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This article was published in World Food Regulation Review, June 2023, p. 26-34.

The 47th meeting of the Codex Alimentarius Com­mittee on Food Labelling (CCFL47) was held mid-May 2023 in Gatineau/Ottawa, Canada. CCFL47 advanced its food labelling international standard­isation work on the revision of the list of allergens of global relevance for mandatory declaration (to amend CXS 1), while considering others for higher relevance at “regional” level based on countries’ risk management decisions and the criteria of prevalence, severity and potency used in four ad hoc FAO/WHO Expert Consultations on this matter. It returned the proposed guidelines on the so-called ‘precautionary allergen labelling (PAL)’, for drafting and discussion of the possible inclusion of triggering thresholds allowing more food choices for people suffering from some food allergies or intolerances. CCFL47 also advanced work on its new guidelines about informa­tion provided for foods offered via E-commerce as well as its new guidelines on the use of new technol­ogies to convey food information to consumers other than on the printed label and whether such infor­mation would be limited to mandatory information or not. CCFL47 also considered several proposals for new work and agreed to start on specific provi­sions for the labelling of prepackaged foods in joint presentation or multipack formats as well as refining the scope for a definition of “added sugars” in the context of nutrition labelling to be led by Costa Rica. CCFL47 returned both the proposal for guidelines on the application of food labelling provision in emer­gencies (such as during a pandemic outbreak or due to a globally disrupting local armed conflict) as well as the proposal for new guidelines on ‘sustainability’ to refine and restrict the scope to comparative claims only. On alcoholic beverage labelling, CCFL47 accepted WHO’s proposal to prepare a discussion paper for consideration at its next session. On trans-fatty acid labelling, CCFL47 decided to wait for the outcome of the Codex Committee on Fats and Oils (CCFO) but maintained it on the agenda for its next session with a discussion paper to be prepared by Canada. CCFL47 did not discuss in detail the stockpile for other possible new work or the criteria and decision-tree for prioritization (or selection) of potential new work.

For the first time since 2019, the 47th session of the Codex Alimentarius Committee on Food Labelling (CCFL) was held in person. It was preceded by a pre-session e-working group held on allergen labelling issues on May 9 and 10. The CCFL47 draft report was adopted also in person on Friday 19 May 2023. More information about the CCFL47 meeting and its working documents are available here.

Allergens lists for mandatory declaration (including possible exemptions)

CCFL47 agreed to advance by one step the proposed draft revision to the General Standard for the La­belling of Pre-packaged Foods with the provisions relevant to allergen labelling. It also agreed to estab­lish a new electronic working group (EWG), chaired by Australia, UK and the USA to further develop the text. CCFL47 kept opened the possibility that the report of the EWG would be further developed by a physical working group (PWG) or a virtual working group (VWG) to be held immediately prior to the next CCFL session. The Codex Committee on Food Hygiene (CCFH) will be informed of the status of the work and in particular the new definition of “food allergens,” as well as revised lists of allergens of global and regional relevance.

Australia introduced the report of the past EWG and VWG on this topic that met virtually prior to the CCFL47, well summed up in CRD2. Australia referred to the four parts of the ad hoc FAO/WHO expert consultation as well as the scientific literature review performed by the International Social Science Liaison Groupii.

CCFL47 agreed with the revised definitions for food allergyiii and food allergensiv and kept the definition of coeliac diseasev as proposed by the PWG and consistent with the definition from the FAO/WHO Expert Consultation despite that Coeliac was a wider syndrome than a one shot reaction to gluten. A debate occurred on making reference to ‘food and ingredi­ents’ or ‘food and substances’ to cover not only food and ingredients, but also food additives (e.g. sulphites) and eventually processing aids residues. There was a notable preference for ‘substances’ used by the FAO/ WHO Expert Consultation which, given the defini­tions set in the Codex Alimentarius Commission’s ProceduralManual, would encompass both ingre­dients and food additives. Currently, in the GSLPF (CXS 1), the definition of ‘ingredient’ (in the list of ingredients) includes food additives and a reference to ‘ingredients,’ which may be sufficient. CCFL47 agreed that at the end of the revision process, the definitions set in the revised GSLPF and the definitions in the Code of Practice for Food Allergen Management for Food Business Operators will need to be aligned. During the discussion, a question was raised about new emerging allergens like peas and lentils and the provision referring to allergen declaration of ‘sub­stances’ not declared on the list of ingredients (be­cause it represents less than 5% w/w of the food)vi.

