Commission Directive 2001/62/EC of 9 August 2001 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 2001-08-09
Institutions: European Commission
Subjects: foodstuff, foodstuffs legislation, plastics

L 221/18

EN

Official Journal of the European Communities

17.8.2001

COMMISSION DIRECTIVE 2001/62/EC

of 9 August 2001

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,

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,

After consulting the Scientific Committee on Food,

Whereas:

Silicones should be regarded as elastomeric materials
rather than plastic materials and therefore should be
deleted from the definition of plastics.

The determination of a quantity of a substance in a
finished material or article is simpler than the deter-
mination of its specific migration level. The verification
of compliance through the determination of quantity
rather than specific migration level should therefore be
permitted under certain conditions.

For certain types of plastics, the availability of generally
recognised diffusion models based on experimental data
allows
the migration level of a
substance under certain conditions, therefore avoiding
complex, costly and time-consuming testing.

the estimation of

Recent collaborative tests indicate that there is greater
variability in the results of analysis for the determination
of overall migration of substances used in plastics when
aqueous food simulants as well as volatile media such as
isooctane, ethanol and other similar solutions are used.

Besides the monomers and other starting substances
fully evaluated and authorised at Community level, there
are also monomers and starting substances evaluated
and authorised in at least one Member State, use of
which may be continued pending their evaluation by the
Scientific Committee on Food and the decision on their
inclusion in the Community list.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(10)

(11)

Commission Directive 90/128/EEC of 23 February 1990
relating to plastic materials and articles intended to
come into contact with foodstuffs (2), as last amended by
Directive 1999/91/EC (3), may be included in the
Community list of approved substances.

For certain substances, the restrictions already estab-
lished at Community level should be amended on the
basis of the information available.

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 only pending a decision on inclusion in
the Community list.

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

For certain additives the restrictions established in this
Directive cannot yet be applied in all situations pending
the collection and evaluation of all the data needed for a
better estimation of the exposure of the consumer in
some
these additives
appear in a list other than that of the additives fully
regulated at Community level.

specific situations. Therefore,

In accordance with the principle of proportionality, it is
necessary and appropriate for the achievement of the
basic objective of ensuring the free movement of plastic
materials and articles intended to come into contact
with foodstuffs, to lay down rules on the definition of
plastics and admitted substances. This Directive confines
itself to what is necessary in order to achieve the objec-
tives pursued in accordance with the third paragraph of
Article 5 of the Treaty.

(12) Directive 90/128/EEC should therefore be amended

accordingly.

On the basis of the new information available to the
Scientific Committee on Food, certain monomers provi-
sionally admitted at national
level as well as other
monomers requested for use following the adoption of

(13)

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

(1) OJ L 40, 11.2.1989, p. 38.

(2) OJ L 75, 21.3.1990, p. 19.
(3) OJ L 310, 4.12.1999, p. 41.

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Official Journal of the European Communities

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HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 90/128/EEC is amended as follows:

1. In Article 1, paragraph 3 is replaced by the following:

For the purposes of

this Directive, “plastics” shall
‘3.
mean the organic macromolecular compounds obtained by
polymerisation, polycondensation, polyaddition or any
other similar process from molecules with a lower molec-
ular weight or by chemical alteration of natural macro-
moles. Other substances or matter may be added to such
macromolecular compounds.

However, the following shall not be regarded as “plastics”:

(i) varnished or unvarnished regenerated cellulose film,
covered by Commission Directive 93/10/EEC (*);

(ii) elastomers and natural and synthetic rubber;

(iii) paper and paperboard, whether modified or not by the

addition of plastics;

(iv) surface coatings obtained from:

— paraffin waxes, including synthetic paraffin waxes,

and/or micro-crystalline waxes,

— mixtures of the waxes listed in the first indent with

each other and/or with plastics;

(v) ion-exchange resins;

(vi) silicones.

(*) OJ L 93, 17.4.1993, p. 27.’

2. In Article 3, paragraphs 4 and 5 are replaced by the

following:

‘4.
Only those monomers and other starting substances
listed in Annex II, Section A, shall be used for the manu-
facture of plastic materials and articles, subject
to the
restrictions specified therein.

By way of derogation from the first subparagraph,
the
monomers and other starting substances listed in Annex
II, Section B, may continue to be used until 31 December
the latest, pending their evaluation by the
2004 at
Scientific Committee on Food.

The lists appearing in Annex II, Sections A and B,
starting

5.
do not
substances used only in the manufacture of:

include monomers

and other

yet

— surface coatings obtained from resinous or polymer-
ised products in liquid, powder or dispersion form,
such as varnishes,

lacquers, paints, etc.,

— epoxy resins,

— adhesives and adhesion promoters,

— printing inks.’

3. 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 restrictions and/or specifications on their use,
out in Annex III, Sections A and B.

is set

For the substances in Annex III, Section B, the specific
migration limits are applied as from 1 January 2004
when the verification of compliance is carried out
in
simulant D or in test media of substitute tests as laid
down in Directives 82/711/EEC and 85/572/EEC.’

