Cosmetics factories selling in the GCC work to ISO 22716:2007 for good manufacturing practice, which the Gulf adopted as GSO 2020:2010. Their products must also meet two Gulf technical regulations approved on 1 May 2024: GSO 1943:2024 for safety, labelling and packaging, and GSO 2528:2024 for claims.
This guide is for quality managers and regulatory staff at cosmetics manufacturers and brand owners that supply GCC markets.
Which standards and regulations apply to a cosmetics maker in the GCC?
Two kinds of document apply, and they work differently. ISO standards are voluntary until a regulator or customer requires them. Gulf technical regulations are mandatory once a member state adopts them.
In practice a GCC cosmetics site combines a GMP standard for the factory, technical regulations for the product, and often ISO 9001 for the management system. The table shows the editions in force at the time of writing.
| Document | Edition in force | What it covers | GCC status |
|---|---|---|---|
| ISO 22716 | 2007, confirmed 2022 | GMP for production, control, storage and shipment | Adopted as GSO 2020:2010 (current). GSO ISO 22716:2008 is historical |
| ISO 22715 | 2006, confirmed 2022 | Packaging and labelling of cosmetic products | Adopted as GSO ISO 22715:2008 (current) |
| GSO 1943 | 2024, edition 4 | Safety requirements, labelling and packaging of cosmetics and personal care products | Gulf technical regulation. Replaced the 2021 edition |
| GSO 2528 | 2024, edition 2 | Criteria for acceptable product claims | Gulf technical regulation |
| ISO 15378 | 2017 plus Amd 1:2024 | GMP for primary packaging of medicinal products | Not a cosmetics standard |
| ISO 9001 | 2026, edition 6 | Quality management system requirements | Voluntary. The 2015 edition is withdrawn |
What does ISO 22716 cover, and what does it leave out?
ISO 22716 gives guidelines for producing, controlling, storing and shipping cosmetic products. It deals with product quality. It does not cover the safety of factory staff or protection of the environment, which remain the company's legal duties.
Two activities are outside its scope: research and development, and distribution of finished products. A brand owner that only designs and sells products will therefore look to its contract manufacturer's GMP rather than its own.
The 2007 edition is still current. According to the ISO 22716 page on iso.org, ISO confirmed it again in December 2022 after a systematic review. In the Gulf, the current adoption is GSO 2020:2010, approved on 31 March 2010. Our ISO 22716 guide covers the GMP requirements in more detail.
What do GSO 1943:2024 and GSO 2528:2024 require?
GSO 1943:2024 is the core product regulation. It sets general safety requirements and parameters, plus labelling and packaging requirements, for all cosmetics and personal care products. Annex 1 gives an illustrative list of the products it covers. Edition 4 replaced the 2021 edition, which GSO now lists as historical.
GSO 2528:2024 sets the criteria for claims. Its scope warns that a product making unacceptable claims may fall outside the cosmetics category altogether. So a claim can change which rules apply to a product, not just what goes on its label.
Labelling also draws on GSO ISO 22715:2008, the Gulf adoption of ISO 22715:2006. That standard itself notes that national regulations can be stricter on several points, so the technical regulation wins where they differ.
Each member state adopts these regulations under its own reference. Saudi Arabia, for example, cites them as SFDA.CO/GSO 1943 and SFDA.CO/GSO 2528.
What does the SFDA check at a Saudi cosmetics factory?
Saudi Arabia shows how the pieces fit together in practice. The SFDA cites the Cosmetic Products Law and its executive regulation under Royal Decree M/49 of 18/6/1436 AH.
The SFDA's investor guide for cosmetics manufacturers sets the licence steps. The site needs a qualified technical manager and a named person responsible for quality. SFDA inspectors visit, and the manufacturer may not start work until it holds a GMP certificate. Licences run for five years, renewal is due six months before expiry, and products are listed in the SFDA electronic system.
The SFDA's guidance on designated conformity assessment bodies (August 2024) shows what those bodies check. They assess the product information file against SFDA.CO 6000. They also apply the SFDA lists of banned and restricted ingredients, colourants, preservatives and UV filters. A GMP certificate is accepted as the minimum quality system, and GMP audits follow ISO/IEC 17021 against ISO 22716.
Other GCC states run their own registration and inspection systems. Confirm the current rules with the regulator in each market you supply.
Does ISO 15378 apply to cosmetics packaging?
Not directly. ISO 15378:2017 sets GMP requirements for primary packaging materials for medicinal products. ISO confirmed it in 2023 and added a climate action amendment in 2024.
A cosmetics maker can borrow its approach when qualifying suppliers of bottles, jars and closures that touch the product. It is not a cosmetics standard, and a cosmetics regulator will not ask for it. Our ISO 15378 guide explains who it is written for.
Where does ISO 9001 fit after the 2026 revision?
ISO 9001 is optional for a cosmetics site, but many combine it with ISO 22716 so that one system covers management review, risk, audits and improvement. ISO published ISO 9001:2026 in September 2026, and iso.org now lists the 2015 edition as withdrawn.
Certification bodies report that certificates to the 2015 edition must move to the 2026 edition by 30 September 2029. Confirm the dates with your own certification body. Our ISO 9001:2026 transition guide sets out the changes.
How AGS can help
The IMS Cosmetics kit contains 53 editable Microsoft Word documents. It includes an integrated quality and GMP manual and policy, 16 procedures, and 20 forms such as batch manufacturing and packaging records and a product information file index. Its 6 checklists include ISO 22716 GMP and GSO safety, labelling and claims checklists. The kit's ISO 9001 content follows the 2015 edition.
Frequently asked questions
Is ISO 22716 certification mandatory in the GCC?
It depends on the country. In Saudi Arabia, the SFDA's investor guide says a manufacturer cannot operate until it holds a GMP certificate. Other GCC states set their own requirements.
Do imported cosmetics have to meet GSO 1943?
Yes, in markets that adopt it. In Saudi Arabia, for example, conformity certificates for imported cosmetic consignments are assessed against SFDA.CO/GSO 1943 and SFDA.CO/GSO 2528.
What is a product information file?
It is the technical file kept for each cosmetic product, with data such as its formula and safety assessment. In Saudi Arabia, designated conformity assessment bodies assess it against SFDA.CO 6000.
Which standards cover halal cosmetics?
Halal cosmetics follow separate standards such as GSO 2055-4:2021. Our halal cosmetics guide compares them.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by ISO, the GCC Standardization Organization or the SFDA. They do not guarantee any registration, inspection or certification outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
