ISO 22716
The international standard for cosmetics Good Manufacturing Practices (GMP), providing guidelines for the production, control, storage, and shipment of cosmetic products. Compliance with ISO 22716 creates a presumption of GMP conformity under the EU Cosmetics Regulation.
ISO 22716:2007 (Cosmetics — Good Manufacturing Practices — Guidelines on Good Manufacturing Practices) is the internationally recognized standard for cosmetic GMP. Published by the International Organization for Standardization, it provides comprehensive guidelines covering all aspects of cosmetic product manufacturing.
The standard addresses: personnel (training, hygiene, health), premises (design, maintenance, cleaning), equipment (design, installation, calibration, maintenance), raw materials and packaging materials (procurement, receipt, storage, quality control), production (operations, packaging, labeling), finished products (storage, release, shipment), quality control laboratory (sampling, testing, out-of-specification results), waste management, documentation (procedures, records, specifications), and internal audits.
Under the EU Cosmetics Regulation (EC 1223/2009), compliance with ISO 22716 is recognized as meeting the GMP requirement. The Official Journal of the European Union published the harmonized reference to ISO 22716 in 2011 (2011/C 123/04), creating a formal presumption of conformity.
ISO 22716 certification is obtained through accredited third-party auditors and is increasingly expected by regulators, retailers, and brand partners worldwide. In the US, the FDA has indicated that its forthcoming cosmetic GMP rules under MoCRA will likely align with ISO 22716.
Related Terms
Good Manufacturing Practices (GMP)
A system of guidelines ensuring cosmetic products are consistently produced and controlled according to quality standards. MoCRA requires FDA to establish cosmetic GMP regulations; in the EU, compliance with ISO 22716 is presumed to satisfy the GMP requirement of EC 1223/2009.
RegulationEU Cosmetics Regulation (EC 1223/2009)
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
RegulationModernization of Cosmetics Regulation Act (MoCRA)
A US federal law (Public Law 117-328, Title XXXV) signed on December 29, 2022, that gives the FDA new authority over cosmetics including mandatory facility registration, product listing, adverse event reporting, safety substantiation, and recall authority.
DocumentProduct Information File (PIF)
A mandatory dossier required under EC 1223/2009 (Article 11) that the Responsible Person must maintain for each cosmetic product on the EU market. It contains the CPSR, product description, manufacturing method, GMP evidence, and claims substantiation.
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