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Biomaterials in contact with food Urs J. Hänggi,
Biomer hanggi_at_biomer.de
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COMMISSION DIRECTIVE 2002/72/EC of 6 August
2002 relating to plastic materials and articles
intended to come into contact with foodstuffs
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Food contact materials (plastics) The general
problem arising from the use of food contact
materials derives from their content of
substances capable of migrating into the
contacted food. Therefore, to protect the
consumer, an assessment of the potential hazards
from oral exposure to those constituents that
migrate into the food must be made.
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Any substance not included in CD 2002/72/EC is
forbidden!
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Consequences in case of real or perceived
damage - if not included producer behaves
illegal and thus has to proof that damage is
not due to his substances (actually
impossible) - if included consumer has to proof
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Base for testing - toxicology of mono- and
oligomers as polymerization never is 100
percent! - toxicology of all additives with mw
lt1000 Da as substances larger than 1000 Da are
not expected to harm
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PLA - Monomer is considered safe - Is in use in
medicine for decades ? accepted for food
packages
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PHB (polyhydroxybutyrate) - toxicology of mono-
and oligomers ? no mono- or oligomers ?
therefore no legal base for evaluation -
however impurities originating from biomass ?
hundreds of unknown substances ? these might be
more dangerous than known substances ?
full program
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Dilemma - PHB and producing strains are known
to be safe ? no need to evaluate - however
liability (desperate or viscious people tend to
sue) ? no insurance is accepting such a risk ?
full program
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ANNEX IV (of CD 2002/72/EC) PRODUCTS OBTAINED BY
MEANS OF BACTERIAL FERMENTATION 3-Hydroxybutanoic
acid-3-hydroxypentanoic acid,-copolymer
(PHB/HV) SML 0,05 mg/kg for Crotonic acid (as
impurity) and in compliance with the
specifications laid down in Annex VPLA
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Suggestion to EU? As long as limits are met,
and as long as producing strain is considered as
safe), PHB of all sources should be
allowed. ) microbial class B0 (B zero)