Oct 16, 2019   8:14 p.m. Vladimíra
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Course syllabus N436S1_4I - Systems for Evaluation of Contaminants in Foodstuffs (FCFT - SS 2019/2020)


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University: Slovak University of Technology in Bratislava
Faculty: Faculty of Chemical and Food Technology
Course unit code: N436S1_4I
Course unit title: Systems for Evaluation of Contaminants in Foodstuffs
Mode of completion and Number of ECTS credits: Exam (3 credits)
Course contents:
1.The most important EU regulatory scheme requiring study of contaminants penetration into the food chain for the area: (allowance 8/0)
 
a.Plant protection products
b.Biocidal products
c.Veterinary drugs
d.REACH
e.Other related regulatory areas of the EU

2.Qualitative requirements of EU legislation for study of contaminants penetration into the food chain (allowance 6/0)
 
a.Quality assurance QA/QC and Good Laboratory Practice
b.Certification, accreditation and authorization
c.Quality system documents
External and internal quality control
d.Quality management: organization and personnel, quality assurance program, the demands for space and environment
Manual quality and standard operating procedures
e.Risk assessment of contaminants: precision and accuracy evaluations of studies as a prerequisite for the usability of data
f.Technical guidelines and instructions of the EU (TNsG) and selected OECD guidelines for testing of chemicals

3.Studies of metabolism and changes of chemicals in the environment and their penetration into the food chain (allowance 6/0)
 
a.The identity of chemical substances
Basic physico-chemical parameters and their influence on the metabolisms and changes of substances
b.Analytical methods including validation parameters for the determination of active substances and impurities for their monitoring in food of plant and animal origin, or feeding stuffs and other products
c.Studies focused on human exposure of foreign substances through the food chain
Studies focused on exposure of animals for food and feed exposure
Studies focused on exposure of the treated products - packaging materials intended to come into contact with food and disinfectants (biocidal products)
d.Exposure scenarios: overview, preparation, interpretation
Overview of the basic toxicological studies
Overview of the basic ecotoxicological studies

4.Planning, realisation and interpretation of studies and assessment principles of documentation according to different regulatory regions of the EU (allowance 6/0)
 
a.The documentation for active substances and preparations: content requirements, hierarchy, RSD preparation, database EU, relevance and use of IUCLID
b.Communication with the institutions of the EU: EFSA, ECHA, EMEA and the competent authorities of the EU member states
c.Evaluation (scoring) studies according to the EU legislation: practical examples
d.Preparation of documentation for risk assessment as a basis for decision making by competent EU institutions


Last modification made by Ing. Tomáš Molnár on 01/29/2019.

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