161 with a new note, that Outcome Different proposals were made on defining the goal of the exercise in the terms of reference for the ewg: - The goal is to avoid making reference to national legislation. - The goal is to reduce and, if possible, avoid making reference to national legislation. As there was no consensus in the Committee on either of these proposals, the Chair concluded that the discussion on the Agenda Item be suspended. 8

9 of the Preamble Proposals for Additional Functional Classes for some food additives in Section 3 of the Codex Class Names and Internation al Numbering System (INS) (CAC/GL ) the new note should not refer to national legislation (in support of the US and Canada comments). ICGMA submitted proposals during the ewg to include additional functional classes for certain food additives, and supported those proposals during the insession working group. Recall that at the 42 nd session, legitimate functional classes associated with food additives in the GSFA were lost when the Committee decided to align them with those in the INS only. Many of the proposed changes to technological purposes identified by ICGMA were endorsed for adoption, i.e., over 20 additives now have additional technological purposes/functions associated with them. JECFA Priority List of Food Additives The WHO Secretariat emphasized the severe financial problems faced by the Organizations for the scientific advice program. Efforts are being undertaken to seek support for scientific advice activities in order to be able to support the work of Codex. Thus far, JECFA has been successfully balancing priorities in spite of decreasing resources. JECFA meetings now will be limited to one/year: 2012 JECFA will consider food additives and flavorings, and 2013 JECFA will consider food additives and contaminants. Outstanding additives on the JECFA priority list, include: - Xanthan gum (INS 415) - Pectin (INS 440) - OSA-modified starch (starch sodium octenyl succinate) (INS 1450) - Monk fruit extract/lo han guo (LHG); Siraitia grosvenorii Swingle - Acacia polyacantha var. Campylacantha, kakamut gum, arabino- galactan protein complex - 72 Flavourings 9

10 - Advantame - Glucoamylase from Trichoderma reesei expressed in Trichoderma reesei - Annatto extracts, bixin-based (INS 160b(i)) and annatto extracts, norbixinbased (INS 160b(ii)) - Nisin (INS 234) 10

11 III. Next Steps CL 2012/5-FA Part B; Deadline: October 15, 2012: - Comments at Step 3 on the provisions for aspartame-acesulfame salt (INS 962) of the GSFA (para. 22 of REP 12/FA and Appendix IX, Part 1); - Proposals for new provisions for nisin (INS 234) in 08.0 Meat and meat products, including poultry and game sub-categories of the GSFA (para. 80); - Proposals for new food additive provisions in food category 16.0 Prepared foods of the GSFA (para. 115); - Proposals for new additive provisions and/or revision of food additive provisions of the GSFA (para. 87). Many electronic working groups (ewgs) were established: Inconsistencies between Food Additive Provisions in the Commodity Standards and the GSFA Australia to lead ewg. Further consider the decision tree approach, and continue work on the discussion paper. Test/revise decision tree based on continued analysis of the five standards for processed meat, the four standards on chocolate and chocolate products, and soups & bouillons. GSFA U.S.A. to lead ewg: Horizontal approach for Acidity Regulators, Emuslifiers, stabilizers, thickeners. Consider provisions in Table 1 and 2 of the GSFA for those food additives in Table 3 with the function acidity regulators or emulsifiers, stabilizer, thickeners. To identify those food categories in the Annex to Table 3 in which the use of acidity regulators or emulsifiers, stabilizers, thickeners was technologically justified and those food categories in which it was not. (The Committee further agreed to circulate the food additive provisions of acidity regulators or emulsifiers, stabilizers, thickeners in Table 3, listed in Appendix X of REP 11/FA, for comments at Step 3 and 6.) Aluminum-containing food additives. Further work on recommendations for adoption, discontinuation and revocation; and, further reduce uses and use levels of aluminium-containing food additives and to seek alternatives to these food additives. International Numbering System (INS) Iran to lead ewg: 11

12 consider the replies to the CL requesting proposals for changes/additions to the INS list and prepare a proposal for circulation for comment at Step 3. Mechanism for Re-Evaluation of Substances by JECFA - Canada to lead ewg: To compile information on 107 food colours evaluated by JECFA since 1956 from members and other organizations, including from the industry producing food additives; To establish a prioritized list of food colours based on prioritization criteria established at 44 th CCFA, for action by CCFA, including for consideration for re-evaluation by JECFA. Database on Processing Aids Led by New Zealand and China. To develop criteria for the entry of substances in the database for processing aids. Next Session The 45 th CCFA session is scheduled for March 18-22, 2013 in Beijing, China with a physical working group to the GSFA to precede the plenary on March 15, 16. The physical working group to the GSFA is to be chaired by the United States of America to consider and prepare recommendations for the plenary regarding the output from the electronic working group. The official report, REP 12/FA, is available at: ftp://ftp.fao.org/codex/reports_2012/rep12_fae.pdf Staff Contact: Maia Jack: (202) , MJack@gmaonline.org 12