ISO 22716 Explained: GMP for Cosmetics

ISO 22716 at a Glance

Cosmetics have no GFSI-style benchmark. When a retailer, brand owner or EU importer wants independent evidence that a cosmetics plant runs under Good Manufacturing Practices, the common reference point is ISO 22716: published in 2007, and the EU's harmonised GMP standard since 2011.^[1][2]

• 17Clauses, from scope and personnel through documentationISO 22716:2007
• 2007Year published; reviewed and confirmed in 2022, so the 2007 edition is currentiso.org
• 2011Year EN ISO 22716 was published as the EU's harmonised GMP standardOJ 2011/C 123/04
• Nov 2027FDA's current target to propose cosmetic GMP rules under MoCRA2026 Unified Agenda

Sources checked as of November 3, 2026, against ISO's catalog record, the EU cosmetics regulation, the U.S. statute and rulemaking agenda, and Kiwa ASI's program page.

What Is ISO 22716?

ISO 22716's full title is Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices. ISO technical committee TC 217, the committee for cosmetics, published it in November 2007 (with a corrected English version in May 2008), and ISO's five-year reviews have confirmed it since; the last review, in 2022, kept the 2007 edition current. It is a compact document: 21 pages covering the whole path from raw material receipt to shipment of finished product.^[1]

Two things make it different from the management-system standards most quality teams know. First, it is cosmetics-specific: the guidance is written for the hygiene, batch, packaging and laboratory realities of a cosmetics plant rather than for any industry. Second, it is a guideline: the clauses say "should," not "shall," and each major section opens with a principle describing what the controls are meant to achieve. An audit against ISO 22716 checks whether your site's practices accomplish what each clause describes.^[1][6]

The scope has clear edges. The guidelines cover the quality of the product, not worker safety or environmental protection, and they do not apply to research and development or to distribution of finished products.^[1]

What Do the 17 Clauses Cover?

The standard runs to 17 clauses. Clauses 1 and 2 set the scope and definitions; clauses 3 through 17 carry the guidance.^[1][6]

Clause titles condensed from the standard's table of contents. The ISO 22716 certification page walks through what an auditor checks under each clause.

If you have run a food plant under GMP, the territory is familiar: people, premises, equipment, materials, production control, laboratory, nonconforming product, complaints, change control, internal audit and documentation, tuned to cosmetics.^[6]

Is ISO 22716 Mandatory?

No. No law in any major market requires an ISO 22716 certificate. What the law requires varies by market, and that difference is exactly why the standard matters:

The practical summary: in the EU, GMP is mandatory and EN ISO 22716 is the recognized way to show it. In the U.S. and Canada, GMP for cosmetics is today a matter of adulteration law, customer requirements and, in the U.S., coming regulation rather than a published federal GMP rule. A U.S. manufacturer selling into the EU meets the EU requirement through its Responsible Person's Product Information File, and an independent audit report backs up that file's GMP statement.^[3][6]

What Does MoCRA Mean for Cosmetics GMP?

MoCRA, the Modernization of Cosmetics Regulation Act of 2022, is the biggest change to U.S. cosmetics law since 1938, and most of it is already in force. Facility registration and product listing have been enforced since July 1, 2024. Responsible persons must hold records substantiating the safety of each product, serious adverse events must be reported to the FDA within 15 business days, and the FDA now holds records-access and mandatory-recall authority.^[9][6]

The GMP piece is the part still to come. The statute tells the FDA to write cosmetic GMP regulations that are consistent, to the extent practicable, and appropriate, with national and international standards, and to include simplified requirements and possibly longer timelines for smaller businesses.^[4] ISO 22716 is not named in the law, but it is the international cosmetics GMP standard the FDA has already worked from once: the agency's 2013 draft guidance says it reviewed ISO 22716 and decided which aspects to incorporate, modify or exclude.^[7]

For everyone else, the practical question is what to build against while the rule is pending. Building your GMP system on ISO 22716 now means working to the international cosmetics GMP standard the FDA has already drawn on once, and the same system EU customers already expect.^[7][6]

How Does ISO 22716 Compare With Other Standards?

ISO 22716 vs. GMP. They aren't rivals: GMP is the discipline, and ISO 22716 is the international document that spells out what GMP means for cosmetics. When a customer asks a cosmetics plant for "GMP," ISO 22716 is usually the concrete answer.^[6]

ISO 22716 vs. ISO 9001. ISO 9001 is a generic quality-management-system requirements standard for any industry; ISO 22716 is a cosmetics-specific GMP guideline about the plant itself, from receiving to shipment. They complement each other, and neither replaces the other.^[1]

ISO 22716 vs. FDA drug cGMP. In the U.S., some products sold as cosmetics are also drugs, such as sunscreens, antiperspirants, anti-dandruff shampoos and fluoride toothpastes. Those must meet FDA's drug cGMP regulations regardless of any cosmetics standard.^[6]

Retailer audit programs. Retailer-driven cosmetics programs build on the same foundation: NSF/ANSI 455-3, the GRMA cosmetics audit standard, lists ISO 22716 and FDA's draft GMP guidance as normative references, so a system built on ISO 22716 maps to what those audits check.^[11]

How Does Certification Work?

Certification is an independent, third-party audit of your site against the standard, clause by clause, ending in an audit report and, where the site meets the criteria, a certificate. Companies pursue it when an EU importer, retailer or brand-owner customer asks for independent evidence of GMP, or to prepare for FDA's coming GMP rules. One independent report can also be shared with several customers, which can reduce the number of second-party audits a plant hosts.^[6]

• Cosmetics manufacturers making skin care, hair care, color cosmetics, fragrances and personal care products
• Contract manufacturers showing GMP to the brands they make product for
• Fillers and packagers, where line clearance, batch coding and packaging controls carry the risk
• Brand owners that outsource manufacturing and want their contract manufacturer's GMP independently verified
• U.S. exporters to the EU, whose Product Information File needs a GMP statement behind it

Two things to confirm. ISO 22716 itself doesn't set a certificate term; each certification program does, and many issue three-year certificates with annual surveillance audits, so confirm the term and schedule when you get a quote. And Kiwa ASI's ISO 22716 audit is an independent third-party audit that isn't covered by ASI Food Safety, LLC's ANAB accreditation, which is for SQF and CanadaGAP.^[6]

1. 01Get the standardISO 22716 is purchased from ISO or a national standards body; it is a 21-page document.
2. 02Map your operations to the 17 clausesWalk your site against each clause, from personnel and premises through documentation, and close the gaps you find. How long preparation takes depends on how much of your GMP system is already documented.
3. 03Build the recordsTraining records, specifications, batch documentation, lab results, complaint files and internal audits are what the auditor reads.
4. 04Book the auditAudit length depends on your facility, products, processes and scope, and is confirmed in your quote.

The ISO 22716 certification page covers the audit criteria clause by clause, the cost lines and who it fits, and is where to start if customers are already asking.^[6]

Frequently Asked Questions