ISO 22716 Certification for Cosmetics GMP
This is the GMP guideline cosmetics makers are judged against in the EU and by most large retailers. Certification shows buyers your creams, shampoos, and colour cosmetics are made, tested, stored, and shipped under control. Your site is audited against the 2007 edition with senior-led audits and a fixed fee. Most sites certify in 6–12 weeks.
What Is ISO 22716 Certification?
ISO 22716 certification is an independent audit confirming that a cosmetics site follows the 2007 Good Manufacturing Practices guidelines. The auditor checks people, premises, equipment, materials, production, quality control, and records. They also check how you handle deviations, complaints, recalls, and change. A site that conforms receives a certificate, usually valid for three years with yearly surveillance.
The guideline covers the production, control, storage, and shipment of cosmetic products. It does not cover research and development, finished-product distribution, worker safety, or the environment.
The audit looks at your site on the shop floor, not just in the office. We follow real batches from raw material receipt to shipment and compare what we see with your records.
The 2007 Edition, EU Rules, and the U.S. MoCRA in 2026
The 2007 edition is current. ISO published it on 15 November 2007 through ISO/TC 217, its cosmetics committee. ISO last confirmed it in December 2022, and it is now under routine systematic review with no replacement announced.
In the EU it is the harmonised GMP standard. Regulation (EC) No 1223/2009 requires cosmetics to be made under GMP. Following EN ISO 22716 gives a presumption that you meet that duty.
In the U.S., MoCRA changed the picture. The Modernization of Cosmetics Regulation Act of 2022 requires facility registration and product listing. It also directs the FDA to write cosmetic GMP rules consistent, where practicable, with international standards. The statutory deadlines for those rules passed without final regulations.
Sources: ISO 22716:2007 (ISO) · MoCRA in 2026 (Foley)
Who Needs ISO 22716 Certification?
Any site making or filling cosmetics for buyers who check GMP before they list your products.
Skin care, hair care, colour cosmetics, and fragrance makers.
Private-label and white-label producers serving several brands.
Sites that fill, label, and pack bulk product.
Makers shipping into the EU, where GMP is a legal duty.
Brands selling through large retailers that audit suppliers.
Companies also making medicines. See ISO certification for pharma.
ISO 22716 Requirements, Topic by Topic
The guideline sets its GMP practices in clauses 3 to 17. Here is what each covers and what the auditor checks.
| Clause | Topic | What the auditor checks |
|---|---|---|
| 3 | Personnel | Roles, training, hygiene, and health rules |
| 4 | Premises | Layout, flow, cleaning, and pest control |
| 5 | Equipment | Design, calibration, cleaning, and maintenance |
| 6 | Raw and packaging materials | Purchasing, receipt, release, and storage |
| 7 | Production | Batch documents, line clearance, and in-process checks |
| 8 | Finished products | Release, storage, shipment, and returns |
| 9 | Quality control laboratory | Methods, samples, results, and retained samples |
| 10 & 11 | Out-of-specification product and waste | Investigation, rework decisions, and disposal |
| 12 | Subcontracting | Written contracts and checks on subcontractors |
| 13 & 14 | Deviations, complaints, and recalls | Investigation, records, and recall readiness |
| 15 & 16 | Change control and internal audit | Changes approved before use, and audits done |
| 17 | Documentation | Controlled, current, and retrievable records |
Because the standard is written as guidelines, auditors look for practices that achieve each aim rather than one fixed method. A small filler and a large multi-line plant can both conform, using controls that fit their size and risk. What every site needs is evidence: records that show the practice happens every time, not only on audit day.
Following a Cosmetics Batch From Receipt to Shipment
Auditors pick a recent batch and follow it through your site and your records. This one trail tests most of the guideline in a single afternoon, and shows quickly whether paperwork matches practice.
How It Compares: ISO 9001, Pharma GMP, ISO 14001, and ISO 45001
Cosmetics makers are often asked for several standards. This is what each one adds.
| Standard | Focus | How it relates |
|---|---|---|
| ISO 9001 | Quality management, any sector | Wider system; the cosmetics guideline adds GMP detail |
| Pharma GMP | Regulatory rules for medicines | Stricter; needed only if you also make drugs |
| ISO 14001 | Environmental management | Covers the environment, which the guideline excludes |
| ISO 45001 | Occupational health and safety | Covers worker safety, which the guideline excludes |
| HACCP | Food safety hazards | For edible or ingestible products, not cosmetics |
How Cosmetics GMP Certification Works
Six stages from the first call to your certificate. Our ISO certification process guide has more detail.
Have a retailer or importer deadline? Share it in the scoping review and we will plan audit dates around it.
Book a free scoping reviewCommon Cosmetics GMP Audit Findings
The gaps that most often hold up a cosmetics GMP certificate.
