REGULATORY ASSISTANCE

FOOD SUPPLEMENTS

FOOD SUPPLEMENTS are evaluated and checked according to a specific legislation:

  • 2002/46 / EC Directive on the approximation of the laws of the Member States relating to food supplements.
  • Regulation (EC) 1170/2009, which modifies the Directive 2002/46/CE which regulates production, packaging, distribution and sale.
  • National decrees.
According to the Ministry of Health definition, food supplements include "food products intended to complement the common diet and which are a concentrated source of nutrients, such as vitamins and minerals, or other substances having a nutritional or physiological effect, in particular, but not exclusively, amino acids, essential fatty acids, fibers and extracts of plant origin, both alone or in combination, in pre-dosed forms".

The Food supplement Technical-Regulatory Area of Bio Basic Europe assists the client by offering consulting services and producing the necessary documentation for the trading of the products, in line with the current regulations concerning safety and protection of public health.

Below is a list of the main technical-regulatory services offered by Bio Basic Europe for producers and manufacturers of food supplements and probiotics:

  • Preliminary evaluation of the labels and check of their compliance with the regulations in force
  • Assessment of the claims in accordance with national guidelines, regulations and European registers
  • Product notification on the Ministry of Health portal
  • Reporting of in vivo efficacy studies / Report of pilot studies for the evaluation of the efficacy and safety of food supplements, probiotics, etc.
  • Contact management with international authorities, in order to identify the necessary activities for importation
  • Support for the organic certification achievement
Bio Basic Europe is also expert in performing clinical monitoring and laboratory tests to substantiate the safety and efficacy of food supplements.

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