Each cosmetic product must be manufactured in compliance with Good Manufacturing Practices (GMP) and with Article 8 of Cosmetics Regulation EU 1223/2003. These Good Manufacturing Practices are defined in ISO 22716, an international quality standard.
The Good Manufacturing Practices are a set of guidelines under the ISO 22716 standard that ensure the reproducibility of a cosmetic product and its production quality. These measures must be respected and also apply to the production, control, storage, and shipping procedures for cosmetic products.
GMP compliance of cosmetic products is required by Cosmetics Regulation EC 1223/2003. Additionally, a declaration of compliance with the ISO 22716 standard must be submitted with the Product Information File (PIF).
Note: The GMP only concern the quality of cosmetic products and not employee safety or environmental protection.
In the framework of European standard ISO 22716, the Good Manufacturing Practices for cosmetic products have two objectives:
Consequently, applying the GMP ensures consumer product conformity and safety by limiting contamination risks (biological, particulate, and cross).
ISO 22716 sets out a number of standards for quality and reproducibility that cosmetic products must meet if they are to be sold on the European market.
This standard focuses on the production, monitoring, storage and transportation of cosmetics. It also more specifically concerns those in the cosmetics industry who are involved in these activities: finished product manufacturers, distributors, importers, and exporters.
The proper measures described in the ISO 22716 standard for compliance with the GMP concern the following areas:
Application Scope of the Good Manufacturing Practices
To obtain a declaration of conformity with the Good Manufacturing Practices, it is necessary to comply with all of the measures listed in the ISO 22716 standard and whose references are published in the OJEU C123/3 of 21 April 2011.
To validate compliance with the ISO 22716 standard, the cosmetics facility must implement an internal audit using a specialised service provider.
The GMP diagnosis and audit may be performed by the responsible person, a third party or an external firm.
Although there is no official certification body for the ISO 22716 standard, the standard is nevertheless mandatory and subject to strict rules.
Once the certificate of compliance has been obtained, it must be added to the cosmetic product’s Product Information File (PIF).
Steps to GMP Compliance: