ISO 22716 — Cosmetics: good manufacturing practice (GMP)
ISO 22716 sets out guidelines on good manufacturing practice (GMP) for cosmetics. Serbia has adopted it as SRPS EN ISO 22716:2011.
It isn’t a management system standard like ISO 9001: it doesn’t ask for context, a policy or objectives, but covers the production process itself — people, premises, equipment, raw materials, production, the finished product, the laboratory, waste and complaints.
Why it matters, and what the law requires
Cosmetic products come into direct contact with human skin, so their safety is essential. Applying ISO 22716 helps companies minimise the risk of contamination, mistakes and nonconformities in production. Regulation (EC) No 1223/2009 requires cosmetics to be made according to good manufacturing practice. ISO 22716 is the harmonised standard that makes this obligation easiest to demonstrate — applying it gives a presumption of conformity. The standard itself and certification against it are not legal requirements; GMP is, and you can demonstrate it in other ways too.
Who it is for
ISO 22716 is used by manufacturers of cosmetic products and by suppliers of raw materials, packaging and services related to the cosmetics industry. Because it also covers storage and shipment, it can be applied by warehouses and by companies that pack or label products; the standard itself excludes research and development and the distribution of finished products.
How it is implemented
- A gap analysis of your current production against GMP requirements.
- Defining responsibilities, hygiene rules and procedures.
- Preparing the documentation (protocols, records, checks, procedures).
- Training staff and carrying out internal audits.
- The certification audit, and maintaining the system through continual improvement.
What changes in daily work
- Every batch has a record showing who produced it, when and from what.
- Raw materials and packaging are released to production only after the required checks.
- Equipment is cleaned between batches to a set procedure, and each clean is recorded, so cross-contamination can be ruled out with evidence.
- Deviations are recorded and dealt with by procedure, rather than settled by word of mouth.
- A complaint is linked to a batch, so a recall can be limited instead of covering everything.
How long implementation takes
Implementing ISO 22716 usually takes 30 to 90 days. Exactly how long depends on the size of the organisation, the number of employees and how much of the above is already in place. On your side, for small and medium-sized organisations it takes 2 to 5 hours a week in total, spread across several people — more on this in our frequently asked questions.
What affects the price
Three things affect the cost of implementation:
- the size of the organisation;
- the number of employees;
- the standard being implemented.
For ISO 22716, what weighs most is the number of production lines and the number of formulations. We can only give an exact price after you get in touch and we have a short conversation about the scope.
Frequently asked questions
Is ISO 22716 a legal requirement?
No. What is required is manufacturing according to good manufacturing practice. In Serbia this is laid down by the Law on General Use Products (Zakon o predmetima opšte upotrebe) and the Regulation on Cosmetic Products (Pravilnik o kozmetičkim proizvodima, Official Gazette of the RS No. 60/2019), fully applicable since 11 April 2023 and aligned with Regulation (EC) No 1223/2009. ISO 22716 is the standard that makes this obligation easiest to demonstrate, but you can demonstrate it in other ways — and even then, certification against the standard isn’t required.
How does it differ from ISO 9001?
ISO 9001 covers the management system — context, policy, objectives and management review. ISO 22716 covers the production process itself and asks for none of those, although it does include internal audits. They can be implemented together when both the system and evidence of manufacturing practice are needed.
Does it apply to contract fillers and contract manufacturers?
It applies to anyone involved in manufacturing, packing, testing, storing and shipping cosmetics — so to contract manufacturing and filling plants as well. The contract sets out who does what and who keeps which records.
Does the standard require a dedicated laboratory?
It requires quality control to exist, with defined methods and records. Whether testing is done in-house or in a contracted laboratory isn’t prescribed — what is prescribed is that the result can be demonstrated.
What about the product safety documentation?
The EU Regulation, and the Serbian Regulation on Cosmetic Products that follows it, require a product information file with a safety report; that is a separate requirement from GMP. The file must include a description of the manufacturing method and a statement of compliance with GMP, so the records kept under ISO 22716 feed straight into it.
General questions — cost and duration, who issues the certificate and how long it is valid — are covered in our frequently asked questions.
Related standards
- ISO 13485 — medical devices; the same logic of demonstrating compliance with regulations, for a different kind of product.
- ISO 9001 — quality management systems; the framework above the manufacturing practice itself.
- Chemicals and biocides — raw materials used in cosmetics are also subject to chemicals legislation — classification, labelling and safety data sheets.
How STANDARDISO can help
We guide you through the whole process — from comparing your current production with GMP requirements, through the documentation for batches, cleaning and quality control, to staff training and preparation for the audit. The certificate is issued by an independent, accredited certification body. Everyone on our team works in English, and we can prepare your documentation in English, Serbian or both.