Regarding the list of allergens viewed as known to cause most of the allergenic reactions and relevant at a global scale, it was reminded that the FAO/WHO Expert Consultation focused only on scientific data about three unique criteria: prevalence, potency and severity. Experts performed a sensitivity analysis and investigated how prevalence could be categorized. CCFL47 agreed on a proposed revised listvii. Thai­land and Indonesia requested the removal of sesame seeds from that list and rather move it to the section (4.2.1.5) for allergens of regional relevanceviii , but CCFL47 disagreed due to the parameter of severity of reactions (fatality rates in some countries like UK, US or France) pointed out in the FAO/WHO Expert con­sultation. Brazilix did not support the removal of soy­bean (and products derived therefrom) from the list of allergens of global relevance (in 4.2.1.4) and its move to those allergens of regional relevance (in 4.2.1.5). CCFL47 kept soybean in the regional relevance list only due to the widespread use of soybean in foods and in foods for infants and young children as the FAO/WHO expert consultation noted low prevalence, low potency and low proportion of anaphylaxis due to soybeans at the global scale. Beyond the qualitative risk assessment, the FAO/WHO expert consultation has set you RfD thresholds and such quantitative risk assessment was based on a grouping process, e.g. the threshold for sesame was grouped with other food allergens. CCFL47 agreed also that the names for specific tree nuts would be included at a later stage as the text was further developed. CCFL47 did not agree with a proposal to change the specified name for “crustacean” to more specific names, i.e. shrimp or crab and noted that a footnote already provided for ingredient declaration to specify the true nature of the food and to be specific and not generic. Japan raised the point that national authorities in charge of aller­gens risk management should decide based on their own determination and population, whether more specific names of fish or crustaceans would be more relevant for national allergic consumers.

With regards to the list of allergens of regional rel­evance, specific aspects about oats and oat allergies were discussed as to whether oats should be retained. Oat allergies are mainly due to cross-contamination with gluten from other cereal grains, not the oats themselves, although it was noted that research was needed in that field and also because detailed global evidence, on the extent to which oats were contami­nated with gluten containing grains and how signif­icant the health impacts of such contamination was to people with coeliac disease, was currently lacking. It was suggested to create a separate section (simi­lar to that of sulphites) to stipulate that oats should always be declared, unless a national authority has enough confidence that risk management practice employed sufficiently control cross-contact with other grains within its jurisdiction. It was also noted that cross-contact was unintentional and could be ad­dressed through PAL strategies. However, given that the work on PAL had not progressed far enough to determine whether oats could be addressed through PAL risk management strategies, oats were kept on the list of regional relevance, flagging the needs to be further considered, including eventually in a separate sectionx.

Presentation of mandatory information

CCFL47 noted proposals for flexibility in how man­datory information should be presented as there were already certain practices in countries that were preferred by their consumers and used by industry. CCFL47 considered different proposals that reflected that the presentation could be through the ingredient list or through a separate statement or through both and couldn’t find consensus so the provision will have to be discussed again in the EWG.

Exemptions

CCFL47 didn’t discuss the way it intends eventually to define relevant criteria, if not a full list itself, of refined substances which may originate from raw materials initially containing allergens but given their advanced treatment, they are known not to be present. As such, the paragraph remained unchanged and will be discussed by the EWG with the following wording: [4.2.1.6 Subject to evaluation using established cri­teria, national authorities may exempt ingredients derived from foods listed in section 4.2.1.4, and where applicable section 4.2.1.5, from being declared.]

