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IP/10/921
Brussels, 13 July 2010
GMOs: Member States to be given full responsibility
on cultivation in their territories
Today the Commission proposed to confer to Member States the freedom to
allow, restrict or ban the cultivation of Genetically Modified Organisms
(GMOs) on part or all of their territory. While keeping unchanged the EU's
science-based GM authorisation system, the adopted package consists of a
Communication, a new Recommendation on co-existence of GM crops with
conventional and/or organic crops and a draft Regulation proposing a
change to the GMO legislation. The new Recommendation on co-existence
allows more flexibility to Member States taking into account their local,
regional and national conditions when adopting co-existence measures. The
proposed regulation amends Directive 2001/18/EC to allow Member States to
restrict or prohibit the cultivation of GMOs in their territory.
Health and Consumer Policy Commissioner, John Dalli said: "Last March, the
Commission promised to present a comprehensive proposal on our future policy visà-vis
GM cultivation by the end of the summer. Today we deliver on that promise.
The concrete measures adopted today will allow Member States the freedom to
decide on GMO cultivation. Experience with GMOs so far shows that Member States
need more flexibility to organise the co-existence of GM and other types of crops
such as conventional and organic crops." The Commissioner added: "Granting
genuine freedom on grounds other than those based on a scientific assessment of
health and environmental risks also necessitates a change to the current legislation. I
stress that, the EU-wide authorisation system, based on solid science, remains fully
in place." To conclude: "This means that a very thorough safety assessment and a
reinforced monitoring system are priorities in GMO cultivation and are therefore
being pursued vigorously. The Commission is committed to follow up actions on
them before the end of the year.”
As of today, a more flexible approach towards cultivation:
The strict authorisation system already in place, which is based on science, safety
and consumer choice, will remain the same.
With the new freedom given to Member States to decide on cultivation, a strong
signal is sent to citizens that Europe takes into account their concerns, which may
vary from one country to another, regarding GMOs. The new approach aims to
achieve the right balance between maintaining an EU authorisation system and the
freedom for Member States to decide on GMO cultivation in their territory. The
proposal delivers on President Barroso's political guidelines, presented in September
2009. Adding this freedom to the legislative framework for GMOs should enable the
authorisation system for GMOs to function effectively. As a first step under existing
legislation, today's new Recommendation on guidelines for the development of
national co-existence measures replaces the previous recommendation of 2003.

The previous Recommendation made a direct link between the establishment of coexistence
measures and the respect of the 0.9% threshold for labelling as GM food,
feed or products intended for direct processing. Member States were advised to limit
co-existence measures (e.g. length of distances between GM and non-GM fields) to
comply with 0.9% GM presence in other crops.
Experience gained over the last years shows that the potential loss of income for
non-GM producers, such as organic and sometimes conventional producers, is not
limited to exceeding the labelling threshold. In certain cases, the presence of GMOs
in certain food products may cause damages to operators who would wish to market
them as not containing GMOs.
The non-binding guidelines included in the new Recommendation on coexistence
better reflect the possibility provided in the existing legislation (Article 26a
of Directive 2001/18/EC) for Member States to adopt measures to avoid the
unintended presence of GMOs in conventional and organic crops. This also allows
for measures aiming to limit GMO content in conventional food and feed to levels
below the labelling threshold of 0.9%. The Recommendation also clarifies that
Member States can establish "GMO-free" area and this new Recommendation
provides better guidance to Member States to develop co-existence approaches.
The European Co-existence Bureau will continue to develop together with Member
States best practices for co-existence as well as technical guidelines on related
issues.
Legal certainty for the future:
The proposal for revising Directive 2001/18/EC aims to secure legal certainty for
Member States when they decide on GMO cultivation on grounds other than those
based on a scientific assessment of health and environmental risks. To this end, the
Commission proposes to include a new article (26b), which would be applicable to
all GMOs that will be authorised for cultivation in the EU, either under Directive
2001/18/EC or under regulation (EC) N°1829/2003. Member States will be able to
restrict or prohibit GMO cultivation in part or all of their territory without recourse to
the safeguard clause. Their decisions will not need to be authorised by the
Commission, but Member States will have to inform other Member States and the
Commission one month before the adoption of their measures. The Member States
will also have to respect the general principles of the Treaties and the Single Market,
and be consistent with the international obligations of the EU.
