EFSA as Risk Assessor

As highlighted previously, the GFL emphasizes the need for independent and objective scientific advice in decision-making processes related to foods. Additionally, the GFL is the founding regulation of EFSA (Article 1).

Article 22 describes that the mission of EFSA is to provide scientific advice and scientific and technical support for all European legislation and policies that affect food and feed safety. For that purpose, they are required (Article 22(4)) to collect and analyze data. Whereas the first few elements within this mission statement focus on the contribution of EFSA to a high level of (consumer) health protection, Article 22(5) also details that advice and support regarding human nutrition, when related to European legislation, is part of this mission.

As described in Article 23, the tasks of EFSA all relate to this mission. These tasks range from providing Community institutions and Member States with the best possible scientific opinions when this is laid down in legislation or upon request to commissioning scientific studies that are related to its mission. However, by defining in Article 23(l) that any other task assigned to EFSA by the Commission that can be placed within its mission could become part of EFSA’s work, the potential for the Authority to provide advice related to food issues is highly broadened.

Article 24 describes the different bodies within the Authority, which include a scientific committee and scientific panels ((Article 24(d)). As described in Article 28(4), these scientific panels are composed of independent scientific experts. Currently, ten permanent scientific panels with independent experts work on a broad range of topics and issues of food and feed safety. Upon request of EFSA, the number and the names of the panels can be adjusted. This is mainly seen to happen when the three-year mandates of the involved scientific experts end.

Of the ten panels, one is mainly focused on nutrition in general, the panel currently known as the Panel on Nutrition, Novel Foods and Food Allergens (Article 28(4)(e)), often abbreviated as the NDA Panel. Scientists in this panel bring a range of expertise to the table and, for example, study (infant) nutrition, food allergy, epidemiology, food technology, and toxicology. The NDA Panel is tasked with providing advice related to different aspects of human nutrition, including (1) the tolerable upper intake levels for nutrients (maximum intake levels), (2) safety of novel foods, (3) food allergens, (4) dietetic products (products that currently fall within the category of foods for specific groups),^[116] (5) population reference intakes for nutrients, and (6) nutrition and health claims on foods.^[117] Together with the Scientific Committee of EFSA, the panels are responsible for issuing scientific advice within their competence (Article 28(1)). The ten chairs of the scientific panels, together with six independent scientific experts, form this Scientific Committee (Article 28(3)). This Committee is tasked (Article 28(2)) with ensuring consistency of the procedures to issue such advice and to harmonize working methods, next to issuing advice upon “multisectoral” or cross-sectional issues.

The scientific advice that EFSA is tasked to provide for the decision-making process related to EU food law is published in so-called scientific opinions (Article 29). A scientific opinion can be developed at the request of the Commission, the European Parliament, or Member States, and EFSA can be tasked to issue such opinions under specific regulatory procedures. It is also possible for EFSA to issue scientific opinions on its own initiative, as long as it deals with aspects within the mission of the Authority. The GFL, in describing the aim of EFSA together with specific elements related to its operations and functions, strictly limits the competence of the Authority to a scientific role and thereby excludes any decision-making powers being attributed to EFSA.^[118]

A. EFSA's Activities

Within the relatively short period of time that the EFSA has existed, the Authority has become a well-recognized institute for scientific advice related to food and food safety issues.^[119] EFSA publishes all its scientific outputs, which include scientific opinions as well as various other publications to support their work.

This includes (1) other scientific outputs of EFSA, either statements of the Scientific Committee or scientific panels (containing fewer details then opinions) or guidance documents of the Scientific Committee or scientific panels (to explain the principles behind the approaches of EFSA); (2) other scientific outputs which include the results of a peer review process on scientific evidence related to pesticides; and (3) supporting publications that are either describing technical processes (so-called Technical Reports), External Scientific Reports related to risk assessment and its methodologies, or Event Reports.^[120]

All the scientific output of EFSA can be found in the EFSA Journal, in which various supporting publications are also published. On December 12, 2021, a total of 8,659 publications were published within the EFSA Journal, all related to the following 15 topics: animal feed, animal health and welfare, biological hazards, chemical contaminants, contaminants in feed, cross-cutting science, data, emerging risks, feed additives, food ingredients and packaging, genetically modified organisms (GMOs), methodology, nutrition, pesticides, and plant health (available via www.efsa.europa.eu/en/publications). With only

Scientific Evidence in Food Assessments 37 five publications, contaminants in feed is the issue that was published upon the least in 2021. Pesticides (with 2,186 publications), feed additives (1,195 publications), food ingredients and packaging (1,156 publications), and nutrition (1,105 publications) are the four subjects upon which the most publications were issued by the panels and the Scientific Committee. Selecting the term “health claim” in the publications related to nutrition results in a total of 1,006 publications (91%).

All questions asked of the EFSA by the different EU institutions (which includes chairs of panels, EFSA itself, the European Parliament, the European Commission, or Member States) are listed in the portal OpenEFSA.

The portal can be accessed via open.efsa.europa.eu and is described as “the single public interface for all information related to EFSA’s scientific work.” On December 12, 2021, a total of 6,735 questions were listed in the portal as open to be answered. Before January 21, 2021, all questions directed to EFSA were listed in the Register of Questions. A total of 20,035 questions were listed as finalized by January 21, 2021, which contained 5,909 questions for the Nutrition Unit. Interestingly, of these almost 6,000 questions, 1,531 were related to health (keyword search “health”), while “novel” as keyword merely resulted in 205 hits; “safe” showed 150 questions (of which many are also related to novel foods), and “tox*” as search term (for toxicity-related questions) found 28 questions. “Aller*”, as a keyword for allergy-related matters, resulted in a total of 25 finished (or withdrawn) questions by January 2021. Even though this explorative search through the former Register of Questions merely addressed questions in English that are considered finalized, these findings do highlight that a large amount of the workload of the NDA Panel so far has been dealing with health claims (almost 26% of the completed questions). EFSA’s Annual Activity Report of 2020 also emphasizes the high interest of the public in the nutrition work of EFSA, specifically health claims.^[121] This workload, especially with the increasing complexity of assessments, cannot be underestimated.^[122]

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Source: Ni Kuei-Jung, Lin Ching-Fu (eds.). Food Safety and Technology Governance. Routledge,2022. — 252 p.. 2022

EFSA as Risk Assessor

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