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Public consultation on the draft scientific guidance for the submission of dossiers on food enzymes

EFSA is holding an open consultation on a draft “scientific Guidance for the submission of dossiers on food enzymes”. This document describes scientific data to be included in applications for the authorisation of new food enzymes, as well as for the extension of use for existing authorisations, submitted under  Regulation (EC) No 1331/2008 and its implementing Rules.

Interested parties are invited to submit written comments by 9 May 2021.

Please use the electronic template provided to submit comments and refer to the line and page numbers. While the template is the only platform to be used for submitting comments, additional information to support your comments can be submitted using the upload function available in the tool (maximum size of 1 Mb). In case of technical issues in uploading the supporting files, you can contact the FIP unit by email: fip [at] (fip[at]efsa[dot]europa[dot]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 EFSA’s Panel on Food Contact Materials, Enzymes and Processing Aids, if found to be relevant for the guidance document.

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 and any additional information supporting the comments should inter alia be copyright-cleared by 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

The comments and the related supporting information submitted will be published (as part of an EFSA report published together with the final opinion) and may be re-used by EFSA in a different context. It should be noted that comments 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. Comments submitted on behalf of an organization are also made publicly available and attributed to the organization in question.

Please note that additional information provided to support comments will be published as well.  Besides ensuring that the submission is copyright-cleared, PC respondents shall make sure that the material can be published as such by EFSA without any need for further editing or redaction, including the masking or suppression of any personally identifiable information (e.g.: person’s name, contact details, signature).

Webinar during the public consultation

Two webinars will be held to enhance the clarity of the draft guidance document.

  • Webinar on the “Toxicological studies for the submission of a dossier on food enzymes” on 29 March 2021, 09.30-12.30 (CET) (for more details, please refer to this dedicated webpage).
  • Webinar on the “Food enzyme intake model (FEIM)” on 31 March 2021, 09.30-12.30 (CET) (for more details, please refer to this dedicated webpage).

Stakeholder online workshop after the public consultation

An online workshop with the relevant stakeholders and interested parties is planned after the public consultation, on 21 and 22 June 2021 (14:00-18:00 CET). The aim is to discuss the comments raised during the public consultation and to exchange views. An on-line registration form will be available in near future.