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
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
Data 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
