SUMMARYIf not otherwise stated, the findings and recommendations given in EFSA 2007c remain valid and applicable. Therefore, the present opinion should be read together with the opinion issued in 2007 (EFSA, 2007c). The Panel reemphasises that the data requirements should be flexible enough to allow new risk assessment developments to be considered when available.The present opinion focuses in particular on the number of animals (vertebrates) used in testing, the harmonisation of risk assessment quotients, ECx versus NOEC, risk assessment for honeybees and aquatic plants, and a number of other issues that should be considered in future risk assessment.
BACKGROUND AS PROVIDED BY EFSAIn November 2005, the Commission initially informed the European Food Safety Authority (EFSA) 2 that they were revising the data requirements for authorisation of active substances and plant protection products in the framework of Council Directive 91/414/EEC. The revision process involved Part A of Annexes II and III and had been organised in order to amend the directives 3 laying down the data requirements for active substances and plant protection products. The Commission had prepared SANCO Working Documents 4 containing the proposed data requirements to revise Annexes II and III to Directive 91/414/EEC and asked the PPR Panel to provide observations and/or possible recommendations, and in particular to verify that the methodology and the approaches presented in the draft data requirements were in line with the scientific state of the art in the relevant field and the extent of its applicability with respect to the risk assessment of plant protection products.Between May 2006 and March 2007, upon request of the Commission, the PPR Panel issued six opinions on the SANCO working documents related to the revision of Annexes II and III to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (EFSA, 2006a, b, c; EFSA, 2007a, b, c).
ACKNOWLEDGEMENTS