4. In Article 3c, paragraph 1 is replaced by the following:

‘1.
General specifications related to plastics materials
and articles are laid down in Annex V, part A. Other
specifications
related to some substances appearing in
Annexes II, III and IV are laid down in Annex V, part B.’

5. In Article 5, the following paragraph 4 is added:

The verification of compliance with the specific
‘4.
migration limits provided for in paragraph 1 may be
ensured by the determination of
the quantity of a
substance in the finished material or article provided that
a relationship between that quantity and the value of the
specific migration of the substance has been established
either by an adequate experimentation or by the applica-
tion of generally recognised diffusion models based on
scientific evidence. To demonstrate the non-compliance of
a material or article, confirmation of the estimated migra-
tion value by experimental testing is obligatory.’

6. Annexes I,

II,

III, V and VI are amended as set out in

Annexes I to V to this Directive.

Article 2

The requirements
introduced by this Directive shall not
apply to materials and articles containing the substances
regulated by the Directive which have been put
into free
circulation in the Community before 1 December 2002.

Article 3

Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 30 November 2002 at latest. They shall forth-
with inform the Commission thereof.

these provisions,

When Member States adopt
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.

Article 4

This Directive shall enter
into force on the 20th day
following its publication in the Official Journal of the European
Communities.

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Official Journal of the European Communities

17.8.2001

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 9 August 2001.

For the Commission

David BYRNE

Member of the Commission

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L 221/21

ANNEX I

In Annex I, paragraph 7, the second indent is replaced by the following:

‘— 12 mg/kg or 2 mg/dm2 in migration tests using the other simulants referred to in Directives 82/711/EEC and

85/572/EEC.’

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Official Journal of the European Communities

17.8.2001

ANNEX II

Annex II is amended as follows:

1. Section A is amended as follows:

(a) The following monomers and other starting substances are inserted:

Ref. No

CAS No

Name

Restrictions and/or specifications

‘12763

00141-43-5

2-Aminoethanol

SML = 0,05 mg/kg. Not for use in
polymers contacting foods for which
simulant D is laid down in Directive
food
85/572/EEC and for
contact only, behind the PET layer

indirect

12765

84434-12-8

N-(2-aminoethyl)-beta-alanine,
sodium salt

SML = 0,05 mg/kg

13395

04767-03-7

2,2-Bis(hydroxymethyl)propio-
nic acid

QMA = 0,05 mg/6 dm2

15030

00931-88-4

Cyclooctene

SML = 0,05 mg/kg. For use only in
polymers contacting foods for which
simulant A is laid down in Directive
85/572/EEC

19110

04098-71-9

1-Isocyanato-3-isocyanatomethyl-
3,5,5-trimethylcyclohexane

QM(T) = 1 mg/kg in FP (as NCO)

21765

106246-33-7

4,4(cid:1)-Methylenebis(3-chloro-2,6-
diethylaniline)

QMA = 0,05 mg/6 dm2

22778

07456-68-0

4,4(cid:1)-Oxybis(benzenesulphonyl
azide)

QMA = 0,05 mg/6 dm2

24073

000101-90-6

Resorcinol diglycidyl ether

QMA = 0,005 mg/6 dm2. Not
for
use in polymers contacting foods for
which simulant D is laid down in
Directive 85/572/EEC and for indirect
food contact only, behind the PET
layer’

(b) For the following monomers and other starting substances, the content of the column ‘Restrictions and/or

specifications’

is replaced by the following:

Ref. No

CAS No

Name

Restrictions and/or specifications

‘13510

01675-54-3

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

According to Commission Directive
2001/61/EC of 8 August 2001 on the
use of certain epoxy derivatives in
materials and articles
intended to
come into contact with foodstuffs (OJ
L 215, 9.8.2001, p. 26).

13610

01675-54-3

Bisphenol A bis(2,3-epoxypropyl)
ether

See “2,2-Bis(4-hydroxyphenyl)propane
bis(2,3-epoxypropyl) ether”

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Ref. No

CAS No

Name

Restrictions and/or specifications

14200

14230

0105-60-2

Caprolactam

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

02123-24-2

Caprolactam, sodium salt

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

(expressed as

15970

00611-99-4

4,4(cid:1)-Dihydroxybenzophenone

SML(T) = 6 mg/kg (15)

17260

00050-00-0

Formaldehyde

SML(T) = 15 mg/kg (22)

18670

00100-97-0

Hexamethylenetetramine

SML(T) = 15 mg/kg (22)
formaldehyde)

(expressed as

19540

00110-16-7

Maleic acide

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

19960

00108-31-6

Maleic anhydride

23050

00108-45-2

1,3-Phenylenediamine

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

(expressed as

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

ana-

(c) The following monomers and other starting substances are transferred from section B to section A:

