Políticas epistémicas y gobernanza. Un análisis comparativo de las regulaciones norteamericana y europea sobre declaraciones de propiedades saludables

  1. Sanz Merino, Noemí 1
  2. José Luis Luján 1
  1. 1 Universitat de les Illes Balears

    Universitat de les Illes Balears

    Palma, España

    ROR https://ror.org/03e10x626

Revista española de ciencia política

ISSN: 1575-6548

Year of publication: 2021

Issue: 55

Pages: 93-117

Type: Article

DOI: 10.21308/RECP.55.04 DIALNET GOOGLE SCHOLAR lock_openDialnet editor

More publications in: Revista española de ciencia política


This article analyzes North American and European health claims regulations. By making use of the concept of epistemic policy, we show that the European regulation is committed to a monistic assessment approach, which favors a certain scientific methodology, while the North American regulation is committed to a pluralist epistemic policy. The comparative analysis of both regulations shows that each epistemic policy depends on particular regulatory objectives. We conclude that there is no single epistemic policy that serves to achieve different regulatory objectives. Moreover, we conclude that the choice of one epistemic policy or another entrenches the objectives of regulation, sets the trajectory of technological innovation and it entails other socio-political implications. In particular, we show how the European epistemic policy is compatible with a hard governance mode, while the North American one is more compatible with a softer governance mode. Finally, we hold that our conclusions are extensible to current evidence-based policy proposals. It is not reasonable, in accordance with our results, to think that there is one single type of scientific evidence useful for all public policies objectives. Committing to one or another epistemic policy would lead to think that only a certain type of political interventions would have supporting evidence.

Funding information

Este trabajo se ha realizado con el apoyo financiero del Fondo Europeo de Desarrollo Regional de la Comisión Europea (FEDER), Ministerio de Ciencia, Innovación y Universidades de España, Agencia Estatal de Investigación (AEI), proyecto de investigación «Estándares de prueba y elecciones metodológicas en la fundamentación científica de las declaraciones de salud» (FFI2017-83543-P), y la ayuda Cas18/00126.

