EFSA's Scientific Committee has launched an open consultation on its draft EFSA Scientific Committee Opinion on biological plausibility of non-monotonic dose responses and their impact on the risk assessment. This document assesses the biological relevance of the apparent non-monotonic dose-responses identified in the external report produced under GP/EFSA/SCER/2014/01, focusing on the in vivo datasets fulfilling most of the checkpoints of the visual/statistics-based analysis. The assessment was completed with cases discussed in EFSA scientific opinions and the update of the literature review. Based on the results of the evaluation, the draft Opinion proposes the approach to be applied during the risk assessment process when apparent non-monotonicity is observed. The proposed approach has been applied to two case studies, Bisphenol A and the phthalate DEHP; these evaluations are reported in dedicated annexes.
Interested parties are invited to submit written comments by 04/02/2021. Please use the electronic template provided to submit comments and refer to the line and page numbers. To submit additional data to support your comments or files, there is an upload function available in the tool (for a maximum size of 1Mb file). Otherwise you can also contact specific unit’s functional mailbox SCER.PublicConsult.EUS.009 [at] efsa.europa.eu. Please note that comments will not be considered if they:
- are submitted after the closing date of the consultation
- are presented in any form other than what is provided for in the instructions and template
- are not related to the contents of the document
- contain complaints against institutions, personal accusations, irrelevant or offensive statements or material
- are related to policy or risk management aspects, which are out of the scope of EFSA's activity.
EFSA will assess all comments which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.
Persons or organizations participating in a Public Consultation of EFSA are responsible for ensuring that they hold all the rights necessary for their submissions and consequent publication by EFSA. Comments should inter alia be copyright cleared5taking into account EFSA’s transparency policy and practice to publish all submissions. In case the submission reproduces third-party content in the form of charts, graphs or images, the required prior permissions of the right holder(s) should have been obtained by the PC respondent.
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Contributions will be published and may be re-used by EFSA in a different context. It should be noted that contributions submitted by individuals in a personal capacity will be published as such, indicating the author’s first and family name, unless a substantial justification for protection is provided by the respondent. Contributions submitted on behalf of an organisation are also made publicly available and attributed to the organization in question.