dc.contributor | Díaz Moreno, Amanda Consuelo | |
dc.creator | Triana Perdomo, Germán Andrés | |
dc.date.accessioned | 2023-02-06T16:37:25Z | |
dc.date.available | 2023-02-06T16:37:25Z | |
dc.date.created | 2023-02-06T16:37:25Z | |
dc.date.issued | 2022 | |
dc.identifier | https://repositorio.unal.edu.co/handle/unal/83319 | |
dc.identifier | Universidad Nacional de Colombia | |
dc.identifier | Repositorio Institucional Universidad Nacional de Colombia | |
dc.identifier | https://repositorio.unal.edu.co/ | |
dc.description.abstract | Los alimentos y suplementos dietarios con probióticos y los beneficios de salud que estos ofrecen al consumidor presentan un desafío para las autoridades al momento de evaluar la seguridad de los microrganismos y la eficacia relacionada con estos beneficios. Este reto ha venido siendo resuelto a partir de diversos puntos de vista plasmados en la regulación a nivel mundial. Para el presente documento, se realizó una revisión de nueve (9) regulaciones sobre los requisitos de seguridad y eficacia que debe cumplir un microorganismo probiótico para entrar al mercado local. Las regulaciones revisadas fueron las de los Estados Unidos, Canadá, la Unión Europea, Japón, China, India, Brasil, Argentina y Colombia. Posteriormente, se hizo un análisis comparativo de estas regulaciones aplicando el método funcional del derecho comparado, identificando similitudes y diferencias entre las mismas. Finalmente, se encontró que las regulaciones existentes son diversas y se relacionan con el contexto donde se desarrollan. De esta manera, se encontraron similitudes y diferencias que permitieron proponer recomendaciones a tener en cuenta en la regulación de Colombia. Adicionalmente, se adelantaron los primeros tres (3) pasos de un Análisis de Impacto Normativo como inicio de la discusión acerca de esta actualización normativa. (Texto tomado de la fuente) | |
dc.description.abstract | Probiotic foods and probiotic dietary supplements, and the health benefits they offer to the consumer present a challenge for authorities when evaluating the safety of microorganisms and the efficacy related to these benefits. This challenge has been resolved from various points of view embodied in regulation worldwide. For this document, a review of nine (9) regulations was carried out on the safety and efficacy requirements that a probiotic microorganism must meet to enter the local market. Regulations reviewed include the ones from the United States, Canada, the European Union, Japan, China, India, Brazil, Argentina, and Colombia. Subsequently, a comparative analysis of these regulations was made applying the functional method of comparative law, identifying similarities and differences between them. Finally, it was found that the existing regulations are diverse and are related to the context where they were developed. In this way, similarities and differences were found that contributed to propose recommendations to be taken into account in the regulation of Colombia. Additionally, the first three (3) steps of a Regulatory Impact Analysis were advanced as the beginning of the discussion about this regulatory update. | |
dc.language | spa | |
dc.publisher | Universidad Nacional de Colombia | |
dc.publisher | Bogotá - Ciencias Agrarias - Maestría en Ciencia y Tecnología de Alimentos | |
dc.publisher | Facultad de Ciencias Agrarias | |
dc.publisher | Bogotá, Colombia | |
dc.publisher | Universidad Nacional de Colombia - Sede Bogotá | |
dc.relation | ANMAT. (2011). Disposición N° 7730/2011. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. https://www.boletinoficial.gob.ar/detalleAviso/primera/61036/20111118?msclkid=e9580ad2a62c11ecbb513e75f384bba6 | |
dc.relation | ANMAT. (2017). Disposición N° 1307/2017. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. http://portal.anmat.gov.ar/Sifega_pdf/Disposicion_1307-2017.pdf | |
dc.relation | ANVISA. (2018a). IN N° 28/2018. Agência Nacional de Vigilância Sanitária. https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/34380639/do1-2018-07-27-instrucao-normativa-in-n-28-de-26-de-julho-de-2018-34380550 | |
