EU Cosmetics Compliance

Background of EU Cosmetics Compliance

The EU regulatory framework for cosmetics is governed by Regulation (EC) No 1223/2009, which sets out the requirements for safety assessment, labeling, and notification to authorities for cosmetics. Anyone wishing to place a cosmetic product on the EU market must designate a legal or natural person in the EU to assume compliance obligations. In addition, the regulation prohibits the placing on the EU market of cosmetic products whose final formulations, ingredients, or combinations of ingredients and/or finished products have been tested on animals. The regulation aims to simplify procedures, streamline terminology and strengthen the regulatory framework for cosmetics to ensure a high level of protection for human health.

About Us

Our company provides comprehensive and high-quality services to fully support compliance with Regulation (EC) No 1223/2009, from cosmetics development, production, and distribution to market support.

Compliance with EU cosmetics regulations is essential for cosmetic companies. The regulatory framework is complex and constantly evolving, making it challenging for companies to navigate on their own. Our comprehensive regulatory compliance services offer a solution to this issue, enabling you to place your products on the EU market. Our team of experts provides tailored solutions to ensure compliance with all regulatory requirements imposed by EU cosmetic regulations. This includes Product Information File (PIF), product safety assessment, product notification submission, Responsible Person (RP), and compliant product labels. Whether you need help with training, specific projects, or long-term cooperation, we will be your partner for success!

Significance of Compliance with EU Cosmetic Regulations

We provide expertise and support in specific areas of cosmetic compliance to help our clients meet the regulatory requirements of the EU Cosmetics Regulation, in order to:

• Protect consumers from unsafe products
• Protect consumers from unfair business practices
• Provide consumers with meaningful information to facilitate sound purchasing decisions
• Implement specific values important to European citizens (e.g., animal testing, etc.)
• Making the EU market work effectively

Our EU Cosmetics Compliance Services

We provide complete scientific and regulatory support to cosmetic companies, including:

• Cosmetic product classification
• Product pre-evaluation
• Product portfolio pre-evaluation
• Product formulation review
• Product label review
• Review of marketing materials
• PIF dossier review and preparation
• Make available checklists and templates for PIF building
• Testing data collection
• Authoring of a PIF, including product formulas, raw materials, various finished products, packaging specifications, and tests.
• PIF review
• Preparation of Cosmetic Product Safety Report (CPSR) and regulatory content briefs
• Stability and compatibility test
• Challenge test or preservative efficacy test (PET)
• Authoring of a CPSR, including cosmetic product safety information and cosmetic product safety assessment.
• Issuing of regulatory content briefs
• Review of labels and claims
• Review of regulatory content profiles for labels and claims, including INCI ingredient lists
• Review of artwork design and marketing materials
• Cosmetic notification in the Cosmetics Products Notification Portal (CPNP)
• EU-based domestic Responsible Person
• Update CPNP and PIF as appropriate
• Regulatory consulting

If you need help or have a question, please feel free to contact us for more details.