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ANNEX IV
In Annex V the previous specifications in part B for reference No 16690 and 18888 are replaced by the following and
new specifications are added for reference No 11530 and 77895
`Reference
No
OTHER SPECIFICATIONS
11530
Acrylic acid, 2-hydroxypropyl ester.
It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 002918-23-2)
16690
Divinylbenzene
It may contain up to 45 % (m/m) of Ethylvinylbenzene
18888
3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer
Definition
The copolymers are produced by the controlled fermentation of Alcaligenes eutro-
phus 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
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
Chemical name
Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
CAS number
080181-31-3
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 chromatography)
Assay
Not
less
than
98 %
poly(3-D-hydroxybutanoate-co-3-D-hydoxypentanoate)
analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxy-
pentanoic acids
Description
White to off-white powder after isolation
Characteristics
Identification tests:
Solubility
Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but
practically insoluble in ethanol, aliphatic alkanes and water
Restriction
QMA for crotonic acid is 0.05 mg/6 dm
2
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
-- 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
10.3.2004
L 71/18
Official Journal of the European Union
EN