Regulatory areas

  • Ordinary foods and food ingredients
  • Food supplements
  • Nutrition and health claims
  • Novel foods and genetically modified organisms (GMO)
  • Foods for specific groups (infant formulas, foods for special medical purposes)
  • Addition of vitamins and minerals
  • Food improvement agents (additives, enzymes, flavourings)
  • Chemical contaminants
  • NDI and GRAS notifications to FDA in the US
  • Feed materials, feed additives and medicated feeds

medfiles from regulatory plan to submission

Regulatory services provided

Framing of regulatory strategies

  • Descriptions of regulatory framework
  • Regulatory positioning
  • Regulatory route identification
  • New product development (NPD) for a functional food product
  • Counselling on positioning of and strategies for borderline products
  • Requests for classification decisions

Evaluation of documentation for European Commission/EFSA and FDA submissions

  • Regulatory and clinical plans
  • Expert evaluation on amount & quality of documentation
  • Gap analysis with respect to the requirements
  • Preparation of guidelines or reports on technical requirements as laid down in the legislation
  • Authority consultations

Compilation of dossiers and submissions to European Commission/EFSA and FDA or national authorities

  • Preparation of dossiers or parts of dossiers
  • Dossier submissions
  • Authority liaison
  • medfiles package labelling check for foodsData searches and literature reviews

Regulatory compliance of food labels

  • Writing and review of package labels for foods, food supplements and feeds
  • Translations of labels into Finnish, Swedish and other languages
  • Regulatory compliance check according to EU regulatory framework
  • Regulatory compliance for national Nordic legislation
  • Checking the mandatory FIC requirements
  • Regulatory conformity of ingredients, descriptions and claims
  • Searching applicable nutrition and health claims for products