Review of the Codex’s report on food allergen threshold levels
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This is a paper for discussion.
This does not represent the views of the Committee and should not be cited.
1. At the 45th session of Codex Committee on Food Labelling (CCFL) in May 2019, FAO and WHO were asked to provide scientific advice on the following subjects by establishing an Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens:
- Validation of Codex’s priority allergen list through risk assessment.
- Threshold levels in foods of the priority allergens
- Appropriate use of precautionary allergen labelling (PAL).
2. In terms of threshold levels for priority allergens, the summary and conclusions report was published in August 2021, but the full report is not available yet. The summary and conclusions suggest that the Expert Committee agreed and defined reference doses (RfD) as mg of protein at the ED05 based on VITAL 3.0. ED05 is the eliciting dose at which 5% of the allergic population might react to a specific allergen.
3. Food allergen risk assessments produced by the Food Standards Agency (FSA) and some members of the food industry are conservative and therefore based on the use of ED01 (i.e. predicted to result in objective reactions in no more than 1% of the allergic population). It is acknowledged that moving from ED01 to ED05 is potentially a significant change and that when COT previously considered the issue of adventitious contamination of soya in wheat flour the Committee advised that the limits should not be relaxed to the ED05. Therefore, the Food Hypersensitivity Policy Team commissioned a review of Codex’s full report on threshold levels to understand whether it is appropriate for the recommended reference doses to be applied to the UK 14 regulated allergens.
Proposed plan on which the views of the Committee are sought
4. A review of Codex’s full report is necessary to understand the methods and scientific evidence considered by the Committee to agree RfDs for each food allergen. It would be helpful to set up a subgroup to review the full report.
5. In terms of timescale, it is anticipated that the full report will be published in early 2023. We anticipate that the review will commence shortly afterwards.
6. Details of the review such as the questions to answer and a deadline for completion should be finalised once the full report is available.
7. At this stage, we would like to make Members aware of the up-coming review and to seek your views on the following questions:
- Do Members agree with the proposed approach?
- Do Members have any other comments or suggestions for the way forward (e.g. potential sub-group members)?
List of Abbreviations and Technical terms
CCFL – Codex Committee on Food Labelling
ED - Eliciting Dose
FAO - Food and Agriculture Organization of the United Nations
FSA - Food Standards Agency
PAL - Precautionary allergen labelling
RfD - Reference dose
VITAL - Voluntary Incidental Trace Allergen Labelling
WHO - World Health Organization
Allergen Bureau, 2019. VITAL program version 3.0 and all new allergen management resources. Available at:
Allergen Bureau releases VITAL® Program Version 3.0 and all new Allergen Management Resources - Allergen Bureau
COT, 2020. Minutes of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment on 7th July 2020. Available at: COT Final Minutes July 2020 (food.gov.uk)
WHO, 2021. Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens Part 2: Review and establish threshold levels in foods of the priority allergens. Summary and Conclusions. Available at: Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens - Part 2: Review and establish threshold levels in foods of the priority allergens