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GMO UNIT
SCIENTIFIC PANEL ON GMO
Minutes of the 83rd Plenary meeting of the Scientific Panel on GMO
Held on 3–4 July 2013, Parma
(Agreed on 11 September 2013)
Participants
Panel members:
1
Andrew Chesson, Patrick du Jardin , Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-
2
Gunn Opsahl Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Løvik , Antoine
1
Messéan, Hanspeter Naegeli, Kaare Nielsen, Jaroslava Ovesná, Joe Perry , Nils Rostoks
and Christoph Tebbe.
Hearing experts:
None.
EFSA:
GMO Unit: Jaime Aguilera, Herman Broll, Yann Devos, Zoltán Divéki, Anders Falk, Andrea
Gennaro, Ana Gomes, Anna Lanzoni, Yi Liu, Sylvie Mestdagh, Irina Olaru, Claudia Paoletti,
Andrea Pericoli, Matthew Ramon and Elisabeth Waigmann.
Other EFSA Units/Directorates: none.
European Commission observers: Maria Mirazchiyska, Sabine Pelsser (DG
SANCO).
Observers (in application of the guidelines for observers): none.
Others: none.
1. Welcome and apologies for absence
The Chair welcomed the participants.
Apologies were received from Andrew Nicholas Edmund Birch.
2. Adoption of agenda
The agenda was adopted without changes.
1
Attended via teleconference.
2
Attended on 3 July only.
European Food Safety Authority – Via Carlo Magno 1/a, 43126 Parma, ITALY
Tel: (+39) 0521 036 200 • Fax: (+39) 0521 036 0200 • www.efsa.europa.eu
Version 1.1
GMO UNIT
3. Declarations of interest
In accordance with EFSA’s Policy on Independence and Scientific Decision-Making
Processes regarding Declarations of Interests (DoIs) and the Decision of the Executive
Director implementing this Policy, EFSA screened the Annual Declaration of Interest (ADoI)
and the Specific Declaration of Interest (SDoI) filled in by the experts invited to the present
meeting. No conflicts of interests relating to the issues discussed in this meeting were
identified during the screening process or in the Oral Declaration of Interest (ODoI) at the
beginning of this meeting.
4. Agreement of the minutes of the 82nd Plenary meeting held on 29–30 May 2013,
Parma
The minutes of the 82nd GMO Plenary meeting (29–30 May 2013) were adopted and will be
published at: EFSA Event: 82nd plenary meeting of GMO Panel
5. Report on written procedures since the 82nd Plenary meeting
There have been no written adoptions since the 82nd Plenary meeting.
6. Scientific outputs submitted for discussion and possible adoption
6.1 Application for authorisation of genetically modified cotton MON 88913 and
derived food and feed submitted under Regulation (EC) No 1829/2003 by
Monsanto (EFSA-GMO-UK-2007-41) (EFSA-Q-2007-085)
Cotton MON 88913 contains one insert consisting of the CP4 epsps expression cassette,
providing herbicide tolerance. Bioinformatics-supported identification of hazards linked to the
formation of new open reading frames caused by the insertion could not be completed due to
the use of an outdated toxin database. Genetic stability studies did not raise safety issues.
No biologically relevant differences which would raise safety concerns were identified in the
composition or agronomic and phenotypic characteristics of plants and seeds obtained from
cotton MON 88913 compared with its conventional counterpart and non-genetically modified
reference varieties. Based on all the available information, there are no indications that the
newly expressed CP4 EPSPS protein in cotton MON 88913 may be allergenic or toxic.
Cotton MON 88913 was found to be as nutritious as commercially available varieties and it is
unlikely that the overall allergenicity of the whole plant is changed. There are no indications
of an increased likelihood of establishment and spread of feral cotton plants. Considering its
intended uses as food and feed, interactions with the biotic and abiotic environment were not
considered to be an issue. Risks associated with an unlikely but theoretically possible
horizontal gene transfer from cotton MON 88913 to bacteria have not been identified. The
monitoring plan and reporting intervals are in line with the intended uses of cotton MON
88913. The EFSA GMO Panel considers, however, that the information available for cotton
MON 88913 is not sufficient to reach a final overall conclusion due to the use of an outdated
toxin database for bioinformatic analyses.
