The Commission infringed the procedural rules of the systems for authorising GMOs in the European Union
Luxembourg, 16-12-2013 — /EuropaWire/ — 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/EC¹, 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 1829/2003², 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 committees³ 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 20104.
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.
Unofficial document for media use, not binding on the General Court.
The full text of the judgment is published on the CURIA website on the day of delivery Press contact: Christopher Fretwell (+352) 4303 3355
Pictures of the delivery of the judgment are available from “Europe by Satellite” (+32) 2 2964106
¹Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ 2001 L 106, p. 1).
²Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ 2003 L 268, p. 1).
³The present case involves the Regulatory Committee on the Release into the Environment of Genetically Modified Organisms, established by Directive 2001/18/EC, and the Standing Committee on the Food Chain and Animal Health, referred to in Regulation (EC) No 1829/2003.
4Commission Decision 2010/135/EU of 2 March 2010 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a potato product (Solanum tuberosum L. line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch (OJ 2010 L 53, p. 11) and Commission Decision 2010/136/EU of 2 March 2010 authorising the placing on the market of feed produced from the genetically modified potato EH92-527-1 (BPS-25271-9) and the adventitious or technically unavoidable presence of the potato in food and other feed products under [Regulation No 1829/2003] (OJ 2010 L 53, p. 15).
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- Digi Communications N.V. announces the launch by RCS & RDS S.A., its subsidiary in Romania, of the Digi Mobil 5G Smart service
- Tauschen Sie Ihren Dripper aus und verändern Sie den Geschmack Ihres Kaffees! HARIO veröffentlicht den Double Mesh Metal Dripper.
- Change your dripper and change the flavor of your coffee! HARIO launches the Double Mesh Metal Dripper
- Matvil Corp. противостоит беспределу судебных властей Молдовы
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 17 – 21 June 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 10 and 14 June 2019
- Digi Communications N.V.: Reporting of legal documents concluded by the company in May 2019 in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018 published
- DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions occurred under DIGI symbol between 3 – 7 June 2019
- PDA Explores the Transformation of Healthcare at 4th Annual European Meeting
- ASI President John Cross Named AGMA Chairman
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 31 May 2019
- Breakthrough on laser powder bed fusion technology brings effective production of larger componentscloser to mainstream
- PDA Announces All-Star Speaker Lineup for Advanced Therapy Medicinal Products Conference
- Digi Communications N.V.: Exercise of stock options by the Executive Directors of the Company
- Digi Communications N.V. announces DIGI Kft., the Hungarian subsidiary of the Company, launches mobile telephony services in Hungary
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 21 and 24 May 2019
- ZYXEL READY WITH 5G SAMPLES IN AUGUST 2019
- Digi Communications N.V. announces the initiation of the share buy-back program as authorized by the Company’s GSM on 30 April 2019
- Digi Communications N.V Q1 2019 Financial Report and the report regarding legal documents for April 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018 released
- Digi Communications N.V. announces the new date of the Conference Call for the presentation of the Q1 2019 Financial Report. Update to the Company’s 2019 Financial Calendar.
- Rhenium-SCT® (SCT= Skin Cancer Therapy) now being offered in Hanau, Germany
- Project consortium aims at driving the adoption of selective laser melting (SLM) for large scale metal parts printing
- Digi Communications N.V. announces the availability of the instructions on the 2018 share dividend payment
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 29 April 2019 – 1 May 2019, under the class B shares buy-back progr
- Biodiversity Report Is Urgent Call to Action Beyond Fixes; Geneva Global Initiative Calls on World Community to Focus on Concrete Actions
- Digi Communications N.V.’s general Shareholders’ meeting resolutions from 30 Apr 2019 approving, amongst others, the 2018 Annual Accounts and the availability of the adopted Annual Financial Report for the year ended Dec 31, 2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions occurred under DIGI symbol, 22 – 26 April 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 15 April 2019 – 19 April 2019s
- XPAND Code was successfully scanned from 200 meters/700 feet at Olympics stadium
- Wasser eingießen, Warten und Einschalten
- Digi Communications N.V.: Reporting of legal documents concluded by the company in March 2019 in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018 published
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 8 and 12 April 2019
- Snowman releases new EP
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 1 – 5 April 2019
- Streamlining adoption of high-speed and high-resolution surface texturing delivered with the Prometheus project
- Customer Data Platform Institute Launches RealCDP to Reduce CDP Confusion
- ASI Technologies Focuses on the future as ASI Drives, and New AGV Pallet Robot, FRED2500
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 25 March 2019 – 29 March 2019
- Towards a Europe of Stakeholder Nations
- Associazione Veneta Lotta alla Talassemia (AVLT) and the UK Thalassaemia Society (UKTS) Clarification on European Regulatory Status of LENTIGLOBIN™
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 19 March 2019 – 22 March 2019
- A new flagship project on Additive Manufacturing skills aims to maintain Europe leading position in industrial competitiveness
- Jeroen Schouten Named Regional Manager, Europe of AeroGo, Inc.
