Commission Directive 2004/19/EC of 1 March 2004 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 2004-03-01
Institutions: European Commission
Subjects: adjuvant, chemical product, foodstuff, marketing, packaging product, public health, raw material

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Official Journal of the European Union

10.3.2004

COMMISSION DIRECTIVE 2004/19/EC

of 1 March 2004

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

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
Member States relating to materials and articles intended to
come into contact with foodstuffs (1), and in particular Article
3 thereof,

the laws of

After consulting the European Food Safety Authority,

Whereas:

Commission Directive 2002/72/EC (2) sets out rules for
plastic materials and articles which are intended to come
into contact with foodstuffs.

Directive 2002/72/EC 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, certain monomers provision-
ally 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
should be
plastic materials and articles. That
amended so as to include other additives evaluated by
the European Food Safety Authority (the Authority).

list

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

(1)

(2)

(3)

(4)

(5)

(7)

(8)

(9)

The current list of additives should become a positive
list in order to harmonise the use of these additives in
the Community. For additives which are already placed
on the market in one or more of the Member States,
sufficient time should be allowed for the submission of
the data necessary for the Authority to carry out an
evaluation of their safety. Therefore, the deadline for the
submission of the data should be set as 31 December
2006.

If the data are in compliance with the Authority require-
ments, it should be possible to continue to use those
their
additives in accordance with national
evaluation is completed. If the data are not in compli-
ance with the Authority requirements or are submitted
later than 31 December 2006 those additives should not
be included in the first positive list.

law until

The date when the list of additives is to become a posi-
tive list should be established no later than 31 December
2007 as it is impossible to know the number of addi-
tives for which the data required by the Authority will
be supplied. That date should be fixed taking into
account the time needed for the Authority to evaluate all
the applications supplied on time.

Some substances used to manufacture plastic materials
and articles intended to come into contact with food are
also added directly to foodstuffs. These substances
should not migrate from the materials or articles into
the foodstuffs in quantities that could exceed the limits
set in the relevant food legislation or in this Directive
whichever provides the lower restriction. In any case,
these substances should not migrate from the materials
or articles into the foodstuffs in quantities having a tech-
nological function in the final food. The users of mate-
rials and articles which may release these substances into
foodstuffs should be appropriately informed in order to
be able to comply with other relevant food legislation.

The current list of additives is incomplete inasmuch as it
does not contain all substances currently accepted in one
or more Member States. Those additives continue to be
regulated by national laws pending a decision on inclu-
sion into the Community list.

(10) Member States should retain the right to lay down rules
concerning substances used as active components in
active food contact materials and articles until Com-
munity provisions are adopted.

(1) OJ L 40, 11.2.1989, p. 38. Directive as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ L
284, 31.10.2003, p. 1).

(2) OJ L 220, 15.8.2002, p. 18. Directive as amended by Directive

2004/1/EC (OJ L 7, 13.1.2004, p. 45).

(11) Directive 2002/72/EC should therefore be amended

accordingly.

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(12)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

— adhesives and adhesion promoters,

— printing inks;

(b) colorants;

(c) solvents.’

HAS ADOPTED THIS DIRECTIVE:

3. The following Articles 4a and 4b are inserted:

Article 1

‘Article 4a

Directive 2002/72/EC is amended as follows:

1. In Article 3, paragraphs 1 and 2 are replaced by the

following:

‘1.
Only those monomers and other starting substances
listed in Annex II, section A may be used for the manufac-
ture of plastic materials and articles subject to the restric-
tions set out therein.

2.
By way of derogation from paragraph 1, the mono-
mers and other starting substances listed in Annex II,
section B may continue to be used until 31 December 2004
at the latest, pending their evaluation by the European Food
Safety Authority (hereinafter referred to as the Authority).’

2. Article 4 is replaced by the following:

‘Article 4

1.
A list of additives which may be used for the manufac-
together with the
ture of plastic materials and articles,
restrictions and/or specifications on their use, is set out in
Annex III.

That list of additives shall be considered to be an incomplete
list until
in accordance with
Article 4a, that it shall become a positive Community list of
authorised additives, to the exclusion of all others.

the Commission decides,

The Commission shall establish, by 31 December 2007 at
the latest, the date when that list shall become a positive
list.