Ref. No

CAS No

Name

Restrictions and/or specifications

‘11530

00999-61-1

Acrylic acid, 2-hydroxypropyl ester

QMA = 0,05 mg/6 dm2

13617

00080-09-1

Bisphenol S

See “4,4(cid:1)-Dihydroxydiphenylsulphone”

13810

00505-65-7

1,4-Butanediol formal

QMA = 0,05 mg/6 dm2

13932

00598-32-3

3-Buten-2-ol

QMA = ND
(DL = 0,02 mg/6 dm2)
To be used only as a co-monomer for
the preparation of polmeric additive

15370

03236-53-1

1,6-Diamino-2,2,4-trimethylhexane

QMA = 5 mg/6 dm2

15400

03236-54-2

1,6-Diamino-2,4,4-trimethylhexane

QMA = 5 mg/6 dm2

15610

00080-07-9

4,4(cid:1)-Dichlorodiphenyl sulphone

SML = 0,05 mg/kg

16090

00080-09-1

4,4(cid:1)-Dihydroxydiphenyl sulphone

SML = 0,05 mg/kg

16390

00126-30-7

2,2-Dimethyl-1,3-propanediol

SML = 0,05 mg/kg

19243

00078-79-5

Isoprene

Voir “2-Methyl-1,3-butadiene”

19490

00947-04-6

Laurolactam

SML = 5 mg/kg

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17.8.2001

Ref. No

CAS No

Name

Restrictions and/or specifications

20260

20410

00101-43-9

Methacrylic acid, cyclohexyl ester

SML = 0,05 mg/kg

02082-81-7

Methacrylic acid, diester with 1,4-
butanediol

SML = 0,05 mg/kg

20590

00106-91-2

Methacrylic acid, 2,3-epoxypropyl
ester

QMA = 0,02 mg/6 dm2

21520

01561-92-8

Methallylsulphonic acid, sodium salt

SML = 5 mg/kg

21640

00078-79-5

2-Methyl-1,3-butadiene

QM = 1 mg/kg in FP or SML = ND
toler-
(DL = 0,02 mg/kg,
ance included)

analytical

21821

00505-65-7

1,4-(Methylenedioxy)butane

See “1,4-Butanediol formal”

22360

01141-38-4

2,6-Naphthalenedicarboxylic acid

SML = 5 mg/kg

22437

00126-30-7

Neopentylglycol

See “2,2-Dimethyl-1,3-propanediol”

22900

00109-67-1

1-Pentene

SML = 5 mg/kg

25380

—

Trialkyl acetic acid (C7-C17), vinyl
esters (= vinyl versatate)

QMA = 0,05 mg/6 dm2

25450

26896-48-0

Tricyclodecanedimethanol

SML = 0,05 mg/kg

25900

00110-88-3

Trioxane

SML = 0,05 mg/kg’

2. Section B is replaced by the following:

‘SECTION B

List of monomers and other starting substances which may continue to be used pending a decision on
inclusion in Section A

Ref. No

CAS No

Name

Restrictions and/or specifications

10599/90A

61788-89-4

Acids, fatty, unsaturated (C18),
dimers, distilled

10599/91

61788-89-4

Acids, fatty, unsaturated (C18),
dimers, non-distilled

10599/92A

68783-41-5

Acids, fatty, unsaturated (C18),
dimers, hydrogenated, distilled

10599/93

68783-41-5

Acids, fatty, unsaturated (C18),
dimers, hydrogenated, non-distilled

11500

00103-11-7

Acrylic acid, 2-ethylhexyl ester

13050

00528-44-9

1,2,4-Benzenetricarboxylic acid

See “Trimellitic acid”

13075

00091-76-9

Benzoguanamine

See “2,4-Diamino-6-phenyl-1,3,5-triazine”

13720

00110-63-4

1,4-Butanediol

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Ref. No

CAS No

Name

Restrictions and/or specifications

14260

14800

15310

15730

16210

16690

16697

17110

18370

18700

21370

21400

21970

22210

25540

25550

00502-44-3

Caprolactone

03724-65-0

Crotonic acid

00091-76-9

2,4-Diamino-6-phenyl-1,3,5-triazine

00077-73-6

Dicyclopentadiene

06864-37-5

3,3(cid:1)-Dimethyl-4-4(cid:1)-diaminodicyclo-
hexylmethane

01321-74-0

Divinylbenzene

00693-23-2

Dodecanedioic acid

16219-75-3

5-Ethylidenebicyclo[2.2.1]hept-2-ene

00592-45-0

1,4-Hexadiene

00629-11-8

1,6-Hexanediol

10595-80-9

Methacrylic acid, 2-sulphoethyl ester

54276-35-6

Methacrylic acid, sulphopropyl ester

00923-02-4

N-methylolmethacrylamide

00098-83-9

Alpha-methylstyrene

00528-44-9

Trimellitic acid

QM(T) = 5 mg/kg in FP

00552-30-7

Trimellitic anhydride

QM(T) = 5 mg/kg in FP (expressed as
trimellitic acid)

