/>iThe 48th session of the Codex Alimentarius Committee on Food Labelling (CCFL48) finalized a historical update of the section on allergens in the General Standard on the Labelling of Prepackaged Foods (GSLPF or CXS 1) and completed work on two new guidelines on the use of new information technologies to convey food labelling and on foods sold in E-commerce. CCFL48 advanced the review of draft guidelines on precautionary allergen labelling (when the “may contain” statement would be used when presence of allergens would be above ‘action levels,’ based on acute reference dose levels of these allergens). CCFL48 returned the proposed amendments to the GSLPF about dedicated sections on pre-packaged foods in multipacks or in joint presentations for further work while making good progress regarding various proposed definition options. CCFL48 endorsed the labelling provisions for dried saffron mandatory country of origin, while guidance from CAC47 on the country of harvest. CCFL48 agreed to work on new guidelines introducing flexibility in mandatory labelling in cases of domestic supply chain disruptions or global emergencies. Despite efforts deployed to reach a consensus, CCFL48 decided to stop work on a definition for a proposed set of guiding principles on sustain-ability (environmental) claims, as well as on alcoholic beverage labelling. Finally, CCFL48 agreed to an internal prioritization mechanism. Proposals on “high in” claims, “added sugars,” and a harmonized definition for “small packages” were all sent back to the inventory for possible future work, provided they are consistent with the next Codex Strategic Plan (2026-2031), sponsored by a Codex member to lead the work and fit within the top tier of CCFL priorities.
CCFL48 was held in person in Québec City (Québec, Canada) from Sunday, October 27 to Friday, November 1st, 2024. The next CCFL meeting (CCFL49) will be held in Spring 2026, in a venue still to be determined. CCFL48 was chaired for the first time by Dr. Parthi MUTHUKUMARASAMY, the current Executive Director of Canada’s Food Inspection Agency (CFIA), who was unanimously praised for his performance in leading the Committee to overcome the difficult issues that were the subjects of discussion at that session. More information about CCFL48 supporting documents and official proceedings are available [ii] [iii].
FOOD ALLERGEN – Standing ovation for the first full revision of the relevant GSLPF provisions since 1985.
CCFL48 finalized the draft revised provisions to the General standard for the labelling of pre-packaged foods (CXS 1) relevant to allergen labelling and sent it for final adoption by CAC47 (as included in Appendix II of CCFL48 report, see endnote iii). CCFL48 agreed to inform the Codex Committee on Food Hygiene (CCFH) about the completion of this work and ask CCFH to ensure a full consistency of concepts used in the Codex Code of practice on allergen management for food business operators (CXC 80) with the newly approved definitions and revised sections of the GSLPF. CAC47 will be held from November 25th to November 30th in Geneva (Switzerland) [iv].
CCFL48 considered the outcome of the work of an intersessional electronic working group (EWG) led by Australia and co-led by the United Kingdom (UK) and the United States of America (USA). A virtual working group (VWG) met prior to CCFL48, and recommendations are included in the report of that VWG. During that process, the EWG and VWG took into account the FAO/WHO Scientific Advice, in particular, the review and validation of the Codex priority allergen list through risk assessment (Part 1) and the review and establishment of exemptions for the food allergens (Part 4). The working groups also considered a literature review performed by the International Social Science Liaison Group (ISSLG) on a review of consumer response to allergen declarations and precautionary allergen labelling [v] [vi].
CCFL48 agreed on definitions for “food allergy,” “food allergens,” “allergenic foods,” and “coeliac disease” [vii]. CCFL48 also agreed to consider that there were two types of allergenic foods and food ingredients: those that are internationally relevant and those that are viewed as relevant for mandatory declaration only at the regional level. However, both are subject to a national risk management decision, as pointed out by Brazil (for soy) and Japan in particular (where scientific names of the fish and the crustacean are more meaningful than just ‘fish’ or ‘crustacean’) [viii].
