GM Free Cymru

GM Soy approvals in Europe: legal requirements are being ignored


John Dalli Commissioner for Health and Consumer Policy European Commission Brussels Belgium

29th November 2011

Dear Commissioner Dalli,

GM Soy approvals in Europe: legal requirements are being ignored

As you will be aware from my two ongoing Petitions (on behalf of EU citizens) relating to the shortcomings of the EFSA assessments and advice on GM crops and food / feed applications, many thousands of consumers have lost faith in a system which is designed to facilitate GM approvals rather than to protect EU consumers and the environment. The Avaaz Petition with more than a million signatures (which you have chosen to ignore) is testament to this. We have not been reassured by the changes that have been made to EFSA Guidelines and working practices, which will not encourage better science but will permit simpler and cheaper applications, lower quality science, and fast track approvals even for varieties with "stacked" GM traits.

We write now about the legality of past Part C consents for the marketing (import and processing) of GM varieties -- particularly GM soy. The consents issued are purportedly designed to achieve "the protection of consumer health within the European market." In our view the consents will do nothing of the sort, since new science is showing significant changes in the composition of GM soy plants in the field, and also the persistence of spray residues on and in soy products brought into the EU. We support Testbiotech and NABU who have argued that the current applications for GM soy consents (from Monsanto and Bayer) do not fulfill the legal requirements as laid out in the Directives and Regulations (1). In their letter to the member states they point out a number of matters which are legally required but which have been ignored by the applicants and by EFSA, and by the member states which have voted for approvals. This is a matter of grave concern.

We come now to an even more serious matter. EFSA Assessments of GM soy marketing applications are supposedly carried out "in accordance with Articles 6(6) and 18(6) of Regulation (EC) No 1829/2003" and "within the meaning of Directive 2001/18/EC (EC, 2001)." In the EFSA Opinion on application EFSA-GMO-NL-2006-36 we find the following words: "............(the application) is for food and feed uses, import and processing and excludes cultivation. Therefore, the environmental risk assessment is limited to accidental release into the environment of GM soybean seeds during transportation and processing for food and feed uses. As this application is not for cultivation, concerns regarding the use of glyphosate herbicides on soybean MON89788 apply only to imported and processed soybean that may have been treated with these glyphosate herbicides in the countries of origin. However, the regulation and risk assessment of glyphosate is within the scope of Directive 91/414/EEC concerning the placing on the market of plant protection products (EC, 1991)."

Quite deliberately, EFSA is making NO assessment of the environmental and health effects of the cultivation of this GM soy, wherever that may be. So the EC is apparently entirely unconcerned about the health effects of GM soy cultivation in places like the US, Argentina, Brazil and Paraguay, presumably on the basis that it is for the regulators in those countries to sort out for themselves. In the light of the deluge of information now coming into the public domain on the direct and indirect effects of GM cultivation in Argentina (for example) it is quite extraordinary that our regulators can simply turn a blind eye and say "it's none of our business." That is unethical and immoral, and we as consumers cannot accept this sort of behaviour from those who supposedly represent our best interests and our wishes. In our view it is also ILLEGAL for EFSA and the EC to apply a lower standard of proof (relating to safety and health and environmental harm) to applications for import for food and feed use, than they do for applications for cultivation. See Note (2) below.

EFSA and the EC have also got into the habit of using this phrase: "in the context of its intended uses." We do not know where this phrase has come from, and it appears to be simply a cynical fudge which in effect allows EFSA and the EC to sidestep all issues related to health and the environment if they are affecting regions and rural populations outside the EU. In the Directives we cannot find any legal justification for the use of this phrase or for the avoidance of the ethical issues involved. Indeed, it seems to us from the 2008 Consolidation of Directives that EFSA and the EC are breaking their own laws and conniving in the environmental degradation of GM soy cultivation areas abroad while turning a blind eye to the suffering of rural populations affected by spray drift and other factors.

To summarise our concerns:

(a) there is nothing in the Directives or Regulations to say that the "approvals test" should be any less rigorous than the test applied for GM crops which might be cultivated in the EU;

(b) there is nothing in the Directives or Regulations to say that harm in the place where the crop is grown should be ignored;

(c) the Directives say that the INDIRECT effects of GM crop cultivation and management MUST be considered in the application and assessment process, and this includes the effects of glyphosate or Roundup spraying on herbicide-tolerant GM crops -- and yet there is a pretence that this comes under the Pesticide regulations.

And yet EFSA, the EC and many of the member states do indeed apply much less rigorous tests for GM materials intended for importation and processing than they do for GM crops intended for cultivation. They also avoid any consideration of the enormous direct and indirect environmental and health damage done in places like Argentina and Paraguay where GM soy is grown on an industrial scale for import into the EU (3). Quite apart from the fact that the Precautionary Principle is comprehensively ignored (and that is illegal in itself), it seems to us that all of these consents for importation and processing are also illegal because they do not properly consider negative impacts in the places of cultivation.

In view of the foregoing notification that EFSA and the EC are ignoring certain of the legal requirements for GM assessments and approvals, as laid out in the Directives, we claim that consents already made are illegal. We hereby request an immediate moratorium on all GM approvals pending a full legal review.

Please acknowledge the safe receipt of this letter. On behalf of GM-Free Cymru, I will be grateful for an early and considered reply.

Yours sincerely,

Dr Brian John GM-Free Cymru


(1) Letter to EU Member States concerning the vote on genetically engineered soybean 40-3-2 (Monsanto) and A5547-127 (Bayer CropScience) 9.11.2011 Christoph Then, Testbiotech Steffi Ober, Naturschutzbund (NABU),

(2) In the 2008 Consolidation of Directive 2001/18/EC and later amending regulations, we find the following:

(8) The precautionary principle has been taken into account in the drafting of this Directive and must be taken into account when implementing it.

(9) Respect for ethical principles recognised in a Member State is particularly important. Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.

(11) Placing on the market also covers import. Products containing and/or consisting of GMOs covered by this Directive cannot be imported into the Community if they do not comply with its provisions.

In the Guidance Notes (p 33) it says this: "Environmental risk assessment (ERA) is defined in Article 2(8) of Directive 2001/18/EC as ‘the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose’. As one of the general obligations under the Directive, Article 4(3) requires Member States and, where appropriate, the Commission to ensure that potential adverse effects on human health and the environment, which may occur in particular directly or indirectly, are accurately assessed on a case-by-case basis taking into account the environmental impact according to the nature of the organism introduced and the receiving environment." In other words, there must be no differentiation made between impacts within the EU and impacts in the country of origin of the GM crops. We respectfully point out that this is a very important matter indeed.

(3) The evidence of environmental and health harm arising from the cultivation of GM soy has repeatedly been brought to the attention of EFSA and the EC, but it has repeatedly been ignored. Once again, we draw your attention to the following:

The information from Prof Andres Carrasco is relevant here, as is the latest report here:

See also:

Antoniou M, Habib M, Howard CV, Jennings RC, Leifert C, Nodari RO, Robinson C, Fagan J. Roundup and birth defects: Is the public being kept in the dark? Earth Open Source, 2011.

GM SOY -- Sustainable? Responsible? by Michael Antoniou, Paulo Brack, Andrés Carrasco, John Fagan, Mohamed Habib, Paulo Kageyama, Carlo Leifert, Rubens Onofre Nodari, Walter Pengue 2010 GLS Gemeinschaftsbank eG and ARGE Gentechnik-frei

ISIS Report 06/10/10 Argentina's Roundup Human Tragedy Ten years of GM soy and glyphosate poisoning have escalated the rates of cancer and birth defects. Claire Robinson