ISO 22716: What Cosmetic GMP Means for Your Skincare Brand
ISO 22716 is the international guideline for good manufacturing practice (GMP) in cosmetics. It covers how cosmetic products are produced, controlled, stored and shipped, not how they are formulated. ISO does not certify anyone; independent certification bodies audit factories against it. In the EU, it is the harmonized standard for the GMP the Cosmetics Regulation requires.
Almost every cosmetics manufacturer lists "ISO 22716" on its website. Ours does too. So you see the badge everywhere and still cannot tell what it means, whether your market requires it, or how to check it is real. This guide answers those questions from the buyer's side.
What is ISO 22716?
ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products. Its full title is "Cosmetics, Good Manufacturing Practices (GMP), Guidelines on Good Manufacturing Practices."
It is a set of guidelines. It gives guidance on the human, technical and administrative factors that affect product quality.
The 2007 edition is the current one. The only later change was a 2008 correction, so "the latest version" is still ISO 22716:2007.
It is specific to cosmetics. It is a cosmetic GMP standard, not a general one.
For a brand, the useful view is this: ISO 22716 describes how your manufacturer should run the plant that makes, checks, stores and ships your product.
What ISO 22716 covers, and what it does not
The standard covers the quality aspects of the product inside the manufacturing operation: production, control, storage and shipment.
It does not cover:
Research and development activities
Distribution of finished products
Safety of plant personnel
Protection of the environment
What ISO 22716 does not do for you
A manufacturer working under ISO 22716 is a strong starting point, but the certificate does not do these jobs for your brand:
It does not approve your formula. The standard is about manufacturing practice, not whether a formula is safe or suitable.
It does not prove your claims. "Brightening", "hydrating" or any other claim needs its own support.
It does not replace stability and preservative testing. Those are separate tests run on your specific formula and packaging. Our guide to cosmetic stability testing explains what they involve.
It does not file your product with regulators. Product listings and notifications with FDA, Health Canada or the EU portal remain the brand's job, ideally with your manufacturer's help. Our compliance guide for selling skincare in the US, Canada and EU walks through each market.
The clauses that matter to a brand
ISO 22716 is organized into these clauses: scope; terms and definitions; personnel; premises; equipment; raw materials and packaging materials; production; finished products; quality control laboratory; treatment of product that is out of specification; wastes; subcontracting; deviations; complaints and recalls; change control; internal audit; and documentation.
Eight of them shape your experience as a buyer. For each, here is what it means in practice and what to ask.
1. Raw materials and packaging materials
In practice: incoming ingredients and components are checked and approved before they are used.
Ask: "How are raw materials and packaging approved before they go into my batch?"
2. Production
In practice: each batch follows defined instructions and is recorded, so it can be traced later.
Ask: "What batch documentation will I receive with each order?"
3. Finished products and quality control laboratory
In practice: finished goods are tested and released against specifications before they ship.
Ask: "Will I get a certificate of analysis (COA) for every batch?"
4. Out of specification and deviations
In practice: there is a set process when a result falls outside specification or a step does not go to plan.
Ask: "What happens to a batch of my product that fails a test?"
5. Subcontracting
In practice: any outsourced step should be controlled to the same standard.
Ask: "Is any step of my product outsourced, and is that site covered too?"
6. Complaints and recalls
In practice: the manufacturer has a way to log complaints and trace and recall a batch.
Ask: "If a customer reports a problem, how do we trace the batch together?" This matters in the US, where under MoCRA the responsible person (the manufacturer, packer or distributor named on the label) keeps adverse event records and reports serious adverse events. If that is your brand, you need your manufacturer's batch records to do it.
7. Change control
In practice: changes to materials, suppliers or processes are assessed before they happen.
Ask: "Will you tell me before a raw material or supplier changes on my product?"
8. Internal audit and documentation
In practice: the plant checks itself and keeps written records of what it does.
Ask: "Can I see your certificate, with the issuing body, scope and expiry date?"
Is ISO 22716 mandatory?
It depends on where you sell.
In the EU
Under the EU Cosmetics Regulation (Regulation (EC) No 1223/2009, Article 8), the manufacture of cosmetic products must comply with good manufacturing practice. Compliance is presumed when manufacture follows the relevant harmonized standards, and EN ISO 22716 is that harmonized standard.
In plain terms: GMP is a legal requirement in the EU, and ISO 22716 is the recognized way to show you meet it. The compliance guide covers the other EU steps, such as product notification.
In the US
The Modernization of Cosmetics Regulation Act (MoCRA) requires FDA to establish GMP regulations for facilities that manufacture cosmetic products. As of 2026, FDA has not yet proposed that rule, and it has moved the GMP rule to its long-term actions list.