25840

03290-92-4

1,1,1-Trimethylolpropane trimetha-
crylate

26230

00088-12-0

Vinylpyrrolidone’

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Official Journal of the European Communities

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ANNEX III

Annex III is amended as follows:

1. The table ‘Incomplete list of additives’

is amended as follows:

(a) The title is replaced by the following:

‘SECTION A

Incomplete list of additives fully harmonised at Community level’

(b) The following additives are inserted:

Ref. No

CAS No

Name

Restrictions and/or specifications

‘35160

06642-31-5

6-Amino-1,3-dimethyluracil

SML = 5 mg/kg

35170

00141-43-5

2-Aminoethanol

35284

00111-41-1

N-(2-aminoethyl)ethanolamine

38840

154862-43-8

Bis(-2,4-dicumylphenyl)
pentaerythritoldiphosphite

SML = 0,05 mg/kg. Not
for use in
polymers contacting foods for which
simulant D is laid down in Directive
85/572/EEC and for
food
contact only, behind the PET layer

indirect

SML = 0,05 mg/kg. Not
for use in
polymers contacting foods for which
simulant D is laid down in Directive
85/572/EEC and for
food
contact only, behind the PET layer

indirect

sum of

the
(as
SML = 5 mg/kg
substance itself, its oxidised form bis
(2,4-dicumylphenyl)pentaerythritol-
phosphate and its hydrolysis product
(2,4-dicumylphenol)

39925

129228-21-3

3,3-Bis(methoxymethyl)-2,5 -
dimethyl hexane

SML = 0,05 mg/kg

40020

110553-27-0

2,4-Bis(octylthiomethyl)-6-methyl-
phenol

SML = 6 mg/kg

41120

10043-52-4

Calcium chloride

41840

00105-60-2

Caprolactam

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

47210

26427-07-6

Dibutylthiostannoic acid polymer
[= thiobis(butyl-tin sulphide),
polymer]

In compliance with the specifications
laid down in Annex V

47540

27458-90-8

Di-tert-dodecyl disulfide

SML = 0,05 mg/kg

48620

00123-31-9

1,4-Dihydroxybenzene

SML = 0,6 mg/kg

48720

00611-99-4

4,4(cid:1)-Dihydroxybenzophenone

SML(T) = 6 mg/kg (15)

52645

10436-08-5

Cis-11-eicosenamide

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Ref. No

CAS No

Name

Restrictions and/or specifications

64800

65920

73160

76730

00110-16-7

Maleic acid

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

66822-60-4

[N-methacryloyloxyethyl-
N,N-dimethyl-N-carboxymethyl-
ammonium chloride, sodium salt-
octadecyl methacrylate-ethyl metha-
crylate-cyclohexyl methacrylate-N-
vinyl-2-pyrrolidone, copolymers

—

—

Phosphoric acid, mono- and di-n-
alkyl (C16 and C18) esters

SML = 0,05 mg/kg

Polydimethylsiloxane, gamma-
hydroxypropylated

SML = 6 mg/kg

81220

192268-64-7

83599

68442-12-6

Poly-[[6-[N-(2,2,6,6-tetramethyl-4-
piperidinyl)-n-butylamino]-1,3,5-
triazine-2,4-diyl][2,2,6,6-tetrame-
thyl-4-piperidinyl)imino]-1,6-hexa-
nediyl[2,2,6,6-tetramethyl-4-piperi-
dinyl)imino]]-alpha-[N,N,N(cid:1),N(cid:1)-te-
trabutyl-N(cid:2)(cid:2)-(2,2,6,6-tetramethyl-4-
piperidinylamino)-hexyl]
[1,3,5-triazine-2,4,6-triamine]-
omega-N,N,N(cid:1),N(cid:1)-tetrabutyl-1,3,5-
triazine-2,4-diamine]

Reaction products of oleic acid, 2-
mercaptoethyl ester, with dichloro-
dimethyltin, sodium sulphide and
trichloromethyltin

SML = 5 mg/kg

SML(T) = 0,18 mg/kg (16)
as tin)

(expressed

85680

01343-98-2

Silicic acid

92150

01401-55-4

Tannic acids

According to the JECFA specifications

93720

00108-78-1

2,4,6-Triamino-1,3,5-triazine

SML = 30 mg/kg

95270

161717-32-4

2,4,6-Tris(tert-butyl)phenyl 2-butyl-
2-ethyl-1,3-propanediol phosphate

SML = 2 mg/kg (as sum of phosphite,
phosphate
hydrolysis
and
product = TTBP)’

the

(c) For the following additives, the content of column ‘Restriction and/or specifications’ is replaced by the following:

Ref No

CAS No

Name

Restrictions and/or specifications

‘40120

—

Bis (polyethylene-
glycol)hydroxymethylphosphonate

SML = 0,6 mg/kg
until 1 January 2004

and

authorised

45200

01335-23-5

Copper iodide

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

and

(expressed as
SML = 1 mg/kg (11)

