Abstract
This chapter examines how the European Union is addressing the challenges brought about by the emergence of a “risk society.” After reconstructing the genesis and evolution of EU risk regulations, i.e. regulations aimed at the protection of health, safety, and the environment, it identifies the main features of the EU approach towards risk. Although the EU institutions have not adopted a harmonized and consistent analytical approach to risk, notably to scientific risk assessment—given that it is conducted by different bodies following diverging methods—it is possible to discern some common and distinctive features in the risk analysis framework that has been gradually adopted to manage an ever-wider range of societal risks (such as food safety, chemicals, pharmaceuticals, medical devices, crop protection, and GMOs). The chapter argues that, by subscribing to a progressive ideal of regulation based on expertise, an embryonic European risk regulation model is taking shape and developing today. Yet a tension between the necessity for a rational, evidence-based decision-making and the wider demand for a flexible, precautionary-oriented regulatory approach represents the defining feature of the EU decision-making paradigm of risk regulation.
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Notes
- 1.
In the long list of food safety crises and scandals of that time appear olive oil, contaminated wine, E. coli, Listeria, Salmonella, polluted drinking water, animal feed, pesticides, etc.
- 2.
Before the Single European Act, one of the main avenues for Community intervention was Article 100 (current Article 115) of the original Treaty of Rome, which allows the EC institutions to adopt directives aimed at harmonizing national provisions that “directly affect the establishment or functioning of the common market” (note that this Article reads: “The Council shall, acting unanimously on a proposal from the Commission and after consulting the European Parliament and the Economic and Social Committee, issue directives for the approximation of such laws, regulations or administrative provisions of the Member States as directly affect the establishment or functioning of the common market”).
- 3.
Article 114 TFEU.
- 4.
See Commission Communication of 30 April 1997 on consumer health and food safety defining risk analysis as being “a systematic procedure comprising the scientific evaluation of hazards and the probability of their emergence in a given context (risk assessment), the assessment of all measures making it possible to achieve an appropriate level of protection (risk management), and the exchange of information with all the parties concerned: decision-makers, inspectors, consumers and producers in order to explain the reasons and to justify the management measures proposed (risk communication).”
- 5.
One of the earliest and most explicit recognition of such an analytical tool for regulation risk may be found in EFTA Court of 5 April 2001, Case E-3/00 Efta Surveillance Authority v Norway [2001] EFTA Court Report 2000/2001, 73, p. 30.
- 6.
In particular, the distinction between risk assessment and risk management has been originally conceived by William Lowrance, Of Acceptable Risk: Science and the Determination of Safety, William Kaufmann, 1976. It has been codified in 1983 with the publication of Risk Assessment in the Federal Government: Managing the Process (also called the Red Book), a study that sought “institutional mechanisms that best foster a constructive partnership between science and government.” Subsequently, this distinction played a crucial role in the development of an organizational separation of risk assessment and risk management in many US regulatory agencies.
- 7.
Notable exceptions are the Community Plant Variety office and the European Aviation Safety which have been delegated authority to adopt final determinations in narrow technical.
- 8.
Explicit references to risk analysis can be found, for example, in Communication of 30 April 1997 on consumer health and food safety, COM(97) 183 final, p. 20; European Commission, First report on the Harmonization of Risk Assessment Procedures, 2000; Commission Communication on the precautionary principle, COM (2000) 1 and in Common Position (EC) No 2/2002 of 17 September 2001.
- 9.
Opinion of Advocate General Mischo in Case 192/01 Commission v Denmark [2003] ECR 9693, paragraph 143.
- 10.
Ibidem, paragraph 89.
- 11.
As effectively put it by Joerges, “to what degree should, could, or does ‘expertise’ replace legal, political and ethical criteria?,” see C. Joerges, Law, Science and the Management of Risks to Health at the National, European and International Level – Stories on Baby Dummies, Mad Cows and Hormones in Beef, in 7 Columb. Journal of European Law 1 (2001).
- 12.
National Research Council (NRC), Risk Assessment in the Federal Government: Managing the Process, Washington, D.C.: National Academy Press, 1983, p. 4.
- 13.
While Article 28 (current Article 34 TFEU) prohibits Member States adopting quantitative restrictions on imports and all measures having an equivalent effect to a quantitative restriction, Article 30 (current Article 36 TFEU) “shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archeological value; or the protection of industrial and commercial property.”
- 14.
Case C-212/91 Angelopharm v. Hambourg, [1994] ECR 17, paragraph 31.
- 15.
Framework Directive 89/391/EEC on the introduction of measures to encourage the improvements in the safety and health of workers at work. This Directive is indeed a framework, with “general principles concerning the prevention of occupational risks… as well as general guidelines for the implementation of the said principles” (Art. 1.2.). It makes employers responsible for ensuring the safety and health of workers in every aspect related to work, and risk assessment is an integral aspect of this mandatory occupational safety and health management (OSHM). According to the Directive, risk assessment must be the starting point of a comprehensive OSHM process. It has a central role because it enables employers to put in place the measures that are necessary to protect the safety and health of their workers.
