Commission Directive 1999/91/EC of 23 November 1999 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 1999-11-23
Institutions: European Commission
Subjects: foodstuff, foodstuffs legislation, plastics

4. 12. 1999

EN

Official Journal of the European Communities

L 310/41

COMMISSION DIRECTIVE 1999/91/EC

of 23 November 1999

amending Directive 90/128/EEC relating to plastic materials and articles intended to come into
contact with foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(9)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/109/EEC of 21
December 1988 on the approximation of the laws of the
Member States relating to materials and articles intended to
come into contact with foodstuffs (1) and in particular Article 3
thereof,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 90/128/EEC is amended as follows:

After consulting the Scientific Committee on Food,

1. the fourth indent of Article 3(5) is deleted;

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

Commission Directive 90/128/EEC (2), as last amended
by Directive 96/11/EC (3), provides in Article 3(2) for the
revision of Annex II thereto.

On the basis of the information available, certain mono-
mers provisionally admitted at national
level may be
included in the Community list.

Other monomers have been requested for use following
the adoption of Directive 90/128/EEC: the technical data
supplied permit their inclusion in the Community list.

Annex III to Directive 90/128/EEC includes a list of
additives, which should be amended so as to include
other
Scientific
additives
Committee on Food.

evaluated by

fully

the

For certain substances, the restrictions already set out
should be amended according to the information avail-
able.

The current total list of additives is an incomplete list
inasmuch as it does not contain all the substances which
are currently accepted in one or more Member States;
accordingly, these substances continue to be regulated
by national laws pending a decision on inclusion in the
Community list.

This Directive establishes purity criteria for only a few
substances, and therefore the other substances which
may require purity criteria remain regulated in this
respect by national
laws pending a decision at
Community level.

The measures contained in this Directive do not go
is necessary to achieve the objectives
beyond what
already provided for in Directive 89/109/EEC.

(1) OJ L 40, 11.2.1989, p. 38.
(2) OJ L 75, 21.3.1990, p. 19.
(3) OJ L 61, 12.3.1996, p. 26.

2. Article 3a is replaced by the following:

‘Article 3a

An incomplete list of additives which may be used for the
manufacture of plastic materials and articles, together with
the restrictions on their use,

is set out in Annex III’;

3. the following Articles 3b and 3c are inserted:

‘Article 3b

Only the products obtained by means of bacterial fermenta-
tion listed in Annex IV may be used in contact with food-
stuffs.

Article 3c

The

specifications

substances
relating
1.
appearing in Annexes II, III and IV are laid down in Annex
V.

to some

The meaning of

2.
the numbers between brackets
appearing in the Column “Restrictions and/or specifications”
is explained in Annex VI’;

4. Annex II is amended as shown in Annex I to this Directive;

5. Annex III
Directive;

is amended as shown in Annex II

to this

6. the texts set out in Annex III to this Directive are added as

Annexes IV, V and VI.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive not later than 31 December 2000. They shall imme-
diately inform the Commission thereof.

Member States shall permit, as from 1 January 2002, the trade
in and use of plastic materials and articles intended to come
into contact with foodstuffs and complying with this Directive.

They shall prohibit, as from 1 January 2003, the manufacture
and importation into the Community of plastic materials and
articles intended to come into contact with foodstuffs and
which do not comply with this Directive.

L 310/42

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Official Journal of the European Communities

4. 12. 1999

2. When Member States adopt those provisions, they shall contain a reference to this Directive or be
accompanied by such a reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

This Directive shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Communities.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 23 November 1999.

For the Commission

Erkki LIIKANEN

Member of the Commission

4. 12. 1999

EN

Official Journal of the European Communities

L 310/43

ANNEX I

Annex II is amended as follows:

1. The fourth indent of paragraph 5 is replaced by the following:

‘— Column 4 (Restrictions and/or specifications). These may include:

— specific migration limit (SML),

— maximum permitted quantity of the substance in the finished material or article (QM),

— maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of

the surface in contact with foodstuffs (QMA),

— any other restriction specifically mentioned,

— any type of specifications related to the substance or to the polymer;’

2. The title of column 4 is modified to ‘Restrictions and/or specifications’;

3. Sections A and B are amended as shown in Appendices 1 to 5.

L 310/44

EN

Official Journal of the European Communities

4. 12. 1999

‘Appendix 1

List of monomers and other starting substances inserted in Section A of Annex II to Directive 90/128/EEC