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Ref No

CAS No

Name

Restrictions and/or specifications

60480

03864-99-1

2-(2(cid:1)-Hydroxy-3,5(cid:1)-di-tert-butyl-
phenyl)-5-chlorobenzotriazole

SML(T) = 30 mg/kg (19)

85840

53320-86-8

Silicic acid, lithium magnesium
sodium salt

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

(expressed as

95725

110638-71-6

Vermiculite, reaction product with
citric acid, lithium salt

SML(T) = 0,6 mg/kg (8)
lithium)’

(expressed as

(d) The following additives are deleted:

Ref. No

CAS No

Name

Restrictions and/or specifications

‘85980

—

Silicic acid, salts’

2. The following Section B is added:

‘SECTION B

Incomplete list of additives referred to in Article 3a, second paragraph

Ref. No

CAS No

Name

Restrictions and/or specifications

30180

02180-18-9

Acetic acid, manganese salt

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

31520

61167-58-6

Acrylic acid, 2-tert-butyl-6-(3-tert-
butyl-2-hydroxy-5-methyl-
benzyl)-4-methylphenyl ester

SML = 6 mg/kg

SML = 0,02 mg/kg (expressed as anti-
monium and
tolerance
included)

analytical

SML(T) = 1 mg/kg (12)
barium)

(expressed

as

SML(T) = 1 mg/kg (12)
barium)

(expressed

as

31920

34230

35760

00103-23-1

Adipic acid, bis(2-ethylhexyl) ester

SML = 18 mg/kg (1)

—

Alkyl(C8-C22)sulphonic acids

SML = 6 mg/kg

01309-64-4

Antimony trioxide

36720

17194-00-2

Barium hydroxide

36800

10022-31-8

Barium nitrate

38240

38560

00119-61-9

Benzophenone

SML = 0,6 mg/kg

07128-64-5

2,5-Bis(5-tert-butyl-2-benzoxazolyl)
thiophene

SML = 0,6 mg/kg

38700

63397-60-4

Bis(2-carbobutoxyethyl)tin-bis(isooctyl
mercaptoacetate)

SML = 18 mg/kg

38800

32687-78-8

N,N(cid:1)-Bis(3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionyl)hydrazide

SML = 15 mg/kg

38820

26741-53-7

Bis(2,4-di-tert-butylphenyl) pentaery-
thritol diphosphite

SML = 0,6 mg/kg

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Official Journal of the European Communities

L 221/29

Ref. No

CAS No

Name

Restrictions and/or specifications

39060

35958-30-6

1,1-Bis(2-hydroxy-3,5-di-tert-butyl-
phenyl)ethane

SML = 5 mg/kg

39090

39120

—

—

N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)
amine

SML(T) = 1,2 mg/kg (13)

N,N-bis(2-hydroxyethyl)alkyl(C8-C18)
amine hydrochlorides

SML(T) = 1,2 mg/kg (13)
N,N-bis(2-hydroxyethyl)alkyl(C8-C18)
amine)

(expressed as

40000

00991-84-4

2,4-Bis(octylmercapto)-6-(4-hydroxy-
3,5-di-tert-butylanilino)-1,3,5-triazine

SML = 30 mg/kg

40020

110553-27-0

2,4-Bis(octylthiomethyl)-6-methylphe-
nol

SML = 6 mg/kg

40160

61269-61-2

N,N(cid:1)-bis(2,2,6,6-tetramethyl-4-piperi-
dyl)hexamethylenediamine-1,2-dibro-
moethane, copolymer

SML = 2,4 mg/kg

40800

13003-12-8

4,4(cid:1)-Butylidene-bis(6-tert-butyl-3-
methylphenyl-ditridecyl phosphite)

SML = 6 mg/kg

40980

19664-95-0

Butyric acid, manganese salt

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

42000

63438-80-2

(2-Carbobutoxyethyl)tin-tris(isooctyl
mercaptoacetate)

SML = 30 mg/kg

42400

10377-37-4

Carbonic acid, lithium salt

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

(expressed as

42480

00584-09-8

Carbonic acid, rubidium salt

SML = 12 mg/kg

43600

04080-31-3

1-(3-Chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride

SML = 0,3 mg/kg

43680

00075-45-6

Chlorodifluoromethane

44960

11104-61-3

Cobalt oxide

SML = 6 mg/kg
and in compliance
with the specifications laid down in
Annex V

SML(T) = 0,05 mg/kg (14) (expressed as
cobalt)

45440

—

Cresols, butylated, styrenated

SML = 12 mg/kg

46720

04130-42-1

2,6-Di-tert-butyl-4-ethylphenol

QMA = 4,8 mg/6 dm2

47600

84030-61-5

Di-n-dodecyltin bis(isooctyl mercap-
toacetate)

SML = 12 mg/kg

48640

00131-56-6

2,4-Dihydroxybenzophenone

SML(T) = 6 mg/kg (15)