At the same time, the EU authorisation system, based on scientific assessment of
health and environmental risks will be maintained and further improved, thus
ensuring the protection of consumers and the functioning of the internal market for
GM and non-GM seeds, as well as for GM food and feed.
The legislative proposal will be adopted through co-decision with the European
Parliament and the Council.
For more information please see:
MEMO/10/325
http://ec.europa.eu/food/food/biotechnology/index_en.htm
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IP/10/921
Bruxelles, le 13 juillet 2010
OGM: les États membres assumeront l'entière
responsabilité de la présence de ces cultures sur
leur territoire
La Commission a proposé aujourd'hui d'accorder aux États membres la
liberté d'autoriser, de restreindre ou d'interdire la culture d'organismes
génétiquement modifiés (OGM) sur la totalité ou une partie de leur territoire.
Les mesures adoptées, qui maintiennent le système d'autorisation de l'Union
européenne (UE) fondé sur des données scientifiques, se composent d'une
communication, d'une nouvelle recommandation sur la coexistence des
cultures génétiquement modifiées avec les cultures conventionnelles et/ou
biologiques et d'une proposition de règlement prévoyant une modification de
la législation relative aux OGM. La nouvelle recommandation donne une plus
grande marge de manœuvre aux États membres tenant compte de leurs
spécificités locales, régionales et nationales lors de l'adoption de mesures
sur la coexistence des cultures. Le règlement proposé modifie la
directive 2001/18/CE de façon à permettre aux États membres de restreindre
ou d’interdire la culture des OGM sur leur territoire.
Le commissaire à la santé et à la politique des consommateurs, M. John Dalli, a
déclaré: «En mars dernier, la Commission s'est engagée à présenter, avant la fin de
l'été, une proposition globale sur la future politique de l'Union européenne
concernant les cultures génétiquement modifiées. Elle a tenu son engagement. Les
mesures concrètes adoptées aujourd'hui donnent aux États membres la liberté
d'accepter ou non ce type de cultures. L'expérience acquise à ce jour dans le
domaine des OGM montre que les États membres ont besoin d'une plus grande
marge de manœuvre pour organiser la coexistence entre les cultures génétiquement
modifiées et d'autres types de cultures, conventionnelles ou biologiques par
exemple.» Et d’ajouter: «L'octroi d'une véritable liberté, permettant la prise en
compte de motifs autres que ceux fondés sur une évaluation scientifique des risques
pour la santé et l'environnement, impose également de modifier la législation
actuelle. Je tiens à préciser que le système d'autorisation à l'échelle de l'Union
européenne, qui repose sur des fondements scientifiques rigoureux, demeure
pleinement en place.» Pour conclure, le commissaire a précisé: «Autrement dit, une
évaluation très minutieuse de la sécurité et un système de contrôle renforcé sont des
priorités dans le domaine de la culture des OGM et leur réalisation est donc
poursuivie énergiquement. La Commission s'est engagée à contrôler, avant la fin de
l'année, l'application des mesures prises à ce sujet.»
Dès aujourd'hui, une approche plus souple est autorisée
Le système d'autorisation strict déjà en place, qui repose sur des données
scientifiques, la sécurité et le choix du consommateur, sera maintenu.

La liberté nouvelle donnée aux États membres d'accepter ou non les cultures
génétiquement modifiées constitue un signal fort adressé aux citoyens: l'Europe tient
compte de leurs préoccupations concernant les OGM, lesquelles peuvent varier d'un
pays à l'autre. La nouvelle approche vise à trouver un bon équilibre entre le maintien
du système d'autorisation de l'UE et le pouvoir de décision accordé aux États
membres en ce qui concerne la présence de cultures génétiquement modifiées sur
leur territoire. La proposition concrétise les orientations politiques du président
Barroso, présentées en septembre 2009. L'adjonction de cette liberté au cadre
législatif en place pour les OGM devrait garantir un fonctionnement efficace du
système d'autorisation de ces organismes. En guise de première étape dans le
cadre de la législation existante, la nouvelle recommandation présentée aujourd'hui,
qui établit des lignes directrices pour l'élaboration de mesures nationales de
coexistence des cultures, remplace la précédente recommandation de 2003.
