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ANNEX II
Part A: General specifications
Plastic material and articles shall not release primary aromatic amines in a detectable quantity (DL = 0,01 mg/kg
of food or food simulant). The migration of the primary aromatic amines appearing in the list in Annex I of this
document is excluded from this restriction.'

PART B:
Other Specifications

Ref. No
OTHER SPECIFICATIONS
11530
Acrylic acid, 2-hydroxypropyl ester.
It may contain up to 25% (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS N. 002918-23-2)
16690
Divinylbenzene
It may contain up to 45% of Ethylvinylbenzene.
18888
3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer
Definition
The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus 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
CH
3
|
CH
3
O
CH
2
O
|
||
|
||
(-O-CH-CH
2
-C-)m - (O-CH-CH
2
-C-)n
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).
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-hydroxypentanoic 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.
Migration
The migration of crotonic acid should not exceed 0.05 mg/kg food.
Restriction
QMA for crotonic acid is 0.05 mg/6 dmē
Purity
Prior to granulation the raw material copolymer powder must contain:
-Nitrogen
-Zinc
-Copper
-Lead
-Arsenic
-Chromium
Not more than 2500 mg/kg of plastic
Not more than 100 mg/kg of plastic
Not more than 5 mg/kg of plastic
Not more than 2 mg/kg of plastic
Not more than 1 mg/kg of plastic
Not more than 1 mg/kg of plastic
23547 Polydimethylsiloxane
(Mw>6800)
Minimum viscosity 100 x 10
-6
m
2
/s (=100 centistokes) at 25
o
C
24903
Syrups, hydrolysed starch, hydrogenated
In compliance with the purity criteria for maltitol syrup E 965(ii) (Commission Directive 95/31/EC of 5 July 1995
(O.J. L 178, 28.7.1995, p.1 as last amended by 2004/46/EC of 16 April 2004 (O.J. L 114, 21.04.2004, p.15 )
25385 Triallylamine
40 mg/kg hydrogel at a ratio of 1kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended
for non-direct food contact use.
38320 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)
stilbene
Not more than 0.05%w/w (quantity of substance used/quantity of the formulation)