48800

00097-23-4

2,2(cid:1)-Dihydroxy-5,5(cid:1)-dichlorodiphe-
nylmethane

SML = 12 mg/kg

L 221/30

EN

Official Journal of the European Communities

17.8.2001

Ref. No

CAS No

Name

Restrictions and/or specifications

48880

00131-53-3

2,2(cid:1)-Dihydroxy-4-methoxybenzophe-
none

SML(T) = 6 mg/kg (15)

49600

26636-01-1

Dimethyltin bis(isooctyl mercaptoace-
tate)

SML(T) = 0,18 mg/kg (16) (expressed as
tin)

49840

02500-88-1

Dioctadecyl disulphide

SML = 3 mg/kg

50160

—

Di-n-octyltin bis(n-alkyl(C10-C16)
mercapto acetate)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50240

10039-33-5

Di-n-octyltin bis(2-ethylhexyl maleate)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50320

15571-58-1

Di-n-octyltin bis(2-ethylhexyl mercap-
toacetate)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50360

—

Di-n-octyltin bis(ethyl maleate)

50400

33568-99-9

Di-n-octyltin bis(isooctyl maleate)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50480

26401-97-8

Di-n-octyltin bis(isooctyl mercaptoa-
cetate)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50560

—

Di-n-octyltin 1,4-butanediol
bis(mercaptoacetate)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50640

03648-18-8

Di-n-octyltin dilaurate

50720

15571-60-5

Di-n-octyltin dimaleate

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50800

50880

—

—

Di-n-octylin dimaleate, esterified

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

Di-n-octyltin dimaleate, polymers
(n = 2-4)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

50960

69226-44-4

Di-n-octyltin ethyleneglycol
bis(mercaptoacetate)

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

51040

15535-79-2

Di-n-octyltin mercaptoacetate

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

51120

—

Di-n-octyltin thiobenzoate 2-ethyl-
hexyl mercaptoacetate

SML(T) = 0,04 mg/kg (17) (expressed as
tin)

51570

00127-63-9

Diphenyl sulphone

SML = 3 mg/kg

51680

00102-08-9

N,N(cid:1)-diphenylthiourea

SML = 3 mg/kg

17.8.2001

EN

Official Journal of the European Communities

L 221/31

Ref. No

CAS No

Name

Restrictions and/or specifications

52000

52320

27176-87-0

Dodecylbenzenesulphonic acid

SML = 30 mg/kg

52047-59-3

2-(4-Dodecylphenyl)indole

SML = 0,06 mg/kg

52880

23676-09-7

4-Ethoxybenzoic acid, ethyl ester

SML = 3,6 mg/kg

53200

23949-66-8

2-Ethoxy-2(cid:1)-ethyloxanilide

SML = 30 mg/kg

58960

00057-09-0

Hexadecyltrimethylammonium
bromide

SML = 6 mg/kg

59120

23128-74-7

1,6-Hexamethylene-bis(3-(3,5-di-tert-
butyl-4-hydroxyphenyl)propionamide)

SML = 45 mg/kg

59200

35074-77-2

1,6-Hexamethylene-bis(3-(3,5-di-tert-
butyl-4-hydroxyphenyl)propionate)

SML = 6 mg/kg

60320

70321-86-7

2-(2-Hydroxy-3,5-bis(1,1-dimethyl-
benzyl)phenyl)benzotriazole

SML = 1,5 mg/kg

60400

03896-11-5

2-(2(cid:1)-Hydroxy-3(cid:1)-tert-butyl-5(cid:1)-
methylphenyl)-5-chlorobenzotriazole

SML(T) = 30 mg/kg (19)

60800

65447-77-0

1-(2-Hydroxyethyl)-4-hydroxy-
2,2,6,6-tetramethyl piperidine-suc-
cinic acid, dimethyl ester, copolymer

SML = 30 mg/kg

61280

03293-97-8

2-Hydroxy-4-n-hexyloxybenzophe-
none

SML(T) = 6 mg/kg (15)

61360

00131-57-7

2-Hydroxy-4-methoxybenzophenone

SML(T) = 6 mg/kg (15)

61440

02440-22-4

2-(2-Hydroxy-5-methylphenyl)benzo-
triazole

SML(T) = 30 mg/kg (19)

61600

01843-05-6

2-Hydroxy-4-n-octyloxybenzophe-
none

SML(T) = 6 mg/kg (15)

63200

51877-53-3

Lactic acid, manganese salt

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

64320

10377-51-2

Lithium iodide

65120

07773-01-5

Manganese chloride

65200

12626-88-9

Manganese hydroxide

65280

10043-84-2

Manganese hypophosphite

65360

11129-60-5

Manganese oxide

SML(T) = 1 mg/kg (11)
iodium)
and
(expressed as lithium)