Documentation findings
- Batch records completed after the event
- Specifications missing for packaging materials
- Deviations logged with no investigation
- Changes made to formulas without change control
- No written agreement with subcontractors
Shop-floor findings
- Line clearance not recorded between batches
- Quarantined and released stock stored together
- Equipment cleaning status not labelled
- Water system not monitored
- Retained samples missing for shipped batches
ISO 22716 Certification Cost and Timeline
We do not publish a list price. Audit days for your scope set the fee, and you get it as one fixed figure.
What sets the audit days
- People: production, QC, warehouse, and office staff
- Sites: plants, filling lines, and warehouses
- Products: creams, liquids, powders, or aerosols
- Processes: making, filling, or packing only
- Integration: combined with ISO 9001 or 14001
How long it takes
| Proposal | Days after scoping |
|---|---|
| To certificate | Usually 6–12 weeks |
| Surveillance | Once a year |
| Renewal | Before the end of year three |
How to Choose an ISO 22716 Certification Body
What to ask, and how we answer.
| Question to ask | Accredify Global's answer |
|---|---|
| Who issues our certificate? | Your proposal names the certification body, before you commit. |
| Will you audit on the shop floor? | Yes. We follow a real batch from receipt to shipment. |
| Can buyers check the certificate? | Yes. Certificates appear on our verification page. |
| Can you combine audits? | Yes, with ISO 9001, 14001, or 45001. |
| Will you also write our procedures? | No. We do not consult, so every audit stays impartial. |
| How is it priced? | A fixed fee, set by audit days, after a free scoping review. |
Frequently Asked Questions About ISO 22716 Certification
Straight answers on the guideline, EU rules, MoCRA, cost, and timeline.
What is ISO 22716?
ISO 22716 is the international guideline on Good Manufacturing Practices (GMP) for cosmetics. It covers the production, control, storage and shipment of cosmetic products. The current edition is ISO 22716:2007.
What is ISO 22716 certification?
It is an independent audit confirming that a cosmetics site follows these GMP guidelines. A certification body checks personnel, premises, equipment, materials, production, quality control, and records, then issues a certificate if the site conforms.
Is ISO 22716 still current?
Yes. The 2007 edition was published in November 2007 and ISO last confirmed it in December 2022. It is now under ISO's routine systematic review, with no replacement announced.
Is ISO 22716 mandatory?
Not as a certificate. In the EU, Regulation (EC) No 1223/2009 requires cosmetics to be made under GMP. Following the harmonised standard EN ISO 22716 gives a presumption of conformity. Many retailers and importers also ask for certification.
Does MoCRA require ISO 22716?
MoCRA directs the FDA to set cosmetic GMP rules that are, where practicable, consistent with national and international standards. The statutory deadlines passed without final rules, so the international guideline remains the most widely used benchmark.
Who needs ISO 22716 certification?
Cosmetic and personal care manufacturers, contract manufacturers, private-label producers, fillers and packers, and companies exporting to the EU or supplying large retailers.
Does the guideline cover research and development?
No. The guideline excludes research and development, distribution of finished products, worker safety, and environmental protection. Those need other standards, such as ISO 45001 and ISO 14001.
What is the difference between ISO 22716 and ISO 9001?
ISO 9001 is a general quality management standard. The cosmetics guideline sets specific GMP practices for hygiene, production, materials and quality control. Many manufacturers hold both.
What are the main ISO 22716 requirements?
It covers personnel, premises, equipment, materials, production, finished products and quality control. It also covers out-of-specification product, waste, subcontracting, deviations, complaints, recalls, change control, internal audit and documentation.
How long does ISO 22716 certification take?
Most cosmetics sites with working GMP practices certify in 6 to 12 weeks from the first audit to the certificate. Several sites or a new quality system take longer.
How much does ISO 22716 certification cost?
The cost follows the audit days your scope needs. Headcount, number of sites, product types and processes set the audit days. A free scoping review gives you a tailored, fixed-fee proposal.
How long is a cosmetics GMP certificate valid?
Typically three years, with surveillance audits each year and a recertification audit before the certificate expires.
Can cosmetics GMP audits be combined with other audits?
Yes. It is often audited alongside ISO 9001, ISO 14001 or ISO 45001 to save time on shared topics like documents, training and internal audit.
Is accredited cosmetics GMP certification available?
Accreditation for cosmetics GMP certification varies by country and accreditation body. Your proposal names the certification body that will issue your certificate. If a buyer requires accredited certification, tell us at scoping.
Does Accredify Global help us write our GMP procedures?
No. Certification must stay impartial, so neither we nor the certification body can write your system. We can explain the guideline and the audit process.
Give Retailers and Importers GMP Proof They Trust
Tell us about your products, sites, and deadlines. We'll confirm your certification scope and send a fixed-fee proposal.
Book your free scoping review →Last reviewed by the Accredify Global certification team.