Labeling related to gluten in packaged foods, medicines, and commercial establishments: regulatory panorama in Brazil
Vigil Sanit Debate, Rio de Janeiro, 2025, v.13: e02317 | Publicado em: 03/10/2025
DOI:
https://doi.org/10.22239/2317-269X.02317Keywords:
Celiac Disease, Gluten free Diet, Product Labeling, Legislation, SupermarketsAbstract
Introduction: Unintentional gluten ingestion often occurs due to a lack of warning or misunderstanding of information about the presence and/or absence of gluten. For the gluten-free diet to be followed appropriately and safely, there must be regulatory measures and strategies for identifying gluten and food sources of this protein in foods, beverages, medicines, and places that sell or distribute food. Objective: To investigate current legislation on presence or absence of gluten in Brazil. Method: Documentary analysis of Brazilian legislation (federal, state, and municipal) related to gluten in foods, beverages, medicines, and places that sell or distribute food. Furthermore, legislation regarding the presentation of foods that do not contain gluten in commercial establishments was investigated. Examples of labels were photographed to illustrate the legislation. Results: Sixty-five laws were found that are current for the federal level (n=5), as well as in the state (n=41) and municipality (n=19) of 22 Brazilian states. These laws are aimed at packaged products (n=5) and establishments that sell food (n=60). Various legislations have non-specific warnings for gluten in relation to permitted expressions, where they must appear on the packaging and formatting. Inconsistencies were observed between warnings suggested in legislation and some products, in addition to non-conformities. Conclusions: For legislation to fulfill the purpose of protecting consumers who need to remove gluten from their diet, it is mandatory that, in addition to being implemented, there is supervision. Furthermore, it is suggested that legislation be updated at a national level.
Downloads
References
1. Ashton JJ, Smith R, Smith T, Beattie RM. Investigating coeliac disease in adults. BMJ. 2020;369. https://doi.org/10.1136/bmj.m2176
2. Muniz JG, Sdepanian VL, Fagundes Neto U. Prevalência da predisposição genética para doença celíaca nos doadores de sangue em São Paulo, Brasil. Arq Gastroenterol. 2016;53(4):267-72. https://doi.org/10.1590/S0004-28032016000400011
3. Elli L, Branchi F, Tomba C, Villalta D, Norsa L, Ferretti F et al. Diagnosis of gluten related disorders: celiac disease, wheat allergy and non-celiac gluten sensitivity. World J Gastroenterol. 2015;21(23):7110-9. https://doi.org/10.3748/wjg.v21.i23.7110
4. Ludvigsson JF, Leffler DA, Bai JC, Biagi F, Fasano A, Green PHR et al. The Oslo definitions for coeliacdisease and related terms. Gut. 2013;62(1):43-52. https://doi.org/10.1136/gutjnl-2011-301346
5. Al-Toma A, Volta U, Auricchio R, Castillejo G, Sanders DS, Cellier C et al. European society for the study of coeliac disease (ESsCD) guideline for coeliac disease and other gluten-related disorders. United Eur Gastroent J. 2019;7(5):583-613. https://doi.org/10.1177/2050640619844125
6. Wieser H. Chemistry of gluten proteins. Food Microbiol. 2007;24(2):115-9. https://doi.org/10.1016/j.fm.2006.07.004
7. Biesiekierski JR. What is gluten? J Gastroent Hepatol. 2017;32(1):78-81. https://doi.org/10.1111/jgh.13703
8. Collar C. Gluten-free dough-based foods and technologies. In: Taylor JRN, Duodu KG, editores. Sorghum and millets: chemistry, technology, and nutritional attributes. Berlin: Elsevier; 2019. p. 331-54.
