Les podcasts de Gastronomie moléculaire
sur le site d'AgroParisTech
1. Des objets de connaissance pour tous les publics
Podcasts audio
En français :
Vrai ou faux ?
Cinq minutes pour raconter l'histoire d'un mets et répondre à une question technique
Comment avoir des frites moins grasses : un bain ? Deux bains ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/f1466/Les_frites_moins_grasses_.html
Comment rattraper une mayonnaise qui a tourné ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/3f6f0/Rattraper_la_mayonnaise.html
Faut-il des bassines en cuivre pour faire des confitures ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/1d440/Les_bassines_a_confiture.html
Faut-il vraiment un bain-marie pour cuire les terrines ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/39d22/Terrines.html
Comment obtenir des oeufs durs au jaune bien centré ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/63733/Oeufs_durs_centres.html
Comment éviter d'avoir des lentilles trop dures ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/36893/Lentilles.html
Peut-on faire la sauce mayonnaise à la cuiller en bois ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/ccdbb/Mayonnaise_blanche_et_ferme.html
Les règles féminines font-elles tourner les sauces ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/4505a/Femmes_et_regles_partie_2.html
La mayonnaise, sauce fragile ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/49aa3/Femmes_et_regles_partie_1.html
Comment avoir des cochons de lait rôtis à la peau croquante ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/f7693/Cochons_de_lait_rotis.html
Faut-il du jus de citron pour avoir des blancs d'oeufs en neige ferme ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/ba296/Blanc_en_neige.html
Les échaudés, notamment les gnocchis, sont-ils cuits quand ils viennent flotter à la surface ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/8f904/Les_gnocchis.html
Faut-il éviter de piquer la viande grillée ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/35956/Griller_des_viandes.html
Faut-il du jaune d'oeuf pour faire une sauce aïolli ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/552f5/_Laiolli_recette_meconnue_et_devoyee.html
Comment saler les viandes que l'on grille ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/92dfe/Le_sel_et_la_viande__une_question_ancienne.html
Est-il vrai que le bouillon ne doit pas bouillir ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/ff0a1/Le_Bouillon.html
Podcasts vidéo :
En français :
Les Cours annuels de gastronomie moléculaire INRA/AgroParisTech. Ces cours durent deux jours, et ils sont intégralement filmés. Les enregistrements sont divisés par demi journées.
Le Cours 2009 : Science, technologie, technique (culinaires) : quelles relations ?
Http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/73895/Les_precisions_culinaires_18.html
Le Cours 2010 : les précisions culinaires
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/f1ba0/Cours_2010_Partie_18.html (2 jours de cours, 8 parties)
L'annonce du Cours 2011
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/675b8/Annonce_cours_Gastronomie_Moleculaire_2011.html (2 jours complets de cours, en plusieurs podcasts)
Le Cours 2011 : Cuisson des légumes et téléenseignement
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/c71ff/Cours_de_Gastronomie_Moleculaire_2011.html (2 jours complets de cours, en plusieurs parties)
Le Cours 2012 : La cuisine note à note
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/706a3/Cours_de_Gastronomie_Moleculaire_2012.html (2 jours complets de cours, en plusieurs parties)
La cuisine note à note : présentation du manifeste/manuel de cette cuisine révolutionnaire
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/d1c19/La_cuisine_Note_a_Note.html
Des débats
L'art culinaire existe-t-il ?
Débat avec Pierre Gagnaire, Pierre Dominique Cécillon, animé par Vincent Olivier (L'Express)
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/8e049/Lart_culinaire_existetil___Partie_1.html (débat, 3 parties)
Des questions techniques illustrées par le calcul et l'expérience
Des jeux avec de la mayonnaise
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/b0967/Experience_sur_la_mayonnaise_2.html
Les émulsions
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/ccdd0/Experience_sur_la_mayonnaise_1.html
Podcasts vidéo en anglais :
Des cours en anglais
Cours de gastronomie moléculaire à l'attention des auditeurs des Hautes Etudes du Goût
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/1c19a/Conference_Ecole_du_Cordon_Bleu__Partie_22.html (cours de gastronomie moléculaire pour les Hautes Etudes du Goût, plusieurs parties)
2. Des documents pédagogiques pour les étudiants et les professionnels (science)
Collèges, lycées
Des conférences pour les collèges et lycées, avec des expériences
Conférence pour les collégiens et lycéens : dans la cuisine, il y a une foule de métiers.
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/345a5/Le_choix_dun_metier.html
La cuisine et la science : quelles relations ?
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/a35c4/Conference_Fete_de_la_Science__Partie_13.html (3 parties)
Pour les enseignants de l'Education nationale :
Des formations pédagogiques
Une formation à la mise en oeuvre des Ateliers expérimentaux du goût et des Ateliers Science & Cuisine
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/a66c5/Comment_mettre_en_oeuvre_les_ateliers_experimentaux_du_gout_.html
Une formation à la mise en oeuvre des Ateliers expérimentaux du goût et des Ateliers Science & Cuisine
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/8cbc1/Formation_ateliers_experimentaux_du_gout.html
Pour les étudiants d'université :
Des cours filmés
Cours de communication scientifique
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/69a85/La_communication_scientifique.html
Débat sur le métier d'ingénieur, la science et ses relations avec la technique et la technologie
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/da981/Science_technologie_technique__quelles_relations_.html
Cours de calcul et de chimie physique : comment calculer le volume maximal d'une émulsion, et comment utiliser un logiciel de calcul formel tel que Maple
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/b3e89/Calcul_sur_la_mayonnaise.html
Journée scientifique à AgroParisTech : 20 ans de gastronomie moléculaire
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/3fb6d/20_ans_de_Gastronomie_Moleculaire_.html
Une présentation des progrès méthodologiques en chimie, à partir d'un article de Lavoisier sur les bouillons de viande. On y montre que Lavoisier a introduit la méthode du zéro
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/7f668/Lavoisier_et_le_bouillon.html
En anglais :
For students mostly : celebrate physical chemistry !
A short calculation : how much mayonnaise can you make from one egg
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/4fef7/How_much_mayonnaise_sauce_can_you_make_from_only_one_egg.html
A long calculation : how to calculate, how much mayonnaise can you make from one egg, and how to use a formal calculation software for the study of this kind of questions
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/f0e13/How_much_mayonnaise_sauce_can_you_make_from_only_one_egg.html
Two differents sessions with the same goal.
Introduction of the Molecular Gastronomy Programme of the Eramus Mundus Master Programme « Food Innovation and Produc Design » (FIPDes) : theoretical aspects
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/3a859/Gastronomie_Moleculaire_et_FIPDes_22.html
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/fe9ab/Chefs_meets_scientists.html
Introduction of the Molecular Gastronomy Programme of the Eramus Mundus Master Programme « Food Innovation and Produc Design » (FIPDes) : chefs meet scientists
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/452dc/Gastronomie_Moleculaire_et_FIPDes_12.html
Introduction to the Molecular Gastronomy Programme of FIPDes, session « Chefs meets scientists » 2012
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/fe9ab/Chefs_meets_scientists.html
Introduction to the Molecular Gastronomy Programme of FIPDes 2012-2013
http://podcast.agroparistech.fr/groups/agroparistech/weblog/f0ec2/Molecular_Gastronomy_activities_and_teaching_in_DIT_Ireland.html
http://podcast.agroparistech.fr/groups/agroparistech/weblog/1bd22/Molecular_Gastronomy_activities_and_teaching_in_AgroParisTech.html
http://podcast.agroparistech.fr/groups/agroparistech/weblog/22e77/Molecular_Gastronomy_activities_and_teaching_in_Napoli_University.html
How to use « FMS » for doing scientific research
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/bde7a/How_to_use_FMS.html
Note by Note Cuisine
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/a5096/Note_by_Note_cuisine.html
Disperse Systems Formalism
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/80938/DSF__Disperse_Systems_Formalism.html
Molecular Gastronomy and Formulation
http://podcast.agroparistech.fr/users/gastronomiemoleculaire/weblog/eda22/Molecular_Gastronomy_and_formulation.html
dimanche 21 octobre 2012
Cuisine note à note, le 20 octobre 2012, à l'Ecole Le Cordon Bleu Paris
Le 20 octobre, nouveau diner note à note dans le cadre des enseignements des Hautes Etudes du Goût, à Paris :
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Et quelques images :
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Menu
Note à Note
Note
by Note Menu
20
OCTOBRE 2012
20
OCTOBER 2012
LES
AMUSES BOUCHES
GOMME
DE LÉGUME ET PAPYRUS DE BETTERAVE
Vegetable « gum »
with beet papyrus
FANTAISIE FUMÉE À
L'ASPERGE
Smoked asparagus
fantasy
ROYALE
DE VOLAILLE JAUNE ET ROUGE
Yellow
and red chicken royale
Champagne
Louis Roederer "Brut Premier"
LE
DÎNER
Instant
infused note
CANNELLONI
DE MANGUE-LANGOUSTINE, EFFERVESCENCE DE CARCASSE
Mango-langoustine
cannelloni, shell froth
Alsace
Gewurztraminer 2010 Albert Mann
VIANDE
« SPRAY » À MANGER
Sp“ready”
to m“eat” spray
Magnum
Saint-Joseph 2009 Stéphane Ogier
BABYNOTE-À-MOUSSE
Mousse-note
« babybel »
TARTE
AUX FRAISES ET CITRON REVISITÉE
Revisited
strawberry and lemon tart
Coteaux
du Layon 2010 Patrick Baudouin
Et quelques images :
samedi 13 octobre 2012
Attention : la nature n'est pas bonne !
