1 The authors are indebted to the referee for critical, useful comments. The considerable revision from an earlier draft is largely inspired by these comments.

2 A good practical definition of its scope is all regulation for Safety, Health, Environment, Investor (and savers’) and Consumer protection (SHEIC), including ‘systemic risks’ in such areas. Note that SHEIC is not exhaustive (e.g. risks connected with terrorism, crime), but this will be ignored here.

3 The terms ‘science’ and ‘scientific knowledge’ are used interchangeably in this contribution.

4 For the definition of EU risk regulation, see section II.

5 Note that we will not delve into the complexity of the use/role of science in policy–making. On this point and in general on the use/misuse of academic knowledge in policy debates see i.a. Frank Heller (ed.) The use and abuse of social science, (Sage, 1986). Julia Hertin et al., “Rationalising the policy mess? Ex ante policy assessment and the utilisation of knowledge in the policy process”, 41 Environment and Planning A (2009), pp. 1185 et sqq.; Henry Lambright, W., “Government and science: a troubled, critical relationship and what can be done about it”, Public Administration Review (2008), pp. 1 et sqq.;Google Scholar Montpetit, Eric, “Scientific credibility, disagreement, and error costs in 17 biotechnology policy subsystems”, 39 Policy Studies Journal (2011), pp. 513 et sqq.CrossRefGoogle Scholar; Schrefler, Lorna, “The usage of scientific knowledge by independent regulatory agencies”, 23 Governance (2010), pp. 309 et sqq.CrossRefGoogle Scholar; Weiss, Carol H., “The many meanings of research utilization”, 39 Public Administration Review (1979), pp. 426 et sqq. Google Scholar 6 This, the authors believe, is best left to the members of the various disciplines that are relevant for EU regulation and policy–making.

6 This, the authors believe, is best left to the members of the various disciplines that are relevant for EU regulation and policy-making.

7 On recent developments in the EU's approach to better/smart regulation, Communication from the Commission: “Smart Regulation in the European Union” COM(2010)543; and Communication from the Commission, “EU Regulatory Fitness”, COM(2012)746. For in depth–analysis of the topic, see i.a. Meuwese, Anne C., Impact Assessment in EU Law–Making, (Alphen aan den Rijn: Kluwer Law International, 2008).Google Scholar

8 The second Barroso mandate runs from 2009 to 2014. For further details, see Speech 09/391 of Jose Manuel Barroso, Passion and responsibility: strengthening Europe in a time of change, European Parliament Plenary, Strasbourg, 15 September (2009), available on the Internet at http://europa.eu/rapid/press-release_SPEECH-09-391_en.htm. Press release on the appointment of the first CSA on December 5, 2011, available on the Internet at: http://europa.eu/rapid/press-release_IP-11-1497_en.htm. The actual appointment of the first CSA (Professor Anne Glover, a biologist) only occurred two years later in December 2011. For further details, see e.g. “EU's overdue chief scientist to be appointed this year”, Nature News Blog, 7 February 2011, available at: http://blogs.nature.com/news/2011/02/eu_gives_itself_three_years_to.html (last accessed September 2014).

9 For one of the few empirical contributions on the topic, see Dovilė Rimkutė and Markus Haverland, “How does the European Commission use scientific expertise? Results from a survey of scientific members of the Commission's expert committees”, Comparative European Politics (2014), available on the Internet at:http://www.palgrave-journals.com/cep/journal/vaop/ncurrent/index.html#27012014.

10 This logic and its implications is set out in Jacques Pelkmans, “The economics of single market regulation”, in Amy Verdun and Alfred Tovias (eds.), Mapping European Economic Integration (Palgrave–Macmillan 2013), pp. 79 et sqq. Google Scholar

11 Quite well captured in the Commission Guidelines on Impact Assessment and relevant annexes. See http://ec.europa.eu/smart-regulation/impact/commission_guidelines/doc/iag_2009_en.pdf. to be revised in 2014.

12 There may be many different circumstances or locations to be investigated (e.g. whether cadmium in phosphate fertilizers is risky depends critically on the type and layers of soil, and this implies great variation), many usages with different dose and/or exposures or distinct conduct (e.g. of workers or consumers) and there might be very complicated human or animal or environmental aspects (e.g. indirect routings of a substance).

