The expert group organized by FAO and WHO for risk analysis on food allergens, at its last meeting on November 14-18, 2022, highlighted the need to define criteria for exemption from labeling of substances derived from food allergens. (1)
The focus is precisely on the decision-making scheme to be followed for risk assessment, with particular regard to ingredients containing or derived from priority allergens and ultra-processed foods.
The work of the expert group should inspire the authorities of the member states and the European Commission-which has so far shirked its allergen risk management duties-and stimulate the progress of Codex Alimentarius.
1) Food allergens in labeling. Codex Alimentarius
The General Standard for the Labeling of Prepackaged Foods (GSLPF) defines the labeling subject requirements for packaged foods. Regarding food allergens:
- the presence of certain foods and ingredients responsible for causing hypersensitivity (priority allergens) must always be declared on the label,
- products that contain priority allergens not declared on the label should not be marketed or otherwise distributed. (2)
1.1) Scientific Opinions FAO, WHO
TheCodex Committee on Food Labeling (CCFL) – at its 45th session (2019) – had asked the FAO/WHO Expert Panel for a scientific opinion on how to update the list of foods and ingredients that may cause hypersensitivity in consumers.
Food allergy experts convened by FAO and WHO therefore organized four meetings, dedicated to the development of:
- approach to be followed in view of the inclusion of new matrices i.e., exclusion from the priority allergen list,
- Review of threshold levels of priority allergens in food,
- evaluation of the criteria of Precautionary Allergen Labeling (PAL),
- criteria for exemption from labeling duties for ingredients derived from priority allergens that are not found to trigger allergic reactions.
1.2) Proposed revisions
Some proposals to revise the Codex Alimentarius ‘General Standard for the Labelling of Prepackaged Foods’ were proposed at the 46th session (2021) of the CCFL Committee, just on the subject of allergens, with regard to:
- Update of some definitions (e.g., allergen, food allergy/intolerance, hypersensitivity),
- Elimination of some exemptions already provided for cases of products with packages of surface area < 10 cm2 and ingredients present < 5% in compound ingredients. (3)
1.3) Code of good practice
Codex Alimentarius then adopted the ‘Code of Practice on Food Allergen Management for Food Business Operators‘ (2020). With the goal of promoting as uniform a level of label information and protection for allergic consumers as possible, on a planetary level. (4)
2) FAO, WHO. Decision-making scheme
The decision-making scheme developed by the panel for the possible exemption of foods and ingredients derived from priority allergens has been developed and tested effectively on some substances already excluded, in some countries, from specific supplementary labeling duties. This scheme considers:
- composition and physicochemical characteristics of the food or ingredient that derives (e.g., refined soybean oil) and/or contains (e.g., soy lecithin) a priority allergen,
- Production process and product specifications,
- history of use, safety and any adverse reactions, routes and concentrations of exposure,
- Intended use and exposure (mg total allergen protein).
2.1) Risk Analysis
Some recommendations of the FAO/WHO expert group include:
- Quantification of total protein. More than one method is recommended, based on different principles, such as amino acid analysis. With proper instrument calibration and sample preparation,
- Evaluation of the potential alteration of protein allergenicity in derivatives. Through specific assays that may involve protein or specific peptide molecular structure (> 15 units), i.e., IgE studies from serum of allergic subjects with confirmed clinical history of food allergy. Clinical evaluation with Oral Food Challenge (OFC) should be done only when necessary and on a case-by-case basis.
3) Allergen labeling in the European Union.
The European Commission and some member states have welcomed proposals to revise the Codex Alimentarius ‘General Standard for the Labelling of Prepackaged Foods’ (see 1.2 above). (5)
The Food Information Regulation EU No 1169/2011 in fact already extends the duty to inform about the presence of allergens to all foods (both those sold pre-wrapped and loose and those given to consumers). (6)
Moreover, the list of allergens subject to mandatory labeling and substances derived from them that are exempted from it can be updated, in the EU, according to procedures similar to those proposed by the FAO/WHO Expert Group (see paragraph 2 above).
3.1) Update allergens and derivatives list, EFSA guidelines.
EFSA published in 2021 the updated version of the guidelines on how to submit applications for exemption from the mandatory indication of food allergens or products derived from them. (7) So as to clarify the administrative and scientific requirements to be fulfilled in theE-Submission Food Chain Platform of the European Commission.
The evaluation process follows similar procedures to regulated products (e.g., novel foods, food additives, feed additives).
You can apply for a General Pre-Submission Advice (GPSA), the requirement to notify the necessary studies, the 30-day time limit for dossier review, and 1 year for its overall evaluation (unless additional information is requested). This was followed by EFSA’s scientific opinion and the Commission’s decision in agreement with thePlants, Animals, Food and Feed (PAFF) Standing Committee. (8)
4) Interim Conclusions
The conclusions of the last FAO/WHO expert group meeting report that RfD/30, even in worst-case scenarios, appears to provide an adequate margin of exposure (MoE) for assessing the safety of derivatives, given that adequate analytical methods for protein determination are available. Further clinical studies can therefore be dispensed with.
The proposed approach is in itself adequate to evaluate possible exemptions and support, in Europe, the requirements for EFSA’s evaluation for the purpose of revising the food allergen list. Provided that applicants are able to provide sufficient data and evidence to demonstrate an assurance of safety, including following the granting of any exemptions from information duties.
Dario Dongo and Andrea Adelmo Della Penna
Notes
(1) FAO/WHO (2023). Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens – Part 4: Review and establish exemption for the food allergens 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
(2) Codex Alimentarius (1985). CXS 1-1985 – General Standard for the Labelling of Prepackaged Foods. Revision 2018 https://bit.ly/3Hye1AR
(3) FAO/WHO (2021). CX/FL 21/46/8 – Food Allergen Labeling. Agenda Item 8, CCFL 46th Session. https://bit.ly/3HdTD6M
(4) Codex Alimentarius (2020). CXC 80-2020 – Code of Practice on Food Allergen Management for Food Business Operators https://bit.ly/3Y242cw
(5) European Union Comments on Agenda Item 8: Food Allergen Labelling (CX/FL 21/46/8). https://food.ec.europa.eu/system/files/2021-09/codex_ccfl_46_agenda-item-08.pdf
(6) Reg. EU 1169/11, Article 21.2
(7) EFSA NDA Panel (2021). Guidance on the preparation and presentation of applications for exemption from mandatory labelling of food allergens and/or products thereof pursuant to Article 21 (2) of Regulation (EU) No 1169/2011. EFSA Journal 19(3):6543, https://doi.org/10.2903/j.efsa.2021.6543
(8) EFSA (2021). Application procedure for exemption from mandatory labeling of food allergens. https://www.efsa.europa.eu/sites/default/files/applications/apdeskapplworkflownutrifoodallergies.pdf
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
