Regulatory AffairsFood Supplements
In the European Union, food supplements are regulated as foods. Harmonised legislation regulates the vitamins and minerals and their sources, which can be used in food supplements production. For other ingredients the European Commission has established harmonised rules to protect consumers against potential health risks maintaining a list of substances which are known or suspected to have adverse effects on health and therefore their use is controlled.
In Europe, food supplements must comply with European Directive 2002/46/EC but are also regulated on a local level in each country.
Labelling of food supplements needs to comply with EC Regulation 1169/2011 laying down the mandatory information required on all food labels.
Authorised Health and Nutritional Claims are regulated by EC Regulation 1924/2006.
E.U. Compliance
Pharmabooks ensures your next food supplement compliance with EU and local legislation on:
- Formulation development advice on ingredients list and reformulation.
- Validation mandatory label information.
- Validation Health and Nutritional Claims.
- Notification process with Local Competent Health Authorities.
- Direct communication with the Local Competent Health Authorities for notification process monitoring.
- Support with import and export documentation and procedures.