For the additives listed in Annex III, section B, the veri-
2.
fication of compliance with the specific migration limits in
simulant D or in test media of substitute tests as laid down
in Article 3(1), second subparagraph of Directive 82/711/
EEC and Article 1 of Directive 85/572/EEC shall apply from
1 July 2006.

1.
A new additive may always be added to the list of
substances referred to in Article 4(1) following an evaluation
of its safety by the Authority.

2. Member States shall provide that any person interested
in the inclusion in the list referred to in Article 4(1) of an
additive, which is already placed on the market in one or
more of the Member States, shall submit data for the evalua-
tion of its safety by the Authority by 31 December 2006 at
the latest.

the “Guidelines of

For the submission of the required data, the applicant shall
the European Food Safety
consult
Authority for the presentation of an application for safety
assessment of a substance to be used in food contact mate-
rials prior to its authorisation”.

3.
If during the examination of the data referred to in
paragraph 2, the Authority calls for supplementary informa-
tion,
to
the additive may continue to be used subject
national
law until the Authority has issued an opinion,
provided that the information is submitted within the time
limits specified by the Authority.

4.
The Commission shall establish, by 31 December
2007 at the latest, a provisional list of additives which may
continue to be used after 31 December 2007 subject to
national law until the Authority has evaluated them.

The inclusion of an additive in the provisional list is

5.
subject to the following conditions:

(a) the additive must be permitted in one or more of the

Member States no later than 31 December 2006;

(b) the data referred to in paragraph 2 concerning that addi-
tive must have been supplied in accordance with the
Authority requirements no later than 31 December
2006.

The lists in Annex III, sections A and B do not yet

3.
include the following additives:

(a) additives used only in the manufacture of:

Article 4b

— surface coatings obtained from resinous or poly-
merised products in liquid, powder or dispersion
form, such as varnishes, lacquers, paints,

— epoxy resins,

Without prejudice to Article 4 of Directive 89/109/EEC,
Member States may not authorise after 31 December 2006
additives referred to in Article 4(1) which were never evalu-
ated by the Scientific Committee on Food or the Authority.’

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4. The following Article 5a is inserted:

6. In Article 8, paragraph 2 is replaced by the following:

‘Article 5a

5.
Additives referred to in Article 4, which are authorised
as food additives by Council Directive 89/107/EEC (*) or
flavourings by Council Directive 88/388/EEC (**) shall not
migrate into:

(a) foodstuffs in quantities having a technological function

in the final foodstuffs;

(b) foodstuffs for which their use is authorised as food addi-
tives or flavourings, in quantities exceeding the restric-
tions provided for in Directive 89/107/EEC or in Direc-
tive 88/388/EEC or in Article 4 of this Directive, which-
ever is the lower;

(c) foodstuffs for which their use is not authorised as food
in quantities exceeding the

additives or flavourings,
restrictions set out in Article 4 of this Directive.

2.
At the marketing stages other than the retail stages,
plastic materials and articles which are intended to be
placed in contact with foodstuffs and which contain addi-
tives referred to in paragraph 1 shall be accompanied by a
written declaration containing the information referred to in
Article 9(1)(b).

3.
By way of derogation from paragraph 1, when the
substances referred to in point (a) of paragraph 1 are used
as active components of active food contact materials and
articles, they may be subject to national provisions pending
the adoption of Community provisions.

(*) OJ L 40, 11.2.1989, p. 27.
(**) OJ L 184, 15.7.1988, p. 61.’

5. Article 7 is replaced by the following:

‘Article 7

‘2.
The verification of compliance with the specific
migration limits provided for in paragraph 1 shall not be
compulsory, if the value of overall migration determination
implies that the specific migration limits referred to in that
paragraph are not exceeded.’

7. Article 9 is amended as follows:

(a) paragraph 1 is replaced by the following:

At

‘1.
the marketing stages other than the retail
stages, plastic materials and articles which are intended
to be placed in contact with foodstuffs shall be accom-
panied by a written declaration, which shall:

(a) be in accordance with Article 6(5) of Directive 89/

109/EEC;

(b) provide,

for substances which are subject

to a
restriction in food, adequate information obtained
by experimental data or theoretical calculation about
their specific migration and, where
the level of
appropriate, purity criteria
in accordance with
Commission Directives 95/31/EC (*), 95/45/EC (**)
and 2002/82/EC (***) to enable the user of these
materials and articles to comply with the relevant
Community provisions or,
in their absence, with
national provisions applicable to food.

