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      Statement on the validity of the conclusions of a mouse carcinogenicity study on sucralose (E 955) performed by the Ramazzini Institute

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          Abstract

          The Panel on Food Additives and Nutrient Sources added to Food ( ANS) was requested from the European Commission to provide a statement on the validity of the conclusions of a mouse study on the carcinogenic potential of sucralose (E 955) performed by the Ramazzini Institute (Soffritti et al., 2016). Sucralose (E 955) is authorised as a food additive in the EU in accordance with Annex II to Regulation ( EC) No 1333/2008 on food additives. According to Commission Regulation ( EU) No 257/2010, the full re‐evaluation of sucralose shall be completed by December 2020. Taking into consideration the publication from Soffritti et al. ( 2016), the technical report and additional information provided by the Ramazzini Institute and other information available for sucralose (E 955), the Panel noted: (i) the design of the bioassay that considers exposure from gestation up to natural death of animals implies an increase in background pathology that results in the possibility of misclassifications and a difficult interpretation of data, especially in the absence of both an appropriate concurrent control group and a recent historical database; (ii) the lack of a dose–response relationship between the exposure to sucralose and incidence of lymphomas and leukaemias (combined); (iii) the lack of a mode of action and failure to meet all the Bradford‐Hill considerations for a cause–effect relationship between intake of sucralose and the development of tumours in male mice only; (iv) a comprehensive database was available for sucralose and no carcinogenic effect was reported in adequate studies in rats and mice. Moreover, there was no reliable evidence of in vivo genotoxicity. Therefore, the Panel concluded that the available data did not support the conclusions of the authors (Soffritti et al., 2016) that sucralose induced haematopoietic neoplasias in male Swiss mice.

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          Most cited references 37

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          Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. Part 2: General Principles

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            Recommendations for conducting the in vivo alkaline Comet assay. 4th International Comet Assay Workshop.

            The in vivo alkaline single cell gel electrophoresis assay, hereafter the Comet assay, can be used to investigate the genotoxicity of industrial chemicals, biocides, agrochemicals and pharmaceuticals. The major advantages of this assay include the relative ease of application to any tissue of interest, the detection of multiple classes of DNA damage and the generation of data at the level of the single cell. These features give the Comet assay potential advantages over other in vivo test methods, which are limited largely to proliferating cells and/or a single tissue. The Comet assay has demonstrated its reliability in many testing circumstances and is, in general, considered to be acceptable for regulatory purposes. However, despite the considerable data published on the in vivo Comet assay and the general agreement within the international scientific community over many protocol-related issues, it was felt that a document giving detailed practical guidance on the protocol required for regulatory acceptance of the assay was required. In a recent meeting held in conjunction with the 4th International Comet Assay Workshop (Ulm, Germany, 22-25 July 2001) an expert panel reviewed existing data and recent developments of the Comet assay with a view to developing such a document. This paper is intended to act as an update to the more general guidelines which were published as a result of the International Workshop on Genotoxicity Test Procedures. The recommendations are also seen as a major step towards gaining more formal regulatory acceptance of the Comet assay.
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              Applying the Bradford Hill criteria in the 21st century: how data integration has changed causal inference in molecular epidemiology

              In 1965, Sir Austin Bradford Hill published nine “viewpoints” to help determine if observed epidemiologic associations are causal. Since then, the “Bradford Hill Criteria” have become the most frequently cited framework for causal inference in epidemiologic studies. However, when Hill published his causal guidelines—just 12 years after the double-helix model for DNA was first suggested and 25 years before the Human Genome Project began—disease causation was understood on a more elementary level than it is today. Advancements in genetics, molecular biology, toxicology, exposure science, and statistics have increased our analytical capabilities for exploring potential cause-and-effect relationships, and have resulted in a greater understanding of the complexity behind human disease onset and progression. These additional tools for causal inference necessitate a re-evaluation of how each Bradford Hill criterion should be interpreted when considering a variety of data types beyond classic epidemiology studies. Herein, we explore the implications of data integration on the interpretation and application of the criteria. Using examples of recently discovered exposure–response associations in human disease, we discuss novel ways by which researchers can apply and interpret the Bradford Hill criteria when considering data gathered using modern molecular techniques, such as epigenetics, biomarkers, mechanistic toxicology, and genotoxicology.
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                Author and article information

                Journal
                EFSA J
                EFSA J
                10.1002/(ISSN)1831-4732
                EFS2
                EFSA Journal
                John Wiley and Sons Inc. (Hoboken )
                1831-4732
                08 May 2017
                May 2017
                : 15
                : 5 ( doiID: 10.1002/efs2.2017.15.issue-5 )
                Author notes
                Article
                EFS24784
                10.2903/j.efsa.2017.4784
                7010144
                © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.

                Page count
                Figures: 0, Tables: 3, Pages: 14, Words: 7823
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                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                May 2017
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

                sweetener, sucralose, carcinogenicity, food additive, e 955

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