Actu alertes
Intoxications alimentaires liées à la consommation de farine de sarrasin
12/10/2012
Dix huit cas
d’intoxication alimentaire sont survenus dans la région
Provence-Alpes-Côte d’Azur entre le 21 septembre et le 10 octobre 2012.
Une enquête a été entreprise par l’Agence régionale de Santé (ARS), et par les services de la concurrence, de la consommation et de la répression des fraudes (DGCCRF) afin d’identifier le ou les produits à l’origine de l’intoxication.
Les boulangeries, magasins ou crêperies qui ont utilisé ou vendu cette farine de sarrasin ou les produits élaborés à partir de celle-ci (pains, crêpes, galettes…) ont été informés de cette contamination et ont cessé la commercialisation de ces produits. Des affichettes informent les consommateurs sur les lieux de vente du retrait et des mises en garde concernant ces produits.
Les personnes qui auraient consommé les produits mentionnés ci-dessus et qui présenteraient ce type de symptômes sont invitées à appeler le 15 ou de consulter rapidement leur médecin traitant en signalant le fait ainsi que le lieu et la date d’achat des aliments.
En savoir plus sur le datura :
Une enquête a été entreprise par l’Agence régionale de Santé (ARS), et par les services de la concurrence, de la consommation et de la répression des fraudes (DGCCRF) afin d’identifier le ou les produits à l’origine de l’intoxication.
Quelle est la cause ?
Ces investigations ont conduit à mettre en cause de la farine de sarrasin bio potentiellement contaminée par du datura, une plante sauvage connue pour sa forte teneur en alcaloïdes toxiques pour l’homme (atropine et scopolamine), qui se développe parfois aux abords des champs et peut contaminer les cultures lors des moissons.Les boulangeries, magasins ou crêperies qui ont utilisé ou vendu cette farine de sarrasin ou les produits élaborés à partir de celle-ci (pains, crêpes, galettes…) ont été informés de cette contamination et ont cessé la commercialisation de ces produits. Des affichettes informent les consommateurs sur les lieux de vente du retrait et des mises en garde concernant ces produits.
Les symptômes
Les symptômes décrits sont ceux d’une intoxication par l’atropine (sécheresse buccale, pupilles dilatées, troubles de la vue, tachycardie, agitation confusion, désorientation spatiotemporelle, hallucinations, paroles incohérentes).Les personnes qui auraient consommé les produits mentionnés ci-dessus et qui présenteraient ce type de symptômes sont invitées à appeler le 15 ou de consulter rapidement leur médecin traitant en signalant le fait ainsi que le lieu et la date d’achat des aliments.
Les recommandations
Si vous possédez un produit bio à base de farine de sarrasin, il est conseillé de contacter le lieu d’achat afin de savoir si le produit est concerné par cette mise en garde ou non.En savoir plus sur le datura :
Qu’est-ce que le datura ?
12/10/2012
Le datura est une plante toxique, dont la consommation peut entraîner des troubles hépatiques, nerveux et sanguins.
lundi 8 octobre 2012
Un accident : faut-il être bête !
Ce matin, je reçois :
"Lecteur et utilisateur régulier de vos ouvrages, résidant à Rennes où vous nous avez fait souvent le plaisir de vous déplacer, je tenais à vous signaler cet article de la presse britannique, qui fait état d'un accident survenu dans un bar : http://www.dailymail.co.uk/news/article-2214268/Teenager-stomach-removed-save-life-drinking-trendy-liquid-nitrogen-cocktail.html
Continuez votre travail, pour notre plus grand intérêt."
Je suis donc allé sur le site du Daily Mail, et j'ai vu la chose. Oui, boire un liquide où subsiste de l'azote liquide, c'est comme avaler un couteau de cuisine !
Faut-il être suicidaire ou inconscient, ou bête !
Je répète la règle (minimale) d'utilisation :
- ne jamais consommer s'il reste de l'azote liquide, des bulles, de la fumée
- mettre des lunettes et des gants pour manipuler
- ne jamais stocker dans un conteneur fermé
- etc !!!!!!!!!!!!!!!!!!!!!!!!!!!!!
De même, pour un couteau de cuisine :
- ne pas l'enfoncer dans le ventre du voisin
- ne pas courir en le tenant la pointe en l'air
- etc.
"Lecteur et utilisateur régulier de vos ouvrages, résidant à Rennes où vous nous avez fait souvent le plaisir de vous déplacer, je tenais à vous signaler cet article de la presse britannique, qui fait état d'un accident survenu dans un bar : http://www.dailymail.co.uk/news/article-2214268/Teenager-stomach-removed-save-life-drinking-trendy-liquid-nitrogen-cocktail.html
Continuez votre travail, pour notre plus grand intérêt."
Je suis donc allé sur le site du Daily Mail, et j'ai vu la chose. Oui, boire un liquide où subsiste de l'azote liquide, c'est comme avaler un couteau de cuisine !
Faut-il être suicidaire ou inconscient, ou bête !
Je répète la règle (minimale) d'utilisation :
- ne jamais consommer s'il reste de l'azote liquide, des bulles, de la fumée
- mettre des lunettes et des gants pour manipuler
- ne jamais stocker dans un conteneur fermé
- etc !!!!!!!!!!!!!!!!!!!!!!!!!!!!!
De même, pour un couteau de cuisine :
- ne pas l'enfoncer dans le ventre du voisin
- ne pas courir en le tenant la pointe en l'air
- etc.
dimanche 7 octobre 2012
Retour sur les OGM
L'étude récente sur les dangers des OGM a fait l'objet d'une expertise indépendante, qui conclut comme indiqué ci dessous. Je ne traduis que l'abstract :
ABSTRACT
Le 19 décembre 2012, Séralini et al. on publié dans le journal Food and Chemical Toxicology le résultat d'études sur 2 ans de rat alimenté avec du maïs génétiquement modifié NK603 avec et sans Roundup WeatherMAX et Roundup GT Plus alone (tous deux sont des produits de protection des plantes qui contiennent du glyphosate). L'EFSA a été mandaté par la Commission européenne pour évaluer la publication, et identifier des précisions qui pourraient être demandées aux auteurs. L'EFSA observe que l'étude de Séralini
et al. (2012) a des objectifs peu clairs, et qu'elle est mal présentée dans la publication, de nombreuses particularités expérimentales, importantes pour la conception, la mise en oeuvre et l'analyse, étant omises. Sans ces indications, il est impossible de parvenir aux conclusions que font les auteurs. On ne peut pas tirer de conclusion sur les différence dans l'incidence des tumeurs entre les groupes d'animaux sur la base de l'analyse et des résultats données par Séralini et al. (2012). En particulier Séralini et al. (2012) tirent des conclusions sur l'incidence de tumeurs pour 10 rats par traitement et par sex, ce qui est un nombre insuffisant d'animaux pour distinguer des effets d'un traitement spécifique et l'occurence par hasard de tumeurs chez les rats. Considérant que l'étude rapportée par la publication de Séralini et al. (2012) était inappropriée dans sa conception, son analyse et sa publication, l'EFSA juge qu'elle est de qualité scientifique insuffisante pour fonder des conclusions en terme de sécurité.
