Responsible Person Support for Cosmetics

Elpisia Europe supports cosmetic and personal care brands with practical Responsible Person and compliance coordination services for products entering the European market.

• Responsible Person support
• CPNP notification assistance
• PIF documentation coordination
• Support relating to applicable SUE communication processes
• Ongoing regulatory support

The Role of the Responsible Person

According to European cosmetic regulations, products sold in Europe must have a designated Responsible Person in the relevant jurisdiction.

The Responsible Person acts as a regulatory contact and supports compliance responsibilities associated with these products.

They are not the manufacturer or safety assessor, and do not create product formulations or conduct safety assessments. Manufacturers carry the responsibility for compliance and documentation accuracy.

Elpisia Europe offers Responsible Person services and regulatory support for cosmetic products within agreed scopes.

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Support Hub

Helping you navigate responsible person duties with ease.

CPNP Help

A professional reviewing cosmetic product notifications on a laptop.

Guidance through CPNP notification processes smoothly.

Organized files and documents representing product information files.

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Label Review

Ensuring your labels meet all regulatory requirements.

Ongoing updates and compliance checks to keep you informed.

Compliance

Key Support

Focused help with regulatory processes and compliance.

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CPNP Assistance

Guidance through notification steps for CPNP compliance.

PIF Coordination

Organizing and managing your product information files.

Labeling Review

Checking labels for all required regulatory details.

FAQs

What is EU RP?

An EU Responsible Person ensures cosmetic products comply with EU regulations.

Do non-EU makers need one?

Yes, non-EU cosmetic manufacturers must appoint an EU Responsible Person for market access.

Can Elpisia prepare CPSR?

Elpisia Europe can prepare the Cosmetic Product Safety Report as part of our responsible person services.

Does Elpisia evaluate claims?

No, Elpisia Europe does not evaluate cosmetic claims; manufacturers are responsible for ensuring compliance with regulations.

How long PIF generally retained?

Elpisia Europe may assist with applicable legal representation and regulatory coordination activities for clinical investigations or IVD performance studies conducted across EU member states, subject to the relevant regulatory requirements and project scope.

Additional jurisdiction-specific requirements may apply for countries outside the European Union.

How are serious undesirable effects handled?

Depending on the project scope and applicable regulations, sponsors may be requested to provide relevant regulatory and study-related documentation necessary for legal representation and regulatory coordination activities.

This may include study protocols, regulatory submissions, ethics-related documentation, and applicable authority correspondence where relevant.