Date: Apr 01, 2017
This article oringally appeared in World Food Regulation Review and is reprinted with permission.
The last session of the Codex Alimentarius Committee on Food Additives reached all its objectives set on its agenda and adopted many food additive provisions while setting the scene to reform its work management procedures in order to respond to a fast growing innovative food technology environment and address its related upcoming regulatory challenges.
In mid-March, governmental food safety man-agers from 50 countries and 32 non-governmental organizations gathered in Macao (China) and found consensus on almost all the items that were on its agenda, even on benzoates, nitrates and nitrites and food additives in wine. The Committee also decided to review at its next year session the remaining pending provisions of “miscellaneous” food additives in the General Standard for Food Additives (GSFA), in the remaining food categories. More importantly, the Committee started to brainstorm about how to prioritize its work in the future, and maybe address in a more timely fashion the needs for global rules to cope with ever faster growing food technology innovations.
GSFA pending provisions: CCFA49 adopted, revoked and discontinued more than 400 provisions and completed the review of the first half of food categories
This is the main landmark success of this CCFA49. Under the chairmanship of Dr Paul Honigfort (USA-FDA) during the pre-session working group, and the chairmanship of Prof Junshi Chen and co-chairmanship of Dr Yongxiang Fan (PRC-CFSRA) during the CCFA49 plenary, the session went through all pending provisions un-der discussion.
Covering the first half-range of all GSFA food categories (i.e. from dairy products to edible casings – including confectionery products, cereals and cereal-based products, edible ices, processed fruits and vegetables, bakery wares and meat prod-ucts), the Committee reviewed all pending food additives provisions, some of which have been waiting to be discussed since 1999. This is a land-mark achievement of that last session, to reduce the so-called backlog by more than a half. The presession working group prepared the decisions of the CCFA plenary. At that point in time, it is worth noting that the debates among delegations were very constructive and this positive atmosphere was also at the source of that success. These exchanges also demonstrated a higher sense of detail, expressed by government representatives to question more in-depth whether the technological justifications provided by the industry at large would fit with real technological needs (i.e. questioning on real-use levels versus proposed maximum levels, or asking for countries where such uses would be already regulated). Based on that discussion, the Commit-tee therefore sent hundreds of provisions for final adoption in the GSFA to the forthcoming Codex alimentarius Commission (40th session or CAC40, Geneva, 17-22 July 2017), but is equally asking the CAC40 to revoke (or amend) several already approved provisions (e.g. sodium aluminosilicate in flavoured fluid milk drinks) or discontinue many others (i.e. draft provisions in the pipeline deleted).
It is therefore very logical that, as announced in the February issue of WFRR (see Vol. 26, Number 9, February 2017, Pages 25-28), CCFA49 decided to embark on new work to complete the review of all pending miscellaneous food additive provisions (i.e. other than sweeteners and colours) in the GSFA, for the second half of the food categories of the GSFA, i.e., from food category 9.0 Fish and fish products, including molluscs, crustaceans, and echinoderms down to 16.0 Prepared foods, with the exception of Wines (see below). Also part of that work, to start between now and the next CCFA meeting (i.e., CCFA50, March 2018 and its pre-session working group), several other pending provisions are under consideration, and especially the newly introduced provisions for other fluid milks in the GSFA, due to the change of the descriptor of that category adopted last year, and the importance of addressing technological needs for food additives, to ensure legal certainty for that food category. The debate held partly this year on the need for food additives in pre-packaged fluid milk (plain) is expected to develop further within the forthcoming year of negotiations, arguably with diverging views on whether milk (skimmed, semi-skimmed, whole), when preserved by an UHT technique, would require the use of stabilizers or not. On a similar note, the Committee also agreed to consider directly at its next pre-CCFA50 session working group the draft provisions for pro-cessed cheeses.
Status quo on benzoates in soft drinks, agreement to not disagree on wines, and further work decided on nitrates and nitrites
The climax of the CCFA49 plenary on the GSFA was marked by three major issues.
