Notification Detail

Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment

Notification Number: 2020/280/F (France)
Date received: 06/05/2020
End of Standstill: 07/08/2020 ( 09/11/2020)

Issue of comments by: Austria,Finland,Sweden
Issue of detailed opinion by: Czech Republic,Spain,Spain
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Message 002

Communication from the Commission - TRIS/(2020) 01601
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2020/0280/F

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 202001601.EN)

1. Structured Information Line
MSG 002 IND 2020 0280 F EN 06-05-2020 F NOTIF


2. Member State
F


3. Department Responsible
Direction générale des entreprises
SQUALPI
Bât. Sieyès -Teledoc 151
61, Bd Vincent Auriol
75703 PARIS Cedex 13
d9834.france@finances.gouv.fr


3. Originating Department
Direction générale de la prévention des risques
Ministère de la transition écologique et solidaire
Tour Séquoïa
92055 La Défense Cedex.
biotech@developpement-durable.gouv.fr
0033 (0)1 40 81 71 56


4. Notification Number
2020/0280/F - C00A


5. Title
Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment


6. Products Concerned
Plant varieties


7. Notification Under Another Act
-


8. Main Content
The purpose of the draft Decree on the genetic modification techniques mentioned in Article L531-2 of the French Environment Code [Code de l’environnement] is to specify the techniques of mutagenesis exempt from the scope of the regulations on GMOs. The draft Decree provides for the exemption of random mutagenesis, with the exception of in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents.

The draft Decree also provides for transitional measures for plant crops obtained via in vitro random mutagenesis, as defined above, which have already been sown or planted on the date of application of the texts provided.


9. Brief Statement of Grounds
At the end of 2014, nine associations sent a letter to the Prime Minister requesting, firstly, the repeal of Article D531-2 of the French Environment Code as it exempts herbicide-tolerant varieties (HTV) from the regulations on genetically modified organisms (GMOs) and, secondly, a moratorium on these HTVs.
The silence maintained by the administration on this request gave rise to an implicit decision of rejection, against which the associations lodged an appeal before the French Council of State (CE). By a decision of 3 October 2016, the latter asked the Court of Justice of the European Union (CJEU) four questions referred for a preliminary ruling and stayed proceedings on the conclusions of the application until the Court had ruled on these questions. By a judgment delivered on 25 July 2018 (case C 528/16), the CJEU thus:
• clarified the scope of Directive 2001/18/EC: the Court states that any product of a mutagenesis technique is a GMO, and that the only products exempt from the evaluation procedure are those of mutagenesis techniques conventionally used in a number of applications and which have a long safety record.
• specified the concept of ‘techniques which have conventionally been used in a number of applications and have a long safety record’: the judgment states in particular, in point 51, that the Directive cannot be interpreted as excluding from its scope ‘organisms obtained by means of new techniques/methods of mutagenesis, which have appeared or have been mostly developed since Directive 2001/18 was adopted'.
The Council of State delivered its decision on 7 February 2020 following the Court's preliminary ruling. It concludes that the techniques of in vitro random mutagenesis subjecting plant cells to chemical or physical mutagenic agents, as well as the techniques of what is termed directed mutagenesis or of genome editing, are not conventionally used techniques which have a long safety record, having appeared or having mainly been developed since the adoption of Directive 2001/18/EC. It follows that the organisms obtained via these techniques must be subject to the regulations on GMOs.
Consequently, the Council of State enjoined the Prime Minister to amend the regulations specifying the techniques of mutagenesis exempt from the regulations on GMOs in order to distinguish them from those which, according to its analysis, fall within the scope of this regulation.
It also enjoins the competent authorities to take all the necessary measures resulting therefrom:
• to identify, within the common catalogue of varieties of agricultural plant species, those varieties that would have been registered without having carried out the evaluation to which they should have been submitted having regard to the technique used to obtain them;
• to assess whether it is necessary to initiate the procedure for the withdrawal of the varieties concerned, the suspension or even the destruction of the crops in place.
The draft Decree on genetic modification techniques mentioned in Article L531-2 of the French Environment Code, which is the subject of this notification, aims to specify the mutagenesis techniques exempt from the scope of the regulations on GMOs. The draft Decree provides for the exemption of random mutagenesis, with the exception of in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents.
This provision means that plant organisms resulting from in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents fall within the scope of the regulations relating to GMOs.
Consequently, once the Decree has been published and is subject to the transitional provisions provided, in particular for growing crops, it will be prohibited in France to cultivate or sell the varieties resulting from in vitro random mutagenesis, consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents, due to them not having been evaluated and authorised under the regulations on GMOs.


10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Article L531-2 of the French Environment Code
Article D531-2 of the French Environment Code


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
-


16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft is neither a sanitary nor phytosanitary measure.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

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en
  Primary Food Processors on 16-07-2020
Click to expand

From: Primary Food Processors (PFP)

To: European Commission – TRIS

Re: TRIS notifications by France about in vitro random mutagenesis (genetically modified organisms) - 2020/280/F, 2020/281/F, 2020/282/F

 

Primary Food Processors is composed of six trade associations, representing manufacturers of sugar, starch, flour, vegetable proteins, cocoa, and vegetable oil and protein-meal products respectively. PFP members process approximately 220 Million tonnes of raw materials (cereals, sugar beet, rapeseeds, soybeans, sunflower seeds, crude vegetable oil, cocoa products, starch potatoes…) employing over 120 000 people in the European Union and providing one million indirect jobs.

 

PFP is extremely concerned about the impact that these draft French regulations would have on the integrity of the EU’s single market and the free movement of both intra-EU and imported crops and seeds that our industries are sourcing on a continuous basis. PFP is also concerned about the implications of these draft regulations on the status of processed products and the ability to continue supplying them to France.

While the notified French legislative orders are today focusing on certain rapeseed varieties, PFP is particularly worried that such decree, if implemented, would also impact other varieties, where those varieties are obtained via “in vitro random mutagenesis”, thus creating huge legal uncertainty for all PFP sectors.

The draft French Decree amends the definition of ‘mutagenesis’, expressly removing “in vitro random mutagenesis” from the techniques that are exempted from the scope of the regulations on GMOs. The resulting in vitro-derived organisms would thus become GMOs and, because they have not been evaluated and authorised under the regulations on GMOs, deemed to be non-authorised GMOs in France.

A differentiation between in-vitro and in-vivo mutagenesis techniques is not implied either in the GMO law (Directive 18/2001, Reg.1829/2003 and Reg. 1830/2003 and related acts) or in the seed legislation. Until now the Commission and the Member States have never made a distinction between in-vivo and in-vitro mutagenesis, neither when implementing the EU seed legislation on plant reproductive material, nor in the existing EU GMO legislation. By revoking and deleting certain varieties obtained via in vitro random mutagenesis from the Official Catalogue of Species and Varieties of Cultivated Crops in France, these varieties will no longer be able to be cultivated in France, however they will not be withdrawn from the European Union catalogue. EU Member States, with the exception of France, will continue to be legally entitled to cultivate these varieties. Considering the current absence of reliable and standard detection methods, PFP members, as food operators, will therefore find it impossible to ensure compliance of the crops they source.

As stated above, they are also very concerned about the legal uncertainty created in France around the status of processed products derived from varieties obtained via in vitro random mutagenesis, due to the introduction of a different definition of GMO compared to the one in Directive 18/2001 which is the reference used in Regulation 1829/2003. Should these products be considered to be derived from (non-authorised) GMOs, this would de facto prevent PFP companies importing into France products that are lawfully produced in other EU Member States.

For the above-mentioned reasons, PFP asks the EU authorities to suspend the application of the proposed Decree.

 

The Primary Food Processors of the EU (PFP) is composed by:

European Committee of Sugar Manufacturers (CEFS)
European Cocoa Association (ECA)
European Flour Milling Association (European Flour Millers)
European Vegetable Protein Federation (EUVEPRO)
European Vegetable Oil and Proteinmeal Industry (FEDIOL)
European Starch Industry Association (Starch Europe)

 


en
  European Coordination Via Campesina on 15-07-2020
Click to expand

 

Re: ECVCs comments on TRIS notifications by France 2020/280/F, 2020/281/F and 2020/282/F

 

Brussels, 13 July 2020  

Name of the company: European Coordination Via Campesina 

Reference of the notifications: 2020/280/F, 2020/281/F and 2020/282/F (the 3 decree proposals will be addressed together in the submission) 

Subject of the notification: ECVC's comments on the proposals for technical regulations notified by France on 6 May 2020: 2020/280/F, 2020/281/F and 2020/282/F 

The European Coordination Via Campesina (ECVC) is an European confederation of national organisations of farmers and agricultural workers. Its main areas of activity/interest are: agriculture and rural development, seed production, livestock production, biodiversity, food security, farmers' rights, etc.  

ECVC hereby submits to the European Commission, pursuant to Directive 2015/1535 of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (the Single Market Transparency Directive), its comments on the following three technical regulations that were notified to the Commission by France on 6 May 2020:

- 2020/280 / F - "Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment",

 

- 2020/281 / F - "Order laying down the list of varieties mentioned in Article 2 of Decree [xx]",

 

- 2020/282 / F - "Order amending the Official Catalogue of Species and Varieties of Cultivated Crops in France (rape seeds and other crucifer seeds)".

 

You can find the submission below both in English and French, but please note that the French version is the original one.

Kind Regards,

Alessandra Turco

Member of the Coordinating Committee of ECVC

 

Submission in French (A translation of the submission in English is available below):

Les membres d’ECVC sont engagés depuis de nombreuses années dans la transition vers une agroécologie paysanne respectueuse de la santé, de l’environnement, de la biosécurité et des demandes sociétales. En tant que paysans, nos membres sont avant tout des producteurs de nourriture. L’alimentation n’est pas qu’une marchandise destinée à augmenter les dividendes versés aux actionnaires des entreprises. Elle impacte directement la santé et le bien-être des personnes qui s’en nourrissent tout en permettant, lors de chaque repas, l’échange et la transmission de valeurs culturelles qui fondent nos civilisations. La confiance des consommateurs dans la sécurité et la qualité des aliments qu’ils achètent est donc un objectif essentiel des politiques publiques.

 

 

I - La confiance des consommateurs dans la sécurité et la loyauté des produits mis en marché

 

En application de la jurisprudence nationale (CE 7 février 2020, France contre Confédération paysanne), le gouvernement soumet un projet de décret afin de restreindre la vente de semences mutées in vitro en France. Le rejet de la proposition française remettrait en cause cette confiance. Elle créerait ainsi de sérieux obstacles d’une part à la poursuite des activités de nos membres qui produisent des aliments de qualité et d’autre part au bon fonctionnement du marché européen qui repose sur des règles sanitaires, environnementales, de biosécurité et de transparence de haut niveau, fondées sur le principe de précaution et proportionnées.

 

Concernant les organismes génétiquement modifiés, le législateur européen a fait le choix, après de longues années de débats, d’une évaluation rigoureuse préalable à toute autorisation de dissémination d’organismes génétiquement modifiés « d’une manière qui ne se produit pas naturellement par multiplication ou recombinaison naturelle »[1]. Cette évaluation doit être suivie, en cas d’autorisation de dissémination, d’une traçabilité et d’un suivi garantissant la possibilité de retrait en cas d’apparition de problèmes sanitaires, environnementaux ou de biosécurité qui n’auraient pas été identifiés lors de l’évaluation préalable. Il n’est certes pas possible ni nécessaire d’évaluer de manière aussi rigoureuse tous les organismes biologiques disséminés ou consommés par les humains. La sécurité avérée de ceux qui sont génétiquement modifiés d’une manière qui se produit naturellement, dans le respect des lois de l’évolution naturelle, repose en effet sur des siècles de co-évolution avec les communautés humaines et sur les connaissances précises qui en découlent. Il n’en est pas de même des organismes qui sont génétiquement modifiés en surmontant « les barrières naturelles de la physiologie de la reproduction ou de la recombinaison »[2], qui n’ont pas été le fruit de techniques « traditionnellement utilisées pour diverses applications et dont la sécurité » ne serait pas « avérée depuis longtemps »[3]. Le choix du législateur européen comme international de réglementer de manière stricte les seconds et non les premiers est donc conforme au principe de précaution et totalement proportionné.

 

La majorité des consommateurs européens rejettent les OGM, qu’ils soient ou non autorisés, notamment pour des raisons éthiques qui leur sont propres. C’est pourquoi la réglementation européenne garantit leur liberté de choix avec ou sans OGM, fondée sur une traçabilité et un étiquetage clair garantissant leur droit de savoir ce qu’ils achètent et ce qu’ils consomment. Pour répondre à la demande de ces consommateurs, de nombreuses filières alimentaires biologiques ou conventionnelles « sans ogm » garantissent l’absence de tout OGM, qu’ils soient ou non autorisés. L’absence d’étiquetage et de traçabilité d’OGM autorisés et commercialisés provoquerait l’effondrement de ces filières du revenu des paysans qui les fournissent, en contradiction flagrante avec la récente décision de la Commission européenne de promouvoir à très grande échelle l’agriculture biologique.

 

 

II- La décision du Conseil d’État français à laquelle se conforme la proposition française est une application directe de cette réglementation européenne, confirmée par la Cour de Justice de l’Union européenne.

 

1) un organisme obtenu par mutagenèse dirigée ou par « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » n’est pas identique à une plante obtenue par sélection de mutations naturelles ou par mutagenèse traditionnelle.

 

La composition chimique d’une séquence génétique résultant d’une mutation naturelle ou obtenue par mutagenèse traditionnelle (consistant à soumettre des plantes entières ou leurs organes de reproduction naturelle à divers agents mutagènes) peut certes être parfois identique à celle d’une séquence génétique obtenue par mutagenèse dirigée ou par « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » telle que définie par le projet de décret français. Mais la plante issue d’une mutation naturelle ou de mutagenèse traditionnelle n’est en aucun cas identique à celle qui est issue de la régénération de cellules soumises aux agents mutagènes chimiques ou physiques des cultures cellulaires in vitro. Prétendre que ces deux plantes seraient identiques est aussi stupide que de prétendre qu’une voiture accidentée qui a été réparée est identique à une voiture neuve sous prétexte que le phare neuf qui a été placé sur la voiture accidentée est identique au phare neuf d’une voiture neuve.

 

La majorité des cellules cultivées in vitro, puis des plantes issues de la régénération de ces cellules, ne sont en effet pas viables et un grand nombre de celles qui survivent présentent trop de défauts pour être développées. Ces défauts sont trouvés à partir du phénotype, souvent uniquement après plusieurs multiplications et cela ne donne aucune garantie que l'ensemble soit sûr. La plante donne l’air d’être sûre alors qu’elle est profondément modifiée. Les cultures cellulaires ne génèrent jamais une seule mutation ou recombinaison comme le revendique l’obtenteur. Elles génèrent toujours des centaines d’autres modifications génétiques. Ces modifications résultent de « réparations » dites « spontanées » des perturbations du génome générées par les multiplications cellulaires in vitro et par les agents mutagènes. Ces « réparations » ou « erreurs » sont soumises aux influences directes des interactions entre les cellules et leur environnement immédiat, entre autre par les miARN circulant qui permettent la communication entre les cellules d’un même organisme. Ces interactions n’influent pas uniquement sur la nature de chaque mutation, mais aussi sur la réorganisation globale du génome qui en résulte et sur les caractères génomiques, métaboliques, protéomiques et autres, tout autant que sur les caractères génétiques de l’organisme qui sera régénéré à partir de ces cellules. L’environnement immédiat de cellules isolées au sein des substances chimiques des cultures cellulaires in vitro (souvent complétées d’autres agents mutagènes chimiques ou physiques plus ciblés) et/ou des « cals » (qui sont des amas désorganisés de cellules), n’est en aucun cas identique à l’environnement immédiat de cellules maintenues dans leur milieu naturel vivant, et reliées aux autres cellules organisées de la plante ou de ses organes de reproduction naturels. Puisque les cellules ne sont pas soumises aux mêmes environnements, les organismes qui résultent de ces deux types de processus de modification génétique ne sauraient être identiques. Des gènes identiques ou proches mais organisés de manière différente ne donnent en effet jamais les mêmes organismes. Les scientifiques nomment variation somaclonale le processus de mutation induit par la multiplication en milieu artificiel des cellules isolées (in vitro). Leurs multiplications ne donnent donc pas des nouvelles cellules identiques.

 

De plus, la sélection de mutations naturelles ou issues de mutagenèse traditionnelle reste soumise au temps long des reproductions naturelles de générations successives des plantes ainsi modifiées. Elle ne génère jamais en un temps aussi court autant de modifications génétiques qui peuvent être produites par les mises en cultures de milliers de cellules prélevées sur les centaines de plantules issues de régénération de cultures cellulaires précédentes. La sélection aussi rapide de quantités aussi importantes de modifications génétiques générées au laboratoire, hors de la régulation de la sélection et de l’évolution naturelles, ne peut donner que des plantes totalement déconnectées du milieu naturel dans lequel elles seront cultivées et exigeant une forte utilisation d’intrants chimiques ou physiques pour pouvoir y survivre. La stabilité des rendements et de la qualité des récoltes dépend d’abord de pratiques agricoles saines et de l’utilisation d’une grande diversité de petits lots de semences adaptés chacun à chaque condition locale de culture et non de quelques gènes de semences produites à très grande échelle par l’industrie, qui imposent une homogénéisation et une artificialisation extrême de la diversité des conditions locales de culture par un usage très intensif d’intrants.

