ISO 22716: cosmetics GMP from raw material to complaint
In the EU, following ISO 22716 gives a presumption of GMP conformity. It also gives US brands a sound basis while FDA's rule is pending.
In Short
- Every material has a status: quarantined, released or rejected.
- Out-of-specification product is investigated and decided by authorised people.
- Changes that affect quality are approved first.
The Cosmetics Manufacturing Guide
The right formula. Stable batches. Traceable jars.
- MoCRA, EU 1223/2009 and Canada
- Formulas, water and materials
- Phases, bulk tests and microbiology holds
- Filling, codes, complaints and recall
Plus Evidence map and four worksheets.
Get the cosmetics guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
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The Cosmetics Manufacturing Guide
The right formula. Stable batches. Traceable jars.
ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products. It is a voluntary standard. In the EU, Article 8 of Regulation (EC) 1223/2009 requires cosmetics to be manufactured in line with good manufacturing practice, and compliance is presumed when manufacture follows the relevant harmonised standard, which is EN ISO 22716. In the US, MoCRA requires FDA to set cosmetic GMP rules, which were not final when we checked on 2 Oct 2026. The standard text is sold by ISO and was not reproduced here.
What the standard covers
ISO's public summary says the standard gives guidelines for the production, control, storage and shipment of cosmetic products. It typically covers areas such as personnel, premises, equipment, materials, production, finished products, the quality control laboratory, out-of-specification product, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation.
More on what the standard covers
ISO's summary says it covers product quality but not staff safety or environmental protection, and does not apply to research and development or distribution of finished products.
People and Premises
Responsibilities are defined and people are trained for their tasks, including hygiene. Premises are designed, cleaned and maintained to protect product, with separate or defined areas for storage, production, quality control and washing.
More on people and Premises
Equipment is suitable, cleaned and calibrated where measurement matters.
Materials and Production
Raw materials and packaging are bought against agreed specifications, received with checks, identified and given a status (quarantine, released or rejected). Each production batch follows written instructions; materials are weighed and checked, and the batch is documented and identified.
Material status: what each means
- Cannot be used until checks are complete.
More on materials and Production
Bulk and finished products are controlled so mix-ups cannot happen.
Release, deviations and out-of-specification
Finished products meet acceptance criteria before release, and release is done by authorised people. Out-of-specification results are investigated and a decision on rework or rejection is made and recorded by authorised people.
Worked Example: Viscosity Out of Specification
- Day 0Lotion batch LB-207 viscosity above the upper limitQC
- Day 0Batch kept in quarantine; investigation openedQA
- Day 2Cause: thickener added at the wrong temperature; deviation recordedQA, production
- Day 3Authorised person approves rework under a documented procedureQA manager
- Day 5Rework retested within specification; batch releasedQA manager
More on release, deviations and out-of-specification
Deviations from instructions are documented with justification and, where needed, corrective action.
Complaints, recalls, change control and audit
Complaints are reviewed and investigated, recalls are possible quickly through batch records, changes that could affect quality are approved before implementation, and internal audits check the GMP system. These are the areas where documented evidence, rather than intent, decides how an audit goes.
Questions
Is ISO 22716 mandatory in the EU?
Regulation 1223/2009 Article 8 requires GMP. Following EN ISO 22716, the harmonised standard, gives a presumption of conformity. Companies can meet GMP another way, but must show it.
Does ISO 22716 apply in the US?
It is voluntary in the US. MoCRA requires FDA to issue cosmetic GMP rules, which were not final when we checked on 2 Oct 2026. Many companies use ISO 22716 meanwhile.
What does ISO 22716 not cover?
ISO's public summary says it covers product quality, not staff safety or environmental protection, and does not apply to research and development or to distribution of finished products. Product safety assessment is a separate requirement under EU Regulation 1223/2009.
Can ISO 22716 be certified?
ISO 22716 is a guideline. Third-party certification bodies offer audits against it, which some customers ask for, but it is not an ISO management system certification like ISO 9001.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global Cosmetics Regulatory Readiness: EU, UK, US, ISO 22716
EU Fragrance Allergen Labelling: Regulation 2023/1545 Readiness
Cosmetic Microbiological Quality (ISO 17516) Readiness Guide
Cosmetic Stability and Preservative Efficacy (ISO 11930)
EU Cosmetics Regulation 1223/2009: Responsible Person, Safety Report, PIF and CPNP
MoCRA Guide: US Cosmetics Registration, Listing, Adverse Events and GMP Status