EFFCI-ZERTIFIZIERUNGSSYSTEM KOSMETIK-GMP

Cosmetic GMP: Changes in the new version of the EFfCI certification system

Dr. Thijs Willaert

Dr. Thijs Willaert is Global Director Sustainability Services.
Oct 19 , 2017
# Consumer goods & HPC

In September 2017, the European Federation of Cosmetic Ingredients EFfCI released a new version of the EFfCI certification system. In this article, we summarize for you what certified companies should pay attention to when switching to the new version.

Since its initial publication in 2005, the EFfCI Standard has been revised four times. The most recent revision was prompted by the publication of ISO 9001:2015, on which the EFfCI Standard is based on. Although the harmonization of the EFfCI system with ISO 9001:2015 brings some changes, the consequences for certified sites are limited.

Timeline

We recommend that sites certified to the 2012 version of the EFfCI system migrate to the new version as soon as possible in order to have completed the transition before the end of 2018. This is because on January 1, 2019, all certificates under the 2012 version will lose their validity.

The switch can be made as part of either a surveillance or recertification audit.

Major changes

  • Like ISO 9001:2015, the new standard places a lot of emphasis on the context of the organization and interested parties
  • In the new version, it is a requirement to have an independent quality department
  • By integrating the standard and the guidance document, it has become more reader-friendly
  • The new standard emphasizes the need to have all the resources needed to successfully implement GMP requirements
  • If activities that are relevant to quality are outsourced, they must comply with GMP requirements
  • Any special storage conditions must be identified on product labels
  • The standard now includes a definition of the term "significant changes", which must be communicated
  • Certified sites must define the retention period of reserve samples
  • The scope of the certification scheme has been extended to logistics service providers. Using Appendix F, companies providing transportation or warehousing services can determine which requirements are relevant to them and which can be excluded
  • A sampling procedure is now possible for companies with multiple locations
Author
Dr. Thijs Willaert

Dr. Thijs Willaert is Global Director Sustainability Services. In this role, he is responsible for the entire ESG service portfolio of DQS. His areas of interest include sustainable procurement, human rights due diligence and ESG audits.

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