Table of contents
Why conduct cosmetic audits?
A cosmetic audit is an essential instrument for assessing compliance with the requirements of Regulation (EC) No 1223/2009 and quality standards such as ISO 22716 (GMP). Regular audits allow cosmetic manufacturers and distributors to identify risks, monitor quality, and confirm compliance with regulatory obligations under EU law.
Types of audits in the cosmetics industry
- Third-party audit – an independent evaluation of processes and compliance at subcontractors or suppliers,
- Product Information File (PIF) audit – verification of compliance with Article 11 and Annex I of Regulation (EC) No 1223/2009,
- Labelling and marketing claims audit – verification of label and marketing content compliance with Article 20 of Regulation (EC) No 1223/2009.
Scope of the audit
The audit typically covers:
- acceptance and control of raw materials,
- production process flow,
- final control and storage conditions,
- completeness of the Product Information File (PIF),
- compliance of labelling and marketing materials,
- implementation of GMP principles in accordance with ISO 22716.
Most common nonconformities identified during audits
- Lack of PIF updates after formula modification,
- Inconsistency between INCI composition on the label and in the safety data sheet,
- Incorrect product labelling (e.g., missing minimum durability date),
- Marketing claims not supported by required documentation,
- Deficiencies in the implementation of Good Manufacturing Practice (GMP).
What does the audit report include?
The audit report includes:
- a description of the audit scope,
- an assessment of compliance with legal and standard requirements,
- identification of nonconformity areas,
- indications of areas requiring verification,
- a summary of the overall level of compliance.
