Europe
In Europe, the regulatory framework governing food supplements is multifaceted.
The primary goal of the harmonised regulations instated by Directive 2002/46/EC is to safeguard consumers from potential health risks associated with food supplements while also preventing misleading claims regarding their benefits.
It meticulously oversees the use of vitamins and minerals and the sources from which they are derived in the production of these products. However, the absence of agreed-upon harmonised maximum permitted levels of vitamins and minerals have enacted Member States to develop their own national limits. This lack of consistency creates barriers to the free movement of food supplements, impeding their distribution and sale across national borders within the European market.
The utilization of « other substances » may be restricted, prohibited, or subjected to scrutiny in accordance with harmonized EU legislation, particularly Regulation (EC) No 1925/2006.
As a solution, we offer:
- Strategic input in the navigation of complex regulatory framework, including the novel food legislation
- Assessment and validation of the formulation/ packaging to meet standard features
- Definition of the labelling and claims support
- Design of clinical trials if necessary
- Help to implement the HACCP regulation to become effective
- Writing of Technical dossiers ready for notification
- Teleicare Notification
- Management of CVL certificate

Get in Touch
Have questions or need expert guidance on regulatory compliance? We’re here to help! Contact us today to discuss how NTLS can support your business.