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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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).

Název v anglickém jazyce

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

Popis výsledku anglicky

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).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

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

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2015

Kód důvěrnosti údajů

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

Název periodika

EFSA JOURNAL

ISSN

1831-4732

e-ISSN

1831-4732

Svazek periodika

13

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

IT - Italská republika

Počet stran výsledku

8

Strana od-do

UNSP 4129

Kód UT WoS článku

000409034600008

EID výsledku v databázi Scopus

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