dc.relation | ANVISA. (2018b). RDC No 241/2018. Agência Nacional de Vigilância Sanitária. https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/34379910/do1-2018-07-27-resolucao-da-diretoria-colegiada-rdc-n-241-de-26-de-julho-de-2018-34379900 | |
dc.relation | ANVISA. (2018c). RDC No 243/2018. Agência Nacional de Vigilância Sanitária. https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/34379969/do1-2018-07-27-resolucao-da-diretoria-colegiada-rdc-n-243-de-26-de-julho-de-2018-34379917 | |
dc.relation | Anvisa. (2021). Guia para instrução processual de petição de avaliação de probióticos para uso em alimentos. Guia N° 21/2021 - Versão 2 (2nd ed.). Anvisa. | |
dc.relation | Au, C., Lin, S., Shao, W., Jin, S., Wen, Y., Singh, J., Basuki, V., Tanaka, H., Ji, E. G., Tee, E.-S., Tan, J. D., Chen, M.-J., Jirawongsy, M., Vinh, L. H., Gray, C., & Lee, Y.-K. (2019). 38 Probiotics Regulation in Asian and Australasian Countries. In G. Vinderola, A. C. Ouwehand, S. Salminen, & A. von Wright (Eds.), Lactic Acid Bacteria Microbiological and Functional Aspects (5th ed.). CRC Press. | |
dc.relation | Benoît, C. (2019). The new political economy of regulation. French Politics, 17(4), 482–499. https://hal-sciencespo.archives-ouvertes.fr/hal-02356384 | |
dc.relation | Binda, S., Hill, C., Johansen, E., Obis, D., Pot, B., Sanders, M. E., Tremblay, A., & Ouwehand, A. C. (2020). Criteria to Qualify Microorganisms as “Probiotic” in Foods and Dietary Supplements. In Frontiers in Microbiology (Vol. 11, p. 1662). Frontiers Media S.A. https://doi.org/10.3389/fmicb.2020.01662 | |
dc.relation | Brown-Turtle, M. (2016). Regulatory Intelligence 101 (2nd ed.). Regulatory Affairs Professionals Society. | |
dc.relation | CAA. (2015a). Guidelines for notification of foods with functional claims. https://www.caa.go.jp/policies/policy/food_labeling/foods_with_function_claims/assets/foods_with_function_claims_220401_0002.pdf | |
dc.relation | CAA. (2015b). For food-related businesses “Foods with functional claims” system begins! Before thinking about product development and sales. https://www.caa.go.jp/policies/policy/food_labeling/foods_with_function_claims/pdf/150810_2.pdf | |
dc.relation | CAA. (2020). Handling and guidance guidelines for foods for specified health use. https://www.caa.go.jp/policies/policy/food_labeling/foods_for_specified_health_uses/notice/assets/food_labeling_cms206_20201117_21.pdf | |
dc.relation | CAA. (2022a). About foods with functional claims. https://www.caa.go.jp/policies/policy/food_labeling/foods_with_function_claims/ | |
dc.relation | CAA. (2022b). For businesses considering application for labeling permission for foods for specified health use. https://www.caa.go.jp/policies/policy/food_labeling/foods_for_specified_health_uses/notice/ | |
dc.relation | CAA. (2022c). What is food for specified health use? | |
dc.relation | CAC. (2019). Manual de Procedimiento (27th ed.). Comisión del Códex Alimentarius. | |
dc.relation | Carbajales, M. (2019). HACIA UNA DEFINICIÓN JURÍDICA DE REGULACIÓN ECONÓMICA. Revista Republicana, 26, 43–66. https://doi.org/10.21017/Rev.Repub.2019.v26.a59 | |
dc.relation | CFIA. (2019). Probiotic claims - Health claims on food labels - Food label requirements. Canadian Food Inspection Agency. https://inspection.canada.ca/food-label-requirements/labelling/industry/health-claims-on-food-labels/eng/1392834838383/1392834887794?chap=10 | |
dc.relation | CFSAN. (2018). SMG 1230A.1 FDA Staff Manual Guides, Volume I-Organizations and Functions Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition. https://www.fda.gov/media/81407/download | |
dc.relation | Chatburn, R. L. (2017). Basics of study design: Practical considerations. Cleveland Clinic Journal of Medicine, 84(9 suppl 2), e10–e19. https://doi.org/10.3949/CCJM.84.S2.03 | |
dc.relation | Codex Alimentarius. (2013). CXG 23-1997 Directrices para el uso de Declaraciones Nutricionales y Saludables. | |
