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Official Journal of the European Communities
L 220/53
Ref. No
Part A: General specifications
The material and article manufactured by using aromatic isocyanates or colorants prepared by diazo-coupling, shall not
release primary aromatic amines (expressed as aniline) in a detectable quantity (DL = 0,02 mg/kg of food or food
simulant, analytical tolerance included). However, the migration value of the primary aromatic amines listed in this
Directive are excluded from this restriction.
Part B: Other specifications
It may contain up to 40 % of Ethylvinylbenzene.
3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer
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 from a single wild-type organism Alcaligenes eutrophus
strain HI6 NCIMB 10442. Master stocks of the organism are 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 microscopi-
cally 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.
Chemical name
CAS number
Structural formula
where n/(m + n) greater than 0 and less or equal to 0,25
Average molecular weight
Not less than 150 000 Daltons (measured by gel permeation chromotography).
Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) analysed after hydrol-
ysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids.
White to off-white powder after isolation
Identification tests:
Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically
insoluble in ethanol, aliphatic alkanes and water.
The migration of crotonic acid should not exceed 0,05 mg/kg food.
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