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Commission must re-instate science in GMO safety assessment and reduce unnecessary testing requirements


04 Jul 2016


Agriculture & Food
Health & Consumers

Brussels, 4 July 2016 – "The European Commission is missing another major opportunity to ensure that European regulatory decisions are based on science. Whereas last month the Commission had the opportunity to choose to reduce unnecessary testing requirements during the GMO risk assessment process, it seems to have chosen to ignore the science that proves – yet again - that some of the testing requirements are in fact not required", said Beat Späth, Director of agricultural biotechnology at EuropaBio, the European Association for Bioindustries.

"Any risk assessment process", he continued, "must be based purely on science and not politics, and it should adhere to basic risk assessment principles, which deem some of the requirements that currently exist for GM food and feed risk assessment to be totally unnecessary. There is no place for politics in the risk assessment stage. Political considerations should remain part of the risk management stage, which follows risk assessment."

In 2013, the Commission imposed mandatory 90-day animal feeding trials for GM food and feed risk assessment in an implementing regulation [1]. This happened for political reasons, and against the will of the EU’s risk assessment body, the European Food Safety Authority (EFSA), which repeatedly dismissed the requirement as unnecessary [2]. The requirement remains in clear contradiction with the principle of science-based risk assessment [3].

The same Implementing Regulation stipulates that the Commission shall a) monitor the outcome of the EU research project GRACE, in which an independent academic consortium concluded in November 2015 that there is no scientific justification for a mandatory 90-day feeding study; and b) publish a review of the testing requirements on the basis of this new scientific information by 30 June 2016 [4]. The Commission has not to our knowledge published the said review. Moreover, its failure to act on this scientific recommendation seems out of line with EU legislation stipulating a clear requirement to replace, reduce and refine the use of animals used for scientific purposes [5].

EuropaBio firmly believes that the EU risk assessment for GMOs should respect the case-by-case approach and only request studies with scientific added value depending on the properties of each individual GMO. Mandatory feeding studies do nothing to ensure safety or build trust in the EU’s authorisation systems, and they add further to the well documented unnecessary delays in the GMO approval process for imports, such as those recently confirmed by the European Ombudsman’s Decision of 15 January 2016 [6].



  1. Implementing Regulation EU No 503/2013 on applications for authorisation of genetically modified food and feed
  2. March 2008December 2013 and June 2016
  3. Reg EC No 178/2002, preamble 18: ‘In order for there to be confidence in the scientific basis for food law, risk assessments should be undertaken in an independent, objective and transparent manner, on the basis of the available scientific information and data’
  4. Article 12.2 of Implementing Regulation EU No 503/2013
  5. Directive 2010/63/EU

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About EuropaBio:

EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 77 corporate and associate members and bio regions, and 16 national biotechnology associations in turn representing over 1800 biotech SMEs.