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      Re‐evaluation of benzyl alcohol (E 1519) as food additive

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          Abstract

          The Panel on Food Additives and Flavourings ( FAF) provided a scientific opinion re‐evaluating the safety of benzyl alcohol (E 1519) when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Benzyl alcohol (E 1519) is authorised as a food additive in the EU in accordance with Annex III to Regulation ( EC) No 1333/2008. The Panel considered benzyl alcohol of low acute toxicity with no concern with respect to genotoxicity and carcinogenicity and established an acceptable daily intake ( ADI) of 4 mg/kg body weight (bw) per day based on a no observable adverse effect level ( NOAEL) of 400 mg/kg bw per day from the carcinogenicity study in rats. The mean and high exposure estimates in the refined exposure scenarios were maximally 0.27 and 0.81 mg/kg bw per day in toddlers, respectively. The exposure estimates to benzyl alcohol (E 1519) were below the ADI of 4 mg/kg bw per day in all population groups. The Panel noted that also the exposure in the regulatory maximum level exposure assessment scenario is below the ADI in all population groups. The Panel concluded that the exposure to benzyl alcohol (E 1519) does not raise a safety concern at the reported uses and use levels.

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          Most cited references61

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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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            Opinion of the Scientific Committee related to Uncertainties in Dietary Exposure Assessment

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              Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data

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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
                30 October 2019
                October 2019
                : 17
                : 10 ( doiID: 10.1002/efs2.v17.10 )
                : e05876
                Author notes
                [*] Correspondence: fip@ 123456efsa.europa.eu
                Article
                EFS25876
                10.2903/j.efsa.2019.5876
                7008871
                32626148
                e83a5fe8-6df7-40f0-81bf-941c9362162c
                © 2019 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.

                History
                Page count
                Figures: 1, Tables: 4, Pages: 24, Words: 14142
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                October 2019
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

                benzyl alcohol,e 1519,food additive,safety,risk assessment,dietary exposure,acceptable daily intake

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