TY - JOUR
T1 - Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003
AU - Arpaia, Salvatore
AU - Birch, Andrew Nicholas Edmund
AU - Chesson, Andrew
AU - du Jardin, Patrick
AU - Gathmann, Achim
AU - Gropp, Jürgen
AU - Herman, Lieve
AU - Hoen-Sorteberg, Hilde-Gunn Opsahl
AU - Jones, Huw
AU - Kiss, József
AU - Kleter, Gijs
AU - Lovik, Martinus
AU - Messéan, Antoine
AU - Naegeli, Hanspeter
AU - Nielsen, Kaare Magne
AU - Ovesna, Jaroslava
AU - Perry, Joe
AU - Rostoks , Nils
AU - Tebbe, Christoph
PY - 2015
Y1 - 2015
N2 - 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).
AB - 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).
KW - renewal authorisation
KW - GM food and feed
KW - Regulation (EC) No 1829/2003
KW - Articles 11 and 23
UR - http://hdl.handle.net/2160/44567
U2 - 10.2903/j.efsa.2015.4129
DO - 10.2903/j.efsa.2015.4129
M3 - Article
SN - 1831-4732
VL - 13
JO - EFSA Journal
JF - EFSA Journal
IS - 6
M1 - 4129
ER -