- Digi Communications N.V. Convocation of the Company’s general shareholders meeting for 30 April 2019 for the approval of, among others, the 2018 Annual Report and of the 2018 Financial Statements
- España arrasa con la competencia y es nombrado como el país ideal para estudiar en el extranjero
- Xverify targets European Email Verification market with local data processing, Dublin office
- Digi Communications N.V. announces the resignation by Mr. Sambor Ryszka from his position as non-executive director of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 11 and 15 March 2019
- Digi Communications N.V.: Reporting of legal documents concluded by the company in February 2019 in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018 published
- Admission of Digi Communications N.V. €200,000,000 5.0% additional senior secured notes due 2023 to the listing on the Official List and trading on Irish Stock Exchange’s Main Securities Market
- Digi Communications N.V. announces the appointment of Dan Ioniță as a non-executive director of RCS & RDS S.A., the Romanian subsidiary of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 4 and 8 March 2019
- Digi Communications N.V. announces share transaction made by an executive director of the Company with class B shares on 4 march 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 25 February – 1 March 2019
- Digi Communications N.V. announces share transaction made by an executive director of the Company with class B shares on 1 march 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 18 and 22 February 2019
- Digi Communications N.V.: finalization and registration by the Company of the conversion of 1,200,000 A shares into an equal number of class B shares
- Digi Communications N.V.: Exercise of stock options by a PDMR in accordance with the stock option plan for the Group’s Romanian employees
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 11 and 15 February 2019
- Report of legal documents concluded by DIGI Communications N.V. in January 2019 or in other period but effective in January 2019
- Digi Communications N.V. announces Availability of Preliminary Financial Report for the year ended December 31, 2018 for Digi Communications N.V. Group
- Mono Solutions launches a new interface to drive the ultimate do-it-with-me (DIWM) experience
- Digi Communications NV Announces Investor Call on the Preliminary Financial Results for the year ended 31 December 2018
- Digi Communications NV: New date of the Conference Call for the 2018 Preliminary financial results; Update to the 2019 Company’s Financial Calendar
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 4 and 8 February 2019
- R.W. Chelsea Holdings Ltd Starts To Hold Fixed Income Investor Meetings In Vienna, Zurich, Geneva and London
- Digi Communications N.V. successfully increased and priced its Offering at €200,000,000 5.0% additional senior secured notes due 2023
- Digi Communications N.V. to offer additional €125,000,000 5.0% senior secured notes due 2023; new notes will be consolidated and treated as its existing €350,000,000; adjustment on interim unaudited consolidated financial statements for the nine-month period ending September 30, 2018
- World's largest superhero statue to be built in Central Europe
- The resignation of Mr. Bendei Ioan – VP and executive director of RCS&RDS S.A., DIGI COMMUNICATIONS N.V.’s subsidiary in Romania
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 28 January 2019 – 1 February 2019
- RCH Group to Showcase Integrated Selling Solutions at EuroCIS
- Mono and bfound partner to expand digital offerings for small businesses in the Middle East
- Digi Communications N.V. publishes the Independent Limited Assurance Report in accordance with Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- ERRATA of the reports dated 15 Jan 2019 and 15 Oct 2018 regarding the legal acts concluded by DIGI Communications N.V. in Dec 2018 and Sep 2018
- REVEALED: Experts reveal the best dates to book your summer holiday in Spain
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 21 – 25 January 2019
- Céline Dion visite son premier concept store de vêtements CELINUNUNU à Paris
- Anytime, anywhere tailored learning opportunities for welding professionals and apprentices alike
- i5invest открива офис в България
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 14 - 18 January 2019
- Mono helps Fonecta strengthen their digital presence offering for SMBs
- The Bucharest Tribunal’s decision regarding the investigation conducted by the Romanian National Anti-corruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V.: Exercise of stock options by a PDMR in accordance with the stock option plan approved by the Company for the Romanian employees of the Group in 2017
- Report of legal acts concluded by DIGI Communications N.V. in accordance with Romanian Law no. 24/2017 and FSA Regulation no. 5/2018 for December 2018
- Digi Communications N.V.: resolution of the Board of Directors to convert class 1,200,000 A shares into an equal number of class B shares for the purpose of the ongoing employees and directors stock option plans
- CELINUNUNU OUVRE SON PREMIER POP-UP À PARIS
- DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 07 – 11 January 2019
- Digi Communications NV: Announcement of the Conference Call for the 2018 Preliminary financial results. Update to the 2019 Company’s Financial Calendar
- A new Government Emergency Ordinance imposing additional corporate taxes with impact on the telecommunications sector in Romania
- DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol between 31 December 2018-04 January 2019
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