The opinion was unanimously adopted by the Panel and will be published on the EFSA
website at: http://www.efsa.europa.eu/en/publications.htm
European Food Safety Authority – Via Carlo Magno 1/a, 43126 Parma, ITALY
Tel: (+39) 0521 036 200 • Fax: (+39) 0521 036 0200 • www.efsa.europa.eu
6.2 Application for authorisation of genetically modified soybean MON 87769
for food and feed uses, import and processing submitted under Regulation
(EC) No 1829/2003 by Monsanto (EFSA-GMO-UK-2009-76) (EFSA-Q-2009-
00836)
The EFSA GMO Panel discussed the draft scientific opinion, with a particular focus on the
environmental and food–feed safety-related sections. Further discussion is needed.
6.3 Application for authorisation of genetically modified maize T25 and derived
food and feed submitted under Regulation (EC) No 1829/2003 by Bayer
BioScience (EFSA-GMO-NL-2007-46) (EFSA-Q-2007-134) and Application
for renewal of authorisation for continued marketing of food produced from
and feed consisting of or containing maize T25 and maize T25 for food and
feed (EFSA-GMO-RX-T25) (EFSA-Q-2007-155)
The EFSA GMO Panel discussed the draft scientific opinion, with a particular focus on the
assessment of the agronomic and phenotypic datasets. Further discussion is needed.
7. New mandates
7.1 Applications under Regulation (EC) No 1829/2003
None.
7.2 Annual post-market environmental monitoring reports of GM plants
None.
7.3 Other requests and mandates
Three mandates were received as follows:
Self-task mandate of the EFSA GMO Panel to deliver a statement supplementing its
environmental risk assessment conclusions and risk management recommendations
on maize 59122 for cultivation (EFSA-Q-2013-00607)
Mandate for the assessment of the scientific elements supporting the Luxembourg
request to take emergency measures on the placing on the market of genetically
modified (GM) maize MON 810 seeds for cultivation purposes in the EU (EFSA-Q-
2013-00590)
Mandate for the assessment of the scientific elements supporting the Italian request
to take emergency measures on the placing on the market of genetically modified
(GM) maize MON 810 seeds for cultivation purposes in the EU (EFSA-Q-2013-
00589)
8. Feedback from the Scientific Committee/the Scientific Panel, Working Groups,
EFSA and the European Commission
8.1 Scientific Committee and other Scientific Panels
None.
3
8.2 Working Groups
Risk assessment of stacked events
The GMO Panel discussed the risk assessment of stacked events containing multiple
herbicide tolerance traits.
Retransformants
The GMO Panel discussed aspects of the risk assessment of retransformed events and how
it should take into consideration the presence/absence of event segregation in the progeny.
8.3 EFSA
None.
8.4 European Commission
A representative of the European Commission updated the Panel on applications that are
undergoing authorisation procedures and on other activities, such as the lawsuit by
Testbiotech, ENSSER and Sanbucus against the EC regarding market approval of
genetically modified soybean MON 87701 MON 89788.
9. Other scientific topics for information and/or discussion
None.
10. Any other business
a) Panel members reporting on meetings and/or conferences they attended on
behalf of the EFSA
None.
b) Paper by Carman et al. and other recent publications
3
The EFSA GMO Unit gave a presentation on the recent paper by Carman et al. 2013 , which
claimed that gastric inflammation and uterine weight increase occurred in standard
commercial pigs fed a GM soy and maize diet for 22.7 weeks in a US farm. It was highlighted
that major drawbacks were identified in the study presented by Carman et al. such as the
lack of controlled and standardised experimental conditions, of comprehensive
characterisation of the GMs/diet, of proper expertise in data generation and interpretation.
Taken together, these study limitations led to the generation of incomplete, inaccurate,
ambiguous and inconsistent results.
The conclusion was that the study presented by Carman et al. is not-compliant with standard
practices/guidelines for toxicological assessment and shows several inaccuracies and
incompleteness in the experimental settings, methodological approaches and data
evaluation. Overall, the study presented is considered unsuitable for concluding on GM plant-
related organ toxicity in pigs.
3
Carman J.A, Vlieger HR, Ver Steeg LJ, Sneller VE, Robinson GW, Clinch-Jones CA, Haynes JI, Edwards JW,
2013. A long-term toxicology study on pigs fed a combined genetically modified (GM) soy and GM maize diet.
Journal of Organic Systems, 8, 38–54.
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