Schedule 4

“SCHEDULE 2B

SPECIFICATIONS

Regulation 7A

Item PM/REF No. Specifications

1 18888 3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER
Definition These 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 H16 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-hydroxybutanoato-co-3-D-hydroxypentanoate).
CAS number 80181-31-3.
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- hydroxybutanoato-co-3-D-hydroxypentanoate) 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.
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
2 23547
POLYDIMETHYLSILOXANE (MW>6800)

Minimum viscosity 100 centistokes at 25°C

3 25385
TRIALLYLAMINE

40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use.

4 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)

5 76721
POLYDIMETHYLSILOXANE (Mw>6800)

Minimum viscosity 100 × 10-6 m2/s (=100 centistokes) at 25°C

6 88640
SOYBEAN OIL, EPOXIDIZED

Oxirane <8%, iodine number <6

7 95859
WAXES, REFINED DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON FEEDSTOCKS

The product shall have the following specifications:

Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)

Viscosity not less than 11 × 10-6 m2/s (=11 centistokes) at 100°C

Average molecular weight not less than 500

8 95883
WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON FEEDSTOCKS

The product shall have the following specifications:

Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w)

Viscosity not less than 8.5 × 10-6 m2/s (=8.5 centistokes) at 100°C

Average molecular weight not less than 480

”

Item	PM/REF No.	Specifications
1	18888	3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPOLYMER
		Definition	These 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 H16 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-hydroxybutanoato-co-3-D-hydroxypentanoate).
		CAS number	80181-31-3.
		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- hydroxybutanoato-co-3-D-hydroxypentanoate) 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.
		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
2	23547	POLYDIMETHYLSILOXANE (MW>6800) Minimum viscosity 100 centistokes at 25°C
3	25385	TRIALLYLAMINE 40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1.5 grams of hydrogel. For use only in hydrogels intended for non-direct food contact use.
4	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)
5	76721	POLYDIMETHYLSILOXANE (Mw>6800) Minimum viscosity 100 × 10-6 m2/s (=100 centistokes) at 25°C
6	88640	SOYBEAN OIL, EPOXIDIZED Oxirane <8%, iodine number <6
7	95859	WAXES, REFINED DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON FEEDSTOCKS The product shall have the following specifications: Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) Viscosity not less than 11 × 10-6 m2/s (=11 centistokes) at 100°C Average molecular weight not less than 500
8	95883	WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON FEEDSTOCKS The product shall have the following specifications: Content of mineral hydrocarbons with carbon number less than 25: not more than 5% (w/w) Viscosity not less than 8.5 × 10-6 m2/s (=8.5 centistokes) at 100°C Average molecular weight not less than 480