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Regulating the Use of Bisphenol A in Baby and Children's Products in the European Union: Current Developments and Scenarios for the Regulatory Future

Published online by Cambridge University Press:  20 January 2017

Tessa Fox
Affiliation:
PhD Candidate at Maastricht University, The Netherlands. Contact details: .
Esther Versluis
Affiliation:
at Maastricht University
Marjolein B.A. van Asselt
Affiliation:
in Risk Governance at the same university

Extract

Parents of newborns and small children have recently been confronted with labels indicating that their purchases of a baby bottle, teethers or sippy cups are now ‘Bisphenol A-free’ (BPA). A synthetic chemical used in the production process of polycarbonate (plastics), Bisphenol A is currently making headline news in the US and the EU. Its questioned safety in food plastics, baby bottles and children's toys has turned plastics into a political issue as it is systematically framed as a risk in media coverage.

Apart from regulatory exposure limits (Tolerable Daily Intake levels (TDI), Bisphenol A is currently not subject to any restrictions in use yet (although BPA will be subject to a ban on the EU level from spring 2011 onwards). However, with the REACH framework (Registration, Evaluation, Authorisation of Chemicals), a new regulatory framework for EU's chemical policy in place since June 2007, these exposure limits may be reviewed and BPA may face regulatory action. This article aims to analyse the regulatory process of Bisphenol A in the EU as an example of an uncertain risk dossier. On the basis of document and media analysis and interviews, the main aim is to gain an understanding of how uncertain risks are being regulated in the European Union. To that end, the self-regulatory behavior of industry is also considered. On the basis of the current regulatory tools in place and the current state of affairs, as well as developments in the controversy around BPA, the paper concludes by presenting four scenarios that illustrate the dynamics of the case and its possible regulatory outcomes.

Type
Articles
Copyright
Copyright © Cambridge University Press 2011

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References

1 “BPA”, 2010, available on the Internet at <http://www.bisphenola.org>.

2 Jennifer Ward Barber, “Why the Food Industry is Fighting for BPA”, 4 May 2010, available on the Internet at <http://www.theatlantic.com/science/archive/2010/05/why-the-food-industry-is-fighting-for-bpa/56098/> (last accessed on 2 August 2010).

3 William Lozito, “Product Naming: Is BPA Free the new Buzzword for Babies”, 23 April 2007, available on the Internet at <http://www.namedevelopment.com/blog/archives/2007/04/product_naming_5.html> (last accessed on 2 August 2010).

4 Vogel, Sarah A., “The Politics of Plastics: The Making and Unmaking of BPA Safety”, 99 American Journal of Public Health (2009), pp. 559 et sqq CrossRefGoogle ScholarPubMed.

5 EPA, “Bisphenol A CASNR 80-05” 2006–2008, available on the Internet at <http://www.epa.gov/iris/subst/0356.htm> (last accessed on 2 August 2010); FDA, “Bisphenol A and Phthalates”, 2007, available on the Internet at <http://www.fda.gov/Food/Food-IngredientsPackaging/ucm166145.htm> (last accessed on 10 August 2010); National Toxicology Programme, “The evaluation of risks to human reproduction”, Expert panel evaluation of BPA August 2007, available on the Internet at <http://ntp.niehs.nih.gov/> (last accessed on 2 August 2010).

6 VWA, “Bisphenol A in babyflesjes” (2006), available on the Internet at <http://www.vwa.nl/onderwerpen/levensmiddelen-food/dossier/babyvoeding/nieuwsoverzicht/nieuwsbericht/23763/geen-aan-toonbare-afgifte-van-bisfenol-a-in-babyflesjes> (last accessed on 10 August 2010); Danish Ministry of Food and Agriculture, “Danish ban on BPA in materials in contact with food for children age 0–3”, 26 April 2010, available on the Internet at <http://www.fvm.dk/Default.aspx?ID=18488&PID=168823&NewsID=6014> (last accessed on 2 August 2010); FSA (UK), “Risk Assessment of BPA Update”, July 2010, available on the Internet at <http://www.food.gov.uk/foodlabelling/packagingbranch/foodcontactmaterialsbpa/> (last accessed on 14 August 2010).

7 EFSA, “Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to 2, 2-EFSA J. 2006”, 2006, available on the Internet at <http://www.efsa.europa.eu/en/scdocs/doc/428.pdf> (last accessed on 10 August 2010).