PM/REF No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

12761

000693-57-2

12-Aminododecanoic acid

SML = 0,05 mg/kg

13180

000498-66-8

Bicyclo[2.2.1]hept-2-ene
nene)

(= norbor-

SML = 0,05 mg/kg

13210

001761-71-3

Bis(4-aminocyclohexyl)methane

SML = 0,05 mg/kg

14650

000079-38-9

Chlorotrifluoroethylene

QMA = 0,05 mg/6 dm2

14841

000599-64-4

4-Cumylphenol

SML = 0,05 mg/kg

16694

013811-50-2

N,N(cid:1)-Divinyl-2-imidazolidinone

QM = 5 mg/kg in FP

16704

000112-41-4

1-Dodecene

SML = 0,05 mg/kg

22331

025513-64-8

Mixture of (40 % w/w) 1,6-diamino-
2,2,4-trimethylhexane and (60 % w/
w)
1,6-diamino-2,4,4-trimethyl-
hexane

QMA = 5 mg/6 dm2

22550

000498-66-8

Norbornene

See “Bicyclo[2.2.1]hept-2-ene”

23175

000122-52-1

Phosphorous acid, triethyl ester

QM = ND (DL = 1 mg/kg in FP)

23547

009016-00-6
063148-62-9

Polydimethylsiloxane (MW > 6800)

In compliance with the specifications
laid down in Annex V

25080

001120-36-1

1-Tetradecene

SML = 0,05 mg/kg

25385

000102-70-5

Triallylamine

25927

027955-94-8

1,1,1-Tris(4-hydroxyphenyl)ethane

In compliance with the specifications
laid down in Annex V

QM = 0,5 mg/kg in FP. For use only
in polycarbonates

26155

001072-63-5

1-Vinylimidazole

QM = 5 mg/kg in FP

26320

002768-02-7

Vinyltrimethoxysilane

QM = 5 mg/kg in FP

26360

007732-18-5

Water

In compliance with Directive 98/83/EC

4. 12. 1999

EN

Official Journal of the European Communities

L 310/45

List of monomers and other starting substances in Section A of Annex II to Directive 90/128/EEC for which the
content of the column “Restriction and/or specifications” is modified

Appendix 2

PM/Ref No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

10060

000075-07-0

Acetaldehyde

SML(T) = 6 mg/kg (2)

13510

001675-54-3

2,2-Bis(4-hydroxyphenyl)propane
bis(2,3-epoxypropyl) ether (= BADGE)

SML(T) = 1 mg/kg (9)
Authorised until 1 January 2005

14200

000105-60-2

Caprolactam

SML(T) = 15 mg/kg (5)

14230

002123-24-2

Caprolactam, sodium salt

SML(T) = 15 mg/kg (5)
(expressed as caprolactam)

15760

000111-46-6

Diethyleneglycol

SML(T) = 30 mg/kg (3)

16990

000107-21-1

Ethyleneglycol

SML(T) = 30 mg/kg (3)

17160

000097-53-0

Eugenol

SML = ND (DL = 0,02 mg/kg, analyt-
ical tolerance included)

19540

000110-16-7

Maleic acid

SML(T) = 30 mg/kg (4)

19960

000108-31-6

Maleic anhydride

SML(T) = 30 mg/kg (4)
(expressed as maleic acid)

25360

—

Trialkyl(C5-C15)
epoxypropyl ester

acetic

acid, 2,3-

QM = 1 mg/kg in FP (expressed as
epoxy group, molecular weight = 43)

L 310/46

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Official Journal of the European Communities

4. 12. 1999

List of monomers and others starting substances deleted from Section B of Annex II to Directive 90/128/EEC

Appendix 3

PM/Ref No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

22428

051000-52-3

Neodecanoic acid, vinyl ester

List of monomers and other starting substances in Section B of Annex II to Directive 90/128/EEC for which the
content of the column “Restrictions and/or specifications” is modified

Appendix 4

PM/Ref No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

16690

001321-74-0

Divinylbenzene

QM = 1 mg/kg in FP or SML = ND
(DL = 0,02 mg/kg, analytical tolerance
included)

20590

000106-91-2

Methacrylic
ester

acid, 2,3-epoxypropyl

QM(T) = 5 mg/kg in FP (expressed as
epoxy group, molecular weight = 43)

22720

000140-66-9

4-tert-Octylphenol

See “4-(1,1,3,3-Tetramethylbutyl)phenol”

25185

000140-66-9

4-(1,1,3,3-Tetramethylbutyl)phenol
(= 4-tert-Octylphenol)

