Commission Directive 2005/79/EC of 18 November 2005 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food   (Text with EEA relevance)
Date: 2005-11-18
Institutions: European Commission
Subjects: food safety, foodstuff, foodstuffs legislation, packaging product, plastics

19.11.2005

EN

Official Journal of the European Union

L 302/35

COMMISSION DIRECTIVE 2005/79/EC

of 18 November 2005

amending Directive 2002/72/EC relating to plastic materials and articles intended to come into
contact with food

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1935/2004 of
the
European Parliament and of the Council of 27 October 2004
on materials and articles intended to come into contact with
food and repealing Directives 80/590/EEC and 89/109/EEC (1),
and in particular Article 5(2) thereof,

(4)

(5)

(6)

A transitional period should be provided for in respect of
PVC gaskets containing epoxidised soybean oil, used to
seal glass jars, which are brought into contact with food
before the 19 November 2006.

Directive 2002/72/EC should therefore be amended
accordingly.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

After consulting the European Food Safety Authority,

HAS ADOPTED THIS DIRECTIVE:

Whereas:

(1)

(2)

(3)

Commission Directive 2002/72/EC (2) establishes a list of
monomers and other starting substances, which may be
used for the manufacture of plastic materials and articles.
On the basis of new information related to the risk
assessment of such substances, certain monomers provi-
sionally admitted at national
level as well as new
monomers should be included in the Community list
of permitted substances in that Directive.

Directive 2002/72/EC also contains an incomplete list of
additives which may be used in the manufacture of
plastic materials
should be
and articles. That
amended so as to include other additives evaluated by
the European Food Safety Authority (the Authority).

list

For certain substances, the restrictions already established
at Community level should be amended on the basis of
the new information available.
In particular for epox-
idised soybean oil (ESBO) the Authority recommended
to decrease its specific migration limit (SML) for PVC
gaskets containing that substance which are used to
seal glass jars containing infant formulae and follow-on
formulae or containing processed cereal-based foods and
baby foods for infants and young children. In fact the
Authority noted that
infants who
regularly eat such foods may exceed the TDI. Therefore
the SML for ESBO is decreased for these particular appli-
cations from 60 to 30 mg/kg of food or food simulant
while it remains unchanged for all other applications.

the exposure of

(1) OJ L 338, 13.11.2004, p. 4.
(2) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive

2004/19/EC (OJ L 71, 10.3.2004, p. 8).

Article 1

Annexes II, III, V and VI of Directive 2002/72/EC are amended
in accordance with Annexes I to IV to this Directive.

Article 2

formulae

PVC gaskets containing epoxidised soybean oil, with reference
number 88640 in section A of Annex III
to Directive
2002/72/EC, which are used to seal glass jars containing
infant
as defined by
and follow-on formulae
Commission Directive 91/321/EEC (3) or containing processed
cereal-based foods and baby foods for
infants and young
children as defined by Commission Directive 96/5/EC (4), filled
before 19 November 2006 and which comply with the
restrictions and/or specifications provided for in Section A of
Annex III to Directive 2002/72/EC as amended by Directive
2004/19/EC, may continue to be placed on the market
provided that the date of filling appears on the materials and
articles.

The date of
filling may be replaced by another indication,
provided that that indication permits the identification of the
date of filling. Upon request the date of filling shall be made
available to the competent authorities and any person enforcing
the requirements of this Directive.

first and second subparagraphs

The
shall apply without
prejudice to Directive 2000/13/EC of the European Parliament
and of the Council (5).

(3) OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive

2003/14/EC (OJ L 41, 14.2.2003, p. 37).

(4) OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive

2003/13/EC (OJ L 41, 14.2.2003, p. 33).

(5) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive

2003/89/EC (OJ L 308, 25.11.2003, p. 15).