The other significant change is the revised paragraph about the ability of national and/or regional competent authorities to exempt some highly refined food ingredients obtained from the allergenic foods listed in the two batches from being declared as “allergenic foods.” Such exemptions are to be subject to a risk assessment to establish the safety of the allergenic food derivative and will be the new section 4.2.1.6 of the future re-published revised GSLPF in its 2024 version. In that regard, it is recommended to read the FAO/WHO briefing summary of Part 4 of the expert consultation [ix].
CCFL48 also significantly clarified the GSLPF on ways to declare foods and food ingredients possibly containing food allergens [x]. These provisions will apply when the allergenic foods or food ingredients are intentionally added and present in the manufactured foods, as opposed to unintentional allergen presence (through cross-contact). Such unintentional presence of allergens will be addressed through guidelines on precautionary allergen labelling (PAL). The section on sulphites was revised so that “when present in concentrations of 10 mg/kg or more in a food, [they] shall always be declared using the specified name ‘sulphite’ or ‘sulfite’ in addition to or as part of the ingredient name.” Sulphites are to be measured “on a sulphur dioxide (SO2) equivalents basis.”
PRECAUTIONARY ALLERGEN LABELLING – Good progress made, new EWG formed.
Proposed New Guidelines
CCFL48 agreed to advance the draft Guidelines on the use of precautionary allergen labelling for mid-process approval by CAC47. The revised draft of the proposed guidelines is included in Appendix III of CCFL48 report (see endnote iii). CCFL48 agreed to inform CCMAS of the progress made on these draft guidelines and encouraged CCMAS to provide further advice on suitable methods of analysis before CCFL49. CCFH will also be informed of the progress made on these guidelines on PAL, and once this work on PAL is completed by CCFL, CCFH will have to consider targeted revisions of CXC 80 to include information on conducting risk assessment in relation to PAL. Further guidance was requested from FAO and WHO on qualitative risk assessment and specific scientific advice on the level of reference doses (expressed in milligrams of the total protein from the allergen) or concentrations for cereals containing gluten or gluten. FAO and WHO were encouraged to develop capacity-building activities for countries on PAL and risk assessment. An EWG led by the USA and co-led by Australia and the UK was tasked to continue drafting these guidelines while leaving open the possibility of holding a VWG (or a PWG) prior to CCFL49 [xi].
Methods of Analysis on the Presence of Food Allergens
Participants highlighted that the recommended RfDs were based on data from Enzyme Linked Immunosorbent Assay (ELISA) and mass spectrometry (MS) methods. Current analytical capabilities allow reaching to reach the limit of quantification (LOQ). Some training is necessary to link the results obtained by these analytical methods and the determination of action levels [xii]. CCFL48 further noted that CCMAS is also reviewing methods of analysis (as requested
by CCFL47) through a dedicated EWG led by USA under the purview of CCMAS. The EWG is currently working on compiling all the relevant methods that meet performance criteria set in the AOAC validation guidelines and the CEN 17855 standard and will make recommendations at the next CCMAS meeting(s), which in turn will formulate recommendations to CCFL49. Codex Guidance on sampling plans sufficient in the Codex General guidelines on sampling (CXG 52), were revised and adopted in 2023.
E-COMMERCE – Go for final adoption and publication.
CCFL48 agreed to forward the draft Guidelines on the provision of food information for pre-packaged foods to be offered via e-commerce to CAC47 for final adoption (as included in Appendix IV of the CCFL48 report,
see endnote iii).
CCFL48 discussed the draft text based on the outcome of an intercessional work (EWG) and the report of the VWG held a few days prior to CCFL48, led by the UK and co-led by Chile, China, India, and Japan. CCFL48 discussed all outstanding issues, including purpose, an indication of a durability clause and related definition, the maintenance under certain conditions of small unit exemptions (from some mandatory labelling particulars), and the proposal that access to information should be at ‘no cost’ to the consumer. CCFL48 simplified the purpose of the guidelines. The issue of durability was moved to the section on voluntary particulars, noting that these aspects were related to providing information prior to shipping food at the point of e-commerce sale, but no definition for durability was finally retained. Exemptions for small units could be allowed by competent authorities in specific circumstances but, in general, would not be considered justified. The reference to “fee” was replaced with “a charge”. With regards to the optional information prior to the point of e-commerce sale, CCFL48 agreed that the provision should read as follows: “A statement may be provided on the product information e-page prior to the point of e-commerce sale to inform the consumer about the relation between the best before, best quality before, use-by, or expiration date and the product shipping date or at the point of delivery” [xiii].