Bibliographic References

  • Aggett, Peter J. 2012. «Dose-response relationships in multifunctional food design: Assembling the evidence», International Journal of Food Sciences and Nutrition, 63 (S1): 37-42. Disponible en: https://doi.org/10.3109/09637486.2011.636344.
  • Aggett, Peter J., Jean-Michel Antoine, Nils-Georg Asp, France Bellisle, Laura Contor, John H. Cummings, John Howlett, Detlef J. G. Müller, Christoph Persin, Loek T. J. Pijls, Gerhard Rechkemmer, Sandra Tuijtelaars y Hans Verhagen. 2005. «PASSCLAIM. Consensus on criteria», European Journal of Nutrition, 44 (supl.1): 5-30. Disponible en: https://doi.org/10.1007/s00394-005-1104-3.
  • Asp, Nils-Georg y Susanne Bryngelsson. 2008. «Health Claims in Europe: New Legislation and PASSCLAIM for Substantiation», The Journal of Nutrition, 138 (6): 1210S-1215S. Disponible en: https://doi.org/10.1093/jn/138.6.1210S.
  • Bagchi, Debasis (ed.). 2014. Nutraceutical and Functional Food Regulations in the United States and Around the World (Second Edition). Londres: Elsevier.
  • Berhaupt-Glickstein, Amanda y William K. Hallman. 2017. «Communicating scientific evidence in qualified health claims», Critical Reviews in Food Science and Nutrition, 57(13): 2811-2824. Disponible en: https://doi.org/10.1080/10408398.2015.1069730.
  • Betz, Gregor. 2013. «In defence of the value free ideal», European Journal for the Philosophy of Science, 3: 207-220. Disponible en: https://doi.org/10.1007/s13194-012-0062-x.
  • Bidlack, Wayne R., Diane Birt, Joseph Borzelleca, Roger Clemens, Nicole Coutrelis, James R. Coughlin, George E. Dunaif, Andrew Ebert, Richard Hall, James T. Heimbach, William Helferich, Bernadene Magnuson, Diane B. McColl, Robert S. McQuate, Ian Munro, Barbara Petersen, Ashley Roberts, Joseph Scimeca, Martin Slayne, Thomas Trautman, Rosetta Newsome, Toni Tarver, Cory Bryant, Fred Shank y Steve Taylor. 2009. «Expert Report: Making decisions about the risks of chemicals in foods with limited scientific information», Comprehensive Reviews in Food Science and Food Safety, 8: 269-303. Disponible en: https://doi.org/10.1111/j.1541-4337.2009.00081.x.
  • Biesalski, Hans K., Peter J. Aggett, Robert Anton, Paul S. Bernstein, Jeffrey Blumberg, Robert P. Heaney, Jeya Henry, John M. Nolan, David P. Richardson, Ben van Ommen, Renger F. Witkamp, Ger T. Rijkers y Iris Zöllner. 2011. «26th Hohenheim Consensus Conference, September 11, 2010. Scientific substantiation of health claims: Evidence-based nutrition», Nutrition, 27: S1-S20. Disponible en: https://doi.org/10.1016/j.nut.2011.04.002.
  • Blumberg, Jeffrey, Robert P. Heaney, Michael Huncharek, Theresa Scholl, Meir Stampfer, Reinhold Vieth, Connie M. Weaver y Steven H. Zeisel. 2010. «Evidence-based criteria in the nutritional context», Nutrition Reviews, 68: 478-484. Disponible en: https://doi.org/10.1111/j.1753-4887.2010.00307.x.
  • Boobis, Alan, Alessandro Chiodini, Jeljer Hoekstra, Pagona Lagiou, Hildegard Przyrembel, Josef Schlatter, Katrin Schütte, Hans Verhagen y Bernhard Watzl. 2013. «Critical appraisal of the assessment of benefits and risks for foods. BRAFO Consensus Working Group», Food and Chemical Toxicology, 55: 659-675. Disponible en: https://doi.org/10.1016/j.fct.2012.10.028.
  • Cartwright, Nancy y Jeremy Hardie. 2013. Evidence-Based Policy: A practical guide to doing it better. Oxford: Oxford University Press. Disponible en: https://doi.org/10.1093/acprof:osobl/9780199841608.001.0001.
  • Cartwright, Nancy y Jacob Stegenga. 2011. «A theory of evidence for evidence-based policy», en William Twining, Philip Dawid y Dimitra Vasilaki (eds.), Evidence, inference and enquiry. Oxford: Oxford University Press. Disponible en: https://doi.org/10.5871/bacad/9780197264843.003.0011.
  • Comisión Europea (CE). 2001. «La gobernanza europea. Un libro blanco (COM 428)», Diario Oficial C, 287. Bruselas. Disponible en: https://cutt.ly/qlzh3BE.
  • Comisión Europea (CE). 2005. Science and Society Action Portfolio. Today’s science for Tomorrow’s Society. Bruselas. Disponible en: https://cutt.ly/Klzjqwm.
  • Comisión Europea (CE). 2006. Science in Society Programme, From Science and Society to Science in Society Towards a framework for cooperative research. Bruselas: Directorate General Research and Technology Development. Disponible en: https://cutt.ly/Blzjtmq.
  • Comisión Europea (CE). 2007. Taking European Knowledge Society Seriously. Report of the Expert Group on Science and Governance to the Science, Economy and Society Directorate. Disponible en: https://cutt.ly/Xlzji0R.
