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PARALLEL TEXTS
Il Tribunale annulla le autorizzazioni della Commissione all'immissione in commercio della patata geneticamente modificata Amflora
Inglese tratto da:
http://europa.eu/rapid/press-release_CJE-13-160_en.htm
Italiano tratto da:
http://europa.eu/rapid/press-release_CJE-13-160_it.htm
Data documento: 13-12-2013
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The General Court has annulled the Commission’s decisions concerning authorisation to place on the market the genetically modified potato Amflora
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Il Tribunale annulla le autorizzazioni della Commissione all'immissione in commercio della patata geneticamente modificata Amflora
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The Commission infringed the procedural rules of the systems for authorising GMOs in the European Union
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La Commissione ha violato le norme procedurali per l’autorizzazione degli OGM nell’Unione
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In the territory of the European Union, genetically modified organisms (GMOs) may be released into the environment or placed on the market only if consent has been given, subject to specific conditions and granted with a view to specified uses, after a scientific assessment of the risks.
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Sul territorio dell’Unione europea, gli organismi geneticamente modificati (OGM) possono essere emessi nell’ambiente o immessi in commercio soltanto quando siano autorizzati, a precise condizioni e per usi determinati, previa valutazione scientifica dei rischi.
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The authorisation system consists of two different procedures which are applied depending on the intended use of the GMOs.
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Il regime di autorizzazione prevede due diverse procedure, applicabili a seconda dell’uso che si prevede di fare degli OGM.
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The aim of the first procedure, whose rules are laid down by Directive 2001/18/EC, is to authorise GMOs with a view to their deliberate release into the environment.
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La prima (disciplinata dalla direttiva 2001/18/CE ), riguarda l’autorizzazione degli OGM ai fini della loro emissione deliberata nell’ambiente:
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Within the framework of that procedure, it is in principle for the Member State with which an undertaking has lodged an application for this purpose to issue consent.
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il rilascio dell’autorizzazione spetta in linea di principio allo Stato membro cui un’impresa ha notificato la richiesta.
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However, the other Member States, and also the Commission, may raise objections vis-à-vis the intended consent decision.
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Gli altri Stati membri e la Commissione possono sollevare obiezioni in merito alla decisione di autorizzazione che si prevede di adottare.
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The second authorisation procedure, set up by Regulation 1829/2003, concerns genetically modified food and feed. In that case, the application for consent is assessed at EU level.
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La seconda procedura di autorizzazione (istituita dal regolamento n.1829/2003 ) per gli alimenti e i mangimi geneticamente modificati, viene svolta a livello dell’Unione.
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Where, in the context of the first procedure, an objection has been raised or, in the context of the second procedure, an application for consent has been submitted, the final decision on the authorisation is taken by the Commission or by the Council on the basis of the scientific opinions of the European Food Safety Authority (EFSA).
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Qualora, nell’ambito della prima procedura venga sollevata un’obiezione oppure, nell’ambito della seconda procedura, venga presentata una richiesta di autorizzazione, la decisione definitiva sull’autorizzazione è adottata dalla Commissione o dal Consiglio, sulla base dei pareri scientifici dell’Autorità europea per la sicurezza alimentare (EFSA).
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In those situations, the Commission is assisted by two committees made up of representatives from the Member States who express their respective opinions with knowledge of the opinions of the EFSA.
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In questi casi, la Commissione è assistita da due comitati, composti dai rappresentanti degli Stati membri, che esprimono il rispettivo parere tenendo conto del parere dell’EFSA.
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If the opinion of the competent committee is in favour of the authorisation of the GMO, the Commission will grant consent.
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Se il parere del comitato competente è favorevole all’autorizzazione dell’OGM, la Commissione rilascia l’autorizzazione.
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If that is not the case, or if no opinion has been given, the Commission will submit a proposal for authorisation to the Council, which may grant or oppose it.
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In caso contrario, oppure in caso di mancata manifestazione del parere, la Commissione sottopone una proposta di autorizzazione al Consiglio, il quale può esprimere il proprio assenso o opporsi.
