Time for the Commission to Act
Mandatory 90-day feeding studies unnecessary
Brussels, 24 November 2015 – “We acknowledge the results of the EU-funded GRACE project and in particular the recommendation to dismiss mandatory 90-day rodent feeding studies in GMO risk assessment,” said Beat Späth, Director of agricultural biotechnology at EuropaBio, the European Association for Bioindustries.
When adopting Implementing Regulation No 503/2013, the European Commission included a mandatory 90-day feeding trial for GM food and feed risk assessment. That same regulation stipulates that the Commission shall monitor the outcome of the GRACE project and review this requirement.In addition, the EU legislation (Directive 2010/63/EU) spells out the principle of the “Three Rs” and makes it a firm legal requirement to replace, reduce and refine the use of animals used for scientific purposes.
GRACE, a European Commission project initiated in 2012 by an independent academic consortium with the aim to test various types of animal feeding trials in order to determine their scientific value for health risk assessments of GM food and feed, determined during their final conference that there is no scientific justification for a mandatory 90-day feeding study, but instead it should be hypothesis-driven and case-by-case.
“We call on the Commission to follow its own regulation and review the requirement to perform 90-day feeding studies in rodents in line with the GRACE recommendation,”added Späth.
EuropaBio firmly believes that the EU risk assessment 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 such as that included in Regulation No 503/2013 do not contribute to safety and make risk assessment timelines longer adding further to the documented undue delays that take place in the GMO approval process.
- 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)”
- Increasing timelines for risk assessment of GMOs in EFSA, EuropaBio, July 2015
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.