GMP – ISO 22716 certification*, why?

Regulation (EC) 1223/2009 relating to cosmetic products came into force on July 11, 2013 throughout Europe. It repeals Directive 76/768/EEC (of July 27, 1976).It is called “cosmetic regulation”.One of the pillars of this new cosmetic regulation is compliance with Good Manufacturing Practices (GMP). The corresponding article states:

“Article 8: Good Manufacturing Practices.

1. The manufacture of cosmetic products complies with good manufacturing practices in order to guarantee the objectives of Article 1.

2. Compliance with Good Manufacturing Practices is presumed when manufacturing is carried out in accordance with the applicable harmonized standards whose references have been published in the Official Journal of the European Union.”

Consequently, since July 2013 all cosmetic products circulating on the European market must be produced in compliance with GMP, described by the ISO 22716 standard.

The declaration of conformity:

The responsible person must attest to compliance with the Good Manufacturing Practices referred to in Article 8 of the cosmetic regulation.This declaration of conformity can be carried out by itself or by a third party and must be found in each DIP of each cosmetic product.

Cosmetic GMP certification

Third-party certification* has a significant commercial impact. In fact, it allows by its obtaining, to prove that the company works according to Cosmetic GMPs to international customers.

Certification obtained by third-part companies such as ATeCQ Certification, allows to initiate administrative procedures with the authorities for exports to countries outside the European Union.

*To be compliant, only the competent authorities are authorized to verify the suitability of production sites to manufacture cosmetic products and deliver an offical GMP certificate for epxort purposes. In France, it is the DGCCRF which is in charge to carry out inspections and deliver official certificate issued according to the Frech decree 2024-1250 and the associated order dated 20 february 2025 .  

GMP – ISO 22716 certification*, for whom?

The entire supply chain for cosmetic products is concerned: manufacturers of raw materials, finished products, manufacturing activities, production, control, storage and transport

GMP – ISO 22716 certification*, how?

A company that would like to enhance its compliance with the standard can contact a certification body, such as ATeCQ Certification, specialized in cosmetics, and agree on a certification audit*.

Rating:

• Perfectly and completely meets the requirements of the ISO 22716 standard = c/ 20 points
• Almost complete compliance with the required requirements: r/15 points
• Partially or weakly meets the required requirements - Minor non-compliance = m / 5 points
• Poorly meets the requirements required by the ISO 22716 standard and/or may cause a risk to the health and safety of the consumer - Major non-compliance = MAJOR / -20 points / 2 weeks to correct the non-compliance and 2 month to remove it.
• Does not meet at all the requirements required by the ISO 22716 standard and consumer health and safety risk - Non-compliance Critical = CRITICAL / -30 points and suspension or no certification.

The objective is to obtain a mark above 75% without major or criticism.

The certificate* issued is valid for 3 years, with annual monitoring.

SUMMARY OF THE CERTIFICATION PROCESS

1. Certification decision according to the ISO 22716 standard
2. Verification of correct Mandatory consideration of requirements.
3. Self-assessment of level according to the standard
4. Selection by the company of a Certification Body
5. Carrying out the Certification audit (more or less 1,5 days)
6. If successful, the Certification body sends its report + action plan + certificate
7. The audit must be renewed annually.