ISO 22716 and GMP: what a cosmetics file needs.
Every cosmetic product must be made under good manufacturing practice. The law presumes it when manufacture follows EN ISO 22716, and the product information file holds a statement saying so. This guide covers the article, the standard, the statement and what an authority checks.
Reviewed by Oğuzhan Eker, M.Sc. Chemist · Last reviewed
01/Article 8
Is GMP a legal duty? Yes. The standard is how you show it.
Article 8 makes good manufacturing practice a duty for every cosmetic product. Following the harmonised standard gives a presumption of conformity; it is not the only way to comply.
Article 8
The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1. […] Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
| Market | The standard behind the presumption |
|---|---|
| European Union | EN ISO 22716:2007 Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. First published in the Official Journal in Commission communication 2011/C 123/04 (OJ C 123, 21.4.2011, p. 3). |
| Great Britain | Great Britain presumes conformity under “designated standards”; notice 0003/21 designates EN ISO 22716:2007. |
| Türkiye | Article 11 of the Cosmetic Products Regulation sets the same rule and points to the same standards: those whose references are published in the EU Official Journal. |
The duty sits with the product. A brand that has its products made by a contract manufacturer still answers for GMP through its Responsible Person, who needs evidence from the manufacturing site.
02/The standard
What does ISO 22716 cover? Making the product, not designing it.
ISO 22716 is a short international standard: first edition November 2007, 21 pages, confirmed again by ISO in 2022. Its full text is sold by ISO and national standards bodies, so we describe it only from ISO’s own summary.
It gives guidelines for the production, control, storage and shipment of cosmetic products.
It covers the quality aspects of the product.
It does not, as a whole, cover the safety of the people working in the plant, nor protection of the environment.
It does not apply to research and development, nor to the distribution of finished products.
ISO is the source for these four lines: ISO 22716:2007 on iso.org. For what each clause asks, read the standard itself; we do not paraphrase a text we cannot quote.
03/In the PIF
What does the GMP part of the PIF look like? A method and a statement.
Article 11(2)(c) names the manufacturing part of the product information file. Two things, kept up to date like the rest of the file.
Article 11(2)(c)
How the product is made
A description of the method of manufacturing: the process steps in order, usually as a flow chart from raw materials to filled pack.
That it is made under GMP
A statement on compliance with good manufacturing practice under Article 8, from the site that makes the product.
What usually backs the statement
A GMP certificate from a certification body, or the manufacturer’s own declaration of conformity with EN ISO 22716. The Regulation asks for the statement; it does not ask for a certificate.
The statement describes the site, so it changes when the site changes: a new contract manufacturer, a second filling line elsewhere, or a certificate that has expired.
04/Inspection
What does an authority check? The file, then the site.
The Regulation gives the authority two routes to GMP. Both start from what the Responsible Person can produce.
Checks run through the product information file, so the method and the GMP statement come first (Article 22).
Authorities also monitor compliance with the principles of good manufacturing practice, which can mean the manufacturing site itself (Article 22).
Where GMP is not met, the authority can require corrective action, withdrawal or recall within a set time limit (Article 25).
A certificate on file helps only if it names the site that actually makes the product and is still valid on the day it is asked for.
05/In Unique Alphabet®
Where does the GMP evidence live? In the product’s file.
Unique Alphabet® keeps the documents; it does not audit sites or issue certificates. The GMP statement sits in the same file as the safety report it supports.
- The GMP certificate or declaration, the flow chart and the test reports go into the product’s file in PIF Files.
- Each document is uploaded with its version and expiry date; a new version archives the old one instead of deleting it.
- You are reminded 30 days before a document expires.
- The safety report section takes either a draft made in the platform or a CPSR you upload.
Questions about GMP.
Is ISO 22716 certification mandatory?
No. Article 8 requires good manufacturing practice; following EN ISO 22716 gives a presumption of conformity. The Regulation asks for a GMP statement in the product information file, not for a certificate.
Does Unique Alphabet issue ISO 22716 certificates?
No. We do not audit manufacturing sites or sell certificates. PIF Files keeps the GMP certificate or declaration, the flow chart and the test reports in each product’s file, with versions and expiry reminders.
Who provides the GMP statement when a contract manufacturer makes the product?
The manufacturing site, since it describes how that site works. The Responsible Person keeps it in the product information file and answers for it.
Which edition of ISO 22716 applies?
ISO 22716:2007. It is the first edition, and ISO confirmed it again in 2022. The EU reference is EN ISO 22716:2007, and Great Britain designates the same standard.
GMP evidence in every product file.
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