Introduction to EU Regulation (EC) No 1223/2009
The European Union (EU) is home to one of the strictest regulatory frameworks for cosmetics, designed to ensure consumer safety and market transparency. At the heart of this framework lies Regulation (EC) No 1223/2009.
Historical background
The roots of EU cosmetic regulation date back to 1976, when the first Cosmetics Directive (76/768/EEC) was introduced. While groundbreaking at the time, the directive faced challenges in keeping pace with scientific advancements, increasing global trade, and growing consumer awareness. To address these issues, Regulation (EC) No 1223/2009 replaced the Directive on July 11, 2013, marking a significant shift from a fragmented directive-based approach to a harmonized regulatory framework.
The primary objectives of the Regulation include:
- Ensuring Consumer Safety: Mandating rigorous safety assessments for all cosmetic products before market entry.
- Harmonizing the Internal Market: Eliminating trade barriers among EU member states by creating uniform rules for cosmetic products.
- Transparency and Traceability: Enhancing consumer confidence through clear labeling and accessible product information.
- Animal Welfare: Upholding the EU’s ban on animal testing for cosmetics and cosmetic ingredients.
Key elements of the Regulation
Regulation (EC) No 1223/2009 introduced several fundamental requirements that must be met by all cosmetic products sold within the EU. These include:
- Definition of the Responsible Person (RP): Every cosmetic product must have a designated RP within the EU. The RP is accountable for ensuring compliance with all regulatory requirements, including safety assessments, labeling, and market notification.
- Safety assessment: Before a product can be placed on the market, a Cosmetic Product Safety Report (CPSR) must be completed by a qualified safety assessor. This ensures that the product is safe for human use under normal or reasonably foreseeable conditions.
- Product Information File (PIF): A detailed dossier, including the CPSR, manufacturing data, and proof of claims, must be maintained and made available to competent authorities upon request.
- Cosmetic Product Notification Portal (CPNP): All cosmetic products must be notified to the CPNP, a central database that facilitates market surveillance by member states.
- Ingredients compliance: The Regulation includes detailed annexes listing substances that are prohibited (Annex II), restricted (Annex III) in cosmetic formulation, as well as authorised colourants, preservatives, and UV filters.
- Labeling requirements: Clear labeling, including ingredient lists and responsible person details, is mandatory to ensure consumer understanding and safety.
By establishing clear guidelines for product safety, labelling, and market entry, it protects consumers while enabling businesses to operate across a harmonized market.
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