 

Ces simples constats justifient le choix du législateur qui exige de soumettre ces plantes à l’application d’une réglementation spécifique. De toute évidence, les plantes ne se multiplient pas naturellement par multiplication puis régénération de cellules isolées in vitro hors de leur milieu naturel constitué de l'ensemble des autres cellules de la plante ou de ses organes reproducteurs. Les techniques de multiplication des plantes par multiplication in vitro puis régénération de cellules végétales isolées génèrent des modifications génétiques « d'une manière qui ne se produit pas naturellement par multiplication ou reproduction naturelles ». Elles ne sont pas considérées par la directive 2001/18 comme des techniques ne produisant pas d’organismes génétiquement modifiées, ni exemptées du champ d’application de cette directive. Les organismes issus de ces techniques doivent donc être soumis aux règles définies par cette directive.

Ces modifications génétiques obtenues par « l’application de technique in vitro aux acides nucléiques » échappent aux auto-régulations de la sélection et de l'évolution
pour au moins deux raisons. D’une part, du point de vue physique, en raison du remplacement de l'environnement naturel des cellules végétales par des substances chimiques. Dautre part, du point de vue temporel, en raison de la quantité de modifications génétiques produites simultanément en court-circuitant le temps long de la sélection de mutations ou autres modifications génétiques naturelles, imposé par les multiplications végétatives ou sexuelles naturelles successives. C'est bien ce franchissement « des barrières naturelles de la physiologie de la reproduction et de la recombinaison génétique [4]» qui justifie le choix du législateur de soumettre ces plantes à la réglementation européenne des OGM dans le respect des engagements internationaux du Protocole de Carthagène.

 

C’est sur le fondement du même constat que le législateur européen a prévu que les « procédés microbiologiques » associés aux cultures cellulaires peuvent être considérés comme des inventions brevetables, ce qui ne serait pas le cas s’ils s’agissait de procédés naturels ou « essentiellement biologiques [5]».

 

2) Une technique qui n’a pas été traditionnellement utilisée pour diverses applications ni principalement développée avant 2001 et dont la sécurité n’est pas avérée depuis longtemps

 

La mise au point des premières variétés de plantes obtenues par « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » date de la fin des années 1980 et leur commercialisation du début des années 1990. Mais elles ont toutes été principalement développées depuis 2001. Il en est de même pour les premières plantes transgéniques mises au point et expérimentées dans les années 1980, commercialisées dans les années 1990, puis principalement développées après 2001. L’utilisation et la sécurité de la « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » ne sont donc pas plus traditionnelle et avérée que l’utilisation et la sécurité de la transgenèse qui n’a pas été considérée par le législateur comme une technique « traditionnellement utilisée pour diverses applications » ou « principalement développée avant 2001 » « et dont la sécurité n’est pas avérée depuis longtemps ». Le respect du principe de précaution qui fonde la réglementation européenne sur les OGM impose donc son application sans exemption particulière à tous les produits issus tout autant de « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » que de transgenèse.

 

 

III – La traçabilité est à la portée des techniques actuelles

 

La traçabilité documentaire, associée à une politique de contrôle stricte et à des sanctions suffisamment dissuasives, a depuis longtemps fait ses preuves dans de nombreuses filières qui n’ont pas besoin d’outils de détection génétique pour fonctionner. De nombreux opérateurs réclament cependant de tels outils pour distinguer la présence d’OGM en cas de contamination fortuite ou de dissémination d’OGM non déclarés. S’il peut être difficile de distinguer une mutation naturelle ou issue de mutagenèse traditionnelle d’une mutation issue de « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques », il est clair que les plantes issues de ces deux familles de techniques se distinguent facilement par une approche matricielle recherchant l’ensemble des modification génétiques, épigénétiques, génomiques, métaboliques, protéomiques et autres caractères identifiables par des marqueurs biologiques des plantes concernées[6]. Il est en effet illusoire d’imaginer pouvoir effacer à l’aide de simples rétro-croisements, fussent-ils assistés par marqueurs, toutes les modifications, surtout celles qui ne sont pas connues, autres que la modification génétique revendiquée, générées par la « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques ». De plus, certaines d’entre elles peuvent n’apparaître qu’après plusieurs générations de multiplication des plantes modifiées.

 

 

IV - Le colza Clearfield

 

Les arrêtés français recensant les variétés inscrites au catalogue commun et obtenues par « mutagenèse aléatoire consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » concernent des colza dotés d’un gène de tolérance aux herbicides obtenue par la technologie Clearfield de BASF. Le colza est une espèce dont il est impossible de contrôler la dissémination par les graines, très légères et dotées d’une rémanence de plusieurs années, ni par son pollen, dispersé sur plusieurs kilomètres par le vent (26km [7]) et par de multiples insectes pollinisateurs. La contamination par les gènes de tolérance aux herbicides de nombreuses espèces sauvages et cultivées apparentées est inévitable et génère tout aussi inévitablement une utilisation accrue des herbicides pour combattre ces nouvelles plantes rendues tolérantes. C’est pour cette raison que l’Union européenne a refusé dès 1997 la culture sur son territoire des colza « Roundup ready ». Aucune raison ne peut aujourd’hui justifier l’autorisation de la culture du colza Clearfield générant les mêmes risques.

 

 

V - L’harmonisation et le bon fonctionnement du marché unique européen

 

La Commission européenne, qui est responsable de l’harmonisation du marché unique, n’a pris aucune initiative visant à harmoniser les règles d’application de l’arrêt de la Cour de justice de l’Union européenne du 25 juillet 2018. Elle a au contraire indiqué que ce sont les États qui doivent appliquer cet arrêt et donc en définir les règles d’application. La proposition française remplit un vide juridique et exécute cette indication de la Commission en conformité avec l’arrêt de la CJUE. Elle ne peut donc pas remettre en cause le bon fonctionnement du marché unique. Puisque la Commission a estimé que ce n’est pas son rôle de discriminer les produits selon la technique utilisée, la France remplit son obligation d’appliquer l’arrêt de la CJUE en le faisant au niveau national.

 

Pour ECVC, les autres États membres et l’Union européenne elle-même doivent adopter une décision conforme à l'arrêt de la CJUE et donc semblable à la décision du Conseil d’État français. Son application sera alors immédiatement harmonisée au sein du marché unique. S’il s’avérait nécessaire d’attendre une clarification au niveau européen, la France pourrait alors actionner une clause de sauvegarde lui permettant de respecter ses obligations, en respectant à la fois la décision de sa plus haute juridiction dans les délais qu'elle a imposés, le 7 août 2020 au plus tard, et les règles de fonctionnement du marché unique.

 

 

Submission in English:

For many years, ECVC members have been committed to the transition towards peasant agroecology that guarantees health, protects the environment and biosafety and responds to societal demands. As farmers, our members are first and foremost food producers. Food is not just a commodity to increase the dividends paid to corporate shareholders. It has a direct impact on the health and well-being of the people who eat it, while at the same time allowing, at each meal, the exchange and transmission of the cultural values that underpin our civilizations. Consumer confidence in the safety and quality of the food they buy is therefore a key objective of public policy.

 

 

I - Consumer confidence in the safety and fairness of the products placed on the market

 

In application of National case (CE February 7th 2020, France against Confédération Paysanne), the government submits a project of Decree so as to restrict the sale of in vitro mutated seeds in France. A rejection of the French proposal would undermine this confidence. It would put up serious barriers on the one hand to the continuation of the activities of our members who produce quality food, and on the other hand, to the proper functioning of the European market which is based on a high level of health, environmental, biosafety and transparency rules. This is underpinned by the precautionary principle, and is proportionate.

 

With regard to genetically modified organisms, the European legislator has chosen after many years of debate, to engage in a rigorous assessment prior to any authorization to release genetically modified organisms "in a way that does not occur naturally by mating and/or natural recombination"[8]. This assessment must be followed, in the event of authorization for release, by traceability and monitoring to ensure the possibility of withdrawal in the event of the emergence of health, environmental or biosafety issue that was not identified during the preliminary assessment. It is certainly not possible nor necessary to assess as rigorously all biological organisms released or consumed by humans. The proven safety of those that are genetically modified in a way that occurs naturally, in accordance with the laws of natural evolution, is based on centuries of co-evolution with human communities and on the precise knowledge derived from this. The same does not apply to organisms that are genetically modified by overcoming "natural physiological reproductive or recombination barriers[9]", that have not been made by "techniques used in traditional breeding and selection" and that do not have "a long safety record"[10]. The choice of the European and international legislator to strictly regulate the latter and not the former is therefore perfectly sensible an in line with the precautionary principle.

 

The majority of European consumers reject GMOs, whether they are authorised or not, also for their own ethical reasons. This is why European regulations guarantee their freedom of choice with or without GMOs, based on traceability and clear labelling guaranteeing their right to know what they are buying and consuming. To meet the demands of these consumers, many organic or conventional "GM-free" food chains guarantee the absence of any GMOs, whether they are authorised or not. The lack of labelling and traceability of authorised and marketed GMOs would cause the collapse of these chains and of the income of the farmers who supply them. This would be in flagrant contradiction with the recent decision of the European Commission to promote organic farming on a very large scale.

 

 

II- The decision of the French Council of State to which the French proposal conforms is a direct application of this European regulation, confirmed by the Court of Justice of the European Union.

 

1) an organism obtained by directed mutagenesis or by "random in vitro mutagenesis consisting of subjecting plant cells grown in vitro to chemical or physical mutagens" is not identical to a plant obtained by natural mutation selection or by traditional mutagenesis.

 

The chemical composition of a genetic sequence resulting from a natural mutation or obtained by traditional mutagenesis (consisting of subjecting whole plants or their natural reproductive organs to various mutagenic agents) may indeed sometimes be identical to that of a genetic sequence obtained by directed mutagenesis or by "random in vitro mutagenesis consisting of subjecting plant cells cultivated in vitro to chemical or physical mutagens" as defined by the French draft decree. However, the plant resulting from a natural mutation or traditional mutagenesis is in no way identical to the one resulting from the regeneration of cells subjected to chemical or physical mutagens of in vitro cell cultures. Pretending that these two plants would be identical is as absurd as claiming that a crashed car that has been repaired is identical to a new car on the pretext that the new headlight that has been placed on the crashed car is identical to the new headlight of a new car.

 

The majority of cells grown in vitro, and then of plants resulting from the regeneration of these cells, are indeed not viable, and many of those that survive have too many defects to be developed. These defects are found from the phenotype, often only after various multiplications, and they give no guarantee that the whole would be safe. The plant looks safe even though it is significantly modified. Cell cultures never simply generate the one single mutation or recombination that the breeder claims. They always generate hundreds of other genetic modifications. These modifications are the result of so-called spontaneous repairs of genome disruptions generated by in vitro cell multiplication and mutagenic agents. These "repairs", or "errors" are subject to the direct influences of interactions between cells and their immediate environment, amongst other through the use of circulating miRNA between cells that permit the inter-cellular communication inside an organism. These interactions not only influence the nature of each mutation, but also the resulting overall reorganization of the genome and the genomic, metabolic, and proteomic traits, as well as the genetic characteristics of the organism that will be regenerated from these cells. The immediate environment of cells isolated within the chemical substances of in vitro cell cultures (often supplemented by other more targeted chemical or physical mutagens) and/or "calluses" (which are disorganized clusters of cells), is in no way identical to the immediate environment of cells maintained in their natural living environment, linked to other organized cells of the plant or its natural reproductive organs. Since the cells are not submitted to the same environment, the organisms resulting from these two types of genetic modification process cannot be identical. Identical or similar genes, or genes that are close but organized in a different way, never give rise to the same organisms. Scientists name somaclonal variation the mutation process induced by the multiplication of isolated cells (in vitro) in an artificial environment. Therefore, their multiplications do not result in new identical cells.

 

Moreover, the selection of natural mutations or mutations resulting from traditional mutagenesis remains subject to the long term natural reproduction of successive generations of the plants thus modified. It never generates in such a short time as many genetic modifications as can be produced following the cultivation of thousands of cells taken from the hundreds of seedlings resulting from the regeneration of previous cell cultures. Such a quick selection of large quantities of genetic modifications generated in the laboratory, outside the regulation of natural selection and evolution, can only result in plants that are totally disconnected from the natural environment in which they are to be cultivated. They also require heavy use of chemical or physical inputs to survive. The stability of crop yields and quality depends first and foremost on sound agricultural practices and the use of a wide variety of small seed lots, each adapted to each local growing condition, and not on a few seed genes produced on a very large scale by industry, which impose an extreme homogenisation and artificialisation of the diversity of local growing conditions through a very intensive use of inputs.

 

These simple observations justify the legislator's choice to require these plants to be subject to the application of specific regulations. Clearly, plants do not multiply naturally by multiplication and then regeneration of plant cells isolated in vitro outside their natural environment consisting of all the other cells of the plant or its reproductive organs. The techniques of plant propagation by in vitro multiplication and then regeneration of isolated plant cells generate genetic modifications "in a way that does not occur naturally by mating and/or natural recombination". They are not considered by Directive 2001/18 as techniques that do not produce genetically modified organisms, nor are they exempted from the scope of this directive. Organisms resulting from these techniques must therefore be subject to the rules laid down by that Directive.


These genetic modifications obtained by "the application of in vitro techniques to nucleic acids" escape the self-regulations of selection and natural evolution for two main reasons. On the one hand, from a physical point of view due to the replacement of the natural environment of plant cells by chemical substances. On the other hand, from a temporal point of view due to the quantity of genetic modifications produced simultaneously by bypassing the long term process of natural mutation selection, or other naturally occurring genetic modifications, that are imposed by successive natural vegetative or sexual multiplication. It is indeed this overcoming "the natural physiological reproductive or recombination barriers[11]" that justifies the choice of legislators to subject these plants to European regulations on GMOs in compliance with the international commitments made under the Cartagena Protocol.

 

It is on the basis of the same observation that the European legislator has provided that "microbiological processes" associated with cell cultures can be considered patentable inventions, which would not be the case if they were natural or "essentially biological[12]" processes.

 

2) A technique that has not been traditionally used for various applications nor mainly developed before 2001 and whose safety has not been proven for a long time.

 

The development of the first plant varieties obtained by "random in vitro mutagenesis, which consists of subjecting plant cells grown in vitro to chemical or physical mutagens" dates back to the late 1980s, and their commercialization to the early 1990s. But they have all been developed mainly since 2001. The same is true of the first transgenic plants developed and tested in the 1980s, commercialized in the 1990s, and then mainly developed after 2001. The use and safety of "random in vitro mutagenesis consisting in subjecting plant cells grown in vitro to chemical or physical mutagens" is therefore no more traditional and proven than the use and safety of transgenesis which has not been considered by the legislator as a technique "traditionally used for various applications" or "mainly developed before 2001" and that do not have "a long safety record". Respect for the precautionary principle, which is the basis of European regulations on GMOs, therefore requires its application without any particular exemption to all products resulting from "random in vitro mutagenesis consisting of subjecting plant cells cultivated in vitro to chemical or physical mutagens" as well as from transgenesis.

 

 

III - Traceability is within the reach of current techniques

 

Documentary traceability combined with a strict control policy and sufficiently dissuasive sanctions have long proved their worth in many sectors that do not require genetic detection tools to operate. However, many operators are calling for such tools to distinguish the presence of GMOs in the event of adventitious contamination or the release of undeclared GMOs. While it may be difficult to distinguish a natural mutation or mutation resulting from traditional mutagenesis from a mutation resulting from "random in vitro mutagenesis consisting of subjecting plant cells cultivated in vitro to chemical or physical mutagens", it is clear that the plants resulting from these two families of techniques can be easily distinguished by a matrix approach seeking all the genetic, epigenetic, genomic, metabolic, proteomic and other characteristics identifiable by biological markers of the plants concerned[13]. It is indeed illusory to imagine being able to erase with the help of simple backcrossing, even if assisted by markers, all the modifications, especially the unknown ones, other than the claimed genetic modification, generated by "random in vitro mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagens". Furthermore, some of them may only appear after several generations of multiplication of the modified plants.

 

 

IV - Clearfield rape

 

The French decrees listing the varieties registered in the common catalogue and obtained by "random mutagenesis consisting of subjecting plant cells cultivated in vitro to chemical or physical mutagens" concern rapeseed with a herbicide tolerant gene obtained by BASF's Clearfield technology. Rapeseed is a species whose spread cannot be controlled only by the seeds, which are very light and have a persistence of several years, as well as by its pollen dispersed over several kilometres by wind (26km selon étude DEFRA[14]) and by multiple pollinating insects. Contamination by the herbicide-tolerant genes of many wild and related cultivated species is inevitable and also inevitably leads to increased use of herbicides to control these new tolerant plants. This is the reason why the European Union refused as early as 1997 "Roundup Ready" rapeseed to be grown on its territory. Today, there is no reason to justify the authorization of the cultivation of Clearfield rapeseed that generates the same risks.

