Regulation (EC) No 1223/2009 (often referred to simply as 1223/2009 is the primary legislative framework governing cosmetic products placed on the market within the European Union (EU). It is a comprehensive set of rules designed to ensure a high level of protection for human health and establish a harmonized single market for cosmetics across all EU member states.
Core Objectives and Compliance
The central aim of the EU Cosmetic Regulation is to mandate Compliance with strict safety standards before any product can be sold. Unlike previous directives, 1223/2009 is a regulation, meaning its provisions are immediately and uniformly applicable across the EU leaving no room for varied national interpretation.
Key elements of mandated Compliance include:
- Product Safety: Every cosmetic product must be safe for human use under normal or reasonably foreseeable conditions.
- Responsible Person: A single entity within the EU must be designated as the Responsible Person (RP), legally accountable for ensuring the product meets all requirements.
- Product Information File (PIF): The RP must maintain a completePIF, which is the core documentation proving the product’s safety (including the CPSR.
- Notification: Before being placed on the market, all products must be notified via the centralized Cosmetic Products Notification Portal CPNP
The Role of Annexes
The detailed rules on ingredients and restrictions are laid out in the Annexes of the Regulation. These are crucial for daily formulation and manufacturing $\text{Guideline}$ adherence:
- Annex II: Prohibited Substances: Lists ingredients that must not be contained in cosmetic products (over 1,300 entries).
- Annex III: Restricted Substances: Lists ingredients that are permitted only subject to specific restrictions, such as maximum concentrations, conditions of use, or warnings that must appear on the label.
- Annex IV: Permitted Colorants: Lists the only colorants permitted in cosmetic products.
- Annex V: Permitted Preservatives: Lists the only preservatives permitted, often with maximum concentration limits.
- Annex VI: Permitted UV Filters: Lists the only UV filters permitted in sun protection products.
These Annexes are dynamic and are updated frequently based on scientific review by the Scientific Committee on Consumer Safety ($\text{SCCS}$), requiring companies to continuously monitor their formulations for ongoing Compliance.
Guideline for the Industry
The 1223/2009 Regulation serves as the foundational Guideline for all steps in the supply chain—from raw material sourcing and manufacturing GMP to final labeling and post-market surveillance. It sets forth specific requirements for:
- The Responsible Person’s duties.
- Rules concerning animal testing (largely banned since 2013).
- Specific requirements for Cosmetic Regulation labeling, including the mandatory listing of ingredients INCI and the display of the Period After PAO symbol.
