GMP Cosmetics ISO 22716: Good Manufacturing Practices for Cosmetics
The GMP reference for cosmetic manufacturers in the EU under Regulation 1223/2009. IgeraIndustria answers on PIF, CPSR, CPNP, safety assessment and cosmetic regulatory compliance.
Reg. 1223
EU Regulation 1223/2009 on cosmetic products: the base law requiring ISO 22716 GMP compliance in the EU.
PIF
Product Information File: mandatory technical dossier for each cosmetic product on the EU market, retained for 10 years.
CPNP
Cosmetic Products Notification Portal: mandatory pre-market notification in the EU for any cosmetic product.
Frequently asked questions — GMP Cosmetics ISO 22716
Is ISO 22716 mandatory for cosmetic manufacturers in the EU?
EU Regulation (EC) 1223/2009 on cosmetic products requires manufacturers and distributors to follow cosmetic GMP, making specific reference to ISO 22716:2007 as the reference standard. Although compliance with ISO 22716 is not a mandatory certification (unlike medicines), the standard is the legal reference that manufacturers must follow and that competent authorities use to assess compliance during inspections. Not following ISO 22716 can result in the product not being available on the EU market. Voluntary certification by an accredited body is a way of proactively demonstrating compliance.
What is the PIF (Product Information File) and what must it contain?
The PIF (Product Information File) is the technical dossier that the manufacturer or responsible person must maintain for each cosmetic product placed on the EU market under Regulation 1223/2009 (Article 11). It must contain: product and packaging description, CPSR (Cosmetic Product Safety Report) signed by a qualified assessor, description of the manufacturing method and GMP compliance declaration (ISO 22716), evidence of the effect claimed for the product, serious undesirable effect data, and animal testing data. The PIF must be available for 10 years after the last batch is marketed.
What is the CPSR and who can sign it?
The CPSR (Cosmetic Product Safety Report) is the cosmetic product safety report required by Regulation 1223/2009 (Annex I). It consists of two parts: Part A (cosmetic product safety information: composition, physicochemical properties, microbiological quality, impurities, packaging, normal and reasonably foreseeable use, product exposure, substance exposure, toxicological profile) and Part B (cosmetic product safety assessment: safety conclusion, warnings, scientific justification). It can only be signed by a qualified cosmetic product safety assessor: they must hold a university degree in pharmacy, toxicology, medicine, biochemistry or a similar discipline with equivalent training.
What is CPNP and when is notification mandatory?
CPNP (Cosmetic Products Notification Portal) is the European Commission cosmetic product notification portal. Before placing a cosmetic product on the EU market, the responsible person must notify it on the CPNP (Article 13 of Regulation 1223/2009). The notification includes: product category, name and physical state, country of marketing, responsible person details, and for products containing nanomaterials or CMR ingredients, additional information. CPNP notification is prior to marketing and its absence is a direct infringement of the Regulation. In the event of a product withdrawal, this must also be notified on CPNP.