(expressed

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

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

L 221/32

EN

Official Journal of the European Communities

17.8.2001

Ref. No

CAS No

Name

Restrictions and/or specifications

65440

—

Manganese pyrophosphite

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

66360

85209-91-2

2-2(cid:1)-Methylene bis(4,6-di-tert-butyl-
phenyl)sodium phosphate

SML = 5 mg/kg

66400

00088-24-4

2,2(cid:1)-Methylenebis(4-ethyl-6-tert-butyl-
phenol)

SML(T) = 1,5 mg/kg (20)

66480

00119-47-1

2,2(cid:1)-Methylenebis(4-methyl-6-tert-
butylphenol)

SML(T) = 1,5 mg/kg (20)

67360

67649-65-4

Mono-n-dodecyltin tris(isooctyl
mercaptoacetate)

SML = 24 mg/kg

67520

54849-38-6

Monomethyltin tris(isooctyl mercap-
toacetate)

SML(T) = 0,18 mg/kg (16) (expressed as
tin)

67600

—

Mono-n-octyltin tris(alkyl(C10-C16)-
mercaptoacetate)

SML(T) = 1,2 mg/kg (18)
tin)

(expressed as

67680

27107-89-7

Mono-n-octyltin tris(2-ethylhexyl
mercaptoacetate)

SML(T) = 1,2 mg/kg (18)
tin)

(expressed as

67760

26401-86-5

Mono-n-octyltin tris(isooctyl mercap-
toacetate)

SML(T) = 1,2 mg/kg (18)
tin)

(expressed as

68078

27253-31-2

Neodecanoic acid, cobalt salt

(expressed
and

as
SML(T) = 0,05 mg/kg
neodecanoic
SML(T)
acid)
= 0,05 mg/kg (14) (expressed as cobalt).
Not
for use in polymers contacting
foods for which simulant D is laid
down in Directive 85/572/EEC

68320

02082-79-3

Octadecyl 3-(3,5-di-tert-butyl-4-
hydroxylphenyl)propionate

SML = 6 mg/kg

68400

10094-45-8

Octadecylerucamide

SML = 5 mg/kg

69840

16260-09-6

Oleylpalmitamide

SML = 5 mg/kg

72160

00948-65-2

2-Phenylindole

SML = 15 mg/kg

72800

01241-94-7

Phosphoric acid, diphenyl 2-ethyl-
hexyl ester

SML = 2,4 mg/kg

73040

13763-32-1

Phosphoric acid, lithium salts

73120

10124-54-6

Phosphoric acid, manganese salt

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

(expressed as

SML(T) = 0,6 mg/kg (10)
manganese)

(expressed as

74400

77440

—

—

Phosphorous acid, tris(nonyl- and/or
dimonylphenyl) ester

SML = 30 mg/kg

Polyethyleneglycol diricinoleate

SML = 42 mg/kg

17.8.2001

EN

Official Journal of the European Communities

L 221/33

Ref. No

CAS No

Name

Restrictions and/or specifications

77520

78320

61791-12-6

Polyethyleneglycol ester of castor oil

SML = 42 mg/kg

09004-97-1

Polyethyleneglycol monoricinoleate

SML = 42 mg/kg

81200

71878-19-8

Poly[6-[(1,1,3,3-tetramethylbutyl)
amino]-1,3,5-triazine-2,4-diyl]-
[(2,2,6,6-tetramethyl-4-piperidyl)-
imino]hexamethylene[(2,2,6,6-tetra-
methyl-4-piperidyl)imino]

SML = 3 mg/kg

81680

07681-11-0

Potassium iodide

82020

19019-51-3

Propionic acid, cobalt salt

83595

119345-01-6

Reaction product of di-tert-butyl-
phosphonite with biphenyl, obtained
by condensation of 2,4-di-tert-butyl-
phenol with friedel craft reaction
product of phosphorus trichloride and
biphenyl

SML(T) = 1 mg/kg (11)
iodium)

(expressed

as

SML(T) = 0,05 mg/kg (14) (expressed as
cobalt)

SML = 18 mg/kg and in compliance
with the specifications mentioned in
Annex V

83700

00141-22-0

Ricinoleic acid

SML = 42 mg/kg

84800

00087-18-3

Salicylic acid, 4-tert-butylphenyl ester

SML = 12 mg/kg

84880

00119-36-8

Salicylic acid, methyl ester

SML = 30 mg/kg

85760

12068-40-5

Silicic acid, lithium aluminium salt
(2:1:1)

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

(expressed as

85920

12627-14-4

Silicic, acid, lithium salt

86800

07681-82-5

Sodium iodide

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

(expressed as

SML(T) = 1 mg/kg (11)
iodium)

(expressed

as

86880

—

Sodium monoalkyl dialkylphenoxy-
benzenedisulphonate

SML = 9 mg/kg

89170

13586-84-0

Stearic acid, cobalt salt

92000

07727-43-7

Sulphuric acid, barium salt

SML(T) = 0,05 mg/kg (14) (expressed as
cobalt)

SML(T) = 1 mg/kg (12)
barium)