 

 

V - Harmonisation and the proper functioning of the single European market

 

The European Commission, which is responsible for harmonising the single market, has not taken any initiative to harmonise the rules implementing the European Court of Justice ruling of 25 July 2018. On the contrary, it has indicated that it is the States that must apply this judgment and therefore define how it is enforced. The French proposal fills a legal loophole and acts of the guidance provided by the Commission in accordance with the ruling of the ECJ. It cannot therefore be an infringement on the proper functioning of the single market. Since the Commission considered that it was not its role to discriminate products according to the technique used, France fulfills its obligation to implement the ECJ judgment by doing so at national level.

 

For ECVC, the other Member States and the European Union itself must adopt a decision in line with the ruling of the ECJ and therefore similar to the decision of the French Conseil d'État. The ruling will thereby be applied in a uniform manner across the Single Market. Should it prove necessary to await clarification at the European level, France could then activate a safeguard clause enabling it to meet its obligations to respect both the decision of its highest court within the deadline it has imposed, 7 August 2020 at the latest, and the rules of operation of the single market.

 

 

 

 

 

 

 

 

 

 

 



[1]     Article 2 de la directive 2001/18

[2]     Article 3.i) du Protocole de Carthagène

[3]     Considérant 17 de la directive 2018 :  La présente directive ne devrait pas s'appliquer aux organismes obtenus au moyen de certaines techniques de modification génétique qui ont été traditionnellement utilisées pour diverses applications et dont la sécurité est avérée depuis longtemps.

[4]     Article 3 i) du Protocole de Carthagène : i) «Biotechnologie moderne» s'entend :

              a) De l'application de techniques in vitro aux acides nucléiques, y compris la recombinaison de l'acide désoxyribonucléique (ADN) et l'introduction directe d'acides nucléiques dans des cellules ou organites,

              b) De la fusion cellulaire d'organismes n'appartenant pas à une même famille taxonomique,

       qui surmontent les barrières naturelles de la physiologie de la reproduction ou de la recombinaison et qui ne sont pas des techniques utilisées pour la reproduction et la sélection de type classique;

[5]     Article 4 de la directive 98/44

[6]                 New Breeding Techniques: Detection and Identification of the Techniques and Derived Products

       Yves Bertheau, Institut National de la Recherche Agronomique (INRA) SPE, Versailles cedex, France; and Muséum National d'Histoire Naturelle (MNHN), CESCO, Paris, France © 2019 Elsevier Inc. All rights reserved.

[7]     Gavin Ramsay et al. Quantifying landscape-scale gene flow in oilseed rape. Final report of DEFRA. Projet RG0216. DEFRA, London (2003)

[8]                 Article 2 of Directive 2001/18

[9]                 Article 3(i) of the Cartagena Protocol

[10]               Recital 17 of Directive 2018 : this Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record.

[11]               Article 3 (i) of the Cartagena Protocol: (i) “Modern biotechnology” means the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.

[12]               Article 4 of Directive 98/44

[13]               New Breeding Techniques: Detection and Identification of the Techniques and Derived Products

       Yves Bertheau, Institut National de la Recherche Agronomique (INRA) SPE, Versailles cedex, France; and Muséum National d'Histoire Naturelle (MNHN), CESCO, Paris, France © 2019 Elsevier Inc. All rights reserved.

[14]   Gavin Ramsay et al. Quantifying landscape-scale gene flow in oilseed rape. Final report of DEFRA. Projet RG0216. DEFRA, London (2003)

fr
  European Coordination Via Campesina on 15-07-2020
Click to expand

 

 

 

Re : Commentaires d'ECVC sur les notifications TRIS de France 2020/280 / F, 2020/281 / F et 2020/282 / F

 

 

 

Bruxelles, le 13 juillet 2020

 

 

 

Nom de l'entreprise: Coordination Européenne Via Campesina

 

 

 

Référence des notifications: 2020/280/F, 2020/281/F, 2020/282/F (les 3 propositions de décret seront traitées ensemble dans la soumission)

 

 

 

Objet de la notification: Commentaires d’ECVC sur les propositions de règlements techniques suivants notifiés par la France le 6 mai 2020: 2020/280 / F, 2020/281 / F et 2020/282 / F

 

 

 

La Coordination Européenne Via Campesina (ECVC) est une confédération européenne d'organisations nationales d'agriculteurs et de travailleurs agricoles. Ses principaux domaines d'activité / d'intérêt sont: l'agriculture et le développement rural, la production de semences, la production animale, la biodiversité, la sécurité alimentaire, les droits des agriculteurs, etc.

 

 

 

ECVC soumet à la Commission européenne, conformément à la directive 2015/1535 du 9 septembre 2015 établissant une procédure pour la fourniture d'informations dans le domaine des réglementations techniques et des règles relatives aux services de la société de l'information (la « directive sur la transparence du marché unique »), ses observations sur les trois règlements techniques suivants qui ont été notifiés à la Commission par la France le 6 mai 2020:

 

 

 

- 2020/280 / F - "Décret modifiant la liste des techniques d'obtention les organismes génétiquement modifiés utilisés traditionnellement sans des désavantages importants en matière de santé publique ou d'environnement",

 

- 2020/281 / F - "Arrêté établissant la liste des variétés mentionné à l'article 2 du décret [xx]",

 

- 2020/282 / F - "Arrêté modifiant le catalogue officiel des espèces et variétés de plantes cultivées en France (semences de colza et autres crucifères)".

 

 

 

La soumission ci-dessous est à la fois en anglais et en français, mais veuillez noter que la version française est l'original.

 

Les membres d’ECVC sont engagés depuis de nombreuses années dans la transition vers une agroécologie paysanne respectueuse de la santé, de l’environnement, de la biosécurité et des demandes sociétales. En tant que paysans, nos membres sont avant tout des producteurs de nourriture. L’alimentation n’est pas qu’une marchandise destinée à augmenter les dividendes versés aux actionnaires des entreprises. Elle impacte directement la santé et le bien-être des personnes qui s’en nourrissent tout en permettant, lors de chaque repas, l’échange et la transmission de valeurs culturelles qui fondent nos civilisations. La confiance des consommateurs dans la sécurité et la qualité des aliments qu’ils achètent est donc un objectif essentiel des politiques publiques.

 

 

 

 

 

I - La confiance des consommateurs dans la sécurité et la loyauté des produits mis en marché

 

 

 

En application de la jurisprudence nationale (CE 7 février 2020, France contre Confédération paysanne), le gouvernement soumet un projet de décret afin de restreindre la vente de semences mutées in vitro en France. Le rejet de la proposition française remettrait en cause cette confiance. Elle créerait ainsi de sérieux obstacles d’une part à la poursuite des activités de nos membres qui produisent des aliments de qualité et d’autre part au bon fonctionnement du marché européen qui repose sur des règles sanitaires, environnementales, de biosécurité et de transparence de haut niveau, fondées sur le principe de précaution et proportionnées.

 

 

 

Concernant les organismes génétiquement modifiés, le législateur européen a fait le choix, après de longues années de débats, d’une évaluation rigoureuse préalable à toute autorisation de dissémination d’organismes génétiquement modifiés « d’une manière qui ne se produit pas naturellement par multiplication ou recombinaison naturelle »[1]. Cette évaluation doit être suivie, en cas d’autorisation de dissémination, d’une traçabilité et d’un suivi garantissant la possibilité de retrait en cas d’apparition de problèmes sanitaires, environnementaux ou de biosécurité qui n’auraient pas été identifiés lors de l’évaluation préalable. Il n’est certes pas possible ni nécessaire d’évaluer de manière aussi rigoureuse tous les organismes biologiques disséminés ou consommés par les humains. La sécurité avérée de ceux qui sont génétiquement modifiés d’une manière qui se produit naturellement, dans le respect des lois de l’évolution naturelle, repose en effet sur des siècles de co-évolution avec les communautés humaines et sur les connaissances précises qui en découlent. Il n’en est pas de même des organismes qui sont génétiquement modifiés en surmontant « les barrières naturelles de la physiologie de la reproduction ou de la recombinaison »[2], qui n’ont pas été le fruit de techniques « traditionnellement utilisées pour diverses applications et dont la sécurité » ne serait pas « avérée depuis longtemps »[3]. Le choix du législateur européen comme international de réglementer de manière stricte les seconds et non les premiers est donc conforme au principe de précaution et totalement proportionné.

 

 

 

La majorité des consommateurs européens rejettent les OGM, qu’ils soient ou non autorisés, notamment pour des raisons éthiques qui leur sont propres. C’est pourquoi la réglementation européenne garantit leur liberté de choix avec ou sans OGM, fondée sur une traçabilité et un étiquetage clair garantissant leur droit de savoir ce qu’ils achètent et ce qu’ils consomment. Pour répondre à la demande de ces consommateurs, de nombreuses filières alimentaires biologiques ou conventionnelles « sans ogm » garantissent l’absence de tout OGM, qu’ils soient ou non autorisés. L’absence d’étiquetage et de traçabilité d’OGM autorisés et commercialisés provoquerait l’effondrement de ces filières du revenu des paysans qui les fournissent, en contradiction flagrante avec la récente décision de la Commission européenne de promouvoir à très grande échelle l’agriculture biologique.

 

 

 

 

 

II- La décision du Conseil d’État français à laquelle se conforme la proposition française est une application directe de cette réglementation européenne, confirmée par la Cour de Justice de l’Union européenne.

 

 

 

1) un organisme obtenu par mutagenèse dirigée ou par « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » n’est pas identique à une plante obtenue par sélection de mutations naturelles ou par mutagenèse traditionnelle.

 

 

 

La composition chimique d’une séquence génétique résultant d’une mutation naturelle ou obtenue par mutagenèse traditionnelle (consistant à soumettre des plantes entières ou leurs organes de reproduction naturelle à divers agents mutagènes) peut certes être parfois identique à celle d’une séquence génétique obtenue par mutagenèse dirigée ou par « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » telle que définie par le projet de décret français. Mais la plante issue d’une mutation naturelle ou de mutagenèse traditionnelle n’est en aucun cas identique à celle qui est issue de la régénération de cellules soumises aux agents mutagènes chimiques ou physiques des cultures cellulaires in vitro. Prétendre que ces deux plantes seraient identiques est aussi stupide que de prétendre qu’une voiture accidentée qui a été réparée est identique à une voiture neuve sous prétexte que le phare neuf qui a été placé sur la voiture accidentée est identique au phare neuf d’une voiture neuve.

 

 

 

La majorité des cellules cultivées in vitro, puis des plantes issues de la régénération de ces cellules, ne sont en effet pas viables et un grand nombre de celles qui survivent présentent trop de défauts pour être développées. Ces défauts sont trouvés à partir du phénotype, souvent uniquement après plusieurs multiplications et cela ne donne aucune garantie que l'ensemble soit sûr. La plante donne l’air d’être sûre alors qu’elle est profondément modifiée. Les cultures cellulaires ne génèrent jamais une seule mutation ou recombinaison comme le revendique l’obtenteur. Elles génèrent toujours des centaines d’autres modifications génétiques. Ces modifications résultent de « réparations » dites « spontanées » des perturbations du génome générées par les multiplications cellulaires in vitro et par les agents mutagènes. Ces « réparations » ou « erreurs » sont soumises aux influences directes des interactions entre les cellules et leur environnement immédiat, entre autre par les miARN circulant qui permettent la communication entre les cellules d’un même organisme. Ces interactions n’influent pas uniquement sur la nature de chaque mutation, mais aussi sur la réorganisation globale du génome qui en résulte et sur les caractères génomiques, métaboliques, protéomiques et autres, tout autant que sur les caractères génétiques de l’organisme qui sera régénéré à partir de ces cellules. L’environnement immédiat de cellules isolées au sein des substances chimiques des cultures cellulaires in vitro (souvent complétées d’autres agents mutagènes chimiques ou physiques plus ciblés) et/ou des « cals » (qui sont des amas désorganisés de cellules), n’est en aucun cas identique à l’environnement immédiat de cellules maintenues dans leur milieu naturel vivant, et reliées aux autres cellules organisées de la plante ou de ses organes de reproduction naturels. Puisque les cellules ne sont pas soumises aux mêmes environnements, les organismes qui résultent de ces deux types de processus de modification génétique ne sauraient être identiques. Des gènes identiques ou proches mais organisés de manière différente ne donnent en effet jamais les mêmes organismes. Les scientifiques nomment variation somaclonale le processus de mutation induit par la multiplication en milieu artificiel des cellules isolées (in vitro). Leurs multiplications ne donnent donc pas des nouvelles cellules identiques.

 

 

 

De plus, la sélection de mutations naturelles ou issues de mutagenèse traditionnelle reste soumise au temps long des reproductions naturelles de générations successives des plantes ainsi modifiées. Elle ne génère jamais en un temps aussi court autant de modifications génétiques qui peuvent être produites par les mises en cultures de milliers de cellules prélevées sur les centaines de plantules issues de régénération de cultures cellulaires précédentes. La sélection aussi rapide de quantités aussi importantes de modifications génétiques générées au laboratoire, hors de la régulation de la sélection et de l’évolution naturelles, ne peut donner que des plantes totalement déconnectées du milieu naturel dans lequel elles seront cultivées et exigeant une forte utilisation d’intrants chimiques ou physiques pour pouvoir y survivre. La stabilité des rendements et de la qualité des récoltes dépend d’abord de pratiques agricoles saines et de l’utilisation d’une grande diversité de petits lots de semences adaptés chacun à chaque condition locale de culture et non de quelques gènes de semences produites à très grande échelle par l’industrie, qui imposent une homogénéisation et une artificialisation extrême de la diversité des conditions locales de culture par un usage très intensif d’intrants.

 

 

 

Ces simples constats justifient le choix du législateur qui exige de soumettre ces plantes à l’application d’une réglementation spécifique. De toute évidence, les plantes ne se multiplient pas naturellement par multiplication puis régénération de cellules isolées in vitro hors de leur milieu naturel constitué de l'ensemble des autres cellules de la plante ou de ses organes reproducteurs. Les techniques de multiplication des plantes par multiplication in vitro puis régénération de cellules végétales isolées génèrent des modifications génétiques « d'une manière qui ne se produit pas naturellement par multiplication ou reproduction naturelles ». Elles ne sont pas considérées par la directive 2001/18 comme des techniques ne produisant pas d’organismes génétiquement modifiées, ni exemptées du champ d’application de cette directive. Les organismes issus de ces techniques doivent donc être soumis aux règles définies par cette directive.

Ces modifications génétiques obtenues par « l’application de technique in vitro aux acides nucléiques » échappent aux auto-régulations de la sélection et de l'évolution pour au moins deux raisons. D’une part, du point de vue physique, en raison du remplacement de l'environnement naturel des cellules végétales par des substances chimiques. Dautre part, du point de vue temporel, en raison de la quantité de modifications génétiques produites simultanément en court-circuitant le temps long de la sélection de mutations ou autres modifications génétiques naturelles, imposé par les multiplications végétatives ou sexuelles naturelles successives. C'est bien ce franchissement « des barrières naturelles de la physiologie de la reproduction et de la recombinaison génétique [4]» qui justifie le choix du législateur de soumettre ces plantes à la réglementation européenne des OGM dans le respect des engagements internationaux du Protocole de Carthagène.

 

 

 

C’est sur le fondement du même constat que le législateur européen a prévu que les « procédés microbiologiques » associés aux cultures cellulaires peuvent être considérés comme des inventions brevetables, ce qui ne serait pas le cas s’ils s’agissait de procédés naturels ou « essentiellement biologiques [5]».

 

 

 

2) Une technique qui n’a pas été traditionnellement utilisée pour diverses applications ni principalement développée avant 2001 et dont la sécurité n’est pas avérée depuis longtemps

 

 

 

La mise au point des premières variétés de plantes obtenues par « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » date de la fin des années 1980 et leur commercialisation du début des années 1990. Mais elles ont toutes été principalement développées depuis 2001. Il en est de même pour les premières plantes transgéniques mises au point et expérimentées dans les années 1980, commercialisées dans les années 1990, puis principalement développées après 2001. L’utilisation et la sécurité de la « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » ne sont donc pas plus traditionnelle et avérée que l’utilisation et la sécurité de la transgenèse qui n’a pas été considérée par le législateur comme une technique « traditionnellement utilisée pour diverses applications » ou « principalement développée avant 2001 » « et dont la sécurité n’est pas avérée depuis longtemps ». Le respect du principe de précaution qui fonde la réglementation européenne sur les OGM impose donc son application sans exemption particulière à tous les produits issus tout autant de « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » que de transgenèse.

 

 

 

 

 

III – La traçabilité est à la portée des techniques actuelles

 

 

 

La traçabilité documentaire, associée à une politique de contrôle stricte et à des sanctions suffisamment dissuasives, a depuis longtemps fait ses preuves dans de nombreuses filières qui n’ont pas besoin d’outils de détection génétique pour fonctionner. De nombreux opérateurs réclament cependant de tels outils pour distinguer la présence d’OGM en cas de contamination fortuite ou de dissémination d’OGM non déclarés. S’il peut être difficile de distinguer une mutation naturelle ou issue de mutagenèse traditionnelle d’une mutation issue de « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques », il est clair que les plantes issues de ces deux familles de techniques se distinguent facilement par une approche matricielle recherchant l’ensemble des modification génétiques, épigénétiques, génomiques, métaboliques, protéomiques et autres caractères identifiables par des marqueurs biologiques des plantes concernées[6]. Il est en effet illusoire d’imaginer pouvoir effacer à l’aide de simples rétro-croisements, fussent-ils assistés par marqueurs, toutes les modifications, surtout celles qui ne sont pas connues, autres que la modification génétique revendiquée, générées par la « mutagenèse aléatoire in vitro consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques ». De plus, certaines d’entre elles peuvent n’apparaître qu’après plusieurs générations de multiplication des plantes modifiées.