SML = ND (DL = 0,01 mgkg, analyt-
ical tolerance included)

4. 12. 1999

EN

Official Journal of the European Communities

L 310/47

List of monomers and other starting substances transferred from Section B to Section A of Annex II to Directive
90/128/EEC

Appendix 5

PM/Ref No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

11000

050976-02-8

Acrylic acid, dicyclopentadienyl ester

QMA = 0,05 mg/6 dm2

11245

002156-97-0

Acrylic acid, dodecyl ester

SML = 0,05 mg/kg (1)

12265

004074-90-2

Adipic acid, divinyl ester

QM = 5 mg/kg in FP. For use only as
comonomer

13060

004422-95-1

1,3,5-Benzenetricarboxylic
trichloride

acid

QMA = 0,05 mg/6 dm2 (measured as
1,3,5-benzenetricarboxylic acid)

13780

002425-79-8

1,4-Butanediol bis(2,3-epoxypropyl)
ether

QM = 1 mg/kg in FP (expressed as
epoxy group, molecular weight = 43)

14020

000098-54-4

4-tert-Butylphenol

SML = 0,05 mg/kg

15130

000872-05-9

1-Decene

SML = 0,05 mg/kg

16360

000576-26-1

2,6-Dimethylphenol

SML = 0,05 mg/kg

16450

000646-06-0

1,3-Dioxolane

SML = 0,05 mg/kg

18220

068564-88-5

N-Heptylaminoundecanoic acid

SML = 0,05 mg/kg (1)

18820

000592-41-6

1-Hexene

SML = 3 mg/kg

19060

000109-53-5

Isobutyl vinyl ether

QM = 5 mg/kg in FP

19150

000121-91-5

Isophthalic acid

SML = 5 mg/kg

19990

000079-39-0

Methacrylamide

= ND (DL

SML
analytical tolerance included)

= 0,02 mg/kg,

20050

000096-05-9

Methacrylic acid, allyl ester

SML = 0,05 mg/kg

20530

002867-47-2

Methacrylic acid, 2-(dimethyla-
mino)ethyl ester

SML = ND (DL = 0,02 mg/kg,
analytical tolerance included)

21730

000563-45-1

3-Methyl-1-butene

QMA = 0,006 mg/6 dm2. For use
only in polypropylene.

22937

001623-05-8

Perfluoropropyl perfluorovinyl ether

SML = 0,05 mg/kg

23770

000504-63-2

1,3-Propanediol

SML = 0,05 mg/kg

23920

000105-38-4

Propionic acid, vinyl ester

SML(T) = 6 mg/kg (2) (expressed as
acetaldehyde)

24760

026914-43-2

Styrenesulphonic acid

SML = 0,05 mg/kg

26170

003195-78-6

N-Vinyl-N-methylacetamide

QM = 2 mg/kg in FP’

L 310/48

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Official Journal of the European Communities

4. 12. 1999

ANNEX II

Annex III is amended as follows:

1. The fourth indent of paragraph 5 is replced by the following:

‘— Column 4 (Restrictions and/or specifications). These may include:

— specific migration limit (SML),

— maximum permitted quantity of the substance in the finished materil or article (QM),

— maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of

the surface in contact with foodstuffs (QMA),

— any other restriction specifically laid down,

— any type of specification related to the substance or to the polymer;’

2. The title of the column 4 is modified into ‘Restrictions and/or specifications’;

3.

‘Incomplete list of additives’

is amended as shown in Appendices 1, 2 and 3.

‘Appendix 1

List of additives inserted in Annex III to Directive 90/128/EEC

PM/REF No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

30080

004180-12-5

Acetic acid, copper salt

SML(T) = 30 mg/kg (7) (expressed as
copper)

30610

—

30612

—

aliphatic,

linear,
Acids, C2-C24,
monocarboxylic,
from natural oils
and fats, and their mono-, di- and
triglycerol esters (branched fatty acids
are
at naturally occurring levels
included)

Acids, C2-C24,
linear,
monocarboxylic, synthetic, and their
mono-, di- and triglycerol esters

aliphatic,

31530

123968-25-2

Acrylic acid, 2,4-di-tert-pentyl-6-[1-
(3,5-di-tert-pentyl-2-hydroxy-
phenyl)ethyl]phenyl ester