L'EFSA conclu donc que l'étude de Séralini et al. rapportée dans leur publication de 2012 ne peut pas conduire à une réévaluation du glyphosate, ni nécessiter une réouverture d'une évaluation de la sécurité du maïs NK603. L'EFSA invite les auteurs de la publication de Séralini et al. (2012) à fournir à l'EFSA des informations plus précise sur leur étude.
Voici le texte complet :
EFSA Journal 2012;10(10):2910
STATEMENT OF EFSA
Review of the Séralini et al. (2012) publication on a 2-year rodent feeding
study with glyphosate formulations and GM maize NK603 as published
online on 19 September 2012 in Food and Chemical Toxicology 1
European Food Safety Authority2, 3
European Food Safety Authority (EFSA), Parma, Italy
ABSTRACT
On 19 September 2012, Séralini et al. published online in the scientific journal Food and Chemical Toxicology a
publication describing a 2-year feeding study in rats investigating the health effects of genetically modified
®
®
(GM) maize NK603 with and without Roundup WeatherMAX and Roundup GT Plus alone (both are
glyphosate-containing plant protection products). EFSA was requested by the European Commission to review
this publication and to identify whether clarifications are needed from the authors. EFSA notes that the Séralini
et al. (2012) study has unclear objectives and is inadequately reported in the publication, with many key details
of the design, conduct and analysis being omitted. Without such details it is impossible to give weight to the
results. Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on the
basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication. In particular,
Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per treatment per sex which
is an insufficient number of animals to distinguish between specific treatment effects and chance occurrences of
tumours in rats. Considering that the study as reported in the Séralini et al. (2012) publication is of inadequate
design, analysis and reporting, EFSA finds that it is of insufficient scientific quality for safety assessment.
Therefore EFSA, concludes that the Séralini et al. study as reported in the 2012 publication does not impact the
ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize
NK603 and its related stacks. EFSA will give the authors of the Séralini et al. (2012) publication the opportunity
to provide further information on their study to EFSA.
© European Food Safety Authority, 2012
Key words
Maize NK603, Roundup, glyphosate, experimental design, rat/rodent feeding study, toxicity, carcinogenicity
1
2
3
On request from European Commission Question No EFSA-Q-2012-00841, approved on 3 October 2012.
Correspondence: sas@efsa.europa.eu
Acknowledgement: EFSA wishes to thank the following EFSA staff: Saghir Bashir, Per Bergman, Danièle Court Marques,
Claudia Paoletti, Manuela Tiramani, Didier Verloo and Elisabeth Waigmann for the support provided to this scientific
output. EFSA also thanks the peer reviewers of this statement Andrew Chesson (member of the GMO Panel) and Alberto
Mantovani (member of the PPR panel).
Suggested citation: European Food Safety Authority; Review of the Séralini et al. (2012) publication on a 2-year rodent
feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and
Chemical Toxicology. EFSA Journal 2012; 10(10):2910. [9 pp.] doi:10.2903/j.efsa.2012.2910. Available online:
www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2012
Review of the Séralini et al. (2012) publication
TABLE OF CONTENTS
Abstract .................................................................................................................................................... 1
Table of contents ...................................................................................................................................... 2
Background as provided by the European Commission........................................................................... 3
Terms of reference as provided by the European Commission ................................................................ 3
EFSA’s approach to address the terms of reference ................................................................................. 3
1. Introduction ..................................................................................................................................... 4
2. Overview of the study as reported in the Séralini et al. (2012) ....................................................... 4
3. Review of the Séralini et al.(2012) publication ............................................................................... 5
3.1.
Study objectives ...................................................................................................................... 5
3.2.
Study Design ........................................................................................................................... 5
3.3.
Feed and Treatment Formulation ............................................................................................ 6
3.4.
Statistical Methods .................................................................................................................. 7
3.5.
Endpoint Reporting ................................................................................................................. 7
Conclusions .............................................................................................................................................. 8
Next steps ................................................................................................................................................. 8
References ................................................................................................................................................ 8
EFSA Journal 2012;10(10):2910
2
Review of the Séralini et al. (2012) publication
BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION
On 19 September 2012, an article4 was published online in the scientific journal Food and Chemical
Toxicology that described a 2-year rat feeding study investigating the health effects of genetically
modified (GM) maize NK603 sprayed during growth with or without a Roundup® (glyphosate-
containing plant protection product) and of Roundup® alone. The authors of the study conclude that
low levels of glyphosate herbicide formulations, at concentrations well below officially set safe limits,
induce severe hormone-dependent mammary, hepatic and kidney disturbances in rats. Similarly, they
report disruption of biosynthetic pathways that may result from overexpression of the EPSPS
transgene in the maize NK603. The authors suggest that such disruptions may have given rise to
comparable pathologies that may be linked to abnormal or unbalanced phenolic acid metabolites or
related compounds.
TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION
EFSA received a mandate from DG SANCO on 26/09/2012 requesting to address the following terms
of reference as a matter of urgency.
(A) Review the scientific publication
(B) Ask any clarification needed to the authors
(C) Advise whether the publication contains new scientific elements that could lead EFSA to
reconsider the outcome of its opinion on maize NK603 and its related stacks
(D) Take into consideration the assessment of Member States
(E) Take into consideration the assessment of the German authorities responsible for the
evaluation of glyphosate
EFSA’S APPROACH TO ADDRESS THE TERMS OF REFERENCE
EFSA decided to address the terms of reference (ToR) in phases. This first EFSA statement addresses
ToR A, B and C solely based on the study information available through the Séralini et al. (2012)
publication.
A second EFSA output will cover all the ToRs and will take into account any information received
from the authors, the assessment activities from the Member States and the assessment of the German
authorities responsible for the evaluation of glyphosate.
Following the publication of Séralini et al. (2012), EFSA set up an internal task force chaired by the
Director of Regulated Products (REPRO) and composed of staff scientists with expertise in
biostatistics, experimental design, mammalian toxicology, biotechnology, biochemistry, pesticide
safety assessments and GMO safety assessments.
The task force was mandated to draft this EFSA statement which has been peer reviewed by two
experts from EFSA’s scientific panels.
4
Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin,
Joël Spiroux de Vendômois (2012) Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified
maize. Food and Chemical Toxicology, http://dx.doi.org/10.1016/j.fct.2012.08.005
EFSA Journal 2012;10(10):2910
3
Review of the Séralini et al. (2012) publication
1.
Introduction
The review presented in this statement is based solely on the details provided in the Séralini et al.
(2012) publication since the complete study documentation is currently not available to EFSA. The
Séralini et al. (2012) publication was reviewed taking into account good scientific practices such as
internationally accepted reporting guidelines (Kilkenny 2010) and internationally agreed study
guidelines (e.g. OECD guidelines for testing of chemicals5).
The Kilkenny et al. (2010) ARRIVE (Animals in Research: Reporting In Vivo Experiments)
Guidelines for Reporting Animal Research detail how to report animal experiments covering the
following areas: abstract, background, ethical statement, study design, experimental procedures,
experimental animals, housing and husbandry, sample size, allocating animals to experimental groups,
experimental outcomes, statistical methods, baseline data, number (of animals) analysed, outcome
estimation, adverse events, interpretation/scientific implications, generalisability/translation and
funding.
2.
Overview of the study as reported in Séralini et al. (2012)
Séralini et al. (2012) report that the study followed 200 five-week old Virgin albino Sprague-Dawley
rats over a period of two years. In total there were 100 female and 100 male rats used in this study.
The rats were acclimatized for 20 days before they were randomly assigned on a weight basis into
groups of 10 animals. Two rats of the same sex were housed together in a cage with a temperature of
22 3°C and humidity of 45-65%. The rats had free access to feed and water, and litter was replaced
twice weekly. Animals were monitored twice weekly with regard to general observation and palpation
of animals, recording of clinical signs, occurrence of tumours, food and water consumption, and
individual body weights.
