EU Food Supplement Directive Compliance
Navigate EU Food Supplements Directive 2002/46/EC — notification procedures, ingredient compliance, and labeling requirements for EU market entry.
Care Europe provides complete EU food supplement compliance: ingredient assessment against EU positive lists, member state notification dossier preparation, and labeling compliance review under EU Directive 2002/46/EC and EU Regulation 1169/2011.
The EU food supplement market is governed by Directive 2002/46/EC, which harmonises rules on vitamins and minerals, while member states maintain additional national regulations for other nutrient categories. Brands entering the EU supplement market must navigate positive lists, maximum permitted levels, Novel Food requirements for new ingredients, and member state notification procedures. Care Europe provides comprehensive compliance support for supplement brands seeking EU market access.
Ingredient Compliance & EU Positive Lists
EU Food Supplements Directive 2002/46/EC establishes positive lists of vitamins and minerals permitted in food supplements, along with the specific chemical forms allowed. Only substances on these positive lists may be used in EU food supplements for the harmonised categories. For other nutrient categories (botanicals, amino acids, etc.), member state regulations apply. Care Europe assesses your supplement formulations against EU positive lists, identifies any non-permitted ingredients, and advises on compliant reformulation or Novel Food authorisation pathways where needed.
Member State Notification Procedures
Most EU member states require notification before a food supplement is placed on their market. France (ANSES), Germany (BfR), Italy (Ministry of Health), and other major markets each have specific notification requirements and formats. Care Europe prepares complete notification dossiers for target EU markets, manages submission to competent authorities, and tracks notification status. We have direct experience with French ANSES notifications and coordinate with regulatory partners for other member state submissions.
Labeling Requirements Under EU Regulation 1169/2011
EU Regulation 1169/2011 on food information to consumers sets mandatory labeling requirements for all food products, including supplements. Supplement-specific requirements include the statement "food supplement", the recommended daily dose, a warning not to exceed the recommended daily dose, and a statement that food supplements should not be used as a substitute for a varied diet. Care Europe reviews your supplement labeling for full compliance with EU 1169/2011 and member state language requirements, ensuring your packaging is market-ready.
Usługi i metody w zakresie
- ✓Ingredient compliance check vs. EU positive lists
- ✓Maximum permitted level assessment
- ✓Novel Food status screening
- ✓ANSES notification dossier (France)
- ✓Member state notification coordination
- ✓Labeling compliance review (EU 1169/2011)
- ✓Health claims assessment (EU 1924/2006)
- ✓Botanical ingredient regulatory status
- ✓Allergen declaration review
- ✓Nutrition declaration format compliance
Standardy regulacyjne i zgodność
- EU Food Supplements Directive 2002/46/EC
- EU Regulation 1169/2011
- EU Regulation 1924/2006 (Health Claims)
- EU Novel Food Regulation 2015/2283
- ANSES notification requirements
Branże, które obsługujemy
- Supplement Brands
- North American Exporters
- Nutraceutical Companies
- Botanical Supplement Brands
- EU Market Entry Clients
- Contract Manufacturers
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Bezpłatna ocena →Często zadawane pytania
What is the EU positive list for food supplements?
The EU positive list is the list of vitamins and minerals — and their specific chemical forms — that are permitted in food supplements under EU Directive 2002/46/EC. Only substances on this list may be used in EU food supplements for the harmonised vitamin and mineral categories. If your supplement contains a vitamin or mineral form not on the positive list, it cannot be sold as a food supplement in the EU without Novel Food authorisation.
Do I need to notify each EU country separately?
Yes. While EU Directive 2002/46/EC harmonises some requirements, food supplement notification is handled at the member state level. France, Germany, Italy, Spain, and most other EU countries require separate notifications. Care Europe coordinates multi-country notification strategies to streamline your EU market entry, prioritising your target markets and managing submissions efficiently.
Can I use my FDA-compliant supplement formulation in the EU?
Not necessarily. EU positive lists are more restrictive than FDA DSHEA regulations. Some ingredient forms permitted in the US are not on EU positive lists. Maximum permitted levels in the EU may be lower than US label claims. Botanical ingredients may require Novel Food assessment. Care Europe's gap analysis identifies exactly which aspects of your formulation require modification for EU compliance.
Dlaczego marki wybierają Care Europe do food supplement eu compliance
Zarejestrowana we Francji
Partner regulacyjny UE z pozycją prawną
Dwujęzyczny EN/FR
Raporty po angielsku i francusku
Most NA–UE
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