Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00027006%3A_____%2F15%3AN0000001" target="_blank" >RIV/00027006:_____/15:N0000001 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.2903/j.efsa.2015.4129" target="_blank" >http://dx.doi.org/10.2903/j.efsa.2015.4129</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.2903/j.efsa.2015.4129" target="_blank" >10.2903/j.efsa.2015.4129</a>

Result language

angličtina

Original language name

Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003

Original language description

According to Articles 11(6) and 23(6) of Regulation (EC) No 1829/2003 on genetically modified food and feed, the European Food Safety Authority should publish detailed guidance to assist applicants in the preparation and presentation of their applications for the renewal of authorisations of that genetically modified food and feed. This guidance document describes the data requirements for renewal applications, which should contain a copy of the authorisation, post-market monitoring and post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies performed by or on behalf of the applicant during the authorisation period. The applicant is requested to assess the collected information and conclude whether the previous risk assessment remains valid. The applicant can also propose amending or complementing the original conditions of the authorisation, including the monitoring plan(s).

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

40402 - GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming

Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

EFSA JOURNAL

ISSN

1831-4732

e-ISSN

1831-4732

Volume of the periodical

13

Issue of the periodical within the volume

6

Country of publishing house

IT - ITALY

Number of pages

8

Pages from-to

UNSP 4129

UT code for WoS article

000409034600008

EID of the result in the Scopus database

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