Iain Moore

GMP Working Group Chair
EFfCI | Belgium

Vincenzo P.M. Rialdi

GMP Working Group Member
EFfCI | Belgium

Regulation

Cosmetic ingredients are a fundamental link in the cosmetic supply chain and their quality assures the safety of the finished cosmetic products.

EFfCI GMP is today the only certifiable Quality Standard for the production and the distribution of cosmetic ingredients.

The EFfCI GMP Certification Scheme celebrates 10 years of suppliers applying the principles of GMP to manufacture and distribution of cosmetic ingredients. The Scheme is an instrumental, effective, and successful part of the assurance of cosmetic ingredient quality. With over 220 certificates in more than 30 countries it is now also a truly global Standard.

The original EFfCI GMP Guide for cosmetic ingredients was first published in 2005. This was inspired on the very well-known and adopted IPEC-PQG Good Manufacturing Practice Guide for Pharmaceutical Excipients. By basing the Guide on pharmaceutical GMPs the highest assurance of product Quality was in-built, and one that had as its prime focus on consumer safety. As cosmetic ingredients are often manufactured by chemical synthesis, and this industry had already implemented Quality management systems based on ISO 9001, it was decided to align the EFfCI GMP Guide to the ISO 9001 clause structure to aid implementation. Through all the subsequent revisions of the Guide that alignment has remained.

Once issued the Guide was well received and many suppliers soon started asking for certification by independent third parties to demonstrate they had adopted the GMPs in their operations. Hence the creation of the EFfCI Certification Scheme in 2010 to include an auditable Standard.

The EFfCI GMP Guide, Standard and Certification Scheme is free to use and access (see www.effci.org) and is globally recognized and used. Growth in certification has been very steady throughout the past 10 years. Once suppliers have certification, they retain it and only stop being certified when there is a major change to their organization, such as a takeover or site closure.

Since 2010, as the graph illustrates, growth has been steady but is now accelerating. Not only are suppliers adopting certification but more and more cosmetic manufacturers are recognizing the value of a certified EFfCI GMP supplier and are requiring this certification as part of their supplier approval processes.

For cosmetics manufacturers the benefits of choosing a supplier with EFfCI GMP certification include:

• The supplier meets an independently audited and world-wide, Quality Standard;
• A common Standard of Quality Management Systems (QMS) and operations across all suppliers with EFfCI GMP;
• Knowing that end-user requirements and expectations are addressed.

For cosmetics ingredients manufacturers (suppliers), the benefits of certification to EFfCI GMP include:

• Operating to a Standard that addresses risks and controls specific to cosmetics ingredients and their markets with relevant requirements;
• Operating to a common Standard that adds onto ISO 9001:2015 and so requires little change to the QMS;
• Being scalable to suppliers of all sizes;
• Operating to a Standard that is widely accepted by cosmetics manufacturers;
• Operating to a Standard that ensures consistent and objective Auditor interpretations.

The EFfCI Certification Scheme Audits are conducted by well-known 3^rd party Certification Bodies (CBs), often the same ones that issue ISO 9001 certificates. These CBs sign a legal agreement with EFfCI to implement the rules behind the Certification Scheme which includes training the Auditors in EFfCI GMPs. These auditors also have to be registered with EFfCI. Once the CBs sign up and have trained Auditors, they can then perform Audits on cosmetic ingredient suppliers and issue GMP Certificates and EFfCI GMP Audit reports.

A cosmetic ingredient supplier desiring to be certified should directly contact an EFfCI registered Certifying Body among those listed on the EFfCI website. Also, here you can confirm an EFfCI Certificate and or Audit report as being compliant to the EFfCI GMP Scheme rules. Certified suppliers are recommended to share not only the Certificate but also the audit reports with their customers.

At the time of the pandemic, with travel so restricted or impossible, to have a credible reliable and high-quality Certification Scheme in place has been essential to the continued supply of cosmetic ingredients which are safe for consumers. The EFfCI GMP Certification scheme has certainly come of age in the past two years.

And now, EFfCI is working on a new Standard, fully aligned with the GMP one, on Industrial Ecology. This is a highly relevant subject which consists of Green Engineering and Green Chemistry with the objective to ensuring cosmetic ingredients are made using more sustainable chemical transformations and processes and aligned with the Circular Economy. After all, we all have the duty to respect our planet and put into practice consequent virtuous behaviors starting from our industrial activities.

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