Corrigendum to Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (OJ L 220 of 15.8.2002)
Date: 2003-02-13
Institutions: European Commission
Subjects: adjuvant, chemical product, foodstuff, marketing, packaging product, plastics, public health

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CORRIGENDA

Corrigendum to Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles
intended to come into contact with foodstuffs

(Official Journal of the European Communities L 220 of 15 August 2002)

On page 18, the text of Commission Directive 2002/72/EC shall be replaced by the following:

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‘COMMISSION DIRECTIVE 2002/72/EC

of 6 August 2002

relating to plastic materials and articles intended to come into contact with foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(8)

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:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

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 2002/17/EC (3), has been frequently and
substantially amended; for reasons of clarity and ration-
ality,

it should therefore be consolidated.

Article 2 of Directive 89/109/EEC lays down that mate-
rials and articles, in their finished state, must not transfer
their constituents to foodstuffs in quantities which could
endanger human health or bring about an unacceptable
change in the composition of the foodstuffs.

In order to achieve this objective in the case of plastic
materials and articles, a suitable instrument is a specific
Directive within the meaning of Article 3 of Directive
89/109/EEC, the general provisions of which are also
applicable to the case in question.

The scope of this Directive must coincide with that of
Council Directive 82/711/EEC (4).

Since the rules established in this Directive are not suit-
able for ion-exchange resins, these materials and articles
will be covered by a subsequent specific Directive.

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

The establishment of a list of approved substances
accompanied by a limit on overall migration and, where
necessary, by other specific restrictions will be sufficient
to achieve the objective laid down in Article 2 of
Directive 89/109/EEC.

(1) OJ L 40, 11.2.1989, p. 38.
(2) OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990, p. 26.
(3) OJ L 58, 28.2.2002, p. 19.
(4) OJ L 297, 23.10.1982, p. 26. Directive as last amended by

Directive 97/48/EC (OJ L 222, 12.8.1997, p. 10).

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 which may
continue to be used pending their evaluation by the
Scientific Committee on Food and the decision on their
inclusion in the Community list;
this Directive will
accordingly be extended in due course to the substances
and sectors provisionally excluded.

(9)

(10)

(11)

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

This Directive establishes specifications for only a few
substances. The other substances, which may require
specifications, therefore remain regulated in this respect
by national laws pending a decision at 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 specific situations; therefore, these additives appear
in a list other than that of the additives fully regulated at
Community level.

(12) Directive 82/711/EEC lays down the basic rules neces-
sary for testing migration of the constituents of plastic
materials
and Council Directive 85/
572/EEC (5) establishes the list of simulants to be used in
the migration tests.

and articles

(13)

(14)

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

(5) OJ L 372, 31.12.1985, p. 14.

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(15)

(16)

(17)

(18)

(19)

(20)

(21)

(22)

The overall migration limit is a measure of the inertness
of the material and prevents an unacceptable change in
the composition of
the foodstuffs, and, moreover,
reduces the need for a large number of specific migra-
tion limits or other restrictions, thus giving effective
control.

Council Directive 78/142/EEC (1) lays down limits for
the quantity of vinyl chloride present in plastic materials
and articles prepared with this substance and for the
quantity of vinyl chloride released by these materials and
articles, and Commission Directives 80/766/EEC (2) and
81/432/EEC (3) establish the Community methods of
analysis for controlling these limits.

liability, there is a need for the
In view of potential
written declaration provided for
in Article 6(5) of
Directive 89/109/EEC whenever professional use is
made of plastic materials and articles which are not by
their nature clearly intended for food use.

Commission Directive 80/590/EEC (4) determines the
symbol that may accompany any material and article
intended to come into contact with foodstuffs.

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 permitted substances. This Directive
confines itself to what is necessary in order to achieve
the objectives pursued in accordance with the third para-
graph of Article 5 of the Treaty.

In accordance with Article 3 of Directive 89/109/EEC,
the Scientific Committee on Food has been consulted on
the provisions liable to affect public health.

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

This Directive should be without prejudice to the dead-
lines set out in Annex VII, Part B within which the
Member States are to comply with Directive 90/
128/EEC, and the acts amending it,

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive is a specific Directive within the meaning

1.
of Article 3 of Directive 89/109/EEC.

(a) consisting exclusively of plastics; or

(b) composed of

two or more layers of materials, each
consisting exclusively of plastics, which are bound together
by means of adhesives or by any other means,

which, in the finished product state, are intended to come into
contact or are brought into contact with foodstuffs and are
intended for that purpose.

3.
For the purposes of this Directive, “plastics” shall mean
the organic macromolecular compounds obtained by polymeri-
sation, polycondensation, polyaddition or any other similar
process from molecules with a lower molecular weight or by
natural macromolecules. Other
chemical
substances or matter may be added to such macromolecular
compounds.

alteration

of

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

(a) varnished or unvarnished regenerated cellulose
covered by Commission Directive 93/10/EEC (5);

film,

(b) elastomers and natural and synthetic rubber;

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

addition of plastics;

(d) 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,

(e) ion-exchange resins;

(f) silicones.

4.
This Directive shall not apply, until further action by the
Commission, to materials and articles composed of two or
more layers, one or more of which does not consist exclusively
of plastics, even if the one intended to come into direct contact
with foodstuffs does consist exclusively of plastics.

Article 2

Plastic materials and articles shall not transfer their constituents
to foodstuffs in quantities exceeding 10 milligrams per square
decimetre of surface area of material or article (mg/dm2)
(overall migration limit). However, this limit shall be 60 milli-
grams of the constituents released per kilogram of foodstuff
(mg/kg) in the following cases:

(a) articles which are

to
containers or which can be filled, with a capacity of not
less than 500 millilitres (ml) and not more than 10 litres (l);

containers or are

comparable

This Directive shall apply to plastic materials and articles

2.
and parts thereof:

(b) articles which can be filled and for which it is impracticable
to estimate the surface area in contact with foodstuffs;

(1) OJ L 44, 15.2.1978, p. 15.
(2) OJ L 213, 16.8.1980, p. 42.
(3) OJ L 167, 24.6.1981, p. 6.
(4) OJ L 151, 19.6.1980, p. 21.

(c) caps, gaskets, stoppers or similar devices for sealing.

(5) OJ L 93, 17.4.1993, p. 27. Directive amended by Directive 93/

111/EC (OJ L 310, 14.12.1993, p. 41).

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Article 3

1.
Only those monomers and other starting substances
listed in Annex II, Sections A and B, may be used for the
manufacture of plastic materials and articles subject to the
restrictions specified.

2.
By way of derogation from the first paragraph the mono-
mers and other starting substances listed in Annex II, Section B,
may continue to be used until 31 December 2004 at latest,
pending their evaluation by the Scientific Committee on Food.

3.

The list in Annex II, Section A, may be amended:

— either by adding substances listed in Annex II, Section B,
according to the criteria in Annex II of Directive 89/
109/EEC, or

— by including “new substances”,

i.e. substances which are
listed neither in Section A nor in Section B of Annex II,
according to Article 3 of Directive 89/109/EEC.

4.
No Member State shall authorise any new substance for
use within its territory except under the procedure in Article 4
of Directive 89/109/EEC.

5.
The lists appearing in Annex II, Sections A and B, do not
yet include monomers and other starting substances used only
in the manufacture of:

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

lacquers, paints, etc.,

— epoxy resins,

— adhesives and adhesion promoters,

— printing inks.

Article 4

An incomplete list of additives, which may be used for the
manufacture of plastic materials and articles, together with the
restrictions and/or specifications on their use,
is set out in
Annex III, Sections A and B.

For the substances in Annex III, Section B, the specific migra-
tion 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.

Article 5

Only the products obtained by means of bacterial fermentation
listed in Annex IV may be used in contact with foodstuffs.

The meaning of the numbers between brackets appearing
2.
in the column “Restrictions and/or specifications” is explained
in Annex VI.

Article 7

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

(a) articles which are

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

containers or are

comparable

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

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

Article 8

1.
Verification of compliance with the migration limits shall
be carried out in accordance with the rules laid down in
Directives 82/711/EEC and 85/572/EEC and the further provi-
sions set out in Annex I.

2.
The verification of compliance with the specific migration
limits provided for in paragraph 1 shall not be compulsory, if it
can be established that compliance with the overall migration
limit laid down in Article 2 implies that the specific migration
limits are not exceeded.

3.
The verification of compliance with the specific migration
limits provided for in paragraph 1 shall not be compulsory, if it
can be established that, by assuming complete migration of the
residual substance in the material or article, it cannot exceed
the specific limit of migration.

The verification of compliance with the specific migration
4.
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
substance has been established either by an adequate experi-
mentation or by the application of generally recognised diffu-
sion models based on scientific evidence. To demonstrate the
non-compliance of a material or article, confirmation of the
estimated migration value by experimental testing is obligatory.

the specific migration of

Article 6

Article 9

1.
General specifications related to plastic 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.

1.
At the marketing stages other than the retail stages, the
plastic materials and articles which are intended to be placed in
contact with foodstuffs shall be accompanied by a written
declaration in accordance with Article 6(5) of Directive 89/
109/EEC.

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Paragraph 1 does not apply to plastic materials and
2.
articles which by their nature are clearly intended to come into
contact with foodstuffs.

Article 10

1.
Directive 90/128/EEC, as amended by the Directives set
out in Annex VII, Part A, is hereby repealed without prejudice
to the obligations of the Member States in respect of the
deadlines for transposition and application laid down in Annex
VII, Part B.

2.
References to the repealed Directives shall be construed
as references to this Directive and be read in accordance with
the correlation table set out in Annex VIII.

Article 11

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

This Directive is addressed to the Member States.

Article 12

Done at Brussels, 6 August 2002.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

FURTHER PROVISIONS APPLICABLE WHEN CHECKING COMPLIANCE WITH THE MIGRATION LIMITS

General provisions

1. When comparing the results of the migration tests specified in the Annex to Directive 82/711/EEC, the specific gravity
of all the simulants should conventionally be assumed to be 1. Milligrams of substance(s) released per litre of simulant
(mg/l) will thus correspond numerically to milligrams of substance(s) released per kilogram of simulant and, taking
into account the provisions laid down in Directive 85/572/EEC, to milligrams of substance(s) released per kilogram of
foodstuff.

2. Where the migration tests are carried out on samples taken from the material or article or on samples manufactured
for the purpose, and the quantities of foodstuff or simulant placed in contact with the sample differ from those
employed in the actual conditions under which the material or article is used, the results obtained should be corrected
by applying the following formula:

Where:

M is the migration in mg/kg;

m is the mass in mg of substance released by the sample as determined by the migration test;

a1

a2

q

is the surface area in dm2 of the sample in contact with the foodstuff or simulant during the migration test;

is the surface area in dm2 of the material or article in real conditions of use;

is the quantity in grams of foodstuff in contact with the material or article in real conditions of use.

3. The determination of migration is carried out on the material or article or, if that is impracticable, using either
specimens taken from the material or article or, where appropriate, specimens representative of this material or article.

The sample shall be placed in contact with the foodstuff or simulant in a manner representing the contact conditions
in actual use. For this purpose, the test shall be performed in such a way that only those parts of the sample intended
to come into contact with foodstuffs in actual use will be in contact with the foodstuff or simulant. This condition is
particularly important in the case of materials and articles comprising several

layers, for closures, etc.