SML = 5 mg/kg

33801

34240

—

—

n-Alkyl(C10-C13)benzenesulphonic
acid

SML = 30 mg/kg

Alkyl(C10-C20)sulphonic acid, esters
with phenols

SML = 6 mg/kg. Authorised until 1
January 2002

36640

000123-77-3

Azodicarbonamide

For use only as a blowing agent

37360

000100-52-7

Benzaldehyde

38320

005242-49-9

4-(2-Benzoxa-
zolyl)-4(cid:1)-(5-methyl-2-ben-
zoxazolyl)stilbene

In compliance with note 10 in Annex
VI

In compliance with the specifications
laid down in Annex V

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Official Journal of the European Communities

L 310/49

PM/REF No

CAS No

(1)

(2)

38510

136504-96-6

Name

(3)

1,2-Bis(3-aminopropyl)ethylenedia-
mine, polymer with N-butyl-2,2,6,6-
tetramethyl-4-piperidinamine and
2,4,6-trichloro-1,3,5-triazine

Restrictions and/or specifications

(4)

SML = 5 mg/kg

38515

001533-45-5

4,4-Bis(2-benzoxazolyl)stilbene

SML = 0,05 mg/kg (1)

38810

080693-00-1

Bis(2,6-di-tert-butyl-4-
methylphenyl)pentaerythritol diphos-
phite

SML = 5 mg/kg (sum of phosphite
and phosphate)

38879

135861-56-2

Bis(3,4-dimethylbenzylidene)sorbitol

39200

006200-40-4

Bis(2-hydroxyethyl)-2-hydroxypropyl-
3-(dodecyloxy)methylammonium
chloride

SML = 1,8 mg/kg

39815

182121-12-6

9,9-Bis(metoxymethyl)fluorene

QMA = 0,05 mg/6 dm2

40120

—

Bis(polyethyleneglycol)
hydroxymethylphosphonate

SML = 0,6 mg/kg. Authorised until 1
January 2002

41680

000076-22-2

Camphor

42320

007492-68-4

Carbonic acid, copper salt

In compliance with note 10 in Annex
VI

SML(T) = 30 mg/kg (7) expressed as
copper)

43515

—

Chlorides
choline
coconut oil fatty acids

of

esters

of

QMA = 0,9 mg/6 dm2

45195

007787-70-4

Copper bromide

SML(T) = 30 mg/kg (7) (expressed as
copper)

45200

001335-23-5

Copper iodide

SML(T) = 30 mg/kg (7) (expressed as
= 1 mg/kg
copper)
(expressed as iodine)

SML

and

45450

068610-51-5

p-Cresol-dicyclopentadiene-isobuty-
lene, copolymer

SML = 0,05 mg/kg (1)

46880

065140-91-2

3,5-Di-tert-butyl-4-hydroxybenzyl
phosphonic acid, monoethyl ester,
calcium salt

SML = 6 mg/kg

47680

000111-46-6

Diethyleneglycol

SML(T) = 30 mg (3)

48460

000075-37-6

1,1-Difluoroethane

49485

134701-20-5

2,4-Dimethyl-6-(1-methylpenta-
decyl)phenol

SML = 1 mg/kg

51700

147315-50-2

2-(4,6-Dphenyl-1,3,5-triazin-2-yl)-5-
(hexyloxy)phenol

SML = 0,05 mg/kg

53610

054453-03-1

Ethylenediaminetetraacetic acid, copper

SML(T) = 30 mg/kg (7) (expressed as
copper)

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Official Journal of the European Communities

4. 12. 1999

PM/REF No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

53650

000107-21-1

Ethyleneglycol

SML(T) = 30 mg/kg (3)

54300

118337-09-0

2,2(cid:1)Ethylidenebis(4,6-di-tert-butyl-
phenyl) fluorophosphonite

SML = 6 mg/kg

54930

025359-91-5

Formaldehyde-1-naphthol,
copolymer
[=Poly(1-hydroxynaphthyl-methane)]

SML = 0,05 mg/kg

57800

018641-57-1

Glycerol tribehenate

60480

003864-99-1

2-(2-Hidroxy-3,5-di-tert-butyl-
phenyl)-5-
chlorobenzotriazole

SML = 30 mg/kg

66560

004066-02-8

2,2(cid:1)Methylenebis(4-methyl-6-cyclo-
hexylphenol)

SML(T) = 3 mg/kg (6)

66580

000077-62-3

2,2(cid:1)Methylenebis[4-methyl-6-(1-
methylcyclo-hexyl)phenol]

SML(T) = 3 mg/kg (6)