 

 

 

 

 

IV - Le colza Clearfield

 

 

 

Les arrêtés français recensant les variétés inscrites au catalogue commun et obtenues par « mutagenèse aléatoire consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques » concernent des colza dotés d’un gène de tolérance aux herbicides obtenue par la technologie Clearfield de BASF. Le colza est une espèce dont il est impossible de contrôler la dissémination par les graines, très légères et dotées d’une rémanence de plusieurs années, ni par son pollen, dispersé sur plusieurs kilomètres par le vent (26km [7]) et par de multiples insectes pollinisateurs. La contamination par les gènes de tolérance aux herbicides de nombreuses espèces sauvages et cultivées apparentées est inévitable et génère tout aussi inévitablement une utilisation accrue des herbicides pour combattre ces nouvelles plantes rendues tolérantes. C’est pour cette raison que l’Union européenne a refusé dès 1997 la culture sur son territoire des colza « Roundup ready ». Aucune raison ne peut aujourd’hui justifier l’autorisation de la culture du colza Clearfield générant les mêmes risques.

 

 

 

 

 

V - L’harmonisation et le bon fonctionnement du marché unique européen

 

 

 

La Commission européenne, qui est responsable de l’harmonisation du marché unique, n’a pris aucune initiative visant à harmoniser les règles d’application de l’arrêt de la Cour de justice de l’Union européenne du 25 juillet 2018. Elle a au contraire indiqué que ce sont les États qui doivent appliquer cet arrêt et donc en définir les règles d’application. La proposition française remplit un vide juridique et exécute cette indication de la Commission en conformité avec l’arrêt de la CJUE. Elle ne peut donc pas remettre en cause le bon fonctionnement du marché unique. Puisque la Commission a estimé que ce n’est pas son rôle de discriminer les produits selon la technique utilisée, la France remplit son obligation d’appliquer l’arrêt de la CJUE en le faisant au niveau national.

 

 

 

Pour ECVC, les autres États membres et l’Union européenne elle-même doivent adopter une décision conforme à l'arrêt de la CJUE et donc semblable à la décision du Conseil d’État français. Son application sera alors immédiatement harmonisée au sein du marché unique. S’il s’avérait nécessaire d’attendre une clarification au niveau européen, la France pourrait alors actionner une clause de sauvegarde lui permettant de respecter ses obligations, en respectant à la fois la décision de sa plus haute juridiction dans les délais qu'elle a imposés, le 7 août 2020 au plus tard, et les règles de fonctionnement du marché unique.

 



[1]     Article 2 de la directive 2001/18

[2]     Article 3.i) du Protocole de Carthagène

[3]     Considérant 17 de la directive 2018 :  La présente directive ne devrait pas s'appliquer aux organismes obtenus au moyen de certaines techniques de modification génétique qui ont été traditionnellement utilisées pour diverses applications et dont la sécurité est avérée depuis longtemps.

[4]     Article 3 i) du Protocole de Carthagène : i) «Biotechnologie moderne» s'entend :

              a) De l'application de techniques in vitro aux acides nucléiques, y compris la recombinaison de l'acide désoxyribonucléique (ADN) et l'introduction directe d'acides nucléiques dans des cellules ou organites,

              b) De la fusion cellulaire d'organismes n'appartenant pas à une même famille taxonomique,

       qui surmontent les barrières naturelles de la physiologie de la reproduction ou de la recombinaison et qui ne sont pas des techniques utilisées pour la reproduction et la sélection de type classique;

[5]     Article 4 de la directive 98/44

[6]                 New Breeding Techniques: Detection and Identification of the Techniques and Derived Products

       Yves Bertheau, Institut National de la Recherche Agronomique (INRA) SPE, Versailles cedex, France; and Muséum National d'Histoire Naturelle (MNHN), CESCO, Paris, France © 2019 Elsevier Inc. All rights reserved.

[7]     Gavin Ramsay et al. Quantifying landscape-scale gene flow in oilseed rape. Final report of DEFRA. Projet RG0216. DEFRA, London (2003)

 


fr
  Canada Grains Council on 14-07-2020
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Please find enclosed comments from the Canada Grains Council. 


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  SNIA on 09-07-2020
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The European Commission will find attached the contribution of the SNIA (Syndicat national de l'industrie de la nutrition animale) to the TRIS notification 2020/280/F.



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  EU-SAGE on 08-07-2020
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 Dear European Commission,

 

enclosed please find the letter on French decree proposal endorsed by members of 132 European research institutes and associations, European Sustainable Agricutulture through Genome Editing, EU-SAGE (www.eu-sage.eu) addressed to Commissioner for Health and Food Safety, Stella Kyriakides.

 

Kind regards


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  European Plant Science Organisation, EPSO on 08-07-2020
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Dear Ladies and Gentlemen,

 

please find attached the submission by the European Plant Science Orgainsation (EPSO) regarding the French draft Decree 2020/280/F.

 

EPSO is an academic non-profit international association.

 

Sincerely,

 

Karin Metzlaff

 


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  Plantum on 07-07-2020
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Dear European Commission, 

Please find the Plantum submission in the attachment. 

Sincerely, 

Niels Louwaars


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  'Plants for the Future' ETP on 07-07-2020
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Dear EU commission,

'Plants for the Future' European Technology Platform hereby submits its Opinion (attached) on the French decree proposal.

Best regards,

 

 


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  Verein der Getreidehändler der Hamburger Börse e. V. on 07-07-2020
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Stellungnahme zum französischen Erlass zur Änderung der Liste der Techniken zur Gewinnung genetisch veränderter Organismen

 

Der Verein der Getreidehändler der Hamburger Börse e.V. (VdG) ist seit über 150 Jahren am Welthandelsplatz Hamburg in Deutschland das anerkannte und offizielle Sprachrohr und die Interessenvertretung des internationalen Groß- und Außenhandels mit Getreide, Ölsaaten, Futtermitteln, Hülsenfrüchten, Fischmehl und Speisesaaten. Wir verstehen uns als Dienstleister gegenüber unseren Mitgliedern und darüber hinaus als Partner von Verwaltung, Politik und Wirtschaft in Berlin, Bonn und Brüssel.

Als deutscher Bundesverband sind wir Mitglied bei COCERAL, dem europäischen Verband, der den Handel mit Getreide, Reis, Futtermitteln, Ölsaaten, Olivenöl, Ölen und Fetten sowie den Handel mit landwirtschaftlichen Betriebsmitteln vertritt.

Wir bedanken uns für die Möglichkeit, eine Stellungnahme zu dem französischen Erlass zur Änderung der Liste der Techniken zur Gewinnung genetisch veränderter Organismen, die traditionell ohne festgestellte Nachteile für die öffentliche Gesundheit oder die Umwelt eingesetzt werden, abgeben zu dürfen.

 

Rückschritt in der Harmonisierung des EU-Rechts

 

Falls der Erlass von Frankreich umgesetzt wird, würden Sorten, die aus zufälliger In-vitro-Mutagenese resultieren als gentechnisch veränderter Organismus (GVO) eingestuft. Dies würde den Anbau und das Inverkehrbringen dieser Sorten in Frankreich aufgrund langwieriger, aufwendiger und kostenintensiver GVO-Zulassungsverfahren deutlich erschweren. Sowohl die Wissenschaft als auch die Gesetzgebung (GVO-Gesetz, Richtlinie 18/2001, Reg.1829/2003 und Reg.1830/2003 und verwandte Gesetze, sowie die Saatgutgesetzgebung) unterscheidet bislang nicht zwischen In-vivo- und In-vitro-Mutagenesetechniken, ebenso wenig wie der Gerichtshof der Europäischen Union in seinem Urteil von 2018 in der Rechtssache C-528/16.

 

Zudem gibt es praktische Schwierigkeiten bei der Trennung von Pflanzensorten, die heute durch In-vivo- und In-vitro-Verfahren gewonnen werden, denn es existieren keine zuverlässigen und standardisierten Nachweismethoden. Daher würde eine Rückverfolgbarkeit unmöglich sein.

 

Ein Konsens unter den EU-Mitgliedstaaten darüber, was ein GVO ist, ist Voraussetzung für das Funktionieren des EU-Binnenmarktes. Der französische Vorschlag einer nationalen Definition und Regulierung von GVO bedeutet Rechtsunsicherheit für alle Marktteilnehmer, die betreffende Produkte mit Frankreich handeln. Daher würde ein Inkrafttreten des Erlasses einen Rückschritt in der Harmonisierung des EU-Rechts bedeuten.

 

Einschränkung des freien EU-Warenverkehrs und des Handels mit Drittstaaten

 

Der französische Erlass würde gegen den Vertrag über die Arbeitsweise der Europäischen Union (Artikel 34) verstoßen, denn er würde den Verkauf von Sorten, die rechtmäßig in anderen Mitgliedstaaten hergestellt und vermarktet werden, unterbinden.[1]

 

Gleichzeitig führt die Ausnahme, die der Erlass für ausschließlich für den Export produziertes Saatgut vorsieht, zu einer Diskriminierung zwischen den Wirtschaftsakteuren in der EU und zu einer Diskriminierung der französischen Landwirte im Vergleich zu anderen EU-Ländern.

 

Der Europäische Gerichtshof hat zudem bereits in der Vergangenheit entschieden, dass eine solche nationale Verordnung ein ungerechtfertigtes Hindernis für den freien EU-Warenverkehr darstelle.[2] Somit wäre eine der vier Grundfreiheiten des europäischen Binnenmarktes willkürlich eingeschränkt.

 

Die möglichen Restriktionen würden auch den Import von Raps und Saatgut aus Kanada, Südamerika und den USA deutlich treffen. Unsere Mitgliedsunternehmen aus dem internationalen Groß- und Außenhandel beziehen ihre Nicht-GVO-Rohstoffe sowohl aus EU- als auch aus Drittstaaten. Bei Getreide, Ölsaaten und Futtermitteln handelt es sich um Massengüter, bei denen viele verschiedene Ladungen unterschiedlicher geografischer Herkunft miteinander vermischt werden können. Nach aktuellem Stand ist es unter diesen Voraussetzungen folglich nicht möglich festzustellen und zu kontrollieren, ob Saatgut und die daraus gewonnenen Produkte durch In-vitro-Mutagenese gewonnen wurden.

 

Die vorgeschlagene französische Regelung würde im Falle eines Inkrafttretens eine massive Störung des EU-Binnenmarktes aufgrund von ungerechtfertigten Behinderungen im freien Saatgutverkehr und der daraus entstandenen Ernte zur Folge haben.

 

Erschwerung der Erreichung von Nachhaltigkeitszielen

 

Für die Entwicklung einer nachhaltigeren Landwirtschaft im Sinne der Farm-to-Fork-Strategie ist es notwendig, dass Landwirte auch in Zukunft angepasste Sorten rechtssicher nutzen können, die mittels innovativer Züchtungstechnologien erzeugt wurden. Dies ist darüber hinaus nach unserer Auffassung auch notwendig, um das von der EU-Kommission vorgestellte Ziel der Klimaneutralität bis 2050 zu erreichen.

 

Die Umsetzung des französischen Erlasses würde dem Innovationsgedanken in der europäischen Landwirtschaft entgegenstehen und so der Wettbewerbsfähigkeit und den Nachhaltigkeitsbestrebungen entgegenwirken.

 

Wie wir in unseren Ausführungen verdeutlicht haben, bewerten wir den Antrag Frankreichs als einen Eingriff in den EU-Binnenmarkt, der sich hinsichtlich unterschiedlicher Aspekte negativ auswirken dürfte, und appellieren an die französischen Behörden, eine Regelung vorzuschlagen, die mit den gemeinsamen Zielen der Mitgliedstaaten vereinbar ist.

 



[1] Urteil des Gerichtshofs der EU vom 14. Dezember 1979, Rechtssache 34/79, Randnr. 12.

[2] Urteil des Gerichtshofs der EU vom 28. Januar 2010, Rechtssache C-333/08, Randnr. 112.


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  Irish Grain and Feed Association on 07-07-2020
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The Irish Grain and Feed Association would like to comment on TRIS notification 2020/280/F

The French Decree aims to amend the list of techniques for obtaining GMOs. These techniques have traditionally been used by plant breeders and there has been no reported draw back for public health or the environment. The Decree aims to differentiate between” in vitro” and “in vivo” mutagenesis whereas it should be noted that EFSA has never considered these separately when doing risk assessments.   It is unclear how products derived from these crops will be treated in the future.  We therefore have concern that the French approach could cause issues for the single market in seed and valuable protein meals. We would ask the Commission to use a standstill period to   examine the proposal and provide a detailed report on the issues raised by many of the chain partners.


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  Ministerio de Agricultura, Ganadería y Pesca on 07-07-2020
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 At VI Meeting of the Argentina-EU bilateral Dialogue on biotechnology applied to agriculture held in March 2019, Argentina conveyed to EU officials its concerns regarding Directive 2001/180 of the Court of Justice of the European Union (CJEU) where the Court ruled that the organisms obtained by mutagenesis techniques constitute GMOs.

Likewise, Argentina views with concern the presentation of France to the TRIS system of notification of legislative projects (decree and orders) in relation to the decision to regulate products obtained from the conventional mutagenesis technique under the same legislation of the EU on GMOs (Directive 2001/18 / EC).

For Argentina, both decisions constitute an obstacle to international trade and considers that they are not based on science.

In this sense, continuing with the active role of Argentina in pursuit of innovation in biotechnology, the country presented within the framework of the Committee on Sanitary and Phytosanitary Measures (SPS) of the World Trade Organization (WTO) two Declarations referring to the theme.

At the 73 SPS / WTO Committee (November 2018), the “INTERNATIONAL DECLARATION ON AGRICULTURAL APPLICATIONS OF PRECISION BIOTECHNOLOGY” was released. It was highlighted that the set of precision biotechnology techniques constitutes an indispensable tool for agricultural innovation. Its use gives farmers access to products that increase productivity while preserving environmental sustainability.

Moreover, on the 74th SPS Committee (March 2019), Argentina presented the “DECLARATION OF THE MINISTERS OF AGRICULTURE OF THE SOUTHERN AGRICULTURAL COUNCIL (CAS) ON TECHNIQUES OF GENETIC EDITION”. With this document, our country, together with the countries of the CAS, emphasize that gene editing techniques represent an opportunity for national agricultural research institutes and biotech small companies to develop products homologous to those generated by methods of conventional breeding.

Both Declarations had the support of a wide number of countries, which translates into the recognition that this set of techniques has for their sustainable innovation.

Under Argentine law, products made from these breeding techniques are classified as GMOs or non-GMOs according to whether they meet the criteria that are applied in the regulations (Res. 39/2019). If they are considered non-GMOs, they are not covered by the GMO regulatory framework. For cases that are considered GMOs, they must complete the requirements corresponding to regulatory standards.

Analyzing specifically the conventional mutagenesis methodology, it must be said that this is a technique for obtaining genetic variability used in the plant breeding process that developed in the mid-20th century and through which the vast majority of crops that have been obtained today they are consumed worldwide. It involves subjecting the tissues or the botanical seed to physical mutagenic agents (such as x-rays, gamma rays) or chemical agents (for example, EMS) to generate variations in nucleic acids that can be potentially useful if they manifest in a resulting observable phenotype. These mutations can consist of changes of one base, of several bases, deletions of one or more bases or group of nucleotides, translocations, chromosomal inversions, etc. All these novel variants can also occur in any genome without applying any mutagenic agent. In fact, "natural" variability is used from the beginning of the history of plant genetic improvement to select those useful or interesting variants to improve a certain characteristic.

Mutagenesis as a concept of source of variability can be obtained naturally or induced. The characteristics or variations produced can be detected by observing the phenotype, whether it is a change in color (as in the examples of ornamental crops), a change in shape (plant architecture) or a change in behavior against an abiotic agent (tolerance to an herbicide) or biotic (resistance to a pathogen). In all cases, these variants may be in the genome, but the visibility of their expression will depend on the environment in which they can be detected. For the herbicide tolerance example, the mutation can be detected in the field, if the culture is contacted with the selective agent, in this case an herbicide. It can also be detected by germinating a group of seeds in contact with the herbicide or in a culture medium containing the selective agent (the herbicide). In any case, the tissues that contain the genetic variant will be able to overcome the selective agent and continue its development.

The way in which the variant was produced - a spontaneous mutation, a mutagen induced mutation or a directed mutation - does not modify the type of result with respect to the phenotype found. Following this reasoning, there are no scientific reasons to discriminate a product according to how the mutation or variant was obtained.


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  German Plant Breeders' Association (BDP) on 07-07-2020
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 Dear Ladies and Gentlemen,

please find the BDP submission regarding French Decree 2020/280/F attached.