Celle-ci établissait un lien direct entre l'instauration de ces mesures et le respect du
seuil de 0,9 % fixé pour la mention obligatoire de la présence d'OGM sur l'étiquette
des denrées alimentaires, des aliments pour animaux ou des produits destinés à
être directement transformés. Elle conseillait aux États membres de limiter les
mesures de coexistence (par exemple la longueur des distances entre parcelles
avec OGM et sans OGM) de manière à respecter le seuil de 0,9 % pour la présence
d'OGM dans d'autres cultures.
L'expérience acquise ces dernières années montre que la perte de revenus
potentielle pour les producteurs ne recourant pas aux OGM, dans le secteur de
l’agriculture biologique et parfois conventionnelle, ne se limite pas aux cas dans
lesquels le seuil d'étiquetage est dépassé. La présence d'OGM dans certains
produits alimentaires peut porter préjudice aux exploitants qui souhaiteraient les
commercialiser comme ne contenant pas d'OGM.
Les lignes directrices non contraignantes figurant dans la nouvelle
recommandation sur la coexistence des cultures reflètent mieux la possibilité
donnée aux États membres par la législation existante (article 26 bis de la
directive 2001/18/CE) d'adopter des mesures visant à éviter la présence accidentelle
d'OGM dans les cultures conventionnelles et biologiques. Elles permettent
également l'instauration de mesures visant à maintenir la teneur en OGM des
denrées alimentaires et des aliments pour animaux conventionnels à des niveaux
inférieurs au seuil d'étiquetage de 0,9 %. Par ailleurs, cette nouvelle
recommandation précise que les États membres peuvent établir des zones «sans
OGM» et leur fournit de meilleures orientations pour l'élaboration de modes de
coexistence des cultures. En coopération avec les États membres, le Bureau
européen pour la coexistence continuera d'élaborer des pratiques exemplaires en la
matière, ainsi que des orientations techniques sur des questions connexes.
Sécurité juridique pour l’avenir
La proposition de révision de la directive 2001/18/CE vise à garantir une sécurité
juridique aux États membres prenant une décision concernant une culture
génétiquement modifiée pour des motifs autres que ceux fondés sur une évaluation
scientifique des risques pour la santé et l'environnement. À cette fin, la Commission
propose l'insertion d'un nouvel article (26 ter), qui serait applicable à l'ensemble
des OGM dont la culture sera autorisée dans l'UE, soit au titre de la
directive 2001/18/CE, soit au titre du règlement (CE) n° 1829/2003.
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Les États membres seront en mesure de restreindre ou d'interdire la culture d'OGM
sur la totalité ou une partie de leur territoire sans invoquer la clause de sauvegarde.
Leurs décisions ne devront pas être autorisées par la Commission, mais ils seront
tenus d'informer celle-ci et les autres États membres un mois avant l'adoption des
mesures concernées. Ils devront également respecter les principes généraux des
traités et du marché unique, et ne pas se mettre en porte-à-faux avec les obligations
internationales de l'UE.
Dans le même temps, le système d'autorisation de l'UE, fondé sur l'évaluation
scientifique des risques pour la santé et l'environnement, sera maintenu et amélioré,
ce qui garantira la protection des consommateurs et le bon fonctionnement du
marché intérieur des semences génétiquement modifiées et non génétiquement
modifiées, et des denrées alimentaires et aliments pour animaux génétiquement
modifiés.
La proposition législative sera adoptée selon la procédure de codécision entre le
Parlement européen et le Conseil.
Pour de plus amples informations, voir:
MEMO/10/325
http://ec.europa.eu/food/food/biotechnology/index_en.htm
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MEMO/10/325
Brussels, 13 July 2010
Questions and Answers on the EU's new approach
to the cultivation of GMOs
Why is the Commission adopting this package today and what does it
include?
In March 2010, the European Commission announced that it would come back
before the summer break with a proposal on how to combine the EU science-based
authorisation system with freedom for Member States to decide on the cultivation of
Genetically Modified Organisms (GMOs). The package adopted today delivers on
this commitment and complies fully with the position set out by President Barroso in
the political guidelines he presented in September 2009.
What are co-existence measures and what does the new
Recommendation on co-existence change?
The objective of co-existence measures, in areas where GMOs are cultivated, is to
avoid the unintended presence of GMOs in other products, preventing the potential
economic loss and the impact of traces of GM crops in non-GM crops, such as
conventional and organic crops.
