In previous decades, the safety of many probiotics available to consumers was based on knowledge of their long history of safe consumption in humans. However, the scope of probiotics is expanding to include non-traditional strains of probiotics, which may offer health benefits but are often absent from food sources and with no history of safe use. whole.
A group of industry and government scientists convened under the auspices of the US Pharmacopeia Probiotics Expert Panel recently began reviewing current approaches to evaluating safety of probiotics from a scientific perspective, while also looking at what regulators are currently asking.
Article, recently published in Toxicological and pharmacological regulationsummarizes scientific frameworks for evaluating the safety of probiotics used in food and dietary supplements, including the importance of comprehensive genomic characterization. The article questions the value of animal testing for human probiotics. Furthermore, the paper examines emerging technologies for safety testing as well as how manufacturing practices play an important role in the safety of the final product.
Recognizing that regulatory approaches to bioproducts While safety varies greatly around the world, the article focuses on scientifically significant methods for safety assessment. Risk levels for probiotics are determined, based on available information on the history of safe use. For strains recognized by the competent authorities as having a sufficient history of safe use and whose genomes are free of genes of concern, no additional testing is recommended. But if there’s a gene of concern or a lack of a history of safe use, additional testing is needed. Safety of genetically modified probiotics or probiotics used as drugs is not covered in this article.
Dr. Mary Ellen Sanders, Executive Scientific Director of the International Scientific Association for Probiotics and Prebiotics (ISAPP), and co-author of the paper, commented: “Current situation, with countries different criteria have different criteria for demonstrating the safety of the same probiotic strain, which is not ideal.This article calls for a more harmonized regulatory approach to probiotic safety, based on sound scientific principles.”
Sanders said that although probiotics in foods and supplements are widely used and have a good safety record, establishing the safety of improved strains may require more extensive testing before launched.
Amy Roe, Principal Toxicologist, Product Safety & Regulatory Affairs, Procter & Gamble Company, led the writing effort. “We hope that this review, which includes the use of modern technologies and methods, will provide helpful recommendations for completing a comprehensive safety assessment of a microbe,” she said. helpful.”
Amy L. Roe et al., Considerations for determining the safety of probiotics: USP Perspectives, Toxicological and pharmacological regulation (2022). DOI: 10.1016/j.yrtph.2022.105266
Provided by the International Scientific Association for Probiotics and Prebiotics
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