Sulphites

The FAO/WHO expert consultation considered that sulphites would not need to be subject to mandatory declaration as they would see that of global relevance. However, CCFL47 considered that given the world­wide spread of current labelling practices, the para­graph should be retained. Discussion also focused on whether the 10 mg/kg triggering threshold should apply to products “as sold” or “as prepared accord­ing to the instructions of use” or “as consumed”. The paragraph to be further worked reads “4.2.1.7 When sulphite is present in a [ready-to-eat] food [or prod­ucts as reconstituted according to the instructions of the manufacturer], at a total concentration of 10 mg/kg or above, it shall always be declared using the specified name ‘sulphite’.”. The rest of the proposed draft text was not discussed and will be reviewed by an EWG.

Precautionary allergen labelling

CCFL47 agreed to return the proposed draft Annex to the GSLPF containing the draft Guidelines on the use of precautionary allergen labelling for redrafting by a new EWG co-chaired by Australia (lead), UK and USA, for consideration at CCFL48. CCFL47 also agreed to request the Codex Committee on Methods of Analysis and Sampling (CCMAS) to recommend suitable analytical methods and guidance on their val­idation and applications including sampling plans for determining allergenic protein in foods (in particular, such methods should detect and quantify unintended allergen presence (UAP) in foods from cross-contact with detection and quantification limits (LOD and LOQ) suitable to determine if UAP is above or below the action levels established by the FAO/WHO Expert Consultation for priority allergens for intakes of foods from 10 g to 1000 g). Such methods were viewed as needed to enable food business operators to perform risk assessments and determine whether a UAP can be controlled below the specified action level for each allergenic food. Priority allergens and the finalized action levels are listed in table 11 of Part 2 of the FAO/ WHO Expert consultation and CCMAS was invited to take into account their recommendations on analyti­cal methodologies requirements. CCMAS should also recommend suitable analytical methods to determine whether the amounts of allergenic food proteins have been removed sufficiently by processing to exempt foods from allergen declaration at action levels above UAP.

As Chair of the EWG on this topic, Australia pointed out the remaining points requiring CCFL47 inputs on the proposed guidelines on the use of “precau­tionary allergen labelling” (PAL) regarding (a) the possible place in the Codex system of the guidelines; (b) whether advice should be sought from CCMAS on the standardized analytical and sampling methods; and (c) whether any advice should be provided to CCFH to ensure consistency with the existing Code of Practice on Allergen Management for Food Business Operators (CXC 80). CCFL47 noted that the report of Part 3 of the FAO/WHO Expert Consultations report on PAL had not yet been published (executive sum­mary only was published) and therefore only general comments would be made to facilitate further drafting.

Proposed place of the text

CCFL47 agreed that the guidelines should be annexed to the Codex General Standard for the Labelling of Pre-packaged Foods (GSLPF – CXS 1) as this would ensure consistency with the Standard and avoid divergences that could potentially arise from different interpretation of the guidelines. It would also facilitate adoption of PAL by countries.

Analytical methods and sampling

Support was expressed to seek advice on standardized analytical methods and sampling from CCMAS as this would ensure that reliable and standardized methods were used for allergen risk assessment in food.

General comments

The guidance on the use of precautionary statements should be consistent with and mirror the provisions of allergen labelling in the GSLPF, which trigger a mandatory labelling provision, when there is a risk for unintended allergens in the food. Cross-references shall be made to section 8.3 instead of section 8.3.1 of the GSLPF. Quantitative risk assessment (as per the principle in 4.2 of the draft) should not be the only decisive factor when determining the use of PAL and it should also be considered to apply a qualitative risk assessment; consideration should also be given to whether the recommended Reference Dose (RfD) would correspond to the allergen itself or the possible presence of the total allergens in the final food or in their simultaneous consumption with other foods in a similar situation. Current RfD should be further considered as concerns were expressed that the RfD were set at an ED05 and whether this would give enough protection to especially vulnerable consum­ers that might still react at levels below the proposed RfD. A footnote on RfD shall be added to refer to the FAO/WHO Expert Consultation Report Part 2. The proposed principles do not provide clear enough guidance on how action levels should be calculated, particularly in terms of determining the amount of foods that should be considered relevant, considering dietary habit differences among several population groups. The use of action levels to guide the declaration of PAL could potentially create additional trade barriers, as an allergen present in a particular food could have two or more different action levels depend­ing on the amount of food used as a reference in each country or by different food business operators. Fur­ther guidance should be considered on how govern­ments and food companies can conduct quantitative risk assessment (or risk management interpretation), to ensure coherent and consistent approaches be­tween countries and that would require the expertise of CCFH to understand how these principles would be applied under Good Hygiene Practices (GHP) by food business operators (as these principles for risk assessment apply to those GHPs rather than to food labelling requirements).

