Published April 3, 2023 | Version v1
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Revised Protocol on Hazard Identification and Characterisation of Sweeteners


The original protocol was approved by the FAF Panel on 17 January 2020 and it was originally published as EFSA supporting publication on 18 February 2020, as Annex of the Technical report. Outcome of the public consultation on a draft protocol for the assessment of hazard identification and characterisation of sweeteners. EFSA supporting publication 2020: EN-1803. 28 pp. doi:10.2903/sp.efsa.2020. EN-1803.

During the implementation of this protocol, the following revisions and further elaborations were introduced:

Section 1.4: a clarification on the key studies to consider in the risk assessment and evaluated according to the protocol was added, in order to take into account substances for which no health-based guidance value (HBGV) was derived.

Section 1.6: it was specified that a more detailed approach for assessing the relevance and reliability of genotoxicity studies has been developed and is currently reported in Appendix B.

Section 1.7.1: regarding human data, additional type of studies (e.g. studies with mixtures, studies on absorption of nutrients), not specified in the inclusion/exclusion criteria of Table 5, have been considered for inclusion, using either a narrative or systematic (i.e. risk of bias evaluation) approach.

Section 1.7.2: regarding animal data, a clarification on how to consider studies performed with mixtures (specified, unspecified, commercial (trade) names) has been added. Additional type of studies (i.e. studies using animal disease models), not specified in the inclusion/exclusion criteria of Table 7, have been considered for inclusion using a narrative approach.

Section 1.9: further details on a stepwise approach on which studies should be considered in the weight of evidence has been added, based on the outcome of the risk of bias (RoB) evaluation of key studies.

Section 1.10: new calls for data more recently launched by EFSA have been added.

Section 1.12: some changes regarding the selection of the key questions for RoB evaluation for human studies have been introduced. Tables on animal and human studies with the decision guiding the scoring for the different RoB questions are currently reported in Appendix C and D. In addition, some further considerations on studies evaluated as tier 3 have been added.

Section 1.13: a revised version of the data extraction forms have been developed, including additional information/explanations on the different fields of the data extraction tables.

Section 1.14: a more detailed description of the different steps of the weight of evidence analysis have been included. The approach has been further developed based on NTP-OHAT, 2019 with some modifications and adaptations.

Section 1.16: some changes have been introduced in order to reflect how the uncertainties for the published opinions on sweeteners were addressed (i.e. Thaumatin (E 957), Neohesperidine dihydrochalcone (E 959)), for which few studies were available and it was thought to express uncertainties in a narrative way only).