(*) OJ L 178, 28.7.1995, p. 1.
(**) OJ L 226, 22.9.1995, p. 1.
(***) OJ L 292, 28.10.2002, p. 1.’;

(b) paragraph 2 is deleted.

8. Annexes II to VI are amended in accordance with Annexes I

to V to this Directive.

Article 2

1. Member States shall adopt and publish, by 1 September
2005 at the latest, the provisions necessary to comply with this
Directive. They shall forthwith communicate to the Commis-
those provisions and a correlation table
sion the text of
between those provisions and this Directive.

The specific migration limits in the list set out in Annexes II
and III are expressed in mg/kg. However, such limits are
expressed in mg/dm2 in the following cases:

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

(a) articles which are containers or are comparable to
containers or which can be filled, with a capacity of less
than 500 ml or more than 10 l;

(a) permit the trade in and use of plastic materials and articles
into contact with foodstuffs and

intended to come
complying with this Directive, from 1 September 2005;

(b) sheet, film or other material or articles which cannot be
filled or for which it is impracticable to estimate the
relationship between the surface area of such material
or article and the quantity of food in contact therewith.

(b) prohibit the manufacture and importation into the Com-
munity of plastic materials and articles intended to come
into contact with foodstuffs and which do not comply with
this Directive, from 1 March 2006.

In those cases, the limits set out in Annexes II and III,
expressed in mg/kg shall be divided by the conventional
conversion factor of 6 in order to express them in mg/dm2.’

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

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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.

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

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 1 March 2004.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

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

1.

in point 8, the definition of QM is replaced by the following:

‘QM = Maximum permitted quantity of the “residual” substance in the material or article. For the purpose of this
Directive the quantity of the substance in the material or article shall be determined by a validated method of
analysis. If such a method does not currently exist, an analytical method with appropriate performance char-
acteristics at the specified limit may be used, pending the development of a validated method;’;

2. the following monomers and other starting substances are inserted, in the appropriate numerical order, in the table

in section A:

Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘13323

000102-40-9

1,3-Bis(2-hydroxyethoxy)benzene

SML = 0,05 mg/kg

16540

000102-09-0 Diphenyl carbonate

SML = 0,05 mg/kg

18896

001679-51-2

4-(Hydroxymethyl)-1-cyclohexene

SML = 0,05 mg/kg

20440

000097-90-5 Methacrylic acid, diester with ethyle-

SML = 0,05 mg/kg

neglycol

22775

000144-62-7 Oxalic acid

SML(T) = 6 mg/kg (29)

23070

000102-39-6

(1,3-Phenylenedioxy)diacetic acid

QMA = 0,05 mg/6 dm2’

3. for the following monomers and other starting substances listed in the table in section A, the content of the columns

‘Name’ or ‘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)

‘11530

00999-61-1

Acrylic acid, 2-hydroxypropyl ester

QMA = 0,05 mg/6 dm2 for the sum
of acrylic acid, 2-hydroxypropyl ester
and acrylic acid, 2-hydroxyisopropyl
ester and in compliance with the speci-
fications laid down in Annex V

13480

000080-05-7

2,2-Bis(4-hydroxyphenyl)propane

SML(T) = 0,6 mg/kg (28)

14950

003173-53-3

Cyclohexyl isocyanate

QM(T) = 1 mg/kg in FP (expressed as
NCO) (26)

18898

000103-90-2 N-(4-Hydroxyphenyl) acetamide

SML = 0,05 mg/kg

22150

000691-37-2

4-Methyl-1-pentene

SML = 0,05 mg/kg

22331

025513-64-8 Mixture

of

(35-45 % w/w)
diamino-2,2,4-trimethylhexane
(55-65 %
trimethylhexane

1,6-
and
w/w)1,6-diamino-2,4,4-

22332

—

of

(40 % w/w)

Mixture
2,2,4-
and
trimethylhexane-1,6-diisocyanate
(60 % w/w) 2,4,4-trimethylhexane-1,6-
diisocyanate

24190

065997-05-9

Rosin wood’

QMA = 5 mg/6 dm2

QM(T) = 1 mg/kg
NCO) (26)

(expressed

as

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4. the following monomers and other starting substances are deleted from the table in section B and inserted, in the

appropriate numerical order, in the table in section A:

Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘10599/90A

10599/91

10599/92A

10599/93

14800

16210

061788-89-4 Acids, fatty, unsaturated (C18), dimers,

distilled

061788-89-4 Acids, fatty, unsaturated (C18), dimers,

non distilled

068783-41-5 Acids, fatty, unsaturated (C18), dimers,
hydrogenated, distilled

068783-41-5 Acids, fatty, unsaturated (C18), dimers,

hydrogenated, non distilled

QMA(T) = 0,05 mg/6 dm2 (27)

QMA(T) = 0,05 mg/6 dm2 (27)

QMA(T) = 0,05 mg/6 dm2 (27)

QMA(T) = 0,05 mg/6 dm2 (27)

003724-65-0

Crotonic acid

QMA(T) = 0,05 mg/6 dm2 (33)

006864-37-5

3,3'-Dimethyl-4,4'-diaminodicyclohex-
ylmethane

SML = 0,05 mg/kg (32). To be used
only in polyamides.

17110

016219-75-3

5-Ethylidenebicyclo[2,2,1]hept-2-ene

QMA = 0,05 mg/6 dm2. The
ratio
surface/quantity of food shall be lower
than 2 dm2/kg

18700

21400

000629-11-8

1,6-Hexanediol

SML = 0,05 mg/kg

054276-35-6 Methacrylic acid, sulphopropyl ester

QMA = 0,05 mg/6 dm2’

5. The following monomers and other starting substances are deleted from the table in Section A:

Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘15370

15400

003236-53-1

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

QMA = 5 mg/6 dm2

003236-54-2

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

QMA = 5 mg/6 dm2’

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ANNEX II

Annex III is amended as follows:

1. point 1 is replaced by the following:

‘1. This Annex contains the list of:

(a) substances which are incorporated into plastics to achieve a technical effect in the finished product, including

“polymeric additives”. They are intended to be present in the finished articles;

(b) substances used to provide a suitable medium in which polymerisation occurs.

For the purposes of this Annex, the substances referred to in (a) and (b) are hereinafter referred to as “additives”.

For the purpose of this Annex, “Polymeric additives” means any polymer and/or prepolymer and/or oligomer
which may be added to plastics in order to achieve a technical effect but which cannot be used in absence of
other polymers as the main structural component of finished materials and articles. It includes also substances
which may be added to the medium in which polymerisation occurs.

The list does not include:

(a) the substances which directly influence the formation of polymers;

(b) colorants;

(c) solvents.’;

2. section A is amended as follows:

(a) the following additives are inserted, in the appropriate numerical order, in the table in section A:

Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘34850

143925-92-2

Amines,
alkyl) oxidised

bis(hydrogenated

tallow

QM = For use only:
(a) in polyolefines at 0,1 % (w/w) but
not in LDPE when it is in contact
with foods for which the Directive
85/572/EEC establishes a reduc-
tion factor less than 3;

(b) in PETat 0,25 % (w/w) in contact
with foods other of
those for
which the simulant D is laid down
in Directive 85/572/EEC 85/572/
EEC

34895

000088-68-6

2-Aminobenzamide

SML = 0,05 mg/kg. To be used only
for PET for water and beverages

39680

000080-05-7

2,2-Bis(4-hydroxyphenyl)propane

SML(T) = 0,6 mg/kg (28)

42880

008001-79-4

Castor oil

45600

003724-65-0

Crotonic acid

QMA(T) = 0,05 mg/6 dm2 (33)

45640

005232-99-5

2-Cyano-3,3-diphenylacrylic
ethyl ester

acid,

SML = 0,05 mg/kg

46700

—

SML = 5 mg/kg

a)

5,7-di-tert-Butyl-3-(3,4- and 2,3-di-
methylphenyl)-3H-benzofuran-2-one
5,7-di-tert-butyl-3-
containing:
(3,4-dimethylphenyl)-3H-benzofu-
ran-2-one (80 to 100 % w/w) and b)
5,7-di-tert-butyl-3-(2,3-dimethyl-
phenyl)-3H-benzofuran-2-one (0 to
20 % w/w)

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Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