dc.relation | Davidsoni, P., Kauffmanni, C., & de Liedekerke, M.-G. (2021). How do laws and regulations affect competitiveness: The role for regulatory impact assessment. https://www.oecd-ilibrary.org/governance/how-do-laws-and-regulations-affect-competitiveness_7c11f5d5-en | |
dc.relation | de Simone, C. (2019). The Unregulated Probiotic Market. In Clinical Gastroenterology and Hepatology (Vol. 17, Issue 5, pp. 809–817). W.B. Saunders. https://doi.org/10.1016/j.cgh.2018.01.018 | |
dc.relation | DNP. (2021). Guía Metodológica de Análisis de Impacto Normativo (AIN) Versión 2.0. https://colaboracion.dnp.gov.co/CDT/ModernizacionEstado/EReI/Guia_Metodologica_AIN.pdf | |
dc.relation | Dronkers, T. M. G., Krist, L., van Overveld, F. J., & Rijkers, G. T. (2018). The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world. Beneficial Microbes, 9(5), 717–723. https://doi.org/10.3920/BM2017.0196 | |
dc.relation | Dudley, S. E., & Brito, J. (2012). Regulation: A Primer (Second Edi). Regulatory Studies Center. | |
dc.relation | Eberle, E. J. (2009). Comparative and Foreign Law. Law Review, 8(3), 451–486. https://openscholarship.wustl.edu/law_globalstudieshttps://openscholarship.wustl.edu/law_globalstudies/vol8/iss3/2 | |
dc.relation | EC. (2002a). Reglamento (CE) N° 178/2002. Parlamento Europeo y Consejo Europeo. https://eur-lex.europa.eu/legal-content/ES/ALL/?uri=CELEX:32002R0178 | |
dc.relation | EC. (2002b). Directiva 2002/46/CE. Parlamento Europeo y Consejo Europeo. https://eur-lex.europa.eu/legal-content/ES/TXT/?uri=CELEX:02002L0046-20210320 | |
dc.relation | EC. (2015). Reglamento (UE) N° 2283/2015. Parlamento Europeo y Consejo Europeo . https://eur-lex.europa.eu/legal-content/ES/TXT/?uri=CELEX:32015R2283 | |
dc.relation | EC. (2006). Reglamento (CE) N° 1924/2006. Parlamento Europeo y Consejo Europeo . https://eur-lex.europa.eu/legal-content/ES/ALL/?uri=CELEX:32006R1924 | |
dc.relation | EFSA. (2010, December 2). Scientific requirements for gastrointestinal microbiota claims. EFSA Scientific Meeting on Health Claims Related to Gut and Immune Function. https://www.efsa.europa.eu/sites/default/files/event/101202/nda101202-p04.pdf | |
dc.relation | EFSA. (2022a, April 11). Nutrition, Novel Foods and Food Allergens . https://www.efsa.europa.eu/en/science/scientific-committee-and-panels/nda | |
dc.relation | EFSA. (2022b, April 13). Biological Hazards. https://www.efsa.europa.eu/en/science/scientific-committee-and-panels/biohaz | |
dc.relation | European Commission. (2022). EU Register of nutrition and health claims made on foods (v.3.6). https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/ | |
dc.relation | FDA. (1977). CFR, Title 21. In Food & Drug Administration. Food and Drug Administration. https://www.ecfr.gov/current/title-21 | |
dc.relation | FDA. (2002a). How U.S. FDA’s GRAS Notification Program Works | FDA. Food Safety Magazine. https://www.fda.gov/food/generally-recognized-safe-gras/how-us-fdas-gras-notification-program-works#authors | |
dc.relation | FDA. (2002b, January). Small Entity Compliance Guide on Structure/Function Claims. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-structurefunction-claims | |
dc.relation | FDA. (2009a, January). Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-evidence-based-review-system-scientific-evaluation-health-claims | |
dc.relation | FDA. (2009b, January). Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act . https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food | |
dc.relation | FDA. (2016). Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry Draft Guidance (Food and Drug Administration, Ed.). https://www.fda.gov/media/99538/download | |
dc.relation | FDA. (2018a). What We Do | FDA. https://www.fda.gov/about-fda/what-we-do | |
dc.relation | FDA. (2018b). Policy Regarding Quantitative Labelling of Dietary Supplements Containing Live Microbials: Guidance for Industry Draft Guidance (Food and Drug Administration, Ed.). https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM51573 | |
dc.relation | FDA. (2022a, March 7). Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard. https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard | |
dc.relation | FDA. (2022b, March 7). Qualified Health Claims. https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims | |
dc.relation | FDA. (2022c, March 7). Structure/Function Claims. https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims | |
dc.relation | FSAAI. (2016). Food Safety and Standards (Transaction of Business and Procedure for the Scientific Committee and Scientific Panel) Regulations, 2016. Food Safety and Standards Authority of India. https://fssai.gov.in/upload/uploadfiles/files/Compendium_SCSP_Version_I_29_09_2021.pdf | |
dc.relation | FSAAI. (2017). Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation, 2017. Food Safety and Standards Authority of India. https://fssai.gov.in/upload/uploadfiles/files/Gazette_Notification_NonSpecified_Food_Ingredients_15_09_2017.pdf | |
dc.relation | FSAAI. (2018). Food Safety and Standards (Advertising and Claims) Regulations, 2018. Food Safety and Standards Authority of India. https://fssai.gov.in/upload/uploadfiles/files/Compendium_Advertising_Claims_Regulations_16_11_2021.pdf | |
dc.relation | FSAAI. (2022). Food Safety and Standards ((Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022. Food Safety and Standards Authority of India. https://fssai.gov.in/upload/advisories/2022/04/624ac1be799dbDirection_Nutra_30_03_2022.pdf | |
dc.relation | Ganguly, N. K., Bhattacharya, S. K., Sesikeran, B., Nair, G. B., Ramakrishna, B. S., Sachdev, H. P. S., Batish, V. K., Kanagasabapathy, A. S., Muthuswamy, V., Kathuria, S. C., Katoch, V. M., Satyanarayana, K., Toteja, G. S., Rahi, M., Rao, S., Bhan, M. K., Kapur, R., & Hemalatha, R. (2011). ICMR-DBT Guidelines for Evaluation of Probiotics in Food. The Indian Journal of Medical Research, 134(1), 22. /pmc/articles/PMC3171912/ | |
dc.relation | Guzmán, V., & Caldera, Y. (2019). Compuestos Bioactivos en Alimentos Funcionales y Suplementos Alimenticios: Rol en la Salud, Prevención de Enfermedades y Regulación en Latinoamérica y El Mundo. ILSI Norandino. www.ilsinorandino.org | |
dc.relation | Hayashi, T. (2009). EL DERECHO ROMANO Y EL CÓDIGO CIVIL EN EL JAPÓN MODERNO: SISTEMÁTICA, PROPIEDAD Y COPROPIEDAD. Revista Chilena de Derecho, 36(1), 9–20. https://doi.org/10.4067/S0718-34372009000100002 | |
dc.relation | Health Canada. (2003). Natural Health Products Regulations. https://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/index.html | |
dc.relation | Health Canada. (2009a). Accepted Claims about the Nature of Probiotic Microorganisms in Food. Health Canada. https://www.canada.ca/en/health-canada/services/food-nutrition/food-labelling/health-claims/accepted-claims-about-nature-probiotic-microorganisms-food.html | |
dc.relation | Health Canada. (2009b). Guidance Document - The Use of Probiotic Microorganisms in Food. Health Canada. https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-document-use-probiotic-microorganisms-food-2009.html | |
dc.relation | Health Canada. (2009c). Guidance Document for Preparing a Submission for Food Health Claims. Health Canada. https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-document-preparing-submission-food-health-claims-2009-1.html | |
dc.relation | Health Canada. (2009d, March 12). Compendium of Monographs. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/compendium-monographs.html | |
dc.relation | Health Canada. (2018). Natural Health Products Ingredients Database Issue Form . Health Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/online-solution/ingredients-database-issue-form.html | |
dc.relation | Health Canada. (2020). Natural Health Products Management of Applications Policy . Health Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-applications-attestations.html | |
dc.relation | Health Canada. (2021a). Guidelines for the Safety Assessment of Novel Foods. Health Canada. https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidelines-safety-assessment-novel-foods-derived-plants-microorganisms/guidelines-safety-assessment-novel-foods-2006.html | |
dc.relation | Health Canada. (2021b). Pathway for Licensing Natural Health Products Making Modern Health Claims. Health Canada. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/pathway-licensing-making-modern-health-claims.html | |
dc.relation | Health Canada. (2022). Probiotics. Health Canada. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=probio&lang=eng | |
dc.relation | Heimbach, J. T. (2008). Health‐Benefit Claims for Probiotic Products. Clinical Infectious Diseases, 46(s2), S122–S124. https://doi.org/10.1086/523327 | |
dc.relation | Hill, C., Guarner, F., Reid, G., Gibson, G. R., Merenstein, D. J., Pot, B., Morelli, L., Canani, R. B., Flint, H. J., Salminen, S., Calder, P. C., & Sanders, M. E. (2014). Expert consensus document: The international scientific association for probiotics and prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nature Reviews Gastroenterology and Hepatology, 11(8), 506–514. https://doi.org/10.1038/nrgastro.2014.66 | |
dc.relation | ICMR, & DBT. (2011). Guidelines for Evaluation of Probiotics in Food. https://main.icmr.nic.in/sites/default/files/guidelines/PROBIOTICS_GUIDELINES.pdf | |
dc.relation | Invima. (2004). Acta SEAB 03 de 2004. Instituto Nacional de Vigilancia de Alimentos y Medicamentos. | |
dc.relation | Invima. (2017a). Acta SEAB 13 de 2017. Instituto Nacional de Vigilancia de Alimentos y Medicamentos. | |
dc.relation | Invima. (2017b). Acta SEPFSD 9 de 2017. Instituto Nacional de Vigilancia de Alimentos y Medicamentos. | |
dc.relation | Invima. (2017c). Acta SEPFSD 10 de 2017. Instituto Nacional de Vigilancia de Alimentos y Medicamentos. | |
dc.relation | Invima. (2018a). Acta SEPFSD 5 de 2018. Instituto Nacional de Vigilancia de Alimentos y Medicamentos. | |
dc.relation | Invima. (2018b). Acta SEPFSD 9 de 2018. Instituto Nacional de Vigilancia de Alimentos y Medicamentos. | |
dc.relation | Invima. (2018c). Acta SEPFSD 15 de 2018. Instituto Nacional de Vigilancia de Alimentos y Medicamentos. | |
dc.relation | Invima. (2019). Acuerdo 2 de 2019. Instituto Nacional de Vigilancia de Medicamentos y Alimentos. https://normograma.info/invima/docs/acuerdo_invima_0002_2019.htm | |
dc.relation | Jacobs, S. F. (2019). Comparative Law and European Union Law. The Oxford Handbook of Comparative Law, 523–556. https://doi.org/10.1093/OXFORDHB/9780198810230.013.47 | |
dc.relation | Juriglobe. (2009). Índice alfabético de los 192 Estados miembros de la ONU y sistemas jurídicos correspondientes. University of Ottawa. http://www.juriglobe.ca/esp/syst-onu/index-alpha.php | |
dc.relation | JuriGlobe. (2009). Mapa del Mundo. University of Ottawa. http://www.juriglobe.ca/esp/rep-geo/cartes/monde.php | |
dc.relation | Katan, M. B. (2012). Why the European Food Safety Authority was right to reject health claims for probiotics. Beneficial Microbes, 3(2), 85–89. https://doi.org/10.3920/BM2012.0008 | |
dc.relation | Koirala, S., & Anal, A. K. (2021). Probiotics-based foods and beverages as future foods and their overall safety and regulatory claims. Future Foods, 3, 100013. https://doi.org/10.1016/j.fufo.2021.100013 | |
dc.relation | Kothari, D., Patel, S., & Kim, S. K. (2019). Probiotic supplements might not be universally-effective and safe: A review. In Biomedicine and Pharmacotherapy (Vol. 111, pp. 537–547). Elsevier Masson SAS. https://doi.org/10.1016/j.biopha.2018.12.104 | |
dc.relation | Koutsoumanis, K., Allende, A., Alvarez-Ordóñez, A., Bolton, D., Bover-Cid, S., Chemaly, M., Davies, R., de Cesare, A., Hilbert, F., Lindqvist, R., Nauta, M., Peixe, L., Ru, G., Simmons, M., Skandamis, P., Suffredini, E., Cocconcelli, P. S., Fernández Escámez, P. S., Prieto-Maradona, M., … Herman, L. (2021). Update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 14: suitability of taxonomic units notified to EFSA until March 2021. EFSA Journal, 19(7), e06689. https://doi.org/10.2903/J.EFSA.2021.6689 | |
dc.relation | Kumar, R., Sood, U., Gupta, V., Singh, M., Scaria, J., & Lal, R. (2020). Recent Advancements in the Development of Modern Probiotics for Restoring Human Gut Microbiome Dysbiosis. Indian Journal of Microbiology, 60(1), 12–25. https://doi.org/10.1007/s12088-019-00808-y | |
dc.relation | Kumari, R., Singh, A., Yadav, A. N., Mishra, S., Sachan, A., & Sachan, S. G. (2020). Probiotics, prebiotics, and synbiotics: Current status and future uses for human health. In New and Future Developments in Microbial Biotechnology and Bioengineering (pp. 173–190). Elsevier. https://doi.org/10.1016/B978-0-12-820528-0.00012-0 | |
dc.relation | Leuschner, R. G. K., Robinson, T. P., Hugas, M., Cocconcelli, P. S., Richard-Forget, F., Klein, G., Licht, T. R., Nguyen-The, C., Querol, A., & Richardson, M. (2010). Qualified presumption of safety (QPS): a generic risk assessment approach for biological agents notified to the European Food Safety Authority (EFSA). Trends in Food Science & Technology, 21(9), 425–435. https://doi.org/10.1016/j.tifs.2010.07.003 | |
dc.relation | Lin, L. (2016). Historia del Derecho Chino y su Sistema Jurídico Contemporáneo. In A. Oropeza García (Ed.), México-China. Culturas y Sistemas Jurídicos Comparados. UNAM, Instituto de Investigaciones Jurídicas. https://archivos.juridicas.unam.mx/www/bjv/libros/7/3020/5.pdf | |
dc.relation | Mandal, A. (2019, February 27). Probiotics History. https://www.news-medical.net/health/Probiotics-History.aspx | |
dc.relation | MAPA. (1999). Resolução N° 18/1999. Agência Nacional de Vigilância Sanitária. https://www.gov.br/agricultura/pt-br/assuntos/inspecao/produtos-vegetal/legislacao-1/biblioteca-de-normas-vinhos-e-bebidas/resolucao-no-18-de-30-de-abril-de-1999.pdf/view | |
dc.relation | Martín, N. G. (2000). Sistemas jurídicos contemporáneos: nociones introductorias y familia jurídica romano-germánica. Jurídica. Anuario Del Departamento de Derecho de La Universidad Iberoamericana, 1(30). https://revistas-colaboracion.juridicas.unam.mx/index.php/juridica/article/view/11424 | |
dc.relation | Maxwell, R. (2018). LibGuides: Guide to International and Foreign Law Research: Legal Systems. University of South Carolina School of Law. https://guides.law.sc.edu/c.php?g=315476&p=2108388 | |
dc.relation | Melchor, S. R., Skoblikov, L., & Schütte, B. (2019). 10 The regulatory framework for the use of probiotics claims in food and food supplements around the world: a comparative analysis (pp. 155–169). https://doi.org/10.3920/978-90-8686-885-8_10 | |
dc.relation | Michaels, R. (2006). The Functional Method of Comparative Law. In The Oxford Handbook of Comparative Law. Oxford University Press. https://doi.org/10.1093/oxfordhb/9780199296064.013.0011 | |
dc.relation | Michaels, R. (2012). Max Planck Encyclopedia of European Private Law (J. Basedow, K. J. Hopt, R. Zimmermann, & A. Stier, Eds.). Oxford University Press. https://global.oup.com/academic/product/max-planck-encyclopedia-of-european-private-law-9780199578955?cc=co&lang=en& | |
dc.relation | MinProtección. (2007). Resolución 3096 de 2007. Ministerio de la Protección Social. http://normograma.invima.gov.co/docs/resolucion_minproteccion_3096_2007.htm | |
dc.relation | MinProtección. (2012). Resolución 684 de 2012. Ministerio de Salud y Protección Social. http://normograma.invima.gov.co/docs/resolucion_minsaludps_0684_2012.htm | |
dc.relation | MinSalud. (2013). Resolución 2674 de 2013. Ministerio de Salud y Protección Social. https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/DE/DIJ/resolucion-2674-de-2013.pdf | |
dc.relation | MinSalud. (2021). Resolución 810 de 2021. Ministerio de Salud y Protección Social. https://www.minsalud.gov.co/Normatividad_Nuevo/Resoluci%C3%B3n%20No.%20810de%202021.pdf | |
