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      Guidance on the assessment of the safety of feed additives for the consumer

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          Abstract

          Draft Endorsed by the FEEDAP Panel 17 May 2017
          Submitted for public consultation 24 May 2017
          End of public consultation 21 July 2017
          Adoption by the FEEDAP Panel 27 September 2017
          Entry into force 1 May 2018

          Abstract

          This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation ( EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the consumer.

          Abstract

          This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1305/full

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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

          (2012)
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            Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment

            (2011)
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              Update: use of the benchmark dose approach in risk assessment

              Abstract The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the NOAEL approach for deriving a Reference Point (RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to apply the BMD approach. Model averaging is recommended as the preferred method for calculating the BMD confidence interval, while acknowledging that the respective tools are still under development and may not be easily accessible to all. Therefore, selecting or rejecting models is still considered as a suboptimal alternative. The set of default models to be used for BMD analysis has been reviewed, and the Akaike information criterion (AIC) has been introduced instead of the log‐likelihood to characterise the goodness of fit of different mathematical models to a dose–response data set. A flowchart has also been inserted in this update to guide the reader step‐by‐step when performing a BMD analysis, as well as a chapter on the distributional part of dose–response models and a template for reporting a BMD analysis in a complete and transparent manner. Finally, it is recommended to always report the BMD confidence interval rather than the value of the BMD. The lower bound (BMDL) is needed as a potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL per ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re‐evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 SC guidance was used, in particular when the exposure is clearly smaller (e.g. more than one order of magnitude) than the health‐based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the expected wide application of the BMD approach.
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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
                17 October 2017
                October 2017
                : 15
                : 10 ( doiID: 10.1002/efs2.2017.15.issue-10 )
                : e05022
                Author notes
                [*] Correspondence: feedap@ 123456efsa.europa.eu
                Article
                EFS25022
                10.2903/j.efsa.2017.5022
                7009902
                9444f7e7-b573-4670-9129-f67ad6568772
                © 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.

                History
                Page count
                Figures: 1, Tables: 2, Pages: 17, Words: 8722
                Categories
                Guidance
                Guidance
                Custom metadata
                2.0
                October 2017
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

                guidance,consumer safety,feed additives
                guidance, consumer safety, feed additives

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