Forty-seven biochemical parameters (from blood and urine) were measured on 11 occasions. The first
measurement was taken before the administration of treatment (baseline) and the following
measurements were taken at months 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24. Anatomopathology parameters
were collected from 36 organs. Animals were sacrificed during the study due to suffering or for ethical
reasons, otherwise pathology examination was performed at the end of the study. Histological
examination was performed on nine organs (brain, colon, heart, kidneys, liver, lungs, ovaries, spleen,
testes).
The treatments studied are three levels of glyphosate tolerant maize NK603 (GMO in the diet at 11%,
22% and 33%) treated and untreated with Roundup WeatherMAX® during its cultivation, its closest
isogenic non-GM maize (Control in the diet at 33%) and Roundup® GT Plus (glyphosate based
formulation referred as Roundup (R) in Séralini et al. (2012) at three increasing doses in drinking
water. For each sex there were 10 treatment groups, each consisting of 10 rats, as follows:
1.
2.
3.
4.
5.
6.
7.
8.
9.
5
Listed
at
effects_20745788
Control 33% maize
GMO 11% maize
GMO 22% maize
GMO 33% maize
GMO 11% maize +R
GMO 22% maize +R
GMO 33% maize +R
R (A) (1.1 x 10-8% of R)
R (B) (0.09% of R)
http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-
EFSA Journal 2012;10(10):2910
4
Review of the Séralini et al. (2012) publication
10. R (C) (0.5% of R)
Séralini et al. (2012) report pathological effects, in particular an increased tumour incidence linked to
treatment with maize NK603 and R in both sexes.
3.
Review of the Séralini et al. (2012) publication
In this section EFSA assesses the Séralini et al. (2012) publication, and highlights open issues that are
usually addressed in a properly conducted, analysed and reported study.
3.1.
Study objectives
Assessment
The study objectives are unclear in the Séralini et al. (2012) publication.
The objectives are the questions that the study is designed to answer. These questions must be pre-
specified as the design of the study, sample size calculation, statistical analysis, study conduct and
reporting are dependent on these. Depending on the objectives of the study different weight is given to
the results in the context of a safety assessment. Without clearly stating the study objectives it is
difficult to determine whether the study design and sample size used are fit for purpose or indeed what
that purpose is.
International study guidelines are designed to meet specific objectives (e.g. OECD guidelines for
chemical testing). If a specific guideline is chosen and followed then the objectives are inherently
defined in the guideline.
Open Issues
The study objectives need to be clearly stated a priori in the study protocol.
3.2.
Study Design
Assessment
Séralini et al. (2012) did not follow the internationally accepted protocols for sub-chronic, chronic
toxicity and carcinogenicity studies (e.g. OECD 408, OECD 451, OECD 452 and OECD 453)
currently recommended in the EU for food and feed safety assessment. Given that Séralini et al.
(2012) conducted a two-year study, it is unclear why an OECD guideline suitable for a two-year
chronic toxicity or carcinogenicity study (i.e. OECD 451, OECD 452 or OECD 453) was not adhered
to.
The strain of rats chosen is known to be prone to development of tumours over their life (Dinse
(2010), Brix (2005), Kaspareit (1999)). By conducting the experiment on this strain of rats over two
years, which is approximately their life expectancy, the observed frequency of tumours is influenced
by the natural occurence of tumours typical of this strain, regardless of any treatment. This is neither
taken into account nor discussed in the Séralini et al. (2012) publication.
The study design includes only one control group which is not suitable to serve as control for all the
treatment groups. In particular, Séralini et al. (2012) claimed effects on the GMO 11%, GMO 11%
+R, GMO 22% and GMO 22% +R without appropriate controls.
Séralini et al. (2012) draw conclusions on carcinogenicity by reporting on the incidence of tumours
based on 10 rats per treatment per sex. There is a high probability that the Séralini et al. (2012)
findings in relation to the tumour incidence are due to chance, given the low number of animals and
the spontaneous occurrence of tumours in Sprague-Dawley rats. This is why relevant guidelines on
EFSA Journal 2012;10(10):2910
5
Review of the Séralini et al. (2012) publication
carcinogenicity testing (i.e. OECD 451 and OECD 453) recommend using at least 50 rats per
treatment per sex. Given the limited number of animals and the chosen study design, no conclusions
on the relationship between treatment and tumour incidence can be drawn from the Séralini et al.
(2012) publication.
There is no mention of any measures taken to reduce the risk of bias such as blinding.
Open Issues
The biological relevance of the rat strain used should be justified with respect to the design
choices.
Suitable controls for all treatment groups are not present.
The sample size (power) calculation is not presented hence it is not possible to assess if the
study was sufficiently powered to meet the unclear objectives.
Measures taken to reduce the risk of bias (e.g. blinding) are not reported.
3.3.
Feed and Treatment Formulation
Assessment
The publication states that “all feed formulations consisted in balanced diets, chemically measured as
substantially equivalent except for the transgene”. However, no detailed information on either the
composition of the various diets used in the experiment or the storage conditions of the feeds over the
course of the two years is provided. The publication does not give any details regarding the possible
presence of harmful substances such as mycotoxins in the feeds used in the study.
Séralini et al. (2012) report only the application rate of the Roundup WeatherMAX® used to spray the
plants and the concentration of the Roundup® GT Plus added to the rats’ drinking water. They state
that the consumption was measured though it is not reported. Without this information it is not
possible to estimate the exposure level. Furthermore, the level of residues of glyphosate and its
metabolites on treated maize are not specified. Hence, their contribution to the reported findings
cannot be assessed. In addition, information on other chemical contaminants e.g. other pesticides
applied on the GM maize as well as on the isogenic non-GM control maize, is not provided.
Open Issues
The appropriateness and comparability of the diets cannot be assessed as critical information
about their composition is not reported.
The stability of the diets cannot be assessed as details of their storage conditions are not
provided.
It is impossible to evaluate whether or not there was any contamination of the diets, e.g. by
mycotoxins, as it is not reported.
The amount of residues of glyphosate and its metabolites in treated maize NK603 is not
reported.
The exposure to GMO, GMO +R and R cannot be evaluated since the food and water intakes
of the GM- and R-treated groups, respectively, are not clearly reported.
EFSA Journal 2012;10(10):2910
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Review of the Séralini et al. (2012) publication
Suitability of the control cannot be determined because information on the possible exposure
to other chemicals.
3.4.
Statistical Methods
Assessment
It is not reported if the statistical analyses were pre-specified in the protocol (i.e. prior to the start of
the study) or in a statistical analysis plan prior to any access to the data.
Summary statistics for all measured parameters (including biochemical and tumour related) by
treatment group and sex are not presented.
Séralini et al. (2012) have chosen an unconventional statistical methodology to analyse the
biochemical parameters instead of commonly used methods (e.g. analysis of variance). The
methodology chosen does not allow for the estimation of the (unbiased) treatment effects and their
associated variations.
Séralini et al. (2012) only present percentages and graphical summaries of the tumour incidences.
There is no modelling-based analysis (e.g. time to event analysis) to estimate the (unbiased) treatment
effects and their associated variations. For both types of analysis the issue of missing data and
multiplicity should also be addressed.
Open Issues
It is not clear if the analysis presented is consistent with any pre-planned analyses.
The reported analysis does not provide the following information needed to draw conclusions:
o o Summary statistics for all measured parameters by treatment group (and sex).
o
3.5.
A summary of drop outs and censoring (e.g. euthanised animals).
Unbiased treatment effect estimates (with confidence intervals) derived from an
appropriate statistical analyses for the chosen design and endpoint. The issues of
handling missing data and multiple testing (multiplicity) should be addressed.
Endpoint Reporting
Assessment
Far more endpoints (and measurement points thereof) than those reported in the publication were
collected by Séralini et al. (2012). It is unclear why the publication does not report the complete set of
samples collected and endpoints measured.
Clinical observations other than tumours are selectively reported: in Table 2 of Séralini et al. (2012), a
summary of the most frequent anatomical pathologies observed is presented; however a clear
presentation of all the specific lesions occurring in the different organs, for each treatment group, is
not provided.
As for the carcinogenicity assessment, attention was mainly focused on the “largest palpable growths”
with only mammary and pituitary tumours being mentioned for females and kidney and skin tumours
for males. A detailed list of all tumour types per sex per group and notation of all histopathological
lesions (including hyperplastic, pre-neoplastic and non-neoplastic) would be needed.
EFSA Journal 2012;10(10):2910
7
Review of the Séralini et al. (2012) publication
Open Issues
All collected endpoints should be reported openly and transparently.