NEW INFORMATION TECHNOLOGY – Go for final adoption and publication.
CCFL48 agreed to forward the Guidelines on the use of technology to provide food information in food labelling to CAC47 for final adoption (as included in Appendix IV of the CCFL48 report; see endnote iii). CCFL48 discussed the report of an intersessional work (EWG) on the draft guidelines, as led by Canada and co-led by India and New Zealand, as revised by the EWG Chair and Co-Chairs, based on written comments submitted prior to CCFL48 in response to a circular letter, and further editorial amendments integrated live. The guidelines include twelve main principles, which were discussed and eventually amended by CCFL48, and they should guide countries’ future development of national guidance or appropriate legislation.
These new guidelines are general in nature but are relevant to all foods, standardized or not. They contain 12 core principles and define Food information as “the information that is the subject of a Codex text about a pre-packaged food” and Technology as “any electronic or digital means, including but not limited to websites, online platforms, and mobile applications.”
Section (5.2) was specifically debated and even subject to an informal in-session drafting group. It related to the concepts of “health,” “nutrition,” and “safety.” It was agreed to retain only ‘safety’ and ‘nutrition’ because the term ‘health’ would account for issues impacting health but unrelated to food safety, yet remaining within the Codex’s mandate, such as nutrition labelling vis-a-vis non-communicable diseases, food allergens, etc. CCFL48 noted the general support for the concept of “health” but agreed to use the term “nutrition” instead. It was also suggested that a reference to other mandatory information as determined by the competent authority be added so that consumers can make better-informed decisions at the time of purchase (online), in addition to the name of the food and food information concerning nutrition and safety (which themselves should always be provided on the label/labelling of the food). The Committee also noted support for the addition of “and any other mandatory food information as determined by the competent authority.”
JOINT PRESENTATION AND MULTIPACK FORMATS – Detailed discussions on “Container” descriptor, but no consensus found on the various proposed options.
CCFL48 agreed to return the draft amendments to the GSLP relevant to joint presentation and multipack formats for redrafting and further consideration by a newly established EWG, to be led by Colombia and co-led by Canada, India, and Jamaica. CCFL48 discussed the outcome of the intersessional work (EWG) held on these proposed provisions based on the CRD 38 prepared by the Colombia chair, proposing amending provisions to the GSLP on the sections relating to the definition of terms, mandatory labelling provisions, and the presentations of such mandatory information (respectively sections 2, 4 and 8 of the GSLPF (CXS 1)). CCFL48 discussed in particular how the two terms, i.e., “joint presentation” and “multipack,” could be best reflected in the GSLPF. The Committee support was split among three proposed options, including self-standing definitions, references in the definition of container, and/or the use of examples in both cases.
PROPOSED NEW WORK – Go ahead to a new Guidance in emergency situations; others retained as possible new work (“high in,” “small packs,” “added sugars”) to be decided at the next meeting(s); others were parked (“sustainability,” “alcoholic beverages labelling”); Kenya entrusted to update the inventory document for new work.
CCFL48 reaffirmed the decision to keep the inventory of future work and emerging issues up to date and, for that purpose accepted Kenya’s proposal to update the CCFL future work inventory table (last version was included in Appendix II of CX/FL 24/48/14) and present the inputs received from Codex members and observers in response to a new Circular Letter to be issued by the Codex Secretariat and by removing those items already approved as new work by CAC47. Kenya will prepare and present the updated discussion paper on future work and emerging issues in advance and at CCFL49 session.