L 302/36

EN

Official Journal of the European Union

19.11.2005

Article 3

the latest,

1. Member States shall adopt and publish, by 19 November
2006 at
the laws, regulations and administrative
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

They shall apply those provisions in such a way as to:

(a) permit the trade in and use of plastic materials and articles
intended to come into contact with food and complying
with this Directive, from 19 November 2006;

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 4

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

Article 5

This Directive is addressed to the Member States.

(b) prohibit

the manufacture

and importation into the
Community of plastic materials and articles intended to
come into contact with food and which do not comply
with this Directive, from 19 November 2007.

Done at Brussels, 18 November 2005.

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.

For the Commission

Markos KYPRIANOU
Member of the Commission

19.11.2005

EN

Official Journal of the European Union

L 302/37

ANNEX I

Annex II to Directive 2002/72/EC is amended as follows:

1. point 2 of the general introduction is replaced by the following:

‘2. The following substances are not included even if they are intentionally used and are authorised:

(a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium
and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in
the lists, if the corresponding free acid(s) is (are) not mentioned;

(b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a

Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

(i)

substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free
acid(s) is (are) not mentioned,

(ii) substances referred to in note 38 of Annex VI.’;

2. section A is amended as follows:

(a)

the following lines are inserted in the table in numerical order:

Reference
No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘11005

012542-30-2

Acrylic acid, dicyclopentenyl ester QMA = 0,05 mg/6 dm2

11500

000103-11-7

Acrylic acid, 2-ethylhexyl ester

SML = 0,05 mg/kg

12786

000919-30-2

3-Aminopropyltriethoxysilane

Residual extractable content of 3-aminopropyl-
triethoxysilane to be less than 3 mg/kg filler. To
be used only for the reactive surface treatment
of inorganic fillers

13317

132459-54-2

N,N′-Bis[4-(ethoxycarbonyl)-
phenyl]-1,4,5,8-naphthalenetetra-
carboxydiimide

SML = 0,05 mg/kg. Purity > 98,1 % (w/w). To
be used only as co-monomer (max 4 %)
for
polyesters (PET, PBT)

14260

000502-44-3

Caprolactone

16955

000096-49-1

Ethylene carbonate

SML = 0,05 mg/kg (expressed as the sum of
caprolactone and 6-hydroxyhexanoic acid)

Residual content = 5 mg/kg of hydrogel at a
maximum ratio of 10 g of hydrogel to 1 kg
of food. The hydrolysate contains ethyleneglycol
having an SML = 30 mg/kg

21370

010595-80-9 Methacrylic acid, 2-sulphoethyl

QMA = ND (DL = 0,02 mg/6 dm2)

ester

22210

000098-83-9

alpha-Methylstyrene

SML = 0,05 mg/kg

22932

001187-93-5

Perfluoromethyl perfluorovinyl
ether

SML = 0,05 mg/kg. Only to be used for anti-
stick coatings

24903

068425-17-2

Syrups, hydrolysed starch, hydro-
genated

In compliance with the specifications laid down
in Annex V

25540

000528-44-9

Trimellitic acid

25550

000552-30-7

Trimellitic anhydride

SML(T) = 5 mg/kg (35)

SML(T) = 5 mg/kg (35)
acid)’

(expressed as trimellitic

L 302/38

EN

Official Journal of the European Union

19.11.2005

(b) in the following lines the content of the columns ‘CAS No’ or ‘Restrictions and/or specifications’ is replaced by the

following:

Reference
No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘10690

000079-10-7

Acrylic acid

SML(T) = 6 mg/kg (36)

10750

002495-35-4

Acrylic acid, benzyl ester

SML(T) = 6 mg/kg (36)

10780

000141-32-2

Acrylic acid, n-butyl ester

SML(T) = 6 mg/kg (36)

10810

002998-08-5

Acrylic acid, sec-butyl ester

SML(T) = 6 mg/kg (36)

10840

001663-39-4

Acrylic acid, tert-butyl ester

SML(T) = 6 mg/kg (36)

11470

000140-88-5

Acrylic acid, ethyl ester

SML(T) = 6 mg/kg (36)

