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].

ENDS

References:

1. Implementing Regulation EU No 503/2013 on applications for authorisation of genetically modified food and feed
2. March 2008, December 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
6. http://www.ombudsman.europa.eu/cases/decision.faces/en/63025/html.bookmark

For additional Information:

• EFSA Timelines, EuropaBio, July 2016
• EuropaBio Press Release: Time for the Commission to Act: Mandatory 90-day Feeding Studies Unnecessary (November 2015)
• Final results and recommendations of the EU research project GRACE, GRACE
• Implementing Regulation No 503/2013 (Article 12)
• Directive 2010/63/EU on the protection of animals used for scientific purposes
• EFSA not supportive of 90 day feeding study requirement : when "molecular, compositional phenotypic, agronomic and other analyses have demonstrated equivalence of the GM food/feed [… performance of 90-day feeding trials with rodents or feeding trials with target animal species have provided little if anything to the overall safety assessment (except for added confirmation of safety)"
• Devos, Naegeli, Perry, & Waigmann. Is the mandatory EU requirement fit for purpose? EMBO reports (2016) : ‘Given the inherent limitations of untargeted 90-day rodent feeding studies [. . .], their mandatory conduct is inconsistent with the EU policy goal of improving animal welfare in scientific research and regulatory testing’. (…_‘. . . safety assessment should focus on known hazards associated with the novel traits [. . .] in order to evaluate plausible risks instead of unknown ones’.

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.