Scientific Evidence in Food Law

Already in their 1997 Green Paper, the European Commission stressed the importance of independent scientific advice as the basis for all regulatory activities of the Community.³⁰ Together with the instruments of control and risk analysis, scientific evidence was described as a third essential instrument to ensure the development of effective consumer health policies.³¹ Within the GFL, the importance of scientific evidence is also highlighted: Article 6 emphasizes the need for scientific evidence to analyze the risk that a food poses, to ensure a high level of consumer protection.

Opinion? Constitutional Framework for Risk Analysis in EU Food Safety Law” (2009) 34(6) Food Policy 529, 529-38.

25 European Commission (1997). The general principles of food law in the European Union—Com­mission Green Paper. COM176.

26 European Commission (2000). White paper on Food Safety. COM719.

27 A.de Boer, supra note 4.

28 European Parliament and the Council. (2002). Regulation (EC) No 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. OJ L 31, 1-24; Szajkowska, supra note 24.

29 European Parliament and the Council. (2002). Regulation (EC) No 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. OJ L 31, 1-24.

30 Vos, s upra note 3.

31 Vos, s upra note 3.

risk analysis, the scientific assessment of a risk is separated from the political (risk management) decision, in which also other considerations are taken into account next to the scientific evidence.

A. Risk Analysis

As previously described in the literature, risk assessment has become one of the key principles of food law in general, as well as in the operations of inter­national organizations working on standards, including Codex Alimentarius and the Sanitary and Phytosanitary Measures Agreement of the World Trade Organization (WTO).^[107] Risk analysis (risk assessment, together with risk management and risk communication) has formed a structured approach to analyze risk and identify measures that can be taken to deal with this risk.^[108] As highlighted already in the recitals of the GFL (specifically in recital 17), this systematic method should provide European policies a solid base upon which effective, proportionate, and targeted actions can be taken. Although this structured approach is expected to result in a more consistent approach to food safety regulations, even over various domains and in dealing with differing risks, it is essential that the full approach be based on scientific information.^[109] In the rapid development of technologies and innovative products, however, sometimes insufficient information is available to fully analyze the risk. In such cases of so-called “scientific uncertainty,” the GFL allows for risk managers to base a provisional management measure upon the precautionary principle (Art 7): only when a first risk assessment has iden­tified the possibility of harmful effects may a provisional measure be taken while further scientific information should be gathered to conduct a com­prehensive risk assessment. Herewith, the risk manager is allowed to ensure a high level of consumer protection, even when the scientific evidence is incomplete. As described in Article 6 of the GFL on risk analysis, however, a risk manager should take the precautionary principle into account next to the results of risk assessment and not instead of such a risk assessment.

B. Risk Assessment in EU Food Law

The scientific process of analyzing whether something could present a risk is based on four steps (Article 3(11) GFL): hazard identification, hazard charac­terization, exposure assessment, and risk characterization.

In EU food law, the tasks of risk assessment and risk management are func­tionally separated: Article 6(d)¹ describes that risk assessment must be based on “available scientific evidence and undertaken in an independent, objec­tive and transparent manner.” Risk assessment was already described in the White Paper on Food Safety to encompass scientific advice and information analysis, which should be based on accurate and up-to-date scientific evidence. This same White Paper suggested that risk assessment and risk management should be functionally separated, for which the to-be-established European Food Authority would be essential in providing scientific advice as risk assessor.

C. Risk Management in EU Food Law

The roles of risk assessor and risk manager are explicitly separated in EU food law. Based on the submitted scientific evidence with its uncertainty and varia­bility, EFSA’s assessment proposes a range of policy measures with differing lev­els of scientific support. In political risk management decisions, these findings are combined with legitimate other concerns to decide upon a policy measure, which includes, inter alia, public health considerations.^[111] As Article 3 of the GFL lays down, weighing the policy alternatives (conducted in consultation with interested parties) should allow for the selection of appropriate preven­tion and/or control options.^[112] For this broad range of tasks (from prevention to control measures), a wide array of decisions are available: from commissioning research projects or recommendations, to informing the general public, and of course to legally binding measures such as administrative decisions.^[113]

The risk management role is fulfilled by the different bodies that develop European policies and by those bodies that make decisions upon prevention and control of risks within the food system: the European Commission, the European Parliament, and individual Member States. The European Com­mission is the sole body that is able to take the initiative for making EU law (known as the full legislative initiative), as defined in Article 17(2) of the Treaty on European Union (TEU).^[114] Since the European Parliament and the Council need to adopt the laws that are drawn up by the Commission in the ordinary legislative procedure (Article 294 of the Treaty on the Functioning of the European Union [TFEU]),^[115] these institutions can also be considered risk managers. With European Union law being part of the legal systems of the Member States that these Member States enforce within their own jurisdictions, the Member States can also function as risk managers in EU food law.

The roles of the risk management bodies involved in decision-making pro­cesses in the European Union thus result from the fact that their roles and responsibilities are laid down in the European Treaties. Although the descrip­tion and especially the separation of tasks within the risk analysis procedure becomes very clear from the GFL, the European bodies involved in risk man­agement are almost not touched upon. Only Article 22(8) and Article 40(1) of the GFL specify the organizations involved in risk analysis: Article 22(8) requires the different organizations (EFSA, the Commission, and the Member States) to cooperate to ensure that risk assessment, risk management, and risk communication functions are well connected; from Article 40(1), it becomes clear that EFSA is able to provide communications related to its mission, while it is defined as the Commission’s role to communicate its risk management decisions. Article 17(2) touches upon the responsibility of the Member States to enforce food law throughout the food chain.

IV.