J Korean Med Sci.  2024 Dec;39(48):e307. 10.3346/jkms.2024.39.e307.

Challenge of Precautionary Allergen Labeling for Ensuring the Safety of Children With Food Allergies

• Lee J
• Kim S
• Jeong K
• Koo JH
• Lee S

• KMID: 2562469
• DOI: http://doi.org/10.3346/jkms.2024.39.e307

Abstract

Background
Precautionary allergen labeling (PAL) is mandatory and legally regulated in Korea. This study aims to investigate the frequency of PAL use in food products, evaluate its competence, and seek direction for improvement.
Methods
Cow’s milk (CM) and hen’s egg white (EW) protein concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). The results validated PAL using the Voluntary Incidental Trace Allergen Labeling ® 3.0 program. A survey was conducted on guardians to compare preferences and understanding of the current and the arbitrarily revised PAL.
Results
PAL was used in 91.8% (280/305) of baby food products. ELISA results using randomly selected baby food products showed that only 16.7% (5/30; No PAL with no contamination, n = 4; PAL with real-contamination risk, n = 1) were validated to PAL. A detectable CM was found in two products (2/26, 7.7%), with one product exceeding the reference dose (10.3 ± 0.17 ppm). EW was not detected at all (0/16). A total of 207 surveys from guardians were collected and categorized into three groups: food allergy (FA, n = 103), diseases other than food allergies (Others, n = 52), and no disease (Control, n = 52). The FA group exhibited the highest frequency of checking food allergen labeling (“always”: 78.6%, “often”: 9.7%), with a similar PAL adherence (“always”: 58.3%, “often”: 10.4%). None of the groups were satisfied with the current PAL. The ‘allergen-free’ statement was mostly preferred across all groups. The FA group notably preferred PAL with concentration statements.
Conclusion
PAL is excessively prevalent and insufficient in ensuring the safety of children with FAs, necessitating a revision towards a more patient-friendly, evidence-based system for affected individuals and their families.

Keyword

Food Labeling; Food Hypersensitivity; Food Contamination; Food Quality; Surveys and Questionnaires

Figure

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  Fig. 1 Preferences for current and revised versions of PAL statements.The survey was conducted among guardians of children with food allergies (FA group), guardians of children with disease other than food allergy (Others group), and guardians of healthy children (no disease; Control group).PAL = precautionary allergen labeling, ANON = anonymous.

Reference

1. Sicherer SH, Sampson HA. Food allergy: a review and update on epidemiology, pathogenesis, diagnosis, prevention, and management. J Allergy Clin Immunol. 2018; 141(1):41–58. PMID: 29157945.

2. Jeong K, Kim J, Ahn K, Lee SY, Min TK, Pyun BY, et al. Age-based causes and clinical characteristics of immediate-type food allergy in Korean children. Allergy Asthma Immunol Res. 2017; 9(5):423–430. PMID: 28677356.

3. Baker MG, Saf S, Tsuang A, Nowak-Wegrzyn A. Hidden allergens in food allergy. Ann Allergy Asthma Immunol. 2018; 121(3):285–292. PMID: 30219174.

4. Westerhout J, Baumert JL, Blom WM, Allen KJ, Ballmer-Weber B, Crevel RW, et al. Deriving individual threshold doses from clinical food challenge data for population risk assessment of food allergens. J Allergy Clin Immunol. 2019; 144(5):1290–1309. PMID: 31445097.

5. Allen KJ, Taylor SL. The consequences of precautionary allergen labeling: safe haven or unjustifiable burden? J Allergy Clin Immunol Pract. 2018; 6(2):400–407. PMID: 29524993.

6. Soon JM, Manning L. “May contain” allergen statements: facilitating or frustrating consumers? J Consum Policy (Dordr). 2017; 40(4):447–472.

7. Pádua I, Moreira A, Moreira P, Melo de Vasconcelos F, Barros R. Impact of the regulation (EU) 1169/2011: allergen-related recalls in the rapid alert system for food and feed (RASFF) portal. Food Control. 2019; 98:389–398.

8. Jeon YH, Kim HH, Park YM, Jang GC, Kim HY, Yum HY, et al. The current status and issue of food allergen labeling in Korea. Allergy Asthma Respir Dis. 2019; 7(2):67–72.

9. Cornelisse-Vermaat JR, Voordouw J, Yiakoumaki V, Theodoridis G, Frewer LJ. Food-allergic consumers’ labelling preferences: a cross-cultural comparison. Eur J Public Health. 2008; 18(2):115–120. PMID: 17584733.

