An EU Responsible Person is an individual or organization established within the European Union that supports certain regulatory responsibilities relating to cosmetic products placed on the EU market under applicable European cosmetic regulations.

This may include support relating to product notification, documentation coordination, and applicable regulatory communication activities.

Under applicable European cosmetic regulations, cosmetic products placed on the EU market generally require a Responsible Person established within the European Union.

For manufacturers located outside the EU, an EU-based Responsible Person may be required before applicable cosmetic products can be placed on the European market.

Elpisia Europe, established within the European Union, provides practical Responsible Person and regulatory coordination support for selected cosmetic and personal care products entering the EU market.

No. Under applicable European cosmetic regulations, the Cosmetic Product Safety Report (CPSR) is generally expected to be prepared and signed by a suitably qualified safety assessor with the appropriate academic and professional qualifications in fields such as pharmacy, toxicology, medicine, or related disciplines.

Elpisia Europe does not perform cosmetic safety assessments. However, depending on the project scope, we may assist clients by coordinating with or referring to external safety assessors or specialized service providers where appropriate.

No. Manufacturers and brand owners generally remain responsible for ensuring that product claims, marketing statements, and promotional materials comply with applicable regulations and are appropriately supported.

Elpisia Europe may assist with practical review of certain mandatory labeling elements relating to applicable regulatory requirements. However, we do not independently verify or substantiate marketing claims, advertising statements, or product efficacy claims.

Manufacturers are generally encouraged to ensure that product claims are accurate, appropriately supported, and aligned with applicable regulatory and advertising requirements.

Under applicable European cosmetic regulations, certain Product Information Files (PIF) may be required to be retained for a specified period after the last batch of the product is placed on the market.

Depending on the applicable regulatory framework and project scope, Elpisia Europe may assist with documentation retention and availability support relating to applicable regulatory requirements and authority requests where relevant.

Applicable European cosmetic regulations may require certain serious undesirable effects to be communicated to the relevant competent authorities.

Elpisia Europe may assist with coordination relating to applicable SUE communication and regulatory reporting processes within the agreed project scope.

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.

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.

Applicable regulations may require certain regulatory and study-related documentation to be retained for extended periods depending on the product type, study scope, and jurisdiction involved.

Retention periods generally depend on the relevant regulatory framework and applicable legal requirements.