The new certification program seeks to support compliance, safety, and quality in worldwide supply chains.
In a January 15, 2025, news release, Eurofins Healthcare Assurance network of companies announced a new good manufacturing practices (GMP) certification program, noting the expanding growth and demand for wellness products in the US1. The new program will be for dietary and food supplements and its aim is to help manufacturers, brands, agents, and retailers achieve compliance, increase consumer confidence, and show a commitment to quality.
The program covers 21 CFR 111/117 and NSF/ANSI 455-2-2024 standards, and as noted on the Eurofins Assurance website, supplements exported to or sold within the US are required to be GMP compliant, as per the 21 CFR part 111 and portions of 21 CFR 117 US federal regulations2. This applies regardless of where the supplement was made.
Based on the needs specified by their customers and stakeholders, Eurofins Healthcare Assurance’s certification program participants can choose between two technical scopes of certification1,2. The program is a combination of a quality management audit and process certification, assessing product types and manufacturing capabilities onsite. The program is in compliance with ISO 17065 standards for impartial conformity assessment2. After completing the program, participants will receive a GMP certificate and license to use Eurofins marks.
The Eurofins Assurance network extends to Asia, Africa, Europe and South America, offering support for compliance and performance improvement across industries’ supply chains.
References
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