9. Sapone A, Bai JC, Ciacci C, Dolinsek J, Green PHR, Hadjivassiliou M et al. Spectrum of glutenrelated disorders: consensus on new nomenclature and classification. BMC Med. 2012;10(13). https://doi.org/10.1186/1741-7015-10-13
10. Haboubi NY, Taylor S, Jones S. Coeliac disease and oats: a systematic review. Postgrad Med J. 2006;82(972):672-8. https://doi.org/10.1136/pgmj.2006.045443
11. Navarro-Contreras AL, Chaires-González CF, Rosas-Burgos EC, Borboa-Flores J, Wong-Corral FJ, Cortez-Rocha MO et al. Comparison of protein and starch content of substituted and complete triticales (X Triticosecale Wittmack): contribution to functional properties. Int J Food Prop. 2014;17(2):421-32. https://doi.org/10.1080/10942912.2011.642440
12. Arentz-Hansen H, Fleckenstein B, Molberg Ø, Scott H, Koning F, Jung G et al. The molecular basis for oat intolerance in patients with celiac disease. PLoS Med. 2004;1(1):1-9. https://doi.org/10.1371/journal.pmed.0010001
13. Pinto-Sánchez MI, Causada-Calo N, Bercik P, Ford AC, Murray JA, Armstrong D et al. Safety of adding oats to a gluten-free diet for patients with celiac disease: systematic review and meta-analysis of clinical and observational studies. Gastroenterology. 2017;153(2):395-409. https://doi.org/10.1053/j.gastro.2017.04.009
14. Wieser H, Segura V, Ruiz-Carnicer A, Sousa C, Comino I. Food safety and cross-contamination of gluten-free products: a narrative review. Nutrients. 2021;13(7):1-14. https://doi.org/10.3390/nu13072244
15. Bai JC, Ciacci C, Melberg J. World gastroenterology organisation global guidelines: celiac disease February 2017. J Clin Gastroenterol. 2017;51(9):755-68. https://doi.org/10.1097/MCG.0000000000000919
16. Sainsbury K, Halmos EP, Knowles S, Mullan B, Tye-Din JA. Maintenance of a gluten free diet in coeliac disease: the roles of self-regulation, habit, psychological resources, motivation, support, and goal priority. Appetite. 2018;125:356-66. https://doi.org/10.1016/j.appet.2018.02.023
17. Silvester JA, Comino I, Kelly CP, Sousa C, Duerksen DR. Most patients with celiac disease on glutenfree diets consume measurable amounts of gluten. Gastroenterology. 2020;158(5):1497-9.e1. https://doi.org/10.1053/j.gastro.2019.12.016
18. Silvester JA, Weiten D, Graff LA, Walker JR, Duerksen DR. Is it gluten-free? Relationship between self-reported gluten-free diet adherence and knowledge of gluten content of foods. Nutrition. 2016;32(7-8):777-83. https://doi.org/10.1016/j.nut.2016.01.021
19. Gutowski ED, Weiten D, Green KH, Rigaux LN, Bernstein CN, Graff LA et al. Can individuals with celiac disease identify gluten-free foods correctly? Clin Nutr Espen. 2020;36:82-90. https://doi.org/10.1016/j.clnesp.2020.01.012
20. Araújo HMC, Araújo WMC. Coeliac disease: following the diet and eating habits of participating individuals in the Federal District, Brazil. Appetite. 2011;57(1):105-9. https://doi.org/10.1016/j.appet.2011.04.007
21. Verma AK, Gatti S, Galeazzi T, Monachesi C, Padella L, Del Baldo G et al. Gluten contamination in naturally or labeled gluten-free products marketed in Italy. Nutrients. 2017;9(2):1-10. https://doi.org/10.3390/nu9020115
22. Brasil. Lei Nº 8.543, de 23 de dezembro de 1992. Determina a impressão de advertência em rótulos e embalagens de alimentos industrializados que contenham glúten, a fim de evitar a doença celíaca ou síndrome celíaca. Diário Oficial União. 24 dez 2003
23. Brasil. Lei No 10.674, de 16 de maio de 2003. Obriga que os produtos alimentícios comercializados informem sobre a presença de glúten, como medida preventiva e de controle da doença celíaca. Diário Oficial União. 19 maio 2003.
