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.