Regulating the use of Bisphenol A in baby and children's products in the European union: Current developments and scenarios for the regulatory future

European Journal of Risk Regulation

Volumn 2, Issue 1, 2011, Pages 21-35

  Fox, Tessa ^a   Versluis, Esther ^a   van Asselt, Marjolein B A ^a  

^a MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84893343955     PISSN: 1867299X     EISSN: 21908249     Source Type: Journal    
DOI: 10.1017/S1867299X00000593     Document Type: Article

References (86)

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2. Jennifer Ward Barber, "Why the Food Industry is Fighting for BPA", May 2010, available on the Internet at (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 (last accessed on 2 August 2010).
4. Sarah A. Vogel, "The Politics of Plastics: The Making and Unmaking of BPA Safety", 99 American Journal of Public Health (2009), pp. 559 et sqq.
5. EPA, "Bisphenol A CASNR 80-05" 2006-2008, available on the Internet at (last accessed on 2 August 2010)
6. FDA, "Bisphenol A and Phthalates", 2007, available on the Internet at (last accessed on 10 August 2010)
7. National Toxicology Programme, "The evaluation of risks to human reproduction", Expert panel evaluation of BPA August 2007, available on the Internet at (last accessed on 2 August 2010).
8. VWA, "Bisphenol A in babyflesjes" (2006), available on the Internet at (last accessed on August 2010)
9. 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 (last accessed on 2 August 2010)
10. FSA (UK), "Risk Assessment of BPA Update", July 2010, available on the Internet at (last accessed on 14 August 2010).
11. 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 (last accessed on 10 August 2010).
12. Available on the Internet at .
13. See Table 1, selection of headlines
14. Jenny Kitzinger, "Researching Risk and the Media", 1 Health, Risk and Society (1999), pp. 55 et sqq.
15. Giandomenico Majone, "Foundations of Risk Regulation: Science, Decision-making, Policy Learning and Institutional Reform, 1 European Journal of Risk Regulation (2010), pp. 5 et sqq.
16. Nick Pidgeon, Roger. E. Kasperson and Paul Slovic, The Social Amplification of Risk (UK: Cambridge University Press, 2003).
17. References made to interviews will be numbered (# 1, #2 etc). The respondents list is anonymous.
18. Health Canada, "Government of Canada takes action on another chemical of concern: BPA", 2008, available on the Internet at (last accessed on 2 August 2010)
19. Frederick vom Saal and J.P. Myers, "Bisphenol A and Risk of Metabolic Disorders", 300 JAMA (2008), pp. 1353 et sqq.
20. Babyplaza, "Het gebruik van Bisphenol A in babyflessen", 2010, available on the Internet at (last accessed on 2 August 2010).
21. E.C. Dodds and W. Lawson, 139 NATURE (1937), pp. 627 et sqq.
22. Poul Harremoës, D. Gee, M. MacGarvin et al., The precautionary principle in the 20th century: Late lessons from early warnings (London: Earthscan, 2002)
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24. Roberta J. Apfel and Susan M. Fisher, To do no harm: DES and the dilemmas of modern medicine (New Haven: Yale University Press, 1984)
25. SA. Ferguson, "Effects on brain and behavior caused by developmental exposure to endocrine disrupters with estrogenic effects", 1 Neurotoxicol Teratol (2002), pp. 1 et sqq.
26. Britt E. Erickson, "Bisphenol A under scrutiny", 86 Chemical and Engineering News (American Chemical Society 2008), pp. 36 et sqq.
27. R.J. Witorsch, "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. 906.
28. P. Goettlich, Various contributions to Mindfully.org, 2006-2010, available on the Internet at (last accessed on 10 August 2010), at p. 8.
29. T.J. Murray, M.V. Maffini, A.A Ucci 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.
30. R. Carr, F. Bertasi, A. Betancourt 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.
31. S. Honma, A. Suzuki, D.L. Buchanan 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.
32. T. Negishi, K. Kawasaki, S. Suzaki 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.
33. Frederick vom Saal, S.C. Nagel, B.G. Timms 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.
34. Frederick vom Saal and C. Hughes, "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.
35. G.M. Gray, J.T. Cohen, G. Cunha 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.
36. [3#] Interview with members of Bureau REACH
37. [4#] Interview with NGO representatives working on chemical substances in the EU
38. James C. Lamb, "Why you should ignore the babybottle scare", 2002, available on the Internet at
39. C. Kubwabo, I. Kosarac and B. Stewart, "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.
40. Laura N. Vandenberg, Russ Hauser, Michele Marcus et al., "Human Exposure to BPA", 24 Reproductive Toxicology (2007), pp. 139 et sqq.
41. Katrina Mountfort, Janet Kelly, Sue M. Jickells 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.
42. [1#] Interview with senior policy advisor and former Members of the ECHA Management Board