Flexibilities in Emergency Situations – Go ahead.
CCFL48 agreed to start new work on the application of food labelling provisions in emergencies and submit the project document for critical review by CCEXEC87 and approval by CAC47 (as included in Appendix VI of the CCFL48 report, see endnote iii). The new work is to be handled via a new EWG, led by the USA, and with a possibility for a pre-CCFL49 VWG, or PWG, to be chaired by the USA. CCFICS will be informed of this new work, given the relevance of existing approved Codex guidelines, as developed by that committee (e.g., Codex Principles and guidelines for the exchange of information in food safety emergency situations (CXS 19)).
The purpose and scope of the proposed work is to provide high-level guidance (i.e., principles and criteria) to assist governments in case of emergencies and to develop national guidance for any flexibilities in mandatory food labelling that might still support a safe and adequate food supply in such emergencies. The future guidelines would include sections on Purpose, Scope, Principles, and/or General Criteria. The proposed new work will take into consideration the Codex Principles and guidelines for the exchange of information in food safety emergency situations (CXS 19) [xiv].
High In – No country support, but kept in the roster for future new work
As there was no formal support from any Codex Member during CCFL48, the Committee agreed to return this item to Part A of the inventory table under the agenda item on future work. Should there be interest in the future, the project document could be accompanied by a discussion paper to provide further clarity on the background and concrete objectives of the work. This proposal, by Canada, aimed at developing new guidelines for the use of “high in” claims made for nutrients that raise public health concerns, particularly for sodium, saturated fats, and sugar. Canada explained that the new work would entail a revision of the Guidelines for the use of nutrition and health claims (CXG 23), specifically to develop guidance on “high in” claims for nutrients of public health concern related to excessive intake.
The proposal followed CCNFSDU’s decision not to pursue nutrient profiling work and CCFL’s completion of the guidelines for front-of-pack nutrition labelling. The WHO representative informed CCFL48 about ongoing WHO work to develop a globally relevant nutrient profiling model (NPM), which foresees thresholds for high (in) levels of nutrients of concern, notably including numerical concentration values for total fats, saturated fats, trans fats, free sugars, and sodium. WHO announced a global NPM available by end of 2024 [xv].
Small Packs – New proposal from industry added to the roster for future new work
CCFL48 agreed to return the proposal for “small packs” to Part A of the inventory table and under the agenda item on future work. CCFL48 noted a proposal from the Observer of the International Chewing Gum Association (ICGA) to review the criteria for small units and packages, including in relation to front-of-pack nutrition labelling, to ensure appropriate and feasible implementation for smaller-sized products. ICGA representative was given a rare opportunity to introduce the proposal for new work that would consist of two steps: a review of the implementation of the current definitions for foods pre-packaged in ‘small units’ (as defined in the CXS 1) and foods pre-packaged in ‘small packages’ (as defined in CXG 2), followed by a discussion of possible identified gaps and formulation of future recommendations based on the review. However, given that no Codex Member indicated a formal support or volunteered to lead on this work, the Committee agreed to keep this item into the Part A of the inventory for possible new work under the agenda item on future work for a possible consideration by CCFL in future meeting(s) [xvi].
Alcoholic Beverages Labelling – WHO left alone, no country acceptance for a global harmonization in Codex, just as of yet.
The discussion paper prepared by the WHO, parent organization of the Codex Alimentarius Commission but observer in Codex meetings, was intensively discussed by CCFL48, but CCFL48 agreed to keep the work on the inventory for future work and recommended that it should be up to a Codex Member to submit a formal project document in reply to the regular circular letter requesting proposals for new work.
Added Sugars – so close, but no; kept in the roster of new work proposals
CCFL48 agreed to keep the topic in Part A of the inventory of future work so that Members could bring forward a new project document in reply to the CL requesting proposals for new work in the future. CCFL48 discussed in detail a proposal that had been subject to an intersessional work (EWG) led by Costa Rica on a discussion paper to establish a clear and harmonized definition of “added sugars” to be based on sound scientific evidence, be practical for industry and understandable for consumers. Costa Rica noted, however, the lack of unambiguous analytical methods to quantify and differentiate “added sugars” from naturally occurring sugars, hence it could be an issue for enforcement purposes, but was not seen as an obstacle to the development of a definition.
