Published online by Cambridge University Press: 20 January 2017
When called upon to regulate risk, the EU carries the threefold onus to (i) protect its people(s); (ii) ensure the functioning of the internal market; and also (iii) to allocate the resources available wisely and efficiently.
This creates a number of pressures and dilemmas for the EU, notably for the Commission when initiating legislation and for the EP and the Council when co-legislating.
According to a familiar script – faithfully narrated by Ragnar Lofstedt in his opening article –, the EU has, in recent years, been subscribing to a progressive ideal of regulation based on evidence. As a result, by making a commitment to the use of optimization tools, such as risk assessment and regulatory impact assessment, the EU has been gradually developing a European risk regulation model that seems to put the EU at the forefront of a wider move towards evidence-based policy-making. Given the historical affection of the EU integration process to technocratic modes of governance, this choice is not surprising.
1 Case T-13/99 Pfizer Animal Health v. Council, 2002 ECR II-3305, para. 201.
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4 Commission Decision 2005/717/EC of 13 October 2005 amending for the purposes of adapting to technical progress the Annex to Directive 2002/95/EC of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment, OJ 2005 L 271, p. 48; Commission Directive 2011/8/EU of 28 January 2011 amending Directive 2002/72/EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles, OJ 2011 L 26/11.
5 Communication from the Commission on the results of the risk evaluation of chlorodifluoromethane, bis(pentabromophenyl)ether and methenamine and on the risk reduction strategy for the substance methenamine, 29 May 2008; EFSA, “EFSA Scientific Opinion on Bisphenol A: evaluation of a study investigating its neurodevelopmental toxicity, review of recent scientific literature on its toxicity and advice on the Danish risk assessment of Bisphenol A”, 8(9) EFSA Journal 2010; p. 1829.
6 Commission Directive 2011/8/EU of 28 January 2011 amending Directive 2002/72/EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles, OJ 2011 L 26/11.
7 See, for instance, Art. 7, para. 1 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, OJ 2003 L 268, p. 1; Art. 17, para. 1 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, OJ 2006 L 404, p. 9; Art. 10, para. 1 and Art. 35, para. 1 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ 2004 L 136, p. 1.
8 Article 11, para. 2, Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC, OJ 2004 L 338, p. 4.
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11 Following the entry into force of the Lisbon treaty, the so-called “Comitology system”, the execution of delegated competence from the Council, has been reformed. In particular comitology was abolished, and the Treaty instead distinguishes between “delegated” acts (Art. 290 TFEU) and “implementing” acts (Art. 291 TFEU), subject to entirely different legal frameworks.