46720

004130-42-1

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

QMA = 4,8 mg/6 dm2

56535

—

Glycerol, esters with nonanoic acid

59280

000100-97-0

Hexamethylenetetramine

68078

027253-31-2

Neodecanoic acid, cobalt salt

SML(T) = 15 mg/kg (22) (expressed as
Formaldehyde)

and
(expressed

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

69920

000144-62-7

Oxalic acid

SML(T) = 6 mg/kg (29)

SML = 30 mg/kg

76866

—

85601

—

Polyesters of 1,2-propanediol and/or
1,3- and/or 1,4-butanediol and/or
polypropyleneglycol with
adipic
acid, which may be end-capped with
acetic acid or fatty acids C12-C18 or
n-octanol and/or n-decanol

Silicates, natural (with the exception
of asbestos)

95000

028931-67-1

Trimethylolpropane trimethacrylate-
methyl methacrylate copolymer’

(b) for the following additives of section A, the content of the column ‘Restrictions and/or specifications’ of the table

is replaced by the following:

Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘45450

068610-51-5

p-Cresol-dicyclopentadiene-isobuty-
lene, copolymer

SML = 5 mg/kg

77895

068439-49-6

Polyethyleneglycol
noalkyl (C16-C18) ether

(EO = 2-6) mo-

SML = 0,05 mg/kg and in compli-
ance with the specifications laid down
in Annex V’

(c) the following additives are deleted from the table in section A:

Reference No

CAS No

(1)

‘56565

67170

(2)

—

—

76865

—

Name

(3)

Restrictions and/or specifications

(4)

Glycerol, esters with nonanoic acid

Mixture of (80 to 100 % w/w) 5,7-
di-tert-butyl-3-(3,4-dimethylphenyl)-
2(3H)-benzofuranone and (0 to 20 %
w/w)5,7-di-tert-butyl-3-(2,3-
dimethylphenyl)-2(3H)-benzofura-
none

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

SML = 5 mg/kg

SML = 30 mg/kg

85600

—

Silicates, natural’

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3. section B is amended as follows:

(a) the following additives are inserted, in the appropriate numerical order, in the table in section B:

Reference No

CAS No

(1)

(2)

‘34650

151841-65-5

Name

(3)

Restrictions and/or specifications

(4)

Aluminium hydroxybis [2,2'-methy-
lenebis
(4,6-di-tert.butylphenyl)
phosphate

SML = 5 mg/kg

38000

000553-54-8

Benzoic acid, lithium salt

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

40720

46640

54880

55200

55280

55360

67896

025013-16-5

tert-Butyl-4-hydroxyanisole (= BHA)

SML = 30 mg/kg

000128-37-0

2,6-Di-tert-butyl-p-cresol (= BHT)

SML = 3,0 mg/kg

000050-00-0

Formaldehyde

001166-52-5

Gallic acid, dodecyl ester

001034-01-1

Gallic acid, octyl ester

000121-79-9

Gallic acid, propyl ester

020336-96-3

Myristic acid, lithium salt

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

SML(T) = 30 mg/kg (34)

SML(T) = 30 mg/kg (34)

SML(T) = 30 mg/kg (34)

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

71935

007601-89-0

Perchloric acid, sodium salt mono-
hydrate

SML = 0,05 mg/kg (31)

068132-00-3

Polycyclopentadiene, hydrogenated

SML = 5 mg/kg (1)

76680

86480

86920

86960

007631-90-5

Sodium bisulphite

007632-00-0

Sodium nitrite

007757-83-7

Sodium sulphite

87120

007772-98-7

Sodium thiosulphate

94400

036443-68-2

Triethyleneglycol bis[3-(3-tert-butyl-
4-hydroxy-5-methylphenyl) propio-
nate]

SML(T) = 10 mg/kg (30) (expressed as
S02)
SML = 0,6 mg/kg

SML(T) = 10 mg/kg (30) (expressed as
S02)
SML(T) = 10 mg/kg (30) (expressed as
S02)
SML = 9 mg/kg’

(b) the following additives are deleted from the table in section B:

Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

‘46720

68078

004130-42-1

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

QMA = 4,8 mg/6 dm2

027253-31-2

Neodecanoic acid, cobalt salt

and
(expressed

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

95000

028931-67-1

Trimethylolpropane trimethacrylate-
methyl methacrylate copolymer’

10.3.2004

EN

Official Journal of the European Union

L 71/17

Annex IV is replaced by the following:

