Good Manufacturing Practice (GMP) for Cosmetics: What ISO 22716 Requires

Quick Answer

Every cosmetic product placed on the EU or UK market must be manufactured in line with Good Manufacturing Practice (GMP), a requirement set out in Article 8 of the Cosmetics Regulation. The internationally recognised way to demonstrate this is compliance with ISO 22716, the dedicated cosmetics GMP standard covering personnel, premises, equipment, raw materials, production, and quality control. A GMP compliance statement is also one of the five mandatory sections of your Product Information File.

What GMP Actually Means in a Cosmetic Context

Good Manufacturing Practice is a set of practical, organisational measures designed to ensure a cosmetic product is manufactured consistently and to the same quality standard, batch after batch. It's not primarily about the finished formula's safety that's the CPSR's job but about whether the physical process producing that formula is controlled, hygienic, and repeatable, a distinction explained clearly in Article 8 of Regulation (EC) No 1223/2009, the legal source of the GMP obligation itself.

Why ISO 22716 Is the Reference Point

The Cosmetics Regulation doesn't spell out GMP requirements in exhaustive technical detail instead, it presumes compliance where manufacturing follows a relevant harmonised standard published in the EU's Official Journal, and ISO 22716:2007 is that standard for cosmetics. It was confirmed as current as recently as 2022, according to the International Organization for Standardization's own reference page, meaning brands and manufacturers can rely on it as the accepted benchmark rather than building a GMP system from scratch.

What ISO 22716 Actually Covers

The standard is organised around the practical realities of running a cosmetic manufacturing operation, addressing personnel training and responsibilities, premises design and cleanliness, equipment suitability and maintenance, control of raw materials and packaging, the production and packaging process itself, quality control testing, and the handling of finished product storage and shipment. It also extends to subcontracting arrangements, deviations from standard process, and how customer complaints and product recalls should be managed a scope the UK's own retained version of the underlying regulation, available via legislation.gov.uk, continues to reference for GB-market products.

GMP and Your Product Information File

This is where GMP compliance becomes directly relevant to your day-to-day compliance paperwork rather than an abstract manufacturing philosophy: a description of the manufacturing method and a GMP compliance statement is one of the five mandatory sections required inside every product's Product Information File. If you haven't yet reviewed exactly what else belongs in that file, our full guide to the Product Information File walks through all five required sections in detail.

Is ISO 22716 Certification Legally Mandatory?

Formal third-party certification against ISO 22716 is not, strictly speaking, a legal requirement the regulation requires GMP compliance, and following the harmonised standard is simply the most straightforward, widely recognised way to demonstrate it. A brand could, in principle, build and document an equivalent quality management system independently, but doing so means proving that system achieves the same outcomes the standard already provides a ready-made framework for, a point reinforced by industry guidance from the Cosmetic, Toiletry and Perfumery Association.

What This Means for Small and Handmade Brands

Full third-party ISO 22716 certification is often disproportionate for a small-batch or handmade cosmetic business, but the underlying GMP obligation still applies regardless of scale. In practice, this means documenting your actual process how ingredients are stored, how equipment is cleaned between batches, how staff are trained, how a batch is recorded and traceable even without pursuing formal certification, so that your PIF's GMP statement genuinely reflects a controlled process rather than an aspirational one.

Common Mistakes Around GMP Compliance

Mistake #1 — Treating the GMP statement as a formality rather than a genuine description of process. An inspection can test whether the statement matches reality, not just whether one exists on file.

Mistake #2 — Assuming small-batch production is automatically exempt. The GMP obligation applies regardless of production scale, even if the practical implementation looks different for a small operation than a large one.

Mistake #3 — Confusing GMP with the CPSR. GMP concerns the manufacturing process; the CPSR concerns the safety of the resulting formula. Both are required, but they answer different questions.

Mistake #4 — Not updating the GMP statement after a change in manufacturing location or process. If you switch co-packers or move production, the PIF's manufacturing description needs to reflect the new reality.

Practical Checklist

• Confirm your manufacturing process is documented in enough detail to support a genuine GMP statement in your PIF.
• Check that raw material and packaging control procedures are actually followed, not just described on paper.
• Review staff training records for anyone involved in production, control, storage, or shipment.
• Maintain a working system for batch traceability, deviations, and complaint handling.
• Reassess whether formal ISO 22716 certification makes sense as your production volume or market ambitions grow.
• Update your PIF's manufacturing and GMP section whenever your production location or process changes.

Frequently Asked Questions

Is ISO 22716 certification legally required to sell cosmetics in the UK or EU?

No. GMP compliance is legally required, and following ISO 22716 is the recognised way to demonstrate it, but formal third-party certification against the standard is not itself mandated by law.

Does GMP cover the safety of the finished formula?

No. GMP addresses the manufacturing process, control, storage, and shipment of the product. The safety of the formula itself is addressed separately through the CPSR.

Do small or handmade cosmetic businesses need to follow GMP?

Yes, the underlying legal obligation applies regardless of production scale, though the practical implementation and the case for formal certification will typically look different for a small operation than a large manufacturer.

Where does the GMP statement need to appear?

It forms part of the Product Information File, specifically within the section describing the manufacturing method and confirming GMP compliance.

Final Word

GMP is easy to overlook because it doesn't produce a single, dramatic document the way a CPSR does it's a background discipline that shows up in your PIF as a statement, but is actually tested by how your production process genuinely runs day to day. Building real GMP practices into your manufacturing process, whether or not you pursue formal ISO 22716 certification, is what makes that statement something you can stand behind during an inspection rather than paperwork written to look complete.

Need help documenting your manufacturing process correctly? NestQual prepares complete Product Information Files, including manufacturing and GMP sections, alongside your CPSR and notification submissions.

Get a CPSR for your product See the Complete Compliance Pack

Sources

1. European Parliament and Council, Regulation (EC) No 1223/2009 on cosmetic products, Article 8 — eur-lex.europa.eu
2. International Organization for Standardization, ISO 22716:2007 — Cosmetics: Good Manufacturing Practices — iso.org
3. UK version, Regulation (EC) No 1223/2009, as retained in UK law — legislation.gov.uk
4. Cosmetic, Toiletry and Perfumery Association (CTPA), Safety of Cosmetics — ctpa.org.uk

This article is for general information and does not constitute legal advice. Always confirm current requirements for your specific product and market with a qualified safety assessor or Responsible Person.