ISO 22716 · Cosmetics

ISO 22716 — Good Manufacturing Practice for cosmetics

For cosmetics placed on the EU market, good manufacturing practice is not the manufacturer's choice — the regulation itself requires it, and ISO 22716 is the way to prove it.

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ℹ️ ISO 22716 is Good Manufacturing Practice (GMP) for cosmetics. For the EU market, compliance with GMP is a legal obligation, while the certificate is voluntary — so the only voluntary part is having someone confirm what you must have anyway.

What is ISO 22716?

ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetic products. It governs what decides product safety but does not show on the label: premises and material flow, staff hygiene, equipment and its cleaning, receipt and control of raw materials and packaging, and batch management from order to shipment.

A separate part covers complaints, deviations and product recalls — the ability to determine from a batch number what went into it and where it went, and to recall it. That is also what inspectors check first. The standard is often implemented together with ISO 9001, because GMP covers production and 9001 the rest of the business.

When is ISO 22716 required?

In the manufacturing, packaging, testing and storage of cosmetics. For placing products on the EU market, the Cosmetic Products Regulation requires production under good manufacturing practice, and ISO 22716 is the standard used as the reference for it.

Regardless of the regulation, the certificate is requested by distributors, retail chains and companies that order private-label production — for them it is the fastest proof that you make their product properly.

Road to certification

Everything revolves around the batch: knowing what is in it, who made it and where it went:

Premises and flowsProduction zoning, separation of material and people flows, hygiene regime and conditions on the premises.

StaffResponsibilities, health requirements, hygiene and training — with records that confirm it.

EquipmentMaintenance, cleaning and, where needed, equipment qualification and calibration of measuring instruments.

Raw materials and packagingReceipt, inspection, storage and supplier evaluation, including packaging that comes into contact with the product.

Production and controlBatch records, in-process control, sampling and release of the finished product.

Complaints and certificationHandling deviations, complaints and recalls, internal audits and the certification audit.

Who issues the certificate

The certificate is issued by an accredited certification body and it is voluntary. Compliance with good manufacturing practice, however, is also checked by the market surveillance authority, whether or not you have a certificate. The obligations of whoever places the product on the EU market — the responsible person, the product information file and product notification — remain theirs, and the certificate does not replace them.

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Scope of our support

Setting up the plant

Zoning, flows and hygiene regime set up according to what you actually produce.

Batch documentation

Production, control and release records, with traceability to the raw material and supplier.

Suppliers and packaging

Criteria for supplier evaluation and incoming inspection, including packaging.

Recalls and complaints

A recall procedure that can be carried out within hours, and a drill that proves it.

Related standards

ISO 9001 covers the rest of the company, ISO 22000 and HACCP are required if you also make food products alongside cosmetics, and ISO 14001 covers waste and solvents from production.

Industries where this standard is most often required:

ISO 22716 training

Training for production teams in the cosmetics industry — hygiene and flows, batch records, raw material control and the product recall procedure. Delivered at your premises, online or as a combination of both.

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ISO 22716 — frequently asked questions

Is ISO 22716 mandatory?

The certificate itself is not. For the EU market, production under good manufacturing practice is mandatory, and ISO 22716 is the standard by which that practice is most often established and demonstrated.

What is a product information file and who is the responsible person?

These are obligations under cosmetics legislation for whoever places the product on the EU market: a designated responsible person and a file with data on the product, its safety and its manufacture. ISO 22716 covers the production part of that story.

Can it be done together with ISO 9001?

Yes, and that is how it is usually done — documentation, training and internal audits are shared, so implementing both is cheaper than one after the other.

How much does ISO 22716 cost?

It depends on the size of the plant, the number of production lines and the current state of the premises and documentation. Send a short description of your production for an indicative quote.

📋 Check the exact price for your organisation →

The EU, the US and other markets

ISO 22716 is the same standard wherever you certify it — what differs is the designation, the accreditation behind the certificate and what your customers ask for.

In the European Union the standard is adopted with an EN prefix, and what your buyer in the Netherlands, Germany or France looks at is not the prefix but the accreditation behind the certificate: a body accredited by a signatory of the international recognition arrangement (Global Accreditation Cooperation, formerly IAF) is recognised in other markets too. What EU partners and EU regulation expect is on the page about the EU market.

For companies with customers in the United States — supplier audits, security questionnaires and how ISO sits alongside SOC 2 — see the page about the US market.

Wherever your customer is, we run the project remotely in English — over Teams, WhatsApp or Viber, with documentation and records in English — and on site when that is easier.

Some of our references

More than 400 organisations in Montenegro and the region have gone through implementation with us — from banks and public bodies to manufacturing, IT, laboratories and hospitality.