What exists today is FDA's cosmetic GMP draft guidance, revised in June 2013. It is non-binding. It drew on ISO 22716:2007 and covers documentation, records, buildings and facilities, equipment, raw materials, production, internal audits, laboratory controls, complaints, adverse events and recalls.
So ISO 22716 is not a US legal requirement today. Two other MoCRA duties do apply now: manufacturers and processors must register their facilities with FDA and renew every two years, and the responsible person handles adverse event records and reporting. Our MoCRA explainer covers those duties in more detail.
One more point that trips people up: FDA registers facilities and product listings. It does not approve cosmetics.
ISO 22716 vs ISO 9001
These two standards are often listed together, and they do different jobs.
ISO 22716 is a GMP guideline specific to cosmetics manufacturing. It focuses on the product: how it is made, controlled, stored and shipped in the plant.
ISO 9001 is a general quality management system standard that any organization can use, in any industry. It focuses on how the business manages quality as a system.
They complement each other, and certifiers can combine cosmetic GMP audits with ISO 9001 audits. Hong Shin holds both ISO 22716 and ISO 9001.
How ISO 22716 certification works
ISO writes the standard. It does not perform certification or issue certificates. Certification is done by external, independent certification bodies, which audit a manufacturing site against the standard.
That has a practical consequence. Any claim of being "certified by ISO" is a misunderstanding at best. A real ISO 22716 certificate names the independent body that issued it and the site it covers.
As a buyer, your focus is simple: is the certificate real, current, and does it cover the place that will make your product?
How to check a manufacturer's ISO 22716 claim
Asking for certificate numbers and verifying them is good practice. This five-point checklist goes further.
Who issued it? The certificate should come from an independent certification body. If it says it was issued by "ISO", ask more questions.
Which site does it cover? Note the site address and company name on the document.
Is that the site that will make your product? Ask where your batches will be made.
When does it expire? Check the date on the certificate and ask for the renewed one when it passes.
What documents come with each order? At minimum, ask whether a certificate of analysis comes with every batch, and what batch records you can request.
For more supplier questions, see our list of questions to ask a cosmetics manufacturer, and our guide to choosing a skincare manufacturer with seven criteria.
Doing this early pays off. You compare manufacturers on substance rather than logos, ask for the right documents before your first run, and walk into retailer and regulator conversations with the paperwork in hand.
How we work under ISO 22716 at Hong Shin
Hong Shin is a Canadian-owned manufacturer, making products in Taiwan and South Korea. We have operated since 2012 and ship to 16 countries.
Our certifications are ISO 22716, the international good manufacturing practice standard for cosmetics, and ISO 9001 for quality management. We also hold SEDEX and BSCI, and our facility is registered with the US FDA.
Here is what that means for your product:
Every batch is made under ISO 22716 cosmetic good manufacturing practice.
A certificate of analysis (COA) is issued with every batch, so you have release data for each order.
Stability and preservative (PET) testing is done in-house before anything goes to production.
Regulatory support for Health Canada NPN and cosmetic notification, US FDA and MoCRA, EU CPNP and UK SCPN, so the filing work your brand owns does not fall on you alone.
First runs start from 1,500 units per SKU on our Taiwan lines and 3,000 units per SKU on our South Korea lines. SPF serums and cream serums are made on the South Korea lines, so they start at 3,000 units per SKU. Lead time is 10 to 12 weeks from formula sign-off.
Ask us the eight clause questions above. When you are ready, send us the brief and we will return a costed quote and specification within 5 business days.
Frequently asked questions
What does ISO 22716 stand for?
ISO 22716 is the ISO standard number for "Cosmetics, Good Manufacturing Practices (GMP), Guidelines on Good Manufacturing Practices." It gives guidance on the human, technical and administrative factors that affect product quality. The current edition is ISO 22716:2007.
Is ISO 22716 required to sell cosmetics in the US?
Not today. MoCRA requires FDA to write GMP rules for cosmetic manufacturing facilities, and as of 2026 FDA has not yet proposed them. Facility registration with FDA under MoCRA is a separate requirement that applies now.
Is ISO 22716 the same as GMP?
It is one GMP standard, and the one the EU recognizes as the harmonized standard under the Cosmetics Regulation. In the US, FDA has its own cosmetic GMP draft guidance, which is non-binding and drew on ISO 22716.
Who issues ISO 22716 certificates?
Independent certification bodies. ISO writes the standard but does not perform certification or issue certificates, so a genuine certificate names the body that audited the site.
Does an ISO 22716 certificate mean a product is safe or approved?
No. ISO 22716 covers manufacturing practice, not formula safety or product claims. FDA registers facilities and product listings but does not approve cosmetics, so formula, testing and filing remain separate steps.