The CCFA49 largely debated the possible revision of the current interim use level of benzoates in water-based flavoured drinks, including “sport”, “energy” or “electrolyte” drinks and particulated drinks (trivially so-called “soft drinks”) at 250 mg/kg (expressed as benzoic acid). Many delegations expressed the views that the interim level could be adopted as final, with a footnote allowing a higher amount (i.e. 500 mg/kg) in cream sodas, root beers and similar types of products, and concentrates in frozen beverages. However, other delegations supportive of the European Union and its 28 member states were of the views that a level of 150 mg/kg would be sufficient to ensure the preservation of such beverages, even in areas with hot cli-mate conditions. Facing this complicated situation, the co-chair of the plenary decided to maintain the interim level until the next CCFA meeting, and wait for promised information from the industry, which could lead to the review by JECFA of the current ADI for benzoates with a view of increasing it.
The moment when the Committee discussed food additive provisions in grape wines was full of suspense in addressing whether the recommendations of the OIV (i.e. the International Organisation of Vine and Wine) could be taken on board by this Codex Alimentarius Committee, especially on food additives of functional classes, such as acidity regulators, stabilizers and antioxidants, with no numerical ADI, normally permitted as GMP level in many foods. Once again, these Codex Alimentarius proceedings were trapped beyond the mere review of technical justifications of using specific food additives in a very particular food category – also subject to many other international regulatory discussions – and the lack of mutual understanding on how the Codex Alimentarius as a food standard-setting institution could trust the work done by other organizations such as OIV, albeit an intergovernmental one. Based on those un-resolved issues, also intensively discussed in the early 2000s within the Codex Committee on General Principles on the terms of cooperation of Codex Alimentarius with other international organizations, led the Committee to conclude – due to lack of consensus – to maintain the draft provisions in grape wines held in the GSFA as draft pro-visions, and to stop discussing how to try to resolve it. Many delegations expressed regrets about this situation, but given that Codex Alimentarius adopts its standards by consensus, there was no other outcome possible to the CCFA49 and its chairs.
Last but not least, the CCFA49 plenary also held a very thorough discussion on the issue of the use of nitrites and nitrates, and the Netherlands posed clearly the terms of the discussion and highlighted the complexity around the use of nitrites and nitrates, namely: (i) although benefits of using nitrites and nitrates in some food preservations – such as fermented meat products – were established, inherent risks may make their future accept ability an issue and a further risk benefit quantification would be needed; (ii) there may be technological alternatives to those ingredients which should be further investigated through re-search and development, (iii) the limits of nitrates and nitrites shall be discussed in the light of a re-vised ADI. Therefore, the Committee decided that further intersession work would be necessary to prepare a further discussion next year at CCFA50 with further investigation into (a) issues which can be addressed by the Codex Committee on Food Additives and what type of scientific advice may be required to help the Committee, (b) what options may exist in terms of risk management measures which may not necessarily all be captured within the establishment of maximum limit in foods, and (c) frame the scope of what could be the request for further scientific advice to be sought in the future from JECFA, or any other form of FAO/WHO sci-entific advice.
Other issues on GSFA
As planned, the Committee easily approved the consequential GFSA changes to align with the pro-visions adopted in the Codex Alimentarius Regional (i.e. Near-East) Standard for Halwa Tehenia (in Codex Stan 309R-2011).
The CCFA49 also decided to discontinue all pending provisions for adipic acid in food categories where no use levels and technological justifications were provided by industry. For all other food categories, where such information was provided, the Committee decided to send the current draft maximum levels in those food categories to JECFA for a Tier 2 exposure assessment, but also to share all the information received on real-use levels to help JECFA to perform more refined expo-sure assessments. It is also reasonable to expect JECFA to issue an additional call for data to address JECFA expert needs.
The Committee, helped greatly by the discussion held in its pre-session working group, introduced into the GSFA proposed draft use levels for further discussion at a later stage (e.g. paprika ex-tracts, many food additives required in other fluid milks, etc.).
