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VOL. 10, ISSUE 4 (2025)
Evolution of nitrosamine regulations: Lessons from pharmaceuticals applied to food safety management
Authors
Mehulkumar Bhupendrabhai Patel, Dr. Anjum Usmani
Abstract
Nitrosamines have
emerged as a critical global concern in both pharmaceutical manufacturing and
food safety due to their carcinogenic and genotoxic potential. This article
examines the evolution of regulatory frameworks designed to control nitrosamine
contamination, highlighting lessons learned from the pharmaceutical sector and
their relevance to food safety management. The review outlines key
contamination incidents that triggered regulatory responses, explores the role
of advanced analytical techniques in detection, and evaluates the development
of international guidelines by bodies such as the EMA, FDA, and WHO.
Furthermore, the analysis emphasizes cross-sector differences in regulatory
philosophy, acceptable intake thresholds, and incident response mechanisms, while
also underscoring the opportunities for harmonization. By integrating Good
Manufacturing Practices (GMP) from pharmaceuticals with Hazard Analysis and
Critical Control Points (HACCP) in food systems, the paper argues for a unified
framework to strengthen public health protection. Future directions call for
global alignment of standards, investment in sensitive detection methods, and
bridging research gaps concerning chronic exposure and interaction effects.
This integrated approach can ensure more consistent, transparent, and
science-driven management of nitrosamine risks across industries.
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Pages:97-107
How to cite this article:
Mehulkumar Bhupendrabhai Patel, Dr. Anjum Usmani "Evolution of nitrosamine regulations: Lessons from pharmaceuticals applied to food safety management". National Journal of Multidisciplinary Research and Development, Vol 10, Issue 4, 2025, Pages 97-107
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