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Food supplements and related products

Food supplements are products intended to supplement the normal diet, which are a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, in dosed form.

In Italy, food supplements can be marketed only after legal notification to the Ministry of Health, that is the Competent Authority assessing the conformity of formulations and claims to the current regulations.

In case of positive outcome, the notified supplement will be included in the Register of food supplements available in the official website of the Ministry of Health.

Together with food supplements, the current legal framework provides for a series of special foods that should comply with specific requirements for the composition and labelling, and that can require to be notified to the Ministry of Health: Foods for specific groups (FSG), that are foods intended for specific population groups with special nutrition requirements (foods intended for infants and young children, foods for special medical purposes, total diet replacements for weight control), as well as gluten-free foods, foods fortified with vitamins, minerals and other substance.

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for food supplements and related products. The unit is made of highly qualified technicians with a long experience in this sector.

The main services offered are:

  • feasibility studies and Regulatory Intelligence for food supplements and related products
  • label evaluation, notification process, FBO registration and other related services
  • drafting of scientific technical rationale for food supplements containing herbal ingredients (botanicals)
  • authorisation process of Novel Foods at the European Commission
  • cooperation for the importation from EU and extra-EU countries
  • cooperation for the preparation of technical and administrative documents for exportation to the European Union and to extra-EU countries
  • Free Sale Certificates
  • HACCP and audits
  • advertising of food supplements and related products
  • foodvigilance and phytosurveillance.