Alignment: the second main pillar of time-consuming and work-intensive issues, successfully dealt with by CCFA49
The CCFA49 plenary reviewed the work coming out of inter-session work and discussion, held during an in-session working group during CCFA49 on the alignment of the GSFA provisions with a number of Codex commodity food standards (i.e. so-called “vertical” standards”) related to frozen fish and fish products, and preserved tomatoes and processed tomato concentrates. As GSFA is meant to become the unique global standard reference regulating food additives, the Committee is in charge of revising the current proposed provisions adopted in Commodity standards and progressively replacing the specific provisions in such Commodity standards by a cross-reference to the GSFA provisions applicable in that food category or part of that food category. It also plans to address which parts of the food additives (generally by functional class) of Table 3 can be permitted – or excluded – in such a commodity standard. Such alignment process is one of the most tedious works, which requires a thorough work of high precision to reflect faithfully the work of current or past Codex Committees, while ensuring a full correspondence (i.e. alignment) between the GSFA and such standards. The chairmanship lead from Australia and New Zealand helps greatly to prepare the decisions of the CCFA, and the quality of all preparatory documents are widely recognized and praised by all delegations attending CCFA meetings.
In that regard, CCFA49 also agreed that the inter-session work until CCFA50 should focus on the alignment process of the remaining standards for fish and fish products, finalize the alignment of the standard on certain canned fruits (canned pears and canned pineapple) and put the last touches to a guidance for existing Codex Commodity Standards on how such alignment process is to be done in the future. This will also include a revised approach on how listing the corresponding commodity standards in the Table 3 (on the use of GMP food additives) of the GSFA itself.
The other major climax of the CCFA49 plenary: setting up work priorities for “CCFA v2.0”
One of the most important pieces of discussion of the last CCFA occurred when delegations ex-pressed views on what could be the best and enhanced ways to organize the future work and priorities of the committee.
Delegations reiterated the four main pillars of the Committee work:
(i) The need for the swift completion of the GSFA (which remains an incomplete and ongoing revised standard in the Codex Alimentarius compendium of international food standards). The Committee estimates to come up with a complete review by 2022. It would also include a process (or several processes) by which the Committee could modernize its ways, to take into account in a more timely manner the proposals for new provisions included in the GSFA, once JECFA has completed evaluations or reevaluations of the safety for their intended uses put forward by petitioners, including the establishment of full specifications, and how the committee intends in particular to address all the pending provisions for colours – in particular
natural colours such as curcumins, paprika extracts or spirulina extracts, without falling back again into more difficult discussions, which would not be directly related to those colours;
(ii) The further work needed on alignment of the Codex commodity standards with the GSFA and, inversely, which is the part of the work which may take up to 2025 to be largely completed;
(iii) The constant updating of the international numbering, functional class and technological purposes of food additives (i.e. the so-called “INS system”)
(iv) The allocation of work priorities to JECFA, so that JECFA may focus on evaluations needed to help the Committee to manage correctly, and in a more expeditious way, the core work on food additives, and to make sure that additional work on sub-stances considered by the industry itself as processing aids (e.g. enzymes) may be addressed differently in the future.
The Committee also agreed that additional (i.e. “stricter”) requirements shall be developed to justify even further the requests for new entries (i.e. new food additive provisions) into the GSFA, in particular in relation to the technological justification types of information, and also maybe characterizing further the concept of “possible misleading of the consumer” and “technological needs”, versus the current technical and safe approach. In doing so, the Committee has commonly agreed to make more difficult future entries of new provisions in food categories which may have not been reviewed by JECFA during the initial evaluation, which also explains the expansion of pending pro-visions in the GSFA and some strong reservations expressed in the past by some delegations.
