04438_11a - 11 Regulatory requirements in the European...

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11 Regulatory requirements in the European Union W. K. DE RAAT, I. A. VAN DE GEVEL, G. F. HOUBEN and B. C. HAKKERT 11.1 Introduction It has been realized for many decades that the use of chemical plant protec- tion products (PPPs) does not have only beneficial sides. Various adverse effects on humans and the environment may occur as well, which is not surprising, as the mode of action of PPPs is virtually always based on toxicity. Although the art of developing PPPs is very much concerned with specificity, it is often not possible to restrict completely the toxicity of PPPs to the target organism. Moreover, most PPPs are xenobiotic by nature, and may therefore have toxic effects not related with their mode of action. Exposure of non-target organisms to PPPs, including humans, cannot be ruled out completely. By reducing persistency and improving application techniques, it is attempted to minimize this exposure. However, effective control often requires a certain degree of persistency, while bringing a sufficient amount on the target is generally accompanied by some spillage. The adverse side effects of PPPs form the major impetus for the regula- tion of their use by governments. In addition there exists another, and in many countries, older impetus. The application of PPPs needs to be suffi- ciently efficacious. Farmers have to be sure that they are using a product that indeed protects the valuable crop against pests and diseases, while it does not affect the quality of the crop. When a product is allowed for use, it should perform as promised on its label. Adverse side effects and efficacy are not fully independent aspects of the regulation of PPPs. They are increasingly becoming two sides of a coin. Efficacy is often measured in terms of the amount needed for a good result. It goes without saying that the amount used is also an important aspect of the problem posed by possible side effects. On the other hand, efficacy and prevention of adverse side effects may be competitive aspects of PPP regu- lation. Very efficacious PPP applications may still not be deemed accept- able, because a less efficacious one is available, which is more acceptable as regards its environmental side effects. The regulation of PPPs is ultimately aimed at achieving a balance between efficacy and side effects which is acceptable for society.
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The regulation of PPPs has a great economic impact on agriculture, consumer and chemical industry. It strongly influences efficiency of plant production, prices of plant-derived products, and costs and risks of the development of PPPs. This, combined with its significance to the quality of human and environmental health, makes it clear that the regula- tion of PPPs is of paramount importance for society. Thus all developed countries have more or less elaborated regulatory systems. These virtu- ally always consist of a registration or authorization process. Some PPPs are allowed for well-defined applications (combinations of pests, crops
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This note was uploaded on 02/20/2010 for the course AS a taught by Professor 11 during the Spring '10 term at École Normale Supérieure.

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04438_11a - 11 Regulatory requirements in the European...

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