Experience gained over the last years shows that Member States need more
flexibility to take into consideration their particular local, regional and national
conditions when defining measures to organise the cultivation of GM, conventional
and organic crops.
The new Recommendation on co-existence recognises that Member States may
adopt measures to avoid the unintended presence of GMOs in other products below
the labelling threshold of 0.9%. When co-existence measures are not sufficient to
prevent the unintended presence of GMOs in conventional or organic crops, Member
States may restrict GMO cultivation in large areas of their territory. Such restriction
measures need to be proportionate to the objective pursued (i.e. protection of
particular needs of conventional or organic farming).
The Commission published in 2009 the second report on national strategies for
coexistence of GM crops with conventional and organic farming. The report shows
that 15 Member States adopted legislation on coexistence while three more notified
draft legislation.
The European Coexistence Bureau (ECoB) develops together with Member States
best practices for co-existence, which take into consideration that Member States
need flexibility to take account of their local and regional conditions.
For more information on ECoB: http://ecob.jrc.ec.europa.eu/

What is the current procedure for authorising the cultivation of GMOs?
GMOs are authorised at EU level on a case-by-case basis on the basis of the
particular uses defined by the application of the company, after a positive
assessment of health and environmental risks. Applications for cultivation of GMOs
can be submitted under Regulation (EC) No 1829/2003 for GM food and feed if
those GMOs are to be used as source material in food and feed production. GMOs
can also be authorised under the Directive for the deliberate release of GMOs into
the environment (Directive 2001/18/EC) for uses other than food/feed. In both cases,
the Member States play a significant role, carrying out the initial risk assessment of
the GMO for cultivation.
For more information on the authorisation procedures: MEMO/10/58
What are the amendments to the current legislation proposed by the
Commission?
The proposed amendment provides for the addition of one article to Directive
2001/18/EC, which explicitly allows Member States to restrict or prohibit cultivation of
GMOs on their territories. Member States may use any grounds to do so, other than
those covered by the health and environmental risk assessment of the EU
authorisation process. Therefore, the proposal gives competence to Member States
to decide on cultivation.
When the legal amendment enters into force, Member States will be free to restrict or
prohibit the cultivation of all or particular GMOs, in parts of or in their entire territory.
This amendment will be applicable to all GMOs that have been authorised for
cultivation in the EU, being under Directive 2001/18/EC or under Regulation (EC) No
1829/2003. According to this proposal Member States are only allowed to adopt
measures against the cultivation of GMOs. They are not allowed to adopt measures
prohibiting the import and/or the marketing in the EU of authorised GM seeds.
Are any GMOs already cultivated in the EU?
Yes. There is one GM maize –MON 810– that is commercially cultivated in the EU.
This product's genetic modification aims to protect the crop against a harmful pest –
the European corn borer. It was authorised in 1998.
A GM starch potato, known as "Amflora" potato, was authorised for cultivation and
industrial processing on 2 March 2010. This starch potato has increased amylopectin
starch content. The starch is intended for industrial uses, such as production of
paper.
What are the GM plants that are authorised in the EU for feed and/or
food uses?
Besides cultivation, the placing on the EU market of GMOs and the use of their
derived products in the food and feed chain is subject to an EU authorisation.
As of today, the list of authorised GMOs includes also: one sugar beet, three
soybean, three oilseed-rape, six cotton and 17 maize products.
One of the most recently authorised GMO is the "Amflora" starch potato. As it is the
case for conventional starch potatoes, "Amflora" is not intended to be used as food.
The by-product of the starch potato (pulp) is authorised as feed. The adventitious or
technically unavoidable presence of this potato in food and animal feed is authorised
up to a level of 0.9%
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The list of authorised GM plants and the precise scope of their authorisation is
available in the EU register of GM food and feed, which can be found here:
http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
Have Member States already prohibited GMO cultivation?
Six Member States (Austria, Hungary, France, Greece, Germany and Luxembourg)
adopted safeguard measures and prohibited the cultivation of the GM maize
MON810 on their territories. Moreover, Austria, Luxembourg and Hungary have
notified to the Commission the prohibition of the cultivation of the "Amflora" potato.
Poland has legislation in place forbidding the marketing of all GM seeds.
