EU Market

EU Cosmetic compliance

Regulatory Compliance Solutions for the EU Cosmetic Industry

Navigating the European cosmetics market involves understanding a comprehensive set of regulations. Ensuring compliance and safety for cosmetic products is paramount. Europe’s regulatory framework, primarily governed by the EU Cosmetics Regulation 1223/2009, ensures that all cosmetic products are safe for human health when used under normal conditions. This regulation harmonizes the standards across EU member states, enabling the free circulation of cosmetic products within the internal market.

Before placing a product on the market, manufacturers must conduct a thorough safety assessment and compile a Product Information File (PIF). Additionally, products must be notified through the Cosmetic Products Notification Portal (CPNP), ensuring no further national notifications are required. Detailed guidance is available on each of these steps to help navigate the regulatory maze with ease.

Labeling is another critical aspect, and it is essential to ensure labels comply with EU requirements. This includes displaying the Responsible Person’s contact information and the product’s country of origin. Furthermore, the importance of Good Manufacturing Practice (GMP) verification cannot be overstated, as it ensures the production process meets ISO 22716 standards.

Cosmetovigilance plays a significant role in maintaining product safety post-market, requiring the reporting of serious undesirable effects to relevant authorities. Resources are also available on ongoing market surveillance and compliance checks, ensuring products remain safe and compliant.

By leveraging the wealth of information and expert guidance available, manufacturers can confidently bring their cosmetic products to the European market. Explore these resources and start the compliance journey today.

Our Services


Regulatory Compliance Consulting

We ensure that cosmetic products meet the stringent standards of EU Cosmetics Regulation 1223/2009. Our team provides detailed guidance and support to help companies navigate the regulatory landscape, ensuring compliance with all necessary legal requirements for market entry in Europe.

Quality Management

Product Information File (PIF) Preparation

We compile and organize the Product Information File (PIF), which includes a product description, detailed Cosmetic Product Safety Report (CPSR), manufacturing methods, proof of claimed effects, and animal testing data. This comprehensive documentation is essential for compliance and must be readily available for authorities.

Safety Assessments

Our qualified toxicologists conduct comprehensive safety assessments of cosmetic products, ensuring compliance with EU regulations on ingredient safety and usage concentrations. We perform a detailed analysis of potential hazards and exposure, culminating in a thorough safety evaluation.

CPNP Notification

We manage the Cosmetic Products Notification Portal (CPNP) process, ensuring that cosmetic products are correctly notified before entering the EU market. This service includes preparing and submitting all required information to the CPNP, streamlining the notification process for our clients.

Biological Evaluation

Labeling and Claims Review

We review product labels and claims to ensure they meet EU regulations, including mandatory information such as the Responsible Person’s contact details and the product’s country of origin. Our service helps companies avoid non-compliance issues related to product labeling and marketing claims.

Good Manufacturing Practice (GMP) Verification

We verify compliance with Good Manufacturing Practices (GMP) according to ISO 22716 standards. This ensures that the manufacturing processes meet the required quality and safety standards, which is crucial for maintaining product integrity and regulatory compliance.

Responsible Person Service

We offer Responsible Person (RP) services, acting as the designated legal entity within the EU responsible for ensuring product compliance with all regulatory requirements. Our service includes handling regulatory responsibilities and acting as the primary contact for competent authorities.

Cosmetovigilance Support

We provide ongoing cosmetovigilance support, monitoring product safety post-market and reporting any serious undesirable effects to relevant authorities. This service ensures that companies maintain compliance and address any safety issues promptly, protecting both consumers and brand reputation.

Ongoing Compliance Monitoring

We offer continuous monitoring services to ensure ongoing compliance with evolving EU regulations and standards. This proactive approach helps companies stay updated on regulatory changes, protecting products from potential market withdrawals and fines.

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