from the earth - into the earth Biomaterials in contact with food Urs J. Hänggi, Biomer

from the earth - into the earth COMMISSION DIRECTIVE 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs

from the earth - into the earth 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.

from the earth - into the earth Any substance not included in CD 2002/72/EC is forbidden!

from the earth - into the earth 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

from the earth - into the earth 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

from the earth - into the earth PLA: - Monomer is considered safe - Is in use in medicine for decades  accepted for food packages

from the earth - into the earth 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

from the earth - into the earth 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

from the earth - into the earth 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:

from the earth - into the earth 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)