A Member State view on the new Council regulation intended to replace Directive 91/414/EC

摘要

Since the implementation of Council Directive 91/414/EC in July 1993, there have been a number of significant events that have influenced the way plant protection products (PPPs) are regulated. In addition, the public generally wish to see tighter controls over their potential exposure to PPPs. The EU has increased in size from 12 to 27 Member States since 1993. This has had implications for how we work together to achieve a harmonized approach and to create an environment in which the workloads involved in the registration of PPPs can be shared between Member States. The original expectation that mutual recognition of authorisations would lead to a fully harmonized approach has not been realized to date. In addition, a number of food safety-relatedincidents have occurred, leading to the decision at Community level to separate the functions of risk assessment and risk management. The practical outcome of this was the establishment of the European Food Safety Authority (EFSA). Against this background of change, it became clear that a new regulatory framework was needed for the approval of active substances and the authorization of PPPs. The draft regulation consolidates the principles of maintaining human, animal and environmental safety as set out in Directive 91/414, and it will strengthen regulatory controls in a number of respects.