ICGMA Report Codex Committee on Food Additives Beijing, China March 2013

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1 ICGMA Report Codex Committee on Food Additives Beijing, China March 2013 Executive Summary The 45 th session of the Codex Committee on Food Additives (CCFA) was held in Beijing, China, March Dr. Junshi Chen, Professor, China National Center for Food Safety Risk Assessment (CFSA), chaired the CCFA session which was attended by 66 member countries, EUMS, 33 international organizations, and FAO and WHO. Maia Jack, Ph.D., Grocery Manufacturers Association, represented ICGMA. The physical working group (pwg) for the Codex General Standard for Food Additives (GSFA) met March prior to the CCFA Plenary, chaired by Paul Honigfort, Ph.D. (United States, OFAS). In-session working groups were also held: - Endorsement and/or revision of maximum levels for food additives and processing aids in Codex standards (March 18, chaired by Paul Brent, Ph.D. (FSANZ/Australia)); - International Numbering System (March 19, chaired by Behzad Marandi (Iran)); - JECFA priorities (March 19, chaired by Matthew Bauder (Health Canada/Canada)) CCFA s key responsibility is to develop the Codex General Standard for Food Additives. This session focused on a number of critical issues including Aluminium-containing food additives, a horizontal approach to endorse provisions, and Note 161, among others. Provisions endorsed for adoption are being sent to the 36 th Codex Alimentarius Commission.

2 ICGMA Priorities The Table below summarizes key ICGMA issues, in the order presented in the Report: Issue ICGMA Support or Intervention Outcome Horizontal Approach to ICGMA provided justification for the use of acidity regulators, or emulsifiers, stabilizers, The physical Working Group to the GSFA decided on use of the following: GSFA and thickeners for a number of different food Acidity regulators are not justified in edible oils and fats. However, provisions for antioxidants in these Justification categories. categories will remain. for use of Antioxidants in edible oil and fats Acidity regulators are justified in egg products. Acidity regulators and color stabilizers in egg Acidity Acidity regulators in fruit and vegetable products (liquid and frozen) Regulators, juices/concentrates/nectars are justified on a case-bycase basis Acidity regulators in fruit and vegetable Emulsifiers, juices/concentrates/nectars Stabilizers, Acidity regulators in Coffee, coffee substitutes, justified tea, herbal infusions and Emulsifiers/stabilizers/thickeners in edible oils Thickeners and fats (i.e., vegetable oil and fish oil) (Agenda 5a) Aluminium- Containing Food Additives (Agenda 5b) Emulsifiers/stabilizers/thickeners in surfacetreated fresh fruit and vegetable (Modified food starches are typically used with organic acids and coating agents in spray applications to thicken and stabilize the film forming mixture in order that it adhere to the surface of the fresh fruit.) ICGMA supported numerous provisions and made interventions when necessary. In accordance with the objectives as stated by JECFA to reduce existing levels of aluminium-containing food additives in foods due to a Provisional Tolerable Weekly Intake (PTWI) of 2 mg/kg b.w., ICGMA members are recommending lower levels (in some cases as much as half) for sodium aluminium phosphate acidic (SALP) (INS 541i) and sodium aluminosilicate (INS 554) provisions. In the 20 th edition of the Codex Procedural Manual, in Section IV Risk Analysis, under Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius (para. 35, p. 110) on Risk Management, it states that risk management should take into account the economic consequences and the feasibility of risk management options In the case of SALP, there are currently no good alternatives. Sodium Acid PyroPhosphate (SAPP) impacts flavor, imparting a pyro-bite which is an astringent metallic taste making baked goods less desirable by the consumer. Calcium Acid PyroPhosphate (CAPP) has similar limitations to SAPP. MonoCalcium Phosphate (MCP) reacts too quickly for commercial operations. Glucono-delta-lactone (GDL) will cause batter/dough to constantly change in characteristics due to the release of carbon dioxide during holding. Air cells that have formed during 2 Acidity regulators in Coffee, coffee substitutes, etc. are E/S/T in edible oils and fats are not justified (as the corresponding Commodity Standards , , and do not have any provisions for these types of additives) E/S/T in surface-treated fresh fruit and vegetable will be considered at the next pwg. There is confusion as to whether the coatings consisting of primarily waxes are considered a food or a food additive. If the latter, then provisions for MFS would be considered a food additive use in a food additive, eliminating the need for specific provisions in this category. The JECFA Secretariat stated that data for sodium aluminium phosphate acidic (INS 541i) and aluminosilicate salts (INS 554, 556, 559) did not provide sufficient information to conclude that Aluminium (Al) from these compounds were less bioavailable thereby contributing minimally to dietary intake of Al. Thus, JECFA concluded that all Al-containing food additives had a similar toxicokinetic profile in their exposure assessment. Since cereal-based products and baked goods were identified as major contributors to the dietary intake of Al, many of these provisions were discontinued. The Committee agreed to forward for adoption the following Sodium Aluminium Phosphate Acidic (INS 541i) provisions of interest: Crackers, excluding sweet 100 mg/kg as Al, Note CC Other ordinary bakery products (e.g., bagels, pita, English 100 mg/kg as Al, Note CC, AA Steamed breads and 40 mg/kg as Al, Note CC, EE Mixes for bread and ordinary bakery 40 mg/kg as Al, Note CC, FF Note CC: Singly or in combination: Aluminium ammonium sulphate (INS 523) and Sodium aluminium phosphates (acidic and basic- INS 541(i),(ii)).