ANNEX III

‘ANNEX IV

PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION

Reference No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

18888

080181-31-3

3-Hydroxybutanoic
pentanoic acid, copolymer

acid-3-hydroxy-

compliance with

In
included in Annex V’

specifications

L 71/18

EN

Official Journal of the European Union

10.3.2004

In Annex V the previous specifications in part B for reference No 16690 and 18888 are replaced by the following and
new specifications are added for reference No 11530 and 77895

ANNEX IV

‘Reference
No

11530

OTHER SPECIFICATIONS

Acrylic acid, 2-hydroxypropyl ester.
It may contain up to 25 % (m/m) of acrylic acid, 2-hydroxyisopropyl ester (CAS No 002918-23-2)

16690

Divinylbenzene
It may contain up to 45 % (m/m) of Ethylvinylbenzene

18888

3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

Definition

The copolymers are produced by the controlled fermentation of Alcaligenes eutro-
phus using mixtures of glucose and propanoic acid as carbon sources. The
organism used has not been genetically engineered and has been derived from a
single wild-type organism Alcaligenes eutrophus strain HI6 NCIMB 10442. Master
stocks of the organism are stored as freeze-dried ampoules. A submaster/working
stock is prepared from the master stock and stored in liquid nitrogen and used to
prepare inocula for the fermenter. Fermenter samples will be examined daily both
microscopically and for any changes in colonial morphology on a variety of agars
at different temperatures. The copolymers are isolated from heat treatment bacteria
by controlled digestion of the other cellular components, washing and drying.
These copolymers are normally offered as formulated, melt
formed granules
containing additives such as nucleating agents, plasticisers, fillers, stabilisers and
pigments which all conform to the general and individual specifications

Chemical name

Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)

CAS number

080181-31-3

Structural formula

Average molecular
weight

Assay

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

Not less than 150 000 Daltons (measured by gel permeation chromatography)

less

than

Not
98 % poly(3-D-hydroxybutanoate-co-3-D-hydoxypentanoate)
analysed after hydrolysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxy-
pentanoic 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

Restriction

QMA for crotonic acid is 0.05 mg/6 dm2

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

10.3.2004

EN

Official Journal of the European Union

L 71/19

Reference
No

77895

OTHER SPECIFICATIONS

Polyethyleneglycol (E0 = 2-6) monoalkyl (C16-C18) ether
The composition of this mixture is as follows:
— polyethyleneglycol (E0 = 2-6)monoalkyl (C16-C18) ether (approximately 28 %)
— fatty alcohols (C16-C18) (approximately 48 %)
— ethyleneglycol monoalkyl (C16-C18) ether (approximately 24 %)’

L 71/20

EN

Official Journal of the European Union

10.3.2004

Annex VI is replaced by the following:

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 reference 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 reference 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 reference 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 reference 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 reference 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 reference 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 reference Nos: 38000, 42400, 64320, 67896, 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 reference 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
(expressed as Iodine) of the following substances mentioned as reference 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 reference Nos: 36720, 36800, 36840 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 reference 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 reference 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 reference 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 reference 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 reference 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 reference 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 reference 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 reference 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 reference Nos: 93120 and 93280.

10.3.2004

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Official Journal of the European Union

L 71/21

(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 reference Nos: 17260, 18670, 54880 and 59280.

(23) 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: 13620, 36840, 40320 and 87040.

(24) 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: 13720 and 40580.

(25) 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: 16650 and 51570.

(26) QM(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities of
the following substances mentioned as reference Nos: 14950, 15700, 16240, 16570, 16600, 16630, 18640,
19110, 22332, 22420, 22570, 25210, 25240 and 25270.

(27) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities

of the following substances mentioned as reference Nos: 10599/90A, 10599/91, 10599/92A and 10599/93.

(28) 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: 13480 and 39680.

(29) 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: 22775 and 69920.

(30) 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: 86480, 86960 and 87120

(31) Compliance testing when there is a fat contact should be performed using saturated fatty food simulants as

simulant D.

(32) Compliance testing when there is a fat contact should be performed using isoctane as substitute of simulant D

(unstable).

(33) QMA(T) in this specific case means that the restriction shall not be exceeded by the sum of the residual quantities

of the following substances mentioned as reference Nos: 14800 and 45600.

(34) 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: 55200, 55280 and 55360.’