GM-Free Cymru, together with many other organizations, has argued forcefully over the past decade that EU consents for GMOs to be cultivated and imported for food and feed use in the EU are actually illegal, on the basis that both EFSA and the EC have consistently neglected to take into account in their assessments the INDIRECT consequences of the use of GMOs in the market place. (Over and again, the Directives and Regulations refer to both direct and indirect effects.) These consequences include harmful effects arising from the use of the herbicides and pesticides (for example Roundup and Liberty) which are routinely used on a large scale during the growing and harvesting of GM crops. In letters and representations to Commissioner John Dalli and to EFSA over the years, we have argued that so much evidence has accumulated for the harmful effects of Roundup and Liberty that it is criminally negligent to have failed to take them into account prior to the issuing of GM authorisations; and this view is now backed up strongly in a new legal dossier commissioned by Testbiotech from Prof Ludwig Kraemer. Prof Kraemer argues that it is not actually necessary to have identified harm associated with the use of these "complementary herbicides" -- he says that the law has been broken because there have not even been any scientific assessments of their impacts. He also accuses the EC of failing in another respect -- through neglecting to employ the Precautionary Principle which is enshrined in the legislation. Finally he says that EFSA and the EC have broken the law through failing to address new evidence of harm (associated with the impacts of herbicides in particular) following initial consents. as we have frequently pointed out in the past, EFSA has never revisited an existing consent or modified it in the light of new material brought to its attention. On the contrary, in response to protests from NGOs (and some member states) EFSA always says that it can see no reason for modifying its existing assessments.
Will this new legal dossier make any difference? We doubt it, since EFSA consistently argues that it is fully aware of ALL of the scientific evidence in the public domain, and that its brilliant GMO Panel Members are up to speed on all of the indirect effects of the use of GMOs, to the extent that these matters are always borne in mind even if they are never actually mentioned.........
22. June 2012 Munich/Brussels http://www.testbiotech.de/en/node/675
The European Food Safety Authority EFSA has for the first time given a positive opinion on the cultivation of genetically engineered soy in the EU. Now the EU Commission and Member States have to make a decision on final market authorisation. The applicant, US company Monsanto, wants to sell its seeds for herbicide tolerant Roundup Ready soy to European farmers. Currently, the genetically engineered soy can be imported but not grown.
But as a new legal dossier prepared on behalf of Testbiotech shows, the authorisation as planned would violate existing EU law because residues remaining in the plants from spraying with the herbicide were not taken into account during risk assessment. Furthermore, EFSA does not foresee monitoring possible health effects from these residues although required to do so by EU law.
Other authorisations already issued for the usage of genetically engineered plants in food and feed suffer from the same deficiencies. According to the legal dossier, written by the well- known EU legal expert Ludwig Kraemer, these authorisations now need to be reevaluated.
“Residues from herbicides regularly sprayed on genetically engineered plants are left out of the risk assessment of these crops. So far, this practice has been fiercely defended by EU Commissioner John Dalli. He is now not only under fire for being too close to industry, but he is also becoming a major legal problem”, Christoph Then says for Testbiotech. “If the genetically engineered soy is authorised on the basis of the risk assessment as elaborated by EFSA, this should be considered a violation of existing EU law.”
Professor Ludwig Kraemer worked as an official for the EU Commission (DG Environment) until 2004. Currently he is active with Client Earth. There are four salient points in his legal dossier:
Despite the fact that current EU legislation has been in place for more than ten years and 45 genetically engineered events have already been authorised for usage in food and feed, observation of potential adverse health effects has not been implemented as required by EU Directive 2001/18 and Regulation 1829/2003. Further residues from spraying with herbicides and emerging cumulative effects are left out of the risk assessment of genetically engineered plants. According to a new draft regulation on the risk assessment of genetically engineered crops presented by the EU Commission, this practice will not be changed in the future. As for the residues from spraying with complementary herbicides, a lot of criticism has been voiced because pesticides like glyphosate (brand name Roundup) are increasingly used in genetically engineered crops and several scientists have warned of associated health risks.
Contact: Christoph Then, Testbiotech, email@example.com, Tel. + 4915154638040, www.testbiotech.org
These are the questions which Testbiotech asked Prof Kraemer to address, relating to the consumption of genetically modified plants and the potential presence of herbicide residues. Testbiotech considered that, in practice, the effects on human health of the consumption of genetically modified food (and feed) appear not to be monitored.
1. Is the present practice of placing genetically modified plants on the market in conformity with the relevant EU provisions?
2. Do Directive 2001/18 and Regulation 1829/2003 both require that the health effects of the use and consumption of genetically modified plants be monitored?
3. Does the precautionary principle allow the EC to disregard the residues of complementary pesticides when the risk assessment of genetically modified plants is made?
4. After the authorisation of a genetically modified plant, has a monitoring of potential adverse effects on human health to be undertaken which takes into consideration the possible presence of herbicide residues and their possible cumulative effect?
Prof Kraemer's conclusiions were as follows:
1. The present practice not to monitor the potential adverse effects on human health of genetically modified plants at the use and consumption stage is not in compliance with existing EU legislation.
2. Directive 2001/18 and Regulation 1829/2003 require both that potential adverse effects on human health of genetically modified plants are controlled during the use and consumption stage, including in those cases that such effects are unlikely to occur.
3. Directive 2001/18 and Regulation 1829/2003 have both the objective to avoid any adverse effect on human health of genetically modified plants. Therefore, the risk assessment must provide, in both cases, that the cumulative effect of herbicide residues on genetically modified plants during the use and consumption stage is controlled.
4. When the monitoring plan for a genetically modified plant does not include the control of the cumulative effect of herbicide residues and genetically modified plants on human health during the use and consumption stage, the authorisation shall have to be amended in order to provide for such a control.