CONCLUSIONS
EFSA notes that the study, as described in the Séralini et al. (2012) publication, is inadequately
reported with many key details of the design, conduct, analysis and reporting being omitted. Without
such details it is impossible to give weight to the subsequent results.
Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on
the basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication.
In particular, Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per
treatment per sex. This falls considerably short of the 50 rats per treatment per sex as recommended in
the relevant international guidelines on carcinogenicity testing (i.e. OECD 451 and OECD 453). Given
the spontaneous occurrence of tumours in Sprague-Dawley rats, the low number of rats reported in the
Séralini et al. (2012) publication is insufficient to distinguish between specific treatment effects and
chance occurrences of tumours in rats.
Considering that the study as reported in the Séralini et al. (2012) publication has unclear study
objectives and given its inadequate design, analysis and reporting, EFSA finds that it is of insufficient
scientific quality for safety assessments. Therefore EFSA, concludes that the Séralini et al. study as
reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not
see a need to reopen the existing safety evaluation of maize NK603 and its related stacks.
NEXT STEPS
To review the study in more detail, beyond what is reported in the Séralini et al. (2012) publication,
access would need to be given to the study documentation and procedures followed, including the
original study protocol, along with documentation on any planned or unplanned changes to it, the
statistical analysis plan, the statistical report/analyses and the final full study report. Therefore, the
authors will be made aware of the content of this EFSA statement and will be given the opportunity to
submit information to EFSA.
A second EFSA output will cover all the ToR and will take into account any information received
from the authors, the already ongoing assessment activities from the Member States (such as Belgium,
France, Germany6 and The Netherlands7) and the assessment of the German authorities responsible for
the evaluation of glyphosate.
REFERENCES
Brix, A. E. et al. (2005). Incidences of selected lesions in control female Harlan Sprague-Dawley rats
from two-year studies performed by the National Toxicology Program. Toxi-cologic Pathology 33
(4), 477-483.
Dinse, D. E. et al. (2010). Comparison of NTP historical control tumor incidence rates in female
Harlan Sprague Dawley and Fischer 344/N rats. Toxicologic Pathology 38 (5), 765-775.
Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta,
Didier Hennequin, Joël Spiroux de Vendômois (2012) Long term toxicity of a Roundup herbicide
6
http://www.bfr.bund.de/cm/343/veroeffentlichung-von-seralini-et-al-zu-einer-fuetterungsstudie-an-ratten-mit-
gentechnischveraendertem-mais-nk603-sowie-einer-glyphosathaltigen-formulierung.pdf
7
http://www.rijksoverheid.nl/bestanden/documenten-en-publicaties/notas/2012/10/03/advies-vwa-bij-onderzoek-naar-
gezondheidsgevolgen-ggo-mais-en-roundup/advies-vwa-bij-onderzoek-naar-gezondheidsgevolgen-ggo-mais-en-roundup.pdf
EFSA Journal 2012;10(10):2910
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Review of the Séralini et al. (2012) publication
and a Roundup-tolerant genetically modified maize. Food and Chemical Toxicology
http://dxdoi.org/10.1016.j.fct.2012.08.00– Pre-release version dated 19th September 2012.
Kaspareit, J. and Rittinghausen, S (1999) Spontaneous neoplastic lesions in Harlan Sprague-Dawley
rats. Exp Toxic Pathol 51: 105-107.
Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG (2010) Improving Bioscience Research
Reporting: The ARRIVE Guidelines for Reporting Animal Research. PLoS Biol 8(6): e1000412.
doi:10.1371/journal.pbio.1000412.
EFSA Journal 2012;10(10):2910
9
ABSTRACT
Le 19 décembre 2012, Séralini et al. on publié dans le journal Food and Chemical Toxicology le résultat d'études sur 2 ans de rat alimenté avec du maïs génétiquement modifié NK603 avec et sans Roundup WeatherMAX et Roundup GT Plus alone (tous deux sont des produits de protection des plantes qui contiennent du glyphosate). L'EFSA a été mandaté par la Commission européenne pour évaluer la publication, et identifier des précisions qui pourraient être demandées aux auteurs. L'EFSA observe que l'étude de Séralini
et al. (2012) a des objectifs peu clairs, et qu'elle est mal présentée dans la publication, de nombreuses particularités expérimentales, importantes pour la conception, la mise en oeuvre et l'analyse, étant omises. Sans ces indications, il est impossible de parvenir aux conclusions que font les auteurs. On ne peut pas tirer de conclusion sur les différence dans l'incidence des tumeurs entre les groupes d'animaux sur la base de l'analyse et des résultats données par Séralini et al. (2012). En particulier Séralini et al. (2012) tirent des conclusions sur l'incidence de tumeurs pour 10 rats par traitement et par sex, ce qui est un nombre insuffisant d'animaux pour distinguer des effets d'un traitement spécifique et l'occurence par hasard de tumeurs chez les rats. Considérant que l'étude rapportée par la publication de Séralini et al. (2012) était inappropriée dans sa conception, son analyse et sa publication, l'EFSA juge qu'elle est de qualité scientifique insuffisante pour fonder des conclusions en terme de sécurité.
L'EFSA conclu donc que l'étude de Séralini et al. rapportée dans leur publication de 2012 ne peut pas conduire à une réévaluation du glyphosate, ni nécessiter une réouverture d'une évaluation de la sécurité du maïs NK603. L'EFSA invite les auteurs de la publication de Séralini et al. (2012) à fournir à l'EFSA des informations plus précise sur leur étude.
Voici le texte complet :
EFSA Journal 2012;10(10):2910
STATEMENT OF EFSA
Review of the Séralini et al. (2012) publication on a 2-year rodent feeding
study with glyphosate formulations and GM maize NK603 as published
online on 19 September 2012 in Food and Chemical Toxicology 1
European Food Safety Authority2, 3
European Food Safety Authority (EFSA), Parma, Italy
ABSTRACT
On 19 September 2012, Séralini et al. published online in the scientific journal Food and Chemical Toxicology a
publication describing a 2-year feeding study in rats investigating the health effects of genetically modified
®
®
(GM) maize NK603 with and without Roundup WeatherMAX and Roundup GT Plus alone (both are
glyphosate-containing plant protection products). EFSA was requested by the European Commission to review
this publication and to identify whether clarifications are needed from the authors. EFSA notes that the Séralini
et al. (2012) study has unclear objectives and is inadequately reported in the publication, with many key details
of the design, conduct and analysis being omitted. Without such details it is impossible to give weight to the
results. Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on the
basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication. In particular,
Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per treatment per sex which
is an insufficient number of animals to distinguish between specific treatment effects and chance occurrences of
tumours in rats. Considering that the study as reported in the Séralini et al. (2012) publication is of inadequate
design, analysis and reporting, EFSA finds that it is of insufficient scientific quality for safety assessment.
Therefore EFSA, concludes that the Séralini et al. study as reported in the 2012 publication does not impact the
ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize
NK603 and its related stacks. EFSA will give the authors of the Séralini et al. (2012) publication the opportunity
to provide further information on their study to EFSA.
© European Food Safety Authority, 2012
Key words
Maize NK603, Roundup, glyphosate, experimental design, rat/rodent feeding study, toxicity, carcinogenicity
1
2
3
On request from European Commission Question No EFSA-Q-2012-00841, approved on 3 October 2012.
Correspondence: sas@efsa.europa.eu
Acknowledgement: EFSA wishes to thank the following EFSA staff: Saghir Bashir, Per Bergman, Danièle Court Marques,
Claudia Paoletti, Manuela Tiramani, Didier Verloo and Elisabeth Waigmann for the support provided to this scientific
output. EFSA also thanks the peer reviewers of this statement Andrew Chesson (member of the GMO Panel) and Alberto
Mantovani (member of the PPR panel).
Suggested citation: European Food Safety Authority; Review of the Séralini et al. (2012) publication on a 2-year rodent
feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and
Chemical Toxicology. EFSA Journal 2012; 10(10):2910. [9 pp.] doi:10.2903/j.efsa.2012.2910. Available online:
www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2012
Review of the Séralini et al. (2012) publication
TABLE OF CONTENTS
Abstract .................................................................................................................................................... 1
Table of contents ...................................................................................................................................... 2
Background as provided by the European Commission........................................................................... 3
Terms of reference as provided by the European Commission ................................................................ 3
EFSA’s approach to address the terms of reference ................................................................................. 3
1. Introduction ..................................................................................................................................... 4
2. Overview of the study as reported in the Séralini et al. (2012) ....................................................... 4
3. Review of the Séralini et al.(2012) publication ............................................................................... 5
3.1.
