General Approaches and Procedures for Pesticide Legislation

Abstract

The use of synthetic chemicals such as plant protection products (PPPs or ‘pesticides’), especially in the last 60–70 years, greatly contributed to an impressive progress in the availability of food to an increasingly numerous mankind. However, the long-term consequences of the deliberate and unavoidable dispersion of these chemicals into the environment were long overlooked and generated health consequences to professional applicators, to bystander general population and to food consumers. An increased awareness of the potential threats of uncontrolled use of substances of poorly known toxicity led to a substantial change in the approach, gradually resulting into an improved legislation in Western Europe and in other developed countries, to the point that today licensed PPPs are among the substances of which the chemical and toxicological properties are best known, much before their introduction into the market and even better than requested for human pharmaceutical drugs. We will trace the pathway which leads to the birth of new PPPs and to their authorization according to the legislation of the European Union. In particular, while active substances are licensed for use in a ‘positive list’ at EU level, the different formulations suitable for use on different cultivations are authorized for the different geographical areas of EU with a ‘mutual recognition’ procedure between member States. Protection of agricultural workers, of consumers, of the environment are embedded into the authorization procedure by requesting that targeted studies run under normalized conditions are conducted prior to marketing. Several chemical and toxicological parameters which are pivotal to risk assessments towards humans, non-target plants and animals are measured and health-based safety levels are established for agricultural workers, for bystanders, for the general population, for the residual presence of the active substance and of its decomposition products in food and in natural drinkable water. For enhanced safety, authorization is released in 10-year periods, in order that unexpected harmful consequences for man and environment can be timely examined and, in case, tackled. The financial cost of this procedure is, of course, not without consequences. Since authorizations are issued in 10-year periods and are subject to voluntary rejuvenation by the licensees, there is a pressure to invest in newer, more profitable active substances rather than to keep into market older ones, which may be as efficient and cheaper, but for which the faintest evidence of health or environmental hazard may prematurely terminate corporate interest. The genesis of EU legislation will be discussed and examples will be brought to highlight key issues.