The migration testing of caps, gaskets, stoppers or similar devices for sealing must be carried out on these articles by
applying them to the containers for which they are intended in a manner which corresponds to the conditions of
closing in normal or foreseeable use.

It shall in all cases be permissible to demonstrate compliance with migration limits by the use of a more severe test.

4. In accordance with the provisions set out in Article 8 of the present Directive, the sample of the material or article is
placed in contact with the foodstuff or appropriate simulant for a period and at a temperature which are chosen by
reference to the contact conditions in actual use, in accordance with the rules laid down in Directives 82/711/EEC and
85/572/EEC. At the end of the prescribed time, the analytical determination of the total quantity of substances (overall
migration) and/or the specific quantity of one or more substances (specific migration) released by the sample is carried
out on the foodstuff or simulant.

5. Where a material or article is intended to come into repeated contact with foodstuffs, the migration test(s) shall be
carried out three times on a single sample in accordance with the conditions laid down in Directive 82/711/EEC using
another sample of the food or simulant(s) on each occasion. Its compliance shall be checked on the basis of the level
of the migration found in the third test. However, if there is conclusive proof that the level of the migration does not
increase in the second and third tests and if the migration limit(s) is (are) not exceeded on the first test, no further test
is necessary.

Special provisions relating to overall migration

6. If the aqueous simulants specified in Directives 82/711/EEC and 85/572/EEC are used, the analytical determination of
the total quantity of substances released by the sample may be carried out by evaporation of the simulant and
weighing of the residue.

If rectified olive oil or any of its substitutes is used, the procedure given below may be followed.

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The sample of the material or article is weighed before and after contact with the simulant. The simulant absorbed by
the sample is extracted and determined quantitatively. The quantity of simulant found is subtracted from the weight of
the sample measured after contact with the simulant. The difference between the initial and corrected final weights
represents the overall migration of the sample examined.

Where a material or article is intended to come into repeated contact with foodstuffs and it is technically impossible to
carry out the test described in paragraph 5, modifications to that test are acceptable, provided that they enable the level
of migration occurring during the third test to be determined. One of these possible modifications is described below.

The test is carried out on three identical samples of the material or article. One of these shall be subjected to the
appropriate test and the overall migration determined (M
). The second and third samples shall be subjected to the
1
same conditions of temperature but the period of contact shall be two and three times that specified and overall
migration determined in each case (M
2

, respectively).
and M
3

The material or article shall be deemed to be in compliance provided that either M
1
overall migration limit.

or M
3

− M
2

does not exceed the

7. A material or article that exceeds the overall migration limit by an amount not greater than the analytical tolerance

mentioned below should therefore be deemed to be in compliance with this Directive.

The following analytical tolerances have been observed:
— 20 mg/kg or 3 mg/dm2 in migration tests using rectified olive oil or substitutes,
— 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.

8. Without prejudice to the provisions of Article 3(2) of Directive 82/711/EEC, migration tests using rectified olive oil or
substitutes shall not be carried out to check compliance with the overall migration limit in cases where there is
conclusive proof that the specified analytical method is inadequate from a technical standpoint.

In any such case, for substances exempt from specific migration limits or other restrictions in the list provided in
Annex II, a generic specific migration limit of 60 mg/kg or 10 mg/dm2, according to the case, is applied. However,
the sum of all specific migrations determined shall not exceed the overall migration limit.

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ANNEX II

LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY BE USED IN THE
MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES

GENERAL INTRODUCTION

1. This Annex contains the list of monomers or other starting substances. The list includes:

— substances undergoing polymerisation, which includes polycondensation, polyaddition or any other similar

process, to manufacture macromolecules,

— natural or synthetic macromolecular substances used in the manufacture of modified macromolecules,
monomers or the other starting substances required to synthesise them are not included in the list,

if the

— substances used to modify existing natural or synthetic macromolecular substances.

2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron,
magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised.
However, names containing “… acid(s), salts” appear in the lists if the corresponding free acid(s) is (are) not mentioned.
In each case the meaning of the term “salts” is “salts of aluminium, ammonium, calcium, iron, magnesium, potassium,
sodium and zinc”.

3. The list also does not include the following substances although they may be present:

(a) substances which could be present in the finished product as:

— impurities in the substances used,

— reaction intermediates,

— decomposition products;

(b) oligomers and natural or synthetic macromolecular substances as well as their mixtures, if the monomers or

starting substances required to synthesise them are included in the list;

(c) mixtures of the authorised substances.

The materials and articles which contain the substances indicated under points (a), (b) and (c) shall comply with the
requirements stated in Article 2 of Directive 89/109/EEC.

4. Substances shall be of good technical quality as regards the purity criteria.

5. The list contains the following information:

— column 1 (Ref. No): the EEC packaging material reference number of the substances on the list,

— column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number,

— column 3 (Name): the chemical name,

— column 4 (Restrictions and/or specifications): These may include:

— specific migration limit (SML),

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

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

the surface in contact with foodstuffs (QMA),

— any other restriction specifically mentioned,

— any type of specifications related to the substance or to the polymer.

6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions

applying to this substance shall be those indicated for the individual compound.

7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take
precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS and the
CAS Registry, the CAS number in the CAS Registry shall apply.

8. A number of abbreviations or expressions are used in column 4 of the table, the meanings of which are as follows:

DL

FP

= Detection limit of the method of analysis;

= Finished material or article;

NCO

= Isocyanate moiety;

ND

= not detectable. For the purpose of this Directive “not detectable” means that the substance should not be
detected by a validated method of analysis which should detect it at the detection limit (DL) specified. If
such a method does not currently exist, an analytical method with appropriate performance characteristics
at the detection limit may be used, pending the development of a validated method;

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QM

= Maximum permitted quantity of the “residual” substance in the material or article;

QM(T)

QMA

= Maximum permitted quantity of the “residual” substance in the material or article expressed as total of
moiety or substance(s) indicated. For the purpose of this Directive the quantity of the substance in the
material or article should be determined by a validated method of analysis. If such a method does not
currently exist, an analytical method with appropriate performance characteristics at the specified limit
may be used, pending the development of a validated method;

= Maximum permitted quantity of the “residual” substance in the finished material or article expressed as mg
per 6 dm2 of the surface in contact with foodstuffs. For the purpose of this Directive the quantity of the
substance in the surface of the material or article should be determined by a validated method of analysis.
If such a method does not currently exist, an analytical method with appropriate performance characteris-
tics at the specified limit may be used, pending the development of a validated method;

QMA(T) = Maximum permitted quantity of the “residual” substance in the material or article expressed as mg of total
of moiety or substance(s) indicated per 6 dm2 of the surface in contact with foodstuffs. For the purpose of
this Directive the quantity of the substance in the surface of the material or article should be determined
by a validated method of analysis. If such a method does not currently exist, an analytical method with
appropriate performance characteristics at the specified limit may be used, pending the development of a
validated method;

SML

SML(T)

= Specific migration limit in food or in food simulant, unless it is specified otherwise. For the purpose of
this Directive the specific migration of the substance should be determined by a validated method of
analysis. If such a method does not currently exist, an analytical method with appropriate performance
characteristics at the specified limit may be used, pending the development of a validated method;

= Specific migration limit in food or in food simulant expressed as total of moiety or substance(s) indicated.
For the purpose of this Directive the specific migration of the substances should be determined by a
validated method of analysis. If such a method does not currently exist, an analytical method with
appropriate performance characteristics at the specified limit may be used, pending the development of a
validated method.

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Section A

List of authorised monomers and other starting substances

Ref. No.

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

10030

10060

10090

10120

10150

10210

10630

10660

10690

10750

10780

10810

10840

11000

11245

11470

11510

11530

11590

11680

11710

11830

11890

11980

12100

12130

12265

12280

12310

12340

12375

12670

12761

12763

12765

12788

12789

12820

000514-10-3

Abietic acid

000075-07-0

Acetaldehyde

000064-19-7

Acetic acid

000108-05-4

Acetic acid, vinyl ester

000108-24-7

Acetic anhydride

000074-86-2

Acetylene

000079-06-1

Acrylamide

015214-89-8

2-Acrylamido-2-methylpropanesulphonic acid

000079-10-7

Acrylic acid

002495-35-4

Acrylic acid, benzyl ester

000141-32-2

Acrylic acid, n-butyl ester

002998-08-5

Acrylic acid, sec-butyl ester

001663-39-4

Acrylic acid, tert-butyl ester

050976-02-8

Acrylic acid, dicyclopentadienyl ester

002156-97-0

Acrylic acid, dodecyl ester

000140-88-5

Acrylic acid, ethyl ester

000818-61-1

Acrylic acid, hydroxyethyl ester

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

SML = 12 mg/kg

SML = ND (DL = 0,01 mg/kg)

SML = 0,05 mg/kg

QMA = 0,05 mg/6 dm2

SML = 0,05 mg/kg (1)

“Acrylic

See
ethyleneglycol”

acid, monoester with

000999-61-1

Acrylic acid, 2-hydroxypropyl ester

QMA = 0,05 mg/6 dm2

000106-63-8

Acrylic acid,

isobutyl ester

000689-12-3

Acrylic acid,

isopropyl ester

000096-33-3

Acrylic acid, methyl ester

000818-61-1

Acrylic acid, monoester with ethyleneglycol

002499-59-4

Acrylic acid, n-octyl ester

000925-60-0

Acrylic acid, propyl ester

000107-13-1

Acrylonitrile

000124-04-9

Adipic acid

004074-90-2

Adipic acid, divinyl ester

002035-75-8

Adipic anhydride

Albumin

Albumin, coagulated by formaldehyde

Alcohols, aliphatic, monohydric, saturated,

linear, primary (C4-C22)

002855-13-2

1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane

000693-57-2

12-Aminododecanoic acid

000141-43-5

2-Aminoethanol

084434-12-8

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

002432-99-7

11-Aminoundecanoic acid

007664-41-7

Ammonia

000123-99-9

Azelaic acid

SML = ND (DL= 0,020 mg/kg, analytical
tolerance included)

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

SML = 6 mg/kg

SML= 0,05 mg/kg

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

SML= 0,05 mg/kg

SML= 5 mg/kg

13.2.2003

EN

Official Journal of the European Union

L 39/11

Ref. No.