Study objectives ...................................................................................................................... 5
3.2.
Study Design ........................................................................................................................... 5
3.3.
Feed and Treatment Formulation ............................................................................................ 6
3.4.
Statistical Methods .................................................................................................................. 7
3.5.
Endpoint Reporting ................................................................................................................. 7
Conclusions .............................................................................................................................................. 8
Next steps ................................................................................................................................................. 8
References ................................................................................................................................................ 8
EFSA Journal 2012;10(10):2910
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Review of the Séralini et al. (2012) publication
BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION
On 19 September 2012, an article4 was published online in the scientific journal Food and Chemical
Toxicology that described a 2-year rat feeding study investigating the health effects of genetically
modified (GM) maize NK603 sprayed during growth with or without a Roundup® (glyphosate-
containing plant protection product) and of Roundup® alone. The authors of the study conclude that
low levels of glyphosate herbicide formulations, at concentrations well below officially set safe limits,
induce severe hormone-dependent mammary, hepatic and kidney disturbances in rats. Similarly, they
report disruption of biosynthetic pathways that may result from overexpression of the EPSPS
transgene in the maize NK603. The authors suggest that such disruptions may have given rise to
comparable pathologies that may be linked to abnormal or unbalanced phenolic acid metabolites or
related compounds.
TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION
EFSA received a mandate from DG SANCO on 26/09/2012 requesting to address the following terms
of reference as a matter of urgency.
(A) Review the scientific publication
(B) Ask any clarification needed to the authors
(C) Advise whether the publication contains new scientific elements that could lead EFSA to
reconsider the outcome of its opinion on maize NK603 and its related stacks
(D) Take into consideration the assessment of Member States
(E) Take into consideration the assessment of the German authorities responsible for the
evaluation of glyphosate
EFSA’S APPROACH TO ADDRESS THE TERMS OF REFERENCE
EFSA decided to address the terms of reference (ToR) in phases. This first EFSA statement addresses
ToR A, B and C solely based on the study information available through the Séralini et al. (2012)
publication.
A second EFSA output will cover all the ToRs and will take into account any information received
from the authors, the assessment activities from the Member States and the assessment of the German
authorities responsible for the evaluation of glyphosate.
Following the publication of Séralini et al. (2012), EFSA set up an internal task force chaired by the
Director of Regulated Products (REPRO) and composed of staff scientists with expertise in
biostatistics, experimental design, mammalian toxicology, biotechnology, biochemistry, pesticide
safety assessments and GMO safety assessments.
The task force was mandated to draft this EFSA statement which has been peer reviewed by two
experts from EFSA’s scientific panels.
4
Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta, Didier Hennequin,
Joël Spiroux de Vendômois (2012) Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified
maize. Food and Chemical Toxicology, http://dx.doi.org/10.1016/j.fct.2012.08.005
EFSA Journal 2012;10(10):2910
3
Review of the Séralini et al. (2012) publication
1.
Introduction
The review presented in this statement is based solely on the details provided in the Séralini et al.
(2012) publication since the complete study documentation is currently not available to EFSA. The
Séralini et al. (2012) publication was reviewed taking into account good scientific practices such as
internationally accepted reporting guidelines (Kilkenny 2010) and internationally agreed study
guidelines (e.g. OECD guidelines for testing of chemicals5).
The Kilkenny et al. (2010) ARRIVE (Animals in Research: Reporting In Vivo Experiments)
Guidelines for Reporting Animal Research detail how to report animal experiments covering the
following areas: abstract, background, ethical statement, study design, experimental procedures,
experimental animals, housing and husbandry, sample size, allocating animals to experimental groups,
experimental outcomes, statistical methods, baseline data, number (of animals) analysed, outcome
estimation, adverse events, interpretation/scientific implications, generalisability/translation and
funding.
2.
Overview of the study as reported in Séralini et al. (2012)
Séralini et al. (2012) report that the study followed 200 five-week old Virgin albino Sprague-Dawley
rats over a period of two years. In total there were 100 female and 100 male rats used in this study.
The rats were acclimatized for 20 days before they were randomly assigned on a weight basis into
groups of 10 animals. Two rats of the same sex were housed together in a cage with a temperature of
22 3°C and humidity of 45-65%. The rats had free access to feed and water, and litter was replaced
twice weekly. Animals were monitored twice weekly with regard to general observation and palpation
of animals, recording of clinical signs, occurrence of tumours, food and water consumption, and
individual body weights.
Forty-seven biochemical parameters (from blood and urine) were measured on 11 occasions. The first
measurement was taken before the administration of treatment (baseline) and the following
measurements were taken at months 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24. Anatomopathology parameters
were collected from 36 organs. Animals were sacrificed during the study due to suffering or for ethical
reasons, otherwise pathology examination was performed at the end of the study. Histological
examination was performed on nine organs (brain, colon, heart, kidneys, liver, lungs, ovaries, spleen,
testes).
The treatments studied are three levels of glyphosate tolerant maize NK603 (GMO in the diet at 11%,
22% and 33%) treated and untreated with Roundup WeatherMAX® during its cultivation, its closest
isogenic non-GM maize (Control in the diet at 33%) and Roundup® GT Plus (glyphosate based
formulation referred as Roundup (R) in Séralini et al. (2012) at three increasing doses in drinking
water. For each sex there were 10 treatment groups, each consisting of 10 rats, as follows:
1.
2.
3.
4.
5.
6.
7.
8.
9.
5
Listed
at
effects_20745788
Control 33% maize
GMO 11% maize
GMO 22% maize
GMO 33% maize
GMO 11% maize +R
GMO 22% maize +R
GMO 33% maize +R
R (A) (1.1 x 10-8% of R)
R (B) (0.09% of R)
http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-
EFSA Journal 2012;10(10):2910
4
Review of the Séralini et al. (2012) publication
10. R (C) (0.5% of R)
Séralini et al. (2012) report pathological effects, in particular an increased tumour incidence linked to
treatment with maize NK603 and R in both sexes.
3.
Review of the Séralini et al. (2012) publication
In this section EFSA assesses the Séralini et al. (2012) publication, and highlights open issues that are
usually addressed in a properly conducted, analysed and reported study.
3.1.
Study objectives
Assessment
The study objectives are unclear in the Séralini et al. (2012) publication.
The objectives are the questions that the study is designed to answer. These questions must be pre-
specified as the design of the study, sample size calculation, statistical analysis, study conduct and
reporting are dependent on these. Depending on the objectives of the study different weight is given to
the results in the context of a safety assessment. Without clearly stating the study objectives it is
difficult to determine whether the study design and sample size used are fit for purpose or indeed what
that purpose is.
International study guidelines are designed to meet specific objectives (e.g. OECD guidelines for
chemical testing). If a specific guideline is chosen and followed then the objectives are inherently
defined in the guideline.
Open Issues
The study objectives need to be clearly stated a priori in the study protocol.
3.2.
Study Design
Assessment
Séralini et al. (2012) did not follow the internationally accepted protocols for sub-chronic, chronic
toxicity and carcinogenicity studies (e.g. OECD 408, OECD 451, OECD 452 and OECD 453)
currently recommended in the EU for food and feed safety assessment. Given that Séralini et al.
(2012) conducted a two-year study, it is unclear why an OECD guideline suitable for a two-year
chronic toxicity or carcinogenicity study (i.e. OECD 451, OECD 452 or OECD 453) was not adhered
to.
The strain of rats chosen is known to be prone to development of tumours over their life (Dinse
(2010), Brix (2005), Kaspareit (1999)). By conducting the experiment on this strain of rats over two
years, which is approximately their life expectancy, the observed frequency of tumours is influenced
by the natural occurence of tumours typical of this strain, regardless of any treatment. This is neither
taken into account nor discussed in the Séralini et al. (2012) publication.
The study design includes only one control group which is not suitable to serve as control for all the
treatment groups. In particular, Séralini et al. (2012) claimed effects on the GMO 11%, GMO 11%
+R, GMO 22% and GMO 22% +R without appropriate controls.