13 Breyer, Stephen, Breaking the vicious circle: towards effective risk regulation, (Harvard University Press, 1993), pp. 42 et sqq.Google Scholar One stunning example of his is that two scientifically plausible models for the risk associated with aflatoxin in grain or peanuts may show risk levels differing by a factor of 40,000.

14 Due to space constraints it is impossible here to do justice to the vast body of literature in this area. On science and values in risk assessment, see e.g. Mayo, Deborah G. and Hollander, Rachelle (eds.), “Introduction”, in Acceptable evidence: science and values in risk management, (New York: Oxford University Press, 1991)Google Scholar; Jasanoff, Sheila, Risk management and political culture, (New York: Russell Sage Foundation, 1986)Google Scholar; Jasanoff, Sheila and Wynne, Brian, “Science and decision–making” in Steve Rayner and Elizabeth L. Malone (eds.), Human choices and climate change, vol. 1 : the societal framework (Columbus, Ohio: Batelle Press, 1998), pp. 1 et sqq. Google Scholar; on the precautionary principle see i.a. Majone, Giandomenico, “What price safety? The precautionary principle and its policy implications”, 40 Journal of Common Market Studies (2002), pp. 89 et sqq.CrossRefGoogle Scholar; Taverne, Dick, The march of unreason: science, democracy and the new fundamentalism, (Oxford: Oxford University Press, 2005)Google Scholar; also Stephen Breyer, supra note 13; on establishing a risk assessment policy, see Millstone, Erik, “Science, risk and governance: radical rhetorics and the reality of reform in food safety governance”, 38 Research Policy (2009), pp. 624 et sqq CrossRefGoogle Scholar; on the the framing of risk assessment, see e.g. Stirling, Andy C. and Scoones, Ian, “From risk assessment to knowledge mapping: science, precaution and participation in disease ecology”, 14 Ecology and Society (2009), pp. 1 et sqq.CrossRefGoogle Scholar

15 DG SANCO, ‘Health effects of smokeless tobacco products’, 6 February 2008.

16 For example, snus is not a significant risk factor for cancers such as on kidneys, the bladder, lung, skin and hematopoietic cancers, all candidates in the case of cigarettes.

17 However these conclusions are drawn by putting on par American smokeless tobacco and snus, which is unlikely to be justified. It is also noted that, in Sweden, data does not support the hypothesis that snus is a gateway to initiation of smoking.

18 T. Hellmuth, T, Classen, R. Kim & S. Kephalopoulos, “Methodological guidance for estimating the burden of disease from environmental noise”, (2012) Copenhagen/Geneva/Brussels, WHO (supported by the JRC), http://www.euro.who.int

19 Nomeval study, “Noise of machinery – evaluation of directive 2000/14, 12 December”’ (2007) for DG Enterprise, European Commission.

20 See EFSA Journal, Special issue (2012), on “Scientific achievements, challenges and perspectives of the EFSA”, available on the Internet at http://www.efsa.europa.eu (last accessed September 2014).

21 A broader discussion on the strengths and weaknesses of current EU impact assessment practice falls outside the scope of this article. For recent reflection on this particular point, see e.g. Alemanno, Alberto and Meuwese, Anne. C., “Impact Assessment of EU Non–Legislative Rulemaking: The Missing Link in “New” Comitology”, 19 European Law Journal, pp. 76 et sqq. (2013)CrossRefGoogle Scholar; Renda, Andrea, Law and Economics in the RIA World, (Cambridge: Intersentia, 2011).Google Scholar

22 Further details on the STAC are available on the Internet at: http://ec.europa.eu/commission_2010-2014/president/advisory-council/index_en.htm.

23 See Communication on smart regulation, supra note 7.

24 See for instance Lofstedt, Ragnar E., “Risk versus Hazard – How to Regulate in the 21st Century”, 2 European Journal of Risk Regulation (2011), pp. 149 et sqq CrossRefGoogle Scholar. On the case of impact assessment, see supra note 21.