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If the Council does not adopt a decision, the Commission will grant the consent.
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Se il Consiglio non adotta alcuna decisione, la Commissione rilascia l’autorizzazione.
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The company BASF Plant Science GmbH first asked the Swedish authorities, through a subsidiary, to authorise the placing on the market of the genetically modified potato Amflora with a view to its cultivation and use for industrial purposes.
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La società BASF Plant Science GmbH ha, da un lato, per mezzo di una sua controllata, chiesto alle autorità svedesi di autorizzare l’immissione in commercio della patata geneticamente modificata Amflora, per la coltivazione e l’utilizzo a fini industriali.
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Several Member States having made observations regarding that application, the taking of the final decision was entrusted to the EU authorities.
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Poiché vari Stati membri avevano trasmesso osservazioni in merito a tale domanda, l’adozione della decisione definitiva è stata rimessa alle autorità dell’Unione.
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Secondly, the company BASF directly initiated an authorisation procedure before the EU authorities with a view to the production of animal feed based on that potato.That latter application also covered the situation of the adventitious presence of GMO traces in food for human or animal consumption.
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Dall’altro lato, la BASF ha essa stessa avviato dinanzi alle autorità dell’Unione una richiesta di autorizzazione relativa alla produzione di mangimi a base di tale patata, che ricomprendeva anche l’ipotesi della presenza accidentale di tracce di OGM negli alimenti destinati al consumo umano o a quello animale.
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After receiving favourable opinions from the EFSA in 2005, the Commission submitted the proposals for authorisation to the committees then, receiving no opinion from them, to the Council, which did not adopt a decision.
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La Commissione, avendo ricevuto nel corso del 2005 alcuni pareri favorevoli da parte dell’EFSA, ha sottoposto le relative proposte di autorizzazione ai comitati e successivamente, in assenza di un parere da parte di questi ultimi, al Consiglio, il quale non ha adottato alcuna decisione.
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In consequence, the Commission could have granted the authorisations applied for at that stage.
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La Commissione avrebbe dunque potuto, in tale fase, rilasciare le autorizzazioni richieste.
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However, having received, during the authorisation procedures, information concerning inconsistencies between different scientific opinions of the EFSA, the Commission did not grant the authorisations but decided to consult that authority again so that the latter could explain its opinions.
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Tuttavia, dato che nel corso delle procedure di autorizzazione le erano state trasmesse informazioni riguardanti talune incoerenze tra i vari pareri scientifici dell’EFSA, la Commissione non ha rilasciato alcuna autorizzazione, ma ha deciso di consultare nuovamente detta autorità affinché fornisse chiarimenti in merito ai suoi pareri.
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In June 2009, the EFSA adopted a consolidated scientific opinion in which it (there being minority opinions conflicting with its conclusions) confirmed that the Amflora potato did not present a risk to human health or to the environment.
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Nel giugno 2009, l’EFSA ha adottato un parere scientifico consolidato nel quale (in presenza di pareri minoritari dissenzienti rispetto alle sue conclusioni) ha confermato che la patata Amflora non presentava rischi né per la salute umana né per l’ambiente.
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Following that opinion, no new draft decisions were put before the competent committees by the Commission, which granted the two authorisations applied for by decisions of 2 March 2010.
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Dopo tale parere, ai comitati competenti non sono stati trasmessi nuovi progetti di decisione di autorizzazione da parte della Commissione, che ha rilasciato le due autorizzazioni richieste con decisioni del 2 marzo 2010.
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Taking the view, however, that the Amflora potato presents a risk to human and animal health and also to the environment, Hungary brought an action for annulment of the Commission’s authorisation decisions.
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Ritenendo che la patata Amflora comportasse nondimeno un rischio per la salute umana e animale nonché per l’ambiente, l’Ungheria ha chiesto al Tribunale UE di annullare le autorizzazione della Commissione.
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France, Luxembourg, Austria and Poland intervened in the proceedings in support of Hungary.