Séralini et al. (2012) draw conclusions on carcinogenicity by reporting on the incidence of tumours
based on 10 rats per treatment per sex. There is a high probability that the Séralini et al. (2012)
findings in relation to the tumour incidence are due to chance, given the low number of animals and
the spontaneous occurrence of tumours in Sprague-Dawley rats. This is why relevant guidelines on
EFSA Journal 2012;10(10):2910
5
Review of the Séralini et al. (2012) publication
carcinogenicity testing (i.e. OECD 451 and OECD 453) recommend using at least 50 rats per
treatment per sex. Given the limited number of animals and the chosen study design, no conclusions
on the relationship between treatment and tumour incidence can be drawn from the Séralini et al.
(2012) publication.
There is no mention of any measures taken to reduce the risk of bias such as blinding.
Open Issues
The biological relevance of the rat strain used should be justified with respect to the design
choices.
Suitable controls for all treatment groups are not present.
The sample size (power) calculation is not presented hence it is not possible to assess if the
study was sufficiently powered to meet the unclear objectives.
Measures taken to reduce the risk of bias (e.g. blinding) are not reported.
3.3.
Feed and Treatment Formulation
Assessment
The publication states that “all feed formulations consisted in balanced diets, chemically measured as
substantially equivalent except for the transgene”. However, no detailed information on either the
composition of the various diets used in the experiment or the storage conditions of the feeds over the
course of the two years is provided. The publication does not give any details regarding the possible
presence of harmful substances such as mycotoxins in the feeds used in the study.
Séralini et al. (2012) report only the application rate of the Roundup WeatherMAX® used to spray the
plants and the concentration of the Roundup® GT Plus added to the rats’ drinking water. They state
that the consumption was measured though it is not reported. Without this information it is not
possible to estimate the exposure level. Furthermore, the level of residues of glyphosate and its
metabolites on treated maize are not specified. Hence, their contribution to the reported findings
cannot be assessed. In addition, information on other chemical contaminants e.g. other pesticides
applied on the GM maize as well as on the isogenic non-GM control maize, is not provided.
Open Issues
The appropriateness and comparability of the diets cannot be assessed as critical information
about their composition is not reported.
The stability of the diets cannot be assessed as details of their storage conditions are not
provided.
It is impossible to evaluate whether or not there was any contamination of the diets, e.g. by
mycotoxins, as it is not reported.
The amount of residues of glyphosate and its metabolites in treated maize NK603 is not
reported.
The exposure to GMO, GMO +R and R cannot be evaluated since the food and water intakes
of the GM- and R-treated groups, respectively, are not clearly reported.
EFSA Journal 2012;10(10):2910
6
Review of the Séralini et al. (2012) publication
Suitability of the control cannot be determined because information on the possible exposure
to other chemicals.
3.4.
Statistical Methods
Assessment
It is not reported if the statistical analyses were pre-specified in the protocol (i.e. prior to the start of
the study) or in a statistical analysis plan prior to any access to the data.
Summary statistics for all measured parameters (including biochemical and tumour related) by
treatment group and sex are not presented.
Séralini et al. (2012) have chosen an unconventional statistical methodology to analyse the
biochemical parameters instead of commonly used methods (e.g. analysis of variance). The
methodology chosen does not allow for the estimation of the (unbiased) treatment effects and their
associated variations.
Séralini et al. (2012) only present percentages and graphical summaries of the tumour incidences.
There is no modelling-based analysis (e.g. time to event analysis) to estimate the (unbiased) treatment
effects and their associated variations. For both types of analysis the issue of missing data and
multiplicity should also be addressed.
Open Issues
It is not clear if the analysis presented is consistent with any pre-planned analyses.
The reported analysis does not provide the following information needed to draw conclusions:
o o Summary statistics for all measured parameters by treatment group (and sex).
o
3.5.
A summary of drop outs and censoring (e.g. euthanised animals).
Unbiased treatment effect estimates (with confidence intervals) derived from an
appropriate statistical analyses for the chosen design and endpoint. The issues of
handling missing data and multiple testing (multiplicity) should be addressed.
Endpoint Reporting
Assessment
Far more endpoints (and measurement points thereof) than those reported in the publication were
collected by Séralini et al. (2012). It is unclear why the publication does not report the complete set of
samples collected and endpoints measured.
Clinical observations other than tumours are selectively reported: in Table 2 of Séralini et al. (2012), a
summary of the most frequent anatomical pathologies observed is presented; however a clear
presentation of all the specific lesions occurring in the different organs, for each treatment group, is
not provided.
As for the carcinogenicity assessment, attention was mainly focused on the “largest palpable growths”
with only mammary and pituitary tumours being mentioned for females and kidney and skin tumours
for males. A detailed list of all tumour types per sex per group and notation of all histopathological
lesions (including hyperplastic, pre-neoplastic and non-neoplastic) would be needed.
EFSA Journal 2012;10(10):2910
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Review of the Séralini et al. (2012) publication
Open Issues
All collected endpoints should be reported openly and transparently.
CONCLUSIONS
EFSA notes that the study, as described in the Séralini et al. (2012) publication, is inadequately
reported with many key details of the design, conduct, analysis and reporting being omitted. Without
such details it is impossible to give weight to the subsequent results.
Conclusions cannot be drawn on the difference in tumour incidence between the treatment groups on
the basis of the design, the analysis and the results as reported in the Séralini et al. (2012) publication.
In particular, Séralini et al. (2012) draw conclusions on the incidence of tumours based on 10 rats per
treatment per sex. This falls considerably short of the 50 rats per treatment per sex as recommended in
the relevant international guidelines on carcinogenicity testing (i.e. OECD 451 and OECD 453). Given
the spontaneous occurrence of tumours in Sprague-Dawley rats, the low number of rats reported in the
Séralini et al. (2012) publication is insufficient to distinguish between specific treatment effects and
chance occurrences of tumours in rats.
Considering that the study as reported in the Séralini et al. (2012) publication has unclear study
objectives and given its inadequate design, analysis and reporting, EFSA finds that it is of insufficient
scientific quality for safety assessments. Therefore EFSA, concludes that the Séralini et al. study as
reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not
see a need to reopen the existing safety evaluation of maize NK603 and its related stacks.
NEXT STEPS
To review the study in more detail, beyond what is reported in the Séralini et al. (2012) publication,
access would need to be given to the study documentation and procedures followed, including the
original study protocol, along with documentation on any planned or unplanned changes to it, the
statistical analysis plan, the statistical report/analyses and the final full study report. Therefore, the
authors will be made aware of the content of this EFSA statement and will be given the opportunity to
submit information to EFSA.
A second EFSA output will cover all the ToR and will take into account any information received
from the authors, the already ongoing assessment activities from the Member States (such as Belgium,
France, Germany6 and The Netherlands7) and the assessment of the German authorities responsible for
the evaluation of glyphosate.
REFERENCES
Brix, A. E. et al. (2005). Incidences of selected lesions in control female Harlan Sprague-Dawley rats
from two-year studies performed by the National Toxicology Program. Toxi-cologic Pathology 33
(4), 477-483.
Dinse, D. E. et al. (2010). Comparison of NTP historical control tumor incidence rates in female
Harlan Sprague Dawley and Fischer 344/N rats. Toxicologic Pathology 38 (5), 765-775.
Gilles-Eric Séralini, Emilie Clair, Robin Mesnage, Steeve Gress, Nicolas Defarge, Manuela Malatesta,
Didier Hennequin, Joël Spiroux de Vendômois (2012) Long term toxicity of a Roundup herbicide
6
http://www.bfr.bund.de/cm/343/veroeffentlichung-von-seralini-et-al-zu-einer-fuetterungsstudie-an-ratten-mit-
gentechnischveraendertem-mais-nk603-sowie-einer-glyphosathaltigen-formulierung.pdf
7
http://www.rijksoverheid.nl/bestanden/documenten-en-publicaties/notas/2012/10/03/advies-vwa-bij-onderzoek-naar-
gezondheidsgevolgen-ggo-mais-en-roundup/advies-vwa-bij-onderzoek-naar-gezondheidsgevolgen-ggo-mais-en-roundup.pdf
EFSA Journal 2012;10(10):2910
8
Review of the Séralini et al. (2012) publication
and a Roundup-tolerant genetically modified maize. Food and Chemical Toxicology
http://dxdoi.org/10.1016.j.fct.2012.08.00– Pre-release version dated 19th September 2012.
