EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate B - Natural Capital
ENV.B.1 - Agriculture, Forests and Soil
Brussels, 01/06/2016
ENV/CP
NOTE TO
DG SANTE. E.3
Subject:
REPLY FROM DG ENV.B.1 TO 3 INTERSERVICE CONSULTATIONS LAUNCHED BY
DG SANTE
ISC/2016/01312 de la DG SANTE
Draft Commission Implementing Decision authorising the placing on the market
for cultivation of genetically modified maize Bt11 (SYN-BTØ11-1) seeds, in
accordance with Directive 2001/18/EC of the European Parliament and of the
Council
ISC/2016/01316 de la DG SANTE
Draft Commission Implementing Decision renewing the authorisation for the
placing on the market of genetically modified maize MON 810 (MON-00810-6)
seeds for cultivation pursuant to Regulation (EC) No 1829/2003 of the European
Parliament and of the Council
Consultation ISC/2016/01321 de la DG SANTE
Draft Commission Implementing Decision authorising the placing on the market
for cultivation of genetically modified maize 1507 (DAS-Ø15Ø7-1) seeds, in
accordance with Directive 2001/18/EC of the European Parliament and of the
Council
Notes signed by: MIKO Ladislav
Deadline for replies: 1/06/2016
Service: DG SANTE. E.3
Favourable opinion
Favourable opinion subject to account being taken of the following comments
Unfavourable opinion
Contact:
(Tel.:
)
Comments
Thank you for consulting DG Environment on the 3 draft proposals indicated in subject.
Before the authorisation in the market of these maize varieties, we would ask that our
comments as presented below are taken into account.
DG SANTE is proposing to authorise or renew the marketing of seeds for cultivation in the EU
of the 3 following maize varieties:
- The genetically modified maize MON810 (for renewal) which confers protection
against certain lepidopteran insect pests, including the European Com Borer (ECB)
(
Ostrinia nubilalis) and pink borers (
Sesamia spp).
- The genetically modified maize Bt11 which confers resistance to the European Corn
borer (Ostrinia nubilalis) and the Mediterranean com borer (Sesamia nonagrioides) and
tolerance to the herbicide glufosinate ammonium.
- The genetically modified maize 1507 which confers resistance to the European Corn
borer (Ostrinia nubilalis) and certain other lepidopteran pests and tolerance to the
herbicide glufosinate ammonium.
These proposals are based on scientific opinions provided by EFSA quite some time ago, which
include environmental risk assessments:
- On maize MON 810, EFSA published an opinion on 30 June 2009 which concluded
that MON 810 is unlikely to have any adverse effect on the environment. Three
additional opinions were published in 2012 (two) and 2015.
- On maize Bt11, EFSA published an opinion on 19 May 2005 which concluded that
there is no evidence to indicate that the placing of maize Bt11on the market is likely to
cause adverse effect on the environment. Since then, 5 additional opinions addressing
or being relevant for maize Bt11 have been published.
- On maize 1507, EFSA published an opinion on 3 March 2005 which concluded that
there is no evidence to indicate that the placing on the market of maize 1507 is likely to
cause adverse effects on the environment. Since then, 6 additional opinions addressing
or being relevant for maize 1507 have been published.
We are concerned that the risk assessments which are used as the basis for the decision are
comparatively old and do not take account of more recent substantial evidence.
Moreover, these assessment have, in our view some additional gaps.
Teosinte is maize's ancestor and the gene flow between maize and teosinte is known. However
the EFSA assessment do
not take into account the occurrence of teosinte in the EU and are
all based on the following assumption: "
for Zea maize any vertical gene transfer is limited to
other maize plants as populations of sexually compatible wild relatives of maize are not known
in Europe". However, the presence of teosinte in Spain is attested in the regions Aragón and
Cataluña and is also suspected to be present in Navarra. In the region of Aragón, information
from 20141 estimated that teosinte could be present in about 200-300 ha. According to other
sources, the total affected surface in Spain would be around 750 ha, most of it located in
Aragón. The difficulties of identification of teosinte could have led to an under-estimation of
the problem. There is no information on the possible presence of teosinte in natural areas. The
development of teosinte as a weed in the fields has been so problematic that the regional
authorities have promoted measures to fight against it in the areas affected2. In November 2014,
a parliamentary question (question E-008766-14) alerted the Commission of the introduction of
teosinte into Aragon and Catalonia (Spain).
Therefore the scientific opinions of EFSA on the 3 GM maize varieties should be up-dated
in order to take into account the presence of teosinte as a weed in the EU and the
1
http://www.aragon.es/estaticos/GobiernoAragon/Departamentos/AgriculturaGanaderiaMedioAmbiente/T
EMAS AGRICULTURA GANADERIA/Areas/03 Sanidad Vegetal/PUBLICACIONES CSCV/I F T
EOSINTE.pdf; https://www.ruralcat.net/c/document library/get file?uuid=f1205dc5-5cbf-4a00-adb7-
127d84c6b0da&groupId=10136; - http://www.ruralcat.net/c/document library/get file?uuid=00058f39-
ecb2-4d88-973c-3bff29035955&groupId=10136
2 https://www.ruralcat.net/web/guest/noticia/-/journal content/2002/10136/9842282/
2