E-commerce

CCFL47 agreed to advance by one step the Proposed Draft Guidelines on the Provision of Food Informa­tion for Prepackaged Foods to be Offered via E-Com­merce for consideration by CAC46 while it established a new EWG, co-chaired by the UK (lead), Chile, Japan, India and China to further develop the Guide­lines by focusing on the text in square brackets and for finalization at CCFL48. The possibility of a physi­cal or virtual working group (PWG) to meet prior to CCFL48 could be held if necessary.

The UK with help of Japan, India and Ghana, had developed a revised version of the guidelines with the help of an EWG.

Exemption for small units

That exemption was challenged but those not in favour of removing the exemption, while not ques­tioning that there was no space limitation, expressed the view that (a) the requirement would place a burden on small business operators due to the com­plexity of the supply chain, and this might prevent them to offer products through this particular portal; (b) small suppliers were not necessarily the producers/ manufacturers of the products, thus they might not have access to information on the products other than on the label. As an alternative, a proposal was made to add a provision that would encourage food business operators to provide additional information which is otherwise exempted for small packages. CCFL47 agreed to keep the exemption for small units and kept a proposal in square brackets for further consideration to read under Principle 5.3: “[Food business operators are encouraged to provide additional information which is otherwise exempted for small packages]”.

New Principle 5.4

CCFL47 agreed to add a new principle indicating that the information on the pre-packaged foods offered for sale in e-commerce shall be provided without any costs for the consumer, but to keep it in square brack­ets for further consideration.

Definitions

The definition of “e-commerce” was debated but at the end CCFL47 agreed to keep the WTO definition that reads “The production, distribution, marketing, sale or delivery of goods and services by electronic means as applicable to foods.” “Food information” was kept as “the information that is the subject of a Codex text about a prepackaged food.” No agreement was found yet on “[Minimum durability” as “the period (e.g. in hours, days, months etc.) between the point of deliv­ery or agreed date for collection in-store and the best before or use-by date, as applicable.]”

Use of modern information technology

CCFL47 agreed to advance the proposed draft Guide­lines by one step to CAC46 and establish a new wEWG, cochaired by Canada (lead), India and New Zealand, to further develop the Guidelines with a spe­cial focus on the text in square brackets, while noting that the whole document remained open for com­ments and further consideration at CCFL48. A phys­ical (PWG) or a virtual working group (v-PWG) may meet prior to the next session of CCFL, to prepare a revised version for consideration by CCFL48.

Canada as chair of the last year EWG pointed out the general agreement on how the general principles of the GSLPF (CXS 1) were handled in the proposed draft. The term “purchaser” was removed and the term “consumer” with a footnote to the GSLPF was retained hence clarifying that the text does not apply to non-retail containers (covered by the General for the Labelling of Non-Retail Containers of Foods (CXS 346).

Canada also clarified that even though the definition of the term “consumer” in the GSLPF did not explic­itly include food bought for catering purposes, this was understood to be implied to both consumers and purchasers for catering use. The scope of the proposed draft should be the same as the GSLPF. The text of the GSLPF should not be repeated but referenced. There was general agreement on the principles that would apply to both mandatory and voluntary information. The text should be a stand-alone set of guidelines, rather than an amendment to the GSLPF.