  • Cox, Louis A. 2015. Breakthroughs in decision science and risk analysis. Hoboken, NJ: John Wiley and Sons.
  • Cranor, Carl F. 1995. «The social benefits of expedited risk assessment», Risk Analysis, 15: 353-358. Disponible en: https://doi.org/10.1111/j.1539-6924.1995.tb00328.x.
  • Cranor, Carl F. 1997. «The normative nature of risk assessment: Features and possibilities», Risk: Health, Safety and Environment, 8 (2): 123-136.
  • Cranor, Carl F. 2006. Toxic Torts. Science, Law and the Possibility of Justice. Cambridge: Cambridge University Press. Disponible en: https://doi.org/10.1017/CBO9780511617713.
  • Cranor, Carl F. 2017. Tragic Failures: How and Why We Are Harmed by Toxic Chemicals. Oxford: Oxford University Press. Disponible en: https://doi.org/10.1093/acprof:oso/9780190635756.001.0001.
  • Dehousse, Renaud. 2016. «Has the European Union moved towards soft governance?», Comparative European Politics, 14: 20-35. Disponible en: https://doi.org/10.1057/cep.2015.7.
  • Directorate-General for Health and Consumers. 2011. «2nd collective answer». Disponible en: https://cutt.ly/Rlzjxi3.
  • Domínguez Díaz, Laura, Virginia Fernández-Ruiz y Montaña Cámara. 2020a. «The frontier between nutrition and pharma: The international regulatory framework of functional foods, food supplements and nutraceuticals», Critical Reviews in Food Science and Nutrition, 60 (10): 1738-1746. Disponible en: https://doi.org/10.1080/10408398.2019.1592107.
  • Domínguez Díaz, Laura, Virginia Fernández-Ruiz y Montaña Cámara. 2020b. «An international regulatory review of food health-related claims in functional food products labeling». Journal of Functional Foods, 68: 103896. Disponible en: https://doi.org/10.1016/j.jff.2020.103896.
  • Dorato, M. 2004. «Epistemic and nonepistemic values in science», en Peter Machamer y Gereon Wolters (eds.), Science, values and objectivity. Pittsburgh: University of Pittsburgh Press.
  • Douglas, Heather E. 2009. Science, policy, and the value-free ideal. Pittsburgh: University of Pittsburgh Press. Disponible en: https://doi.org/10.2307/j.ctt6wrc78.
  • Edinger, Wieke H. 2016. «Promoting Educated Consumer Choices. Has EU Food Information Legislation Finally Matured?», Journal of Consumer Policy, 39: 9-22. Disponible en: https://doi.org/10.1007/s10603-015-9307-3.
  • European Food Safety Authority. Panel on Dietetic Products, Nutrition and Allergies (EFSA-NDA). 2011. «General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims», EFSA Journal, 9 (4): 2135. Disponible en: https://doi.org/10.2903/j.efsa.2011.2135.
  • European Food Safety Authority. Panel on Dietetic Products, Nutrition and Allergies (EFSA-NDA). 2017. «Scientific and technical guidance for the preparation and presentation of an application for authorisation of a Health Claim (2 revision)», EFSA Journal, 15 (1): 4680. Disponible en: https://doi.org/10.2903/j.efsa.2017.4680.
  • European Parliament and Council. 2006. «European Parliament and Council Regulation No. 1924/of the European Parliament and of the Council on Nutrition and Health Claims Made on Foods», OJ L, 404 (30-12-2006): 12. Disponible en: https://cutt.ly/vlzkiKz.
  • Gilsenan, Mary. 2011. «Nutrition and health claims in the EU: A regulatory overview», Trends in Food Science and Technology, 22: 536-542. Disponible en: https://doi.org/10.1016/j.tifs.2011.03.004.
  • González‐Díaz, Cristina, Diana Gil‐González y Carlos Álvarez‐Dardet. 2018. «Scientific Evidence on Functional Food and Its Commercial Communication: A Review of Legislation in Europe and the USA», Journal of Food Science, 83 (11): 2710-2717. Disponible en: https://doi.org/10.1111/1750-3841.14359.
  • Gregori, Dario y Claudia Elena Gafare. 2012. «Multifunctional food: Medical evidence and methodological notes on substantiating health claims?», International Journal of Food Sciences and Nutrition, 63 (S1): 29-36. Disponible en: https://doi.org/10.3109/09637486.2011.653553.
  • Haack, Susan. 2014. Evidence Matters. Science, Proof, and Truth in the Law. Cambridge: Cambridge University Press. Disponible en: https://doi.org/10.1017/CBO9781139626866.
  • Hart, Andy, Jeljer Hoekstra, Helen Owen, Marc Kennedy, Marco J Zeilmaker, Nynke de Jong y Helga Gunnlaugsdottir. 2013. «Qalibra: a general model for food risk-benefit assessment that quantifies variability and uncertainty», Food and Chemical Toxicology, 54: 4-17. Disponible en: https://doi.org/10.1016/j.fct.2012.11.056.