Member States could now reconsider their safeguard measures on GMO cultivation,
when there is no scientific justification, and rather use the more flexible
Recommendation on co-existence adopted today to avoid unintended GMO
presence in other crops.
Once the addition proposed today of the relevant article to Directive 2001/18/EC is
applicable, Member States will be able to restrict or prohibit GMO cultivation without
resorting to the safeguard clause when no new scientific risk is identified.
Are there any other GMOs for cultivation on which the EU could take
decision before the legal change is applicable?
There are more than ten requests for authorisation of GMOs for cultivation (or for
their renewal), at different stages of the procedure.
Four GMOs are at an advanced stage. They have received a favourable European
Food Safety Authority (EFSA) opinion and their authorisation procedure (or renewal
of authorisation procedure) is ongoing. The favourable EFSA opinion concerning the
renewal of the authorisation of MON810 maize, conferring protection to the plant
against certain insects, was adopted in June 2009. There are two other GM maize
products - Bt Maize 1507 (filed by Pioneer) and Bt maize Bt 11 (filed by
Syngenta) -, which also confer protection to the plant against certain insects. The
favourable EFSA opinions were respectively adopted in January 2005 and April 2005
and draft decisions to authorise these two GMOs were voted on 25 February 2009 in
the framework of the Regulatory Committee under Directive 2001/18/EC. No
qualified majority was obtained. The fourth one is maize NK 603 (filed by
Monsanto), which is tolerant to the herbicide RoundUp. EFSA adopted a favourable
opinion on this product in June 2009.
From a procedural point of view, the next step for MON810 and NK603 would be the
submission of a draft decision to the Standing Committee for Food Chain and Animal
Health (SCoFCAH) (first step of the comitology procedure). Bt 11 and Bt 1507 are in
the middle of the Comitology procedure, the next procedural step being the
submission of decisions to the Council.
What improvements have been made to the environmental risk
assessment of GMOs since the Council’s request in December 2008?
The Commission and EFSA, together with the Member States, are working on the
particular areas for improvement of the implementation of the GMO legislation,
identified by the 2008 Environment Council conclusions.
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The update of the EFSA guidelines for the environmental risk assessment is ongoing
and covers the specific areas requested by the Council. Given the complexity of the
topic, the need to ensure a broad consultation process and the large number of
public comments (approximately 500), EFSA is expected to finish the guidelines in
November 2010. The Commission will then discuss these guidelines with Member
States to give them normative value with the Member States' endorsement.
Furthermore, EFSA is engaged in dialogue with Member States and stakeholders,
enabling them to contribute to its scientific work. EFSA has created a network of
Member State experts to exchange scientific knowledge and experience. EFSA is
also considering all Member States' comments during the entire risk assessment
process.
In addition, EFSA has a comprehensive set of internal mechanisms and working
processes to safeguard the independence of the scientific work of its Scientific
Committee and Panels, including a comprehensive policy on declarations of interest
for its scientific experts. EFSA keeps this policy under regular review, and as
encouraged by the Commission, will continue to strengthen the examination of the
independence of its experts.
The Commission is analysing how to further reinforce the post-market environmental
monitoring of GMO crops, in line with the provisions of the current legislation and the
2008 Environment Council conclusions.
When will the Commission finalise the report on the socio-economic
implications of GMOs?
In December 2008, the Council requested the Commission to provide a report on the
socio-economic implications of GMOs by June 2010.
This report should be based on information provided by Member States, which have
made an important effort to compile information on the socio-economic implications
of GMOs and, notably, of their cultivation. But given that Member States'
contributions arrived later than expected, the Commission will finalize its report
by the end of 2010. This report will then be submitted to the European Parliament
and to the Council for consideration and further discussion.
Can we anticipate a speeding-up of the authorization process of GMOs
and a rising of surface of GM cultivated areas in the EU?
There is no speeding up of authorisations or weakening of the rigorous
environmental risk assessment requirements of the legislation. The proposal the
Commission adopts today does not change these requirements. To the contrary,
work on the implementation of the 2008 Council conclusions is since ongoing.
Moreover, ensuring a safety assessment following the highest scientific standards
and a reinforcement of the monitoring function were and remain priorities for the
Commission as concerns GMO cultivation.
For more information please see:
http://ec.europa.eu/food/food/biotechnology/index_en.htm
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