d'efficacité de ces toxines Bt et un recours à des méthodes de lutte potentiellement plus préjudiciables à l'environnement, des stratégies appropriées de gestion de ce risque associées à un plan de surveillance spécifique devront être mises en œuvre ;

- aucun risque spécifique associé au maïs 1507 x 59122 n'a été identifié pour les espèces non-cibles étudiées. Les limites de certaines études ne permettent toutefois pas d'écarter de possibles effets sur les organismes non-cibles. L'évaluation des risques du maïs 1507 x 59122 sur les organismes non-cibles n'a pas été finalisée du fait d'incertitudes résiduelles associées au maïs 59122 ;

- les plans de surveillance spécifique et générale proposés par le pétitionnaire manquent de précisions et devront être complétés avant toute mise sur le marché ;

- les mesures visant à assurer la coexistence entre les filières seront définies par les autorités compétentes pour les différents seuils de présence fortuite d'OGM applicables selon les filières considérées.

Le CS du HCB recommande que, si elle était autorisée, la mise sur le marché du maïs 1507 x 59122 soit accompagnée de mesures propres à répondre au risque de développement de résistance aux toxines qu'il exprime, à surveiller d'éventuels effets non anticipés selon un plan de surveillance générale actualisé, à suivre l'évolution de la sole cultivée aux dépens des espaces naturels, et à respecter les exigences de coexistence des filières.

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Annexe 1 : Saisine

<figure><img src="image_7.png" /></figure>

Liberté • Égalité • Fraternité

RÉPUBLIQUE FRANÇAISE

MINISTÈRE DE L'AGRICULTURE
DE L'AGROALIMENTAIRE ET DE LA FORÈT

Direction générale de
l'alimentation

Service des actions
sanitaires en production
primaire

Sous direction de la
qualité et de la protection
des végétaux

Bureau de la
biovigilance, des
biotechnologies et de la
qualité des végétaux

251, rue de Vaugirard
75732 Paris cedex 15

Madame Christine NOIVILLE
Présidente du Haut conseil des
biotechnologies
à l'attention de Madame Joëlle BUSUTTIL
244, boulevard Saint-Germain
75007 PARIS

1 5 JUIL. 2015

Paris, le

Objet : saisine du Haut conseil des biotechnologies sur un dossier de demande de mise sur le marché d'OGM

Références : saisine HCB - dossier NL-2005-28

Affaire suivie par : Anne Grevet

tél. : 01 49 55 58 25 fax : 01 49 55 59 49

courriel : anne.grevet@agriculture.gouv.fr

PJ : 1 dossier

Madame la Présidente,

Dans le cadre du règlement 1829/2003 relatif aux denrées alimentaires et
aliments pour animaux génétiquement modifiés, l'évaluation des dossiers de
demande de mise sur le marché est confiée à l'Autorité européenne de sécurité
des aliments (AESA). Pendant cette période d'évaluation, l'AESA consulte les États
membres sur les dossiers. Lorsque l'AESA a rendu un avis, la Commission
européenne propose au vote des États membres un projet de décision.

Le dossier suivant est susceptible de faire prochainement l'objet d'un avis de
l'AESA, qui sera suivi d'un vote des États membres sur un projet de décision :

* dossier EFSA-GMO-NL-2005-28, concernant la mise sur le marché du maïs génétiquement modifié 1507x59122 pour la culture, l'importation, la transformation, l'alimentation humaine et animale.

Dans la perspective d'un vote des États membres sur ce dossier, j'ai
l'honneur de vous demander, par la présente saisine, de bien vouloir procéder à
une évaluation de ce dossier afin de rendre un avis au plus tard le 30 novembre
2015.

Je vous prie de croire, Madame la Présidente, à l'assurance de ma
considération distinguée.

<figure><img src="image_8.png" /></figure>

Le sous-directeur de la qualité
et de la protection des végétaux

Alain TRIDON
Annexe 2 : Elaboration de l'avis

Cet avis a été élaboré par le CS du HCB à partir de la discussion de rapports d'expertise et d'un projet d'avis en séance du 26 novembre 2015⁴⁶ ainsi que des vérifications et compléments ultérieurs par voie électronique sous la présidence du Dr Jean-Christophe Pagès et la vice-présidence du Dr Pascal Boireau et du Dr Claudine Franche.

Le CS du HCB est un comité pluridisciplinaire composé de personnalités scientifiques nommées par décret au titre de leur spécialité en relation avec les missions du HCB. Par ordre alphabétique des noms de famille, le CS du HCB est composé de :

Claude Bagnis, Avner Bar-Hen, Marie-Anne Barny, Florence Bellivier, Philippe Berny, Yves Bertheau, Pascal Boireau, Thierry Brévault, Bruno Chauvel, François-Christophe Coléno, Denis Couvet, Elie Dassa, Hubert De Verneuil, Nathalie Eychenne, Claudine Franche, Philippe Guerche, Joël Guillemain, Guillermina Hernandez-Raquet, André Jestin, Bernard Klonjkowski, Marc Lavielle, Valérie Le Corre, Olivier Lemaire, Didier Lereclus, Rémi Maximilien, Eliane Meurs, Cédric Moreau de Bellaing, Nadia Naffakh, Didier Nègre, Jean-Louis Noyer, Sergio Ochatt, Jean-Christophe Pagès, Daniel Parzy, Catherine Regnault-Roger, Michel Renard, Patrick Saindrenan, Pascal Simonet, Marie-Bérengère Troadec, Bernard Vaissière, Jean-Luc Vilotte<fnref n="47" />.

Le dossier a été examiné par 12 experts rapporteurs sélectionnés parmi les membres du CS pour leurs compétences dans les disciplines requises pour l'analyse du dossier.

Les membres du CS du HCB remplissent annuellement une déclaration publique d'intérêts. Ils sont également interrogés sur l'existence d'éventuels conflits d'intérêts avant l'examen de chaque dossier. Susceptible de participer à l'élaboration du futur avis de l'EFSA en tant que membre du panel OGM de l'EFSA, Philippe Guerche n'a contribué ni à l'analyse de ce dossier, ni à l'élaboration de cet avis. Aucun membre du CS n'a déclaré avoir de conflits d'intérêts qui auraient pu interférer avec l'élaboration de cet avis.

<footnote n="46">⁴⁶ Membres du CS présents et représentés lors de la discussion du projet d'avis en séance du 26 novembre 2015 : Marie-Anne Barny, Yves Bertheau, Pascal Boireau, Thierry Brévault, Bruno Chauvel, Elie Dassa, Hubert De Verneuil, Claudine Franche, Philippe Guerche, Joël Guillemain, André Jestin, Marc Lavielle, Valérie Le Corre, Olivier Lemaire, Didier Lereclus, Rémi Maximilien, Eliane Meurs, Nadia Naffakh, Didier Nègre, Sergio Ochatt, Jean-Christophe Pagès, Catherine Regnault-Roger, Michel Renard, Pascal Simonet, Marie-Bérengère Troadec, Bernard Vaissière, Jean-Luc Vilotte. Il est noté que Yves Bertheau a présenté sa démission du Comité scientifique le 3 février 2016.</footnote>

<footnote n="47">⁴⁷ Composition du CS en vigueur suite au décret de nomination des membres du HCB du 30 décembre 2014.</footnote>