25 This has been noted elsewhere, see for instance the Minutes of the first STAC meeting available on the Internet at: http://ec.europa.eu/commission_2010-2014/president/pdf/advisory-council/4_-_minutes_meeting_feb_2013.pdf(last accessed September 2014). See also Ragnar Lofstedt, supra note 24.

26 On this point, see supra, note 24.

27 On this point see STAC, “Science for an informed, sustainable and inclusive knowledge society”, and Ortwin Renn, “To be responsive to public needs, we should be sensitive to gut feelings, but should subordinate our policies to them” in BEPA, “Science and Society. Time for a new deal”, 3 Berlaymont Paper (2013), pp. 11 et sqq, available on the Internet at: http://ec.europa.eu/commission_2010-2014/president/advisory-council/documents/berl_papers_issue_3.pdf(last accessed September 2014).

28 In relation to this point, see also a recent quote from CSA Anne Glover: “I believe that it can only be useful to MEPs and ministers, because they would come here with a scientific briefing taking account of issues within all the member states. We would be ahead of the game if Europe organised itself like that” in “EU science advisor ‘Lots of policies are not based on evidence’”, Euractiv, 24 July 2012, available on the Internet at: http://www.euractiv.com/innovation-enterprise/chief-scientifc-adviser-policy-p-interview-514074 (last accessed September 2014).

29 See STAC, supra note 27. On public engagement with science see also Stilgoe, Jack and Wilsdon, James, “The new politics of public engagement with science?” in Richard Holliman et al. (ed.), Investigating science communication in the information age: implications for public engagement and popular media , (Oxford: Oxford University Press, 2008).Google Scholar

30 Note that in the UK the post exists since 1964. On that specific experience and more broadly on the use of scientific advice, see Robert Doubleday and James Wilsdon, “Future directions for scientific advice in Whitehall”, Project Report (London: Alliance for Useful Evidence & Cambridge Centre for Science and Policy, 2013), available on the Internet at: http://sro.sussex.ac.uk/47848/

31 “Evidence–based Union? A new alliance for science advice in Europe”, The Guardian, 24 June 2014, available on the Internet at: http://www.theguardian.com/science/political-science/2014/jun/23/evidence-based-union-a-new-alliance-for-science-advice-in-europe (last accessed September 2014).

32 Interview with Anne Glover, 8 July 2014. 33 The text of the Letter of Intent is available on the Internet at: http://www.easac.eu/fileadmin/PDF_s/Letter_of_intent_final.pdf

33 The text of the Letter of Intent is available on the Internet at: http://www.easac.eu/fileadmin/PDF_s/Letter_of_intent_final.pdf

34 Further detail on EASAC's composition and activities available at: http://www.easac.eu/home.html. Key sectors on which EASAC provides advice to the European Commission are: climate change, agriculture and food security, and public health.

35 As explained in point 4 of the Letter of Intent (see supra, note 33), the two organisations both work in the field of science advice for the EU, but their roles are quite distinct.

36 EASAC-JRC, “Impact of engineered nanomaterials on health: considerations for benefit-risk assessment”, Joint EASAC–JRC Report (2011), available on the Internet at: http://ihcp.jrc.ec.europa.eu/our_activities/nanotechnology/nanoreport-10-11/JRC-EASAC-report.pdf (last accessed September 2014).

37 See the recent reaction of Corporate Europe Observatory, at: http://corporateeurope.org/power-lobbies/2014/07/position-chief-scientific-advisor-president-european-commission

38 In relation to this point see Alemanno and Meuwese, supra note 21.

39 On this point, see also the recent letter of BusinessEurope to President Barroso of 6 June 2014, available on the Internet at: http://www.businesseurope.eu/content/default.asp?PageID=568&DocID=33005 (last accessed September 2014).

40 The Geneva International Risk Governance Council offers an interesting example. See IRGC, Risk governance deficits, Geneva, http://www.irgc.org (2009).

41 See Millstone, Erik, “Science, risk and governance: radical rhetorics and the reality of reform in food safety governance”, 38 Research Policy (2009), pp. 624 et sqq.CrossRefGoogle Scholar