How to compare apples with pears - Testbiotech writes to EU Commission and German Government

5.3. 2012 The European Commission is planning to adopt new regulation on the risk assessment of genetically engineered plants used in food and feed. However, the standards are not sufficiently rigorous to exclude risks to human health and the environment. Testbiotech published a tabled overview on some deficiencies on 25 of January 2012 ( After a meeting with the Commission on 14 of February, Testbiotech continues to maintain the concerns. The most evident deficiencies are now summarised in a letter to EU Commissioner John Dalli and the German Minister of Agriculture Ilse Aigner:

  • Comparative risk assessment is still seen as the standard procedure. Instead of comprehensive risk assessment there will only be reduced 'check up' based on a presumption that risks from genetically engineered plants can be regarded as equivalent to those derived from conventional breeding. This is like comparing apples with pears.
  • The most relevant step in comparative risk assessment (the investigation of substantial equivalence) is still based on a concept that allows the introduction of flawed data (see also joined media release with GeneWatchUK,
  • Interactions with the environment that can impact the plants composition are not tested sufficiently. There is no stress test under defined conditions to investigate the functional stability of the gene construct.
  • Testing for health risks is still not based on a stepwise concept that entails mandatory investigations such as toxicity tests on cell cultures, targeted investigation of relevant health risks and mandatory long term and multi generational studies.
  • There is no request to apply more recent technologies, such as metabolic profiling.
  • Stacked events are still investigated less rigorously than single events.
  • The necessary interplay with pesticide regulation is missing. Residues from spraying with complementary herbicides should be seen as constituents of the plant that have to be fully assessed during the risk assessment of the genetically engineered plants.
  • Combinatorial effects should be taken into account, but the requirements for investigation of synergistic, additive and accumulated effects are not sufficiently defined.
  • The need to establish fully evaluated methods to measure the expression of the newly introduced gene constructs is not mentioned.
  • The need for further targeted investigations where there are uncertainties is not defined.
  • Post-marketing monitoring to allow identification of negative health effects and correlation with specific products is not defined.