43. [5#] Interview with expert risk assessment panel member Food and Safety Authority, the NL
44. [2#] Interview with Professors in chemical engineering at Dutch Universities
45. Stephen H. Safe, Lea Pallaroni, Kyungsil Yoon et al., "Problems for Risk Assessment of Endocrine Active Estrogenic Compounds", 110 Health Perspectives (2002), pp. 925 et sqq.
46. 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
47. ECB (2008), European Union Risk Assessment Report Draft: Updated Risk Assessment of 4,4'-isopropylidenediphenol (Bisphenol A) (CAS No. 80-05-7
48. EINECS No. 201-245-8), European Commission, European Chemicals Bureau, Existing Substances, available on the Internet at .
49. 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
50. The studies they refer to include: Negishi et al. (2004), Carr et al. (2003), Ryan and Vandenberg (2006), Adriani (2003).
51. EJRC, "Bisphenol A and baby bottles: Challenges and Perspectives" (2010), available on the Internet at .
52. Marjolein B.A. van Asselt and Ellen Vos, "The Precautionary Principle and the Uncertainty Paradox", 8 Journal of Risk Research (2006), pp. 313 et sqq.
53. O. Renn, "Risk Governance: Towards an Integrative Approach", IRGC White Paper 1 (Geneva, Switzerland: International Risk Governance Council (IRGC), 2006).
54. Esther Versluis, Marjolein B.A. van Asselt, Tessa Fox et al., "Calculable Risks? An Analysis of the Seveso Regime", Journal of hazardous materials (forthcoming).
55. Martin Krayer von Kraus, "Uncertainty in Policy Relevant Sciences" (PhD thesis on file at the Technical University of Denmark, 2005)
56. Marjolein B.A. van Asselt, Perspectives on Uncertainty and Risk: The PRIMA Approach to Decision Support (Dordrecht, The Netherlands: Kluwer Academic Publishers, 2000).
57. O. Renn and Karen Walker, Global Risk Governance: Concept and Practice Using the IRGC Framework (NL: Springer, 2008).
58. 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
59. 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
60. 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" (Rhys Dogana, "Comitology: Little Procedures with Big Implications", 20 West European Politics (1997), pp. 31 et sqq.).
61. This does not only apply to the chemical sector, but on a more general note for regulatory regimes on risk (see Sheila Jasanoff, Designs on Nature: Science and Democracy in Europe and the United States (USA, Princeton University Press, 2005) and Esther Versluis, Enforcement Matters. Enforcement and Compliance of the European Directives in Four Member States (Delft: Eburon, 2003)).
62. 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
63. U. Heudorf, V. Mersch-Sundermann and J. Angerer, "Phthalates: Toxicology and Exposure", 5 Int J Hyg Environ Health (2007), pp. 623 et sqq.
64. S. Sathyanarayana, C.J. Karr, P. Lozano et al., "Baby Care Products: Possible Sources of Infant Phthalate Exposure"
65. Pediatrics (2008), pp. 260 et sqq., available on the Internet at .
66. EU Commission IP/99/829 (1999), p. 2, available on the Internet at .
67. [1#] Interview with former members of the ECHA Management Board
68. [4#] Interview with NGO representatives working on chemical substances in the EU
69. [3#] Interview with members of Bureau REACH
70. [4#] Interview with NGO representatives working on chemical substances in the EU
71. FDA, "FDA's current Perspective on BPA", 2010, available on the Internet at .
72. Alberto Alemanno, "The Fabulous Destiny of Bisphenol A", 4 European Journal of Risk Regulation (2010), pp. 397-400.
73. EFSA, "EFSA considers more than 800 studies on BPA, to finalise opinion in September", Press release 2010, available on the Internet at .
74. This paragraph refers to the "general feeling" prior to 25/26 November 2010 when BPA was banned in a Commission decision
75. 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
76. 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 (last accessed on 2 August 2010).
77. This procedure is in line with the current nomination of the various types of phthalates (DINP, DEHP and DBP) under REACH
78. 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
79. BFR (Bundesinstitut für Risikobewertung), "BPA", 2010, available on the Internet at .
80. Anthony Giddens, Modernity and Self-Identity: Self and Society in the Late Modern Age (UK: Cambridge Polity Press, 1991), at p. 29.
81. Marjolein B.A. van Asselt, Susan A. van't Klooster, Philip W.F. van Notten et al., Foresight in Action. Developing policy oriented scenarios (UK: Earthscan, 2010).
82. Michael D. Rogers, "Scientific and Technological Uncertainty: The Precautionary Principle, Scenarios and Risk Management", 4 JRR (2001), pp. 1 et sqq.
83. 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.
84. Various newsreports: EC in the UK, "Chemical to be banned in the use of baby bottles" (2010), available on the Internet at .
85. EFSA, "Bisphenol A", 2010, available on the Internet at .
86. Various news sources: "Food Production Daily, EU to ban BPA in baby bottles" (2010), available on the Internet at .