Sincerely,

Markus Gierth


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  Seed Association of the Americas (SAA) on 07-07-2020
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On behalf of the Seed American Association (SAA) we hereby present in attached format, a letter with contributions but also expressing concern about the French proposal that seriusly affects and create barriers to seed and grain trade for many countries globaly and to French companies as well.

SAA - www.saaseed.org - is a non-governmental organization that fully represents the interests of the seed industry within the Americas. The main purposes of the SAA are to educate and support development, marketing, and free movement of the seed within the continent and globally, while advocating seed industry legislation as to ensure fair and science-based seed regulations


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  AIC on 06-07-2020
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AIC position on the French Decree considering in-vitro mutagenesis techniques under the GMO framework

The Agricultural Industries Confederation (AIC) in the UK is deeply concerned by the implications of the French Decree considering in-vitro mutagenesis techniques under the GMO framework. It clearly undermines a harmonized area of EU law and risks a distortion of the EU single market and thus presents barriers to trade.

In recent years the UK had concerns about an increasing amount of erucic acid being found in the oil of oilseed rape. After scientific study it was concluded this was mainly due to the continuing emergence in the field of older varieties that were higher in erucic acid than modern varieties. There is also the continued issue of cruciferous weeds such as charlock, runch and hedge mustard, which contain erucic acid and are difficult to control with available products. The use of Clearfield varieties has been a helpful tool to growers and agronomists as part of Integrated Crop Management, giving more flexibility so that herbicide applications can be timed when they are more likely to be most effective to minimise older variety volunteers and cruciferous weeds emerging in and competing with oilseed rape crops. This in turn has given growers enhanced confidence that they can establish a viable oilseed rape crop which can meet the end market legal specifications. As the legal limit for erucic acid in vegetable oil is now reduced to 2%, it is of even greater importance that growers retain the option to grow Clearfield varieties.

Regarding the availability of seed, it is understood that production of Clearfield varieties will now move out of France so the seed will continue to be produced and available to the market. However there is significant concern amongst breeders about the wider impact this ruling would have across Europe, in terms of damaging confidence in bringing new traits to market and therefore stifling innovation. The investment in bringing new traits to the European market, which takes a number of years, would be questioned, to the detriment of plant breeders, farmers and consumers. In addition, the area of oilseed rape grown in 2021 harvest in the EU is predicted to fall almost 14% against the five year average (Commission Crop Market Observatory). Oilseed rape is a valuable source of pollen and nectar to bees and other pollinating insects and further decreases in the area grown could have a negative impact on populations of these valuable group of insects.

The status of the oil and meal produced is currently unclear and this is of significant concern for the functioning of markets. An amount of oil and rapemeal is exported from the UK to France each year and segregation is not currently possible.

Rapemeal is an important source of European produced vegetable protein. As in the 2019/20 EU Feed Protein Balance sheet, 9 million tonnes of rapeseed meal from EU rapeseed production was used by the EU animal feed industry. Therefore any negative action to damage confidence around growing and using rapeseed it is not in the interests of the European Union.


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  COCERAL on 06-07-2020
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 French Decree and the in-vivo /in vitro distinction:

huge impact on EU internal market with unclear rules and gains

 

COCERAL is the European association representing the trade in cereals, rice, feedstuffs, oilseeds, olive oil, oils and fats and agrosupply. COCERAL is the voice of collectors, distributors, exporters, importers and agribulk storers of the above-mentioned commodities. COCERAL represents almost 3000 operators in Europe trading in cereals, oilseeds, rice, feedstuffs, olive oil, oils and fats, as well as agrosupply (agricultural inputs), covering about 80% to 85% of the trade flows of agri-commodities to and from Europe. COCERAL membership includes large corporations and cooperatives plus family companies alike – all operating in EU.

Trade plays a vital role in the supply chain, moving agricultural commodities from areas of surplus to areas of deficit efficiently and at affordable prices. This is a strategic contribution of global trade towards enhancing food security worldwide.

Introducing arguments more related to the legislation, the differentiation between in-vitro and in-vivo mutagenesis techniques is not grounded either in the GMO law (Directive 18/2001, Reg.1829/2003 and Reg. 1830/2003 and related acts) nor in the seed legislation.

To our knowledge, never the Commission or Member States made such a distinction, nor did it the European Court of Justice in its seminal ruling of 2018, in the Case C-528/16.

At the same time, the European Food Safety Authority (EFSA) never highlighted such a different background for risk-assessment purposes, and never commented on in-vitro varieties having per se more hazardous features when compared against those in-vivo.

This scientific regulatory distinction has never been clearly in place or actioned along the entire food&feed supply chains for risk assessment or risk management purposes, nor for classification only. Furthermore, there are practical difficulties in separating now plant varieties obtained by in-vivo and in-vitro processes. In addition, there are practical problems due to lack of reliable and standard detection methods and as traders, we are worried that traceability will be impossible. The new regulatory framework put in place by the national legislator seems to fall short in delivering clear benefits. This is apparently due by putting in the same basket very different end-products and crops, having as the only common feature the process techniques in-vitro.

Another argument further complicating things is the exemption made under the Decree, for seeds for export only, still allowed for the Annex I B list varieties with unjustified discrimination across economic players in the EU and discrimination for French farmers when compared to other EU countries. This will happen as food&feed from other European countries, produced from varieties obtained by in vitro mutagenesis will enter in France without any labelling and competing with local production.

Eventually, COCERAL:

·         Considers the French Decree will clash against Primary EU legislation (Treaty and overarching principles), higher in the hierarchy of the sources, and for this, it is simply illegal and cannot have juridical consequences.

·         Considers the French Decree does not abide by the Principle of Proportionality or Subsidiarity as tenets of the EU Law. Such barriers to trade have not proven clear gains in terms of consumers' health or other goals;

·         Regrets that the French Decree will introduce national rules in a legislative field which is supposed to be under complete EU harmonization (under Secondary Legislation)- with a direct impact on the Treaty of the Functioning of the European Union (TFEU) and a breach in the legal certainty of the EU legislative framework;

·         Is concerned about the possible disruptions to the functioning of the common internal market for seeds, with unequal conditions for the economic players (farmers and food chain players)

·         Laments of possible spill-over effects into other related pieces of legislation (Organic farming, labelling and transparency in the food and feed sectors…)

·         Is concerned about the impossibility of putting in place clear traceability in the commodity market

·         Highlights the lack of detection methods to identify varieties obtained in-vitro compared to those obtained in-vivo, with unenforceability of the Decree

·         Welcomes further scientific and de-facto clarifications from EFSA and the Member States as solicited by the letter sent by the Commission- on the value of the in-vivo vs in-vitro distinction.

·         Expresses concerns about loopholes in the Decree: namely the fate of products derived from in-vitro varieties legally cultivated (as from the Decree derogations) for the year 2020 and resulting in end-products or food which could stay on the market for the very next years (as food or as ingredients).

 

While COCERAL believes that the Decree will have an impact on the EU internal market, at the current stage we are not in a position - as done by the Commission's services, in a first-desk appraisal- to dismiss also relevant effects on trade from and to third countries (Technical Barriers to Trade-TBT and Specific Trade Concerns - under the WTO provisions). We understand it was part of the process to focus on the internal market aspects only. However, an in-depth parallel evaluation would be welcomed for this, as from a preliminary assessment we cannot rule out this impact and trade-related distortions.

For the above-mentioned reasons, COCERAL asks the EU authorities to deliver a reasoned opinion on the consequences of the Decree, and the French authorities to supply a more fit-for-purpose legal framework.

 

 

Annex- Legal background

Considering in a stepwise manner the hierarchy of the legal sources, COCEERAL believes the French Decree will clash with Primary legislation (TFEU) and Secondary legislation (Regulations and Directives) and for this is not able to produce legal consequences, whilst impacting on the internal regulatory and economic order. In particular we can envisage the following problematic aspects.

o    Breach of the principle of Subsidiarity. Under Article 5(3) TEU there are three preconditions for intervention by Union institutions in accordance with the principle of subsidiarity: (a) the area concerned does not fall within the Union’s exclusive competence (i.e. non-exclusive competence); (b) the objectives of the proposed action cannot be sufficiently achieved by the Member States (i.e. necessity); (c) the action can, therefore, by reason of its scale or effects, be implemented more successfully by the Union (i.e. added value). With the case under focus, the three conditions are met and an EU harmonised regulatory framework is clearly required.

o    Breach of the principle of Proportionality. The principle is in the Treaty on European Union under Article 5, implying that ‘the content and form of Union action shall not exceed what is necessary to achieve the objectives of the Treaties’. Due to the harmonization in place in the GMO area deemed relevant to achieve the policy objectives, the principle of Proportionality is clearly contravened by the French Decree.

o    Breach of the Internal Market order - with specific reference to articles 4(2)(a), 26, 27, 114 and 115 of the Treaty on the Functioning of the European Union (TFEU), governing internal market provisions.

o    The Decree is escaping the full harmonization in place since 2001 with GMO Directive 2001/18, and the traceability and labelling requirements under Reg. 1829/2003 and 1830/2003 establishing that harmonised labelling requirements should be laid down for genetically modified feed to provide final users. Under reg. 1830/2003 whereas (2), the Commission made it clear that " Differences between national laws, regulations and administrative provisions concerning traceability and labelling of GMOs as products or in products as well as traceability of food and feed produced from GMOs may hinder their free movement, creating conditions of unequal and unfair competition. A harmonised Community framework for traceability and labelling of GMOs should contribute to the effective functioning of the internal market." Huge costs in relabeling and repackaging of products will be in charge of the business players without concrete benefits in terms of consumers health or environmental protection. At the same time, consumers will be necessarily misled, as the varieties listed in the French Decree are not considered GMOs under the fully harmonised EU legislation and risk assessment.

In particular, it will not be possible to ascertain traceability as under the Regulation (EC) No 1830/2003 (art. 5). This implies that business partners unwilling to disclose such information to EU countries will remain on safe grounds without transmitting information on HVTs, as there is no such EU-wide binding obligation in place.

The Decree will have no utility in redressing global trade or in providing better information to end consumers.

Segregation, low-level presence and threshold policies on the adventitious or technically unavoidable presence of material consisting, containing or produced from GMOs (art. 47 of Reg. 1829/2003) will be equally ineffective and there will be no practical means to have them in place according to the General Food Law requirements and the specific one stemming from the GMO legislation (reg. 1830/2003).  Official control authorities will not be allowed to control and detect for such varieties listed under the French Decree, as per art. 11 of reg. 1830/2003, due to the lack of detection methods and on top of that, of clear provisions at the EU level classifying them as GMOs.

o    According to the Organic regulation Reg. 834/2007 (art. 4 and art. 9) and Reg. 848/2008 (art. 11), compounds considered GMOs will not be allowed in end products. Business stakeholders will be deprived of viable compounds sourcing, while it will be impossible for them to strictly comply with the provisions. The same can be said for official control authorities.

o    At present, the Decree is also posing challenges to the transboundary movements of GMOs as under Reg. 1946/2004. This regulation is intended at establishing a common EU system of notification and information for transboundary movements of genetically modified organisms (GMOs) and to ensuring coherent implementation of the provisions of this Protocol on behalf of the Community. As a result of the French Decree this will not be possible and business partners from third countries could ask the Commission to return to the fully harmonised EU regulatory framework in order to avoid extra-compliance costs with the French legislation. French authorities would be allowed (under art. 14) to take "appropriate measures" to block imports of in-vitro varieties, undermining third countries' trust in fully integrated EU legislation in the GMOs field.

 

 

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  Royal Dutch Grain and Feed Trade Association on 06-07-2020
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 The Royal Dutch Grain and Feed Trade Association (‘Het Comité’) is the Dutch association representing the trade in cereals, oilseeds, pulses and feed materials. The Royal Dutch Grain and Feed Trade Association represents 120 companies -whom are based in the Netherlands- active in the trading or supply chain of cereals, oilseeds, pulses and feed materials. More info can be found on www.graan.com

Trade plays a vital role in the supply chain, moving agricultural commodities from areas of surplus to areas of deficit efficiently and at affordable prices. This is a strategic contribution of global trade towards enhancing food security worldwide.

Introducing arguments more related to the legislation, the differentiation between in-vitro and in-vivo mutagenesis techniques is not grounded either in the GMO law (Directive 18/2001, Reg.1829/2003 and Reg. 1830/2003 and related acts) nor in the seed legislation.

To our knowledge never the Commission or Member States made such a distinction, nor did it the European Court of Justice in its seminal ruling of 2018, in the Case C-528/16.

At the same time, the European Food Safety Authority (EFSA) never highlighted such a different background for risk-assessment purposes, and never commented on in-vitro varieties having per se more hazardous features when compared against those in-vivo.

This scientific regulatory distinction has never been clearly in place or actioned along the entire food&feed supply chains for risk assessment or risk management purposes, nor for classification only. Furthermore, there are practical difficulties in separating now plant varieties obtained by in-vivo and in-vitro processes. In addition, there are practical problems due to lack of reliable and standard detection methods and as traders, we are worried that traceability will be impossible. The new regulatory framework put in place by the national legislator seems to fall short in delivering clear benefits. This is apparently due by putting in the same basket very different end-products and crops, having as the only common feature the process techniques in-vitro.

Another argument further complicating things is the exemption made under the Decree, for seeds for export only, still allowed for the Annex I B list varieties with unjustified discrimination across economic players in the EU and discrimination for French farmers when compared to other EU countries. This will happen as food&feed from other European countries, produced from varieties obtained by in vitro mutagenesis will enter in France without any labelling and competing with local production.

Eventually, The Royal Dutch Grain and Feed Trade Association:

  •  Considers the French Decree will clash against Primary EU legislation (Treaty and overarching principles), higher in the hierarchy of the sources, and for this it is simply illegal and cannot have juridical consequences.
  • Considers the French Decree does not abide by the Principle of Proportionality or Subsidiarity[1] as tenets of the EU Law. Such barriers to trade have not proven clear gains in terms of consumers 'health or other goals;
  • Regrets that the French Decree will introduce national rules in a legislative field which is supposed to be under complete EU harmonization (under Secondary Legislation)- with a direct impact on the Treaty of the Functioning of the European Union (TFEU[2]) and a breach in the legal certainty of the EU legislative framework;
  • Is concerned about the possible disruptions to the functioning of the common internal market for seeds, with unequal conditions for the economic players (farmers and food chain players)
  •  Laments of possible spill-over effects into other related pieces of legislation (Organic farming, labelling and transparency in the food and feed sectors…)
  • Is concerned about the impossibility of putting in place clear traceability in the commodity market
  • Highlights the lack of detection methods to identify varieties obtained in-vitro compared to those obtained in-vivo, with unenforceability of the Decree
  •  Welcomes further scientific and de-facto clarifications from EFSA and the Member States as solicitated by the letter sent by the Commission- on the value of the in-vivo vs in-vitro distinction.
  •  Expresses concerns about loopholes in the Decree: namely the fate of products derived from in-vitro varieties legally cultivated (as from the Decree derogations) for the year 2020 and resulting in end-products or food which could stay on the market for the very next years (as food or as ingredients).

While The Royal Dutch Grain and Feed Trade Association believes that the Decree will have an impact on the EU internal market, at the current stage we are not in a position as done by the Commission's services, in a first desk appraisal- to dismiss also relevant effects on trade from and to third countries (Technical Barriers to Trade-TBT and Specific Trade Concerns- SPS- under the WTO provisions). We understand it was part of the process to focus on the internal market aspects only. However, an in-depth parallel evaluation would be welcomed for this, as from a preliminary assessment we cannot rule out this impact and trade-related distortions.

 

For the above-mentioned reasons, The Royal Dutch Grain and Feed Trade Association asks the EU authorities to deliver a reasoned opinion on the consequences of the Decree and the French authorities to supply a more fit-for-purpose legal framework .



[1] Under Article 5(3) TEU there are three preconditions for intervention by Union institutions in accordance with the principle of subsidiarity: (a) the area concerned does not fall within the Union’s exclusive competence (i.e. non-exclusive competence); (b) the objectives of the proposed action cannot be sufficiently achieved by the Member States (i.e. necessity); (c) the action can therefore, by reason of its scale or effects, be implemented more successfully by the Union (i.e. added value). In the case under focus, the three conditions are met and the EU law

[2] With specific reference to articles 4(2)(a), 26, 27, 114 and 115 of the Treaty on the Functioning of the European Union (TFEU), governing internal market provisions.


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  International Seed Federation on 06-07-2020
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International Seed Federation hereby submits to the European Commission its comments on the notification of three draft decrees filed by France.


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  EuropaBio on 06-07-2020
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EuropaBio, the European Association for Bio-industries, is the recognised voice of the European biotech community championing world-class solutions for society's challenges. 

With this letter EuropaBio would like to share its concerns about Notification 2020/280/F by France to the Commission under Directive (EU) 2015/1535 regarding “Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment”.  

