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Public consultation on the draft EFSA Scientific Committee opinion "Evaluation of existing guidelines for their adequacy for the microbial characterisation and environmental risk assessment of micro-organisms obtained through synthetic biology"

EFSA's Scientific Committee has launched an open consultation on its draft opinion "Evaluation of existing guidelines for their adequacy for the microbial characterisation and environmental risk assessment of micro-organisms obtained through synthetic biology". This document proposes answers to the request from the European Commission, to consider synthetic biology developments for agri-food use in the near future and if the use of this technology is expected to constitute potential risks and hazards for the environment. The adequacy of existing guidelines for risk assessment has been evaluated by this draft Opinion, which is endorsed by the Scientific Committee for public consultation. Also updated guidance is suggested where needed. The scope of this draft Opinion is limited to living synthetic biology micro-organisms (SynBioM) expected to be deliberately released into the environment.

Interested parties are invited to submit written comments by 04/06/2020 (extended deadline). 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.005 [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.

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 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.

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.