CAS No

(1)

(2)

Name

(3)

12970

004196-95-6

Azelaic anhydride

Restrictions and/or specifications

(4)

13000

001477-55-0

1,3-Benzenedimethanamine

SML= 0,05 mg/kg

13060

004422-95-1

1,3,5-Benzenetricarboxylic acid trichloride

13075

000091-76-9

Benzoguanamine

13090

000065-85-0

Benzoic acid

13150

000100-51-6

Benzyl alcohol

QMA = 0,05 mg/6 dm2
1,3,5-Benzenetricarboxylic acid)

(measured as

“2,4-Diamino-6-phenyl-1,3,5-tria-

See
zine”

13180

000498-66-8

Bicyclo[2.2.1]hept-2-ene (=Norbornene)

13210

001761-71-3

Bis(4-aminocyclohexyl)methane

13326

000111-46-6

Bis(2-hydroxyethyl)ether

SML= 0,05 mg/kg

SML= 0,05 mg/kg

See “Diethyleneglycol”

13380

000077-99-6

2,2-Bis(hydroxymethyl)-1-butanol

See “1,1,1-Trimethylolpropane”

13390

000105-08-8

1,4-Bis(hydroxymethyl)cyclohexane

13395

004767-03-7

2,2-Bis(hydroxymethyl)propionic acid

13480

000080-05-7

2,2-Bis(4-hydroxyphenyl)propane

13510

001675-54-3

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

QMA = 0,05 mg/6 dm2

SML = 3 mg/kg

According to Commission Directive
2002/16/EC of 20 February 2002 on
the use of certain epoxy derivatives in
materials and articles intended to come
into contact with foodstuffs (OJ L 51,
22.2.2002, p. 27)

13530

038103-06-9

2,2-Bis(4-hydroxyphenyl)propane bis(phthalic anhydride)

SML = 0,05 mg/kg

13550

000110-98-5

Bis(hydroxypropyl) ether

13560

0005124-30-1

Bis(4-isocyanatocyclohexyl)methane

See “Dipropyleneglycol”

“Dicyclohexylmethane-4,4(cid:1)-diiso-

See
cyanate”

13600

047465-97-4

3,3-Bis(3-methyl-4-hydroxyphenyl)2-indolinone

SML = 1,8 mg/kg

13607

000080-05-7

Bisphenol A

13610

001675-54-3

Bisphenol A bis(2,3-epoxypropyl) ether

13614

038103-06-9

Bisphenol A bis(phthalic anhydride)

13617

000080-09-1

Bisphenol S

13620

010043-35-3

Boric acid

13630

000106-99-0

Butadiene

13690

000107-88-0

1,3-Butanediol

13720

000110-63-4

1,4-Butanediol

13780

002425-79-8

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

13810

000505-65-7

1,4-Butanediol formal

13840

000071-36-3

1-Butanol

13870

000106-98-9

1-Butene

13900

000107-01-7

2-Butene

See “2,2-Bis(4-hydroxyphenyl)propane”

“2,2-Bis(4-hydroxyphenyl)propane

See
bis(2,3-epoxypropyl) ether”

See “2,2-Bis(4-
hydroxyphenyl)propane
anhydride)”

bis(phthalic

See “4,4(cid:1)-Dihydroxydiphenyl sulphone”

(expressed

as
SML(T) = 6 mg/kg (23)
Boron) without prejudice to the provi-
sions of Directive 98/83/EC on water
for human consumption (OJ L 330,
5.12.1998, p. 32).

QM = 1 mg/kg in FP or SML = not
detectable (DL = 0,020 mg/kg, analytical
tolerance included)

SML(T) = 0,05 mg/kg (24)

QM = 1 mg/kg in FP (expressed as
Epoxy group, Mw = 43)

QMA = 0,05 mg/6 dm2

L 39/12

EN

Official Journal of the European Union

13.2.2003

Ref. No.

CAS No

(1)

(2)

13932

000598-32-3

3-Buten-2-ol

Name

(3)

Restrictions and/or specifications

(4)

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

14020

000098-54-4

4-tert-Butylphenol

SML = 0,05 mg/kg

14110

000123-72-8

Butyraldehyde

14140

000107-92-6

Butyric acid

14170

000106-31-0

Butyric anhydride

14200

000105-60-2

Caprolactam

14230

002123-24-2

Caprolactam, sodium salt

14320

000124-07-2

Caprylic acid

14350

000630-08-0

Carbon monoxide

14380

000075-44-5

Carbonyl chloride

14411

008001-79-4

Castor oil

14500

009004-34-6

Cellulose

14530

007782-50-5

Chlorine

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

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

(expressed

as

QM = 1 mg/kg in FP

14570

000106-89-8

1-Chloro-2,3-epoxypropane

14650

000079-38-9

Chlorotrifluoroethylene

See “Epichlorohydrin”

QMA = 0,5 mg/6 dm2

14680

000077-92-9

Citric acid

14710

000108-39-4

m-Cresol

14740

000095-48-7

o-Cresol

14770

000106-44-5

p-Cresol

14841

000599-64-4

4-Cumylphenol

14880

000105-08-8

1,4-Cyclohexanedimethanol

14950

003173-53-3

Cyclohexyl

isocyanate

15030

000931-88-4

Cyclooctene

15070

001647-16-1

1,9-Decadiene

15095

000334-48-5

Decanoic acid

15100

000112-30-1

1-Decanol

15130

000872-05-9

1-Decene

15250

000110-60-1

1,4-Diaminobutane

15272

000107-15-3

1,2-Diaminoethane

15274

000124-09-4

1,6-Diaminohexane

15310

000091-76-9

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

15370

003236-53-1

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

15400

003236-54-2

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

15565

000106-46-7

1,4-Dichlorobenzene

15610

000080-07-9

4,4(cid:1)-Dichlorodiphenyl sulphone

SML = 0,05 mg/kg

See
“1,4-Bis(hydroxymethyl)cyclohexane”

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

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

SML = 0,05 mg/kg

SML = 0,05 mg/kg

See “Ethylenediamine”

See “Hexamethylenediamine”

QMA = 5 mg/6 dm2

QMA = 5 mg/6 dm2

QMA = 5 mg/6 dm2

SML = 12 mg/kg

SML = 0,05 mg/kg

13.2.2003

EN

Official Journal of the European Union

L 39/13

Ref. No.

CAS No

(1)

(2)

Name

(3)

15700

005124-30-1

Dicyclohexylmethane-4,4(cid:1)-diisocyanate

15760

000111-46-6

Diethyleneglycol

15790

000111-40-0

Diethylenetriamine

15820

000345-92-6

4,4(cid:1)-Difluorobenzophenone

15880

000120-80-9

1,2-Dihydroxybenzene

15910

000108-46-3

1,3-Dihydroxybenzene

15940

000123-31-9

1,4-Dihydroxybenzene

Restrictions and/or specifications

(4)

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

(expressed

as

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

SML = 5 mg/kg

SML = 0,05 mg/kg

SML = 6 mg/kg

SML = 2,4 mg/kg

SML = 0,6 mg/kg

15970

000611-99-4

4,4(cid:1)-Dihydroxybenzophenone

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

16000

000092-88-6

4,4(cid:1)-Dihydroxybiphenyl

16090

000080-09-1

4,4(cid:1)-Dihydroxydiphenyl sulphone

16150

000108-01-0

Dimethylaminoethanol

16240

000091-97-4

3,3(cid:1)-Dimethyl-4,4(cid:1)-diisocyanatobiphenyl

16360

000576-26-1

2,6-Dimethylphenol

16390

000126-30-7

2,2-Dimethyl-1,3-propanediol

16450

000646-06-0

1,3-Dioxolane

16480

000126-58-9

Dipentaerythritol

16570

004128-73-8

Diphenylether-4,4(cid:1)-diisocyanate

16600

005873-54-1

Diphenylmethane-2,4(cid:1)-diisocyanate

16630

000101-68-8

Diphenylmethane-4,4(cid:1)-diisocyanate

16650

000127-63-9

Diphenyl sulphone

16660

000110-98-5

Dipropyleneglycol

16690

001321-74-0

Divinylbenzene

SML = 6 mg/kg

SML = 0,05 mg/kg

SML = 18 mg/kg

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

SML = 0,05 mg/kg

SML = 0,05 mg/kg

SML = 0,05 mg/kg

(expressed

as

(expressed

(expressed

(expressed

as

as

as

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

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

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

SML(T) = 3 mg/kg (25)

QMA = 0,01 mg/6 dm2 or SML = ND
(DL = 0,02 mg/kg, analytical
tolerance
included) for the sum of divinylbenzene
and ethylvinylbenzene and in compli-
ance with the specifications laid down
in Annex V

16694

013811-50-2

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

QM = 5 mg/kg in FP

16697

000693-23-2

n-Dodecanedioic acid

16704

000112-41-4

1-Dodecene

16750

000106-89-8

Epichlorohydrin

16780

000064-17-5

Ethanol

16950

000074-85-1

Ethylene

16960

000107-15-3

Ethylenediamine

16990

000107-21-1

Ethyleneglycol

17005

000151-56-4

Ethyleneneimine

17020

000075-21-8

Ethylene oxide

17050

000104-76-7

2-Ethyl-1-hexanol

SML = 0,05 mg/kg

QM = 1 mg/kg in FP

SML = 12 mg/kg

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

SML = ND (DL = 0,01 mg/kg)

QM = 1 mg/kg in FP

SML = 30 mg/kg

L 39/14

EN

Official Journal of the European Union

13.2.2003

Ref. No.

CAS No

(1)

(2)

17160

000097-53-0

Eugenol

Name

(3)

17170

061788-47-4

Fatty acids, coco

17200

068308-53-2

Fatty acids, soya

17230

061790-12-3

Fatty acids, tall oil

17260

000050-00-0

Formaldehyde

17290

000110-17-8

Fumaric acid

17530

000050-99-7

Glucose

18010

000110-94-1

Glutaric acid

18070

000108-55-4

Glutaric anhydride

18100

000056-81-5

Glycerol

Restrictions and/or specifications

(4)

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

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

18220

068564-88-5

N-Heptylaminoundecanoic acid

SML = 0,05 mg/kg (1)

18250

000115-28-6

Hexachloroendomethylenetetrahydrophthalic acid

SML = ND (DL = 0,01 mg/kg)

18280

000115-27-5

Hexachloroendomethylenetetrahydrophthalic anhydride

SML = ND (DL = 0,01 mg/kg)

18310

036653-82-4

1-Hexadecanol

18430

000116-15-4

Hexafluoropropylene

18460

000124-09-4

Hexamethylenediamine

18640

000822-06-0

Hexamethylene diisocyanate

18670

000100-97-0

Hexamethylenetetramine

18820

000592-41-6

1-Hexene

18867

000123-31-9

Hydroquinone

18880

000099-96-7

p-Hydroxybenzoic acid

SML = ND (DL = 0,01 mg/kg)

SML = 2,4 mg/kg

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

(expressed

as

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

(expressed

as

SML = 3 mg/kg

See “1,4-Dihydroxybenzene”

18897

016712-64-4

6-Hydroxy-2-naphthalenecarboxylic acid

SML = 0,05 mg/kg

18898

000103-90-2

N-(4-Hydroxyphenyl) acetamide

19000

000115-11-7

Isobutene

19060

000109-53-5

Isobutyl vinyl ether

19110

004098-71-9

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

19150

000121-91-5

Isophthalic acid

19210

001459-93-4

Isophthalic acid, dimethyl ester

19243

000078-79-5

Isoprene

19270

000097-65-4

Itaconic acid

19460

000050-21-5

Lactic acid

19470

000143-07-7

Lauric acid

19480

002146-71-6

Lauric acid, vinyl ester

19490

000947-04-6

Laurolactam

19510

011132-73-3

Lignocellulose

19540

000110-16-7

Maleic acid

19960

000108-31-6

Maleic anhydride

19975

000108-78-1

Melamine

19990

000079-39-0

Methacrylamide

Only to be used in liquid crystals and
behind a barrier layer in multilayered
plastics

QM = 5 mg/kg in FP

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

SML = 5 mg/kg

SML = 0,05 mg/kg

(expressed

as

See “2-Methyl-1,3-butadiene”

SML = 5 mg/kg

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

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

(expressed

as

See “2,4,6-triamino-1,3,5-triazine”

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

13.2.2003

EN

Official Journal of the European Union

L 39/15

Ref. No.

