Introduction

The importance of scientific evidence as the basis of policy is highly empha­sized within Europe, especially concerning the regulation of risks.¹ One of the sectors in which science is key in policy development is the field of food and food safety.

Nutritional sciences, however, are developing at high speed, and new insights regarding new, innovative products and technologies, but also health effects of food and food ingredients, are evolving rapidly. And while nutritional sciences thrive with ongoing critical appraisal of their concepts and ideas, food laws and subsequent guidelines require definite statements concerning food safety and health. This results in the issue that legislation is often based on dated or even outdated scientific concepts and cannot make use of the most recent

1 European Commission, Strengthening Evidence Based Policy Making Through Scientific Advice Review­ing Existing Practice and Setting Up a European Science Advice (Luxembourg, Publications Office of the European Union 2015); B. Stibernitz, “A Brief Comment on Science-based Risk Regulation Within the European Union”, (2012) 3(1) European Journal of Risk Regulation 86, 86—91.

2 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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, p. 1—24. Consolidated version 26 May 2021.

3 E. Vos, “EU Food Safety Regulation in the Aftermath of the BSE Crisis” (2000) 23:3 Journal of Consumer Policy, 227, 227-55.

DOI: 10.4324/9781003271918-4 advancements.^[86] Especially in subsequently developed sectoral legislation, that, for example, deals with the authorization of health claims^[87] or with the authori­zation of new food products,^[88] scientific evidence is key: when health effects or safety of the products requesting market access is not established within a scientific dossier, the risk assessor will not advise the risk manager to allow such a claim or product on the European market.^[89] The tension between nutritional sciences and law becomes evident in the use of scientific findings under these specific food laws: consensus must be reached upon the established effects and the causal relationships identified between ingredients and these effects, but it is highly uncertain when new and innovative methods are sufficiently developed to be accepted under these regulatory procedures.

The process of analyzing scientific evidence related to food authorizations is often referred to as risk assessment.^[90] In the General Food Law, the concepts of risk assessment, risk management, and risk communication are used to describe the systematic risk analysis approach upon which food policy and decisions should be based. EU food legislation, however, does not only deal with risks: while the authorization procedure for novel foods requires scientific evidence for proving that a product is not unsafe, also, for health claims, scientific find­ings are required that establish the health effect or the efficacy of the product bearing the claim. The authority that conducts risk assessments in the EU, EFSA, describes its efforts as scientific assessments.^[91] It could therefore be ques­tioned whether EU food law provides a mandate for only risk assessment, while in nutritional sciences, risks and benefits of foods are often studied concur­rently, or whether there is a legal basis for conducting such scientific assessments. This chapter aims to unravel the role of the EFSA as laid down in law and to

Scientific Evidence in Food Assessments 29 analyze the practical reality of scientific advice provided under the mandate of European food law.

II.