CEN/ISO 22716:2007 – Presumption of Conformity with Cosmetic GMP in Europe
Prepared between 2002 and 2006 by ISO Technical Committee 217, Working Group 6, the ISO standard 22716:2007 was published in November 2007.
While being an international standard, ISO 22716:2007 was adopted by the European Committee for Standardization (CEN) to become also a European Harmonized Standard (as published in the Official Journal of the European Union on April 21st 2011 – 2011/C 123/04) in reference to the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.
ISO 22716:2007 provides guidelines for the production, control, storage and shipment of finished cosmetic products. However, it is not aimed at covering the quality aspects of the product, the personnel engaged in the manufacturing site or the protection of the environment.
Given its structure, the standard may be divided to the following sections:
- Introduction & definitions
- Premises & equipment
- Manufacturing process
- Deviations, complains & recalls
Evidence on Good Manufacturing Practices (GMP) is one of the essential elements when building up a Product Information File (PIF) of a Cosmetic product in conformity with the New Cosmetic Regulation, EC 1223/2009.
CEN/ISO 22716:2007 was initiated to support the evidence of conformity with Good Manufacturing Practices on Cosmetic product aimed for the European Market(as well as other international markets), thus supporting their market entry and free circulation within the European Union;