Pretensiones y realidad de Europa para una Mejor Gobernanza en el caso de la Regulación de las declaraciones de propiedades saludables

Resumen

Analizamos los objetivos de la política de la Comisión Europea de introducir una forma más abierta, más participativa y menos jerárquica de regular la ciencia y la tecnología, en un caso particular: la Regulación Europea de las Declaraciones de Propiedades Saludables. Este marco regulatorio relativamente reciente, en principio orientado al consumidor y modificado recientemente por la nueva regulación europea de transparencia, proporciona un caso de prueba para las aspiraciones de las instituciones europeas de mejorar la gobernanza de la ciencia y la tecnología. Sin embargo, nuestro análisis muestra que estas aspiraciones no se han cumplido. La regulación europea de las declaraciones de propiedades saludables no permite ninguna participación relevante del público o de los consumidores, ni la participación de las partes interesadas en la toma de decisiones. No ofrece ningún mecanismo para facilitar el debate público o de los consumidores con respecto a los objetivos elegidos por la regulación, los estándares científicos ni los costes-beneficios involucrados, en particular las consecuencias que son el resultado de las decisiones de los reguladores. Al contrario que en las regulaciones de las declaraciones de propiedades saludables de los Estados Unidos y Japón, por ejemplo, los supuestos epistémicos y políticos subyacentes al enfoque europeo tienden a dificultar el logro de la mayoría de los objetivos participativos.
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Bagchi, Debasis (2019). Nutraceutical and Functional Food Regulations in the United States and around the World (3rd Edition). New York: Academic Press.

Biesalski, Hans Konrad, et al. (2011). 26th Hohenheim Consensus Conference, September 11, 2010—Scientific substantiation of health claims: Evidence-based nutrition. In Nutrition, 27(10), S1–S20. https://doi.org/10.1016/j.nut.2011.04.002

Blumberg, Jeffrey, et al. (2010). Evidence-based criteria in the nutritional context. In Nutrition Reviews, 68(7) (August), 478–484. https://doi.org/10.1111/j.1753-4887.2010.00307.x

Boer, Ali de & Bast, Aalt (2015). International legislation on nutrition and health claims. In Food Policy, 55 (August), 61–70. https://doi.org/10.1016/j.foodpol.2015.06.002

Consumer Affairs Agency (CAA) (2015). What are “Foods with Function Claims”? (Guidance for consumers). Govern of Japan: Food Labelling Division (pubd online December 2015). https://www.caa.go.jp/policies/policy/food_labeling/information/pamphlets/pdf/151224_1.pdf

Council of the European Communities (1984/2005). Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising. In Official Journal of the European Union L, 250 (September), 17–20 (Latest consolidated version: 12/06/2005)

Dehousse, Renaud (2016). Has the European Union moved towards soft governance? In Comparative European Politics, 14, 20–35. https://doi.org/10.1057/cep.2015.7

Directorate General Health and Consumer Protection (2001). Discussion paper on Nutritional Claims and Functional Claims (SANCO/1341/2001). Brussels: European Commission. https://ec.europa.eu/food/system/files/2016-10/labelling_nutrition-claims-claims_discussion_paper_en.pdf

Directorate-General for Health and Consumers (2011). 2nd Collective answer (to comments on EFSA”s opinions and stakeholder concerns. Brussels: European Commission (pubd online May, 2011). https://ec.europa.eu/food/safety/labelling_nutrition/claims/health_claims_en

Domínguez Díaz, Laura & Fernández-Ruiz, Virginia & Cámara, Montaña (2020). An international regulatory review of food health-related claims in functional food products labeling. In Journal of Functional Foods, 60(10), 1738-1746. https://doi.org/10.1080/10408398.2019.1592107

European Commission (EC) (2001). European governance - A white paper (COM/2001/0428 final). In Official Journal of the European Union C 287 (October 12), 1–29.