CAS No

(1)

(2)

Name

(3)

20020

000079-41-4

Methacrylic acid

Restrictions and/or specifications

(4)

20050

000096-05-9

Methacrylic acid, allyl ester

SML = 0,05 mg/kg

20080

002495-37-6

Methacrylic acid, benzyl ester

20110

000097-88-1

Methacrylic acid, butyl ester

20140

002998-18-7

Methacrylic acid, sec-butyl ester

20170

000585-07-9

Methacrylic acid, tert-butyl ester

20260

000101-43-9

Methacrylic acid, cyclohexyl ester

20410

002082-81-7

Methacrylic acid, diester with 1,4-butanediol

20530

002867-47-2

Methacrylic acid, 2-(dimethylamino)-ethyl ester

SML = 0,05 mg/kg

SML = 0,05 mg/kg

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

20590

000106-91-2

Methacrylic acid, 2,3-epoxypropyl ester

QMA = 0,02 mg/6 dm2

20890

000097-63-2

Methacrylic acid, ethyl ester

21010

000097-86-9

Methacrylic acid,

isobutyl ester

21100

004655-34-9

Methacrylic acid,

isopropyl ester

21130

000080-62-6

Methacrylic acid, methyl ester

21190

000868-77-9

Methacrylic acid, monoester with ethyleneglycol

21280

002177-70-0

Methacrylic acid, phenyl ester

21340

002210-28-8

Methacrylic acid, propyl ester

21460

000760-93-0

Methacrylic anhydride

21490

000126-98-7

Methacrylonitrile

SML = ND (DL = 0,020 mg/kg,
lytical tolerance included)

ana-

21520

001561-92-8

Methallylsulphonic acid, sodium salt

SML = 5 mg/kg

21550

000067-56-1

Methanol

21640

000078-79-5

2-Methyl-1,3-butadiene

21730

000563-45-1

3-Methyl-1-butene

21765

106246-33-7

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

21821

000505-65-7

1,4-(Methylenedioxy)butane

21940

000924-42-5

N-Methylolacrylamide

22150

000691-37-2

4-Methyl-1-pentene

22331

025513-64-8

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

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

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

QMA = 0,05 mg/6 dm2

See “1,4-Butanediol formal”

SML = ND (DL = 0,01 mg/kg)

SML = 0,02 mg/kg

QMA = 5 mg/6 dm2

22332

028679-16-5

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

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

(expressed

as

22350

000544-63-8

Myristic acid

22360

001141-38-4

2,6-Naphthalenedicarboxylic acid

22390

000840-65-3

2,6-Naphthalenedicarboxylic acid, dimethyl ester

22420

003173-72-6

1,5-Naphthalene diisocyanate

22437

000126-30-7

Neopentylglycol

22450

009004-70-0

Nitrocellulose

22480

000143-08-8

1-Nonanol

22550

000498-66-8

Norbornene

22570

000112-96-9

Octadecyl

isocyanate

SML = 5 mg/kg

SML = 0,05 mg/kg

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

(expressed

as

See “2,2-Dimethyl-1,3-propanediol”

See “Bicyclo[2.2.1]hept-2-ene”

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

(expressed

as

L 39/16

EN

Official Journal of the European Union

13.2.2003

Ref. No.

CAS No

(1)

(2)

22600

000111-87-5

1-Octanol

22660

000111-66-0

1-Octene

22763

000112-80-1

Oleic acid

Name

(3)

Restrictions and/or specifications

(4)

SML = 15 mg/kg

22778

007456-68-0

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

QMA = 0,05 mg/6 dm2

22780

000057-10-3

Palmitic acid

22840

000115-77-5

Pentaerythritol

22870

000071-41-0

1-Pentanol

22900

000109-67-1

1-Pentene

22937

001623-05-8

Perfluoropropylperfluorovinyl ether

22960

000108-95-2

Phenol

23050

000108-45-2

1,3-Phenylenediamine

23155

000075-44-5

Phosgene

23170

007664-38-2

Phosphoric acid

23175

000122-52-1

Phosphorous acid, triethyl ester

23187

Phthalic acid

23200

000088-99-3

o-Phthalic acid

SML = 5 mg/kg

SML = 0,05 mg/kg

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

See “Carbonyl chloride”

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

See “Terephthalic acid”

23230

000131-17-9

Phthalic acid, diallyl ester

SML = ND (DL = 0,01 mg/kg)

23380

000085-44-9

Phthalic anhydride

23470

000080-56-8

alpha-Pinene

23500

000127-91-3

beta-Pinene

23547

009016-00-6
063148-62-9

Polydimethylsiloxane (Mw > 6 800)

In compliance with the specifications
laid down in Annex V

23590

025322-68-3

Polyethyleneglycol

23651

025322-69-4

Polypropyleneglycol

23740

000057-55-6

1,2-Propanediol

23770

000504-63-2

1,3-Propanediol

23800

000071-23-8

1-Propanol

23830

000067-63-0

2-Propanol

23860

000123-38-6

Propionaldehyde

23890

000079-09-4

Propionic acid

23920

000105-38-4

Propionic acid, vinyl ester

23950

000123-62-6

Propionic anhydride

23980

000115-07-1

Propylene

24010

000075-56-9

Propylene oxide

24051

000120-80-9

Pyrocatechol

24057

000089-32-7

Pyromellitic anhydride

24070

073138-82-6

Resin acids and Rosin acids

24072

000108-46-3

Resorcinol

24073

000101-90-6

Resorcinol diglycidyl ether

SML = 0,05 mg/kg

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

(expressed

as

QM = 1 mg/kg in FP

See “1,2-Dihydroxybenzene”

SML = 0,05 mg/kg (expressed as Pyro-
mellitic acid)

See “1,3-Dihydroxybenzene”

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
food
contact only, behind the PET layer.

indirect

13.2.2003

EN

Official Journal of the European Union

L 39/17

Ref. No.

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

24100

008050-09-7

Rosin

24130

008050-09-7

Rosin gum

24160

008052-10-6

Rosin tall oil

24190

009014-63-5

Rosin wood

24250

009006-04-6

Rubber, natural

24270

000069-72-7

Salicylic acid

24280

000111-20-6

Sebacic acid

24430

002561-88-8

Sebacic anhydride

24475

001313-82-2

Sodium sulphide

24490

000050-70-4

Sorbitol

24520

008001-22-7

Soybean oil

24540

009005-25-8

Starch, edible

24550

000057-11-4

Stearic acid

24610

000100-42-5

Styrene

24760

026914-43-2

Styrenesuphonic acid

24820

000110-15-6

Succinic acid

24850

000108-30-5

Succinic anhydride

24880

000057-50-1

Sucrose

24887

006362-79-4

5-Sulphoisophthalic acid, monosodium salt

24888

003965-55-7

5-Sulphoisophthalic acid, monosodium salt, dimethyl ester

24910

000100-21-0

Terephthalic acid

24940

000100-20-9

Terephthalic acid dichloride

24970

000120-61-6

Terephthalic acid, dimethyl ester

25080

001120-36-1

1-Tetradecene

25090

000112-60-7

Tetraethyleneglycol

25120

000116-14-3

Tetrafluoroethylene

25150

000109-99-9

Tetrahydrofuran

25180

000102-60-3

N,N,N(cid:1),N(cid:1),-Tetrakis(2-hydroxypropyl)ethylenediamine

25210

000584-84-9

2,4-Toluene diisocyanate

25240

000091-08-7

2,6-Toluene diisocyanate

25270

026747-90-0

2,4-Toluene diisocyanate dimer

See “Rosin”

SML = 0,05 mg/kg

SML = 5 mg/kg

SML = 0,05 mg/kg

SML = 7,5 mg/kg

SML(T) = 7,5 mg/kg
Terephthalic acid)

SML = 0,05 mg/kg

SML = 0,05 mg/kg

SML = 0,6 mg/kg

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

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

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

(expressed

as

(expressed

(expressed

(expressed

as

as

as

25360

Trialkyl(C5-C15)acetic acid, 2,3-epoxypropyl ester

QM = 1 mg/kg in FP (expressed as
Epoxy group, Mw = 43)

25380

—

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

QMA = 0,05 mg/6 dm2

25385

000102-70-5

Triallyamine

25420

000108-78-1

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

25450

026896-48-0

Tricyclodecanedimethanol

25510

000112-27-6

Triethyleneglycol

In compliance with the specifications
laid down in Annex V

SML = 30 mg/kg

SML = 0,05 mg/kg

25600

000077-99-6

1,1,1-Trimethylolpropane

SML = 6 mg/kg

L 39/18

EN

Official Journal of the European Union

13.2.2003

Ref. No.

CAS No

(1)

(2)

Name

(3)

25840

25900

25910

25927

25960

26050

26110

26140

26155

26170

26320

26360

003290-92-4

1,1,1-Trimethylolpropane trimethacrylate

000110-88-3

Trioxane

024800-44-0

Tripropyleneglycol

027955-94-8

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

000057-13-6

Urea

000075-01-4

Vinyl chloride

000075-35-4

Vinylidene chloride

000075-38-7

Vinylidene fluoride

001072-63-5

1-Vinylimidazole

003195-78-6

N-Vinyl-N-methylacetamide

002768-02-7

Vinyltrimethoxysilane

007732-18-5

Water

Restrictions and/or specifications

(4)

SML = 0,05 mg/kg

SML = 0,05 mg/kg

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

See Council Directive 78/142/EEC

QM = 5 mg/kg in FP or SML = ND
(DL = 0,05 mg/kg)

SML = 5 mg/kg

QM = 5 mg/kg in FP

QM = 2 mg/kg in FP

QM = 5 mg/kg in FP

In compliance with Directive 98/83/EC

13.2.2003

EN

Official Journal of the European Union

L 39/19

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

Section B

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

10599/90A

061788-89-4

Acids, fatty, unsaturated (C

18

), dimers, distilled

10599/91

061788-89-4

Acids, fatty, unsaturated (C

18

), dimers, non-distilled

10599/92A

068783-41-5

Acids, fatty, unsaturated (C

18

), dimers, hydrogenated, distilled

10599/93

068783-41-5

000103-11-7

Acids, fatty, unsaturated (C18), dimers, hydrogenated, non-distilled
Acrylic acid, 2-ethylhexyl ester

11500

13050

14260

14800

15730

16210

17110

18370

18700

21370

21400

21970

22210

25540

25550

26230

000528-44-9

1,2,4-Benzenetricarboxylic acid

See “Trimellitic acid”

000502-44-3

Caprolactone

003724-65-0

Crotonic acid

000077-73-6

Dicyclopentadiene

006864-37-5

3,3(cid:1)-Dimethyl-4,4(cid:1)-diaminodicyclohexylmethane

016219-75-3

5-Ethylidenebicyclo[2.2.1]hept-2-ene

000592-45-0

1,4-Hexadiene

000629-11-8

1,6-Hexanediol

010595-80-9

Methacrylic acid, 2-sulphoethyl ester

054276-35-6

Methacrylic acid, sulphopropyl ester

000923-02-4

N-Methylolmethacrylamide

000098-83-9

alpha-Methylstyrene

000528-44-9

Trimellitic acid

000552-30-7

Trimellitic anhydride

000088-12-0

Vinylpyrrolidone

QM(T) = 5 mg/kg in FP

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

in

L 39/20

EN

Official Journal of the European Union

13.2.2003

ANNEX III

INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC
MATERIALS AND ARTICLES

1. This Annex contains the list of:

GENERAL INTRODUCTION

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

intended to be present in the finished articles;

(b) substances used to provide a suitable medium in which polymerisation occurs (e.g. emulsifiers, surfactants,

buffering agents etc.).

