FAQ
Frequently Asked Questions
Common questions about EU regulatory consulting, REACH compliance, EU Cosmetics Regulation, and Care Europe services.
1 What is EU regulatory consulting?
EU regulatory consulting helps brands understand and comply with European regulations before placing products on the EU market. EU regulations — including REACH (EC 1907/2006), EU Cosmetics Regulation 1223/2009, and EU Food Supplements Directive 2002/46/EC — differ significantly from FDA and Health Canada frameworks. A regulatory consultant like Care Europe assesses your products against EU requirements, identifies compliance gaps, prepares required documentation (Product Information Files, notification dossiers), and manages submissions to EU regulatory authorities.
2 What is REACH compliance?
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is EU Regulation EC 1907/2006 — one of the world's most comprehensive chemical safety regulations. REACH requires manufacturers and importers of chemical substances to register them with the European Chemicals Agency (ECHA) and demonstrate their safe use. For cosmetic and supplement brands, REACH compliance involves assessing whether your ingredients are registered, checking for SVHC (Substances of Very High Concern) restrictions, and ensuring your Safety Data Sheets are compliant. Care Europe provides specialist REACH compliance consulting.
3 What is EU Cosmetics Regulation 1223/2009?
EU Regulation 1223/2009 is the primary legislation governing cosmetic products in the European Union. It requires every cosmetic product placed on the EU market to have: (1) a designated EU Responsible Person — a legal entity established within the EU; (2) a Product Information File (PIF) containing product description, safety report, manufacturing information, and claims substantiation; (3) a safety assessment by a qualified Cosmetic Product Safety Assessor (CPSA); and (4) notification through the Cosmetic Products Notification Portal (CPNP). Care Europe manages this entire process for brands entering the EU cosmetic market.
4 Do you provide French-language reports?
Yes. Care Europe is a bilingual EN/FR regulatory consultancy. All regulatory documents, reports, and communications can be provided in both English and French. French-language documentation is particularly important for French market entry — ANSES food supplement notifications and ANSM cosmetic submissions often require French-language dossiers. Our bilingual capability is a genuine differentiator for brands targeting the French market.
5 How long does EU market entry take?
Timeline depends on your product type and target markets. For cosmetics: CPNP notification preparation takes 4–8 weeks once your PIF and safety assessment are complete. For food supplements entering France: ANSES notification dossier preparation takes 4–8 weeks, and the notification process itself takes 2–3 months. For REACH compliance: a regulatory gap analysis takes 2–4 weeks; full substance registration can take 3–6 months. Care Europe provides a detailed timeline estimate after reviewing your product documentation.
6 Are you SIREN registered?
Yes. Care Europe is a SIREN-registered French entity. SIREN (Système d'Identification du Répertoire des Entreprises) is the French business registration system administered by INSEE. Our SIREN registration provides the legal standing required to act as EU Responsible Person for cosmetic products, submit regulatory notifications to French authorities (ANSES, ANSM), and provide legally recognised regulatory consulting services within the EU.
7 Can you help with food supplement EU compliance?
Yes. EU food supplement compliance is one of our core services. We assess your supplement formulations against EU positive lists (permitted vitamins, minerals, and their chemical forms under Directive 2002/46/EC), screen for Novel Food requirements, prepare member state notification dossiers (including ANSES notifications for France), and review your labeling for compliance with EU Regulation 1169/2011. We also advise on health claims under EU Regulation 1924/2006.
8 How do I get started?
Getting started is simple. Contact us through our contact form or email info@care-europe.com with a brief description of your products and target EU markets. We will respond within 24 hours with an initial assessment and a proposal for a regulatory gap analysis — the first step in any EU market entry project. The gap analysis gives you a clear picture of what EU compliance requires for your specific products before you commit to the full process.