dc.relation | MOH. (2004). Notice of the Ministry of Health on Issuing the Regulations on the Evaluation of Fungal and Probiotic Health Foods Weifa Jianfa [2001] No. 84. In Ministry of Health. http://www.nhc.gov.cn/sps/s3585/200804/8eafce69b178442eace396b7bc7bf8ef.shtml | |
dc.relation | MordorIntelligence. (2020). Probiotics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026). https://www.mordorintelligence.com/industry-reports/probiotics-market | |
dc.relation | National Diet. (2013). Food Labelling Act. Dieta Nacional de Japón. https://www.japaneselawtranslation.go.jp/en/laws/view/3649/je | |
dc.relation | NHC. (2013). Regulations on the Application and Acceptance of Hygienic Administrative Licensing for New Food Raw Materials. National Health Commission. https://zwfw.nhc.gov.cn/kzx/zcfg/xspylsp_237/202101/t20210107_1567.html | |
dc.relation | Nyanzi, R., Jooste, P. J., & Buys, E. M. (2021). Invited review: Probiotic yogurt quality criteria, regulatory framework, clinical evidence, and analytical aspects. Journal of Dairy Science, 104(1), 1–19. https://doi.org/10.3168/jds.2020-19116 | |
dc.relation | Obis, D., Paris, M., & Ouwehand, A. (2019). 22 The Safety of Lactic Acid Bacteria for Use in Foods. In G. Vinderola, A. Ouwehand, S. Salminen, & A. von Wright (Eds.), Lactic Acid Bacteria Microbiological and Functional Aspects (5th ed.). CRC Press. | |
dc.relation | OECD. (2015). Regulatory Policy in Perspective. In Regulatory Policy in Perspective. OECD. https://doi.org/10.1787/9789264241800-en | |
dc.relation | OECD. (2018). OECD Regulatory Policy Outlook 2018. In OECD Regulatory Policy Outlook 2018. OECD. https://doi.org/10.1787/9789264303072-en | |
dc.relation | Orbach, B. (2012). What Is Regulation? http://ssrn.com/abstract=2143385 | |
dc.relation | Parliament of Canada. (n.d.). Food and Drug Regulations. Retrieved October 1, 2021, from https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html | |
dc.relation | Parliament of Canada. (1985). Food and Drugs Act. Parliament of Canada. https://laws.justice.gc.ca/PDF/F-27.pdf | |
dc.relation | Peivasteh-Roudsari, L., Pirhadi, M., Karami, H., Tajdar-oranj, B., Molaee-Aghaee, E., & Sadighara, P. (2020). Probiotics and food safety: An evidence-based review. Journal of Food Safety and Hygiene, 5(1), 1–9. https://doi.org/10.18502/jfsh.v5i1.3878 | |
dc.relation | Poder Ejecutivo Nacional. (1969). Código Alimentario Argentino - Capítulo XVII. Poder Ejecutivo Nacional. | |
dc.relation | Presidencia de la República. (2006). Decreto 3249 de 2006. Presidente de la República de Colombia. http://normograma.invima.gov.co/docs/decreto_3249_2006.htm | |
dc.relation | Presidencia de la República. (2008). Decreto 3863 de 2008. Presidente de la República de Colombia. https://normograma.info/invima/docs/decreto_3863_2008.htm | |
dc.relation | Presidencia de la República. (2015). Decreto 1595 de 2015. Presidente de la República de Colombia. http://normograma.invima.gov.co/docs/decreto_1595_2015.htm | |
dc.relation | Presidente de la Nación Argentina. (1999). Decreto N° 815 /99. Presidente de la Nación Argentina. http://www.alimentosargentinos.gob.ar/contenido/marco/Decreto_815/815-99.htm | |
dc.relation | Reid, G., Araya, M., Morelli, L., Sanders, M. E., Stanton, C., Pineiro, M., & ben Embarek, P. (2002). Guidelines for the Evaluation of Probiotics in Food. http://www.fao.org/es/ESN/Probio/probio.htm | |
dc.relation | Ricci, A., Allende, A., Bolton, D., Chemaly, M., Davies, R., Girones, R., Herman, L., Koutsoumanis, K., Lindqvist, R., Nørrung, B., Robertson, L., Ru, G., Sanaa, M., Simmons, M., Skandamis, P., Snary, E., Speybroeck, N., Kuile, B. ter, Threlfall, J., … Fernandez Escamez, P. S. (2017). Scientific Opinion on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA. EFSA Journal, 15(3), e04664. https://doi.org/10.2903/J.EFSA.2017.4664 | |
dc.relation | Roobab, U., Batool, Z., Manzoor, M. F., Shabbir, M. A., Khan, M. R., & Aadil, R. M. (2020). Sources, formulations, advanced delivery and health benefits of probiotics. In Current Opinion in Food Science (Vol. 32, pp. 17–28). Elsevier Ltd. https://doi.org/10.1016/j.cofs.2020.01.003 | |