24. Guimarães VO, Lima HCFM, Moraes ARF. Avaliação das rotulagens de alimentos frente à legislação vigente e do uso de alegações não regulamentadas. Rev Inst Adolfo Lutz. 2022;1-18. https://doi.org/10.53393/rial.2022.v81.39118
25. Radeski E, Piccoli C, Sturner J, Spinelli RB. Avaliação de rótulos em alimentos especializados. Rev Persp. 2022;46(173):97-106. https://doi.org/10.31512/persp.v.46.n.173.2022.210.p.97-106
26. Bastos AP, Sales S, Bastos W, Rodrigues C, Pessoa PP. Análise de rótulos de macarrões integrais de acordo com a legislação em relação ao teor de fibra e informações obrigatórias. Braz J Food Res. 2019;10(2):143-57. https://doi.org/10.3895/rebrapa.v10n2.10288
27. Mattioni B, Scheuer PM, Antunes AL, Paulino N, Francisco A. Compliance with gluten-free labelling regulation in the brazilian food industry. Cereal Chem. 2016;93(5):518-22. https://doi.org/10.1094/CCHEM-08-15-0158-R
28. Falcomer AL, Santos Araújo L, Farage P, Monteiro JS, Nakano EY, Zandonadi RP. Gluten contamination in food services and industry: a systematic review. Crit Rev Food Sci Nutr. 2020;60(3):479-93. https://doi.org/10.1080/10408398.2018.1541864
29. Lopes JF, Carvalho MA, Machado NC. Labeling food allergens in the packaged food pyramid groups in Brazil: analysis of descriptions, ambiguities, and risks. Rev Paul Pediatr. 2022;40:1-7. https://doi.org/10.1590/1984-0462/2022/40/2021079in
30. Agência Nacional de Vigilância Sanitária – Anvisa. Resolução RDC No 727, de 1 de julho de 2022. Dispõe sobre a rotulagem dos alimentos embalados. Diário Oficial União. 1 jul 2022.
31. European Commission – EC. Regulamento de execução Nº 828, de 30 de julho de 2014. Relativo aos requisitos de prestação de informações aos consumidores sobre a ausência ou a presença reduzida de glúten nos géneros alimentícios. Jornal Oficial da União Europeia. 30 jul 2014.
32. US Food and Drug Administration – FDA. Food labeling; gluten-free labeling of foods. 17 CFR Part 101. Silver Spring: US Food and Drug Administration; 2013.
33. Food and Agriculture Organization of United Nations – FAO. Revised version standard for food for special dietary use for persons intolerant to glúten. Codex Alimentarius. 2008[acesso 13 mar 2024]. Disponível em:https://www.fao.org/fao-who-codexalimentarius/sh-proxy/ en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B118-1979%252FCXS_118e_2015.pdf
34. Cela N, Condelli N, Caruso MC, Perretti G, Di Cairano M, Tolve R et al. Gluten-free brewing: issues and perspectives. Fermentation. 2020;6(2):1-26. https://doi.org/10.3390/fermentation6020053
35. Araújo HMC, Araújo WMC, Botelho RBA, Zandonadi RP. Doença celíaca, hábitos e práticas alimentares e qualidade de vida. Rev Nutr. 2010;23(3):467-74. https://doi.org/10.1590/S1415-52732010000300014.
36. Brasil. Lei No 8.078, de 11 de setembro de 1990. Dispõe sobre a proteção do consumidor e dá outras providências. Diário Oficial União. 11 set 1990.
37. Agência Nacional de Vigilância Sanitária – Anvisa. Perguntas e respostas: rotulagem de alimentos alergênicos. 5a ed. Brasília: Agência Nacional de Vigilância Sanitária; 2017[acesso 27 out 2023]. Disponível em: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/alimentos/perguntas-erespostas-arquivos/rotulagem-de-alergenicos.pdf
38. Agência Nacional de Vigilância Sanitária – Anvisa. Guia sobre programa de controle de alergênicos: versão 2: guia no 5. Brasília: Agência Nacional de Vigilância Sanitária; 2018[acesso 15 dez 2023]. Disponível em: http://antigo.anvisa.gov.br/documents/10181/2779 039/%281%29Guia+Programa+Controle+de+Alergenicos+versao+2.pdf/69af35f5-cc11-412e-ade5-4d47fef14f5e
39. Rodríguez JM, Estévez V, Bascuñán K, Ayala J, Araya M. Commercial oats in gluten-free diet: a persistent risk for celiac patients. Front Nutr. 2022;9:1-6. https://doi.org/10.3389/fnut.2022.986282
40. Janatuinen EK, Pikkarainen PH, Kemppainen TA, Kosma VM, Järvinen RMK, Uusitupa MIJ et al. A comparison of diets with and without oats in adults with celiac disease. N Engl J Med. 1995;333(16):1033-7. https://doi.org/10.1056/NEJM199510193331602
41. Thompson T. Do oats belong in a gluten-free diet? J Am Diet Assoc. 1997;97(12):1413-6. https://doi.org/10.1016/S0002-8223(97)00341-6
42. Mujico JR, Lombardía M, Mena MC, Méndez E, Albar JP. A highly sensitive real-time PCR system for quantification of wheat contamination in gluten-free food for celiac patients. Food Chem. 2011;128(3):795-801. https://doi.org/10.1016/j.foodchem.2011.03.061
43. Chen Y, Fritz RD, Kock L, Garg D, Davis RM, Kasturi P. A stepwise, “test-all-positives” methodology to assess glutenkernel contamination at the serving-size level in glutenfree (GF) oat production. Food Chem. 2018;240:391–5. https://doi.org/10.1016/j.foodchem.2017.07.153
44. Ministério da Agricultura Pecuária e Abastecimento (BR). Instrução normativa No 65, de 10 de dezembro de 2019. Estabelece os padrões de identidade e qualidade para os produtos de cervejaria. Diário Oficial União. 11 dez 2019.