The Committee agreed to start new work on the la­belling of prepackaged foods in joint presentation and multipack formats and submit the project document for approval by the forthcoming CAC46. It established a new EWG, cochaired by Colombia (lead) and Jamai­ca to prepare a proposed draft text for circulation for comments and then further consideration by CCFL48.

Labelling flexibility in cases of emergency

CCFL47 agreed to establish a new EWG, chaired by the USA, to develop an updated discussion paper and a possible project document on developing guidelines on “Application of food labelling provision in emergencies”, taking into account the discussions held at CCFL47 and the written comments, especially with respect to the scope and the need for definitions for “emergency” and “flexibility”; for further consider­ation by CCFL48.

USA introduced its past discussion paper and recalled that CCFL46 had discussed the possibility of future work to assist countries in establishing flexibilities in food labelling requirements when necessary to assure supply chain resilience during national or global public health emergencies, such as the COVID-19 pandemic (or a regional armed conflict). Before starting new work, several concerns were raised by members that a better understanding of the issues involved was needed. CCFL47 noted that there were a number of different emergencies e.g., pandemic and wars, that had affected food trade in the past and needed different considerations. A collection of more information and examples would be needed as a starting point. The situation might differ between importing and exporting countries and importing countries might have more issues. A broad exchange might also be interesting for other Codex Committees (such as the CCFICS), and it would be interesting to get the views of other Codex Committees. There could be a meeting/ workshop in the margins of the CAC. The title shall be changed to “Application of food labeling provisions in emergencies”. Definitions of “emergencies” and “flexibilities” should be includ­ed. Domestic flexibilities may be included. Situations like the financial crisis in 2008 could be considered as an emergency. Work priorities may need to be estab­lished depending on what other work the committee will take on. The USA stated that while the discussion paper already included a number of examples, they were prepared to lead an exploratory working group to further clarify the intended work especially with­in the main aspects to be covered, the criteria when the emergency threshold was reached and how many definitions were needed.

CCFL47 did not agree to start new work on the devel­opment of guidelines on food sustainability. Instead, it agreed to establish a dedicated EWG cochaired by New Zealand (lead), the European Union, the USA, and Costa Rica to revise the discussion paper and project document with a focus on (a) stocktaking work being undertaken by other international orga­nizations on sustainability-related labelling claims on food; (b) identifying areas where the Committee could provide guidance on sustainability-related labelling claims on food; (c) identify possible areas for revi­sions to the General Guidelines on Claims (CXG 1) for claims in general, including sustainability-related labelling claims on food. The EWG was asked to take into account discussion held during CCFL47 and all the written comments submitted for consideration by it. A physical (PWG) or virtual working group (v-PWG), could meet prior to the next session of CCFL, to prepare revised proposals for consideration by CCFL48.

New Zealand introduced the discussion paper pre­pared with the assistance from the European Union by highlighting that sustainability was a global issue and there is increasing consumer interest about sustainability of products, including food products. Tackling this issue would require a multi-sectoral approach with a range of organizations to collaborate and take ownership, and that CCFL clearly had a role to play. There are tangible risks that consumers could be mis­led through the proliferation of sustainability claims on food labels, many of which might not even fulfil the current requirements set in the General Guide­lines on Claims (CXG 1). New Zealand drew attention of the Committee to CRD17, containing an updated work proposal.

While there was agreement that sustainability was an important topic for the world and for Codex alimentarius and the Joint FAO/WHO food standard program, views differed largely on whether it was the right moment to start new Codex work on sustainability re­lated to labelling and claims or further reflection may be needed to better define what was to be achieved and what the consequences of such work could be when implemented at country levels. Arguments in favour of starting work immediately included that (a) it was timely as some countries were already considering developing regulations in this area; (b) the UN Food Systems Summit stocktaking exercise would take place in July and many Codex members were also part of the Healthy diets and sustainable food systems coalitionxi for which such a work would be a strong signal; (c) more consumers were considering sus-tainability in their purchasing decisions and needed guidance that was clear and not misleading; (d) an increasing number of sustainability related claims were on the market; (e) sustainability labelling is fully in line with the Codex mandate and would allow consumers to make informed choices; (f) High-level guidance could prevent a plethora of unsubstantiated claims especially with regards to social responsibility; (g) the Codex General Guidelines on Claims (CXG 1) were not sufficient nor specific enough to substantiate sustainability claims; (h) currently these food labels were often integrated in the marketing strategy, and not always clear for consumers due to a large number of non-comparable claims; and (i) a framework for sustainability labelling was needed.