9 See Table 1, selection of headlines.

10 Kitzinger, Jenny, “Researching Risk and the Media”, 1 Health, Risk and Society (1999), pp. 55 et sqq. CrossRefGoogle Scholar; Majone, Giandomenico, “Foundations of Risk Regulation: Science, Decision-making, Policy Learning and Institutional Reform, 1 European Journal of Risk Regulation (2010), pp. 5 et sqq. CrossRefGoogle Scholar; Pidgeon, Nick, Kasperson, Roger. E. and Slovic, Paul, The Social Amplification of Risk (UK: Cambridge University Press, 2003)CrossRefGoogle Scholar.

11 References made to interviews will be numbered (# 1, #2 etc). The respondents list is anonymous.

12 EPA, “Bisphenol A CASNR 80-05” 2006–2008, supra note 5; VWA, “BPA in Babyflesjes”, supra note 6; Danish Ministry of Food and Agriculture, “Danish ban on BPA in materials in contact with food for children age 0–3”, supra note 6.

13 Health Canada, “Government of Canada takes action on another chemical of concern: BPA”, 2008, available on the Internet at <http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2008/2008_59-eng.php> (last accessed on 2 August 2010); Saal, Frederick vom and Myers, J.P., “Bisphenol A and Risk of Metabolic Disorders”, 300 JAMA (2008), pp. 1353 et sqq.CrossRefGoogle Scholar

14 Babyplaza, “Het gebruik van Bisphenol A in babyflessen”, 2010, available on the Internet at <http://babyplaza.be/> (last accessed on 2 August 2010).

15 Dodds, E.C. and Lawson, W., 139 NATURE (1937), pp. 627 et sqq CrossRefGoogle Scholar.

16 Harremoe¨s, Poul, Gee, D., MacGarvin, M. et al., The precautionary principle in the 20th century: Late lessons from early warnings (London: Earthscan, 2002)Google Scholar; Meyers, Robert, D.E.S. – The bitter pill (New York: Seaview/Putnam, 1983)Google Scholar; Apfel, Roberta J. and Fisher, Susan M., To do no harm: DES and the dilemmas of modern medicine (New Haven: Yale University Press, 1984)Google Scholar; Ferguson, SA., “Effects on brain and behavior caused by developmental exposure to endocrine disrupters with estrogenic effects”, 1 Neurotoxicol Teratol (2002), pp. 1 et sqq Google Scholar.

17 Erickson, Britt E., “Bisphenol A under scrutiny”, 86 Chemical and Engineering News (American Chemical Society 2008), pp. 36 et sqq Google Scholar.

18 Witorsch, R.J., “Low-dose in utero effects of xenoestrogens in mice and their relevance to humans: an analytical review of the literature”, 40 Food Chem Toxicol (2002), pp. 905 et sqq., at p. 906CrossRefGoogle ScholarPubMed.

19 P. Goettlich, Various contributions to Mindfully.org, 2006–2010, available on the Internet at <http://www.mindfully.org> (last accessed on 10 August 2010), at p. 8.

20 Sarah A. Vogel, “The Politics of Plastics”, supra note 4.

21 Sarah A. Vogel, “The Politics of Plastics”, supra note 4.

22 Frederick vom Saal and J.P. Myers, “Bisphenol A and Risk of Metabolic Disorders”, supra note 13.

23 T.J., Murray, Maffini, M.V., Ucci, A.A et al., “Induction of mammary gland ductal hyperplasias and carcinoma in situ following fetal bisphenol A exposure”, 3 Reprod Toxicol (2007), pp. 383 et sqq Google Scholar.

24 Carr, R., Bertasi, F., Betancourt, A. et al., “Effect of neonatal rat Bisphenol A exposureon performance in the Morris water maze”, A Journal of Toxicology and Environmental Health (2003), pp. 2077 et sqq.CrossRefGoogle Scholar; Honma, S., Suzuki, A., Buchanan, D.L. et al., “Low dose effect of in utero exposure to bisphenol A and diethylstilbestrol on female mouse reproduction”, 16 Reprod Toxicol (2002), pp. 117 et sqq. CrossRefGoogle ScholarPubMed; Negishi, T., Kawasaki, K., Suzaki, S. et al., “Behavioral alterations in response to fear-provoking stimuli and tranylcypromine induced by perinatal exposure to bisphenol A and nonylphenol in male rats”, 112 Environ. Health Perspect (2004), pp. 159 et sqq. CrossRefGoogle ScholarPubMed; Saal, Frederick vom, Nagel, S.C., Timms, B.G. et al., “Implications for human health of the extensive bisphenol A literature showing adverse effects at low doses: A response to attempts to mislead the public”, 2 Toxicology (2005), pp. 244 et sqq. CrossRefGoogle Scholar; Saal, Frederick vom and Hughes, C., “An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment”, 2 Environ. Health Perspect (2005), pp. 926 et sqq CrossRefGoogle Scholar.