European Commission (EC) (2006). From Science and Society to Science in Society. Towards a framework for cooperative research. Brussels: European Commission. https://op.europa.eu/en/publication-detail/-/publication/4bd7721c-677f-457d-8ba3-9186f64c1823

European Commission (EC) (2007). Taking European Knowledge Society Seriously. Report of the Expert Group on Science and Governance to the Science, Economy and Society Directorate. Brussels: European Commission. https://op.europa.eu/en/publication-detail/-/publication/5d0e77c7-2948-4ef5-aec7-bd18efe3c442

European Commission (EC) (2008). Public Engagement in Science: Report of the Science in Society Session. Brussels: European Commission. https://op.europa.eu/en/publication-detail/-/publication/2d7d42ad-d69e-46ab-94bd-035b068ae676/language-en

European Commission (2013). Options for Strengthening Responsible Research and Innovation. https://op.europa.eu/en/publication-detail/-/publication/1e6ada76-a9f7-48f0-aa86-4fb9b16dd10c/language-en

European Commission (2017). Horizon 2020 Work Programme 2018-2020, 16. Science with and for Society. Brussels, European Commission. https://ec.europa.eu/research/participants/data/ref/h2020/wp/2018-2020/main/h2020-wp1820-swfs_en.pdf

European Food Safety Authority (EFSA) (2016). General guidance for stakeholders on health claim applications. In EFSA Journal, 14(1), 4367(1–38). https://doi.org/10.2903/j.efsa.2016.4367

European Food Safety Authority (EFSA) (2017). Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2). In EFSA Journal, 15(1), 4680(1–31). https://doi.org/10.2903/j.efsa.2017.4680

European Food Safety Authority (EFSA) (2021a). General scientific guidance for stakeholders on health claim applications (Revision 1). In EFSA Journal, 19(3), 6554. https://doi.org/10.2903/j.efsa.2021.65543

European Food Safety Authority (EFSA) (2021b). Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3). In EFSA Journal, 19(3), 6554. https://doi.org/10.2903/j.efsa.2021.6554

European Parliament and Council (2005). Common opinion of the European Parliament and the Council of the European Union on Regulation (EC) No ..../2005 of the European Parliament and of the Council on nutrition and health claims made on foods (Brussels, 15 November). https://ec.europa.eu/food/system/files/2016-10/labelling_nutrition-claims-common_position05_en.pdf

European Parliament and Council (2006). Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. In Official Journal of the European Union L 404 (December), 9–25.

European Parliament and Council (2008). Regulation (EC) No 353/2008 of 18 April 2008 establishing implementation rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council. In Official Journal of the European Union L 109 (April), 11–16.

European Parliament and Council (2019). Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC. In Official Journal of the European Union L 231 (September), 1–28.

European Parliament, Council of the European Union, and European Commission (2016). Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making of 13 April 2016. In Official Journal of the European Union, L 123/1 (May 12). http://data.europa.eu/eli/agree_interinstit/2016/512/oj

Food and Drugs Administration (FDA) (2003). Consumer health information for better nutrition initiative: Task Force Final Report. United States (pubd online July 2003), https://www.fda.gov/food/food-labeling-nutrition/consumer-health-information-better-nutrition-initiative-task-force-final-report

Food and Drugs Administration (FDA) (2009/2018). Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims (FDA-2007-D-0371) (pubd online January 2009, revised 2018). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-evidence-based-review-system-scientific-evaluation-health-claims

Greer, Scott L. & Vanhercke, Bart (2010). The hard politics of soft law: The case of health. In Elia Mossialos, Govin Permanand, Rita Baeten & Tamara Hervey (eds.), Health Systems Governance in Europe: The Role of European Union Law and Policy (Health Economics, Policy and Management). Cambridge, UK: Cambridge University Press.

Gregori, Dario & Gafare, Claudia Elena (2012). Multifunctional food: Medical evidence and methodological notes on substantiating health claims? In International Journal of Food Sciences and Nutrition, 63(sup1), 29–36. https://doi.org/10.3109/09637486.2011.653553

Guéguen, Daniel & Marissen, Vicky (2022). Science-based and evidence-based policy-making in the European Union: coexisting or conflicting concepts? In Bruges Political Research Papers, 88 (September). Department of European political and governance studies. College of Europe. https://www.coleurope.eu/sites/default/files/research-paper/wp88%20Marisen_Guegen.pdf

Guston, David H. (2000). Between politics and science: Assuring the integrity and productivity of research. Cambridge: Cambridge University Press.

Iwatani, Shun & Yamamoto, Naoyuki (2019). Functional food products in Japan: A review. In Food Science and Human Wellness, 8(2), 96–101. https://doi.org/10.1016/j.fshw.2019.03.011

Jasanoff, Sheila (1990). The fifth branch: science advisers as policymakers. Cambridge: Harvard University Press.

Jasanoff, Sheila (2003). Technologies of Humility: Citizen Participation in Governing Science. In Minerva, 41 (September), 223–244. doi: https://doi.org/10.1023/A:1025557512320

Joss, Simon & Durant, John (eds.) (1995). Public Participation in Science: The Role of Consensus Conferences in Europe. London: Science Museum.

