Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics.
This regulation sets very high requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetics products circulating onto the European Market will have to be produced according to the Cosmetics Good Manufacturing Practices described by the ISO 22716 standard.
All participants in the cosmetics products chain, European and non-European, are concerned. Ingredients producers, products final assembler, distributors and importers/exporters, all actors are involved and new responsibilities have been defined.
Total support for compliance with Regulation (EC) No 1223/2009, from R&D of cosmetic products, production, distribution, through to market support.
On the 11th July 2013, the European Union (EU) Cosmetics Directive 76/768/EEC was replaced by Regulation (EC) No 1223/2009 (the “Cosmetic Products Regulation”), which harmonizes and simplifies the cosmetics regulations across the EU member states. The aim of the Regulation is to simplify procedures, streamline terminology and strengthen the regulatory framework for cosmetics with a view to ensuring a high level of protection of human health.
The Regulation states that notification must be provided to the designated competent authority prior to placing a cosmetic product on the European market and a Product Information File (PIF) for each cosmetic product must be maintained and made available upon request. Our experts have a thorough understanding of the regulatory requirements needed to successfully document safety, manufacturing information, and label information to support the marketing of a cosmetic product in Europe.
THE COSMETICS GOOD MANUFACTURING PRACTICES
Cosmetics Good Manufacturing Practices are a set of hands-on advice, operational rules and organizational guidelines especially focused on human, technical and administrative factors affecting product quality.
The objective of the GMP is to define the activities which lead to the final product corresponding to the expected specifications, and therefore product safety.
ISO 22716 is the standard describing the Cosmetics Good Manufacturing Practices. It has been written in collaboration with cosmetics industry professionals and promotes best-in-class methods. The scope of ISO 22716 is not only limited to production activities but also includes control, storage and expedition.
EU Cosmetics Regulation Services
Aqai’s experts provide cosmetics companies with complete scientific and regulatory support for compliance with Regulation (EC) No 1223/2009 include:
- GMP (Good Manufacturing Practices) Certification
- Cosmetics Testing
- Cosmetic Safety Assessments
- Cosmetics Ingredient Profiles
- Product Information Files (PIFs)
- Cosmetic Product Safety Reports (CPSR)
- Part A Cosmetic Product Safety Information
- Part B Cosmetic Product Safety Assessment
- Regulatory Compliance Support
- Regulatory consulting
- Product notifications
- PIF assembly
- Clinical Studies for Claim Substantiation
- Design, placement, and monitoring
- Product Labelling Review and Support