3 holding will be lost from the batter/dough when processed, leading to a decrease in volume. Once baked, insufficient gas remains to provide proper expansion. SALP is a moderately slow-acting acid and allows for a more controlled release of carbon dioxide which consequently impacts processing condition, the finished product volume, and provides better dough/batter handling. Note AA: For use in biscuit dough. Note EE: For use as a raising agent. Note FF: For use as a raising agent in mixes for steamed breads and buns. The Committee agreed to forward for adoption the following Sodium Aluminosilicate (INS 554) provisions of interest: Dairy-based drinks, flavoured and/or fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based 60 mg/kg as Al, Note KK Beverage 570 mg/kg as Al, Note RR Milk powder and cream powder 265 mg/kg as Al, Note QQ Milk and cream powder 570 mg/kg as Al mg/kg as Al, Note LL Seasonings and mg/kg as Al, Note MM Mixes for soups and 570 mg/kg as Al Mixes for sauces and 570 mg/kg as Al International Numbering System (Agenda 6) Note 161 Subject to national legislation of ICGMA sought the addition of color stabilizer to citric acid, used in egg products (liquid and frozen). As there have been trade impediments for some sweeteners/colors used in some foods (as they are not yet adopted in the GSFA due to their link with Note 161), industry felt the Note KK: For use in dry mix hot chocolate only. Note LL: For use in salt applied to dry salted cheeses during manufacturing only. Note MM: For use at 1,700 mg/kg in seasonings applied to foods in food category Note RR: For use in powdered beverage whiteners only. The Chair of the physical Working Group suggested that those aluminium-containing food additive provisions that were discontinued could be reconsidered at a later date provided that data are forthcoming, demonstrating that the PTWI would not be exceeded. Thus, a dietary intake assessment would need to be done. The INS in-session working group endorsed this use. Of critical interest however, during the GSFA physical Working Group deliberations, it became clear that the INS standard now reflects food additive uses that are indicative and not not exhaustive. Industry is now encouraged to consider all potential functions for each additive listed in the INS. Should future discussions address a function not identified in the INS, then those provisions may be discontinued on that basis. CCFA agreed to establish an electronic working group led by the United Kingdom, and assisted by the United States, to: Identify concerns regarding the 3