Kamioka, Hiroharu, et al. (2019). Quality of systematic reviews of the Foods with Function Claims registered at the Consumer Affairs Agency web site in Japan: a prospective systematic review. In Nutrients, 11(7), 1583. https://doi.org/10.3390/nu11071583

Khedkar, Sukhada & Bröring, Stefanie & Ciliberti, Stefano (2017). Exploring the Nutrition and Health Claims Regulation (EC) No. 1924/2006: What is the impact on innovation in the EU food sector? In Journal of Food Sciences and Nutrition, 68(1), 10–17. https://doi.org/10.1080/09637486.2016.1212818

Lengwiler, Martin (2008). Participatory Approaches in Science and Technology: Historical Origins and Current Practices in Critical Perspective. In Science, Technology, & Human Values, 33(2), 186–200. https://doi.org/10.1177/0162243907311262

Levidow, Les & Carr, Susan & Wield, David (2005). European Union regulation of agribiotechnology: precautionary links between science, expertise and policy. In Science and Public Policy, 32(4), 261–276.

López Mas, Roberto & Luján, José Luis (2022). The essentiality of nutrients: a challenge to methodological monism in the scientific substantiation of health claims. In International Journal of Food Sciences and Nutrition, 73(2), 149–153. https://doi.org/10.1080/09637486.2021.1948508

Rantala, Kati & Alasuutari, Noora & Kuorikoski, Jaakko (2023). The logic of regulatory impact assessment: From evidence to evidential reasoning. In Regulation & Governance (First published: 19 June 2023). https://doi.org/10.1111/rego.12542

Sanz Merino, Noemí (2020). La comunicación social de la ciencia a través del etiquetado de alimentos saludables en los EEUU y Europa. In Revista Comunicación, 1(18), 66–84. https://doi.org/10.12795/Comunicacion.2020.i18.04

Sanz Merino, Noemí (2021). Praxeologies in Regulatory Science. A case of Benefits Assessment. In A. Muñoz van den Eynde & C. Polino (Coordinators), Pocket Science: The Praxeological Dimension of Scientific Culture. Madrid: CIEMAT, 67- 81, 160–164.

Sanz Merino, Noemí (2022). Policy Styles and Epistemic Policies in the Regulation of Health Claims. A Comparison of Europe, the United States, and Japan. In Social Epistemology, 36(4), 449–465. https://doi.org/10.1080/02691728.2021.2004467

Sarvaranta, Leena et al. (2023). Futures of Science for Policy in Europe: Scenarios and Policy Implications. Directorate-General for Research and Innovation Common Strategy and Foresight Service. European Commission. https://op.europa.eu/en/publication-detail/-/publication/424ea70a-640c-11ee-9220-01aa75ed71a1/language-en/format-PDF/source-293925594

Schomberg, René von (2014). The quest for the ‘right’ impacts of science and technology: A framework for responsible research and innovation. In M. van den Hoven, N. Doorn, T. Swierstra, B. Koops & H. Romijn (eds.), Responsible Innovation 1: Innovative Solutions 23 for Global Issues. New York: Springer, 33–50. https://doi.org/10.1007/978-94-017-8956-1_3

Todt, Oliver & Luján, José Luis (2017). Health Claims and Methodological Controversy in Nutrition Science. In Risk Analysis, 37(5), 958–968. https://doi.org/10.1111/risa.12665

Todt, Oliver & Luján, José Luis (2021). Health claim regulation for public health: individual choice or libertarian paternalism? In Teorema, XL, 1, 193–213.

Valtueña, Silvia & Siani, Alfonso (2017). Health claims made on food in the EU: The edge between scientific knowledge and regulatory requirements. In Trends in Food Science & Technology, 69 (November), 315-323. https://doi.org/10.1016/j.tifs.2017.01.005

Woolley, Richard et al. (2024). Responsible Research and Innovation. In Alis Oancea, Gemma E. Derrick, Nuzha Nuseibeh & Xin Xu (eds.), Handbook of Meta-Research. Massachusetts, US: Edward Elgar, 32–45. https://doi.org/10.4337/9781839105722.00010
Sanz Merino, N., & Todt, O. (2025). Pretensiones y realidad de Europa para una Mejor Gobernanza en el caso de la Regulación de las declaraciones de propiedades saludables. Artefactos. Revista De Estudios Filosóficos Sobre Ciencia Y Tecnología, 14, e32954. https://doi.org/10.14201/art2025.32954

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