Drinking Water Contact Materials
Drinking Water Contact Materials

For the use of plastic materials in contact with drinking water other regulations than those for the use of plastics in contact with food are applicable. In the European Union currently there is no harmonized regulation of drinking water contact materials available. A number of member states operate national acceptance schemes, e.g. France, Germany, The Netherlands, United Kingdom, resulting in differing test requirements, acceptance criteria and acceptance levels among member states.
We are well familiar with these regulatory requirements and offer the following services:

 

Regulatory Affairs Services
  • Development of registration strategy and test program for new monomers and additives
  • Compilation and submission of complete registration dossiers to competent authorities in Europe (individual member states) and to NSF in USA
  • Assessment of the safety of chemicals used in the manufacture of drinking water contact plastic materials as well as of NIAS (Non Intentionally Added Substances)
  • Expert reports
  • Discussion with regulatory authorities and scientific bodies on client’s behalf
  • Compliance checks of products and ingredients
  • 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.