Delegations in favor of a further reflection and clari­fication indicated that (a) current guidance on claims was comprehensive enough to deal with sustainabil-ity-related claims as with any other claims; (b) it was not clear what differentiated sustainability claims from other claims with respect to the need for specific guid­ance and that should work be considered, it should focus on updating and strengthening CXG 1 with a view to cover all types of claims including sustainabil-ity-related claims; (c) Sustainability was a complex topic that goes beyond the mandate of Codex, and it was important to carefully scope any work appropri­ately within the role of CCFL; (d) other international organizations were already working in this area and there was concern that Codex might duplicate work of others; (e) the outcome of the work on a blueprint for the future of Codex should be awaited before embark­ing on sustainability related work; (f) labelling was just the final aspect of this topic and the important area was measuring sustainability in order to come to comparable systems while a better overview of the im­pact of different systems was needed before commit­ting to new work; (g) sustainability claims were based on diverse criteria which creates challenges such as how to prevent “greenwashing” and consumer confu­sion through the halo-effect; (h) as sustainability was a complex topic, before embarking on this new work, information on the comparability of claims would be needed on what this work would include and consid­eration of implications on trade; (i) one observer stat­ed that sustainability labelling was very promotional and might benefit mainly the processed food industry while codex should rather encourage warnings than claims; (j) many opportunities for exploring this topic not subject to much work and a risk of not being able to establish high-level principles.

Tom Heilandt, Codex Alimentarius Commission’s Secretary, explained that the way the work was pre­sented in the project document was falling within the Codex mandate, because it was suggested to develop high-level guiding principles. Tom H. was also of the opinion that ‘claim,’ as defined in the General Guide­lines on Claims (CXG 1), was very general and could cover adequately sustainability claims.

Added sugars definition

CCFL47 agreed that Costa Rica would prepare in ad­vance of CCFL48 a discussion paper on the definition for added sugars while taking into account the need for including added sugar(s) into the list of mandatory particulars presented in the nutrient declaration (e.g., nutrition fact panel). Codex members and observers will be consulted on that discussion paper via a Codex circular letter.

TFAs – trans fatty acids

CCFL47 agreed to defer discussions on trans fatty acids until CCFL48, also pending the outcome of the discussions in the CCFO. Canada would then prepare a discussion paper outlining possible new work on trans fatty acids for consideration by CCFL48 while taking into account the WHO Guideline on Saturated Fatty Acids and Trans-Fatty Acidsxii published on May 15, 2023.

Alcoholic beverages labelling

CCFL47 agreed to retain the item on labelling of alcoholic beverages on its next meeting agenda and re­quested the WHO to prepare a discussion paper based on the outcome of comments received in response to a Codex circular letter to be issued by the Codex Secre­tariat on this matter.

The WHO representative expressed the views that alcoholic beverage labelling increases the awareness of health risks and product composition. The represen­tative highlighted that labelling was also the primary source of information for consumers at the point of purchase and consumption. Noting that alcohol warnings remained outside the scope of obligations in the International Conventions to Control Psycho­active Substances, and that alcoholic beverages were also typically exempted from many requirements of national legislation governing food labelling, it was creating a considerable regulatory divergence among countries. It was recalled that WHO member coun­tries unanimously adopted the 2022-2030 WHO Action plan on Alcohol Prevention, calling members to reduce the harmful use of alcohol through alcoholic beverage labelling. Following subsequent discussions held at CCFL44, CCFL45 and CCFL46, it was noted that a discussion paper for consideration by CCFL47 was not prepared due to the COVID-19 pandemic. WHO representative recommended that this matter be maintained on the CCFL agenda and proposed, in the absence of a Codex member to lead the work, that a CL could be issued and then WHO prepare a discus­sion paper to be presented at CCFL48.

