2002L0072 — EN — 02.02.2004 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B ►C1 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) ◄
(OJ L 220, 15.8.2002, p. 18)
Amended by:
Official Journal
No page date
►M1 Commission Directive 2004/1/EC of 6 January 2004 L 7 45 13.1.2004
Corrected by:
►C1 Corrigendum, OJ L 39, 13.2.2003, p. 1 (2002/72/EC)
▼B
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,
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 tomaterials 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) Commission Directive 90/128/EEC of 23 February 1990 relating
to plastic materials and articles intended to come into contactwith foodstuffs (
2), as last amended by Directive 2002/17/EC (3),
has been frequently and substantially amended; for reasons of
clarity and rationality, it should therefore be consolidated.
(2) Article 2 of Directive 89/109/EEC lays down that materials and
articles, in their finished state, must not transfer their constitu-ents to foodstuffs in quantities which could endanger humanhealth or bring about an unacceptable change in the compositionof the foodstuffs.
(3) In order to achieve this objective in the case of plastic materialsand articles, a suitable instrument is a specific Directive withinthe meaning of Article 3 of Directive 89/109/EEC, the generalprovisions of which are also applicable to the case in question.
(4) The scope of this Directive must coincide with that of Council
Directive 82/711/EEC (4).
(5) Since the rules established in this Directive are not suitable for
ion-exchange resins, these materials and articles will be coveredby a subsequent specific Directive.
(6) Silicones should be regarded as elastomeric materials rather than
plastic materials and therefore should be excluded from the defi-
nition of plastic.
(7) The establishment of a list of approved substances accompaniedby a limit on overall migration and, where necessary, by otherspecific restrictions will be sufficient to achieve the objectivelaid down in Article 2 of Directive 89/109/EEC.
(8) Besides the monomers and other starting substances fully evalu-ated and authorised at Community level, there are alsomonomers and starting substances evaluated and authorised inat least one Member State which may continue to be usedpending 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 thesubstances and sectors provisionally excluded.
(9) The current list of additives is an incomplete list inasmuch as itdoes not contain all the substances which are currently acceptedin one or more Member States; accordingly, these substances2002L0072 — EN — 02.02.2004 — 001.001 — 2
(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).▼C1
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continue to be regulated by national laws pending a decision on
inclusion in the Community list.
(10) This Directive establishes specifications for only a fewsubstances.The other substances, which may require specifica-tions, therefore remain regulated in this respect by national lawspending a decision at Community level.
(11) For certain additives the restrictions established in this Directivecannot 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 additivesfully regulated at Community level.
(12) Directive 82/711/EEC lays down the basic rules necessary for
testing migration of the constituents of plastic materials and arti-
cles and Council Directive 85/572/EEC (1) establishes the list of
simulants to be used in the migration tests.
(13) The determination of a quantity of a substance in a finishedmaterial or article is simpler than the determination of its
specific migration level.The verification of compliance through
the determination of quantity rather than specific migration levelshould therefore be permitted under certain conditions.
(14) For certain types of plastics the availability of generally recog-nised diffusion models based on experimental data allows theestimation of the migration level of a substance under certain
conditions, therefore avoiding complex, costly and time-
consuming testing.
(15) The overall migration limit is a measure of the inertness of thematerial and prevents an unacceptable change in the compositionof the foodstuffs, and, moreover, reduces the need for a large
number of specific migration limits or other restrictions, thus
giving effective control.
(16) Council Directive 78/142/EEC (2) lays down limits for the quan-
tity of vinyl chloride present in plastic materials and articlesprepared with this substance and for the quantity of vinyl
chloride released by these materials and articles, and Commis-
sion Directives 80/766/EEC (
3) and 81/432/EEC (4) establish the
Community methods of analysis for controlling these limits.
(17) In view of potential liability, there is a need for the writtendeclaration 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.
(18) Commission Directive 80/590/EEC (5) determines the symbol
that may accompany any material and article intended to comeinto contact with foodstuffs.
