Food Additives & Food Supplements
Food Additives and
Food Supplements

Any substance added to food intentionally must be approved for the respective purpose. This applies to all substances having a technological effect in food but it does not apply to processing aids used in the manufacture of food.
According to Regulation (EC) 1332/2008 and Regulation (EC) 234/2011 within the near future also enzymes being used as processing aids in the manufacture of food will have to be approved and included in a “EU positive list of enzymes”. Industry has time until September 2013 to submit dossiers for food enzymes which are already on the market in th EU. Currently there are only few European countries having a national positive list of food processing enzymes.
Food supplements are sources of nutrients or of other substances having a nutritional or physiological effect. In the European Union there is not yet a completely harmonized regulation for food supplements. Next to the “classical” supplements like vitamins and minerals (regulated in Directive 2002/46/EC) there are other nutrients which might be added to food and that must comply with other legislation, e.g. Directive 89/398/EEC and Directive 2001/15/EC (foodstuffs for particular nutritional purposes), or Regulation (EC) 97/258 on novel food. These nutrients may be chemically synthesized, isolated from animal or plant material or obtained by fermentation processes.
The WTC team is well familiar with the different production processes and the regulatory requirements applying to the different substances and offer the following services:

 

Services
  • Review of existing data and analysis of data gaps with regard to regulatory requirements
  • Development of registration strategy and test program
  • Compilation and submission of complete registration dossiers to EU and/or national European authorities
  • Literature search for data on efficacy and safety of the substance
  • Assessment of the safety of the substance
  • Expert reports
  • Compliance checks of products and ingredients
  • Compliance certification
Safety Testing Services
  • Conception, execution and management of experimental studies as needed at a testing facility of our clients’ choice:
    • physical-chemical properties
    • efficacy studies
    • development  / validation of analytical methods
    • mutagenicity studies
    • toxicity studies
    • ADME studies
  • The tests will be performed according to the relevant international test guidelines, e.g. OECD, EC, FDA, etc.
  • Project Management and scientific monitoring of laboratory testing.