HomelabelsAllergen labelling, exemption criteria for derived substances

Allergen labelling, exemption criteria for derived substances

The group of experts organized by FAO and WHO for risk analysis on food allergens, in its last meeting on 14-18 November 2022, highlighted the need to define the criteria for exemption from labeling of substances derived from food allergens. (1)

Attention is focused precisely on the decision-making scheme to be followed for risk assessment purposes, with particular regard to ingredients that contain or derive 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 escaped to its allergen risk management duties – and stimulate the progress of Codex Alimentarius.

1) Food allergens on the label. Codex Alimentarius

The General Standard for the Labeling of Prepackaged Foods (GSLPF) defines the material labeling 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

The Committee di Codex Alimentarius dedicated to food labeling (Codex Committee on Food Labelling, CCFL) - in the 45th session (2019) - had asked the FAO/WHO expert group for a scientific opinion on how to update the list of foods and ingredients that can cause hypersensitivity in consumers.

The experts on food allergies convened by FAO and WHO have therefore organized four meetings, dedicated to the development of:

  • approach to follow in view of the introduction of new matrices or the exclusion from the list of priority allergens,
  • level review allergen threshold priorities in food,
  • criteria evaluation Precautionary Allergen Labeling (PAL),
  • criteria for exemption from labeling duties for ingredients derived from priority allergens that are not capable of triggering allergic reactions.

1.2) Revision proposals

Some proposals of revision of Codex Alimentarius 'General Standard for the Labeling of Prepackaged Foods' were proposed at the 46th session (2021) of the CCFL Committee, precisely on the subject of allergens, with regard to:

  • updating of some definitions (e.g. allergen, food allergy/intolerance, hypersensitivity),
  • elimination of some exemptions already envisaged for the cases of products with surface packaging < 10 cm2 and ingredients present in < 5% of the 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 aim of promoting as uniform a level as possible, worldwide, of information on the label and the protection of allergic consumers. (4)

2) FAO, WHO. Decision scheme

The decision scheme elaborated by the group of experts for the possible exemption of foods and ingredients derived from priority allergens, it was developed and effectively tested on some substances already excluded, in some countries, from the duties of specific additional labelling. This scheme considers:

  • composition and physico-chemical characteristics of the food or ingredient which 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 concern:

  • quantification of total proteins. It is recommended to use more than one method, based on different principles, such as amino acid analysis. With proper instrument calibration and sample preparation,
  • evaluation of the potential alteration of the allergenicity of the proteins in the derivatives. Through specific assays that can relate to the molecular structure of proteins or specific peptides (> 15 units), or studies on IgE from serum of allergic subjects with confirmed clinical history of food allergy. The clinical evaluation with Oral Food Challenge (OFC) should only be done if necessary and on a case-by-case basis.
Fig. 1 – Process scheme for evaluating the exemption of claims on the presence of food allergens (FAO/WHO, 2023)

3) Allergen labeling in the European Union

The European Commission and some Member States have welcomed the proposals for revision of the Codex Alimentarius 'General Standard for the Labeling of Prepackaged Foods' (see above, par. 1.2). (5)

The Food Information Regulation EU No 1169/2011 in fact already extends the duty to inform on the presence of allergens to all foods (both those sold pre-wrapped and loose, and those administered to consumers). (6)

My list of the allergens subject to mandatory labeling and of the substances derived from them which are instead exempt from them can moreover be updated, in the EU, according to procedures similar to those proposed by the FAO/WHO group of experts (see above, paragraph 2).

3.1) Update of the list of allergens and derivatives, 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) In order to clarify the administrative and scientific requirements to be fulfilled in theE-Submission Food Chain Platform of the European Commission.

The evaluation process follows methods similar to regulated products (e.g. novel foods, food additives, feed additives).

It is possible to apply of a General Pre-Submission Advice (GPSA), the obligation to notify the necessary studies, the 30-day deadlines for verification of the dossier and 1 year for its overall evaluation (unless requests for additional information). Below, scientific opinion of EFSA and decision of the Commission in agreement with the PAFF Standing Committee (Plants, Animals, Food and Feed). (8)

4) Provisional conclusions

The conclusions of the last meeting of the FAO/WHO group of experts report that the RfD/30, even in the worst-case scenario, appears to provide an adequate margin of exposure (MoE) for the safety assessment of derivatives, given that adequate assay methods are available for protein determination. Further clinical studies can therefore be dispensed with.

The approach proposed is in itself adequate to evaluate possible exemptions and support, in Europe, the requirements required for the evaluation of EFSA for the purpose of revising the list of food allergens. Provided that the applicants are able to provide sufficient data and evidence to demonstrate a guarantee of safety, even following the granting of any exemptions from the information duties.

Dario Dongo and Andrea Adelmo Della Penna


(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 Labeling of Prepackaged Foods. 2018 revision 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 Labeling (CX/FL 21/46/8). https://food.ec.europa.eu/system/files/2021-09/codex_ccfl_46_agenda-item-08.pdf

(6) EU Reg. 1169/11, article 21.2

(7) EFSA NDA Panel (2021). Guidance on the preparation and presentation of applications for exemption from mandatory labeling 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

Andrea Adelmo Della Penna

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.

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