EU data generation

The U.S. EPA and many other organizations point out that, when information about potential risks is incomplete, basing decisions to avoid unnecessary health risks is potentially the best option.8 When a good set of scientific data is available on a material, then the Precautionary Principle is not appropriate. Scientific data generated in the EU Risk Assessments or under risk assessment programs, such as REACH, that deem materials safe for continued use should effectively rule out the use of Precautionary Principle. 

In 1981, the OECD Principles of GLP were finalized and led to the OECD Council Decision on the Mutual Acceptance of Data (MAD) which states that Data generated in the testing of chemicals in an OECD member country in accordance with OECD Test Guidelines and OECD principles of Good Laboratory Practice shall be accepted in other member countries for purposes of assessment and other uses relating to the protection of man and the environment . The OECD recommended in 1983 that implementation of GLP compliance should be verified by laboratory inspections and study audits. The EC later ratified the OECD principles and a number of Directives (e.g., 2004/9/EC, 2004/10/EC) indicates that tests must be carried out in compliance with the principles of GLP and that also that EU Member States must incorporate into their laws the requirement for all nonclinical safety studies to be conducted in compliance with GLP, and that premises conducting such studies must be inspected by a national authority. 

Field residue data, which are generated to meet requirements in the pesticide registration process, are used to regulate the use of agriculture products within the European Union (EU). This article examines the best practices to conduct crop field trials and to generate crop residue samples in Europe in order to provide part of the data that the agrochemical producers of the active ingredients must provide to the EU Commission. 

Fig. 6. Molecular structure of [Eu(L4)2]+. This figure was generated from data obtained from the Cambridge Crystallographic Data Centre as published...

Fig. 12. Molecular structures of [Eu(L30)(H2O)]3+ (top) and [Eu(L31)(H20)]3 + (bottom used as a model for [Eu(L29)(H20)]3 + ). These figures were generated from data obtained from the Cambridge Crystallographic Data Centre as published originally in Refs. (69,70).

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