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La Francia, il Lussemburgo, l’Austria e la Polonia sono intervenuti nella causa a sostegno dell’Ungheria.
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In its judgment delivered today, the General Court has found, first of all, that the Commission, before adopting the contested decisions, did not submit the amended drafts of those decisions, together with the EFSA’s consolidated opinion of 2009 and the minority opinions, to the competent committees.
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Nell’odierna sentenza, il Tribunale rileva innanzitutto che la Commissione, prima di adottare le decisioni impugnate, non ha sottoposto ai comitati competenti i progetti modificati di tali decisioni unitamente al parere consolidato dell’EFSA del 2009 e ai pareri minoritari.
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Whereas the enacting terms of the contested decisions are identical to those of the draft decisions initially submitted to the competent committees and to the Council, that is not the case with the scientific foundation used by the Commission in order to adopt those decisions.
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Orbene, mentre i dispositivi delle decisioni impugnate sono identici a quelli dei progetti di decisione inizialmente sottoposti ai comitati competenti e al Consiglio, lo stesso non può dirsi del fondamento scientifico sulla cui base la Commissione ha adottato tali decisioni.
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In consequence, the General Court finds that, by having decided to request a consolidated opinion from the EFSA, and by basing the contested decisions on, inter alia, that opinion without allowing the competent committees to comment on the opinion or on the amended draft decisions, the Commission departed from the rules of the authorisation procedures.
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Pertanto, il Tribunale osserva che la Commissione, avendo deciso di chiedere all’EFSA un parere consolidato e avendo fondato le decisioni impugnate in particolare su tale parere, senza consentire ai comitati competenti di prendere posizione né sul parere né sui progetti di decisione modificati, ha violato le norme delle procedure di autorizzazione.
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In that respect, the General Court takes the view that, if the Commission had complied with those rules, the result of the procedure or the content of the contested decisions could have been substantially different.
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Il Tribunale afferma inoltre che, se la Commissione avesse rispettato tali norme, gli esiti della procedura o il contenuto delle decisioni impugnate avrebbero potuto essere sostanzialmente diversi.
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As the votes on the previous drafts within the committees were very divided, and as the conclusions of the EFSA’s consolidated opinion of 2009, coupled with the minority opinions, expressed more uncertainties than the previous opinions of the EFSA, it was therefore possible that the members of the committees might review their position and decide for or against the authorisations applied for.
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Infatti, posto che i voti sui progetti anteriori espressi in seno ai comitati erano stati molto divisi, e che le conclusioni del parere consolidato dell’EFSA del 2009, accompagnate da pareri minoritari, avevano espresso maggiori incertezze rispetto ai precedenti pareri dell’EFSA, non si poteva escludere che i membri dei comitati potessero rivedere la loro posizione e decidere pro o contro le autorizzazioni richieste.
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Furthermore, if there had been an unfavourable opinion or if there had been no opinion from the committees, the Commission would have been obliged to submit the proposals for authorisation to the Council, which could have decided for or against the authorisations in question.
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Per di più, in presenza di un parere negativo o in assenza di parere da parte dei comitati, la Commissione sarebbe stata tenuta a sottoporre le proposte di autorizzazione al Consiglio, il quale avrebbe potuto decidere pro o contro le autorizzazioni.
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It was only at the end of that procedure, when there is no decision by the Council, that the Commission could have adopted its decisions.
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Solo dopo aver portato a termine detta procedura, ed in assenza di decisioni da parte del Consiglio, la Commissione avrebbe potuto adottare le sue decisioni.
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In that regard, the General Court finds that the addition in the drafts of the contested decisions of a statement of reasons referring to a new opinion of the EFSA by way of scientific foundation constitutes a substantial alteration to those drafts in relation to their previous version.
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Il Tribunale rileva che il fatto di avere aggiunto, nei progetti delle decisioni impugnate, una motivazione riferita a un nuovo parere dell’EFSA quale fondamento scientifico, rappresenta una modifica sostanziale di tali progetti rispetto alle loro precedenti versioni.