While several members and observers supported the WHO proposal, it was questioned whether this was in line with Codex procedure as there was no proposal from members. Tom H. clarified that according to the Codex procedures, the Directors General of FAO and WHO could place items on the agenda of Codex meetings and then Codex members could discuss and decide how to take the matters forward. Tom H. confirmed that the existing Codex labelling texts applied also to alcoholic beverages, however they did not seem to be widely applied by Codex members. Tom H. suggested to include a question in the circular letter regarding this matter in addition to questions as to what actions Codex could take.

Other proposals for new work

CCFL47 reaffirmed the need to keep the inventory of future work and emerging issues stockpile up to date and further agreed that the volunteering of Italy to update that paper for consideration at CCFL48, based also on responses that will be received via a Codex circular letter requesting members and observers to provide information on items for further inclusion in the discussion paper.

Mechanism for priority setting

CCFL’s Canada Secretariat agreed to revise the ap­proach and criteria taking into account comments provided at CCFL47, and including the request of CCEXEC to consider the request of WHO to consider the reduction of sodium intake when prioritizing and undertaking new work. The Codex Secretariat would issue a dedicated circular letter requesting com­ments on the revised document for consideration by CCFL48.

To find out more about the CCFL47 meeting, working documents may be found here: https://www.fao.org/ fao-who-codexalimentarius/meetings/detail/en/?meet-ing=CCFL&session=47 and the final report will be posted here: https://www.fao.org/fao-who-codexali-mentarius/committees/committee/related-meetings/ en/?committee=CCFL


i Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens:

Part 1 – Codex priority list of allergens and risk assessment; https://www.who.int/news-room/events/de-tail/2020/11/30/default-calendar/ad-hoc-joint-fao-who-expert-consultation-on-risk-assessment-of-food-allergens-part1

Part 2 – Threshold levels for priority allergens; https://www.who.int/news-room/events/de-tail/2021/03/15/default-calendar/ad-hoc-joint-fao-who-expert-consultation-on-risk-assessment-of-food-al-lergens-part2-review-and-establish-threshold-levels-in-foods-of-the-priority-allergens

Part 3 – Precautionary Labelling for priority Allergens; https://www.who.int/news-room/events/de-tail/2021/10/18/default-calendar/ad-hoc-joint-fao-who-expert-consultation-on-risk-assessment-of-food-allergens-part-3-review-and-establish-precautionary-labelling-in-foods-of-the-priority-allergens

Part 4 – Decision-tree to decide on possible exemptions https://www.who.int/news-room/events/ detail/2022/11/14/default-calendar/ad-hoc-joint-fao-who-expert-consultation-on-risk-assessment-of-food-allergens-part-4-review-and-establish-exemption-for-the-food-allergens

ii The International Social Science Liaison Group, is currently chaired by the Food Standards Australia New Zealand (FSANZ) authority is a forum for government organizations involved in the social sciences of food regulation, food safety and public health nutrition to discuss and collaborate on issues of mutual interest. It currently brings practitioners from Australia, New Zealand, Canada, the European Union, the United Kingdom and the United States of America. Interested readers may refer to https://www.one2022.eu/node/272

iii Current draft: “Food allergy” means a reproducible adverse health effect arising from an immunoglobulin class E (IgE) antibody or non-IgE antibody immune-mediated response following oral exposure to a food.

iv Current draft: “Food allergen” means a food or ingredient [or substance or processing aid] used in food, usually a protein or protein derivative that can elicit IgE-mediated or other specific immune-mediated reac­tions in susceptible individuals.

v Current draft: “Coeliac disease” means a chronic im­mune-mediated intestinal disease in genetically predis­posed individuals induced by exposure to dietary gluten proteins that come from wheat, rye, barley and triticale (a cross between wheat and rye).