25 Ibid., p. 24.

26 Gray, G.M., Cohen, J.T., Cunha, G. et al., “Weight of the evidence evaluation of low-dose reproductive and developmental effects of bisphenol A”, 10 Hum Ecol Risk Assess. (2004), pp. 875 et sqq CrossRefGoogle Scholar.

27 #3 Interview with members of Bureau REACH; #4 Interview with NGO representatives working on chemical substances in the EU.

28 James C. Lamb, “Why you should ignore the babybottle scare”, 2002, available on the Internet at <http://www.quackwatch.org/04ConsumerEducation/babybottle.html>; Kubwabo, C., Kosarac, I. and Stewart, B., “Migration of BPA from plastic baby bottles, baby bottle liners and reusable polycarbonate drinking bottles”, 26 Food Additives and Contaminant (2009), pp. 928 et sqq. CrossRefGoogle Scholar; Saal, Frederick vom, Nagel, S.C., Timms, B.G. et al., “Implications for human health of the extensive bisphenol A literature showing adverse effects at low doses”, supra note 24, pp. 244 et sqq Google Scholar.

29 Vandenberg, Laura N., Hauser, Russ, Marcus, Michele et al., “Human Exposure to BPA”, 24 Reproductive Toxicology (2007), pp. 139 et sqq CrossRefGoogle ScholarPubMed.; Mountfort, Katrina, Kelly, Janet, Jickells, Sue M. et al., “Investigations into the potential degradation of polycarbonate baby bottles during sterilization with consequent release of BPA”, 14 Food Additives and Contaminants (1997), pp. 737 et sqq CrossRefGoogle Scholar.

30 #1 Interview with senior policy advisor and former Members of the ECHA Management Board; #5 Interview with expert risk assessment panel member Food and Safety Authority, the NL.

31 #2 Interview with Professors in chemical engineering at Dutch Universities.

32 Safe, Stephen H., Pallaroni, Lea, Yoon, Kyungsil et al., “Problems for Risk Assessment of Endocrine Active Estrogenic Compounds”, 110 Health Perspectives (2002), pp. 925 et sqq CrossRefGoogle ScholarPubMed.

33 Sarah A. Vogel, “The Politics of Plastics”, supra note 4; S. Honma et al., “Low dose effect of in utero exposure to bisphenol A”, supra note 24; T. Negishi, K. Kawasaki, S. Suzaki et al., “Behavioral alterations by exposure to BPA”, supra note 24.

34 G.M. Gray, J.T. Cohen, G. Cunha et al., “Weight of the evidence evaluation”, supra note 26.

35 Both reports taken together, ECB (2003), European Union Risk Assessment Report of 4,4'-isopropylidenediphenol (Bisphenol-A) (CAS No: 80-05-7), Institute for Health and Consumer Protection, European Chemicals Bureau, European Commission Joint Research Centre, 3rd Priority List (Luxembourg: Office for Official Publications of the European Communities, EUR 20843 EN), available on the Internet at <http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=ora>; ECB (2008), European Union Risk Assessment Report Draft: Updated Risk Assessment of 4,4'-isopropylidenediphenol (Bisphenol A) (CAS No. 80-05-7; EINECS No. 201-245-8), European Commission, European Chemicals Bureau, Existing Substances, available on the Internet at <http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=ora>.

36 Consistency assessment refers to whether a specific test can be repeated and is considered to be significant by EFSA to identify possible patterns that would underline the presence of a risk.

37 Ibid., p. 35.

38 The studies they refer to include: Negishi et al. (2004), Carr et al. (2003), Ryan and Vandenberg (2006), Adriani (2003).

39 ECB, Risk Assessment Report 2008, supra note 35, at p. 120.

40 EJRC, “Bisphenol A and baby bottles: Challenges and Perspectives” (2010), available on the Internet at <http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/14221/1/eur%2024389_bpa%20%20baby%20bottles_chall%20%20persp%20(2).pdf>.

