EFSA GMO Newsletter February/March/April 2013

News

Testbiotech and the European Network of Scientists for Social and Environmental Responsibility (ENSSER) filed a lawsuit against the EU Commission regarding market approval of the genetically engineered soybean MON 87701 x MON 89788 (http://www.testbiotech.org/en/node/781).

Testbiotech published a new report on GRACE, an EU-funded research project on the risk assessment of genetically engineered plants. Testbiotech investigations revealed that a large proportion of the project participants have either close ties to the biotech industry or are involved in EFSA activities. Testbiotech is calling for the project to be stopped and an independent review carried out (http://www.testbiotech.de/en/node/787).

Testbiotech filed a comment on EFSA's Scientific Opinion on the application for the placing on the market of maize 59122 for cultivation (http://www.testbiotech.de/en/node/788).

Testbiotech filed a comment on EFSA's Scientific Opinion on the application for the placing on the market of Bt maize MON810 in pollen (http://www.testbiotech.org/en/node/766).

Testbiotech filed a comment on EFSA's Scientific Opinion on the application for the placing on the market of herbicide tolerant genetically modified oilseed rape GT73 for food and feed uses, import and processing (http://www.testbiotech.org/en/node/745).

Testbiotech analysed data on the genetically engineered maize MON89034 x NK603 presented by the US company, Monsanto to the Indian authorities. The plants, so called stacked events, are produced by crossing two genetically engineered plants. The maize produces two insecticidal toxins and is herbicide-tolerant. The report published today shows the data from Monsanto are not consistent, suffer from several flaws and some even are completely outdated (http://www.testbiotech.de/node/760).

Testbiotech published an English version of a report on the effects of the cultivation of genetically engineered plants in the USA: “30 years of genetically engineered plants - 20 years of commercial cultivation in the United States: a critical assessment” (http://www.testbiotech.org/node/763). The German version was written for Martin Häusling, Green Party, Member of the European Parliament.

Recently a study was published exploring the potential toxicity of Bt proteins on mammals (http://esciencecentral.org/journals/JHTD/JHTD-1-104.pdf). The study shows that mice show haematoxicity when feeding on Bt toxins Cry1Aa, Cry1Ab, Cry1Ac or Cry2A. However, the study might suffer from some weaknesses such as unclear reporting of methods and the results will need further investigation.
Toxicity of Bt proteins in mammalian cells was also the subject of an in vitro study that was partly funded by Testbiotech (Mesnage et al., 2012; http://onlinelibrary.wiley.com/doi/10.1002/jat.2712/abstract). Also here, negative effects could be attributed to the intake of Bt toxin Cry1Ac.

Votes

On 25 February, the Standing Committee on the Food Chain & Animal Health (SCFCAH) voted in favour of the EU Commission's draft GM regulation (http://ec.europa.eu/food/plant/standing_committees/sc_modif_genet/docs/s...). The full text of the Regulation has not been published yet.

New opinions

On 24 April, EFSA published a Scientific Opinion on a request from the European Commission related to the prolongation of prohibition of the placing on the market of genetically modified oilseed rape events GT73 for import, processing and feed uses in Austria (http://www.efsa.europa.eu/en/efsajournal/pub/3201.htm). According to the GMO Panel, “there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape GT73.”

On 24 April, EFSA published a Scientific Opinion on a request from the European Commission related to the prolongation of prohibition of the placing on the market of genetically modified oilseed rape events Ms8, Rf3 and Ms8 x Rf3 for import, processing and feed uses in Austria (http://www.efsa.europa.eu/en/efsajournal/pub/3202.htm). According to the GMO Panel, “there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape Ms8, Rf3 and Ms8 x Rf3.”

On 16 April 2013, EFSA published an opinion on herbicide tolerant genetically modified maize 98140 for food and feed uses, import and processing (http://www.efsa.europa.eu/en/efsajournal/pub/3139.htm). For the first time ever, EFSA partly rejected an application due to improper data. According to a EFSA press release, “EFSA was prevented from reaching a conclusion overall on the potential risks posed by herbicide tolerant GM maize 98140 to human and animal health as the application did not meet all the minimum standards set out by the Authority’s guidance document.”

On 26 March 2013, EFSA published a positive opinion on maize 59122 for food and feed uses, import, processing and cultivation (http://www.efsa.europa.eu/en/efsajournal/pub/3135.htm).
According to EFSA, maize 59122 “is as safe as its conventional counterpart and commercial maize varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation of maize 59122 is unlikely to raise safety concerns for the environment.”

On 12 February 2013, EFSA published a positive opinion on the herbicide-tolerant oilseed rape GT73 for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape GT73 (http://www.efsa.europa.eu/en/efsajournal/pub/3079.htm).

New authorisations
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