EU Regulatory Consulting for Cosmetics & Supplements
Navigate REACH, EU Cosmetics Regulation 1223/2009, and EU food supplement directives with an experienced France-based regulatory team.
Care Europe provides end-to-end EU regulatory consulting — from REACH substance registration to EU Cosmetics Regulation compliance and food supplement notification — for brands entering or operating in European markets.
Entering the European market requires navigating a complex web of regulations that differ significantly from North American frameworks. Care Europe provides expert regulatory pathway consulting to help supplement brands, cosmetic companies, and North American exporters achieve full EU compliance. Our bilingual (EN/FR) team bridges the gap between your existing compliance documentation and EU regulatory requirements.
REACH Compliance Consulting
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation EC 1907/2006 is one of the most comprehensive chemical safety regulations in the world. Care Europe guides manufacturers through substance identification, safety data sheet preparation, downstream user obligations, and SVHC (Substances of Very High Concern) assessment. We help you determine whether your products require full registration or fall under exemptions, saving time and resources while ensuring full legal compliance.
EU Cosmetics Regulation 1223/2009 Pathway
The EU Cosmetics Regulation requires a Product Information File (PIF), a qualified Cosmetic Product Safety Assessor (CPSA) safety assessment, and notification through the Cosmetic Products Notification Portal (CPNP) before any cosmetic product can be placed on the EU market. Care Europe prepares and reviews PIFs, coordinates with accredited safety assessors, and manages CPNP submissions — ensuring your products are market-ready with full regulatory documentation.
Food Supplement Directive Compliance
EU Food Supplements Directive 2002/46/EC harmonises rules on vitamins and minerals used in food supplements, while national regulations in France, Germany, and other member states add additional requirements. Care Europe assesses your supplement formulations against EU positive lists, advises on maximum permitted levels, and prepares notification dossiers for member state authorities. We also advise on EU Regulation 1169/2011 labeling requirements to ensure your packaging meets all mandatory information standards.
Services & Methods Included
- ✓ REACH substance pre-registration assessment
- ✓ SVHC (Substances of Very High Concern) screening
- ✓ Safety Data Sheet (SDS) review and preparation
- ✓ Product Information File (PIF) preparation
- ✓ CPNP notification management
- ✓ EU positive list ingredient compliance check
- ✓ Maximum permitted level assessment
- ✓ Member state notification dossier preparation
- ✓ Regulatory gap analysis (NA vs EU)
- ✓ Labeling compliance review (EU 1169/2011)
Regulatory Standards & Compliance
- EU Regulation 1223/2009
- REACH Regulation EC 1907/2006
- EU Food Supplements Directive 2002/46/EC
- EU Regulation 1169/2011
- ISO 22716 GMP
Industries We Serve
- Supplement Brands
- Cosmetic Companies
- North American Exporters
- EU Market Entry Clients
- Pharmaceutical Companies
- Contract Manufacturers
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Tell us about your product and regulatory challenge. We'll respond within 24 hours with an honest assessment and clear next step.
Get a Free Assessment →Frequently Asked Questions
What is EU regulatory consulting and why do I need it?
EU regulatory consulting helps brands understand and comply with European regulations before placing products on the EU market. EU regulations differ significantly from FDA/Health Canada frameworks — for example, REACH requires chemical substance registration, and EU Cosmetics Regulation mandates a Product Information File and CPNP notification. Without proper consulting, brands risk product seizure, fines, or market exclusion.
How long does EU regulatory consulting typically take?
Timeline depends on the scope. A regulatory gap analysis for a single product line typically takes 2–4 weeks. Full CPNP notification preparation takes 4–8 weeks. REACH registration for a new substance can take 3–6 months. Care Europe provides a detailed timeline estimate after reviewing your product documentation.
Do you provide consulting in both English and French?
Yes. Care Europe is a bilingual EN/FR consultancy. All regulatory documents, reports, and communications can be provided in both English and French. This is particularly important for French market entry, where regulatory authorities may require French-language documentation.
Why brands choose Care Europe for eu regulatory consulting
Registered in France
EU regulatory partner with legal standing
Bilingual EN/FR
Reports in English and French
NA–EU Bridge
We understand both regulatory worlds
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