The fate of biocontrol agents under the European phytopharmaceutical regulation: how this regulation hinders the approval of botanicals as new active substances

Abstract

The use of biocontrol agents (BCAs) is growing across the world and in Europe in particular, where novel ways of farming are highly encouraged and implemented. However, although the social pressure is high to increase the number of BCAs in use within the EU, the European plant protection products (PPP) regulation (EC) N°1107/2009 does not define clearly what BCAs are. Therefore, problems and drawbacks are observed throughout the whole authorisation process. Consequently, this situation impedes drastically the rapid implementation of botanical BCAs and their subsequent use in the field. Previous studies described in detail the fate of BCAs and the current administrative process that leads to their approval. Drawbacks are described for GMOs but surprisingly scarcely for pesticides. Therefore, the present study pinpoints the drawbacks of the approval process of botanical BCAs. To achieve this goal, a comparative study of 5 substances (4 of plant origin and 1 chemical) was performed. This study clearly reveals the present weaknesses and loopholes in the European PPP regulation process. The results of the present study may be useful to initiate and promote a major change in the evaluation and the regulation process of BCAs. This should allow designing a novel and innovative framework enabling the development of future plant protection products according to the sustainable use of pesticides, described in the corresponding (EC) Directive N°128/2009 (SUD). This work targets farmers, policy makers, NGOs and scientists interested in issues related to this topic. Keywords Plant protection products. Biocontrol agents. Botanicals. Active substances. Regulatory improvements Highlights • There is a strong and increasing public demand for a general use of biocontrol agents. • Unfortunately, BCAs are not clearly defined within the European plant protection products (PPP) regulation. • Although BCAs are nevertheless considered as active substances, the approval pathway is strictly identical to that for synthetic chemicals and acts as a brake for mixtures of substances, especially botanicals. • Consequently, this drawback which occurs during the regulation process is seriously hindering the implementation and the field use of botanical BCAs.

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