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Public consultation: guidance on threshold of toxicological concern approach

EFSA's Scientific Committee has launched an open consultation for the guidance on the use of the Threshold of Toxicological Concern (TTC) approach in food safety assessment. This document proposes guidance on the use of the TTC approach, updating the Scientific Committee opinion of 2012 by considering the latest developments in the field. This guidance is meant for EFSA Panels/Units for the use of the TTC approach as a screening and prioritization tool for the safety assessment of chemicals, when hazard data are incomplete and human exposure can be estimated as low. The TTC approach should not be used for substances for which EU legislation requires the submission of toxicity data or when data are available that allow risk assessment.

Interested parties are invited to submit written comments by 10 January 2019.

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.004 [at] . Please note that comments will not be
considered if they:

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
  • 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

Copyright-cleared contributions

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 cleared1 taking 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

Publication of contributions

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.