The list does not include the substances which directly influence the formation of polymers (e.g. the catalytic system).

2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron,
magnesium, potassium, sodium and zinc of the authorised acids, phenols or alcohols which are also authorised.
However, names containing “...acid(s), salts” appear in the lists if the corresponding free acid(s) is (are) not mentioned.
In such cases the meaning of the term “salts” is “salts of aluminium ammonium, calcium, iron, magnesium, potassium,
sodium and zinc”.

3. The list does not include the following substances although they may be present:

(a) substances which could be present in the finished product such as:

— impurities in the substances used,
— reaction intermediates,
— decomposition products;

(b) mixtures of the authorised substances.

The materials and articles which contain the substances indicated in (a) and (b) shall comply with the requirements
stated in article 2 of Directive 89/109/EEC.

4. Substances shall be of good technical quality as regards the purity criteria.

5. The list contains the following information:

— column 1 (Ref. No): the EEC packaging material reference number of the substances on the list,
— column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number,
— column 3 (Name): the chemical name,
— column 4 (Restrictions and/or specifications). These may include:

— specific migration limit (SML),
— maximum permitted quantity of the substance in the finished material or article (QM),
— maximum permitted quantity of the substance in the finished material or article expressed as mg per 6 dm2 of

the surface in contact with foodstuffs (QMA),

— any other restriction specifically laid down,
— any type of specification related to the substance or polymer.

6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions

applying to this substance shall be those indicated for the individual compound.

7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take
precedence over the CAS number. If there is an inconsistency between the CAS number reported in EINECS and the
CAS registry, the CAS number in the CAS registry shall apply.

13.2.2003

EN

Official Journal of the European Union

L 39/21

Section A

Incomplete list of additives fully harmonised at Community level

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

30000

000064-19-7

Acetic acid

30045

000123-86-4

Acetic acid, butyl ester

30080

004180-12-5

Acetic acid, copper salt

30140

000141-78-6

Acetic acid, ethyl ester

30280

000108-24-7

Acetic anhydride

30295

000067-64-1

Acetone

30370

30400

30610

30612

30960

31328

—

—

—

—

—

—

31530

123968-25-2

Acetylacetic acid, salts

Acetylated glycerides

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

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

-C
Acids, aliph., monocarb. (C
6

22

), esters with polyglycerol

Acids, fatty, from animal or vegetable food fats and oils

Acrylic
phenyl)ethyl)phenyl ester

acid,

2,4-di-tert-pentyl-6-(1-(3,5-di-tert-pentyl-2-hydroxy-

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

SML = 5 mg/kg

31730

000124-04-9

Adipic acid

33120

—

Alcohols, aliph, monoh., sat.,

-C
linear, primary (C
4

24

)

33350

009005-32-7

Alginic acid

33801

34240

34281

34475

34480

—

—

—

—

—

n-Alkyl(C

10

-C

13

)benzenesulphonic acid

SML = 30 mg/kg

Alkyl(C

-C

20

10

)sulphonic acid, esters with phenols

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

Alkyl(C8-C22)sulphuric acids, linear, primary with an even number of carbon
atoms

Aluminum calcium hydroxide phosphite, hydrate

Aluminium fibers, flakes and powders

34560

021645-51-2

Aluminium hydroxide

34690

011097-59-9

Aluminium magnesium carbonate hydroxide

34720

001344-28-1

Aluminium oxide

35120

013560-49-1

3-Aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether

35160

006642-31-5

6-Amino-1,3-dimethyluracil

SML = 5 mg/kg

35170

000141-43-5

2-Aminoethanol

35284

000111-41-1

N-(2-aminoethyl)ethanolamine

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

L 39/22

EN

Official Journal of the European Union

13.2.2003

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

35320

007664-41-7

Ammonia

35440

001214-97-9

Ammonium bromide

35600

001336-21-6

Ammonium hydroxide

35840

000506-30-9

Arachidic acid

35845

007771-44-0

Arachidonic acid

36000

000050-81-7

Ascorbic acid

36080

000137-66-6

Ascorbyl palmitate

36160

010605-09-1

Ascorbyl stearate

36640

000123-77-3

Azodicarbonamide

36840

012007-55-5

Barium tetraborate

36880

008012-89-3

Beeswax

36960

003061-75-4

Behenamide

37040

000112-85-6

Behenic acid

37280

001302-78-9

Bentonite

37360

000100-52-7

Benzaldehyde

37600

000065-85-0

Benzoic acid

37680

000136-60-7

Benzoic acid, butyl ester

37840

000093-89-0

Benzoic acid, ethyl ester

38080

000093-58-3

Benzoic acid, methyl ester

38160

002315-68-6

Benzoic acid, propyl ester

For use only as a blowing agent

expressed

SML(T) = 1 mg/kg
as
Barium (12) and SML(T) = 6 mg/kg (23)
expressed as Boron) without prejudice
to the provisions of Directive 98/83/EC
on water for human consumption (OJ
L330, 5.12.1998, p. 32).

In compliance with note 9 in Annex VI

38320

005242-49-9

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

In compliance with the specifications
laid down in Annex V

38510

136504-96-6

1,2-Bis(3-aminopropyl)ethylenediamine, polymer with N-butyl-2,2,6,6-tetra-
methyl-4-piperidinamine and 2,4,6-trichloro-1,3,5-triazine

SML = 5 mg/kg

38515

001533-45-5

4,4'-Bis(2-benzoxazolyl)stilbene

SML = 0,05 mg/kg (1)

38810

080693-00-1

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

38840

154862-43-8

Bis(2,4-dicumylphenyl)pentaerythritol-diphosphite

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

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

38879

135861-56-2

Bis(3,4-dimethylbenzylidene)sorbitol

38950

079072-96-1

Bis(4-ethylbenzylidene)sorbitol

39200

006200-40-4

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

SML = 1,8 mg/kg

39815

182121-12-6

9,9-Bis(methoxymethyl)fluorene

QMA = 0,05 mg/6 dm2

39890

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

Bis(methylbenzylidene)sorbitol

39925

129228-21-3

3,3-Bis(methoxymethyl)-2,5-dimethylhexane

40120

068951-50-8

Bis(polyethyleneglycol)hydroxymethylphosphonate

SML = 0,05 mg/kg

SML = 0,6 mg/kg

13.2.2003

EN

Official Journal of the European Union

L 39/23

Restrictions and/or specifications

(4)

SML(T) = 6 mg/kg (23)
(expressed as Boron) without prejudice
to the provisions of Directive 98/83/EC
on water for human consumption (OJ L
330, 5.12.1998, p.32).

SML(T) = 0,05 mg/kg (24)

In compliance with note 9 in Annex VI

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

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

Ref. No

CAS No

(1)

(2)

40320

010043-35-3

Boric acid

Name

(3)

40400

010043-11-5

Boron nitride

40570

000106-97-8

Butane

40580

000110-63-4

1,4-Butanediol

41040

005743-36-2

Calcium butyrate

41120

010043-52-4

Calcium chloride

41280

001305-62-0

Calcium hydroxide

41520

001305-78-8

Calcium oxide

41600

012004-14-7
037293-22-4

Calcium sulphoaluminate

41680

000076-22-2

Camphor

41760

008006-44-8

Candelilla wax

41840

000105-60-2

Caprolactam

41960

000124-07-2

Caprylic acid

42160

000124-38-9

Carbon dioxide

42320

007492-68-4

Carbonic acid, copper salt

42500

—

Carbonic acid, salts

42640

009000-11-7

Carboxymethylcellulose

42720

008015-86-9

Carnauba wax

42800

009000-71-9

Casein

42960

064147-40-6

Castor oil, dehydrated

43200

—

Castor oil, mono- and diglycerides

43280

009004-34-6

Cellulose

43300

009004-36-8

Cellulose acetate butyrate

43360

068442-85-3

Cellulose, regenerated

43440

008001-75-0

Ceresin

43515

—

Chlorides of choline esters of coconut oil fatty acids

QMA = 0,9 mg/6 dm2

44160

000077-92-9

Citric acid

44640

000077-93-0

Citric acid, triethyl ester

45195

007787-70-4

Copper bromide

45200

001335-23-5

Copper iodide

45280

—

Cotton fibers

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

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

and

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

45450

068610-51-5

p-Cresol-dicyclopentadiene - isobutylene, copolymer

SML = 0,05 mg/kg

45560

014464-46-1

Cristobalite

45760

000108-91-8

Cyclohexylamine

45920

009000-16-2

Dammar

45940

000334-48-5

n-Decanoic acid

L 39/24

EN

Official Journal of the European Union

13.2.2003

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

46070

46080

46375

46380

46480

46790

46800

46870

46880

010016-20-3

alpha-Dextrin

007585-39-9

beta-Dextrin

061790-53-2

Diatomaceous earth

068855-54-9

Diatomaceous earth, soda ash flux-calcined

032647-67-9

Dibenzylidene sorbitol

004221-80-1

3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester

067845-93-6

3,5-Di-tert-butyl-4-hydroxybenzoic acid, hexadecyl ester

003135-18-0

3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester

065140-91-2

3,5-Di-tert-butyl-4-hydroxybenzylphosphonic
calcium salt

acid, monoethyl

ester,

SML = 6 mg/kg

47210

026427-07-6

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

In compliance with the specifications
laid down in Annex V.

47440

47540

47680

48460

48620

48720

49485

49540

51200

51700

51760

52640

52645

52720

52730

52800

53270

53280

53360

53440

53520

53600

53610

53650

54005

54260

54270

54280

54300

54450

54480

54930

55040

000461-58-5

Dicyanodiamide

027458-90-8

Di-tert-dodecyl disulphide

000111-46-6

Diethyleneglycol

000075-37-6

1,1-Difluoroethane

000123-31-9

1,4-Dihydroxybenzene

000611-99-4

4,4'-Dihydroxybenzophenone

134701-20-5

2,4-Dimethyl-6-(1-methylpentadecyl)phenol

000067-68-5

Dimethyl sulphoxide

000126-58-9

Dipentaerythritol

SML = 0,05 mg/kg

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

SML = 0,6 mg/kg

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

SML = 1 mg/kg

147315-50-2

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

SML = 0,05 mg/kg

025265-71-8
000110-98-5

Dipropyleneglycol

016389-88-1

Dolomite

010436-08-5

cis-11-Eicosenamide

000112-84-5

Erucamide

000112-86-7

Erucic acid

000064-17-5

Ethanol

037205-99-5

Ethylcarboxymethylcellulose

009004-57-3

Ethylcellulose

000110-31-6

N,N'-Ethylenebisoleamide

005518-18-3

N,N'-Ethylenebispalmitamide

000110-30-5

N,N'-Ethylenebisstearamide

000060-00-4

Ethylenediaminetetraacetic acid

054453-03-1

Ethylenediaminetetraacetic acid, copper salt

000107-21-1

Ethyleneglycol

005136-44-7

Ethylene-N-palmitamide-N'-stearamide

009004-58-4

Ethylhydroxyethylcellulose

—

—

Ethylhydroxymethylcellulose

Ethylhydroxypropylcellulose

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

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

118337-09-0

2,2'-Ethylidenebis(4,6-di-tert-butylphenyl) fluorophosphonite

SML = 6 mg/kg

—

—

Fats and oils, from animal or vegetable food sources

Fats and oils, hydrogenated, from animal or vegetable food sources

025359-91-5

Formaldehyde-1-naphthol, copolymer [=poly(1-hydroxynaphthylmethane)]

