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EU Authorisation for GMOs: some experiences from 2005

Christoph Then, Greenpeace. EU Authorisation for GMOs: some experiences from 2005. Old crops: MON810: for cultivation and import before 1998 (Reassessment end 2006) Bt 176: for cultivation before 1998, grown in Spain on large scale in 2005

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EU Authorisation for GMOs: some experiences from 2005

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  1. Christoph Then, Greenpeace EU Authorisation for GMOs: some experiences from 2005

  2. Old crops: MON810: for cultivation and import before 1998 (Reassessment end 2006) Bt 176: for cultivation before 1998, grown in Spain on large scale in 2005 RR Soy: import since 1996, new application for cultivation and reassessment for end of 2006 EU Authorisation overview (1)

  3. New crops: Bt11, NK603, GT73, MON863, GA21, 1507 approved for food and feed MON863xMON810 approved for processing Bt11, 1507 for cultivation: opinion of EFSA published MON863xMON810xNK603, import opinion of EFSA published Ms8, Rf3, import, opinion of EFSA published LL rice, import, pending EU Authorisation overview (2)

  4. (1) Application sent directly to EFSA (European Food Safety Authority) (2) EFSA sends its opinion to member states and Commission (3) regulatory commitee (Qualified majority?) (4) council of ministers (Qualified majority?) (5) EU Commission Regulation 1829/2003: centralised procedure for feed, food and cultivation

  5. All research done by industry GMO panel of EFSA nearly without expertise for environment Most requirements of EFSA´s GMO guidelines are not mandatory scientific standards used are not transparent (something which is statistically significant is declared of no biological relevance) no full access to data procedure is not following normal democratic standars uncertainities not mentioned Some basic deficiencies of EU authorisation procdure

  6. Assessment of health risks

  7. GE pea: immune response in mice • The transgenic transfer of a protein gene from a donor plant species even to a closely related species may lead to the synthesis of structural variants possessing altered immunogenicity I Arpad Pusztai (epigenetics conference, Greenpeace, 2005)

  8. Regulation (EC) No 178/2002 Article 14(4): In determining whether any food is injurious to health, regard shall be had: (a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations; (b) to the probable cumulative toxic effects; (c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers. Legal requirements

  9. Evaluation of GMOs on health • In Monsanto tests, with a GM maize NK603, 50 significative differences were noticed on rats eating it during 90 days. These have been judged « not important » with bizarre explanations by 2 scientists from a governmental commission. • Other differences were found in similar experiments with GM rape GT73 on livers (up to 20% increase in weigth) and kidneys of rats. Gilles Eric Seralini (epigenetics conference, Greenpeace, 2005)

  10. Evaluation of GMOs on health • For the GM maize MON 863 (90d tests), finally accepted by EFSA (...) • Significant increase of white blood cells, lymphocytes in males • Decrease of reticulocytes (young red cells) in females • Significant increase of blood sugar in females Elevated frequency of abnormal organ parameters (inflammation, regeneration…) in male kidneys… And the french Commission doesn’t conclude in a first instance but doesn’t accept to ask to do the tests again and to make them longer, for economical reasons ! Gilles Eric Seralini (epigenetics conference, Greenpeace, 2005)

  11. Obviously, GMOs are less tested than pesticides on health • Although there are designed to contain new pesticides (new herbicide metabolites or new insecticides) • There are believed to be well-tested : the 90d tests for rats (only on 1 species) are not obligatory and not performed for all GMOs, but are the longest ones • (...) • The companies say a seed cannot be evaluated like a chemical, it costs too much Gilles Eric Seralini (epigenetics conference, Greenpeace, 2005)

  12. “The following findings clearly indicate major failures of statistical analyses as performed by Monsanto: introduction of irrelevant variability sources as use of additional animal groups likely to dilute biological effects, methodological errors such as wrong test system in general which is not suitable to detect very important effects, statistical techniques not performed properly; such as the Student test with too small animal groups that do not allow all significant effects to be seen, differences in average growth and weight not mentioned by Monsanto, conceptual errors in Monsanto'sstatistical analysis. In conclusion, after the above remarks, it is essential for Monsanto's whole statistical analysis to be done again, before any decision about market access can be taken. In a second step further analyses from other feeding studies delivered to EU authorities should be done to find out if there are further indications that Bt toxins influence animals' state of health. If market approval for these kind of products is sought, new tests need to be developed, such as initial studies of these new Bt toxins on human cells.” MON 863, preliminary findings of CRII GEN

  13. risk assessment for environment

  14. several unintended additional fragments of the inserted genes. The implications of these genome irregularities in 1507 to the environmental and food/feed safety of this GM maize remain unknown. many statistically significant differences are seen in the compositional analysis of 1507. These differences could cause adverse effects on human and animal health or the environment. statistical differences were seen in the toxicological assessment of 1507. Therefore, it remains unknown whether GM maize 1507 is safe, especially in the long-term, as human food or animal feed. Example maize 1507 (Pioneer)

  15. unknown toxicity of 1507 to non-target European lepidoptera. unknown exudation of Cry1F through the roots of 1507 and unknown accumulation in the soil. A possible increase in the lignin content of parts of 1507 cannot be ruled out. The monitoring plan lacks a recommendation to test for adverse effects on lepidoptera or the wider environmental effects of the Bt toxin from 1507. Example maize 1507 (Pioneer)

  16. Drugs: a defined substance is tested – in accordance with a precisely described procedure to the point where clinical tests are carried out on human beings. GMOs: Plants are living systems whose characteristics change constantly as a result of processes such as growth, flowering, seed formation and environmental influences, whereas the quality of drugs must be stable. Interaction with the environment – outcrossing, spreading and impacts on complex ecosystems and so forth – doesn't have to be taken into account in testing drugs. Ethical question: should we do animal experiments just for producing maize and soy? Comparison with authorisation of pharmaceuticals

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