dc.relation | SAMR. (2018). Announcement on Standardizing the Labeling of Functional Claims of Health Foods. State Agency for Market Regulation. https://www.samr.gov.cn/tssps/zcwj/202108/t20210819_333749.html | |
dc.relation | SAMR. (2019a). Regulations on Declaration and Review of Probiotic Health Foods (Draft for Comments). State Administration for Market Regulation. | |
dc.relation | SAMR. (2019b). Measures for the Administration of Health Food Raw Materials Catalogue and Health Function Catalogue. State Administration for Market Regulation. https://gkml.samr.gov.cn/nsjg/fgs/201908/t20190820_306117.html | |
dc.relation | SAMR. (2022). Announcement on Issuing the List of Health Functions Allowed for Health Food Claims, Non-nutrient Supplements (2022 Edition) and Supporting Documents (Draft for Comment). State Administration for Market Regulation. https://www.samr.gov.cn/hd/zjdc/202201/t20220113_339092.html | |
dc.relation | Samuel, G. (2014). An Introduction to Comparative Law Theory and Method. In An Introduction to Comparative Law Theory and Method. Hart Publishing. https://doi.org/10.5040/9781849468442 | |
dc.relation | Sanz, Y., Portune, K., Gómez Del Pulgar, E. M., & Benítez-Páez, A. (2016). Targeting the Microbiota: Considerations for Developing Probiotics as Functional Foods. In The Gut-Brain Axis Dietary, Probiotic, and Prebiotic Interventions on the Microbiota (pp. 17–30). Elsevier Inc. https://doi.org/10.1016/B978-0-12-802304-4.00002-5 | |
dc.relation | Smith, A. B. (2019). 40 The Regulation of Probiotics in the United States. In G. Vinderola, A. C. Ouwehand, S. Salminen, & A. von Wright (Eds.), Lactic Acid Bacteria Microbiological and Functional Aspects. CRC Press. | |
dc.relation | Turck, D., Bresson, J., Burlingame, B., Dean, T., Fairweather‐Tait, S., Heinonen, M., Hirsch‐Ernst, K. I., Mangelsdorf, I., McArdle, H. J., Naska, A., Neuhäuser‐Berthold, M., Nowicka, G., Pentieva, K., Sanz, Y., Sjödin, A., Stern, M., Tomé, D., van Loveren, H., Vinceti, M., … Siani, A. (2017). Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2). EFSA Journal, 15(1), e04680. https://doi.org/10.2903/j.efsa.2017.4680 | |
dc.relation | United States Congress. (1938). Federal food, drug and cosmetic act. https://www.law.cornell.edu/uscode/text/21/chapter-9 | |
dc.relation | van Hoecke, M. (2016). Methodology of Comparative Legal Research. Law and Method. https://doi.org/10.5553/rem/.000010 | |
dc.relation | van Loveren, H., Sanz, Y., & Salminen, S. (2012). Health Claims in Europe: Probiotics and Prebiotics as Case Examples. Annual Review of Food Science and Technology, 3(1), 247–261. https://doi.org/10.1146/annurev-food-022811-101206 | |
dc.relation | von Wright, A. (2019). 42 Safety Assessment of Probiotics in the European Union (EU). In Gabriel Vinderola, A. C. Ouwehand, S. Salminen, & A. von Wright (Eds.), Lactic Acid Bacteria Microbiological and Functional Aspects (5th ed.). CRC Press. | |
dc.relation | World Bank. (2021). World Bank Country and Lending Groups – World Bank Data Help Desk. https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups | |
dc.relation | Zheng, J., Wittouck, S., Salvetti, E., Franz, C. M. A. P., Harris, H. M. B., Mattarelli, P., O’toole, P. W., Pot, B., Vandamme, P., Walter, J., Watanabe, K., Wuyts, S., Felis, G. E., Gänzle, M. G., & Lebeer, S. (2020). A taxonomic note on the genus Lactobacillus: Description of 23 novel genera, emended description of the genus Lactobacillus beijerinck 1901, and union of Lactobacillaceae and Leuconostocaceae. International Journal of Systematic and Evolutionary Microbiology, 70(4), 2782–2858. https://doi.org/10.1099/ijsem.0.004107 | |
dc.rights | Atribución-CompartirIgual 4.0 Internacional | |
dc.rights | http://creativecommons.org/licenses/by-sa/4.0/ | |
dc.rights | info:eu-repo/semantics/openAccess | |
dc.title | Análisis de regulaciones sobre evaluación de seguridad y eficacia de probióticos en alimentos y suplementos dietarios | |
dc.type | Trabajo de grado - Maestría | |