10. Marra CA, Harvard S, Grubisic M, Galo J, Clarke A, Elliott S, et al. Consumer preferences for food allergen labeling. Allergy Asthma Clin Immunol. 2017; 13(1):19. PMID: 28392808.

11. Allergen Bureau. VITAL Scientific Expert Panel 2019 Summary Recommendations – the New Allergen Reference Doses for VITAL^® Program Version 3.0. Updated 2019. Accessed November 1, 2023. https://allergenbureau.net/vital-scientific-expert-panel-2019-summary-recommendations-the-new-allergen-reference-doses-for-vital-program-version-3-0/ .

12. Remington BC, Westerhout J, Meima MY, Blom WM, Kruizinga AG, Wheeler MW, et al. Updated population minimal eliciting dose distributions for use in risk assessment of 14 priority food allergens. Food Chem Toxicol. 2020; 139:111259. PMID: 32179163.

13. Taylor SL, Baumert JL, Kruizinga AG, Remington BC, Crevel RW, Brooke-Taylor S, et al. Establishment of Reference Doses for residues of allergenic foods: report of the VITAL Expert Panel. Food Chem Toxicol. 2014; 63:9–17. PMID: 24184597.

14. Fiocchi A, Risso D, DunnGalvin A, González Díaz SN, Monaci L, Fierro V, et al. Food labeling issues for severe food allergic patients. World Allergy Organ J. 2021; 14(10):100598. PMID: 34703523.

15. Neogen Corporation. VITAL 3.0 Allergen Calculator. Accessed July 31, 2024. https://www.neogen.com/neocenter/resources/vital-3-0-allergen-calculator/ .

16. Zurzolo GA, Peters RL, Koplin JJ, de Courten M, Mathai ML, Tye-Din JA, et al. The practice and perception of precautionary allergen labelling by the Australasian food manufacturing industry. Clin Exp Allergy. 2017; 47(7):961–968. PMID: 28295718.

17. Taylor SB, Christensen G, Grinter K, Sherlock R, Warren L. The allergen bureau vital program. J AOAC Int. 2018; 101(1):77–82. PMID: 29202911.

18. Koeberl M, Clarke D, Allen KJ, Fleming F, Katzer L, Lee NA, et al. Food allergen management in Australia. J AOAC Int. 2018; 101(1):60–69. PMID: 29202903.

19. Joshi A, Kale S, Chandel S, Pal DK. Likert scale: explored and explained. Br J Appl Sci Technol. 2015; 7(4):396–403.

20. Allen KJ, Turner PJ, Pawankar R, Taylor S, Sicherer S, Lack G, et al. Precautionary labelling of foods for allergen content: are we ready for a global framework? World Allergy Organ J. 2014; 7(1):10. PMID: 24791183.

21. DunnGalvin A, Roberts G, Schnadt S, Astley S, Austin M, Blom WM, et al. Evidence-based approaches to the application of precautionary allergen labelling: report from two iFAAM workshops. Clin Exp Allergy. 2019; 49(9):1191–1200. PMID: 31325393.

22. Blom WM, van Dijk LM, Michelsen-Huisman A, Houben GF, Knulst AC, Linders YF, et al. Allergen labelling: current practice and improvement from a communication perspective. Clin Exp Allergy. 2021; 51(4):574–584. PMID: 33440035.

23. Gupta R, Kanaley M, Negris O, Roach A, Bilaver L. Understanding precautionary allergen labeling (PAL) preferences among food allergy stakeholders. J Allergy Clin Immunol Pract. 2021; 9(1):254–264.e1. PMID: 33007499.

24. Zurzolo GA, Mathai ML, Koplin JJ, Allen KJ. Precautionary allergen labelling following new labelling practice in Australia. J Paediatr Child Health. 2013; 49(4):E306–E310. PMID: 23489385.

25. Tham EH, Leung DY. How different parts of the world provide new insights into food allergy. Allergy Asthma Immunol Res. 2018; 10(4):290–299. PMID: 29949829.

26. Cox AL, Nowak-Wegrzyn A. Innovation in food challenge tests for food allergy. Curr Allergy Asthma Rep. 2018; 18(12):74. PMID: 30377836.

27. Holzhauser T, Johnson P, Hindley JP, O’Connor G, Chan CH, Costa J, et al. Are current analytical methods suitable to verify VITAL^® 2.0/3.0 allergen reference doses for EU allergens in foods? Food Chem Toxicol. 2020; 145:111709. PMID: 32866515.