The scope has been further limited to developing a definition of “added sugars” in the context of the “with no sugar addition” claim set in CXG 23. Noting the support from a significant number of Codex Members to develop a new definition for “added sugars,” CCFL48’s Chairperson offered dedicated time for a detailed review of the scope and purpose of the proposed new work. However, no consensus could be reached after attempts to refine the scope and purpose. The Chairperson proposed to discontinue the discussion at this time and to keep the topic on the inventory list for future work [xvii].
Sustainability and Environmental Claims – possible to revisit it at a later stage.
The proposal put forward and led by New Zealand, which had been subject to an intersessional EWG, was debated during CCFL48. While there was general support from a large number of Codex Members for this work and its importance, CCFL48 noted a lack of consensus and agreed not to start new work on sustainability labelling claims and to return the proposed topic to Part B of the inventory table relating to previous work identified by the Committee, noting that the topic could still be reopened for discussion, should a new proposal be elaborated in the future.
MISCELLANEOUS
Prioritization Mechanism on Emerging Issues /New Work Proposals – Guidelines adopted (to be published as information document)
CCFL48 formally adopted its own priority-setting mechanism (as included in Appendix VII of CCFL48 report). It establishes criteria and scores for the relevance of each proposal to the CCFL mandate (yes, no, partly), and high-to-low scores about its impact on consumer health; if and how far it helps address false, misleading, or deceptive labelling practices; its impact on consumer’s ability to make an informed decision; and its impact on international trade. The main purpose is to help rank future new work proposals and help CCFL focus on those at the top tier.
Endorsement – Country of harvest for dried saffron still unresolved, guidance from CAC requested, other endorsements went through.
CCFL48 agreed to endorse the section of the standard on Country of origin (mandatory declaration) but could not reach an agreement on the mandatory declaration of Country of harvest and thus was unable to endorse the provision. CCFL48 thus referred the matter to CCEXEC87 and CAC47 for consideration and further guidance. CCFL48 also agreed to endorse the labelling provisions in the standards for fish oils (amendment to existing CXS 329), dried or dehydrated roots, rhizomes, and bulbs – turmeric, as well as the new Regional Standard for Castilla lulo (naranjilla). CCFL48 agreed to inform all committees to take note of the General standard for the labelling of pre-packaged foods (CXS 1) and the General standard for the labelling of non-retail containers of foods (CXS 346) and strive to follow the format, terminology, and the flow to avoid redundancy for any future labelling provisions.
Endnotes:
[i] Food Production Systems Engineer, Food Standards & Food Safety Regulatory Specialist, Counsellor at Keller and Heckman LLP Brussels office
[ii] See CCFL48 webpage: https://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCFL&session=48&
[iii] See REP24/CCFL48: https://www.fao.org/fao-who-codexalimentarius/meetings/en/
[iv] See CAC47 Agenda and working documents:
[v] See FAO/WHO reports on allergen labelling (Part 1 to 5): https://www.who.int/groups/ad-hoc-joint-fao-who-expert-consultation-on-risk-assessment-of-food-allergens
[vi] See ISSLG literature review on Consumers and [Food] Allergens Labelling (FSANZ, 2020): https://www.foodstandards.gov.au/sites/default/files/science-data/Documents/Allergens%20-%20ISSLG%20-%20Combined%20Report%20October%202020.pdf
[vii] “Allergenic Food” means a food (including ingredients, food additives, and processing aids) that can elicit immunoglobulin class E (IgE)-mediated or other specific immune-mediated reactions in susceptible individuals.
“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).
“Food allergen” means the substance in an allergenic food, usually a protein or protein derivative, that can elicit IgE-mediated or other specific immune-mediated reactions in susceptible individuals.
