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Biomaterials in contact with food
Urs J. Hänggi, Biomer
[email protected]
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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 <1000 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:
3-Hydroxybutanoic·acid-3-hydroxypentanoic·acid,·copolymer ¶
Definition· ¶
The·copolymers·are·produced·by·the·controlled
fermentation·of·Alcaligenes·eutrophus·cepa·using·mixtures
of·glucose·and·propanoic·acid·as·carbon·sources.·The
organism·used·has·not·been·genetically·engineered·and·has
been·derived·froma·single·wild-type·organism· Alcaligenes
eutrophus·strain·HI6·NCIMB·10442.·Master·stocks·of·the
organismare·stored·as·freeze-dried·ampoules.·A
submaster/working·stock·is·prepared·from·the·master
stock·and·stored·in·liquid·nitrogen·and·used·to·prepare
inocula·for·the·fermenter.·Fermenter·samples·will·be
examined·daily·both·microscopically·and·for·any·changes·in
colonial·morphology·on·a·variety·of·agars·at·different
temperatures.·The·copolymers·are·isolated·from·heat
treatment·bacteria·by·controlled·digestion·of·the·other
cellular·components,·washing·and·drying.·These
copolymers·are·normally·offered·as·formulated,·melt
formed·granules·containing·additives·such·as·nucleating
agents,·plasticisers,·fillers,·stabilisers·and·pigments·which
all·conform·to·the·general·and·individual·specifications. ¶
Average·molecular
Not·less·than·150·000·Daltons·(measured·by·gel
weight¶
permeation·chromotography).¶
Assay¶
Not·less·than·98·%·poly(3-D-hydroxybutanoate-co-3-Dhydroxypentanoate)·analysed·after·hydrolysis·as·a·mixture
of·3-D-hydroxybutanoic·and·3-D-hydroxypentanoic·acids.¶
Migration·¶
The·migration·of·crotonic·acid·should·not·exceed·0,05
mg/kg·food.¶
Purity·¶
Prior·to·granulation·the·raw·material·copolymer·powder
must·contain:¶
¶
—·Nitrogen·Not·more·than·2·500·mg/kg·of·plastic¶
¶
—·Zinc·Not·more·than·100·mg/kg·of·plastic¶
—·Copper·Not·more·than·5·mg/kg·of·plastic¶
¶
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—·Lead·Not·more·than·2·mg/kg·of·plastic¶
¶
—·Arsenic·Not·more·than·1·mg/kg·of·plastic¶
¶
—·Chromium·Not·more·than·1·mg/kg·of·plastic¶
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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)