Cosmetics are regulated in the European Union by Regulation (EC) No 1223/2009.
The main objectives of this regulation are to create a set of rules that all cosmetics comply with and to ensure a high level of protection for human health.
One of the requirements of the regulation is that prior to placing the product on the market a safety assessment must be carried out. The regulation specifies that this safety assessment should be in the form of a cosmetic product safety report.
The cosmetic product safety report is the cosmetic safety assessor’s opinion that the product is safe in normal and foreseeable use and complies with the requirements of Regulation (EC) No 1223/2009.
Cosmetic Regulation - Compliance Overview
REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009
This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.
EU and UK
- UK Product Safety and Metrology Guidance for the market of Great Britain (England, Scotland and Wales)
- EU Cosmetic Regulation 1223/2009 for Products placed in the Northern Irland and/or EU
In short words, to comply with the Cosmetic Regulation 1223/2009, all cosmetic products placed in the EU/UK market should have:
- A Responsible Person (RP)
- A Cosmetic Product Safety Report (CPSR) written by a Qualified Person
- Keep a Product Information File (PIF)
- Labelling accordingly with the requirements
- Comply with Good Manufacturing Practice (GMP)
- Register the product in the Cosmetic Product Notification Portal (CPNP) - EU Portal and SCPN - UK Portal
The 10 Principles
- Roles and Responsabilities
- Good Manufacturing Practices (GMP)
- Documentation (PIF)
- Serious Undesirable Effects
- Cosmetovigilance/Market Surveillance
Above you have a summary of the Cosmetic Regulation in the EU/UK, you can find more detailed information in the Official Journal of the European Union.
The general guidance on the link below covers all cosmetic products that are available to a member of the public in Great Britain (GB). This includes products that are sold or given away (for example, free samples) and products used on the public by professionals.
This guidance is to support understanding of Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.