Food Contact Substances
Food Contact Substances


For the manufacture of Food Contact Materials (FCM) detailed regulations are applicable for the different materials and products like plastics, paper and board, coatings, multi-layer materials, rubber, elastomers, silicones, printing inks etc. Additionally, there are national differences in the regulatory requirements.
WTC is well familiar with these regulatory requirements. In the past 25 years we issued more than 1000 compliance certificates for different food contact materials. In the past 20 years we submitted more than 400 successful petitions to European authorities (EFSA and national authorities) and US-FDA (and other countries).

 

Regulatory Affairs Services
  • Development of registration strategy and test program
  • Compilation and submission of complete registration dossiers to competent authorities in Europe (EFSA and individual nations), in USA (FDA), in other countries
  • Assessment of the safety of chemicals used in the manufacture of FCM as well as of NIAS (Non Intentionally Added Substances)
  • Expert reports
  • Negotiations with regulatory authorities and scientific bodies on client’s behalf
  • Compliance checks of products and ingredients
  • Compliance certification
  • Preparation of compliance documentation (according to Regulation (EC) No. 1935/2004)
  • Consulting on Good Manufacturing Practice (GMP)
  • Advice on tests to be performed to check compliance (coordination and management of testing)
  • Migration calculation
Safety Testing Services
  • Conception, execution and management of experimental studies as needed at a testing facility of our clients’ choice:
    • physical-chemical properties
    • migration 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 studies.