SML = 0,05 mg/kg

000064-18-6

Formic acid

13.2.2003

EN

Official Journal of the European Union

L 39/25

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

55120

000110-17-8

Fumaric acid

55190

029204-02-2

Gadoleic acid

55440

009000-70-8

Gelatin

55520

55600

—

—

Glass fibers

Glass microballs

55680

000110-94-1

Glutaric acid

55920

000056-81-5

Glycerol

56020

099880-64-5

Glycerol dibehenate

56360

56486

56487

56490

56495

56500

56510

56520

56540

56550

56565

56570

56580

56585

—

—

—

—

—

—

—

—

—

—

—

—

—

—

Glycerol, esters with acetic acid

Glycerol, esters with acids, aliph., sat.,
carbon atoms (C
-C
number of carbon atoms (C

-C

18

14

)

linear, with an even number of
) and with acids, aliph., unsat., linear, with an even

16

18

Glycerol, esters with butyric acid

Glycerol, esters with erucic acid

Glycerol, esters with 12-hydroxystearic acid

Glycerol, esters with lauric acid

Glycerol, esters with linoleic acid

Glycerol, esters with myristic acid

Glycerol, esters with oleic acid

Glycerol, esters with palmitic acid

Glycerol, esters with nonanoic acid

Glycerol, esters with propionic acid

Glycerol, esters with ricinoleic acid

Glycerol, esters with stearic acid

56610

030233-64-8

Glycerol monobehenate

56720

026402-23-3

Glycerol monohexanoate

56800

030899-62-8

Glycerol monolaurate diacetate

56880

026402-26-6

Glycerol monooctanoate

57040

57120

57200

57280

57600

57680

—

—

—

—

—

—

Glycerol monooleate, ester with ascorbic acid

Glycerol monooleate, ester with citric acid

Glycerol monopalmitate, ester with ascorbic acid

Glycerol monopalmitate, ester with citric acid

Glycerol monostearate, ester with ascorbic acid

Glycerol monostearate, ester with citric acid

57800

018641-57-1

Glycerol tribehenate

57920

000620-67-7

Glycerol triheptanoate

58300

—

Glycine, salts

58320

007782-42-5

Graphite

58400

009000-30-0

Guar gum

58480

009000-01-5

Gum arabic

58720

000111-14-8

Heptanoic acid

59360

000142-62-1

Hexanoic acid

59760

019569-21-2

Huntite

59990

007647-01-0

Hydrochloric acid

60030

012072-90-1

Hydromagnesite

L 39/26

EN

Official Journal of the European Union

13.2.2003

Ref. No

CAS No

(1)

(2)

Name

(3)

60080

012304-65-3

Hydrotalcite

60160

000120-47-8

4-Hydroxybenzoic acid, ethyl ester

60180

004191-73-5

4-Hydroxybenzoic acid,

isopropyl ester

60200

000099-76-3

4-Hydroxybenzoic acid, methyl ester

60240

000094-13-3

4-Hydroxybenzoic acid, propyl ester

Restrictions and/or specifications

(4)

60480

003864-99-1

2-(2'-Hydroxy-3,5'-di-tert-butylphenyl)-5-chlorobenzotriazole

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

60560

009004-62-0

Hydroxyethylcellulose

60880

009032-42-2

Hydroxyethylmethylcellulose

61120

009005-27-0

Hydroxyethyl starch

61390

037353-59-6

Hydroxymethylcellulose

61680

009004-64-2

Hydroxypropylcellulose

61800

009049-76-7

Hydroxypropyl starch

61840

000106-14-9

12-Hydroxystearic acid

62140

006303-21-5

Hypophosphorous acid

62240

001332-37-2

Iron oxide

62450

000078-78-4

Isopentane

62640

008001-39-6

Japan wax

62720

001332-58-7

Kaolin

62800

—

Kaolin, calcined

62960

000050-21-5

Lactic acid

63040

000138-22-7

Lactic acid, butyl ester

63280

000143-07-7

Lauric acid

63760

008002-43-5

Lecithin

63840

000123-76-2

Levulinic acid

63920

000557-59-5

Lignoceric acid

64015

000060-33-3

Linoleic acid

64150

028290-79-1

Linolenic acid

64500

—

Lysine, salts

64640

001309-42-8

Magnesium hydroxide

64720

001309-48-4

Magnesium oxide

64800

00110-16-7

Maleic acid

65020

006915-15-7

Malic acid

65040

000141-82-2

Malonic acid

65520

000087-78-5

Mannitol

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

65920

066822-60-4

N-Methacryloyloxyethyl-N,N-dimethyl-N-carboxymethylammonium
chloride, sodium salt -octadecyl methacrylate-ethyl methacrylate-cyclohexyl
methacrylate-N-vinyl-2-pyrrolidone, copolymers

66200

037206-01-2

Methylcarboxymethylcellulose

66240

009004-67-5

Methylcellulose

66560

004066-02-8

2,2'-Methylenebis(4-methyl-6-cyclohexylphenol)

66580

000077-62-3

2,2'-Methylenebis(4-methyl-6-(1-methylcyclohexyl)phenol)

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

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

66640

009004-59-5

Methylethylcellulose

13.2.2003

EN

Official Journal of the European Union

L 39/27

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

66695

—

Methylhydroxymethylcellulose

66700

009004-65-3

Methylhydroxypropylcellulose

66755

002682-20-4

2-Methyl-4-isothiazolin-3-one

67120

012001-26-2

Mica

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

67170

—

67180

—

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-dime-
thylphenyl)-2(3H)-benzofuranone

SML = 5 mg/kg

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

SML = 5 mg/kg (1)

67200

001317-33-5

Molybdenum disulphide

67840

—

Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-buta-
nediol and/or with glycerol

67850

008002-53-7

Montan wax

67891

000544-63-8

Myristic acid

68040

003333-62-8

7-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin

68125

037244-96-5

Nepheline syenite

68145

080410-33-9

2,2',2"-Nitrilo(triethyl
tris(3,3',5,5'-tetra-tert-butyl-1,1'-bi-phenyl-2,2'-diyl)phosphite)

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

68960

000301-02-0

Oleamide

69040

000112-80-1

Oleic acid

69760

000143-28-2

Oleyl alcohol

70000

070331-94-1

2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]

70240

012198-93-5

Ozokerite

70400

000057-10-3

Palmitic acid

71020

000373-49-9

Palmitoleic acid

71440

009000-69-5

Pectin

71600

000115-77-5

Pentaerythritol

71635

025151-96-6

Pentaerythritol dioleate

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

71670

178671-58-4

Pentaerythritol tetrakis (2-cyano-3,3-diphenylacrylate)

SML = 0,05 mg/kg

71680

006683-19-8

Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]

71720

000109-66-0

Pentane

72640

007664-38-2

Phosphoric acid

73160

—

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

SML = 0,05 mg/kg

73720

000115-96-8

Phosphoric acid, trichloroethyl ester

74010

145650-60-8

Phosphorous acid, bis(2,4-di-tert-butyl-6-methylphenyl) ethyl ester

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

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

74240

031570-04-4

Phosphorous acid, tris(2,4-di-tert-butylphenyl)ester

74480

000088-99-3

o-Phthalic acid

L 39/28

EN

Official Journal of the European Union

13.2.2003

Ref. No

CAS No

(1)

(2)

Name

(3)

76320

000085-44-9

Phthalic anhydride

76721

76730

76865

009016-00-6
063148-62-9

—

—

Polydimethylsiloxane (Mw > 6800)

Polydimethylsiloxane, gamma-hydroxypropylated

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 C

or n-octanol and/or n-decanol

-C

10

18

Restrictions and/or specifications

(4)

In compliance with the specifications
laid down in Annex V

SML = 6 mg/kg

SML = 30 mg/kg

76960

025322-68-3

Polyethyleneglycol

77600

061788-85-0

Polyethyleneglycol ester of hydrogenated castor oil

77702

—

Polyethyleneglycol esters of aliph. monocarb. acids (C
6
ammonium and sodium sulphates

-C

22

) and their

77895

068439-49-6

Polyethyleneglycol(EO = 2-6) monoalkyl (C

16

-C

18

) ether

SML = 0,05 mg/kg

79040

009005-64-5

Polyethyleneglycol sorbitan monolaurate

79120

009005-65-6

Polyethyleneglycol sorbitan monooleate

79200

009005-66-7

Polyethyleneglycol sorbitan monopalmitate

79280

009005-67-8

Polyethyleneglycol sorbitan monostearate

79360

009005-70-3

Polyethyleneglycol sorbitan trioleate

79440

009005-71-4

Polyethyleneglycol sorbitan tristearate

80240

029894-35-7

Polyglycerol ricinoleate

80640

—

-C
Polyoxyalkyl (C
2

) dimethylpolysiloxane
4

80720

008017-16-1

Polyphosphoric acids

80800

025322-69-4

Polypropyleneglycol

81220

192268-64-7

Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperidinyl)-n-butylamino]-1,3,5-triazine-
2,4-diyl][(2,2,6,6-tetramethyl-4-piperidinyl)imino]-1,6-hexanediyl-
[(2,2,6,6-tetramethyl-4-piperidinyl)imino]]-alpha-[N,N,N',N'-tetrabutyl-
N"-(2,2,6,6-tetramethyl-4-piperidinyl)-N"-[6-(2,2,6,6-tetramethyl-4-
piperidinylamino)-hexyl]-[1,3,5-triazine-2,4,6-triamine]-omega-
N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine]

SML = 5 mg/kg

81515

087189-25-1

Poly(zinc glycerolate)

81520

007758-02-3

Potassium bromide

81600

001310-58-3

Potassium hydroxide

81760

—

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

SML(T) = 30 mg/kg (7)
(expressed as Copper); SML = 48 mg/kg
(expressed as Iron)

81840

000057-55-6

1,2-Propanediol

81882

000067-63-0

2-Propanol

82000

000079-09-4

Propionic acid

82080

009005-37-2

1,2-Propyleneglycol alginate

82240

022788-19-8

1,2-Propyleneglycol dilaurate

82400

000105-62-4

1,2-Propyleneglycol dioleate

82560

033587-20-1

1,2-Propyleneglycol dipalmitate

82720

006182-11-2

1,2-Propyleneglycol distearate

82800

027194-74-7

1,2-Propyleneglycol monolaurate

13.2.2003

EN

Official Journal of the European Union

L 39/29

Restrictions and/or specifications

(4)

Ref. No

CAS No

(1)

(2)

Name

(3)

82960

001330-80-9

1,2-Propyleneglycol monooleate

83120

029013-28-3

1,2-Propyleneglycol monopalmitate

83300

001323-39-3

1,2-Propyleneglycol monostearate

83320

83325

83330

—

—

—

Propylhydroxyethylcellulose

Propylhydroxymethylcellulose

Propylhydroxypropylcellulose

83440

002466-09-3

Pyrophosphoric acid

83455

013445-56-2

Pyrophosphorous acid

83460

012269-78-2

Pyrophyllite

83470

014808-60-7

Quartz

83599

068442-12-6

Reaction products of oleic acid, 2-mercaptoethyl ester, with dichlorodime-
thyltin, sodium sulphide and trichloromethyltin

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

83610

073138-82-6

Resin acids and Rosin acids

83840

008050-09-7

Rosin

84000

008050-31-5

Rosin, ester with glycerol

84080

008050-26-8

Rosin, ester with pentaerythritol

84210

065997-06-0

Rosin, hydrogenated

84240

065997-13-9

Rosin, hydrogenated, ester with glycerol

84320

008050-15-5

Rosin, hydrogenated, ester with methanol

84400

064365-17-9

Rosin, hydrogenated, ester with pentaerythritol

84560

009006-04-6

Rubber, natural

84640

000069-72-7

Salicylic acid

85360

000109-43-3

Sebacic acid, dibutyl ester

85600

85610

—

—

Silicates, natural

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

85680

001343-98-2

Silicic acid

85840

053320-86-8

Silicic acid,

lithium magnesium sodium salt

86000

—

Silicic acid, silylated

86160

000409-21-2

Silicon carbide

86240

007631-86-9

Silicon dioxide

86285

—

Silicon dioxide, silanated

86560

007647-15-6

Sodium bromide

86720

001310-73-2

Sodium hydroxide

87040

001330-43-4

Sodium tetraborate

87200

000110-44-1

Sorbic acid

87280

029116-98-1

Sorbitan dioleate

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

SML(T) = 6 mg/kg (23)
(expressed as Boron) without prejudice
to the provisions of Directive 98/83/EC
on water for human consumption (OJ L
330, 5.12.1998, p.32).

