歐盟和美國微生物農藥登記程序之比較

Differences in Microbial Pesticide Registration Processes in the EU and USA

梁瑩如(Ying-Ru Liang) ； 謝奉家(Feng-Chia Hsieh)

《臺灣農藥科學》 9期 (2020/12) Pp. 21-35

https://doi.org/10.6671/TPS.202012_(9).02

摘要

農藥依其有效成分可分為化學農藥與生物農藥兩類，功用在於防治植物害蟲或病害，其中微生物製劑（microbial biological control agents, MBCAs）是指含有活體微生物的生物農藥。微生物農藥具有控制病蟲害的潛力，但由於歐盟的登記制度較複雜而提高進入歐盟市場的門檻。與之相較，美國對於微生物農藥登記的限制較少。本文的主要目的在於介紹美國與歐盟間的登記程序差異，並比較因不同登記程序所造成的影響與產生的結果。由所收集之文獻資料顯示，平均而言，在歐盟註冊一個微生物農藥需比在美國註冊多耗費1.6年的時間。在2009年歐盟針對農藥管理法規進行修正，並於2011年開始實施新規定，此舉改善了歐盟登記程序並使得登記流程顯著地縮短，因此改善登記程序可有效提升審查速率，促進微生物農藥在市場的品項增加。臺灣在近幾年也在生物農藥登記法規上逐漸鬆綁，並藉由改善登記流程期能增加微生物農藥在市場的品項。

關鍵字

微生物農藥 ； 登記 ； 法規 ； 歐盟 ； 美國

並列摘要

Microbial biological control agents (MBCAs) are biological pesticides comprise living microbes. Although MBCAs have shown potential to control pests and diseases, a number of barriers have prevented these agents from becoming widely adopted in the European Union (EU), such as regulations which are less flexible than those of the USA. The objective of this study was to compare (1) differences in biological pesticides registration process between the EU and USA and (2) the practical implications of these different registration procedures in those regions. Our findings showed that the EU biological pesticide registration process is more complex and less flexible than that of the USA. As a result, pesticide registration takes an average of 1.6 years longer in the EU than in the USA. In 2009, EU-level regulatory amendments improved active substance registration procedures, and the number of biological pesticide agents in the EU market increased. Recently, registration procedures pertaining to biological pesticides have also been amended for greater flexibility in Taiwan in order to increase the number of microbial pesticides in the Taiwanese market.

並列關鍵字

microbial pesticides ； regulation ； European Union (EU) ； USA ； Taiwan