Therefore, the REACH regulation challenges the chemicals industry to develop rapid, relevant, cost-effective in vitro assays to reliably predict human toxicity. In addition to drawbacks such as lack of regulatory acceptance another challenge for in vitro assays is that multiple models are needed to replace one in vivo model. The European Food Safety Authority (EFSA) is a European agency whose role is to provide independent scientific advice and
information in the form of opinions and technical reports to support Community legislation and policies and to collect and analyse data allowing assessment and monitoring of risks in the food and feed sector. The work of EFSA is mainly carried out in different expert panels dealing with, besides other food related fields, for instance with food additives, Talazoparib clinical trial genetically modified organisms, Ibrutinib cost food contaminants, transmissible animal diseases and pesticides and their residues. In a new regulation (EU, 2010), the EU Commission recommended that alternative models should include in vitro and in silico methods, as well as reduction and refinement of in vivo tests. Specifically for ADME determination, the EU Commission favoured the use of in vitro models from the same species as those used in pivotal studies and
in human materials (microsomes and intact cell systems). A risk assessment method considering the 3Rs currently explored by the EFSA is the Qualified Presumption of Safety (QPS) approach for micro-organisms. The QPS approach is based on the presumption that if for a taxonomic group of micro-organisms safety concerns can be excluded, any strain
of this group can be considered as safe and that consequently further assessment (also employing animal tests) can be waived, thus reducing unnecessary animal tests. In the European Union (EU) risk assessment and authorisation of plant protection products (PPPs) was at the time of the workshop carried out according to the provisions laid down in Council Directive 91/414/EEC (EFSA, 2007). This directive has been replaced by Regulation (EC) 1107/2009 of the European Parliament and Oxymatrine the Council which will be fully applicable by 14th June 2011 (EU, 2010). PPPs that are designed to control pests are toxic by definition and are normally actively brought into the environment. Therefore, extensive testing before any decision on authorisation is mandatory. Testing requirements for the assessment of active substances with respect to possible human health effects include a battery of in vivo tests (acute, subchronic and chronic tests, reproduction toxicity) and are laid down in Annex II to Directive 91/414/EEC while in Annex III testing requirements for the final plant protection product are listed. The same data requirements are laid down also in the new regulation.