L 39/30

EN

Official Journal of the European Union

13.2.2003

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

87520

062568-11-0

Sorbitan monobehenate

87600

001338-39-2

Sorbitan monolaurate

87680

001338-43-8

Sorbitan monooleate

87760

026266-57-9

Sorbitan monopalmitate

87840

001338-41-6

Sorbitan monostearate

87920

061752-68-9

Sorbitan tetrastearate

88080

026266-58-0

Sorbitan trioleate

88160

054140-20-4

Sorbitan tripalmitate

88240

026658-19-5

Sorbitan tristearate

88320

000050-70-4

Sorbitol

88600

026836-47-5

Sorbitol monostearate

88640

008013-07-8

Soybean oil, epoxidised

88800

009005-25-8

Starch, edible

88880

068412-29-3

Starch, hydrolysed

88960

000124-26-5

Stearamide

89040

000057-11-4

Stearic acid

89200

007617-31-4

Stearic acid, copper salt

89440

—

Stearic acid, esters with ethyleneglycol

90720

058446-52-9

Stearoylbenzoylmethane

90800

005793-94-2

Stearoyl-2-lactylic acid, calcium salt

90960

000110-15-6

Succinic acid

91200

000126-13-6

Sucrose acetate isobutyrate

91360

000126-14-7

Sucrose octaacetate

91840

007704-34-9

Sulphur

91920

007664-93-9

Sulphuric acid

92030

010124-44-4

Sulphuric acid, copper salt

92080

014807-96-6

Talc

In compliance with the specifications
laid down in Annex V

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

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

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

92150

001401-55-4

Tannic acids

According to the JECFA specifications

92160

000087-69-4

Tartaric acid

13.2.2003

EN

Official Journal of the European Union

L 39/31

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

92195

92205

92350

92640

92700

—

Taurine, salts

057569-40-1

Terephthalic acid, diester with 2,2'-methylenebis(4-methyl-6-tert-butylphenol)

000112-60-7

Tetraethyleneglycol

000102-60-3

N,N,N',N'-Tetrakis(2-hydroxypropyl)ethylenediamine

078301-43-6

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

92930

120218-34-0

Thiodietha-
nolbis(5-methoxycarbonyl-2,6-dimethyl-1,4-dihydropyridine-3-carboxylate)

93440

93520

93680

93720

94320

94960

95200

95270

013463-67-7

Titanium dioxide

000059-02-9
010191-41-0

alpha-Tocopherol

009000-65-1

Tragacanth gum

000108-78-1

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

000112-27-6

Triethyleneglycol

000077-99-6

1,1,1-Trimethylolpropane

001709-70-2

1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene

161717-32-4

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

95725

110638-71-6

Vermiculite, reaction product with citric acid,

lithium salt

95855

007732-18-5

Water

SML = 5 mg/kg

SML = 6 mg/kg

SML = 30 mg/kg

SML = 6 mg/kg

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

the

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

In compliance with Directive 98/
83/EEC

95859

95883

95905

95920

95935

96190

96240

96320

—

—

Waxes, refined, derived from petroleum based or synthetic hydrocarbon
feedstocks

In compliance with the specifications
laid down in Annex V

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

In compliance with the specifications
laid down in Annex V

013983-17-0

Wollastonite

—

Wood flour and fibers, untreated

011138-66-2

Xanthan gum

020427-58-1

Zinc hydroxide

001314-13-2

Zinc oxide

001314-98-3

Zinc sulphide

L 39/32

EN

Official Journal of the European Union

13.2.2003

Section B

Incomplete list of additives referred to in Article 4, second paragraph

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

30180

002180-18-9

Acetic acid, manganese salt

31520

061167-58-6

Acrylic
methylphenyl ester

acid,

2-tert-butyl-6-(3-tert-butyl-2-hydroxy-5-methylbenzyl)-4-

31920

34230

35760

000103-23-1

Adipic acid, bis(2-ethylhexyl) ester

—

Alkyl(C8-C22)sulphonic acids

001309-64-4

Antimony trioxide

36720

017194-00-2

Barium hydroxide

36800

010022-31-8

Barium nitrate

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

as

Manganese)

SML = 6 mg/kg

SML = 18 mg/kg (1)

SML = 6 mg/kg

SML = 0,02 mg/kg (expressed
as Antimony and analytical
tolerance included)

SML(T) = 1 mg/kg (12)
(expressed as Barium)

SML(T) = 1 mg/kg (12)
(expressed as Barium)

SML = 0,6 mg/kg

SML = 0,6 mg/kg

SML = 18 mg/kg

38240

38560

38700

38800

38820

39060

39090

39120

40000

40020

40160

40800

40980

42000

42400

42480

43600

43680

000119-61-9

Benzophenone

007128-64-5

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

063397-60-4

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

032687-78-8

N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionyl)hydrazide

SML = 15 mg/kg

026741-53-7

Bis(2,4-di-tert-butylphenyl) pentaerythritol diphosphite

035958-30-6

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

—

—

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

N,N-Bis(2-hydroxyethyl)alkyl(C

-C
8

18

)amine hydrochlorides

SML = 0,6 mg/kg

SML = 5 mg/kg

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

SML(T) = 1,2 mg/kg (13)
expressed as Tertiary amine
(expressed excluding HCl)

000991-84-4

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

SML = 30 mg/kg

110553-27-0

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

061269-61-2

N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)hexamethylenediamine-1,2-
dibromoethane, copolymer

SML = 6 mg/kg

SML = 2,4 mg/kg

013003-12-8

4,4'-Butylidene-bis(6-tert-butyl-3-methylphenyl-ditridecyl phosphite)

SML = 6 mg/kg

019664-95-0

Butyric acid, manganese salt

063438-80-2

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

010377-37-4

Carbonic acid,

lithium salt

000584-09-8

Carbonic acid, rubidium salt

004080-31-3

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

000075-45-6

Chlorodifluoromethane

44960

011104-61-3

Cobalt oxide

45440

45650

46720

47600

48640

—

Cresols, butylated, styrenated

006197-30-4

2-Cyano-3,3-diphenylacrylic acid, 2-ethylhexyl ester

004130-42-1

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

084030-61-5

Di-n-dodecyltin bis(isooctyl mercaptoacetate)

000131-56-6

2,4-Dihydroxybenzophenone

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

SML = 30 mg/kg

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

SML = 12 mg/kg

SML = 0,3 mg/kg

SML = 6 mg/kg
in
compliance with the specifica-
tions laid down in Annex V

and

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

SML = 12 mg/kg

SML = 0,05 mg/kg

QMA = 4,8 mg/6 dm2

SML = 12 mg/kg

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

13.2.2003

EN

Official Journal of the European Union

L 39/33

Ref. No

CAS No

(1)

(2)

Name

(3)

48800

48880

49600

49840

50160

000097-23-4

2,2'-Dihydroxy-5,5'-dichlorodiphenylmethane

000131-53-3

2,2'-Dihydroxy-4-methoxybenzophenone

026636-01-1

Dimethyltin bis(isooctyl mercaptoacetate)

002500-88-1

Dioctadecyl disulphide

—

Di-n-octyltin bis(n-alkyl(C

-C

) mercaptoacetate)

16

10

50240

010039-33-5

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

50320

015571-58-1

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

50360

—

Di-n-octyltin bis(ethyl maleate)

50400

033568-99-9

Di-n-octyltin bis(isooctyl maleate)

50480

026401-97-8

Di-n-octyltin bis(isooctyl mercaptoacetate)

50560

—

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

50640

003648-18-8

Di-n-octyltin dilaurate

50720

015571-60-5

Di-n-octyltin dimaleate

50800

50880

—

—

Di-n-octyltin dimaleate, esterified

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

50960

069226-44-4

Di-n-octyltin ethyleneglycol bis(mercaptoacetate)

51040

015535-79-2

Di-n-octyltin mercaptoacetate

51120

—

Di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate

000127-63-9

Diphenyl sulphone

000102-08-9

N,N'-diphenylthiourea

027176-87-0

Dodecylbenzenesulphonic acid

052047-59-3

2-(4-Dodecylphenyl)indole

023676-09-7

4-Ethoxybenzoic acid, ethyl ester

023949-66-8

2-Ethoxy-2'-ethyloxanilide

000057-09-0

Hexadecyltrimethylammonium bromide

51570

51680

52000

52320

52880

53200

58960

59120

59200

60320

60400

60800

61280

61360

023128-74-7

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

SML = 45 mg/kg

035074-77-2

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

SML = 6 mg/kg

070321-86-7

2-[2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)phenyl]benzotriazole

SML = 1,5 mg/kg

003896-11-5

2-(2'-Hydroxy-3'-tert-butyl-5'-methylphenyl)-5-chlorobenzotriazole

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

065447-77-0

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

SML = 30 mg/kg

003293-97-8

2-Hydroxy-4-n-hexyloxybenzophenone

000131-57-7

2-Hydroxy-4-methoxybenzophenone

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

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

Restrictions and/or specifications

(4)

SML = 12 mg/kg

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

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

SML = 3 mg/kg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SML(T) = 3 mg/kg (25)

SML = 3 mg/kg

SML = 30 mg/kg

SML = 0,06 mg/kg

SML = 3,6 mg/kg

SML = 30 mg/kg

SML = 6 mg/kg

L 39/34

EN

Official Journal of the European Union

13.2.2003

Ref. No

CAS No

(1)

(2)

Name

(3)

61440

61600

63200

002440-22-4

2-(2'-Hydroxy-5'-methylphenyl)benzotriazole

001843-05-6

2-Hydroxy-4-n-octyloxybenzophenone

051877-53-3

Lactic acid, manganese salt

64320

010377-51-2

Lithium iodide

65120

007773-01-5

Manganese chloride

65200

012626-88-9

Manganese hydroxide

65280

010043-84-2

Manganese hypophosphite

65360

011129-60-5

Manganese oxide

65440

—

Manganese pyrophosphite

Restrictions and/or specifications

(4)

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

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

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

SML(T) = 1 mg/kg (11)
(expressed
Iodine)
SML(T) = 0,6 mg/kg (8)
(expressed as Lithium)

as

and

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

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

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

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

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

66360

66400

66480

67360

67520

085209-91-2

2,2'-Methylene bis(4,6-di-tert-butylphenyl) sodium phosphate

SML = 5 mg/kg

000088-24-4

2,2'-Methylene bis(4-ethyl-6-tert-butylphenol)

