EFfCI GMP简介
The quality of cosmetic ingredients is critical to assure the safety, quality and efficacy of cosmetic
products and related personal care products. Cosmetic ingredients have a wide range of applications and
are essential components of the cosmetic product formulation. Therefore, applying appropriate good
manufacturing practice (GMP) principles to cosmetic ingredients is essential.
EFfCI is a European trade association representing the chemical and natural ingredient industries, the
suppliers and service providers for the cosmetic industries. EFfCI was set up in 2000 to represent the
collective interests of more than 100 cosmetic ingredient companies in Europe.
The idea underlying this definition of GMP for Cosmetic Ingredients is to provide manufacturers with a
tool for implementing an appropriate and workable GMP system.
The authors would very much appreciate comments as input in the further development of this document.
This is the fifth edition of this document.
The original document was issued in 2005 and updated in 2008 (when details of the certification scheme
and standard were added), aligned with ISO 9001:2008 in 2010 and comprehensively amended following
collaboration with the French cosmetic manufacturing association, FEBEA when the opportunity was
taken to introduce quality risk management approaches to aid the implementation of suitable GMP
principles to chemical synthesis and related manufacturing processes.
The inclusion of the Certification Scheme in 2008 allowed cosmetic ingredient suppliers to provide
independent certification in order to show that their products have been prepared in accordance with the
EFfCI GMP Guide. Certification requires the supplier to hold a valid ISO 9001 Certificate which covers
at least all of the activities in the manufacture and supply of cosmetic ingredients.
In this version, there has been a comprehensive and complete review and revision of the Guide and
Standard, including the alignment to ISO 9001:2015, a new side-by-side presentation of the GMP Guide
and Standard (―CI-GMP‖) and a revision of all the Appendices. The previous Appendix D has been
incorporated into the main text.
In addition, this document has been revised in collaboration with a team of experts from the Personal
Care Products Council (PCPC) in order to ensure the GMP criteria are relevant globally.
This ensures that this edition of the GMP for cosmetic ingredients reflects the most recent version of the
standard ISO 9001 and provides the best basis for Certification to the GMP for Cosmetic Ingredients
worldwide.