The draft Decree was initiated following the decision of the Conseil d'État in February 2020 which ruled that organisms obtained via in vitro random mutagenesis subjecting plant cells to chemical or physical mutagenic agents, and the techniques of directed mutagenesis or of genome editing, are not conventionally used techniques with a long safety record.[1] While the Conseil d'État indicated that “based on the documents in the file both the so-called « directed » or « genome editing » techniques or methods and the techniques of random in vitro mutagenesis subjecting plant cells to chemical or physical mutagens, as mentioned in point 23 of the decision of the Conseil d’État of 3 October 2016, appeared after the date of adoption of Directive 2001/18/EC or have developed mainly since that date; it follows from the above that such techniques or methods must be regarded as being subject to the obligations imposed on genetically modified organisms by that Directive”, it requested the French Government to take action, after consultation of the Haut Conseil des Biotechnologies.

The French draft decree introduces an arbitrary distinction between the techniques of random mutagenesis and their exemption from the provisions of Directive 2001/18/EC. In particular, it seeks to exclude in vitro random mutagenesis consisting of subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents from the exemption. As a consequence, according to the proposed draft decree cultivation in France of plants resulting from in vitro random mutagenesis would require authorisation pursuant to Directive 2001/18/EC. 

We note that the distinction between in vivo and in vitro random mutagenesis, proposed in the French draft decree, is not substantiated and lacks any scientific basis. To date, no country in the world, none of the EU Member States, the European Commission, the European Food Safety Authority, or the Court of Justice of the EU  have made such a distinction for regulatory or any other purposes. Random mutagenesis has been used in plant breeding for decades and there is no scientific justification to submit certain random mutagenesis techniques to the GMO regulation. Different types of random mutagenesis have comparable effects on the plant genome and any differentiation in this group is arbitrary and scientifically unfounded regarding the resulting product characteristics. The decree, adopted in unamended form, would mean losing legal certainty for the whole breeding sector regarding the classification of breeding products in use for decades without any underlying safety concern.

The original intention of the notified draft decree and related Notifications [2020/281/F – “Order laying down the list of varieties mentioned in Article 2 of Decree”, and 2020/282/F – “Order amending the Official Catalogue of Species and Varieties of Cultivated Crops in France] were targeted changes to the implementation of Directive 2001/18/EC in France (French Environmental Code) to prohibit the cultivation and marketing of seeds of certain herbicide tolerant oilseed rape varieties in France.

Nevertheless, the proposed changes to the French Environmental Code raise valid questions and create uncertainty as other EU legal acts refer to the same definition of a GMO (including the exemptions) from Directive 2001/18/EC. These include among others, Regulation 1829/2003 of 22 September 2003 on genetically modified food and feed, and Regulation 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.

It is practically not possible to enforce the newly proposed differentiation within the group of random mutagenesis products since detectability and distinguishability of mutations existing in natural populations compared to intentionally introduced mutations has significant limitations. This was confirmed by the European Network of GMO Laboratories in the report “Detection of food and feed plant products obtained by new mutagenesis techniques” which concluded that detection and identification of the genome alterations that could have been produced naturally is not feasible by using routinely applied detection methods.[2]

By adopting the decree, France would regard food and feed products obtained via in vitro random mutagenesis techniques as GMOs and subject them to the provisions of Directive 2001/18/EC. While the draft decree does not refer to Regulation 1829/2003 and Regulation 1830/3003, it raises questions regarding implications for trade and food and feed use.

With its own interpretation of harmonized EU law, France creates an illegitimate national deviation from the GMO Directive. It opens the door to a patchwork of differing definitions and interpretations, directly challenging the internal market.

The proposal is in clear contradiction with one of the fundamental principles of the EU, the right to the free movement of goods originating in Member States and of goods from third countries which are in free circulation in the Member States, as established by Article 28 of the Treaty on the Functioning of the European Union, and also contradicts the EU case-law.[3] The decree would create major issues for the free movement of seeds and harvested crops for food and feed within the EU and would lead to a distortion of the internal market, as well as potential disruption of international trade flows. It is of the utmost importance to provide uniform interpretation of EU law to provide the needed legal certainty for the breeding companies in the EU.

The draft national decree by the French Government would have impact on the commodity market within and outside of France, as well as on innovation, competitiveness, and international trade in general. The decision of the Conseil d'État is still subject to many open questions, amongst others regarding the consistency with EU law and the implementation by the French Government. EuropaBio calls on the Commission to object to this draft decree which would distort the EU internal market.

 


[1] Decision of Conseil d'État, 7 February 2020, Organisms obtained by mutagenesis (see online in original language).

[3]  Judgment of the Court of Justice of the EU on 20 February 1979 Cassis de Dijon laid down the principle that any product legally marketed in a Member State, must be allowed onto the market of any other Member State.

 



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  La Coopération Agricole on 03-07-2020
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La Coopération Agricole is the joint representative body for French agricultural, forestry, agrifood and agribusiness companies. We represent 2300 agricultural cooperatives, 3 in 4 French farmers.

Please find enclosed our comments on the technical regulation that France notified to the Commission on 6th May regarding in vitro random mutagenesis (genetically modified organisms, GMOs).


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  Copa-Cogeca on 03-07-2020
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GOL(20)4526:1 – DDJ/lb

 

European Commission

 

DG GROW

 

Unit B.2 “Regulatory Barriers”

 

By e-mail: GROW-B2@ec.europa.eu

 

 

 

Brussels, 1st July 2020

 

 

 

Re: France's TRIS notifications on in vitro random mutagenesis (genetically modified organisms) references 2020/280/F, 2020/281/F, 2020/282/F.

 

 

 

Copa and Cogeca represent 22 million farmers and their family members as well as 20,000 agricultural cooperatives that are dedicated to providing 446 million citizens across the EU with safe, nutritious, high-quality and affordable food every day. They wish to submit their comments on the three technical regulations that France notified to the Commission on 6th May regarding in vitro random mutagenesis (genetically modified organisms, GMOs).

 

Copa and Cogeca have understood the following elements from the French legislative proposals:

 

  • The draft French decree alters the exemptions to the GMO definition and thus subjects products obtained from in vitro mutagenesis to the GMO Directive requirements and the regulations that derive thereof. 

  • The first ruling concerns the seven herbicide-tolerant (HT) varieties of rapeseed that are listed in the French catalogue. These will be removed from both the French and thus the Union catalogue, unless they have also been listed in a Member State other than France. As a result, it will no longer be possible to cultivate these seven varieties after August 2020 neither in France nor elsewhere in Europe, if the French catalogue remains the only one justifying their being listed in the Union catalogue.

  • The second ruling also lists HT rapeseed varieties registered in the Union catalogue via a catalogue other than the French catalogue. These varieties will no longer be able to be cultivated in France, but will not be withdrawn from the Union catalogue. EU Member States, with the exception of France, will be able to continue to cultivate these varieties.

     

    Copa and Cogeca are extremely concerned about the impact of these draft French rulings on the integrity of the EU’s single market and the free movement of HT rapeseed varieties, seeds from these rapeseed varieties as well as other products such as meal and vegetable oil derived from these varieties. The draft rulings create additional technical obstacles to trade, notably of meal derived from these varieties, keeping in mind that the EU is hugely dependent on imports of high-protein content materials to feed livestock. We are equally concerned about the consequences of these draft rulings for farm management.

    In the context of the Green Deal and notably the objectives to reduce the use of plant protection products, Copa and Cogeca does not wish to see the use of varieties made tolerant to herbicides through in vitro random mutagenesis subjected to the requirements laid out in Directive 2001/18/EC and as a result banned from cultivation in a large majority of EU Member States given their prior opt-out decisions.

    If the rapeseed varieties made tolerant to herbicides by in vitro random mutagenesis were classed as GMOs in the scope of Directive 2001/18/EC, this would raise the question of contaminated plots within agricultural holdings. Farmers would have to bear the incurred costs of destroying harvests contaminated with these HT rapeseed varieties, classed as GMOs, as well as the restrictions due to the monitoring of these contaminated plots. This would also generate additional costs downstream from farms due to the management of batches containing these non-authorised GMOs and due to control and traceability difficulties stemming from the inability to detect by analysis the in vivo or in vitro type of breeding behind the mutation of HT varieties, including varieties that have been freely available for further breeding of new varieties.

    The European Commission and Member States have never drawn a distinction between in vivo and in vitro mutagenesis, neither when implementing the legislation on plant reproductive material seeds, nor in the GMO legislation. The European Court of Justice ruling in case C-528/16 on mutagenesis did not make this distinction either. In light of this, Copa and Cogeca question whether these draft rulings are compliant with European law and call on the European Commission to settle this matter and to require France to take the subsequent decisions.

     

 


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  BASF SE on 01-07-2020
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 Dear Sirs,

please find the BASF contribution in the attachment.

Best regards,

Gérardine Garcon


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  Terres Univia on 29-06-2020
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Please find attached Terres Univia's observations on this notification.


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  FEDIOL on 29-06-2020
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From: EU vegetable oil and proteinmeal association (FEDIOL)

To: European Commission, TRIS website

Subject: FEDIOL stakeholder contribution to the notification by France of three draft legal acts related to the status of certain plant varieties obtained via in vitro mutagenesis (notifications 2020/0280/F, 2020/0281/F and 2020/0282/F)

FEDIOL, the EU vegetable oil and protein meal industry association, represents the interests of the European oilseed crushers, vegetable oil refiners and bottlers. FEDIOL members are 10 national associations and associated company members in 7 other EU countries. With about 180 facilities in Europe, the sector provides 20,000 direct employments. Its members process approximately 55 million tonnes of basic products a year, both of EU origin and imported from third country markets. The sector processes notably rapeseed, sunflower seed, soybeans and linseed into oils and meals for food, feed, technical and energy uses essentially on the European market.


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  BFA on 29-06-2020
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Position of the Belgian Feed Association

 

The Belgian Feed Association would like to comment on the “French Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment” in accordance with the TRIS Regulation (Directive (EU) 2015/1535).

 

The new French definition of in vitro random mutagenesis “consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques” (consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents) goes far beyond the interpretation of the European Court of Justice ruling on mutagenesis (the Case C-528/16) and creates an unprecedented situation pre-empting current efforts in Europe and in the World to establish a broad-based scientific consensus on the appropriate definitory framework for New Genomic Techniques. By creating its own definition, the French draft decree undermines a harmonized area of EU legislation (Directive 2001/18 and related regulations), which could severely impact the functioning of the Single Market in the EU.

 

Until now the Commission as well as Member States have never made a distinction between in vivo and in vitro mutagenesis, neither when implementing the EU seed legislation on plant reproductive material, nor in the existing EU GMO legislation. We therefore do consider the proposed definition of in-vitro mutagenesis as technically flawed and legally arbitrary. We would like to stress that the European Food Safety Authority (EFSA) has never indicated there would be a difference between in vitro/in vivo techniques for risk-assessment purposes.

 

BFA believes that the French Decree would have a direct adverse impact on the proper functioning of the EU internal market and free movement of products if adopted. Our interpretation is Intra-community trade obstacles would be created not only for seeds but also for resulting products. The French Decree would basically impose its rules to other Member States if they want to trade with France. However trade obstacles would not only within the EU borders but also outside of the EU, as the French decree could create non-Tariff technical barriers to trade for plants or seeds entering the EU market. Without any legitimate Public or Plant Health objective this could trigger infringements procedures by Exporting Countries both under WTO SPS and TBT Agreements.

 

On the basis of facts highlighted above we would welcome the extension of the standstill period under TRIS in order to allow the French competent authorities to review its decree to ensure compliance with both EU Single Market and WTO rules.

 


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  FEFAC on 29-06-2020
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FEFAC, the European Compound Feed Manufacturers’ Federation, would like to comment on the “French Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment” in accordance with the TRIS Regulation (Directive (EU) 2015/1535).

The French decree establishes a de novo definition of in vitro random mutagenesis “consistant à soumettre des cellules végétales cultivées in vitro à des agents mutagènes chimiques ou physiques” (consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents) which goes far beyond the interpretation of the European Court of Justice ruling on mutagenesis (the Case C-528/16) and creates an unprecedented situation pre-empting current efforts in Europe and in the World to establish a broad-based scientific consensus on the appropriate definitory framework for New Genomic Techniques.

Until now the Commission as well as Member States have never made a distinction between in vivo and in vitro mutagenesis, neither when implementing the EU seed legislation on plant reproductive material, nor in the existing EU GMO legislation. We therefore do consider the proposed definition of in vitro mutagenesis as technically flawed and legally arbitrary. We would like to stress that the European Food Safety Authority (EFSA) has never indicated there would be a difference between in vitro/in vivo techniques for risk-assessment purposes. The French proposal of creating its own definition undermines a harmonized area of EU legislation (Directive 2001/18/EC and related regulations), which could severely impact the functioning of the Single Market in the EU.

Furthermore, the indistinguishability of the varieties obtained in vitro and in vivo seeds remains a serious challenge for any private or official control system. It is virtually impossible to detect, on the basis of the product (seed/crop) itself, whether the product was the result of random in vitro mutagenesis. To start with, there is a complete absence of definitive lists of in vitro varieties for agronomical purposes. We therefore think it is practically unfeasible to engage in any authorization or enforcement activities in the framework of the GMO-Directive.

We believe that the French Decree would have a direct adverse impact on the proper functioning of the EU internal market and free movement of products if adopted. Our interpretation is Intra-community trade obstacles would be created not only for seeds but also for resulting products. The French Decree would basically impose its rules to other Member States if they want to trade with France. However, trade obstacles would not only be within the EU borders but also outside of the EU, as the French decree could create non-Tariff technical barriers to trade for plants or seeds entering the EU market. Without any legitimate Public or Plant Health objective, this could trigger infringements procedures by Exporting Countries both under WTO SPS and TBT Agreements.

On the basis of facts highlighted above, we would welcome the extension of the standstill period under TRIS in order to allow the French competent authorities to review its decree to ensure compliance with both EU Single Market and WTO rules. We would also appreciate if the EU Commission could provide us with its detailed opinion on this French decree.


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  Euroseeds on 29-06-2020
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European Commission

 

DG Growth

 

Unit B2 "Prevention of technical barriers"

 

 

 

Brussels, 29 June 2020

 

 

 

 

  

 

Re                    : TRIS notifications by France about in vitro random mutagenesis (genetically modified organisms)

 

Y. ref.              : 2020/280/F, 2020/281/F, 2020/282/F

 

O. ref.              : 20.0303.1 Euroseeds TRIS submission

 

 

 

 

I am Garlich von Essen, the Secretary General of Euroseeds, the voice of the European seed sector, representing the interests of those active in research, breeding, production and marketing of seeds of agricultural, horticultural and ornamental plant species (www.euroseeds.eu).

 

 

 

Euroseeds hereby submits to the European Commission, pursuant to Directive 2015/1535 of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (the “Single Market Transparency Directive”), its comments on the following three technical regulations that were notified to the Commission by France on 6 May 2020:

 

 

 

·         2020/280/F – “Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment”,

 

·         2020/281/F – “Order laying down the list of varieties mentioned in Article 2 of Decree [xx]”,

 

·         2020/282/F – “Order amending the Official Catalogue of Species and Varieties of Cultivated Crops in France (rape seeds and other crucifer seeds)”.

 

 

 

These three draft proposals share the same background, as set out by France in the accompanying “Brief Statement of Grounds”.[1] They are therefore addressed together hereinafter as the “French Proposal”.

 

 

 

For at least the reasons set out in this submission, Euroseeds respectfully submits that the French Proposal seriously risks to create barriers to the activities of its members and to distort the proper functioning of the internal market in general.

 

 

 

 

 

A.            The French Proposal

 

 

 

1.            The French Proposal essentially consists of two elements.

 

 

 

a.         First, it qualifies organisms obtained via in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents (hereinafter for simplification referred to as in vitro random mutagenesis or simply in vitro mutagenesis) as regulated genetically modified organisms (“GMOs”) under Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (“the GMO Directive”).

 

 

 

GMOs obtained via the techniques listed in Article D531-2 of the French Environmental Code (“Code de l’environnement”) are not subject to the provisions of Title III of Book V of the legislative part of the French Environmental Code, nor to its Articles L125-3 and L515-13. However, the draft Decree amends the definition of ‘mutagenesis’, expressly excluding “in vitro random mutagenesis” from the list. The resulting organisms would thus become non-exempted GMOs.

 

 

 

Article D531-2, of the French Environmental Code is amended as follows:

 

 

 

1. In the first paragraph, after the words ‘as giving rise to a genetic modification’, the words ‘or which have been traditionally used without any noted drawbacks with regard to public health or the environment’ are inserted;

 

 

 

2. 2(a) reads as follows (the underlined being inserted): ‘a) Random mutagenesis, with the exception of in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents

 

 

 

b.         Secondly, it revokes and deletes certain herbicide tolerant varieties obtained via in vitro random mutagenesis from the Official Catalogue of Species and Varieties of Cultivated Crops in France.

 

 

 

2.            The French Proposal thus has the effect of effectively de-harmonizing a harmonized area of EU law (point B. below), thus creating unwarranted obstacles to the free movement of seeds and crops within the internal market. These effects are furthermore immediately apparent given that the French Proposal revokes and deletes varieties obtained via in vitro random mutagenesis from the Official Catalogue thereby also frustrating the functioning of the “Common Catalogue” under Directive 2002/53 (point 0. below). France’s national narrowing of the exemption for organisms obtained through mutagenesis also has significant spillover effects, also beyond the marketing of seeds, into other European legislative instruments (point D. below). Since furthermore the French Proposal is not based on science, it cannot be complied with and hence risks to be unenforceable, thus increasing legal uncertainty for market operators and controlling agencies (point E. below). Finally, (point F. below), the French Proposal risks to create technical barriers to trade under the WTO’s Technical Barriers to Trade (“TBT”) Agreement for goods imported in France (and the EU in general) from outside the EU for essentially the same reasons as the obstacles it creates for goods circulating within the EU.

 

 

 

3.            In view thereof, Euroseeds respectfully urges the Commission to issue a detailed opinion pursuant to Article 5 of the Single Market Transparency Directive. Euroseeds submits that for (inter alia) the reasons outlined in this submission, France should withdraw the French Proposal.

 

 

 

 

 

B.            The French Proposal creates national discrepancies in a harmonized area of EU law

 

 

 

4.            As said, the French Proposal amends Article D531-2 of the French Environmental Code as it stood – the mirror image of Annex I.B (1) of the GMO Directive – as follows:

 

 

 

Annex I B of Directive 2001/18

Original Article D531-2, 2° of the French Environmental Code

French Proposal

(1) mutagenesis

a) mutagenesis

a) Random mutagenesis, with the exception of in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents

 

 

 

The French Proposal thus restricts, at national level, the harmonized scope of Article 3(1) and Annex I.B of the GMO Directive by redefining ‘mutagenesis’. However, the GMO Directive provides no legal ground for qualifying organisms obtained via in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents as regulated GMOs. The proposed definition is, however, technically arbitrary and legally flawed.

 

 

 

5.            It is technically arbitrary because the French Proposal lacks any technical explanation or justification. Any unsubstantiated differentiation of in vitro versus other forms of mutagenesis is a priori artificial. The motivation for including it in the French Proposal is completely obscure. As the Commission knows, the in vitro-aspect only refers to the environment in which the technique of mutagenesis is applied. The outcome, however, is the same as other forms of mutagenesis, independent of the environment in which it was applied.

 

 

 

Furthermore, the traits (such as herbicide tolerance) encountered in varieties that result from random in vitro mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents can also be found in varieties that result from other forms of random mutagenesis, such as e.g. the Clearfield sunflower, which is tolerant to the same herbicide. Other examples are listed in Annex I and II[2].. Nonetheless, pursuant to the French Proposal, herbicide tolerant varieties that result from in vitro random mutagenesis are now suddenly regulated GMOs, whereas others with the same trait are not and no justification for this artificial division is provided. Neither should be regulated GMOs. 

 

 

 

6.            The French Proposal is also legally flawed. First of all, pursuant to recital 13 of the preamble of the GMO Directive, this directive should be interpreted consistently with the Cartagena Protocol on Biosafety to the Convention of Biological Diversity (“Cartagena Protocol”), which was ratified by the EU on 27 August 2002.[3] In the view of Euroseeds, at least recitals 2 and 5 of the preamble of Regulation 1946/2003 on transboundary movements of GMOs indicate that the EU legislator intended to equate the notion of GMO, as defined in the GMO Directive, to that of “living modified organism” or “LMO”, as defined in Article 3(g) of the Cartagena Protocol.[4] The Cartagena Protocol defines a LMO in a product-based manner as “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology”, whereby “modern biotechnology” is limitatively defined as the application of in vitro nucleic acid techniques or cell fusion beyond the taxonomic family. Random in vitro mutagenesis does not fall within the definition. Qualifying organisms obtained via in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents as regulated GMOs is therefore inconsistent with the Cartagena Protocol.

 

 

 

Secondly, taking a closer look at the GMO Directive itself, Article 3(1) stipulates that the directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex I.B, in particular “mutagenesis”. There is no indication or legal ground in the GMO Directive that the exemption of Article 3(1) should not apply to in vitro random mutagenesis, as opposed to other forms of (random) mutagenesis. Neither at the European, nor at the Member State level has a distinction ever been made between in vivo and in vitro mutagenesis, neither when implementing the seed legislation on plant reproductive material, nor in the GMO legislation. Euroseeds furthermore wishes to emphasize that not even the ruling of 25 July 2018 of the European Court of Justice (“CJEU”) in Confédération Paysanne (case C-528/16) made any such distinction.

 

 

 

Thirdly, however, even when applying the narrow interpretation[5] given to the scope of the exemption of Article 3(1) of the GMO Directive by the CJEU in the Confédération Paysanne ruling of 25 July 2015 (case C-528/16), the exclusion in the French Proposal of in vitro random mutagenesis from the scope of the mutagenesis exemption still falls foul of Article 3(1) of the GMO Directive, because even a preliminary look at the IAEA mutant variety database[6] (which is furthermore incomplete, in that it underreports the amount of relevant varieties) and a selection of literature dating from before 2001 on the topic already show that a substantial number of varieties from different crops resulting from in vitro mutagenesis have been registered and that the technique was well established and applied in different varieties prior to the adoption of the GMO Directive (see Annex I/II[7]). By no means can it be considered that the technique has appeared or has been mostly developed since the adoption of the GMO Directive. The development of herbicide tolerant rapeseed varieties through in vitro mutagenesis can be traced back to the 1980’s.[8] It follows that even under the broad criterion of recital 17 of the GMO Directive’s preamble, organisms obtained by in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents cannot amount to regulated GMOs in the sense of that harmonizing directive.

 

 

 

7.            The French Proposal is therefore an isolated, national initiative, which creates an untenable market landscape. Organisms obtained via in vitro random mutagenesis are considered regulated GMOs in France while they are, to Euroseeds’ knowledge, not in other Member States. At the same time and as will be further discussed below, certain varieties are revoked, on those grounds, from the French Official Catalogue, whereas other Member States do not share this view.

 

 

 

8.            What necessarily follows is a distortion of the internal market. The GMO Directive is grounded in Article 114 of the Treaty on the Functioning of the European Union (“TFEU”) (formerly Article 95 of the Treaty establishing the European Community), which sets out strict rules and conditions for national deviations from a harmonized area of EU law. As is expressly clarified in its own Article 1 as well as in recital 7 of its preamble, the GMO Directive approximates the provisions of national law for the purposes of the establishment and functioning of the internal market. Once harmonized, national provisions can, as a matter of principle, no longer deviate as a result of the primacy of European Union law. Pursuant to Article 288 TFEU, a directive “shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods”.

 

 

 

The French Proposal, however, is not about forms or methods. It directly impinges on the result to be achieved by the harmonizing effect of the GMO Directive. By amending Article D531-2, 2(a) of the French Environmental Code and thus restricting the harmonized definition of ‘mutagenesis’ at a national level, France creates an illegitimate national deviation from the GMO Directive. As said, there is no indication that any other Member State shares the definition set out in the French Proposal and, even if other Member States were to share or follow the French Proposal, the French Proposal in any event risks to result in a patchwork of differing definitions and thus in the very barriers to trade the GMO Directive sought to prevent.

 

 

 

 

 

9.            Against this backdrop and bearing in mind that the French Proposal effectively seeks to de-harmonize a harmonized area of EU law, with all the potential proliferating effect this initiative may trigger, Euroseeds submits that, for this reason alone, the French Proposal risks to amount to an unjustified barrier to intra-EU trade within the meaning of the Single Market Transparency Directive.

 

 

 

 


 

 

C.            The French Proposal distorts the functioning of the common market for seeds

 

 

 

10.          The French Proposal revokes and deletes certain varieties from the French Official Catalogue of Species and Varieties of Cultivated Cropsdue to their obtainment via an in vitro random mutagenesis technique”.[9]

 

 

 

11.          Although the precise legal basis for the French Proposal is generally unclear, at least a part of it[10] refers to Article 14 of Directive 2002/53 of 13 June 2002 on the common catalogue of varieties of agricultural plant species (“the Common Catalogue Directive”). It is assumed, in the absence of any of the other paragraphs of that provision being relevant in this case, that, more specifically, France intended to refer to § 2(a) of that Article 14. According to that paragraph, “Member States may revoke the acceptance of a varietyif the laws, regulations and administrative provisions adopted in pursuance of this Directive are not complied with”.

 

 

 

12.          Whereas France seems to assume that the French Proposal is the only and inevitable result of its reliance on this Article 14, Euroseeds wishes to point the Commission to the fact that, contrary to the first paragraph of Article 14 which contains an obligation to revoke an accepted variety under certain conditions (which do not apply here)(“Member States shall ensure that acceptance of a variety is revoked…”), the second paragraph of Article 14 merely entitles Members States to proceed to such a revocation under certain conditions (“Member States may revoke…”).

 

 

 

It furthermore follows from the French Proposal that France seems to assume, without any further justification, that those conditions (i.e. “if the laws, regulations and administrative provisions adopted in pursuance of this Directive are not complied with”) are met in the present case. Euroseeds respectfully submits that “the laws, regulations and administrative provisions adopted in pursuance of this Directive” for all the varieties which France now seeks to delist (pursuant to Article 15 of the Common Catalogue Directive), were (and indeed still are, pending the French Proposal) complied with at the time of their listing / admission to the French Official Catalogue (and hence also the Common Catalogue). The only reason why France claims that these conditions are not or no longer complied with is because it now effectively seeks to rewrite the French “laws, regulations and administrative provisions adopted in pursuance of this Directive”, in a fashion which, according to Euroseeds (as explained above), is furthermore non-compliant with EU law.

 

 

 

Euroseeds submits that in view hereof – i.e. both because France’s right of revocation under Article 14(2)(a) is only optional and because the alleged cause of non-compliance lies in France’s attempt to retroactively change the (harmonized) rules – it is absolutely paramount that the French Proposal be treated with caution and should be assessed in strict respect for the Common Catalogue’s essential substantive and procedural requirements.

 

13.      This is particularly important since, according to France’s own “Brief Statement of grounds” accompanying its TRIS notification, it not only seeks to prevent the cultivation of the varieties concerned on its soil, but also their marketing: once the Decree has been published and is subject to the transitional provisions provided, in particular for growing crops, it will be prohibited in France to cultivate or place on the market the varieties resulting from in vitro random mutagenesis” and also, in another version, “once the Decree has been published and is subject to the transitional provisions provided, in particular for growing crops, it will be prohibited in France to cultivate or sell the varieties resulting from in vitro random mutagenesis” (own emphasis).

 

 

 

Such a prohibition to “place on the market / sell the varieties” (without further defining what that means, i.e. does it only cover the placing on the market of propagating material, or also that of products, such as food or feed, resulting therefrom?) obviously has far reaching consequences for the free movement of material of the varieties concerned lawfully grown and placed on the market in other Member States.

 

 

 

According to Euroseeds, the French Proposal therefore necessarily needs to be assessed under the requirements set out in Articles 16 and/or 18 of the Common Catalogue Directive, to which France does not refer in the French Proposal.

 

 

 

14.          The common catalogue is set up to harmonize the rules under which (propagating material of) plant varieties are allowed to be marketed and thus to boost productivity.[11]  It is compiled on the basis of the respective national catalogues and lists all varieties of which the seed and propagating material are not subject to any marketing restrictions as regards variety. Pursuant to Article 16(1) of the Common Catalogue Directive, “Member States shall ensure that, with effect from the publication referred to in Article 17, seed of varieties accepted in accordance with this Directive or in accordance with principles corresponding to those of this Directive is not subject to any marketing restrictions relating to variety”. On this basis, the varieties that the French Proposal now seeks to revoke, have all been admitted in France (and other Member States), so that their seeds could move freely throughout the EU.

 

 

 

15.          Pursuant to Article 16(2) and/or Article 18 (depending on the circumstances) of the Common Catalogue Directive, imposing restrictions on the use of the varieties or on the marketing of their propagating material is only possible if a Member State, in this case, France, on the substance, were to prove that the conditions outlined in those provisions are met (which France has not done or even attempted to do) and, in terms of procedure, is authorized by a decision adopted under the comitology procedure to do so.

 

 

 

16.          Instead, the French Proposal unilaterally seeks to revoke and delete the varieties in question, bypassing both the above substantive and procedural requirements. The French Proposal, also for this reason, thus risks to create a distortion of the EU single market and thus barriers to trade: the seed of the varieties in question, which had all been admitted in France, can no longer be produced in France, without complying (although it is unclear how – see further below), with the stringent rules of the GMO framework. Furthermore, the marketing into France of seeds of those varieties originating in another Member State (where it will be deemed to meet all relevant obligations), will be hindered without France having provided any justification for such barrier. This of course has a significant impact. Without being exhaustive, Clearfield oilseed rape varieties as listed in the French Proposal[12] represent a quite high percentage of the total oilseed rape cultivation area in some member states and the respective harvests are traded and processed - without separation - as commodities between member states. In addition, France is an important country when it comes to the production of seeds of Clearfield oilseed rape varieties as listed in the French proposal which makes France an important player for the seed supply with respective Clearfield oilseed rape seeds for other countries[13].

 

 

 

17.          Finally, Euroseeds draws the Commission’s attention to the fact that, while the French Proposal is seemingly confined to certain herbicide tolerant rapeseed varieties, its (potential) effects extend to other varieties as well. As explained above, the French Proposal builds on a restricted, national definition of ‘mutagenesis’ pursuant to which all organisms obtained via in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents are deemed regulated GMOs in France. It follows that nothing in this approach is limited to the rapeseed varieties currently mentioned in the French Proposal, nor to herbicide tolerant varieties for that matter. Concretely, the (potential) effects extend to any existing variety that is listed but not mentioned in the French Proposal as well as to any future variety obtained via in vitro random mutagenesis technique, as defined. This risks to create massive legal uncertainty (on that principle: see further below in point E.).

 

 

 

 

 

D.            The French Proposal has important spillover effects, also beyond the marketing of seeds, into other, related pieces of EU internal market legislation

 

 

 

18.          While, as discussed above, the immediate focus of the French Proposal appears to be on the GMO and Common Catalogue Directives, its knock-on or spillover effects, however, are much broader, since many other European legislative instruments are inextricably linked with both those directives.

 

 

 

19.          To start with, the decision to revoke and delist the varieties included in the French Proposal will have a spillover effect on other pieces of legislation, in particular the seed marketing legislation (such as Directive 2002/57 of 13 June 2002 on the marketing of seed of oil and fibre plants, mentioned above, but also all other seed marketing directives[14]) because the seed of the delisted varieties will no longer be eligible for certification (and of course further marketing) under those directives.

 

 

 

20.          Furthermore, France’s intention to unilaterally deviate from the harmonized exemption in Article 3(1) of the GMO Directive, not only triggers obligations for all those wishing to cultivate or market the varieties concerned under Part B or Part C of the GMO Directive itself, but potentially also under a myriad of related EU rules which all directly or indirectly rely on or refer to the GMO Directive as far as the definition of and/or the exemptions (or sometimes exclusions) from the GMO-concept is concerned, such as:

 

 

 

-       Directive 2009/41 of 6 May 2009 on the contained use of genetically modified micro-organisms;

 

-       Regulation 1829/2003 of 22 September 2003 on genetically modified food and feed;

 

-       Regulation 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms;

 

-       Regulation 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms;

 

-       Regulation 2018/848 of 30 May 2018 on organic production and labelling of organic products;

 

-       Regulation 1107/2009 of 21 October 2009 concerning the placing of plant protection products on the market;

 

-       Etc.

 

 

 

21.          Various obligations follow from these related EU rules, both on the side of the market operators (such as product requirements, authorization for placing on the market, labeling, traceability, etc.) as well as on the side of the Member States (such the related inspection and control measures).  

 

 

 

To name but a few trade barrier questions that could potentially arise in regard to such obligations if the French Proposal is adopted:

 

 

 

-       As highlighted earlier, France, in its Brief Statements of Grounds accompanying the French Proposal, states that the French Proposal is not just about cultivation, but also seeks to prohibit the “placing on the market of the varieties”. To the extent that this “placing on the market of the varieties” refers also to harvested material or processed products of those varieties, how will that affect France’s position towards the aforementioned Regulation 1829/2003?[15] The authorization for placing on the market of food/feed consisting of, containing or produced from GMOs under Regulation 1829/2003 is organized at EU level, but starts with an application filed at Member State level with a national authority. Will France insist on following the authorization procedure under this regulation for all food or feed whose production process involves the use of in vitro random mutagenesis, where the same product would not require any such authorization according to the other Member States? Will France’s national representative change its position in the Standing Committee that is to approve the Commission’s proposal to grant or refuse an authorization? Will combined Part B and Part C applications under the GMO Directive and Regulation 1829/2003 now have to lead to a different outcome (qualifying organisms resulting from in vitro random mutagenesis that are intended for other purposes than placing on the market as regulated GMOs, but the same organism as or in a food/feed as exempted/excluded)?

 

 

 

-       How will the French Proposal work out for the rules on co-existence between GM crops and conventional crops (within France, but also at France’s borders with countries that do not qualify organisms obtained from in vitro random mutagenesis as regulated GMOs), including the rules on adventitious or technically unavoidable presence of material of the revoked varieties during seed production, cultivation, harvest, transport or processing - steps that may be performed by separate operators, potentially spread out across different Member States. The French Proposal frustrates this mechanism by creating a de-harmonized understanding of what constitutes a regulated GMO. It compromises – also taking into account the issue of detectability as discussed in point E. below) - any calculation that must be made to establish whether the relevant threshold of adventitious presence is met as well as the steps that an operator must prove have been taken to avoid the material (to establish that the presence is ‘adventitious’) as it will be entirely unclear which materials must be avoided, whether the origin thereof matters and what the potential impact is of having steps in the production and distribution line performed in France.