The Committee took note of the willingness of some delegations to embark upon a completely new work on regulating the use of processing aids at the international level. The Committee recognized the importance of this unregulated area in many countries around the world, and probably the need to develop Codex recommendations or even a General Standard on Processing Aids, but it equally recognized that this task is huge and should be streamlined in order to avoid overloading the Committee compared to its immediate priorities on the four pillars – at least for the next 5 years (i.e. until the GSFA is mostly completed). The Committee also noted the views expressed to address the presence of unsuitable substances in foods, mainly related to forbidden or fraudulent practices, which may also be addressed jointly with other Commit-tees (such as the Codex Committee on Contaminants in Food and Feed).
The Committee agreed that USA and China, helped by Australia, Canada, Iran, and with further inputs by the Codex Alimentarius Commission secretariat and the Joint FAO/WHO secretariats shall prepare in advance of the next CCFA meeting (i.e. by October 2017) a revised discussion paper to develop “Future Strategies for CCFA” with the leitmotiv proposed by the CCFA Chair: “one CCFA approach”. The Committee also noted the willing-ness of other countries (especially the European Union) to contribute from the start to that redrafting and brainstorming exercise and it is expected that China is going address that offer, in suggesting early inputs into that process.
CCFA49 amended the International Numbering System (INS) for several Food Additives but maintained all listed enzymes in the INS
The Committee agreed to follow the recommendations of an insession working group held during CCFA49, which built on the outcome of intersession work regarding further changes to the INS. CCFA49 agreed to insert new natural color anthocyanin extracts (i.e. from hibiscus and elder-berry) as well as a new form of lecithin (i.e. hydroxylated lecithin), iron tartrate and sodium polyacrylate. CCFA49 however rejected the suggestion to consider trehalose as a food additive, given its regulatory status as a food ingredient in many countries around the world. The CCFA49 also agreed to allocate a new functional class and related technological purpose for sucralose and sodium carbonate.
The CCFA49 also followed the recommendation of the in-session working group to wait before taking any decisions in relation to the enzyme-producing industry request to take out all the enzymes out from the INS systems, as countries called for caution in relation to their possible status as food additives in some jurisdictions and possibly also in some commodity standards.
The next INS intersession working group will also address more inputs on the technological purpose of DL-malic acid (INS 296) as a ‘sequestrant’ in some processed fruits and vegetables.
JECFA priorities: new work added to the already long list of substances for JECFA review, and uncertainty introduced on the overall prioritization process sent back to the strategic discussion
CCFA49 plenary followed most of the recommendations put forward by an in-session working group meeting during the CCFA49 at some exceptions:
Benzoates were removed pending the further assessment of the availability of new scientific data expected to be presented at the next session (CCFA50) as to whether a full revaluation may be required in the future;
For cassia gum, a food additive currently permit-ted in many food categories at GMP level as included in Table 3, the Committee agreed to take it off the list, but pointed out that the food industry (supplying industry) was given until December 2017 to provide a suitable method for the determination of anthraquinones (a naturally occurring toxicant) at a level of less than 0.5 mg/kg in cassia gum. In the absence of any further inputs, CCFA50 will endorse the withdrawal of the tentative specifications of cassia gum (although it was evaluated in 2009 with ADI unspecified) and all the currently approved provisions for cassia gum will be deleted from the GSFA (in other words, cassia gum may be phased out and banned at the international level because it lacks an adequate method of analysis)
CCFA49 in particular assigned new work on the review of nisin and natamycin at the request of the Russian Federation, while noting that the scope of the evaluation may go beyond the scope of expertise of JECFA, and it may be further considered ad-dressing those aspects (i.e. alleged antimicrobial resistance) through other FAO/WHO scientific ad-vice routes.
One landmark decision of CCFA49 was to avoid any discussion on allocating any longer a higher priority to some requests in the list of priorities as-signed to JECFA. The main reason for that had been the on-going discussion about the work management of the committee, which is to be addressed in a more strategic approach at the next session (see above). Several delegations insisted on the fact that some of the requests for JECFA evaluations were already included at last CCFA sessions, and they should be considered in priority (such as the entry for spirulina extracts). The Committee did ac-knowledge the need for further prioritization, but based on its CCFA49 decisions, it means that it is now left up to the JECFA Joint FAO/WHO secretariat to pick and choose among the long list of pending requests the ones they consider will be ready for review by the next June 2018 meeting, when JECFA is to issue the traditional call for data in the course of summer 2017. The Joint JECFA secretariat generally focuses on requests where the dossier is thought ready for submission, and by grouping the requests according to chemical groups or functional classes or urgency expressed during CCFA meetings.