“Food allergy” means a reproducible adverse health effect arising from an IgE antibody or non-IgE antibody immune-mediated response following oral exposure to a food.
[viii] Internationally relevant allergenic foods: Cereals containing gluten such as wheat and other Triticum species; rye and other Secale species; barley and other Hordeum species and products thereof [Note: includes spelt, Khorasan, and other specific cereals containing gluten that are species or hybridized strains under the genus names of Triticum, Secale, and Hordeum. 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)] [Note: in addition to the specified name of ‘wheat,’ ‘rye,’ and ‘barley,’ the word ‘gluten’ may be used]. These can be declared as wheat’, ‘rye’, ‘barley’. Crustacea and products thereof declared as ‘crustacea’. Eggs and products thereof, as ‘egg.’ Fish and products thereof, as ‘fish.’ Peanuts and products thereof as ‘peanut.’ Milk and products thereof as ‘milk’. Sesame and products thereof as ‘sesame’. Specific tree nuts (Almond (Prunus amygdalus); Cashew (Anacardium occidentale); Hazelnut (Corylus spp. ); Pecan (Carya illinoinensis); Pistachio (Pistacia vera); Walnut (Juglans spp.) and products thereof, respectively as ‘almond,’ ‘cashew,’ ‘hazelnut,’ ‘pecan,’ ‘pistachio,’ and ‘walnut.’
Regionally relevant allergenic foods: Buckwheat and products thereof; Celery and products thereof; Oats and other Avena species (and their hybridized strains) and products thereof [Note: 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]; Lupin and products thereof, Mustard and products thereof, Soybean and products thereof; specific tree nuts (Brazil nut (Bertholletia excelsa), Macadamia (Macadamia spp.), pine nut (Pinus spp.)) and products thereof; to be declared respectively as ‘buckwheat,’ ‘celery,’ ‘oats,’ ‘lupin,’ ‘mustard,’ ‘soy.’
The main changes compared to current GSLPF is for sesame, considered as internationally relevant (due to high potency of the reaction), and soy ‘retrograded’ as regionally relevant only. The declaration of any other foods and ingredients as allergenic foods, including those listed below, may also be required using a specified name in addition to or as part of the ingredient name, while the ingredient declaration should specify the true nature of the food and be specific and not generic. Such declaration shall be based on available risk assessment data for the respective population(s), taking into account risk management considerations. For that purpose, national authorities should perform an assessment of the risks 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 Part. 1 of the FAO/WHO risk assessment of food allergens.
[ix] See Exemption for Highly Refined Food Ingredients: https://iris.who.int/bitstream/handle/10665/379046/B09032-eng.pdf?sequence=1 and FAO/WHO Part 4 (see endnote v for reference), where case studies have been presented for Glucose syrups, Alcohol distillates, Peanut oil, Soybean oil, Soy lecithin, Soy phytosterols/tocopherols, Fish gelatine, Ice structuring protein (ISP), Wheat-based maltodextrins, Isinglass, Lactitol, Extensively hydrolysed infant formula.
[x] The specified name for the foods and ingredients listed subject to allergen labelling shall be declared in a clear and distinct manner, such as through the use of font type, style, or colour that contrasts from the surrounding text. They shall be declared in the list of ingredients or in a separate statement or in both as determined by the competent authority. If used, the separate statement shall commence with the word ‘Contains’ (or equivalent word) and be placed directly under or in close proximity to the list of ingredients when present. If a separate statement is used on the label, the specified name for each of the allergenic foods must be declared in the statement, even if that specified name is already shown in the list of ingredients.
Where a food is exempt from declaring a list of ingredients, and no list of ingredients is present, allergenic foods shall be declared in a separate statement made in accordance with section 8.3.2.1.
For single-ingredient foods, the declaration of allergenic foods does not apply if they are declared as part of, or in conjunction with, the name of the food.
