NSF/ANSI 455-3 was developed to promote good manufacturing practices for cosmetics.
Part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the new law overhauling FDA’s regulatory powers and rules for cosmetic products in the U.S., requires the agency, by December 2024, to establish good manufacturing practices (GMP) requirements for facilities that manufacture or process cosmetic products distributed in the U.S. In June, FDA hosted a virtual listening session to gather opinions on how FDA should develop regulations to establish these GMPs. One of the topics of the listening session was whether any national or international standards already exist that “would be practicable for good manufacturing practices regulations for cosmetic products.” (For more on the changes MoCRA enacts, read this article.) During the listening session, standards-writing body NSF International (NSF: Ann Arbor, MI) suggested that FDA adopt NSF/ANSI 455-3, the American National Standard for Good Manufacturing Practices for Cosmetics.
When determining what course to take in setting an official federal GMP standard for cosmetics, and when deciding whether an existing standard could work, FDA notes that it will be considering “whether there are specific items in the standard which are perceived to be burdensome or for which a less-burdensome alternative exists that would protect the public health and ensure that cosmetic products are not adulterated.” It will also be considering whether a standard offers “sufficient flexibility within good manufacturing practices for cosmetic products to ensure regulations are practicable for all sizes and types of facilities to which such practices may apply.” The agency also noted that regulations should “not impose undue economic hardship.” Namely, it states, “To what extent are manufacturers of cosmetic products already following a national or international standard for good manufacturing practices? For manufacturers of cosmetic products that are not currently following such a national or international standard, what would it cost to implement good manufacturing practices consistent with such a standard?”
The NSF/ANSI 455-3 standard was developed in 2018 in partnership with a consortium of retailers and manufacturers known as the Global Retailer and Manufacturer Alliance (GRMA). “The result is an American National Standards Institute (ANSI)–accredited standard that includes both ISO 22716:2007, the international standard for cosmetics GMP, and the FDA Draft Guidance for Cosmetic GMP. NSF/ANSI 455-3 provides a platform for national participation and control, and follows ANSI’s essential requirements for due process, including openness, balance, and consensus," NSF stated in a press release. The standard addresses cosmetic compliance both internationally and domestically.
“We have the solution,” said Katherine Fillinger, senior manager of global certification for NSF, in the press release. “NSF/ANSI 455-3 is the existing GMP standard with the greatest utility to maximize benefits and minimize limitations. It has the versatility and national control to meet current and future needs of consumers, manufacturers, and regulators, domestically and globally.”
NSF emphasizes the flexibility of NSF/ANSI 455-3 to suit a variety of manufacturer processes and situations. The standard can also be changed in an inclusive way that NSF says prevents a singular interest from overpowering others, with the process requiring formal discussion between parties, ensuring “voting interests are balanced between industry, public health, and users of the standard.” It notes that “substantial consensus” is required to make changes. Furthermore, NSF points out, changes can be made quickly as needed, “quicker than regulation.”
Overall, says NSF, adopting NSF/ANSI 455-3 as the federal GMP standard for cosmetics in the U.S. would be a more cost-efficient alternative for FDA rather than building a unique new federal standard from the ground up. “In summary, due to continuous management practices of NSF as a standard-writing body, NSF/ANSI 455-3 is the only public standard that can still easily be modified to meet any rulemaking criteria prior to the compliance deadline,” it concluded.