11590

000106-63-8

Acrylic acid, isobutyl ester

SML(T) = 6 mg/kg (36)

11680

000689-12-3

Acrylic acid, isopropyl ester

SML(T) = 6 mg/kg (36)

11710

000096-33-3

Acrylic acid, methyl ester

SML(T) = 6 mg/kg (36)

11830

000818-61-1

Acrylic acid, monoester with
ethyleneglycol

SML(T) = 6 mg/kg (36)

11890

002499-59-4

Acrylic acid, n-octyl ester

SML(T) = 6 mg/kg (36)

11980

000925-60-0

Acrylic acid, propyl ester

SML(T) = 6 mg/kg (36)

13720

000110-63-4

1,4-Butanediol

20020

000079-41-4 Methacrylic acid

SML(T) = 5 mg/kg (24)

SML(T) = 6 mg/kg (37)

20080

002495-37-6 Methacrylic acid, benzyl ester

SML(T) = 6 mg/kg (37)

20110

000097-88-1 Methacrylic acid, butyl ester

SML(T) = 6 mg/kg (37)

20140

002998-18-7 Methacrylic acid, sec-butyl ester

SML(T) = 6 mg/kg (37)

20170

000585-07-9 Methacrylic acid, tert-butyl ester

SML(T) = 6 mg/kg (37)

20890

000097-63-2 Methacrylic acid, ethyl ester

SML(T) = 6 mg/kg (37)

21010

000097-86-9 Methacrylic acid, isobutyl ester

SML(T) = 6 mg/kg (37)

21100

004655-34-9 Methacrylic acid, isopropyl ester

SML(T) = 6 mg/kg (37)

21130

000080-62-6 Methacrylic acid, methyl ester

SML(T) = 6 mg/kg (37)

21190

000868-77-9 Methacrylic acid, monoester with
ethyleneglycol

SML(T) = 6 mg/kg (37)

21280

002177-70-0 Methacrylic acid, phenyl ester

SML(T) = 6 mg/kg (37)

21340

002210-28-8 Methacrylic acid, propyl ester

SML(T) = 6 mg/kg (37)

21460

000760-93-0 Methacrylic anhydride

SML(T) = 6 mg/kg (37)

24190

008050-09-7

Rosin wood

See “Rosin” (Reference No 24100)’

19.11.2005

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Official Journal of the European Union

L 302/39

(c)

the following line is deleted:

Reference
No

CAS No

(1)

(2)

‘11000

050976-02-8

Name

(3)

Acrylic acid, dicyclopentadienyl
ester

Restrictions and/or specifications

(4)

QMA = 0,05 mg/6 dm2’

3.

in section B the following lines are deleted:

Reference
No

(1)

‘11500

CAS No

(2)

Name

(3)

Restrictions and/or specifications

(4)

000103-11-7

Acrylic acid, 2-ethylhexyl ester

14260

000502-44-3

Caprolactone

21370

010595-80-9

Methacrylic acid, 2-sulphoethyl
ester

22210

000098-83-9

alpha-Methylstyrene

25540

000528-44-9

Trimellitic acid

QM(T) = 5 mg/kg in FP

25550

000552-30-7

Trimellitic anhydride

QM(T) = 5 mg/kg in FP (expressed as trimellitic
acid)’

L 302/40

EN

Official Journal of the European Union

19.11.2005

Annex III to Directive 2002/72/EC is amended as follows:

ANNEX II

1. point 2 is replaced by the following:

‘2. The following substances are not included even if they are intentionally used and are authorised:

(a) salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium
and sodium of authorised acids, phenols or alcohols. However, names containing “… acid(s), salts” appear in
the lists, if the corresponding free acid(s) is (are) not mentioned;

(b) salts (including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. For these salts a

Group SML = 25 mg/kg (expressed as Zn) apply. The same restriction for Zn applies to:

(i)

substances whose name contains “… acid(s), salts” which appear in the lists, if the corresponding free
acid(s) is (are) not mentioned,

