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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 ,
Esther Versluis  and
Marjolein B.A. van Asselt
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
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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
Information
European Journal of Risk Regulation , Volume 2 , Issue 1 , March 2011 , pp. 21 - 35
Copyright
Copyright © Cambridge University Press 2011

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References

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

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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>.

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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.

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52 Ibid., p. 50.

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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.

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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>.

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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.