  • Heaney, Robert. 2008. «Nutrients, endpoints, and the problem of proof», Journal of Nutrition, 138: 1591-1595. Disponible en: https://doi.org/10.1093/jn/138.9.1591.
  • Hieke, Sophie y Klaus G. Grunert. 2018. «Consumers and health claims», en Michele J. Sadler (ed.), Foods, Nutrients and Food Ingredients with Authorised EU Health Claims (vol. 3). Amsterdam: Elsevier. Disponible en: https://doi.org/10.1016/B978-0-08-100922-2.00002-4.
  • Jasanoff, Sheila. 1990. The fifth branch: science advisers as policymakers. Cambridge: Harvard University Press.
  • Jasanoff, Sheila. 2005. Designs on Nature: Science and Democracy in Europe and the United States. Princeton, NJ: Princeton University Press. Disponible en: https://doi.org/10.1515/9781400837311.
  • Jukola, Saana. 2019. «On the evidentiary standards for nutrition advice», Studies in History and Philosophy of Biological and Biomedical Science, 73: 1-9. Disponible en: https://doi.org/10.1016/j.shpsc.2018.05.007.
  • Khedkar, Sukhada, Stefanie Bröring y Stefano Ciliberti. 2017. «Exploring the Nutrition and Health claims Regulation (EC) No. 1924/2006: What is the impact on innovation in the EU food sector?», Journal of Food sciences and Nutrition, 68 (1): 10-17. Disponible en: https://doi.org/10.1080/09637486.2016.1212818.
  • Knudsen, Jette S. 2018. «Government regulation of corporate social responsibility: The implications for corporate governance», en Ciaran Driver y Grahame Thomson (eds.), Corporate Governance in Contention. Oxford: Oxford University Press.
  • Lalor, Fiona y Patrick G. Wall. 2011. «Health claims regulations. Comparison between USA, Japan and European Union», British Food Journal, 113 (2): 298-313. Disponible en: https://doi.org/10.1108/00070701111105358.
  • Laudan, Larry. 1984. Science and values. Berkeley: University of California Press.
  • Laudan, Larry. 2004. «The epistemic, the cognitive and the social», en P. Machamer y G. Wolters (eds.), Science, values and objectivity. Pittsburgh: University of Pittsburgh Press.
  • Longino, Helen. 1990. Science as Social Knowledge. Princeton: Princeton University Press.
  • Luján, José L. y José A. López Cerezo. 2004. «De la promoción a la regulación. El conocimiento científico en las políticas públicas de ciencia y tecnología», en José Luis Luján y Javier Echeverría (eds.), Gobernar los riesgos. Ciencia y valores en la sociedad del riesgo. Madrid: Biblioteca Nueva.
  • Luján, José L. y Oliver Todt. 2015. «The role of values in methodological controversies: the case of risk assessment», Philosophia Scientiae, 19 (1): 45-56. Disponible en: https://doi.org/10.4000/philosophiascientiae.1031.
  • Luján, José L. y Oliver Todt. 2018a. «The dilemmas of science for policy», EMBO Reports, 19 (2): 194-196. Disponible en: https://doi.org/10.15252/embr.201744795.
  • Luján, José L. y Oliver Todt. 2018b. «Regulatory Science: between Technology and Society», en Belén Laspra y José Antonio López Cerezo (eds.), Spanish Philosophy of Technology. Cham: Springer.
  • Maggetti, Martino. 2015. «Hard and Soft Governance», en Kennet Lynggaard, Karl Loefgren y Ian Manners (eds.), Research Methods in European Union Studies. Londres: Palgrave Macmillan.
  • Marks, Harry. 2003. «Rigorous uncertainty: Why RA fisher is important», International Journal of Epidemiology, 32: 932-937. Disponible en: https://doi.org/10.1093/ije/dyg288.
  • Martinez, Steve. 2017. «Use of health and nutrition-related claims on new food products in the USA from 1989 to 2010», Agro Food Industry Hi Tech, 28 (2): 43-47.
  • Mitchell, Sandra. 2004. «The prescribed and proscribed values in science policy», en Peter Machamer y Gereon Wolters (eds.), Science, values and objectivity. Pittsburgh: University of Pittsburgh Press.
  • Oberthür, Sebastian. 2019. «Hard or Soft Governance? The EU’s Climate and Energy Policy Framework for 2030», Politics and Governance, 7 (1): 17-27. Disponible en: http://dx.doi.org/10.17645/pag.v7i1.1796.
  • Osimani, Barbara. 2020. «Epistemic gains and epistemic games: Reliability and higher order evidence in medicine and pharmacology», en Adam LaCaze y Barbara Osimani (eds.), Uncertainty in pharmacology. Epistemology, methods, and decisions. Cham: Springer. Disponible en: https://doi.org/10.1007/978-3-030-29179-2_15.
  • Parker, Betty. 2003. «Food for health. The Use of Nutrient Content, Health, and Structure/Function Claims in Food Advertisements», Journal of Advertising, 32 (3): 47-55. Disponible en: https://doi.org/10.1080/00913367.2003.10639135.