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As a consequence, those decisions cannot be considered to be identical to the previous drafts and proposals.
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Di conseguenza, le decisioni non possono essere considerate identiche ai progetti e alle proposte anteriori.
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In addition, the consolidated opinion of 2009, which includes major differences in relation to the previous opinions of the EFSA, must be treated as a new substantive assessment and not as a simple, purely formal confirmation of the assessments of the risks contained in the previous opinions.
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Peraltro, il parere consolidato del 2009, che presenta notevoli differenze rispetto ai pareri anteriori dell’EFSA, deve essere considerato come una nuova valutazione nel merito, e non come una mera conferma, prettamente formale, delle valutazioni dei rischi contenute nei pareri anteriori.
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In those circumstances, because the Commission significantly failed to fulfil its procedural obligations, the General Court has annulled the contested decisions.
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In conclusione, poiché la Commissione ha violato in modo sostanziale i suoi obblighi procedurali, il Tribunale annulla le decisioni impugnate.
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NOTE:
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IMPORTANTE:
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An appeal, limited to points of law only, may be brought before the Court of Justice against the decision of the General Court within two months of notification of the decision.
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Contro la decisione del Tribunale, entro due mesi a decorrere dalla data della sua notifica, può essere proposta un'impugnazione, limitata alle questioni di diritto, dinanzi alla Corte.
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NOTE:
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IMPORTANTE:
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An action for annulment seeks the annulment of acts of the institutions of the European Union that are contrary to European Union law.
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Il ricorso di annullamento mira a far annullare atti delle istituzioni dell’Unione contrari al diritto dell’Unione.
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The Member States, the European institutions and individuals may, under certain conditions, bring an action for annulment before the Court of Justice or the General Court.
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A determinate condizioni, gli Stati membri, le istituzioni europee e i privati possono investire la Corte di giustizia o il Tribunale di un ricorso di annullamento.
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If the action is well founded, the act is annulled.
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Se il ricorso è fondato, l'atto viene annullato.
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The institution concerned must fill any legal vacuum created by the annulment of the act.
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L'istituzione interessata deve rimediare all’eventuale lacuna giuridica creata dall’annullamento dell’atto. |
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LISTEN WITH READSPEAKER
The General Court has annulled the Commission’s decisions concerning
authorisation to place on the market the genetically modified potato Amflora
The Commission infringed the procedural rules of the systems for
authorising GMOs in the European Union
In the territory of the European Union, genetically modified organisms (GMOs)
may be released into the environment or placed on the market only if consent has
been given, subject to specific conditions and granted with a view to specified
uses, after a scientific assessment of the risks.
The authorisation system consists of two different procedures which are
applied depending on the intended use of the GMOs.
The aim of the first procedure, whose rules are laid down by Directive
2001/18/EC, is to authorise GMOs with a view to their deliberate release into
the environment.
Within the framework of that procedure, it is in principle for the Member
State with which an undertaking has lodged an application for this purpose to
issue consent.
However, the other Member States, and also the Commission, may raise
objections vis-à-vis the intended consent decision.
The second authorisation procedure, set up by Regulation 1829/2003, concerns
genetically modified food and feed. In that case, the application for consent is
assessed at EU level.
Where, in the context of the first procedure, an objection has been raised
or, in the context of the second procedure, an application for consent has been
submitted, the final decision on the authorisation is taken by the Commission or
by the Council on the basis of the scientific opinions of the European Food
Safety Authority (EFSA).
In those situations, the Commission is assisted by two committees made up of
representatives from the Member States who express their respective opinions
with knowledge of the opinions of the EFSA.
If the opinion of the competent committee is in favour of the authorisation
of the GMO, the Commission will grant consent.
If that is not the case, or if no opinion has been given, the Commission will
submit a proposal for authorisation to the Council, which may grant or oppose
it.
If the Council does not adopt a decision, the Commission will grant the
consent.
The company BASF Plant Science GmbH first asked the Swedish authorities,
through a subsidiary, to authorise the placing on the market of the genetically
modified potato Amflora with a view to its cultivation and use for industrial
purposes.