41 van Asselt, Marjolein B.A. and Vos, Ellen, “The Precautionary Principle and the Uncertainty Paradox”, 8 Journal of Risk Research (2006), pp. 313 et sqq CrossRefGoogle Scholar.

42 O. Renn, “Risk Governance: Towards an Integrative Approach”, IRGC White Paper 1 (Geneva, Switzerland: International Risk Governance Council (IRGC), 2006).

43 Esther Versluis, Marjolein B.A. van Asselt, Tessa Fox et al., “Calculable Risks? An Analysis of the Seveso Regime”, Journal of hazardous materials (forthcoming).

44 Wynne, Brian, “Creating Public Alienation: Expert Cultures of Risk and Ethics”, 4 Science as Culture (2001), pp. 445 et sqq. CrossRefGoogle Scholar; WRR, “Onzekere Veiligheid. Verantwoordelijkheden rond fysieke veiligheid” (NL: Amsterdam University Press, 2008, available in English, “Uncertain Safety”); Lofstedt, Ragnar. E., Risk Management in Post-Trust Societies (USA: Palgrave Macmillan, 2005)CrossRefGoogle Scholar; Gezondheidsraad, “Voorzorg met rede” (Den Haag: Gezondheidsraad, 2008, publication no. 2008/18, available in English, Health Council of the Netherlands, “Prudent Precaution” (The Hague: Health Council of the Netherlands, 2008; publication no. 2008/18)); O. Renn, “Risk Governance”, supra note 42.

45 Martin Krayer von Kraus, “Uncertainty in Policy Relevant Sciences” (PhD thesis on file at the Technical University of Denmark, 2005); van Asselt, Marjolein B.A., Perspectives on Uncertainty and Risk: The PRIMA Approach to Decision Support (Dordrecht, The Netherlands: Kluwer Academic Publishers, 2000)CrossRefGoogle Scholar.

46 Ibid., p. 43.

47 WRR, “Onzekere Veiligheid”, supra note 44.

48 Renn, O. and Walker, Karen, Global Risk Governance: Concept and Practice Using the IRGC Framework (NL: Springer, 2008)CrossRefGoogle Scholar.

49 Freshfield Bruckhaus Deringer describes the influence on China and the Asian region, whereas Majone sheds light on the consequences for the US and Bowman looks at the global implications.

50 Giandomenico Majone, “Foundations of Risk Regulation”, supra note 10, pp. 5 et sqq.; Freshfields Bruckhaus Deringer, “Food Safety Update: BPA” (March 2010), available on the Internet at <http://www.fvm.dk/Default.aspx?ID=18488&PID=168823&NewsID=6014>; Bowman, Diana and Calster, Geert van, “Reflecting on REACH: Global Implications of the European Union's Chemical Regulation”, 375 Nanotech & le Bus (2007), available on the Internet at <http://heinonline.org/HOL/LandingPage?collection=journals&handle=hein.journals/nantechlb4&div=47&id=&page=>Google Scholar.

51 Commission Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Official Journal of the European Union L 396 of 30 December 2006.

52 Ibid., p. 50.

53 The term ‘comitology’ relates to “the procedures by which the Commission makes decisions about the implementation of European Union (EU) legislation in collaboration with committees of national experts. These committees of national experts, usually civil servants from the national administrations, assist and advise the Commission on a wide variety of matters related to the implementation of individual pieces of Union legislation” ( Dogana, Rhys, “Comitology: Little Procedures with Big Implications”, 20 West European Politics (1997), pp. 31 et sqq. CrossRefGoogle Scholar).

54 Ibid., p. 50.

55 Giandomenico Majone, “Foundations of Risk Regulation”, supra note 10, pp. 5 et sqq.; Wiener, Jonathan B., Rogers, Michael D. and Sand, Peter H., The Reality of Precaution: Comparing Risk Regulation in the US and the EU (US: Stylus Publishing, 2010)Google Scholar.

56 This does not only apply to the chemical sector, but on a more general note for regulatory regimes on risk (see Jasanoff, Sheila, Designs on Nature: Science and Democracy in Europe and the United States (USA, Princeton University Press, 2005)CrossRefGoogle Scholar and Versluis, Esther, Enforcement Matters. Enforcement and Compliance of the European Directives in Four Member States (Delft: Eburon, 2003)Google Scholar).

57 [1] Phthalates have the purpose to soften the polyvinyl chloride in products and facilitate the molecules to slide next to each other in the production process.