  • Radaelli, Claudio M. y Anne C. M. Meuwese. 2010. «Hard Questions, Hard Solutions: Proceduralisation through Impact Assessment in the EU», West European Politics, 33 (1): 136-153. Disponible en: https://doi.org/10.1080/01402380903354189.
  • Rapp, Mark S., Thomas Schmid y Michael Wolff. 2011. «Hard or Soft Regulation of Corporate Governance?», HHL Research Paper Series in Corporate Governance, 6: 1-38. Disponible en: https://dx.doi.org/10.2139/ssrn.1930847.
  • Sánchez, Sylvie y Antonio Casilli. 2008. «Status and use of food products with health claim (FPHC) in the USA, Japan and France: an anthropological perspective», Food Quality and Preference, 19: 682-691. Disponible en: https://doi.org/10.1016/j.foodqual.2008.06.007.
  • Sanz Merino, Noemí. 2020. «La comunicación social de la ciencia a través del etiquetado de alimentos saludables en los EEUU y Europa», Comunicación. Revista Internacional de Comunicación Audiovisual, Publicidad y Estudios Culturales, 1 (18): 66-84. Disponible en: https://doi.org/10.12795/Comunicacion.2020.i18.04.
  • Sanz Merino, Noemí. 2021. «Modelos de evaluación de las declaraciones sobre propiedades saludables en alimentos y su impacto en las comprensión y apropiación públicas de la ciencia», Revista Iberoamericana de Ciencia, Tecnología y Sociedad, 16 (46): 149-166.
  • Shrader-Frechette, Kristin. 2004. «Using Metascience to Improve Dose-Response Curves in Biology: Better Policy Through Better Science», Philosophy of Science, 71: 1026-1037. Disponible en: https://doi.org/10.1086/426772.
  • Shrader-Frechette, Kristin. 2005. «Objectivity and professional duties regarding science and technology», en Wenceslao González (ed.), Science, Technology and Society: A Philosophical Perspective. A Coruña: Netbiblo.
  • Shrader-Frechette, Kristin. 2010. «Conceptual Analysis and Special-interest Science», Synthese, 177: 449-469. Disponible en: https://doi.org/10.1007/s11229-010-9792-5.
  • Steel, Daniel. 2010. «Epistemic values and the argument from inductive risk», Philosophy of Science, 77, 14-34. Disponible en: https://doi.org/10.1086/650206.
  • Stirling, Andrew. 2007. «Risk, Precaution and Science», EMBO reports, 8: 309-315. Disponible en: https://dx.doi.org/10.1038%2Fsj.embor.7400953.
  • Tijhuis, Mariken, Mikko Pohjola, Helga Gunnlaugsdottir, Nikos Kalogeras, O. Leino, Michiel Luteijn, Sveinn Magnússon, Gaby Odekerken, Margherita Poto, Jouni Tuomisto, Øydis Ueland, B. C.White, F. Holm y Hans Verhagen. 2012. «Looking beyond borders: Integrating best practices in benefit-risk analysis into the field of Food and Nutrition», Food and Chemical Toxicology, 50: 77-93. Disponible en: https://doi.org/10.1016/j.fct.2011.11.044.
  • Todt, Oliver y José L. Luján. 2017. «Health Claims and Methodological Controversy in Nutrition Science», Risk Analysis, 37 (5): 958-968. Disponible en: https://doi.org/10.1111/risa.12665.
  • United States Court of Appeals, District of Columbia Circuit (US DC Circuit). 1999. «Durk PEARSON and Sandy Shaw, American Preventive Medical Association and Citizens for Health, Appellants, vs. Donna E. SHALALA, Secretary, United States Department of Health and Human Services, et al.», Appellees, 98-5043, 98-5084 (15 de enero). Disponible en: https://cutt.ly/Ylzvq7K.
  • United States Food and Drug Administration (US-FDA). 1990. Nutrition Labelling and Education Act. Public Law 101-553, 104 Sat. 2353 codified at 21 USC 343 (1993). Disponible en: https://cutt.ly/hlzcbwz.
  • United States Food and Drug Administration (US-FDA). 2003. Consumer health information for better nutrition initiative: Task Force Final Report. Disponible en: https://cutt.ly/nlzcUYb.
  • United States Food and Drug Administration (US-FDA). 2009. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims. Office of Nutrition and Food Labelling. Disponible en: https://cutt.ly/0lzcASk.
  • Wandall, Birgitte. 2004. «Values in Science and Risk Assessment», Toxicology Letters, 152: 265-272. Disponible en: https://doi.org/10.1016/j.toxlet.2004.05.010.
  • Whittaker, Margaret. 2015. «Risk assessment and alternatives assessments», Risk Analysis, 35: 2129-2136. Disponible en: https://doi.org/10.1111/risa.12549.
  • Wilholt, Torsten. 2009. «Bias and values in scientific research», Studies in History and Philosophy of Science, 40: 92-101. Disponible en: https://doi.org/10.1016/j.shpsa.2008.12.005.