Novel probiotics and prebiotics: road to the market

作者：Kumar Himanshu; Salminen Seppo^*; Verhagen Hans; Rowland Ian; Heimbach Jim; Banares Silvia; Young Tony; Nomoto Koji; Lalonde Melanie

来源：Current Opinion in Biotechnology, 2015, 32: 99-103.

DOI：10.1016/j.copbio.2014.11.021

Novel probiotics and prebiotics designed to manipulate the gut microbiota for improving health outcomes are in demand as the importance of the gut microbiota in human health is revealed. The regulations governing introduction of novel probiotics and prebiotics vary by geographical region. Novel foods and foods with health claims fall under specific regulations in several countries. The paper reviews the main requirements of the regulations in the EU, USA, Canada and Japan. We propose a number of areas that need to be addressed in any safety assessment of novel probiotics and prebiotics. These include publication of the genomic sequence, antibiotic resistance profiling, selection of appropriate in vivo model, toxicological studies (including toxin production) and definition of target population.

• 出版日期2015-4