Regulatory Opportunities and Challenges in Commercialising Biobased Chemicals

L. Bergeson
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Abstract

The 21st Century has witnessed intense renewed interest in commercialising new biobased chemicals, defined generally to include chemicals that are derived fromplants andother renewablematerials. The Toxic Substances Control Act (TSCA) is the U.S. law that regulates industrial chemical substances, including biobased chemicals, used in applications other than food, drugs, cosmetics, and pesticides, or uses that are regulated by other federal authorities. TSCA was significantly amended in 2016, and stakeholders need now more than ever to understand how TSCA applies to biobased chemicals to appreciate the implications of new TSCA on their commercial operations. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.
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生物基化学品商业化的监管机遇和挑战
21世纪,人们对新型生物基化学品的商业化产生了浓厚的兴趣,生物基化学品通常包括从植物和其他可再生材料中提取的化学品。《有毒物质控制法》(TSCA)是美国法律,规定工业化学物质,包括生物基化学物质,用于食品、药品、化妆品和杀虫剂以外的应用,或由其他联邦当局监管的用途。TSCA于2016年进行了重大修订,利益相关者现在比以往任何时候都更需要了解TSCA如何适用于生物基化学品,以了解新TSCA对其商业运营的影响。这样做将更好地确保不间断的业务运营和一致的TSCA合规。
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