(19) In accordance with the principle of proportionality, it is neces-sary and appropriate for the achievement of the basic objectiveof ensuring the free movement of plastic materials and articlesintended to come into contact with foodstuffs, to lay down ruleson 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 paragraph ofArticle 5 of the Treaty.
(20) In accordance with Article 3 of Directive 89/109/EEC, theScientific Committee on Food has been consulted on the provi-sions liable to affect public health.2002L0072 — EN — 02.02.2004 — 001.001 — 3
(1) OJ L 372, 31.12.1985, p. 14.
(2) OJ L 44, 15.2.1978, p. 15.
(3) OJ L 213, 16.8.1980, p. 42.
(4) OJ L 167, 24.6.1981, p. 6.
(5) OJ L 151, 19.6.1980, p. 21.
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(21) The measures provided for in this Directive are in accordance
with the opinion of the Standing Committee on the Food Chain
and Animal Health.
(22) This Directive should be without prejudice to the deadlines 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
1.This Directive is a specific Directive within the meaning of
Article 3 of Directive 89/109/EEC.
2.This Directive shall apply to plastic materials and articles and
parts thereof:
(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 ofadhesives 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 thatpurpose.
3.For the purposes of this Directive, ‘plastics’ shall mean the
organic macromolecular compounds obtained by polymerisation, poly-
condensation, polyaddition or any other similar process from molecules
with a lower molecular weight or by chemical alteration of naturalmacromolecules.Other substances or matter may be added to suchmacromolecular compounds.
However, the following shall not be regarded as ‘plastics’:
(a) varnished or unvarnished regenerated cellulose film, covered by
Commission Directive 93/10/EEC (
1);
(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 ifthe one intended to come into direct contact with foodstuffs doesconsist exclusively of plastics.
Article 2
Plastic materials and articles shall not transfer their constituents to
foodstuffs in quantities exceeding 10 milligrams per square decimetreof surface area of material or article (mg/dm
2) (overall migration limit).2002L0072 — EN — 02.02.2004 — 001.001 — 4
(1) 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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However, this limit shall be 60 milligrams of the constituents released
per kilogram of foodstuff (mg/kg) in the following cases:
(a) articles which are containers or are comparable to containers or
which can be filled, with a capacity of not less than 500 millilitres(ml) and not more than 10 litres (l);
(b) articles which can be filled and for which it is impracticable to esti-
mate the surface area in contact with foodstuffs;
(c) caps, gaskets, stoppers or similar devices for sealing.
Article 3
1.Only those monomers and other starting substances listed in
Annex II, Sections A and B, may be used for the manufacture ofplastic materials and articles subject to the restrictions specified.
2.By way of derogation from the first paragraph the monomers and
other starting substances listed in Annex II, Section B, may continue tobe used until 31 December 2004 at latest, pending their evaluation bythe 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 manu-
facture 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 migration
limits are applied as from 1 January 2004 when the verification of
compliance is carried out in simulant D or in test media of substitute
tests as laid down in Directives 82/711/EEC and 85/572/EEC.
Article 5
Only the products obtained by means of bacterial fermentation listed in
Annex IV may be used in contact with foodstuffs.
Article 6
1.General specifications related to plastic materials and articles are
laid down in Annex V, Part A.Other specifications related to somesubstances appearing in Annexes II, III and IV are laid down in Annex
V, Part B.
2.The meaning of the numbers between brackets appearing in the
column ‘Restrictions and/or specifications’ is explained in Annex VI.2002L0072 — EN — 02.02.2004 — 001.001 — 5
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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/dm2in
the following cases:
(a) articles which are containers or are comparable to containers or
which can be filled, with a capacity of less than 500 ml or more
than 10 l;
(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 contacttherewith.
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/dm
2.
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 provisions set out in AnnexI.
