Food Contact MaterialsConsulting, Testing and Registration
Services
Harlan Laboratories is a market leader with over 25 years of
experience in services for food contact materials.
Analytics & Migration TestingHarlan Laboratories analytical
laboratories are accredited as testing facilities according to the
international standard ISO 17025.
We offer migration testing with new food contact substances as
well as compliance testing of final food contact materials and
articles, including plastics and polymers, multi-layer materials,
paper & board and coatings.
Overall and specific migration Migration modelling Determination
of actual contents in polymers End tests according to FDA (21 CFR
170-199) Paper compliance testing according to BfR Analysis
according to EU Pharmacopoeia Determination of migrants: monomers,
additives, oligomers and
degradation products Determination of heavy metals and residual
solvents Development and validation of methods Characterisation of
polymers and polymeric additives (GPC) Determination of hydrolysis
in digestive fluids Reporting of analytical methods according to
CEN standard format
Regulatory ServicesGuidance through the registration process for
approval of new substances in food contact materials:
Consulting on registration strategies Design of test programmes
for migration and toxicological studies Evaluation of test reports
and data gap analysis Study monitoring & coordination Dossier
compilation & submission Negotiations with authorities
Preparation of expert reports and safety assessments
Purpose: Inclusion of new monomers and additives for plastic
materials in
Regulation (EU) No 10/2011 Clearance of new substances at US-FDA
by food contact
notifications (FCN) Inclusion of substances in positive lists of
EU member states, e.g.
the German BfR recommendations
Further services for packaging materials: Compilation of Drug
Master Files (Type III) Packaging materials Compliance check for
pharmaceutical packaging according to
requirements of European Pharmacopoeia
Harlan Laboratories
Toxicology testing Genotoxicity testing Short- and long term
toxicity testing Carcinogenicity studies Metabolism and
accumulation studies Reproduction toxicity studies
Harlan, Harlan Laboratories and the Harlan logo are trademarks
of Harlan Laboratories, Inc.
2012 Harlan Laboratories, Inc.www.harlan.com /crs
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Were Harlan Laboratories.
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