[xi] CCFL48 agreed with the definition of “Precautionary allergen labelling” (or PAL) as “a statement made in the labelling of pre-packaged foods to indicate a risk from the unintended presence of a food allergen(s) due to cross-contact with an allergenic food that has been identified by a risk assessment.” CCFL48 generally agreed that effective food allergen management practices, including controls to prevent or minimize the unintended presence of food allergens caused by cross-contact with allergenic foods shall be implemented in accordance with the Codex Code of practice on allergen management for food business operators (CXC 80) adopted in 2020. The use of PAL shall therefore be restricted to those situations in which the unintended presence of a food allergen(s) cannot be prevented or controlled using these allergen management practices. The decision to use PAL should be based on the findings of a risk assessment, which can include but is not limited to a quantitative risk assessment of unintended food allergen presence (see in particular Sections 3.3.1 to 3.3.6 of the FAO/WHO Expert consultation (Part 3) providing guidance for the risk assessment of unintended food allergen presence (see endnote v)). Where CCFL48 couldn’t find an agreement yet was on the conditions under which PAL could be used and on globally relevant action levels based on internationally agreed reference doses (RfD). CCFL48 found some common ground to define action levels as the reference dose (expressed mg total protein from the allergen) divided by the amount of the food (kg)) while such amount of food would be determined based on the quantity that can reasonably be expected to be consumed on a single ating occasion, preferably by using the 50th percentile. Several countries (led by Brazil) were of the view that such determination should rather be subject to national flexibility (and accountability), as it would entail some risk management decisions. In principle, there was no objection with the proposed reference doses proposed for the main allergenic foods provided in the draft Guidelines. Concerns were raised with respect to the level of protection for the most vulnerable consumers and whether the available data provided the necessary assurances that the proposed thresholds provided an equivalent or better level of protection in terms of defining action levels and on how these RfDs were derived (i.e., the eliciting dose ED05 chosen, instead of ED01). The triggering points for using PAL were to be further discussed (i.e., whether PAL should be used only when RfDs – or action levels – are exceeded or use of PAL even when RfDs – or action levels – are not exceeded).
[xi] Subject to future discussions, the draft guidelines also foresaw that in the case where a reference dose was not established for a particular food allergen in these guidelines, that regional or national authorities could establish a reference dose consistent with recognized principles (described in Part 2 of the FAO/WHO expert consultation) for the purposes of determining an action level. The guidelines also foresee that PAL shall be accompanied by education and information programs to ensure understanding and appropriate use of PAL by consumers, health care providers and food business operators. With regards to the PAL statement itself, it would commence with the words ‘May contain’ (or equivalent words) and include the identified allergenic food(s) using the specified names (just agreed by CCFL48 for inclusion in the GSLPF). The PAL statement shall contrast distinctly from surrounding text such as through the same font type, style or color used for declarations of allergenic foods as per the future amended GSLPF (2024 version). These provisions may be revisited by the EWG as well.
[xii] See, in particular, Table 11. Action Levels (ALs) for priority allergens based on recommended RfDs and calculated for predefined intake categories; Table 13. LOQ required for analytical methods to meet calculated ALs taking into account method performance; and Table 15. Assessment of test method performance for selected allergenic foods. See FAO/WHO Expert consultation Part 2 (see endnote v for reference).
[xiii] Other definitions were added to the guidelines on E-commerce, i.e., “At the point of delivery” means the moment when consumers receive pre-packaged food. “E-commerce” means the production, distribution, marketing, sale, or delivery of goods and services by electronic means as applicable to foods. “Food information” means the information that is the subject of a Codex text about a pre-packaged food. “Prior to the point of e-commerce sale” means provided before consumers commit to ordering and purchasing the food. “Product information e-page” means the virtual space on any consumer-facing transactional electronic platform, which is intended to facilitate informed e-commerce sale.