2.The verification of compliance with the specific migration limits
provided for in paragraph 1 shall not be compulsory, if it can be estab-
lished 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 estab-
lished that, by assuming complete migration of the residual substance
in the material or article, it cannot exceed the specific limit of migra-tion.
4.The verification of compliance with the specific migration limits
provided for in paragraph 1 may be ensured by the determination of the
quantity of a substance in the finished material or article provided thata relationship between that quantity and the value of the specificmigration of the substance has been established either by an adequateexperimentation or by the application of generally recognised diffusionmodels based on scientific evidence.To demonstrate the non-compli-
ance of a material or article, confirmation of the estimated migration
value by experimental testing is obligatory.
Article 9
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 accordancewith Article 6(5) of Directive 89/109/EEC.
2.Paragraph 1 does not apply to plastic materials and articles which
by their nature are clearly intended to come into contact with food-
stuffs.
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 obliga-
tions of the Member States in respect of the deadlines for transpositionand application laid down in Annex VII, Part B.
2.References to the repealed Directives shall be construed as refer-
ences 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 .2002L0072 — EN — 02.02.2004 — 001.001 — 6
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Article 12
This Directive is addressed to the Member States.2002L0072 — EN — 02.02.2004 — 001.001 — 7
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ANNEX I
FURTHER PROVISIONS APPLICABLE WHEN CHECKING COMPLI-
ANCE 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:
M¼m/C1a2
a1/C1q/C11 000
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;
a1is the surface area in dm2of the sample in contact with the foodstuff or
simulant during the migration test;
a2is the surface area in dm2of the material or article in real conditions of
use;
q 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 Direc-
tive, 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.2002L0072 — EN — 02.02.2004 — 001.001 — 8
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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.
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 deter-
mined quantitatively.The quantity of simulant found is subtracted from the
weight of the sample measured after contact with the simulant.The differ-
ence 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 migra-
tion determined (M1).The second and third samples shall be subjected to the
same conditions of temperature but the period of contact shall be two and
three times that specified and overall migration determined in each case (M2and M3, respectively).
The material or article shall be deemed to be in compliance provided that
either M1or M3-M2does not exceed the overall migration limit.
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/dm2in migration tests using rectified olive oil or
substitutes,
— 12 mg/kg or 2 mg/dm2in 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.2002L0072 — EN — 02.02.2004 — 001.001 — 9
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ANNEX II
LIST OF MONOMERS AND OTHER STARTING SUBSTANCES
WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATE-
RIALS 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 macromole-
cules,
— natural or synthetic macromolecular substances used in the manufacture
of modified macromolecules, if the monomers or the other starting
substances required to synthesise them are not included in the list,
— 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 corre-sponding 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 synthe-
sise 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 dm
2of 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 = Detection limit of the method of analysis;2002L0072 — EN — 02.02.2004 — 001.001 — 10
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FP = Finished material or article;
NCO = Isocyanate moiety;ND = not detectable.For the purpose of this Directive ‘not detect-
