FLF, Alm.del - 2011-12 - Bilag 205: Henvendelse af 2/3-12 fra Dyrenes Beskyttelse vedrørende dyreforsøg i relation til godkendelse af genetisk modificerede fødevarer og foderstoffer

BRIEFINGFebruary 2012Animal welfare position on the obligatory use of the 90 day animal test for the authorisationof genetically modified food and feedOverviewThe Commission is presently drafting implementing rules concerning applications for authorisation ofgenetically modified food and feed, in accordance with regulation (EC) No 1829/2003. In the draft regulation,an issue of utmost animal welfare concern has been raised. The draft regulation calls for the obligatory useof an animal testing method which over many years has never yielded any additional significant or usefulresults. We strongly hope that the Commission has not bowed to pressure by certain member states to callfor obligatory testing.Our concernsThis risk assessment is currently carried out according to guidelines of European Food Safety Authority(EFSA). However, the proposed Implementing Regulation will drive the risk assessment. The issue is that theproposed regulation contains an obligation to always perform the repeated dose 90 –day oral toxicity study inrodents (Recitals 10, 11 and 12 and Annex II point 1.4.4.1). This test is designed to test the safety of simplesubstances for humans and animals. It involves subjecting the animals to repeat doses of a substance over aperiod of 90 days, resulting in high concentrations being fed which represent an unbalanced, unnatural diet.This making it difficult to compare results with the diet of humans. The test has always been carried out on acase-by-case basis determined by EFSA. The newly published EFSA guidance for risk assessment for foodand feed from genetically modified plants (Published January 2012) places the repeated dose 90 –day oraltoxicity study in rodents in a list of tests (OECD guideline 408) which may be selectively applied for toxicitytesting. This guidance therefore maintains a case-by-case approach in order to decide whether a 90 daysanimal feeding study is needed.From an animal welfare point of view it is important to maintain the case-by-case approach. Eurogroup findsthe obligatory call a contradiction to the Commission’s objective to reduce, refine and replace animal testingand to replace it with more modern, state-of-the-art science. There is no scientific reasoning behind thedecision to make this test obligatory, it is purely political. In addition to the animal welfare concerns, it will addextra, unnecessary costs on industry.Furthermore, the Commission wants to show it is flexible and for that reason has included a provisionunder Article 13 to review by 2016 the requirements of the 90 day study in case new scientific informationis available. This will not solve the fundamental problem of additional testing. There is at the moment noscientific justification to impose the 90 day study in the first place. The Commission should rather focuson providing resources for the development of more state-of-the-art techniques which include the 3Rs, inparticular testing strategies or tests based on ‘omics’ technology.We urge Member States to carefully examine the draft regulation submitted by the European Commissionand to support rules which keep the current situation, where a request to perform the 90 day study must ineach case be based on a scientific opinion by EFSA.6 rue des Patriotes – B - 1000 BrusselsTel : +32 (0)2 740 08 20 - Fax : +32 (0)2 740 08 29Email : [email protected]www.eurogroupforanimals.org

In accordance with the applicable guidance of the EFSA1, the safety assessment of the genetically modifiedfood or feed should include studies related to new components resulting from the genetic modification, themolecular characterisation of the genetically modified plant, the comparative analysis of the compositionand the phenotype of the genetically modified plant compared to its conventional counterpart. Depending onthe characteristics of the genetically modified plant and on the outcome of that first set of studies, the EFSAguidance indicates that it may be necessary to perform additional studies. In that respect, the EFSA considersthat notwithstanding its limitations, a 90-day feeding study in rodents with whole food or feed is, when justified,the primary additional study to address uncertainties identified in the course of the safety assessment.It has, however, not been proved possible to define with the necessary precision the level of uncertainties whichwould require the submission of 90-day feeding studies in applications for genetically modified plants containingsingle transformation events. Therefore, in order to ensure a high level of protection of human and animalhealth, as well as to improve consumer confidence, such studies should be, for the time being, requested in allapplications related to genetically modified plants with single transformation events and, where appropriate, ongenetically modified plants containing stacked events.Studies to demonstrate that a genetically modified food or feed fulfils the requirements of Regulation (EC)No 1829/2003 involving the use of laboratory animals should be carried out in accordance with Directive 86/609/EEC of 24November 1986 on the approximation of laws, regulations and administrative provisions of theMember States regarding the protection of the animals used for experimental and other scientific purposes2which will be repealed by Directive 2010/63/EU of the European Parliament and Council of 22 September2010 regarding the protection of the animals used for scientific purposes3, and should be kept to a minimumwhile ensuring an adequate demonstration of the safety of the genetically modified food or feed. The currentuncertainties in relation to the need and design of 90-day feeding trials will be addressed by a large researchproject under the 2012 work programme of Theme 2 "Agriculture and Fisheries, Food and Biotechnologies" ofthe seventh Framework Programme for Research (FP7). The requirements regarding animal feeding trials in thecontext of GMO risk assessments should be reviewed in the light of the outcome of this project expected to beavailable by the end of 2015 at the latest. Other credible scientific knowledge which might be available at thattime should also be taken into account.Article 13

1.4.4.1. 90-day feeding study in rodents with whole genetically modified food/feed: sentinel study for toxicity andnutritionThe applicant shall include a 90-day feeding study with whole food and feed in rodents for the assessmentof food and feed containing, consisting of or produced from genetically modified plants with a singletransformation event or with stacked transformation events which are not obtained by conventional crossing ofgenetically modified plants containing a single transformation event.In the case of stacked transformation events obtained by conventional crossing of genetically modified plantscontaining a single transformation event, a 90-day feeding study with whole food and feed in rodents shallbe included for each genetically modified plant with a single transformation event of which it is obtained. Anadditional 90-day feeding study with whole food and feed in rodents with the genetically modified plant with thestacked transformation events shall be included where indications of potential adverse effects are identifiedduring the assessment of (i) the stability of the inserts, (ii) the expression of the inserts and (iii) the potentialsynergistic or antagonistic effects resulting from the combination of the transformation events.The protocol for 90-day feeding study in rodents with whole genetically modified food/feed shall be incompliance with the Guidance of the EFSA scientific committee on conducting repeated-dose 90-day oraltoxicity study in rodents on whole food/feed4.1.4.4.2. Animal studies with respect to reproductive and developmental toxicity testingWhen information required in Sections 1.4.1, 1.4.2 and 1.4.3on the genetically modified food and feed suggestthe potential for reproductive, developmental or chronic toxicity or in case of indications of adverse effects fromthe 90-day feeding study in rodents (such as functional and/or histological modifications of nervous, endocrine,reproductive or immunological tissues/organs), appropriate testing shall be performed. OECD protocols forreproductive, developmental and chronic toxicity testing (see Table 1 of Section 1.7) may be adapted for thepurposes of testing the whole genetically modified food and feed.Given that the 90-day feeding study in rodents is only designed to detect effects on adult reproductive organweights and histopathology and that it does not detect other effects on reproduction or development, testingof the whole food and feed beyond a 90-day rodent feeding study shall be conducted where hazards in thisrespect have been identified.