Food Supplements

FOOD SUPPLEMENTS

The nutritional supplement area is ruled by the European Directive 2002/46/CE in order to ensure both an high standard of public health safeguard and a free flow of these products within European Union, guaranteeing an optimal consumer’s information and security through an appropriate labeling.
According to the European regulatory framework, food supplements means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination. Usually they’re marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.
In Italy, a food supplement can be commercialized on the market exclusively after being notified to the Department of Health. SAPORITI CONSULTING helps companies launching new nutritional supplements and reviewing already marketed products with the following services offer:
R&D - FORMULATION DEVELOPMENT
  • development of food supplement formulations intended for adults
  • development of food supplement formulations for pediatric end users
  • modify pre-existing formulations in order to claim specific activities
  • formulation variation in order to comply with regulation in force
  • evaluation and choice of active ingredients and excipients
  • market research aimed to find innovative ingredients and packaging
  • evaluation of vitamins and minerals to formulate nutritional supplements
  • shelf-life evaluation and definition
REGULATORY AFFAIRS
  • drafting and review of labelling and package leaflet complying with European and Italian regulation
  • drafting and review of labelling and package leaflet complying with Swiss regulation
  • evaluation of maximum and minimum permitted levels of vitamins and minerals
  • “novel foods” ingredients evaluation
  • botanical derived ingredients evaluation
  • nutritional and health claim attribution
  • beauty claims attribution
  • gluten free, lactose free and no-sugar added products
  • readability criteria evaluation and definition
  • ingredients list and allergen list definition
  • electronic notification of food supplements to Italian Health Authority
  • electronic notification of previously notified food supplements to Italian Health Authority
  • product technical dossier
QUALITY ASSURANCE
  • stability studies definition
  • in-process quality control procedures and finished product quality control procedures definition
  • contact with a network of accredited laboratory of analysis
  • support in defining company’s HACCP plan and self-monitoring plans
  • support in certifying Halal, Kosher, Vegan, Biologica, GMP and ISO
  • support during audit for Italian and foreign companies