(ii) substances referred to in note 38 of Annex VI.’;

2. section A is amended as follows:

(a)

the following lines are inserted in numerical order:

Reference
No

CAS No

(1)

(2)

‘30340

330198-91-9

30401

—

Name

(3)

Restrictions and/or specifications

(4)

12-(Acetoxy)stearic acid, 2,3-bis
(acetoxy)propyl ester

Acetylated mono- and diglycerides
of fatty acids

31542

174254-23-0 Acrylic acid, methyl ester, telomer

QM = 0,5 % (w/w) in FP

with 1-dodecanethiol, C16-C18
alkyl esters

43480

064365-11-3

Charcoal, activated

In compliance with the specifications laid down
in Annex V, Part B

62245

012751-22-3

Iron phosphide

For PET polymers and copolymers only

64990

025736-61-2 Maleic anhydride-styrene,

copolymer, sodium salt

In compliance with specifications laid down in
Annex V

66905

000872-50-4 N-Methylpyrrolidone

66930

068554-70-1 Methylsilsesquioxane

67155

—

Mixture of 4-(2-Benzoxazolyl)-4′-
(5-methyl-2-benzoxazolyl)stilbene,
4,4′-bis(2-benzoxazolyl) stilbene
and 4,4′-bis(5-methyl-2-benzoxa-
zolyl)stilbene)

76415

019455-79-9

Pimelic acid, calcium salt

Residual monomer in methylsilsesquioxane:
< 1 mg methyltrimethoxysilane/kg of methylsil-
sesquioxane

Not more than 0,05 % w/w (quantity of
substance used/quantity of the formulation). In
compliance with the specifications laid down in
Annex V

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Official Journal of the European Union

L 302/41

(1)

76815

(2)

—

(3)

(4)

Polyester of adipic acid with
glycerol or pentaerythritol, esters
with even numbered, unbranched
C12-C22 fatty acids

In compliance with the specifications laid down
in Annex V

76845

031831-53-5

Polyester of 1,4-butanediol with
caprolactone

In compliance with the specifications laid down
in Annex V

77370

070142-34-6

Polyethyleneglycol-30 dipolyhy-
droxystearate

79600

009046-01-9

Polyethyleneglycol tridecyl ether
phosphate

80000

009002-88-4

Polyethylene wax

81060

009003-07-0

Polypropylene wax’

SML = 5 mg/kg. For materials and articles
intended for contact with aqueous foods only. In
compliance with the specification laid down in
Annex V

(b) in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the

following:

Reference
No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘30080

004180-12-5 Acetic acid, copper salt

SML(T) = 5 mg/kg (7) (expressed as Copper)

35760

001309-64-4 Antimony trioxide

SML = 0,04 mg/kg (39) (expressed as Antimony)

40580

000110-63-4

1,4-Butanediol

SML(T) = 5 mg/kg (24)

42320

007492-68-4

Carbonic acid, copper salt

SML(T) = 5 mg/kg (7) (expressed as Copper)

45195

007787-70-4

Copper bromide

SML(T) = 5 mg/kg (7) (expressed as Copper)

45200

001335-23-5

Copper iodide

SML(T) = 5 mg/kg (7) (expressed as Copper)

53610

054453-03-1

Ethylenediaminetetraacetic acid,
copper salt

SML(T) = 5 mg/kg (7) (expressed as Copper)

81515

087189-25-1

Poly(zinc glycerolate)

SML(T) = 25 mg/kg (38) (as Zinc)

81760

—

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

88640

008013-07-08 Soybean oil, epoxidised

SML(T) = 5 mg/kg (7) (expressed as Copper)

SML = 60 mg/kg. However in the case of PVC
gaskets used to seal glass jars containing infant
formulae and follow-on formulae as defined by
Commission Directive 91/321/EEC or
containing processed cereal-based foods and
baby foods for infants and young children as
defined by Directive 96/5/EC, the SML is
lowered to 30 mg/kg