[xiv] As it is reasonable to expect that emergencies disrupting supply chains will occur in the future, such as human pandemics, climate change, animal disease outbreaks, natural disasters, disruption of critical infrastructure networks, war, or famine. Such emergencies, generally not predictable, involve critical time constraints and pressure on decision-makers, and the disrupting supply chains may occur in combination with one another and may be experienced globally or regionally, though even local or regional emergencies can have far-reaching global effects. The proposed new work intends to identify flexibilities to competent authorities, which of the mandatory required information on foods offered for sale domestically and on foods exported to other countries, where acceptance from the importing country is confirmed by the competent authority, could be skipped in cases of emergencies. In particular, those risk-based decisions on food labelling exemptions to ensure safe and adequate food supply, with consideration be given to vulnerable populations while ensuring fair practices in trade in such scenarios.
[xv] During the discussion, Codex members questioned whether “high in” claims are compatible with the current CXG 23, which typically supports voluntary, positive claims. High in claims carry more of a negative aspect and might need to be mandatory to ensure effectiveness, which may not fit within the framing of the current guidelines. They also pointed out unclear definitions of the roles of CCFL and CCNFSDU in relation to the establishment of Nutrient Reference Values for nutrients associated with NCDs (NRV-NCDs), such as the ones already developed for sodium and saturated fat. Some members also raised concerns about the potential overlap with the existing Guidelines on front-of-pack nutrition labelling, recalling past challenges in reaching a consensus on this issue and indicating a reluctance to revisit it at this time.
[xvi] See CCFL48’s CRD 20: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-714-48%252FCRDs%252FCRD20%252Ffl48e_crd20.pdf
[xvii] During the discussion, it was noted the differentiation between total sugars and “added sugars” was essential to avoid misleading information. It was also noted that such a definition could also be useful and be drafted in the context of the Guidelines on nutrition labelling (CXG 2). Before agreeing formally on a worded definition for added sugars, CCFL should first clarify how such definition would be used in existing or future Codex texts. It was pointed out that CCNFSDU may need to develop the definition itself, while CCFL could consider where such a definition could be applied in the Codex system. It was noted that national regulations defining “added sugars” on food labelling were different depending on the situation of “added sugars” intake in each country or region, and the issue of “added sugars” should rather be considered within CXG 2.
CCFL48 noted the EU intervention, indicating that current available scientific opinions indicated clearly that mono- and di-saccharides, as well as sugars naturally present in honey, syrups, concentrated fruit juices, and fruit juices, had the same nutritional health effects. As such, the EU and its Member States consider that any new work in this area should first consider all sugars, meaning covering both “added sugars” and “free sugars.” They claimed that a wide range of mono- and disaccharides and other nutritive sweeteners were added to foods, and all should be identified as “added sugars” to distinguish them from intrinsic sugars that are naturally found in foods that are otherwise nutritious. IDF indicated that lactose should be excluded from the definition of “added sugars,” as it is naturally present in dairy products, and that lactose was currently excluded from the classification of free sugars in the 2015 WHO Guidelines on sugar intake for adults and children. Other interventions called for a mandatory inclusion of “added sugars” on the label, as “consumers had a right to access to full information relating to them” through their indication as a subtotal of « total sugars » in the nutrition declaration panel, or within the list of ingredients (e.g., quantitative indication of the type of “added sugars”). It was noted that such a Codex definition would also support WHO efforts on reducing the consumption of “added sugars,” including “free sugars,” and the ban of their use in food products for children of one to three years old. There was a call by the IFU that should the work proceed, some nuanced and science-based approach should be adopted, especially for 100% fruit and vegetable juices, which contain only naturally occurring sugars present in the fruits themselves. It was emphasized that CCNFSDU would be consulted, especially before proceeding with any further work on CXG 23, and CCMAS would also be consulted on the issue of methods of analysis. A proposal was put forward to onsult the ISSLG to ensure that any definition could adequately be well understood by the consumers, as intended to be drafted and used. The Representative of WHO noted that the development of a definition for “added sugars” in Codex would require considering the concept of free sugars to prevent misleading consumers to believe that products with free sugars that contain no “added sugars” are not harmful to diets and health, in order to be protective of health of consumers.