Several Member States having made observations regarding that application,
the taking of the final decision was entrusted to the EU authorities.
Secondly, the company BASF directly initiated an authorisation procedure
before the EU authorities with a view to the production of animal feed based on
that potato.That latter application also covered the situation of the
adventitious presence of GMO traces in food for human or animal consumption.
After receiving favourable opinions from the EFSA in 2005, the Commission
submitted the proposals for authorisation to the committees then, receiving no
opinion from them, to the Council, which did not adopt a decision.
In consequence, the Commission could have granted the authorisations applied
for at that stage.
However, having received, during the authorisation procedures, information
concerning inconsistencies between different scientific opinions of the EFSA,
the Commission did not grant the authorisations but decided to consult that
authority again so that the latter could explain its opinions.
In June 2009, the EFSA adopted a consolidated scientific opinion in which it
(there being minority opinions conflicting with its conclusions) confirmed that
the Amflora potato did not present a risk to human health or to the environment.
Following that opinion, no new draft decisions were put before the competent
committees by the Commission, which granted the two authorisations applied for
by decisions of 2 March 2010.
Taking the view, however, that the Amflora potato presents a risk to human
and animal health and also to the environment, Hungary brought an action for
annulment of the Commission’s authorisation decisions.
France, Luxembourg, Austria and Poland intervened in the proceedings in
support of Hungary.
In its judgment delivered today, the General Court has found, first of all,
that the Commission, before adopting the contested decisions, did not submit the
amended drafts of those decisions, together with the EFSA’s consolidated opinion
of 2009 and the minority opinions, to the competent committees.
Whereas the enacting terms of the contested decisions are identical to those
of the draft decisions initially submitted to the competent committees and to
the Council, that is not the case with the scientific foundation used by the
Commission in order to adopt those decisions.
In consequence, the General Court finds that, by having decided to request a
consolidated opinion from the EFSA, and by basing the contested decisions on,
inter alia, that opinion without allowing the competent committees to comment on
the opinion or on the amended draft decisions, the Commission departed from the
rules of the authorisation procedures.
In that respect, the General Court takes the view that, if the Commission had
complied with those rules, the result of the procedure or the content of the
contested decisions could have been substantially different.
As the votes on the previous drafts within the committees were very divided,
and as the conclusions of the EFSA’s consolidated opinion of 2009, coupled with
the minority opinions, expressed more uncertainties than the previous opinions
of the EFSA, it was therefore possible that the members of the committees might
review their position and decide for or against the authorisations applied for.
Furthermore, if there had been an unfavourable opinion or if there had been
no opinion from the committees, the Commission would have been obliged to submit
the proposals for authorisation to the Council, which could have decided for or
against the authorisations in question.
It was only at the end of that procedure, when there is no decision by the
Council, that the Commission could have adopted its decisions.
In that regard, the General Court finds that the addition in the drafts of
the contested decisions of a statement of reasons referring to a new opinion of
the EFSA by way of scientific foundation constitutes a substantial alteration to
those drafts in relation to their previous version.
As a consequence, those decisions cannot be considered to be identical to the
previous drafts and proposals.
In addition, the consolidated opinion of 2009, which includes major
differences in relation to the previous opinions of the EFSA, must be treated as
a new substantive assessment and not as a simple, purely formal confirmation of
the assessments of the risks contained in the previous opinions.
In those circumstances, because the Commission significantly failed to fulfil
its procedural obligations, the General Court has annulled the contested
decisions.
NOTE:
An appeal, limited to points of law only, may be brought before the Court of
Justice against the decision of the General Court within two months of
notification of the decision.
NOTE:
An action for annulment seeks the annulment of acts of the institutions of
the European Union that are contrary to European Union law.
The Member States, the European institutions and individuals may, under
certain conditions, bring an action for annulment before the Court of Justice or
the General Court.
If the action is well founded, the act is annulled.
The institution concerned must fill any legal vacuum created by the annulment
of the act.
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