58 Heudorf, U., Mersch-Sundermann, V. and Angerer, J., “Phthalates: Toxicology and Exposure”, 5 Int J Hyg Environ Health (2007), pp. 623 et sqq. CrossRefGoogle Scholar; Sathyanarayana, S., Karr, C.J., Lozano, P. et al., “Baby Care Products: Possible Sources of Infant Phthalate Exposure”, 2 Pediatrics (2008), pp. 260 et sqq., available on the Internet at <http://pediatrics.aappublications.org/cgi/content/full/121/2/e260>CrossRefGoogle Scholar.

60 #1 Interview with former members of the ECHA Management Board; #4 Interview with NGO representatives working on chemical substances in the EU.

61 #3 Interview with members of Bureau REACH; #4 Interview with NGO representatives working on chemical substances in the EU.

62 FDA, “FDA's current Perspective on BPA”, 2010, available on the Internet at <http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm197739.htm#current>.

63 ECB, European Risk Assessment Report, supra note 35.

64 ECB, European Risk Assessment Report, supra note 35.

65 Alemanno, Alberto, “The Fabulous Destiny of Bisphenol A”, 4 European Journal of Risk Regulation (2010), pp. 397400 CrossRefGoogle Scholar.

66 EFSA, “EFSA considers more than 800 studies on BPA, to finalise opinion in September”, Press release 2010, available on the Internet at <http://www.efsa.europa.eu/en/press/news/cef20100713.htm>.

67 This paragraph refers to the “general feeling” prior to 25/26 November 2010 when BPA was banned in a Commission decision.

68 Commission Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Official Journal of the European Union L 396 of 30 December 2006.

69 Danish Ministry of Food and Agriculture, “Danish ban on BPA in materials in contact with food for children age 0–3”, 26 April 2010, available on the Internet at <http://www.fvm.dk/Default.aspx?ID=18488&PID=168823&NewsID=6014> (last accessed on 2 August 2010).

70 ECB, Risk Assessment report, supra note 35.

71 This procedure is in line with the current nomination of the various types of phthalates (DINP, DEHP and DBP) under REACH.

72 Only in the US are there any restrictions posed at state level (in California and Missouri). Canada is the first country worldwide that has imposed restrictions on the use and import of BPA

73 BFR (Bundesinstitut für Risikobewertung), “BPA”, 2010, available on the Internet at <http://www.bfr.bund.de/cd/template/index>.

74 Giddens, Anthony, Modernity and Self-Identity: Self and Society in the Late Modern Age (UK: Cambridge Polity Press, 1991), at p. 29 Google Scholar.

75 van Asselt, Marjolein B.A., van 't Klooster, Susan A., van Notten, Philip W.F. et al., Foresight in Action. Developing policy oriented scenarios (UK: Earthscan, 2010)Google Scholar.

76 Rogers, Michael D., “Scientific and Technological Uncertainty: The Precautionary Principle, Scenarios and Risk Management”, 4 JRR (2001), pp. 1 et sqq.CrossRefGoogle Scholar

77 Susan A. van 't Klooster, “Toekomstverkenning: Ambities en de praktijk” (PhD Thesis on file at Maastricht University, 2007); Marjolein B.A. van Asselt, Susan A. van 't Klooster, Philip W.F van Notten et al., “Foresight in Action”, supra note 75.

78 These scenarios were developed prior to the acceptance date of this article, and prior to the release of the EFSA advice in September 2010. The EFSA advice has been released and the EU Commission has announced its plans to ban BPA by summer 2011. However, these scenarios are still useful in order to understand and define the situation that presented itself on November 26, 2010. Furthermore, it will help us to look into possible futures since the BPA ban is not in place yet.

79 Various newsreports: EC in the UK, “Chemical to be banned in the use of baby bottles” (2010), available on the Internet at <http://ec.europa.eu/unitedkingdom/press/frontpage/2010/1005_en.htm>.

80 EFSA, “Bisphenol A”, 2010, available on the Internet at <http://www.efsa.europa.eu/en/ceftopics/topic/bisphenol.htm>.

81 Various news sources: “Food Production Daily, EU to ban BPA in baby bottles” (2010), available on the Internet at <http://www.foodproductiondaily.com/Quality-Safety/EU-to-ban-bisphenol-A-in-baby-bottles>.

82 Ibid., p. 80.

83 Ibid., p. 80.

84 Ibid., pp. 78, 79, 80.

85 Ibid., pp. 78, 79, 80.