89200

007617-31-4

Stearic acid, copper salt

SML(T) = 5 mg/kg (7) (expressed as Copper)

92030

010124-44-4

Sulphuric acid, copper salt

SML(T) = 5 mg/kg (7) (expressed as Copper)

96190

020427-58-1

Zinc hydroxide

SML(T) = 25 mg/kg (38) (as Zinc)

96240

001314-13-2

Zinc oxide

96320

001314-98-3

Zinc sulphide

SML(T) = 25 mg/kg (38) (as Zinc)

SML(T) = 25 mg/kg (38) (as Zinc)’

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(c)

the following lines are deleted:

Reference
No

CAS No

(1)

‘30400

(2)

—

Name

(3)

Acetylated glycerides

Restrictions and/or specifications

(4)

38320

005242-49-9

4-(2-Benzoxazolyl)-4′-(5-methyl-
2-benzoxazolyl)stilbene

In compliance with the specifications laid down
in Annex V’

3. section B is amended as follows:

(a)

the following lines are inserted in numerical order:

Reference
No

CAS No

(1)

(2)

Name

(3)

‘31500

025134-51-4 Acrylic acid, acrylic acid,

2-ethylhexyl ester, copolymer

Restrictions and/or specifications

(4)

SML(T) = 6 mg/kg (36) (expressed as acrylic acid)
and SML = 0,05 mg/kg (expressed as acrylic
acid, 2-ethylhexyl ester)

38505

351870-33-2

cis-endo-Bicyclo[2.2.1]heptane-
2,3-dicarboxylic acid, disodium
salt

SML = 5 mg/kg. Not to be used with poly-
ethylene in contact with acidic foods. Purity
≥ 96 %

38940

110675-26-8

2,4-Bis(dodecylthiomethyl)-6-
methylphenol

SML(T) = 5 mg/kg (40)

49595

057583-35-4 Dimethyltin bis(ethylhexyl

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

mercaptoacetate)

63940

008062-15-5

Lignosulphonic acid

SML = 0,24 mg/kg and to be used only as
dispersant for plastics dispersions

66350

085209-93-4

2,2′-Methylenebis(4,6-di-tert-
butylphenyl) lithium phosphate

SML = 5 mg/kg and SML(T) = 0,6 (8) (expressed
as Lithium)

67515

057583-34-3 Monomethyltin tris(ethylhexyl

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

mercaptoacetate)

69160

014666-94-5 Oleic acid, cobalt salt

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

76681

—

Polycyclopentadiene, hydrogenated

SML = 5 mg/kg (1)

85950

037296-97-2

Silicic acid, magnesium-sodium-
fluoride salt

SML = 0,15 mg/kg (expressed as fluoride). Only
to be used in layers of multilayers materials not
coming into direct contact with food

95265

227099-60-7

1,3,5-Tris(4-benzoylphenyl)
benzene

SML = 0,05 mg/kg’

(b) in the following lines the content of the columns ‘Name’ and ‘Restrictions and/or specifications’ is replaced by the

following:

Reference
No

CAS No

(1)

(2)

‘40020

110553-27-0

Name

(3)

Restrictions and/or specifications

(4)

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

SML(T) = 5 mg/kg (40)

50160

—

Di-n-octyltin bis(n-alkyl(C10-C16)
mercaptoacetate)

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

19.11.2005

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Official Journal of the European Union

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(1)

(2)

(3)

(4)

50240

010039-33-5 Di-n-octyltin bis(2-ethylhexyl

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

maleate)

50320

015571-58-1 Di-n-octyltin bis(2-ethylhexyl

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

mercaptoacetate)

50360

—

Di-n-octyltin bis(ethyl maleate)

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

50400

033568-99-9 Di-n-octyltin bis(isooctyl maleate)

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

50480

026401-97-8 Di-n-octyltin bis(isooctyl mercap-

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

toacetate)