4 the importing country aimed in particular at consistency with Section 3.2 of the Preamble (Agenda 9b) and Proposed draft food additives provisions for aspartame - acesulfame salt (Agenda 5c and 5d) need to broker a compromised approach as the discussion on Note 161 ensued. Industry provided the below perspective to several government delegations in anticipation of Agenda Item 9b. Issue: Continued discussion of Note 161 has forestalled progress on critical food additive provisions currently used in international trade. While there is no objection in the Committee that the use of Note 161 (which undermines the international and scientific basis of Codex Alimentarius) should be reduced, there is also no consensus if the Note should be discontinued and/or deleted from existing provisions where it is used. Goal: To resolve concerns regarding Note 161 as quickly as possible in order that sweetener/color provisions are advanced for inclusion into the GSFA, thereby eliminating existing trade barriers due to lack of adopted provisions. Strategy: 1. Convince the CCFA to proceed with discussions on draft provisions even if this means certain provisions may be subject to the addition of Note 161 Place in bracketed text [Note 161] for all sweetener and color provisions in the Step process, and resume discussions about scientific justification for the use of these additives in a variety of provisions. Eventually, upon resolution of Note 161, the bracketed text can then be replaced or deleted accordingly. a. Scientific justification should be limited to safety considerations (and not technological justification) when the food category in question has already been identified by CCFA as requiring sweeteners or colors per 39 CCFA CRD 1 Appx V or 40 CCFA CRD 2 Appx 2, respectively. b. The Committee should follow The Procedure for Consideration Of the Entry And Review Of Food Additive Provisions in the General Standard for Food Additives ; section on Consideration of Conditions of Use in the Specific Food Categories. 1 c. The Committee should also confirm its commitment to avoid introducing Note 161 as much as possible. The Chair of the provisions with note 161, as contained in the compilation document on the use of aspartame, acesulfame K, and the double salt in specific food categories and the reasons for these concerns (Appendix 8 of CRD 2). Explore the use of alternative note(s) or other approaches that could address the concerns which have resulted in the application of note 161 or to demonstrate that note 161 is no longer needed for the particular provision. Information should be provided to the working group that, when used in conjunction with the principles set out in Section 3.2 of the preamble to the GSFA, would justify the removal of Note 161, or justify the use of another more appropriate note. 1 Paragraph 4 which reads as follows:«4. When establishing the acceptable maximum level of use for an additive in a specified food category, the Committee on Food Additives considers the technological justification for the proposed level and the exposure assessment in accordance with Sections 3.1 and 3.2 of the Preamble of the General Standard for Food Additives. If more than one maximum use level is proposed, and the Committee cannot reach consensus on the appropriate maximum use level, the delegations supporting and the delegations opposing the proposed maximum use level should provide additional justification for their proposed levels to address any specific concerns raised by the Committee, by the next available session, to the Committee on Food Additives, for consideration in its next session. Proposals lacking justification will no longer be considered, and the proposed level for which justification has been provided will be forwarded for adoption.» See Procedural Manual on page 59 and 60 of the 20th edition. 4

5 Committee should follow Measures to Facilitate Consensus as defined in the Procedural Manual (see page 212 of 20th edition). 2. Establish an electronic Working Group with the proposed Terms of Reference: To consider the need for Note 161 in view of the Preamble to the GSFA, Codex Procedural Manual, and Article 3 of the WTO SPS agreement; To consider the feasibility of replacing or revising Note 161, that conform to the Codex Statements of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to which other Factors are Taken into Account and are consistent with Sections 3.1 and 3.2 of the Preamble to the GSFA with the goal to reduce and, if possible, avoid making reference to national legislation. 5