66755

002682-20-4

2-Methyl-4-isothiazolin-3-one

67170

67180

—

—

Mixture of (80 to 100 % w/w) 5,7-di-
tert-butyl-3-(3,4-dimethyphenyl)-2
(3H)-benzofuranone and (0 to 20 %
w/w)5,7-di-tert-butyl-3-(2,3-di-me-
thylphenyl)-2(3H)-benzofuranone

Mixture of (50 % w/w) phthalic acid,
n-decyl n-octyl ester,
(25 % w/w)
phthalic acid di-n-decyl ester, and
(25 % w/w) phthalic acid di-n-decyl
ester, and (25 % w/w) phthalic acid
di-n-octyl ester

SML = ND (LD = 0,02 mg/kg, analyt-
ical tolerance included)

SML = 5 mg/kg

SML = 5 mg/kg (1)

68145

080410-33-9

2,2(cid:1),2(cid:3)-Nitrilo[triethyl tris(3,3(cid:1),5,5(cid:1)-
tetra-tert-butyl-1,1(cid:1)-bi-phenyl-2,2(cid:1)-
diyl)phosphite]

SML = 5 mg/kg (sum of phosphite
and phosphate)

71635

025151-96-6

Pentaerythritol dioleate

73720

000155-96-8

Phosphoric acid, trichloroethyl ester

SML = 0,05 mg/kg. Not
for use in
polymers contacting foods for which
simulant D is laid down in Directive
85/572/EEC

SML = ND (LD = 0,02 mg/kg, analyt-
ical tolerance included)

74010

145650-60-8

Phosphorous acid, bis
butyl-6-methylphenyl) ethyl ester

(2,4-di-tert-

SML = 5 mg/kg (sum of phosphite
and phosphate)

76721

009016-00-6
063148-62-9

Polydimethylsiloxane (MW > 6800)

In compliance with the specifications
laid down in Annex V

76865

—

SML = 30 mg/kg

Poliyesters of 1,2-propanediol and/or
1,3- and 1,4-butanediol and/or poly-
propyleneglycol with adipic acid, also
end-capped with acetic acid or fatty
acids C10-C18 or n-octanol and/or
n-decanol

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Official Journal of the European Communities

L 310/51

PM/REF No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

77895

068439-49-6

Polyethyleneglycol(EO = 2-6) mono-
alkyl(C16-C18) ether

SML = 0,05 mg/kg

81515

087189-25-1

Poly(zinc glycerolate)

81760

—

Powders, flakes and fibres of brass,
bronze, copper, stainless steel,
tin
and alloys of copper, tin and iron

SML(T) = 30 mg/kg (7) (expressed as
copper); SML = 48 mg/kg (expressed
as iron)

85360

000109-43-3

Sebacic acid, dibutyl ester

85610

—

Silicates, natural, silanated (with the
exception of asbestos)

85840

053320-86-8

acid,
Silicic
sodium salt

lithium magnesium

SML(T) = 0,6 mg/kg (8) (expressed s
lithium)

86285

—

Silicon dioxide, silanated

88640

008013-07-8

Soybean oil, epoxidised

89200

007617-31-4

Stearic acid, copper salt

In compliance with the specificatins
laid down in Annex V

SML(T) = 30 mg/kg (7)
copper)

(expresed as

89440

—

Stearic acid, esters with ethylene-
glycol

SML(T) = 30 mg/kg (3)

92030

010124-44-4

Sulphuric acid, copper salt

SML(T) = 30 mg/kg (7) (expressed as
copper)

92700

078301-43-6

2,2,4,4-Tetramethyl-20-
(2,3-epoxypropyl)-7-oxa-3,20-diaza-
dispiro[5.1.11.2]-heneicosan-21-one,
polymer

SML = 5 mg/kg

92930

120218-34-0

Thiodiethanolbis(5-methoxycarbo-
nyl-2,6-dimethyl-1,4-dihydropyri-
dine-3-carboxylate)

SML = 6 mg/kg

94960

000077-99-6

1,1,1-Trimethylopropane

SML = 6 mg/kg

95725

110638-71-6

Vermiculite,
citric acid,

reaction product with

lithium salt

SML(T) = 0,6 mg/kg (8) (expressed as
lithium)

95855

007732-18-5

Water

In compliance with Directive 98/83/EC

95859

95883

—

—

Waxes, refined, derived from petro-
leum based or synthetic hydrocarbon
feedstocks

In compliance with the specifications
laid down in Annex V

White mineral oils, paraffinic, derived
from petroleum based hydrocarbon
feedstocks

In compliance with the specifications
laid down in Annex V

L 310/52

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Official Journal of the European Communities

