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EFSA Guidance on Renewal of GMO Food Authorization Available

放大字体  缩小字体 Date:09 Jul 2019  Source:FOOD COMPLIANCE INTERNATIONAL  Writer:Global Foodmate  Views:209
The authorization of genetically modified (GM) food and feed in the European Union is limited to 10 years. The authorisation holder needs to request renewal of the authorization at the latest one year before expiry date of the authorisation to continue commercialization. This comprises a separate application with the European Commission which will forward the application dossier to the European Food Safety Authority (EFSA). The latter instance, functioning as the European risk assessor, has published guidance on the submission of applications of the renewal of authorisation of  genetically  modified  food  and  feed. It elaborates on the format and structure of the application as well as the presentation of data. Essentially, the required information largely corresponds with the original application for authorization of GM food and feed.

important to note for renewal applications is the legal obligation to include all new information that has become available in relation to the safety in use of the GM food and/or feed and the risks of the GM food and/or feed to human and animal health and the environment. The applicant may however also propose amendments or completions to the original authorization.

In order to assess completeness of the renewal application, the applicant needs to provide  a checklist to show the dossier meets the structure and data requirements.

Administrative guidance on the submission of applications for renewal of authorisation of genetically modified food and feed under Articles 11 and 23 of Regulation (EC) No 1829/2003 (14 June 2019)
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