45. Gumienna M, Górna B. Gluten hypersensitivities and their impact on the production of gluten-free beer. Eur Food Res Technol. 2020;246(11):2147-60. https://doi.org/10.1007/s00217-020-03579-9
46. Agência Nacional de Vigilância Sanitária – Anvisa. Resolução RDC No 770, de 12 de dezembro de 2022. Estabelece frases de alerta para substâncias, classes terapêuticas e listas de controle em bulas e embalagem de medicamentos. Diário Oficial União. 13 dez 2022.
47. Agência Nacional de Vigilância Sanitária – Anvisa. Instrução normativa N° 200, de 12 de dezembro de 2022. Estabelece as substâncias, classes terapêuticas e listas de controle que necessitam de frases de alerta quando presentes em medicamentos, sejam como princípio ativo ou excipiente, e suas respectivas frases. Diário Oficial União. 14 dez 2022.
48. Sdepanian VL, Scaletsky ICA, Morais MB, Fagundes-Neto U. Pesquisa de gliadina em medicamentos: informação relevante para a orientação de pacientes com doença celíaca. Arq Gastroenterol. 2001;38(3):176-82. https://doi.org/10.1590/S0004-28032001000300007
49. Governo do Estado do Rio de Janeiro. Lei No 7.067, de 30 de setembro de 2015. Cria o selo estadual “sem glúten” para produtos fabricados ou comercializados que não contenham glúten em sua composição. Diário Oficial do Estado. 1 out 2015.
50. Governo do Estado do Paraná. Lei No 18.757 de 20 de abril de 2016. Institui o selo estadual sem glúten para produtos fabricados ou comercializados que não contenham glúten em sua composição. Diário Oficial do Estado. 22 abr 2016.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Health Surveillance under Debate: Society, Science & Technology

This work is licensed under a Creative Commons Attribution 4.0 International License.
COPYRIGHT ALLOWANCE The author (s) hereinafter designated as the ASSIGNOR hereby assign and transfer, free of charge, the ownership of the copyrights related to this ARTICLE to the Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debate, represented by FUNDAÇÃO OSWALDO CRUZ, established at Av. Brasil, nº 4365, Manguinhos, Rio de Janeiro, RJ, Brazil, CEP 21045-900, under the conditions set out below: (a) The terms and conditions set forth in this Agreement shall apply to the following: 1. The ASSIGNOR declares that they s(he) is (are) the author (s) and owner (s) of the copyrighted property of the ARTICLE submitted. 2. The ASSIGNOR declares that the ARTICLE does not infringe the copyrights and / or other property rights of third parties, that the disclosure of images (if any) has been authorized and that they s(he) assume(s) full moral and / or property liability for its content, before third parties. 3. THE ASSIGNOR assigns and transfers all copyrights relating to the ARTICLE to the ASSIGNEE, especially the rights of editing, publication, translation into another language and reproduction by any process or technique. The ASSIGNEE becomes the exclusive owner of the rights related to the ARTICLE, and any reproduction, totally or partially, is prohibited in any other means of publicity, printed or electronic, without prior written authorization from the ASSIGNEE. 4. The assignment is free and, therefore, there will be no remuneration for the use of the ARTICLE by the ASSIGNEE.