It is also worth noting that CCFA49 agreed to add two new colours for a reevaluation by JECFA, namely Red 2G and Brilliant Black; pending confirmation of the availability of scientific information at the next CCFA50 meeting (i.e. the dossiers must be promised to be ready by December 2018 and supported by a country sponsor as per common practice of the Committee).
Last but not least, CCFA49 also agreed to add Gold and Silver on the list of priorities for a full JECFA (re)evaluation and establishment of specifi-cations for their unique claimed intended use into decorations for some confectionery products, but also some fine bakery wares covered by GSFA food category 05.4.
CCFA49 also took note of the outcome of last JECFA meeting on food additives
The Committee noted the conclusions of the JECFA evaluation and reevaluation of some sub-stances, and the revision or establishment of specifications (i.e. Allura Red AC, Quinoline Yellow, Pectins, Tartrazine, Xanthan gum).
The Committee also noted the requests for further information expected by JECFA to complete the safety evaluation and/or the final adoption of full specifications (i.e. carob bean gum; cassia gum (see also above); rosemary extracts; steviol glycosides; most of the modified starches).
The Committee also agreed to call for information for the future adoption of OSA-modified gum arabic and lutein esters from Tagates erecta as GMP food additives in Table 3of the GSFA.
In relation to the review of the endorsement of the revised specifications for pectins, the CCFA49 plenary also agreed to introduce a sentence – the impact of which remains to be further gauged and better understood – in the preamble of the Codex Alimentarius standard which compiles all the food additive specifications developed by JECFA and approved by the CCFA. Indeed, at the request of the European Union, and as a compromise to adopt the revised specifications for pectins, the following sentence is to become an international Codex ‘norm’, once finally approved forthcoming July CAC40: “The use of secondary food additives (e.g. antioxidants, carriers, stabilisers, preservatives used in preparations) if referred to in specifications shall comply with the GSFA provisions.”
The Committee also noted the adoption of a new safety evaluation procedure for flavourings by JECFA.
CCFA to respond to questions from other Codex Alimentarius Committees
CCFA49 endorsed the proposed provisions in a series of commodity standards. However, CCFA49 also requested further inputs from the Codex Committee on Fats and Oils to clarify the technological needs for using several emulsifiers in vegetable fats and oils. CCFA49 has also directed questions back to the Codex Committee on Processed Fruits and Vegetables to provide further inputs on techno-logical justifications for the use of (i) emulsifiers, stabilizers, thickeners and xanthan gum in fruits and vegetable juices and nectars; (ii) acidity regulators and tartrates in dried fruits; (iii) tartrates in fruit-based spreads (such as chutney) corresponding to the relevant GSFA food category; and (iv) more inputs on the use of colours in French fries with its indirect impact of the levels of presence of neo-formed acrylamide during processing (i.e. frying).
In addition to its regular work of adopting, revoking or discontinuing food additive provisions in the GSFA and providing alignment in commodity standards , the last session of the Codex alimentarius Committee on Food Additives took steps to modernize its level of timely deliveries of international standards and recommendations on food additives, while reinforcing some criteria for consideration of new entries into the overall system (INS, evaluation, new provisions, alignment).
The Committee also projected itself well beyond the expected completion of the GSFA – planned to be mainly achieved in 2022 – and the full alignment process between GSFA and commodity standards foreseen to be completed by 2025/2028. CCFA49 indeed envisaged developing further international guidance – or even regulation – through a possible general standard on processing aids to be adopted by functional class. If confirmed at the next session, that huge task may occupy the Committee for years – if not decades – before being completed, depending on the level of consensus, yet to be found around this quite complex forthcoming piece of international negotiations.