THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear friends and colleagues,
A coalition of European NGOs are challenging a decision of the EU Commission to authorize a new GM Monsanto soyabean at the European Court of Justice. The GM soyabean has a unique combination of pest resistant and herbicide tolerant properties. The soyabeans are mostly grown in Brazil and exported to the EU for food, feed and processing. The NGOs allege that the European Food Safety Authority has not carried out the risk assessments as legally required.
We reproduce the press release and the summary below.
The full documents can be obtained at: http://www.testbiotech.de/node/772
The technical dossier and the legal dossier for the initial complaint against the European Commission can be obtained at: http://www.testbiotech.org/en/node/694
With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang
Malaysia
Email: twnet@po.jaring.my
Website: https://biosafety-info.net/ and http://www.twn.my/
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Item 1
Media Release
Lawsuit filed against EU authorisation of genetically engineered Soybeans
Environmental organisations and scientists jointly bring the case to the European Court of Justice
Munich/ Luxembourg, 21 March 2013. The European Network of Scientists for Social and Environmental Responsibility (ENSSER), the Society for Ecological Research, the foundation Manfred-Hermsen-Stiftung for Nature Conservation and Environmental Protection, the Foundation on Future Farming, the non-profit organisation Sambucus and Testbiotech are challenging a decision made by the EU Commission to authorise a new genetically engineered Monsanto soybean at the European Court of Justice. The soybeans will be mostly sold and grown in Brazil under the brand name Intacta, the harvest will be imported to the EU for use in food and feed. This product is a unique combination of two traits in soybeans: The plants express an insecticidal protein and are resistant to the herbicide glyphosate, commonly known under trademarks such as Roundup. According to the plaintiffs, the European Food Safety Authority EFSA has not carried out the risk assessments for the genetically engineered soybean as legally required. Therefore, the EU Commission should not have given its permission for marketing of the products derived from these plants.
The reasons given to the court for challenging the decision are, in particular, (1) the conclusion that this soybean can be regarded as equivalent with soybeans from conventional breeding, (2) there has been no investigation of combinatorial effects, (3) flawed examination of allergenic risks and (4) there is no obligation for monitoring health effects at the stage of consumption.
“Because of the legal process we mostly focused our legal challenge on those criteria which are requested by EFSA´s own guidance. If more general scientific standards were applied this case would have actually become much broader”, says Christoph Then for Testbiotech. “This case is meant to put pressure on the Commission and the EFSA to give much more weight to the protection of human and animal health as well as of the environment.”
The EU Commission gave its permission for use of the soybeans in food and feed at end of June 2012. In August 2012, the five organisations filed a complaint against this decision. Commissioner Tonio Borg rejected the complaint in January 2013, but three of the organisations were allowed to file a legal case at the ECJ, under EU regulation 1367/2006.
The requirements in EU regulations such as Directive 2001/18 and Regulation 1829/2003, state that genetically engineered plants should only be authorised for placing on the market after a scientific evaluation of the highest possible standards. This case aims to enforce the implementation of these requirements.
Contacts:
Testbiotech: Christoph Then, info@testbiotech.org, Tel +49 15154638040, www.testbiotech.org
ENSSER: Hartmut Meyer, hmeyer@ensser.org, www.ensser.org
Foundation on Future Farming: www.zs-l.de
Manfred-Hermsen-Stiftung: www.m-h-s.org
Sambucus: www.sambucus.org
Society for Ecological Research: www.oekologische-forschung.de
Further information:
Text filed to European Court of Justice: http://www.testbiotech.de/node/772
Text of the complaint as filed: http://www.testbiotech.org/en/node/694
Reply from the EU Commission to the complaint: http://www.testbiotech.de/node/776
Item 2
London, 18 March 2013
IN THE GENERAL COURT OF THE EUROPEAN UNION
(1) TESTBIOTECH
(2) EUROPEAN NETWORK OF SCIENTISTS FOR SOCIAL AND ENVIRONMENTAL RESPONSIBILITY (“ENSSER”)
(3) SAMBUCUS
Applicants
Represented by Kassie Smith QC and Julianne Kerr Stevenson, Barristers, Monckton Chambers
Against
THE EUROPEAN COMMISSION
Defendant
SUMMARY
1. Testbiotech, ENSSER and Sambucus challenge the European Commission’s decision, dated 8 January 2012, refusing to review its Decision 2012/347 granting a market authorisation under Regulation 1829/2003 on genetically modified food and feed (“GM Regulation”) to Monsanto Europe SA for its genetically modified soybean “MON 87701 x MON 89788” (“the Soybean”) [PD/7]. This Decision will hereinafter be referred to as the “Commission Decision” [PD/7].