6 Outlook Proposed New Work/ ewgs General Standard for Food Additives The Committee agreed to establish an ewg, led by U.S.A., to: o Prepare recommendations for the entry in the GSFA on proposals for new food additive provisions in food category 16.0 Prepared food ; o Prepare recommendations for the entry in the GSFA of proposals for new entry and revision of existing provisions, contained in CX/FA 13/45/12, except those for food category Grape wine and its sub-categories and those for aspartame (INS 951) and aspartame-acesulfame salts (INS 962); o Prepare proposals for the provisions in Table 1 and 2 of the GSFA of Table 3 multi-functional food additives with acidity regulator function which were held at the current session for a function other than as acidity regulators ; and o Prepare proposals for consideration of the provisions in Table 1 and 2 of Table 3 multi-functional food additives with emulsifier, thickener, stabilizer functions which were held at the current session for a function other than as emulsifier, thickener, stabilizer. The Committee agreed to establish a physical Working Group (pwg) for the GSFA, chaired by U.S.A., to meet immediately prior to its 46th Session to consider and prepare recommendations for the Plenary on: o The remaining recommendations on the horizontal approach for food additives with a technological function of emulsifier, stabilizer, thickener listed in Appendix 3 of CX/FA 13/45/7 (food categories , and from food category 06.1 to ) and the related provisions; and o The reports of the electronic Working Groups on: (i) the GSFA; (ii) Food category Grape wine ; and (iii) Note 161. Guidelines for the Simple Evaluation of Food Additives Intake (CAC/GL ) The Committee agreed to: o start new work on the revision of the Guidelines o forward the project document as revised to the 36th Session of the Commission for approval as new work (Appendix VI) o establish an ewg, led by Brazil, to prepare proposed draft revised Guidelines. Application of the Decision-Tree on the Alignment of the Food Additive Provisions of Commodity Standards and Relevant Provisions of the GSFA The Committee agreed to establish an ewg, led by Australia to: o finish work on the alignment of the meat standards, including a proposal for the revision of the relevant food categories of the GSFA and revision of the food additive sections of the meat standards; and o continue working on the alignment of the Standard for bouillons and consommés and the standards related to chocolate and cocoa products. 6

7 International Numbering System The Committee agreed to establish an electronic Working Group, led by Iran, to consider the replies to the CL requesting proposals for changes and/or additions to the INS and to prepare proposals for circulation for comments at Step 3. JECFA Priority List The Committee agreed to forward the Priority List of Compounds Proposed for Evaluation to FAO and WHO. Proposed Prioritized List of Colors for Re-Evaluation by JECFA The Committee agreed to establish an electronic Working Group, led by Canada, to prepare a discussion paper that would consider different options for the use of the outcomes of the prioritization exercise and other feasible steps to identify compounds for re-evaluation by JECFA. Discussion Paper on Use of Food Additives in Food Additives Committee supported the recommendation of the JECFA Secretariat to develop guidance on how to address the use of secondary additives in additives. The Delegation of the European Union agreed to prepare a discussion paper. Database on Processing Aids Criteria for Entry into the Database China will develop a database (outside of the Codex process) to provide a repository list of processing aids with information submitted by interested countries and international organizations. The Committee recommended that China use the following criteria for entry of processing aids into the database: o The substance should conform to the definition of food processing aids as described in the Procedural Manual of the Codex Alimentarius Commission and the Guidelines on Substances used as Processing Aids (CAC/GL ); and o The substance is used as a processing aid by one or more countries. Developments during the 45 th CCFA During deliberations of the GSFA physical Working Group, the Chair indicated that the functional classes associated with each additive in the INS are indicative of an additive s use in foods. Consequently, it would behoove industry to assess whether other functions need to be incorporated into the INS standard for each additive listed. During the physical Working Group, some provisions were being limited to specific functional classes. It would be important for industry to ensure those specific provisions do not have other uses. If so, a new food additive provision would have to be submitted for possible inclusion into the Step process. 7

8 Next Session. The next session of CCFA is expected to be held in approximately 12 months, location and dates TBD. More Information. The official report of the meeting can be found at: ftp://ftp.fao.org/codex/reports/reports_2013/rep13_fae.pdf. ICGMA Staff Contact for CCFA. Maia Jack: ( ) 8