- 16.
Risk assessment of existing chemicals is provided by Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, p. 1.
- 17.
Regulation 726/2004 of the European Parliament and of the Council 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 136/1; Directive 2001/83 of the European Parliament and of the Council on the Community code relating to medicinal products for human use, OJ. 2001, L 311/67; and Directive 2001/82 of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, OJ. 2001 L 82/1.
- 18.
Regulation 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, OJ 2009 L 342/59.
- 19.
See Articles 4(1) and (2) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, [2001] OJ L 106/1.
- 20.
Directive 98/08/EC concerning the placing of biocides on the market.
- 21.
Regulation 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1). The 1998 Rotterdam PIC Convention refers to “risk evaluation” as a precondition for regulatory action.
- 22.
See Article 16(2) of Directive 2000/60/EC establishing a framework for Community action in the field of water policy, OJ 2000 L327/1.
- 23.
Commission Decision 2004/210/EC of 3 March 2004, OJ L66, pp. 45–50. There are three committees: Scientific Committees on Consumer Products (SCCP); Scientific Committee on Health and Environmental (SCHER); and Risks Scientific Committee on emerging and Newly Identified Health Risks (SCENIHR). To coordinate these committees an Inter-Committee, made up of the Chairs and Vice-Chairs of the three Committees, has been established. Its main task is to assist the Commission on matters relating to the harmonization of risk assessment. In addition, it deals with questions which are common to more than one Committee, diverging scientific opinions, and exchange of information on the activities of the Committees.
- 24.
Under REACH, the purpose of a socioeconomic analysis (SEA) is to evaluate what costs and benefits an action will create for society by comparing what will happen if this action is implemented as compared to the situation where the action is not implemented.
- 25.
Similarly, risk management is defined within the OECD as a decision-making process involving considerations of political, social, economic, and technical factors with relevant risk assessment information relating to hazard so as to develop, analyze, and compare regulatory and non-regulatory options and to select and implement appropriate regulatory response to that hazard. See descriptions of selected key generic terms used in chemical hazard/risk assessment; OECD/IPCS, October 2003, available at http://www.oecd.org.
- 26.
See, to that effect, Case C-473/98 Toolex [2000] ECR I-5681, paragraph 45.
- 27.
Case T-70/99 Alpharma v Council [2002] ECR II-3495.
- 28.
See, for instance, Art. 17, par. 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 L 404, p. 9; Art. 10, par. 1, and Art. 35, par. 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 L 136, p. 1 as well as Article 11, par. 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, L 338, p. 4.
- 29.
See Article 7 of Regulation 1829/2003.
- 30.
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1).
- 31.
Case T-13/99 Pfizer Animal Health v. Council, 2002 ECR II-3305, paragraph 201. This has been echoed inter alia in the general food regulation where it may be read “it is recognized that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based.” See Recital (19) of this Regulation.
- 32.
The inclusion of “other legitimate factors” in food risk assessment is confirmed by Article 7(1) of Regulation 1829/2003 on Genetically Modified Food and Feed [2003] OJ L287.
- 33.
Article 68.1 REACH.
- 34.
Case T-13/99 Pfizer Animal Health v. Council, 2002 ECR II-3305, paragraph 201.
- 35.
To know more on this point, see p. 395 et seq.
- 36.
The pharmaceutical sector represents an exception as its main regulation (Regulation 2309/93) rules out the possibility that the Commission’s decision to grant a marketing authorization be based on economic or other nonscientific criteria. This decision “must be taken in the interest of public health, based on the objective scientific criteria of the quality, the safety and the efficacy of the medicinal product concerned.” See the third recital of the regulation.
- 37.
Case T-13/99 Pfizer Animal Health v. Council, 2002 ECR II-3305, paragraph 163.
- 38.
European Commission, Impact Assessment Guidelines, SEC(2009) 92, p. 4. The new guidelines contain an interesting Part III: Annexes to Impact Assessment Guidelines, which finally provides a more detailed methodological guidance to the Commission services than in the past.
- 39.
Ibidem, p. 6.
- 40.
Communication from the Commission of 11 December 2002 on the collection and use of expertise by the Commission: principles and guidelines—“Improving the knowledge base for better policies” [COM(2002) 713 final—Not published in the Official Journal].
- 41.
Commission communication “General principles and minimum standards for consultation of interested parties by the Commission” COM(2002)704 (hereinafter “minimum standards”).
- 42.
Inter-Institutional Agreement (IIA) on Better Lawmaking between the European Parliament, the Council and the Commission (2003) (OJ EU 2003, C 321).