50560

—

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

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

50640

003648-18-8 Di-n-octyltin dilaurate

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

50720

015571-60-5 Di-n-octyltin dimaleate

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

50800

50880

—

—

Di-n-octyltin dimaleate, esterified

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

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

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

50960

069226-44-4 Di-n-octyltin ethyleneglycol

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

bis(mercaptoacetate)

51040

015535-79-2 Di-n-octyltin mercaptoacetate

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

51120

67180

—

—

Di-n-octyltin thiobenzoate
2-ethylhexyl mercaptoacetate

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

SML(T) = 0,006 mg/kg (17) (expressed as Tin)

SML = 5 mg/kg (1)’

(c) The following line is deleted:

Reference
No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘76680

068132-00-3

Polycyclopentadiene, hydrogenated

SML = 5 mg/kg (1)’

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ANNEX III

In Part B of Annex V, the following lines are inserted in numerical order:

Reference No

‘24903

Syrups, hydrolysed starch, hydrogenated

OTHER SPECIFICATIONS

In compliance with the purity criteria for maltitol syrup E 965(ii) (Commission Directive 95/31/EC
(OJ L 178, 28.7.1995, p. 1) as last amended by 2004/46/EC (OJ L 114, 21.04.2004, p. 15))

43480

Charcoal, activated

To be used only in PET at maximum 10 mg/kg of polymer. Same purity requirements as for
Vegetable Carbon (E 153) set out by Commission Directive 95/45/EC ((OJ L 226, 22.9.1995,
p. 1). Directive as last amended by Directive 2004/47/EC (OJ L 113, 20.4.2004, p. 24)) with
exception of ash content which can be up to 10 % (w/w).

64990

Maleic anhydride-styrene, copolymer, sodium salt

MW fraction < 1 000 is less than 0,05 % (w/w)

67155

Mixture of 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzoxazolyl)stilbene, 4,4'-bis(2-benzoxazolyl) stilbene
and 4,4'-bis(5-methyl-2-benzoxazolyl)stilbene

Mixture obtained from the manufacturing process in the typical ratio of
(13-17 %).

(58-62 %):(23-27 %):

76845

Polyester of 1,4-butanediol with caprolactone

MW fraction < 1 000 is less than 0,05 % (w/w)

76815

Polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched
C12-C22 fatty acids

MW fraction < 1 000 is less than 5 % (w/w)

79600

Polyethyleneglycol tridecyl ether phosphate

Polyethyleneglycol (EO ≤ 11) tridecyl ether phosphate (mono-and dialkyl ester) with a maximum
10 % content of polyethyleneglycol (EO ≤ 11) tridecylether’

19.11.2005

EN

Official Journal of the European Union

L 302/45

ANNEX IV

Annex VI is amended as follows:

1. the notes (8), (14) and (16) are replaced by the following:

‘(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 Reference Nos 38000, 42400, 64320, 66350, 67896, 73040, 85760,
85840, 85920 and 95725.

(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 Reference Nos 44960, 68078, 69160, 82020 and 89170.

(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 Reference Nos 49595, 49600, 67520, 67515 and 83599.’;

2. the following notes are added:

‘(35) 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 Reference Nos 25540 and 25550.

(36) 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 Reference Nos 10690, 10750, 10780, 10810, 10840, 11470, 11590,
11680, 11710, 11830, 11890, 11980 and 31500.

(37) 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 Reference Nos 20020, 20080, 20110, 20140, 20170, 20890, 21010,
21100, 21130, 21190, 21280, 21340 and 21460.

(38) 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 Reference Nos 81515, 96190, 96240 and 96320 as well as of salts
(including double salts and acid salts) of zinc of authorised acids, phenols or alcohols. The same restriction for Zn
applies to the names containing “… acid(s), salts” which appear in the lists, if the corresponding free acid(s) is (are)
not mentioned.

(39) Migration limit might be exceeded at very high temperature.

(40) 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 Reference Nos 38940 and 40020.’