Food Supplement Registration in European Union

The European Union represents one of the largest and most regulated markets for food supplements. With increasing demand for wellness, preventive healthcare, and functional ingredients, the EU offers strong commercial potential for global nutraceutical brands. However, gaining market access requires navigating strict regulations, including Directive 2002/46/EC, Regulation (EC) 1924/2006, and the EU Novel Food Regulation (EU 2015/2283).

As an experienced partner for Food Supplement Registration in the European Union, DDReg ensures your product meets compliance from formulation through market entry and post-market safety.

DDReg provides comprehensive support across the full lifecycle whether you need assistance with dietary supplement registration in European Union, nutraceutical registration, import requirements, or EU novel food regulation services.

• ✔ 16+ years of global regulatory expertise
• ✔ Deep understanding of EU harmonized and Member-State-specific requirements
• ✔ Strategic support to accelerate approvals and reduce compliance risks
• ✔ Trusted EU food supplement consultant for global brands

As a trusted partner for Food Regulatory Consulting in the UK, DDReg offers comprehensive, tailor-made services covering every stage of compliance, from formulation assessment to post-market support.

• + Product Classification and Regulatory Assessment
  • Identify applicable regulatory pathway based on composition and claims
  • Determine category: Food Supplement, Fortified Food, FSMP, or Medicinal Product
  • Novel ingredient assessment under EU Novel Food Regulation (EU 2015/2283)
  • Member-State notification strategy for faster access
• + Ingredient & Formula Compliance
  • Ingredient validation based on Directive 2002/46/EC permitted substances
  • Risk-based assessment for botanicals, probiotics, enzymes, amino acids
  • Evaluation of contaminants, additives, heavy metals & allergen statements
  • EU maximum permitted levels & country-specific restrictions mapping
• + Label Compliance & Health Claims Evaluation
  • Label audit based on Regulation (EU) No 1169/2011
  • Mandatory statements, warnings, and nutrient reference values (NRVs)
  • Validation of permitted nutrition & health claims under Regulation (EC) 1924/2006
  • Support with claim substantiation and EFSA opinion requirements
• + Dossier Preparation & Registration / Notification Support
  • Preparation of complete technical file, formulation data, and label pack
  • Submission to national authorities as required
  • Novel Food dossier preparation and support through EFSA scientific review
  • Ongoing liaison with regulatory authorities
• + Importation & EU Representation
  • Assistance to import food supplements into European Union
  • Appointment of an EU-based legal representative / importer of record
  • Compliance with customs, GMP evidence, and border checks
• + Post-Market Surveillance & Compliance
  • Monitoring of regulatory updates and safety alerts
  • Support with product variations, recalls, or safety reporting
  • Ongoing compliance supervision across EU Member States