2. Regulation 1829/2003 on genetically modified food and feed (“the GM Regulation”) [AU/1] provides that, in order to protect human and animal health, food and feed that consists of, contains, or is produced from genetically modified organisms should undergo a risk and safety assessment before it is placed on the market in the European Union.
3. The genetically modified soybean “MON 87701 x MON 89788”, the “Soybean”, is a hybrid product. It is created by traditional breeding methods, used to combine the genetic material of two parent plants: soybean MON 87701 and soybean MON 89788 (“the Parents”). The Parents are also both genetically modified plants.
4. Monsanto Europe SA (“Monsanto”) filed application EFSA-GMO-NL-2009-73 (“the Application”) in the Netherlands, seeking authorisation under the GM Regulation for the Soybean and its derived products for food and feed uses, import and processing in the European Union [PD/1]. The Application excludes cultivation within the EU.
5. Following a period of consultation with the representatives of the Member States, EFSA issued an Opinion on the Application on 26 January 2012 (“the EFSA Opinion”) [PD/3]. That Opinion recommended granting Monsanto’s application because EFSA had a reached a positive conclusion based on its risk and safety assessment of the Soybean.
6. Testbiotech understands that the Council failed to reach a decision on the Application because the matter was reverted to the Commission. Accordingly, in the absence of a decision by the Council, and on the basis of the EFSA Opinion, the Commission decided on 28 June 2012 to grant the market authorisation [PD/5].
7. The Applicants each sought an internal administrative review of that decision, on 6 August 2012, under Article 10 of the Aarhus Regulation and Article 36 of the GM Regulation (“Request for Internal Review”) [PD/6]. The Applicants contended that the authorisation of the Soybean is unlawful and/or based on a manifest error. The Applicants drew attention to the fact that in a number of areas EFSA failed to comply with its own Guidance in carrying out the safety and risk assessment of the Soybean. The Applicants submitted that this frustrated their legitimate expectation that EFSA would comply with its own Guidance. The Commission had failed to remedy these concerns in granting Monsanto’ application for a marketing authorisation for the Soybean.
8. The Commission responded to the Applicants’ Requests for Internal Review on 8 January 2013. The Commission rejected the submissions made by the Applicants in their Requests for Internal Review. (“the Commission Decision”) [PD/7].[1]
9. The Grounds upon which Testbiotech, ENSSER, and Sambucus challenge the Commission’s decision are, in summary:
a. Ground A: EFSA’s assessment that the Soybean is ‘substantially equivalent’ to its appropriate comparators is unlawful, is based on a scientific assessment which was not carried out in accordance with its own guidance, and/or is based on a manifest error of assessment;
b. Ground B: EFSA’s failure to give adequate or any consideration to the potential synergistic/combinatorial effects between the Soybean and other factors, and/or to require an adequate toxicity assessment to be conducted is contrary to its own guidance, legal obligations and/or it constitutes a manifest error of assessment;
c. Ground C: EFSA’s failure to require an adequate immunological assessment to be carried out is contrary to its own guidance, legal obligations and/or constitutes a manifest error of assessment.
d. Ground D: EFSA’s determination that no post-market authorisation monitoring of the consumption of the Soybean is manifestly in error and/or is vitiated by the flaws identified by Grounds A to C.
10. The Applicants request that the Court:
a. Declare the application admissible and well-founded;
b. Annul the contested decision;
c. Order the Commission to pay Testbiotech, ENSSER and Sambucus’ costs; and
d. Order any other measure deemed appropriate.
[1] ENSSER and Sambucus received identical copies of Commission Decision barring the name of the addressee, see: [PD/10] and [PD/12]