 

 

 

-       Will French exporters of organisms obtained through in vitro random mutagenesis now have to be treated differently under Regulation 1946/2003, whereas this regulation specifically implements the abovementioned Cartagena Protocol and its recital 16 expressly states that “it is necessary to ensure the identification of GMOs being exported from or imported into the Community. With regard to traceability, labelling and identification of imports into the Community, such GMOs are subject to rules in Community legislation. With regard to exports similar rules should apply” (own emphasis)?

 

 

 

-       Etc.

 

 

 

22.          In sum, the French Proposal shakes up the entire EU internal market for seeds (and beyond), whose functioning is in part based on the assumption that there is a consensus, due to the harmonizing effect of the GMO Directive, of which organisms amount to GMOs and which do not. If every EU country now gets to choose by itself what organisms (or techniques) it regulates as GM(O) or not, it is clear that the consequences for the EU internal market cannot be overseen, not just in terms of cultivation, not just in terms of seeds, and not just in France, but also in terms of all stages of the placing on the market of every product anywhere in the EU deemed to consist of, contain or to be produced from a GMO.

 

 

 

 

 

E.            The French Proposal is unenforceable – legal uncertainty

 

 

 

23.          The Commission is familiar with the report from the European Network of GM Laboratories of 26 March 2019 on “Detection of food and feed plant products obtained by new mutagenesis techniques”,[16] in the wake of the abovementioned CJEU decision of 25 July 2018. This report essentially concluded that it is virtually impossible to detect, on the basis of the product (seed/crop) itself, whether the product was the result of conventional breeding or of a form of (in that case: targeted) mutagenesis.  As a result, it was found unfeasible to engage in any authorization or enforcement activities in the specifically transgenic framework of the GMO-Directive.

 

 

 

24.          While this report was about genome-edited organisms, Euroseeds submits that the same conclusions necessarily apply here, mutatis mutandis. For the reasons outlined above, the notion of ‘in vitro’ only refers to the environment in which a mutagenesis process is applied. The outcome is indistinguishable from other conventionally bred organisms.

 

 

 

25.          It follows that the French definition is afflicted with problems of enforceability, such as for inspection and control measures, under the GMO Directive. It the first order, this affects France, but at the same time it is completely unclear how market operators, such as Euroseeds’ members, or other Members States are supposed to take into account that such a distinction should now be made in France. Furthermore, these practical considerations undermine any objective that France would attempt to advance to justify the restrictions. One fails to see how any of these restrictions can be justified or necessary, if it is not even feasible to differentiate between goods that fall under the restrictions and those that do not.  

 

 

 

26.          This is all the more so since the French Proposal risks to have a significant impact on the right of breeders to use material of varieties that is available in the market, for further breeding, as recognized in the so-called “breeder’s exemption” foreseen in Article 15(c) of the EU Plant Variety Rights Regulation 2100/94  and Article 15(1)(iii) UPOV 1991 of which the EU is a member . Contrary to what the term may suggest, the breeders’ exemption is not merely an exception to the right of plant variety right holders, but rather the confirmation of an internationally accepted rule that every breeder of new varieties has the right to access and use commercially available material of already existing protected varieties for the purpose of further breeding. This principle is expressly recognized in the 15th recital of the preamble to Regulation 2100/94, which states that: “Whereas in order to stimulate plant breeding, the system basically confirms the internationally accepted rule of free access to protected varieties for the development therefrom, and exploitation, of new varieties” (own emphasis).

 

 

 

It follows that, based on this principle, plant material - developed by in vitro random mutagenesis and not previously having been qualified as a GMO – has freely roamed between breeders for integration into their breeding programs for many years, without any requirement or need to document or trace the use of such material. In other words: breeders cannot tell reliably (i.e. inform the French or other authorities) which of their varieties has material resulting from in vitro random mutagenesis as defined by the French Proposal crossed into it.

 

 

 

27.          According to Euroseeds, also this fact therefore necessarily leads to the conclusion that the French Proposal risks to severely distort the EU single market, not at least because it runs counter to the fundamental EU principle of legal certainty (to name but one such principle). According to this principle, rules should be clear and precise so that individuals may be able to ascertain unequivocally what their rights and obligations are, and may take steps accordingly. Therefore, the legal consequences of an act must be foreseeable. The CJEU has held that, in reviewing the legality of an act based on legal certainty, while a degree of uncertainty regarding the meaning and scope of a rule of law is inherent, “the examination is confined to the question of whether the legal measure at issue displays such ambiguity as to make it difficult to resolve with sufficient certainty any doubts as to the scope or meaning of the contested regulation”.[17] In the present context, Euroseeds submits that, due to inter alia the impossibility to distinguish an organism resulting from in vitro random mutagenesis from any other crop resulting from random mutagenesis and therefore to respect the obligations of traceability, post-marketing control, labelling or co-existence under the abovementioned GMO legislation, the French Proposal is insufficiently clear and precise for individuals to be able to ascertain unequivocally what their rights and obligations under that GMO legislation are.

 

 

 

 

 

F.            Risk for similar barriers in relation to goods imported from outside the EU – TBT/SPS

 

 

 

28.          In only one out of the three notifications made in the context of the Single Market Transparency Directive, has France indicated that the French Proposal creates TBT (technical barriers to trade) – namely the identified as “Order laying down the list of varieties mentioned in Article 2 of Decree [xx]” with notification number 2020/281/F.

 

 

 

29.          It should be noted, however, that all three proposals notified risk to create such TBTs, if not already a problem under the SPS Agreement, as all the three proposals that constitute the French Proposal are intertwined. If one of them creates TBT or SPS issues, is must necessarily be concluded that they all have a part in this. The order laying down the list of varieties, does so in implementation of Article 2 of the “Decree amending the list of techniques for obtaining genetically modified organisms traditionally used without any noted drawbacks with regard to public health or the environment” with notification number 2020/280/F. Finally, the “Order amending the Official Catalogue of Species and Varieties of Cultivated Crops in France (rape seeds and other crucifer seeds)”, with notification Number 2020/282/F, gives effect to the other two by deleting the varieties listed.

 

 

 

30.          Second, it is clear that the French Proposal – encompassing the three proposals – may have a significant effect on the trade of other members under the SPS or at least the TBT-Agreement. Not only is export of seeds of varieties that have been revoked and deleted from the official French catalogue from France to the other members barred, the French Proposal also risks to create obstacles to international trade for goods imported in France (and the broader EU) from outside the EU for essentially the same reasons as obstacles are created for goods from other Member States. The proposed qualification of organisms obtained via in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents as non-exempted GMOs in France necessarily affects imports as this will trigger the various obligations under the applicable GMO framework.[18] It follows that France erects a barrier for those products imported into the Union from a country that does not consider the product in question as regulated, including all Members to the Cartagena Protocol that apply the definition of a LMO, which, as explained above, does not pertain to organisms obtained through random in vitro mutagenesis. France has not substantiated, invoked or even referenced any justification for restricting free movement in the EU. France has neither substantiated how the French Proposal is necessary to protect human, animal or plant life or health, is based on scientific principles or is based on sufficient scientific evidence, as required by the SPS Agreement. The same is true regarding the absence of any legitimate objective in the sense of the TBT Agreement.

 

 

 

31.          The barriers that risk to be created by the French Proposal indeed affect present trade. Various varieties from different crops that have been obtain by random in vitro mutagenesis originate outside of the EU.[19] It follows e.g. from available third country market data[20] in relation to the Clearfield tolerant oilseed rape varieties targeted by the French Proposal, that the percentage of the cultivation area for Clearfield tolerant oilseed rape in Ukraine counts for 16%. With a total oilseed rape cultivation area of around 1,3 Mio ha[21], this counts for 208.000 ha. The main importer of oilseed rape from Ukraine is traditionally the EU and the share of France accounts for 40% of these imported oilseeds[22]. Since the Clearfield oilseed rape is traded as a commodity, a separation of respective oilseeds never took place. In the future these oilseeds as well as respective products would be regarded as unapproved GMOs in France which risks to create a huge barrier for trade.

 

 

 

Within the WTO, the challenge of trading products resulting from certain new breeding techniques (commodities and seeds) under the current lack of global harmonization was recognized. In the “International Statement on Agricultural Applications of Precision Biotechnology”, a number of third countries within the Committee on Sanitary and Phytosanitary measures expressed their concern that differing domestic regulatory approaches for products derived from precision biotechnology may result not only in internationally asynchronous approvals, but also in asymmetry of regulatory approaches, and create potential trade issues that could impede innovation. They call upon governments to exercise due consideration to avoid arbitrary and unjustifiable distinctions between end products derived from precision biotechnology and similar end products obtained through other production methods[23]. The same concerns apply mutatis mutandis to the French Proposal.

 

 

 

G.           Request for action

 

 

 

In view of the above, Euroseeds requests the Commission, to deliver a detailed opinion to France, pursuant to the Single Market Transparency Directive, expressing its concern about the French Proposal for (inter alia) the reasons outlined in this submission. It is the position of Euroseeds that France should withdraw the French Proposal.

 

 

 

 

 

*             *

 

 

 

Annex I: Examples from the IAEA mutant variety database 20.0311

 

Annex II: Literature References with examples 20.0315.1

 

Annex III: Market data 20.0316

 



[2] Annex I: 20.0311 and Annex II: 20.0315

[3] See Council Decision 2002/628/EC concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety, and the Declaration by the European Community in accordance with article 34(3) of the convention on biological diversity.

[4] Also the definition of GMO in Article 3 (2) of Regulation 1946/2003, but also for example in Article 2 (5) of Regulation (EC) No 1829/2003 on of 22 September 2003 on genetically modified food and feed, which exclude mutagenesis techniques from the definition, demonstrate the reconciliation of the GMO definition with the LMO definition of the Cartagena Protocol.

[5] i.e. that “only organisms obtained by means of techniques/methods which have conventionally been used in a number of applications and have a long safety record” at the time of the adoption of the GMO Directive are excluded from its scope.

[7] Annex I: 20.0311 and Annex II: 20.0315.1

[8] Microspore mutagenesis and selection: Canola plants with field tolerance to the imidazolinones E.B. Swanson*, M.J. Herrgesell, M. Arnoldo, D.W. Sippell and R. S. C. Wong

Theor Appl Genet (1989) 78:525-530

[9]  Article 1 of 2020/281/F – “Order laying down the list of varieties mentioned in Article 2 of Decree [xx]”.

[10] https://ec.europa.eu/growth/tools-databases/tris/en/search/?trisaction=search.detail&year=2020&num=282, where it is stated that: “In this regard, the French authorities intend to apply Article 14 of Directive 2002/53/EC to remove the varieties of agricultural plant species registered in the French national catalogue identified as being the result of in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagenic agents”.

[11] Recital 4 of the preamble of Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants.

[13] France holds a share of around 20% of the Winter oilseed rape seed production and around 80% of the summer oilseed rape seed production for Clearfield tolerant oilssed rape varieties in Europe.

[15] Regulation 1829/2003 defines a GMO with reference to Articles 2 and 3 of the GMO Directive. This Regulation applies to (a) GMOs for food/feed use, (b) food/feed containing or consisting of GMOs, (c) food/feed produced from GMOs and (d) food containing ingredients produced from GMOs. It stipulates detailed obligations in terms of requirements, authorization for placing on the market and labeling.

[17] Judgment in Belgium v. Commission, C-110/03, § 31.

[18] First, recital 11 of the GMO Directive clarifies that placing on the market under the GMO Directive also covers imports into the Union (i.e. France). Products containing or consisting of GMOs cannot be imported if they do not comply with its provisions. Second, also the requirements arising from Regulation 1829/2003 apply to products imported from third countries, as is confirmed in Recital 43 of this regulation. Finally and more generally, the intent of the European legislator to ensure the traceability, labelling and identification of GMOs being imported into the Union, is confirmed in Regulation 1946/2003 on transboundary movements of genetically modified organisms, which implements the Cartagena Protocol.

[19] For those that have been registered in the IAEA mutant variety database – which, as mentioned, is incomplete, in that it underreports the amount of relevant varieties - prior to the adoption of the GMO Directive, reference can be made to the Annex.

[20] Annex III (20.0316).

[23] WTO Statement 2018 Agricultural Applications of Precision Biotechnology. Available at: https://docs.wto.org/dol2fe/Pages/FE_Search/ExportFile.aspx?id=249267&filename=q/G/SPS/GEN1658R2.pdf


en
  Association Française des Biotechnologies Végétales on 29-06-2020
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 France has proposed to change its “Code de l’Environnement” to implement the ruling of the Court of Justice of the European Union (ECJ) in case C-528/16 and Decision N°. 388649 of the French Conseil d’Etat.

 

The French government proposes two changes at the Article D. 531-2:

 

 

 

1.    In the first paragraph, after the words "as giving rise to a genetic modification", the words "or which have been the subject of traditional use without proven harm to public health or the environment" are inserted.

 

 

 

For AFBV, the proposed added phrase is unnecessary.  This constitutes a limitation on all the exempted or excluded techniques, which the Conseil d’Etat did not request in Article 2 of its decision.

 

 

 

2.   The a) of 2 ° is worded as follows:

 

"(A) Random mutagenesis, with the exception of in vitro random mutagenesis consisting in subjecting plant cells cultivated in vitro to chemical or physical mutagens".

 

 

 

In the current state of the draft Decree, the consequence will be that plants and varieties resulting from random mutagenesis in vitro consisting of subjecting plant cells cultivated in vitro to chemical or physical mutagens will be considered in France as non-exempt GMOs and, as such, will be subject to the French legislation on GMOs, whilst in the rest of Europe, as well as in the rest of the world, such plants will be outside the scope of GMO legislation. 

 

 

 

The French proposal disharmonizes a harmonized area of EU law (Directive 2001/18/EC and related regulations), thus creating obstacles to the free movement of seeds and crops within the internal market.  It risks creating a distortion of the EU single market and therefore hindering trade: seeds of varieties produced from in vitro mutagenesis, which had until now all been accepted in France, can no longer be produced in France for export to other Member States or outside the EU, without respecting the strict rules of the GMO framework.

 

 

 

France’s national limitation of the exemption provided in Directive 2001/18/EC has significant repercussions on other European legislative instruments and undermines the entire internal market of the EU not only for seeds but also for derived products.

 

 

 

Finally, the French proposal risks creating technical barriers to trade under the WTO Agreement on Technical Barriers to Trade ("TBT") to goods imported into France (and the EU in general) from outside the EU. In a recent USDA report, it is suggested that trade with Canada, Latin America and EU member states may be affected.

 

https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=French%20implementation%20of%20European%20Court%20of%20Justice%20ruling%20jeopardizes%20exports%20of%20rapeseed%20to%20France_Paris_France_06-08-2020

 

 

 

As you are aware such Decree should be taken after having received the opinion of the French Haut Conseil des Biotechnologies which to our knowledge has not been given so far.  In addition, the Commission has recently has issued a mandate to EFSA requesting a scientific opinion on techniques of random mutagenesis in vitro (Mandate N° M-2020-0104).

 

 

 

We believe that it is premature to modify the a) of 2 ° of Article D.531-2 before receiving the opinions of the HCB and EFSA.  Furthermore, it would be desirable for any modification of the term "mutagenesis" in Directive 2001/18/EC following the decision of the CJEU to be taken in concert with the Commission and the Member States.  Indeed, any initiative taken independently of the other EU Member States is likely to create a distortion of the internal market negatively affecting the French and European agricultural and food sectors.

 

 

For these reasons, it seems desirable that the draft decree be suspended pending the conclusions of the scientific opinions of HCB and EFSA and that it be subsequently modified, if necessary, to take those opinions into account. In this context, the draft orders taken in connection with this Decree should also be suspended. 


es
  ANOVE on 26-06-2020
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 REFERENCIA: OBSERVACIONES A NOTIFICACIONES DE FRANCIA (MUTAGENESIS) BAJO PROCEDIMIENTO DIRECTIVA 2015/1535.

ASUNTO: NOTIFICACIONES 2020/280 F, 2020/281 F y 2020/282 F

REMITENTE:

Asociación Nacional de Obtentores Vegetales (ANOVE)

Calle Antonio Maura, 7 (28014 Madrid) España

En su nombre: Antonio Villarroel como Secretario General

E-mail: antonio.villarroel@anove.es


es
  ANOVE on 26-06-2020
Click to expand

 REFERENCIA: OBSERVACIONES A NOTIFICACIONES DE FRANCIA (MUTAGENESIS) BAJO PROCEDIMIENTO DIRECTIVA 2015/1535.

ASUNTO: NOTIFICACIONES 2020/280 F, 2020/281 F y 2020/282 F

REMITENTE:

Asociación Nacional de Obtentores Vegetales (ANOVE)

Calle Antonio Maura, 7 (28014 Madrid) España

En su nombre: Antonio Villarroel como Secretario General

E-mail: antonio.villarroel@anove.es