Cosmetics — Good Manufacturing Practices (GMP): Guidelines on Good Manufacturing Practices
The international Good Manufacturing Practices standard for cosmetics — guidelines on the production, control, storage, and shipment of cosmetic products. It is the global cosmetics-GMP baseline (referenced by the EU Cosmetics Regulation and endorsed via ICCR), and in the US it is expected to inform the mandatory GMP regulations FDA must establish under MoCRA.
What this does not cover
stated in the document's own scope- Covers GMP for cosmetics manufacturing, control, storage, and shipment; it does not address product safety assessment or the ingredient-safety and labelling rules of cosmetics law.
- Is guidance on GMP, not a general quality management system standard — that role is ISO 9001.
- Does not cover research and development of new cosmetic products, which fall outside its stated scope.
- Provides the manufacturing-quality baseline, not the market-authorisation or product-notification requirements set by each jurisdiction.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ISO 22716:2007 gives guidelines on Good Manufacturing Practices for cosmetics. It describes the practical, organisational, and operational controls for the production, control, storage, and shipment of cosmetic products, addressing personnel, premises, equipment, raw and packaging materials, production, finished products, the quality-control laboratory, treatment of out-of-specification product, waste, subcontracting, deviations, complaints and recalls, change control, internal audit, and documentation. It translates general GMP principles into the cosmetics context, aiming to ensure product quality and consumer safety, and it is written as guidance on how a cosmetics operation should be run rather than as a certifiable set of pass/fail clauses.
Scope & applicability
Manufacturing, control, storage, and shipment of cosmetic products; addresses product quality rather than personnel safety or environmental aspects.
Legal basis & how it acquires force
ISO 22716 is a voluntary international consensus standard; on its own it imposes no legal obligation. It acquires force by reference in cosmetics law. The EU Cosmetics Regulation (EC) No 1223/2009 requires manufacture in compliance with GMP and points to the harmonised standard EN ISO 22716 as giving a presumption of conformity. It is also endorsed internationally through the International Cooperation on Cosmetics Regulation (ICCR). In the United States, the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 directs FDA to establish mandatory cosmetics GMP, and ISO 22716 is the recognised reference expected to inform that rulemaking.
Document structure
| Part | Covers |
|---|---|
| Personnel | Organisation, training, hygiene and health, and visitors |
| Premises and equipment | Design, layout, maintenance, cleaning and sanitation of facilities and equipment |
| Materials and production | Raw and packaging materials, water, production operations, and identification and handling of bulk and finished product |
| Finished products and laboratory | Release, storage, shipment, returns, and the quality-control laboratory and testing |
| Out-of-specification, waste, subcontracting | Treatment of nonconforming product, waste handling, and control of subcontracted operations |
| Deviations, complaints, changes, audit, documentation | Deviations, complaints and recalls, change control, internal audit, and the documentation system |
Key requirements
- Apply GMP across personnel, premises, equipment, and materials
- Control production and in-process steps with defined responsibilities
- Operate quality control including out-of-specification handling
- Maintain documentation and product traceability
Implementation tips
- Use ISO 22716 as your GMP baseline ahead of FDA’s MoCRA cosmetic-GMP rulemaking
- Stand up adverse-event recordkeeping now — MoCRA makes it a US obligation
- Right-size the system to product risk; cosmetics GMP is proportionate, not pharma-heavy
Revision notes
Published 2007 and widely adopted; its prominence grew with the US MoCRA (2022), which directs FDA to establish mandatory cosmetic GMP expected to align with ISO 22716.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
ISO 22716 is the global cosmetics-GMP baseline. In Europe it is the harmonised standard (EN ISO 22716) supporting the GMP requirement of the Cosmetics Regulation (EC) No 1223/2009; internationally it is endorsed through ICCR as the common reference for cosmetics manufacturing quality; and it is positioned to inform the mandatory US cosmetics GMP that FDA must establish under MoCRA. It complements, rather than duplicates, general QMS standards such as ISO 9001.
ISO 22716:2007: frequently asked questions
Quick answers to common questions about ISO 22716:2007.
What does ISO 22716 cover?
Good Manufacturing Practices for cosmetics — the production, control, storage, and shipment of cosmetic products, including personnel, premises, equipment, materials, production, the quality-control laboratory, subcontracting, complaints, recalls, change control, and documentation.
Is ISO 22716 legally required?
The standard is voluntary, but it is referenced by cosmetics law. The EU Cosmetics Regulation (EC) No 1223/2009 requires GMP and points to EN ISO 22716 for a presumption of conformity, and in the US it is the recognised reference expected to inform the mandatory GMP FDA must set under MoCRA.
How does ISO 22716 relate to MoCRA?
The Modernization of Cosmetics Regulation Act (2022) directs FDA to establish mandatory GMP for cosmetics. ISO 22716 is the internationally recognised cosmetics-GMP standard expected to inform that rulemaking, though the binding US requirement is the FDA regulation itself once issued.
Is ISO 22716 the same as ISO 9001?
No. ISO 22716 is cosmetics-specific GMP guidance focused on manufacturing quality and consumer safety. ISO 9001 is a general quality management system standard. They are complementary but distinct.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.