Risk Assessment
RISK ASSESSMENT
The laboratory deals with:
- Drafting of tailor-made analysis plans, risk assessment based on materials, production process, intended use and target markets.
- Conformity assessment of specific migrations through calculation and modeling.
- Study of worst case simulants, calculation of residual content. Toxicological risk assessment.
- Search for NIAS / IAS from objects intended for contact with food.
- IAS substances – Intennionally added substances – are intentionally added substances, which may migrate from objects.
- NIAS – Non Intennionally added substances – are substances not added intentionally, which may migrate from objects
NIAS/IAS INVESTIGATION
The Laboratory has gained distinctive experience and expertise in Nias / IAS research from objects intended for contact with food. These analyzes are carried out using HS-GCMS, GC-MS and LC Q TOF techniques, in order to identify volatile, semi-volatile, and non-volatile, polar and non-polar compounds, in line with the analytical and scientific principles of risk assessment. internationally recognized. The screening tests performed with GC-MS technique compare the quantities of analytes with internal standard, making a semi-quantitative evaluation. The qualitative recognition is performed through the NIST library supplied with the instrument.
The screening performed with the high definition LC-Q TOF technique, performing analyzes with positive and negative ionization and different chromatographic columns, recognizes polar and non-volatile substances through a database developed over the years by the Laboratory Manager in collaboration with Sciex, with the University of Pisa and the University of Florence. Through these softwares some substances are able to be recognized if present in the database of the laboratory which currently has about 6000 molecules, others are characterized by a brute formula. For identified molecules that do not have a legal limit, the laboratory operates according to TTC logic.
The approach corresponds to what was decided in international technical commissions (e.g. ILSI group) and in the technical commission of the Italian Packaging Institute, which consequently produced an official guideline, the analytical part of which was presented in Milan on 16 December 2016. by Dr. Vitulli.
WORST CASE APPROACH FOR SPECIFIC MIGRATION TEST
The Food Contact Center, to reduce the costs related to the risk assessment, proposes the specific migration of substances subject to SML exclusively in the simulant chemically most similar to the contaminant, since the migration in the more severe simulant also covers the migration in other simulants, in line with Reg 10/2011, paragraph 2.2. Screening approaches, paragraph 2.2.4, and with the draft version of the Guidelines produced by the JRC on testing methods.
This approach allows a safe risk assessment based on scientific evidence, as well as a significant reduction in the cost of tests and sustainable quality control for companies.
TARGET-UNTAGETED APPROACH
According to this approach, screening tests are proposed with multiple techniques in order to check for the presence of restricted substances (SML) or any substances not intentionally added (NIAS). Given the different chemical nature of the same, ad HOC analytical techniques are necessary, specifically:
HS-GCMS, GC-MS and LC Q TOF, in order to identify volatile, semi-volatile, and non-volatile, polar and non-polar compounds, in line with internationally recognized analytical and scientific principles of risk assessment
Each technique is complementary to the other, and allows a detection of all possible contaminants, as per the JRC guideline on testing conditions for food contact
By deconvolution of the chromatograms obtained from all the screening tests, as shown in the diagram above, the following will be verified, using the appropriate technique: phthalates, additives (antioxidants, slip agents, etc.) monomers and oligomers, hydrocarbons (Mosh & Moah), diisopropylnaphthalene, Bisphenol A, perfluorinated substances or other anti-damp / grease resins, components of inks and adhesives.
The screening tests performed with GC-MS technique compare the quantities of analytes with internal standard, making a semi-quantitative evaluation. The qualitative recognition is performed through the NIST library supplied with the instrument; the comparison between the detected mass spectra and those present in the library is expressed as a percentage matching probability.
The screening tests performed with the HPLC / QTOF technique instead recognize the molecules through the use of a database developed over the years by the Laboratory Manager in collaboration with Sciex, with the University of Pisa and the University of Florence. Through these softwares some substances are able to be recognized if present in the database of the laboratory which currently has about 6000 molecules, others are characterized by a brute formula.
The laboratory also provides for a screening of inorganic elements, in line with the logic of risk assessment.
On 23-24 February 2021 the Food Contact Center was part of one of the first meetings of the technical commission that participated in the online workshop “Best practice to identify and quantify unknown migrant substances from materials in contact with food”, organized by ILSI Europe (Life Science Institute).
Food Contact Center participates in the expert group as the only Italian laboratory.
