EU REGULATORY MARKET-ACCESS SUPPORT

EU Regulatory Market-Access Support

IFC GLOBAL LLC coordinates defined regulatory work for companies preparing products for the European Union market. We begin with product classification, the responsible legal role and the evidence already available, then document the agreed service and any specialist partner work.

EU cosmetics services

• Cosmetic Product Safety Report (CPSR) coordination with a qualified safety assessor;
• Product Information File (PIF) compilation;
• fragrance-allergen assessment;
• CPNP preparation and submission assistance;
• EU cosmetic label review and cosmetic-claims review;
• accelerated stability, challenge and patch-test coordination through qualified laboratories;
• EU Responsible Person and representation-scope coordination where separately agreed.

A CPSR, PIF, CPNP notification and Responsible Person appointment are different obligations. Portal assistance does not by itself make IFC GLOBAL LLC the EU Responsible Person, and none of these steps is government product approval.

EU food and supplement reviews

• EU food label review;
• food-supplement label review;
• nutritional panel verification;
• nutrition, health and other food-claims review.

REACH and chemical compliance

• importer versus eligible Only Representative route assessment;
• substance identity, annual tonnage, exemption and existing-data review;
• inquiry, co-registrant, joint-submission and data-access coordination;
• dossier, SDS, Candidate List and qualified EEA partner coordination where applicable.

IFC GLOBAL LLC does not claim to act as an EEA-established Only Representative itself. Where that route is appropriate, the eligible EEA legal entity and its responsibilities must be confirmed by separate written agreement.

Other product routes

For medical devices, chemicals, electrical products and other regulated goods, we can coordinate an initial regulatory-route and documentation-readiness review. Any required Notified Body, Authorized Representative, laboratory, safety assessor or legal specialist is identified separately.

Start with the product and market

Send the product description, intended use, ingredients or technical specification, manufacturer location, target EU countries, artwork and existing evidence. We will identify the next verifiable step, the responsible role and any prerequisite work before a proposal is issued.