Kaspareit, J. and Rittinghausen, S (1999) Spontaneous neoplastic lesions in Harlan Sprague-Dawley
rats. Exp Toxic Pathol 51: 105-107.
Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG (2010) Improving Bioscience Research
Reporting: The ARRIVE Guidelines for Reporting Animal Research. PLoS Biol 8(6): e1000412.
doi:10.1371/journal.pbio.1000412.
EFSA Journal 2012;10(10):2910
9
Une question fréquente
Des étudiants nombreux posent (en substance) la même question :
"Passionné(e) de chimie et de cuisine, je souhaite orienter mes futurs travaux vers un domaine qui me permettra d'allier ces deux passions."
Comment répondre ?
Analysons d'abord du point de vue de l'emploi, car il serait irresponsable de ne pas envisager que les études conduisent à un travail (et l'on sait combien j'aime le mot "travail", qui donne le mot "travaux" figurant dans la question posée).
Il y a l'industrie, qui produit des biens et des services, et l'administration, qui ne devrait être qu'un "appui" à l'industrie : si l'on fait des routes, c'est pour que la nation -qui les paye- les utilise, pas seulement pour que ceux qui les font -qui reçoivent leur financement de la nation-, non ?
Donc il semble légitime d'inviter les étudiants à penser qu'ils doivent plutôt viser un travail dans l'industrie... en se souvenant que les Canadiens ont raison de nommer "industrie" le secteur de la restauration commerciale, les restaurants en un mot : pas de différence de nature entre un cuisiniers avec quelques employés, dans un restaurant, et une petite entreprise de quelques personnes.
Un travail dans l'industrie ? S'ils sont intéressés par la "cuisine", il faut donc inviter nos jeunes amis à viser l'industrie alimentaire... dans toute sa diversité : cela va de la boulangerie, au restaurant, au fournisseurs de denrées pour le restaurant, au producteur de spécialités, jusqu'à la multinationale qui produit ou distribue des produits alimentaires.
Il y a donc du choix, des possibilités d'emploi !
Cela dit, une personne qui travaille dans ces secteurs fera-t-elle de la "chimie" et de la "cuisine" ?
Analysons les termes :
La cuisine, d'abord : il s'agit d'une activité qui allie lien social, art, technique, mais dans des proportions qui varient, de la baraque à frites (technique) au restaurant de haute cuisine (art). Pour faire de la bonne cuisine technique, il faut être un bon technicien. Pour faire de la belle cuisine artistique, il faut être un artiste.
La chimie, ensuite : le terme est aujourd'hui confus, mais il ne tient qu'à nous qu'il le devienne demain moins.
Historiquement la chimie était un "art chimique", c'est-à-dire une activité technique : fabrication de savons, métaux, cosmétiques, aliments, etc. Puis lentement, une composante technologique s'est ajoutée, puis une composante scientifique.
De quoi parle notre jeune ami : de technique ? Produire des aliments ? Dans l'acception ancienne, produire un aliment ou orchestrer des réarrangements d'atomes ("réactions chimiques"), c'est pareil. De technologie : améliorer la technique par la connaissance des réarrangements d'atomes, c'est bien la mission des ingénieurs de l'industrie alimentaire. Science ? Là, il s'agit de "faire des découvertes", et la cuisine est bien éloignée, parce que la science n'a pas vocation de produire à manger.
A ce jour, le mot "chimie" pose donc problème, parce que l'on confond la science chimique et ses applications. Or la chimie a si mauvaise presse que l'industrie chimique voudrait ne plus être nommée ainsi, alors que la science chimique voudrait conserver le nom.
C'est peut-être l'occasion de réserver le nom de "chimie" à la science des réarrangements d'atomes (voir mon livre La Sagesse du Chimiste, Ed JC Béhar), ce qui conduirait à répondre à notre jeune ami qu'il n'y aura jamais de chimie en cuisine !
Finalement, notre jeune ami veut-il être scientifique, technologue (ingénieur), technicien ou artiste ?
J'ai l'espoir que cette analyse, qui conduit inévitablement à la dernière question, l'aidera à dépasser les fantasmes que nous avons tous, notamment de croire que l'on peut mêler la science chimique et l'art culinaire. Répétons qu'il n'existera jamais de carré rond !
"Passionné(e) de chimie et de cuisine, je souhaite orienter mes futurs travaux vers un domaine qui me permettra d'allier ces deux passions."
Comment répondre ?
Analysons d'abord du point de vue de l'emploi, car il serait irresponsable de ne pas envisager que les études conduisent à un travail (et l'on sait combien j'aime le mot "travail", qui donne le mot "travaux" figurant dans la question posée).
Il y a l'industrie, qui produit des biens et des services, et l'administration, qui ne devrait être qu'un "appui" à l'industrie : si l'on fait des routes, c'est pour que la nation -qui les paye- les utilise, pas seulement pour que ceux qui les font -qui reçoivent leur financement de la nation-, non ?
Donc il semble légitime d'inviter les étudiants à penser qu'ils doivent plutôt viser un travail dans l'industrie... en se souvenant que les Canadiens ont raison de nommer "industrie" le secteur de la restauration commerciale, les restaurants en un mot : pas de différence de nature entre un cuisiniers avec quelques employés, dans un restaurant, et une petite entreprise de quelques personnes.
Un travail dans l'industrie ? S'ils sont intéressés par la "cuisine", il faut donc inviter nos jeunes amis à viser l'industrie alimentaire... dans toute sa diversité : cela va de la boulangerie, au restaurant, au fournisseurs de denrées pour le restaurant, au producteur de spécialités, jusqu'à la multinationale qui produit ou distribue des produits alimentaires.
Il y a donc du choix, des possibilités d'emploi !
Cela dit, une personne qui travaille dans ces secteurs fera-t-elle de la "chimie" et de la "cuisine" ?
Analysons les termes :
La cuisine, d'abord : il s'agit d'une activité qui allie lien social, art, technique, mais dans des proportions qui varient, de la baraque à frites (technique) au restaurant de haute cuisine (art). Pour faire de la bonne cuisine technique, il faut être un bon technicien. Pour faire de la belle cuisine artistique, il faut être un artiste.
La chimie, ensuite : le terme est aujourd'hui confus, mais il ne tient qu'à nous qu'il le devienne demain moins.
Historiquement la chimie était un "art chimique", c'est-à-dire une activité technique : fabrication de savons, métaux, cosmétiques, aliments, etc. Puis lentement, une composante technologique s'est ajoutée, puis une composante scientifique.
De quoi parle notre jeune ami : de technique ? Produire des aliments ? Dans l'acception ancienne, produire un aliment ou orchestrer des réarrangements d'atomes ("réactions chimiques"), c'est pareil. De technologie : améliorer la technique par la connaissance des réarrangements d'atomes, c'est bien la mission des ingénieurs de l'industrie alimentaire. Science ? Là, il s'agit de "faire des découvertes", et la cuisine est bien éloignée, parce que la science n'a pas vocation de produire à manger.
A ce jour, le mot "chimie" pose donc problème, parce que l'on confond la science chimique et ses applications. Or la chimie a si mauvaise presse que l'industrie chimique voudrait ne plus être nommée ainsi, alors que la science chimique voudrait conserver le nom.
C'est peut-être l'occasion de réserver le nom de "chimie" à la science des réarrangements d'atomes (voir mon livre La Sagesse du Chimiste, Ed JC Béhar), ce qui conduirait à répondre à notre jeune ami qu'il n'y aura jamais de chimie en cuisine !
Finalement, notre jeune ami veut-il être scientifique, technologue (ingénieur), technicien ou artiste ?
J'ai l'espoir que cette analyse, qui conduit inévitablement à la dernière question, l'aidera à dépasser les fantasmes que nous avons tous, notamment de croire que l'on peut mêler la science chimique et l'art culinaire. Répétons qu'il n'existera jamais de carré rond !
samedi 6 octobre 2012
Les savanturiers
Fabienne Chauvière me fait l'amitié de me recevoir sur France Inter : http://www.franceinter.fr/emission-les-savanturiers-herve-this-physico-chimiste
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