000119-47-1

2,2'-Methylene bis(4-methyl-6-tert-butylphenol)

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

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

067649-65-4

Mono-n-dodecyltin tris(isooctyl mercaptoacetate)

SML = 24 mg/kg

054849-38-6

Monomethyltin tris(isooctyl mercaptoacetate)

67600

—

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

67680

027107-89-7

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

67760

026401-86-5

Mono-n-octyltin tris(isooctyl mercaptoacetate)

68078

027253-31-2

Neodecanoic acid, cobalt salt

68320

68400

68860

69840

72160

72800

73040

002082-79-3

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

010094-45-8

Octadecylerucamide

004724-48-5

n-Octylphosphonic acid

016260-09-6

Oleylpalmitamide

000948-65-2

2-Phenylindole

001241-94-7

Phosphoric acid, diphenyl 2-ethylhexyl ester

013763-32-1

Phosphoric acid,

lithium salts

73120

010124-54-6

Phosphoric acid, manganese salt

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

SML(T) = 1,2 mg/kg (18)
(expressed as Tin)

SML(T) = 1,2 mg/kg (18)
(expressed as Tin)

SML(T) = 1,2 mg/kg (18)
(expressed as Tin)

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

in polymers

SML = 6 mg/kg

SML = 5 mg/kg

SML = 0,05 mg/kg

SML = 5 mg/kg

SML = 15 mg/kg

SML = 2,4 mg/kg

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

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

13.2.2003

EN

Official Journal of the European Union

L 39/35

Ref. No

CAS No

(1)

(2)

Name

(3)

—

—

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

Polyethyleneglycol diricinoleate

061791-12-6

Polyethyleneglycol ester of castor oil

009004-97-1

Polyethyleneglycol monoricinoleate

071878-19-8

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-tetramethyl-
4-piperidyl) imino]

007681-11-0

Potassium iodide

019019-51-3

Propionic acid, cobalt salt

Restrictions and/or specifications

(4)

SML = 30 mg/kg

SML = 42 mg/kg

SML = 42 mg/kg

SML = 42 mg/kg

SML = 3 mg/kg

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

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

119345-01-6

Reaction product of di-tert-butylphosphonite with biphenyl, obtained by
condensation of 2,4-di-tert-butylphenol with Friedel Craft reaction product
of phosphorous trichloride and biphenyl

SML = 18 mg/kg
in
compliance with the specifica-
tions mentioned in Annex V.

and

000141-22-0

Ricinoleic acid

000087-18-3

Salicylic acid, 4-tert-butylphenyl ester

000119-36-8

Salicylic acid, methyl ester

012068-40-5

Silicic acid,

lithium aluminium salt(2:1:1)

012627-14-4

Silicic acid,

lithium salt

007681-82-5

Sodium iodide

—

Sodium monoalkyl dialkylphenoxybenzenedisulphonate

013586-84-0

Stearic acid, cobalt salt

007727-43-7

Sulphuric acid, barium salt

—

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

038613-77-3

Tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-biphenylylene diphosphonite

000096-69-5

4,4'-Thiobis(6-terc-butyl-3-methylphenol)

SML = 42 mg/kg

SML = 12 mg/kg

SML = 30 mg/kg

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

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

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

SML = 9 mg/kg

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

SML(T) = 1 mg/kg (12)
(expressed as Barium)

SML = 15 mg/kg

SML = 18 mg/kg

SML = 0,48 mg/kg

041484-35-9

Thiodiethanol bis(3-(3,5-di-tert-butyl-4-hydroxy phenyl) propionate)

SML = 2,4 mg/kg

000123-28-4

Thiodipropionic acid, didodecyl ester

000693-36-7

Thiodipropionic acid, dioctadecyl ester

000122-20-3

Triisopropanolamine

028931-67-1

Trimethylolpropane trimethacrylate-methyl methacrylate copolymer

040601-76-1

027676-62-6

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

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

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

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

SML = 5 mg/kg

SML = 6 mg/kg

SML = 5 mg/kg

001843-03-4

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

SML = 5 mg/kg

74400

77440

77520

78320

81200

81680

82020

83595

83700

84800

84880

85760

85920

86800

86880

89170

92000

92320

92560

92800

92880

93120

93280

94560

95000

95280

95360

95600

L 39/36

EN

Official Journal of the European Union

13.2.2003

ANNEX IV

PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION

Ref. No

CAS No

(1)

(2)

Name

(3)

Restrictions and/or specifications

(4)

18888

080181-31-3

3-Hydroxybutanoic
pentanoic acid, copolymer

acid-3-hydroxy-

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

13.2.2003

EN

Official Journal of the European Union

L 39/37

ANNEX V

SPECIFICATIONS

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.

Part B: Other specifications

Ref. No

OTHER SPECIFICATIONS

16690

Divinylbenzene

It may contain up to 40 % of Ethylvinylbenzene.

18888

3-Hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer

Definition

The copolymers are produced by the controlled fermentation of Alcaligenes eutrophus cepa 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 microscopi-
cally 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

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

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

Assay

Description

Characteristics

Identification tests:

Solubility

Migration

Purity

— Nitrogen

— Zinc

— Copper

Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate) analysed after hydrol-
ysis as a mixture of 3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids.

White to off-white powder after isolation

Soluble in chlorinated hydrocarbons such as chloroform or dichloromethane but practically
insoluble in ethanol, aliphatic alkanes and water.

The migration of crotonic acid should not exceed 0,05 mg/kg food.

Prior to granulation the raw material copolymer powder must contain:

Not more than 2 500 mg/kg of plastic

Not more than 100 mg/kg of plastic

Not more than 5 mg/kg of plastic

L 39/38

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Official Journal of the European Union

13.2.2003

Ref. No

OTHER SPECIFICATIONS

— Lead

— Arsenic

Not more than 2 mg/kg of plastic

Not more than 1 mg/kg of plastic

— Chromium

Not more than 1 mg/kg of plastic

23547

Polydimethylsiloxane (Mw > 6 800)

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

25385

Triallylamine

40 mg/kg hydrogel at a ratio of 1 kg food to a maximum of 1,5 grams of hydrogel. For use only in hydrogels intended for
non-direct food contact use.

38320

4-(2-Benzoxazolyl)-4(cid:1)-(5-methyl-2-benzoxazolyl) stilbene

Not more than 0,05 %w/w (quantity of substance used/quantity of the formulation)

43680

Chlorodifluoromethane

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

47210

Dibutylthiostannoic acid polymer

H
Molecular unit = (C
8

S
18

Sn
3

2

)n (n = 1,5-2)

76721

Polydimethylsiloxane (Mw > 6 800)

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

83595

Reaction product of di-tert-butylphosphonite with biphenyl, obtained by condensation of 2,4-di-tert-butylphenol with Friedel Craft
reaction product of phosphorous trichloride and biphenyl

Composition:

— 4,4(cid:1)-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 38613-77-3) (36-46 % w/w (*)),
— 4,3(cid:1)-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 118421-00-4 (17-23 % w/w (*)),
— 3,3(cid:1)-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(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(cid:1)-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS.No 112949-97-

0) (< 5 % w/w (*)).

Other specifications:

— Phosphor content of min. 5,4 % to max. 5,9 %
— Acid value of max. 10 mg KOH per gram
— Melt range of 85-110 °C

88640

Soybean oil, epoxidized

Oxirane < 8 %,

iodine number < 6

95859

Waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks

The product should have the following specifications:

— Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
— Viscosity not less than 11 × 10–6 m2/s (= 11 centistokes) at 100 °C
— Average molecular weight not less than 500.

95883

White mineral oils, paraffinic derived from petroleum based hydrocarbon feedstocks

The product should have the following specifications:

— Content of mineral hydrocarbons with Carbon number less than 25, not more than 5 % (w/w)
— Viscosity not less than 8,5 × 10–6 m2/s (= 8,5 centistokes) at 100 °C
— Average molecular weight not less than 480

(*) Quantity of substance used /quantity of formulation

13.2.2003

EN

Official Journal of the European Union

L 39/39

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 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 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 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 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 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 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 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 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 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 Ref. 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 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 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 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 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 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 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 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 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 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 Ref. Nos: 17260 and 18670.

(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 Ref. 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 Ref. Nos: 13720 and 40580.

L 39/40

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Official Journal of the European Union

13.2.2003

(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 Ref. 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 Ref. Nos: 14950, 15700, 16240, 16570, 16600, 16630, 18640, 19110, 22332,
22420, 22570, 25210, 25240 and 25270.

13.2.2003

EN

Official Journal of the European Union

L 39/41

ANNEX VII

Part A

REPEALED DIRECTIVE AND ITS AMENDMENTS

(Referred to by Article 10(1))

Commission Directive 90/128/EEC (OJ L 349, 13.12.1990, p. 26)

Commission Directive 92/39/EEC (OJ L 168, 23.6.1992, p. 21)

Commission Directive 93/9/EEC (OJ L 90, 14.4.1993, p. 26)

Commission Directive 95/3/EC (OJ L 41, 23.2.1995, p. 44)

Commission Directive 96/11/EC (OJ L 61, 12.3.1996, p. 26)

Commission Directive 1999/91/EC (OJ L 310, 4.12.1999, p. 41)

Commission Directive 2001/62/EC (OJ L 221, 17.8.2001, p. 18)

Commission Directive 2002/17/EC (OJ L 58, 28.2.2002, p. 19)

Part B

DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW

(Referred to by Article 10(1))

Directive

For transposition

To permit trade in those
products which comply with
this Directive

To prohibit trade in those
products which do not
comply with this Directive

Deadlines

90/128/EEC (OJ L 349, 13.12.1990,
p. 26)

31 December 1990

1 January 1991

1 January 1993

92/39/EEC (OJ L 168, 23.6.1992, p. 21)

31 December 1992

31 March 1994

1 April 1995

93/9/EEC (OJ L 90, 14.4.1993, p. 26)

1 April 1994

1 April 1994

1 April 1996

95/3/EC (OJ L 41, 23.2.1995, p. 44)

1 April 1996

1 April 1996

1 April 1998

96/11/EC (OJ L 61, 12.3.1996, p. 26)

1 January 1997

1 January 1997

1 January 1999

1999/91/EC (OJ L 310, 4.12.1999,
p. 41)

2001/62/EC (OJ L 221, 17.8.2001,
p. 18)

31 December 2000

1 January 2002

1 January 2003

30 November 2002

1 December 2002

1 December 2002

2002/17/EC (OJ L 58, 28.2.2002, p. 19)

28 February 2003

1 March 2003

1 March 2004
1 March 2003 for mate-
rials and articles which
contain Divinylbenzene

L 39/42

EN

Official Journal of the European Union

13.2.2003

ANNEX VIII

CORRELATION TABLE

Directive 90/128/EEC

This Directive

Article 1

Article 2

Article 3

Article 3a

Article 3b

Article 3c

Article 4

Article 5

Article 6

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-

ANNEX I

ANNEX II

ANNEX III

ANNEX IV

ANNEX V

ANNEX VI

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-

Article 1

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

Article 10

Article 11

Article 12

ANNEX I

ANNEX II

ANNEX III

ANNEX IV

ANNEX V

ANNEX VI

ANNEX VII

ANNEX VIII’