Industries
Industries We Serve
Care Europe provides EU regulatory consulting for supplement brands, cosmetic companies, North American exporters, and any brand seeking EU market access.
Supplement Brands
Food supplement brands entering the EU market face a complex regulatory landscape. EU Directive 2002/46/EC governs vitamins and minerals with strict positive lists and maximum permitted levels. Member state notification procedures (ANSES in France, BfR in Germany) must be completed before market placement. Care Europe guides supplement brands through ingredient compliance assessment, Novel Food screening, notification dossier preparation, and EU labeling requirements under EU Regulation 1169/2011.
Cosmetic Companies
EU Cosmetics Regulation 1223/2009 is one of the most comprehensive cosmetic regulatory frameworks globally. Every cosmetic product requires a Product Information File (PIF), a safety assessment by a qualified Cosmetic Product Safety Assessor, and CPNP notification before EU market placement. Care Europe prepares complete PIFs, coordinates with accredited safety assessors, manages CPNP submissions, and can act as your EU Responsible Person — providing everything you need for EU cosmetic market access.
North American Exporters
North American brands with strong FDA or Health Canada compliance documentation often assume EU market entry is straightforward — it is not. REACH chemical regulations, EU cosmetic ingredient restrictions, food supplement positive lists, and member state notification requirements create a complex compliance landscape. Care Europe specialises in bridging this gap: we understand both North American and EU regulatory frameworks and provide a clear, actionable roadmap for EU market entry.
EU Market Entry Clients
Whether you are a startup planning your first EU launch or an established brand expanding from one EU market to others, Care Europe provides structured market entry support. Our EU market entry program includes regulatory gap analysis, compliance roadmap development, EU Responsible Person designation, member state notification coordination, and ongoing regulatory maintenance. We prioritise your target markets and manage the regulatory process so you can focus on your business.
French Market Specialists
The French market has specific regulatory requirements beyond EU-wide harmonisation. ANSES oversees food supplement notifications in France, requiring French-language dossiers with specific data formats. ANSM regulates cosmetics and pharmaceuticals with French-specific requirements. Care Europe is a SIREN-registered French entity with direct experience in ANSES and ANSM submissions. Our bilingual EN/FR capability ensures your French market entry documentation meets all authority requirements.
Pharmaceutical Companies
Pharmaceutical companies operating at the cosmetic-pharmaceutical interface — borderline products, medicated cosmetics, and nutraceuticals with health claims — require specialist regulatory expertise. Care Europe advises on product classification under EU law, helps navigate the boundary between cosmetics and medicinal products, and provides regulatory strategy for products that may be regulated differently across EU member states.
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We provide bespoke EU regulatory consulting for any brand entering European markets. Contact us to discuss your specific requirements.
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