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Abstract

We are daily faced with a great deal of risks that we manage on our own. Not all risks are regulated in our society. In fact, are usually regulated product and service risks that cannot be sufficiently controlled on the individual consumer-level, those that because of their nature or size go beyond the sphere of action of individuals and/or involve a public interest, like for example environmental or climate risks, as well as those related to externalities, situations where the risk-producer has no incentive to prevent or reduce the risk, or may even receive a benefit from imposing a risk on others. In advanced countries, we benefit from unprecedented, favourable conditions of life, including on health and safety, reflected in a dramatic increase of average lifetime, but new threats and risks have appeared, linked to technology, economic and population growth, which dwarf the ability of individuals to manage risks by themselves. Risks subject to regulatory action are often complex, uncertain or ambiguous. Risk managers therefore need to apply a structured approach. The concept of risk analysis, including the assessment, management and communication of risk, stays at the core of the EU and internationally recognised approach to risk. It is based on a technical definition of risk and involves a science-based approach to risk assessment and the functional separation between assessment and management. The risk analysis paradigm is integrated into the EU decision-making process, across many policy sectors, but important differences remain, which reflect historically different sectoral regulatory cultures and the specificities of the various legal frameworks.

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Notes

  1. 1.

    In this work we do not make a strict terminological distinction between legislation and regulation since under the EU Treaties general legislation may be introduced by both “directives” and “regulations”. Nevertheless, the different nature of the instruments referred to will be clear from the context of the discussion.

  2. 2.

    Certain regulatory responsibilities have been delegated by the European Parliament and the Council to the European Commission, which however is subject to the control of the two institutions for its delegated acts. Moreover, contrary to a common but erroneous opinion, the Commission is a political, not a bureaucratic institution, which is independent from the EU Member States but politically accountable to the European Parliament.

  3. 3.

    See in particular the so-called Meroni doctrine, which arose from cases C-9/56 and C-10/56 (Meroni v High Authority [1957/1958] ECR 133), mentioning restrictive conditions for the delegation of powers, in particular that the delegation of power can only relate to clearly defined executive powers, the use of which must be entirely subject to the supervision of the delegating authority and that consequently it is not permissible to delegate broad discretionary powers that give to an agency a wide margin of appreciation. This makes it problematic for the EU delegating to an independent agency ample normative powers like those attributed to the US FDA.

  4. 4.

    Nevertheless, the name of EFSA, which is designated as an “authority” (differently from other “agencies”) although it has not been given regulatory powers, may perhaps be seen as a trace of some (frustrated) wish to “externalise” risk management together with risk assessment in the food safety area following the BSE crisis.

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Delogu, B. (2016). EU Risk Policy and Risk Analysis. In: Risk Analysis and Governance in EU Policy Making and Regulation. Springer, Cham. https://doi.org/10.1007/978-3-319-30822-7_3

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