FOOD CONTACT MATERIALS

• • Toxicological evaluation of NIAS from food contact materials

• • Self-derivation of the Specific Migration Limit (SML) based on international guidelines (from experimental data; or from Threshold of Toxicological Concern approach, via a combination of in silico methods, i.e., VEGA and OECD QSAR; or from the application of read across approach)

• • Derivation of the Specific Migration Limit for Carcinogens based on the Virtually Safe Dose (FDA approach)

• • Supporting Quality Experts in the identification of the needed analytical conditions to perform migration studies from the food contact materials in line with EU Reg. 10/2011 and EU Reg. 1935/2004

• • Evaluation of potential for mutagenicity based on experimental data and in silico methods (OECD QSAR Toolbox, VEGA Hub, Leadscope Model Applier)

• • Declaration of Conformity of the use of the food contact material for the specific application

• • Toxicological evaluation of food additives, enzymes, impurities by means of literature search

• • Self-derivation of Acceptable Daily Intake (ADI)

• • Gap-analysis to understand the tests/analysis that might be missing to finalise the safe assessment

• • “In silico” predictions for substances without experimental data and interpretation of results by our ERT® (European Registered Toxicologist)

• • Supporting the petitioning process to introduce a substance in a positive EU list (EU Reg 10/2011 and country specific lists)

• • Personalized training RA and QC professionals

• • Regulatory consultancy also available, via third party

BIOTECHNOLOGICAL
SKILLS

We are experts in optimizing biological processes and in creating innovative, customized, and cutting-edge products