4. 12. 1999

List of additives in Annex III to Directive 90/128/EEC for which the content of column “CAS No” is modified

Appendix 2

PM/REF No

CAS No

(1)

(2)

39890

087826-41-3
069158-41-4
054686-97-4
081541-12-0

Name

(3)

Restrictions and/or specifications

(4)

Bis(methylbenzylidene)sorbitol

68125

037244-96-5

Nepheline syenite

Appendix 3

List of additives in Annex III to Directive 90/128/EEC deleted

PM/REF No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

76720

009016-00-6
063148-62-9

Polydimethylsiloxane’

4. 12. 1999

EN

Official Journal of the European Communities

L 310/53

The following Annexes IV, V and VI are added:

ANNEX III

‘ANNEX IV

PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION

PM/REf No

CAS No

(1)

(2)

Name

(3)

Restrictions
and/or specifications

(4)

18888

80181-31-3

3-hydroxybutanoic
xypenta-noic acid, copolymer

acid-3-hydro

SML = 0,05 mg/kg for crotonic acid (as
impurity) and in compliance with the
specifications laid down in Annex IV.

ANNEX V

SPECIFICATIONS

Part A: General specifications

(to be fixed later)

Part B: Other specifications

PM/Ref No

Other specifications

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-hydroxybutanoate-co-3-D-hydroxypentanoate)

— CAS No

80181-31-3

— Structural formula

CH3

CH2

O

CH3

O

C-)m - (

CH-CH2-

(-O-
where n/(m + n) greater than 0 and less or
equal to 0,25

O-CH-CH2-

C-)n

L 310/54

EN

Official Journal of the European Communities

4. 12. 1999

PM/Ref No

Other specifications

— Average molecular weight Not less than 150 000 daltons (measured by gel permeation chro-

matography).

— Assay

Description

Characteristics

— Identification tests:

— Solubility

less

than

Not
poly(3-D-hydroxybutanoato-co-3-D-
hydroxypentanoato) analysed after hydrolysis as a mixture of 3-D-
hydroxybutanoic and 3-D-hydroxypentanoic acids.

98 %

White to off-white powder after isolation

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

— Copper

— Lead

— Arsenic

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

— Chromium

Not more than 1 mg/kg of plastic.

POLYDIMETHYLSILOXANE (Mw > 6 800)
Minimum viscosity 100 × 10-6 m2/s (= 100 centistokes) at 25 °C

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-(2-BENZOXAZOLYL)-4'-(5-METHYL-2-BENZOXAZOLYL) STILBENE
Not more than 0,05 % w/w (quantity of substance used/quantity of the formulation)

POLYDIMETHYLSILOXANE (Mw > 6 800)
Minimum viscosity 100 × 10-6 m2/s (=100 centistokes) at 25 °C

SOYBEAN OIL, EPOXIDISED
Oxirane < 8 %,

iodine number < 6

WAXES, REFINED, DERIVED FROM PETROLEUM BASED OR SYNTHETIC HYDROCARBON FEED-
STOCKS
The product should 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

WHITE MINERAL OILS, PARAFFINIC DERIVED FROM PETROLEUM BASED HYDROCARBON
FEEDSTOCKS
The product should 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

23547

25385

38320

76721

88640

95859

95883

4. 12. 1999

EN

Official Journal of the European Communities

L 310/55

ANNEX VI

NOTES RELATED TO THE COLUMN “RESTRICTIONS AND/OR SPECIFICATIONS”

(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the
following substances mentioned as PM/REF Nos: 10060 and 23920.

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the
following substances mentioned as PM/REF Nos: 15760, 16990, 47680, 53650, 89440.

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the
following substances mentioned as PM/REF Nos: 19540, 19960.

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the
following substances mentioned as PM/REF Nos: 14200, 14230.

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the
following substances mentioned as PM/REF Nos: 66560 and 66580.

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the
following substances mentioned as PM/REF Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200, 92030.

SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the
following substances mentioned as PM/REF Nos: 85840 and 95725.

SML(T) = in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of
the following substances:

(a) Badge (=2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether:

(b) Badge.H

O.
2

(d) Badge.HCl.

(e) Badge.2HCl

(f) Badge.H

2O.HCl

However in aqueous food simulants, the SML(T) should also include Badge.2H
2O (c) unless the material or article is
labelled for use in contact only with those foods and/or beverages for which it has been demonstrated that the sum
of the migration levels of the five abovementioned substances (a)(b)(d)(e)(f) cannot exceed 1 mg/kg.

(10) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food
in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive
89/109/EEC.’