vi Current draft reads: “Where an ingredient is itself the product of two or more ingredients, such a compound ingredient may be declared, as such, in the list of ingre­dients, provided that it is immediately accompanied by a list, in brackets, of its ingredients in descending order of proportion (m/m). Where a compound ingredient (for which a name has been established in a Codex stan­dard or in national legislation) constitutes less than 5% of the food, the ingredients need not be declared, except for the foods and ingredients listed in section 4.2.1.4 (i.e., allergens of global relevance), 4.2.1.7 (i.e., sulph­ites) and where applicable section 4.2.1.5 (i.e., allergens of regional relevance) and food additives which serve a technological function in the finished product.”

vii Current draft section 4.2.1.4 reads: “4.2.1.4 The fol­lowing foods and ingredients are known to trigger food allergy or coeliac disease and shall always be declared using the specified name in addition to or as part of the ingredient name1

1 In accordance with Section 4.1.1 of the General Standard for the Labelling of Pre-packaged Foods (CXS 1-1985), the ingredient declaration should specify the true nature of the food and be specific and not generic.

2 Includes spelt, Khorasan, and other specific cereals containing gluten that are species or hybridized strains under the genus names of Triticum, Secale and Hor-deum. Specified names are to be used according to the associated genus. Hybridized strains are to use specified names in conjunction from all of the parent genera (e.g. ‘wheat’ and ‘rye’ for triticale).”

viii Thailand and Indonesia arguments: “(a) allergic reactions from consumers with sesame allergies is rarely report in Asia and thus not considered significant in their countries; (b) severity assessment of sesame needs more data relating to frequencies of anaphylaxis prior to include sesame as a priority food allergen; (c) sesame had never been listed as an allergen ingredient to be de­clared before, and this change to a mandatory declara­tion would have an impact on food business operators, especially small business operators with a cost burden arising from changing their labels.”

ix Brazil arguments: “(a) global prevalence of soybean allergy was similar or higher than the prevalence of oth­er allergens included in the priority list; (b) prevalence of soybean allergy is higher in infants, especially among those that are allergic to milk, in Brazil; (c) higher potency than other allergens in the priority list, such as shrimp, other crustaceans, amongst others; (d) known to trigger non-IgE mediated food allergies, conditions that could cause significant adverse health effects, particularly in infants and young children (when soy is used in infant formulas); (e) soybeans are already recognized as an allergen by Codex and most national authorities, and therefore food business operators are familiar with implementing risk management controls for these allergens and consumers with soy allergy were used to checking for the declaration of soy presence in food products.”

x Draft section 4.2.1.5 currently reads: “4.2.1.5. In addition to the foods and ingredients listed in section 4.2.1.4, the declaration of any other foods and ingredi­ents, including those listed below may also be required3 using a specified name in addition to or as part of the ingredient name4. This shall be based on available risk assessment data for the respective population(s)5 taking into account risk management considerations.

3 These foods and ingredients are not included in 4.2.1.4 but have been recommended to be considered for risk management at the regional or national level (see FAO and WHO Risk assessment of food allergens: Part 1:

4 In accordance with Section 4.1.1 of the General Stan­dard for the Labelling of Pre-packaged Foods (CXS 1­1985), the ingredient declaration should specify the true nature of the food and be specific and not generic.

5 The assessment of risk in the respective population(s) to be based on the evidence criteria of prevalence, potency and severity of immune mediated adverse re­actions to the food or ingredient as established by FAO and WHO Risk assessment of food allergens: Part 1: Review and validation of Codex Alimentarius prior­ity allergen list through risk assessment. https://doi.  org/10.4060/cb9070en.

6 Oats can be tolerated by most but not all people who are intolerant to gluten. Therefore, the allowance of oats that are not contaminated with wheat, rye or barley in foods covered by this standard may be determined at the national level.

xi See https://www.who.int/initiatives/food-systems-for-health/the-coalition-of-action-on-healthy-diets-from-sustainable-food-systems-for-children-and-all

xii See https://www.who.int/publications/i/ item/9789240073630