- 43.
On how to turn this commitment into practice, see the Inter-institutional Agreement on a “Common Approach to Impact Assessment” (November 2005). Yet the definition of what constitutes a “substantive amendment” is for each institution to determine. See <http://ec.europa.eu/governance/better_regulation/documents/ii_common_approach_to_ia_en.pdf> accessed on 21 February 2010.
- 44.
Although the distinction between these forms of acts was not always clear before the Lisbon Treaty, today Article 290 et seq. shed some light on this point by clearly distinguishing between legislative acts and non-legislative acts (delegated and implementing acts).
- 45.
Under the Commission’s rules of procedure (Art 2), the Commission defines annual priorities and adopts a work program for each year. This program sets out major political priorities and identifies legislative initiatives, executive, and other acts that the Commission intends to adopt for the realization of these priorities. The President presents the Commission work programme to the Parliament and the Council.
- 46.
This conclusion has recently been confirmed by European Court of Auditors’ report on the Commission’s impact assessment system. See Report by the European Court of Auditors on the Commission’s impact assessment system: Impact Assessment in the EU Institutions: Do they support decision-making? Special Report n. 3/2010, September 2010, 34–41.
- 47.
IA 2009, p. 18.
- 48.
Report by the European Court of Auditors on the Commission’s impact assessment system: Impact Assessment in the EU Institutions: Do they support decision-making? Special Report n. 3/2010, September 2010.
- 49.
In the preamble (21) of the general food regulation, the principle is defined as “a mechanism for determining risk management measures or other actions in order to ensure the high level of health protection chosen in the Community.”
- 50.
As long as Member State action falls within the sphere of application of EU law.
- 51.
See also Protocol No 30 on the application of the Principle of Subsidiarity and Proportionality.
- 52.
Case C-331/88 Fedesa and Others [1990] ECR I-4023, paragraph 13; Joined Cases C-133/93, C-300/93 and C-362/93 Crispoltoni and Others [1994] ECR I-4863, paragraph 41; Case C-157/96 National Farmers’ Union and Others [1998] ECR I-2211, paragraph 60; and Case C-189/01 Jippes and Others [2001] ECR I-5689, paragraph 81; Case C-3/00 Denmark v Commission [2003] ECR I-2643, paragraph 49.
- 53.
Case C-331/88 Fedesa and Others [1990] ECR I-4023, paragraph 13.
- 54.
Pfizer, paragraph 411.
- 55.
Ibidem, paragraph 410.
- 56.
See GATT, the Agreement on Technical Barriers to Trade (TBT), the Agreement on Sanitary and Phytosanitary Measures (SPS), the General Agreement on Trade in Services (GATS), the Agreement on Agriculture (in the Preamble, as well as in Article 20 of this Agreement non-trade concerns in the Agricultural sector are mentioned), and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). In particular, this last Agreement facilitates the international recognition of denominations of origin and certificates of specificity that have been granted in accordance with the relevant Community regulations.
- 57.
Key terms such as sanitary (to protect human life and health) and phytosanitary measures (to protect animal and plant life and health) are defined in the SPS Agreement, Annex A.
- 58.
Since the 1979 Tokyo Round some countries feared that the lowering of border measures would be circumvented by disguised protectionist measures in the form of technical regulations, notably sanitary and phytosanitary regulations. For this reason, already on that occasion, a Plurilateral Agreement was adopted on Technical Barriers to Trade, also called “Standards Code.”
- 59.
Article 3 SPS and 2.4 TBT.
- 60.
All international standards are presumed necessary to achieve a legitimate objective. See Article 3 SPS and 2.5 TBT.
- 61.
Under the “necessity test,” a measure can only be found “too restrictive to trade” when there is an alternative measure that it is not only less trade restrictive but also achieves the same level of protection as that achieved by the measure adopted.
- 62.
Articles 2.2 and 5.1 SPS and Articles 5.6 SPS and 2.2 TBT, respectively.
- 63.
Article 2 SPS provides that: “[m]embers have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement.”
- 64.
Article 3 (13) of Regulation 178/2002.
- 65.
The legal basis for the role of the European Food Safety Authority in risk communications is established in Articles 23 (j) and 40 of Regulation (EC) N° 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (O.J. N° L 31 of 1 February 2002)5.
- 66.
Under Article 123 of the REACH Regulation, “The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in preparations or in articles, with a view to coordinating Member States in these activities.”
- 67.
Founding document Regulation (EC) no 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control.
- 68.
Case T-13/99 Pfizer Animal Health v. Council, 2002 ECR II-3305, paragraph 201.
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Alemanno, A. (2012). Regulating the European Risk Society. In: Alemanno, A., den Butter, F., Nijsen, A., Torriti, J. (eds) Better Business Regulation in a Risk Society. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-4406-0_3
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