(expressed

as

92320

—

Tetradecyl-polyethyleneglycol
(EO = 3-8) ether of glycolic acid

SML = 15 mg/kg

92560

38613-77-3

Tetrakis(2,4-di-tert-butyl-phenyl)-4-4(cid:1)-
biphenylylene diphosphonite

SML = 18 mg/kg

L 221/34

EN

Official Journal of the European Communities

17.8.2001

Ref. No

CAS No

Name

Restrictions and/or specifications

92800

00096-69-5

4,4(cid:1)-Thiobis(6-tert-butyl-3-methyl-
phenol)

SML = 0,48 mg/kg

92880

41484-35-9

Thiodiethanol
bis(3-(3-5-di-tert-butyl-4-
hydroxyphenyl)propionate)

SML = 2,4 mg/kg

93120

93280

94560

95280

00123-28-4

Thiodipropionic acid, didodecyl ester

SML(T) = 5 mg/kg (21)

00693-36-7

Thiodipropionic acid, dioctadecyl
ester

SML(T) = 5 mg/kg (21)

00122-20-3

Triisopropanolamine

SML = 5 mg/kg

40601-76-1

1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-
dimethylbenzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trione

SML = 6 mg/kg

95360

27676-62-6

1,3,5-Tris(3,5-di-tert-butyl-4-hydroxy-
benzyl)-1,3,5-triazine-2,4,6-
(1H,3H,5H)-trione

SML = 5 mg/kg

95600

01843-03-4

1,1,3-Tris(2-methyl-4-hydroxy-5-tert-
butylphenyl)butane

SML = 5 mg/kg’

17.8.2001

EN

Official Journal of the European Communities

L 221/35

ANNEX IV

Annex V is amended as follows:

1. Part A of Annex V is replaced by the following:

‘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.’

2. The following specifications are inserted in the table of Part B of Annex V:

PM/Ref. No

Other specifications

‘43680

CHLORODIFLUOROMETHANE

—

Content of chlorofluoromethane less than 1 mg/kg of the substance

47210

DIBUTYLTHIOSTANNOIC ACID POLYMER

—

Molecular unit = (C8H18S3Sn2)n (n = 1,5-2)

83595

REACTION PRODUCT OF DI-TERT-BUTYLPHOSPHONITE WITH BIPHENYL, OBTAINED BY
CONDENSATION OF 2,4-DI-TERT-BUTYLPHENOL WITH FRIEDEL CRAFT REACTION
PRODUCT OF PHOSPHORUS TRICHLORIDE AND BIPHENYL

Composition

— 4,4'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No 38613-77-3) (36-46 % w/w (1))

— 4,3'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No 118421-00-4) (17-23 % w/w)

— 3,3'-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No 118421-01-5) (1-5 % w/w)

— 4-Biphenylene-0,0-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite]

(CAS No 91362-37-7) (11-19 % w/w)

— Tris(2,4-di-tert-butylphenyl)phosphite
(CAS No 31570-04-4) (9-18 % w/w)

— 4,4'-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butyl-

phenyl)phosphonite
(CAS No 112949-97-0) < 5 % w/w)

Other specifications

— Phosphor content of minimum 5,4 % to 5,9 %

— Acid value of maximum 10 mg KOH per gram

— Melt range of 85-110 °C

(1) Quantity of substance used/quantity of formulation.’

L 221/36

EN

Official Journal of the European Communities

17.8.2001

Annex VI is replaced by the following text:

ANNEX V

‘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) 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.

(3) 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 and 89440.

(4) 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 and 64800.

(5) 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 and 41840.

(6) 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.

(7) 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 mentioned as PM/REF Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.

(8) 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 mentioned as PM/REF Nos: 42400, 64320, 73040, 85760, 85840, 85920 and 95725.

(9) 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.

(10) 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 mentioned as PM/REF Nos: 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and
73120.

(11) 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 mentioned as PM/REF Nos: 45200, 64320, 81680 and 86800.

(12) 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 mentioned as PM/REF Nos: 36720, 36800 and 92000.

(13) 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 mentioned as PM/REF Nos: 39090 and 39120.

(14) 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 mentioned as PM/REF Nos: 44960, 68078, 82020 and 89170.

(15) 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 mentioned as PM/REF Nos: 15970, 48640, 48720, 48880, 61280, 61360 and 61600.

(16) 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 mentioned as PM/REF Nos: 49600, 67520 and 83599.

(17) 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 mentioned as PM/REF Nos: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640,
50720, 50800, 50880, 50960, 51040 and 51120.

(18) 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 mentioned as PM/REF Nos: 67600, 67680 and 67760.

(19) 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 mentioned as PM/REF Nos: 60400, 60480 and 61440.

(20) 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 mentioned as PM/REF Nos: 66400 and 66480.

(21) 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 mentioned as PM/REF Nos: 93120 and 93280.

(22) 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 mentioned as PM/REF Nos: 17260 and 18670.’