• Bruce Ballantine and Bethan Devonald.
• Business Decisions Limited, Heronswood House, Maidstone Road, Pembury, Kent TN2 4DD, UK.
• Regul. Toxicol. Pharmacol. 2006 Feb 1; 44 (1): 57-68.

AbstractThis paper begins by explaining the importance of improving the quality of the regulatory process, particularly in the European Union (EU), using tools and techniques such as Regulatory Impact Assessment (RIA). It describes the principal features of the RIA process, including good practices and practical problems. The paper then outlines the historical development of the RIA process in the EU and describes the new approach adopted recently by the European Commission. It also evaluates the effectiveness of the new approach--in theory and in practice--using as one example the RIAs undertaken on the New Chemicals Policy (REACH) by the European Commission, Member States, and stakeholders. A further section describes recent work undertaken by Business Decisions Limited and THE WEINBERG GROUP on Impact Assessments for the Animal Health Industry, the Polycarbonates Industry and the Nickel Industry. The paper finally draws a number of conclusions and makes a number of recommendations for further improvements in the quality of the regulatory process in the European Union.

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