able’ 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 perfor-
mance characteristics at the detection limit may be used,
pending the development of a validated method;
QM = Maximum permitted quantity of the ‘residual’ substance in the
material or article;
QM(T) = 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 perfor-
mance characteristics at the specified limit may be used,
pending the development of a validated method;
QMA = Maximum permitted quantity of the ‘residual’ substance in the
finished material or article expressed as mg per 6 dm
2of 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 analy-
tical method with appropriate performance characteristics at the
specified limit may be used, pending the development of a vali-
dated 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 dm2of 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 = 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 perfor-
mance characteristics at the specified limit may be used,
pending the development of a validated method;
SML(T) = 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.2002L0072 — EN — 02.02.2004 — 001.001 — 11
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Section A
List of authorised monomers and other starting substances
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
10030 000514-10-3 Abietic acid
10060 000075-07-0 Acetaldehyde SML(T) = 6 mg/kg (2)
10090 000064-19-7 Acetic acid10120 000108-05-4 Acetic acid, vinyl ester SML = 12 mg/kg
10150 000108-24-7 Acetic anhydride
10210 000074-86-2 Acetylene10630 000079-06-1 Acrylamide SML = ND (DL = 0,01 mg/
kg)
10660 015214-89-8 2-Acrylamido-2-methylpropanesulphonic
acidSML = 0,05 mg/kg
10690 000079-10-7 Acrylic acid
10750 002495-35-4 Acrylic acid, benzyl ester
10780 000141-32-2 Acrylic acid, n-butyl ester
10810 002998-08-5 Acrylic acid, sec-butyl ester10840 001663-39-4 Acrylic acid, tert-butyl ester
11000 050976-02-8 Acrylic acid, dicyclopentadienyl ester QMA = 0,05 mg/6 dm
2
11245 002156-97-0 Acrylic acid, dodecyl ester SML = 0,05 mg/kg (1)
11470 000140-88-5 Acrylic acid, ethyl ester
11510 000818-61-1 Acrylic acid, hydroxyethyl ester See ‘Acrylic acid, monoester
with ethyleneglycol’
11530 000999-61-1 Acrylic acid, 2-hydroxypropyl ester QMA = 0,05 mg/6 dm2
11590 000106-63-8 Acrylic acid, isobutyl ester11680 000689-12-3 Acrylic acid, isopropyl ester
11710 000096-33-3 Acrylic acid, methyl ester11830 000818-61-1 Acrylic acid, monoester with ethylene-
glycol
11890 002499-59-4 Acrylic acid, n-octyl ester11980 000925-60-0 Acrylic acid, propyl ester
12100 000107-13-1 Acrylonitrile SML = ND (DL= 0,020 mg/
kg, analytical tolerance
included)
12130 000124-04-9 Adipic acid
12265 004074-90-2 Adipic acid, divinyl ester QM = 5 mg/kg in FP.Or use
only as comonomer
12280 002035-75-8 Adipic anhydride2002L0072 — EN — 02.02.2004 — 001.001 — 12
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Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
12310 Albumin
12340 Albumin, coagulated by formaldehyde
12375 Alcohols, aliphatic, monohydric, saturated,
linear, primary (C4-C22)
12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5-trimethylcy-
clohexaneSML = 6 mg/kg
12761 000693-57-2 12-Aminododecanoic acid SML= 0,05 mg/kg
12763 000141-43-5 2-Aminoethanol SML = 0,05 mg/kg.Not for
use in polymers contacting
foods for which simulant D
is laid down in Directive 85/
572/EEC and for indirect
food contact only, behind the
PET layer
12765 084434-12-8 N-(2-Aminoethyl)-beta-alanine, sodium salt SML= 0,05 mg/kg
12788 002432-99-7 11-Aminoundecanoic acid SML= 5 mg/kg
12789 007664-41-7 Ammonia
12820 000123-99-9 Azelaic acid
12970 004196-95-6 Azelaic anhydride13000 001477-55-0 1,3-Benzenedimethanamine SML= 0,05 mg/kg
13060 004422-95-1 1,3,5-Benzenetricarboxylic acid trichloride QMA = 0,05 mg/6 dm
2
(measured as 1,3,5-Benzene-
tricarboxylic acid)
13075 000091-76-9 Benzoguanamine See ‘2,4-Diamino-6-phenyl-
1,3,5-triazine’
13090 000065-85-0 Benzoic acid
13150 000100-51-6 Benzyl alcohol
13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene (=Norbornene) SML= 0,05 mg/kg
13210 001761-71-3 Bis(4-aminocyclohexyl)methane SML= 0,05 mg/kg13326 000111-46-6 Bis(2-hydroxyethyl)ether See ‘Diethyleneglycol’
13380 000077-99-6 2,2-Bis(hydroxymethyl)-1-butanol See ‘1,1,1-Trimethylolpro-
pane’
13390 000105-08-8 1,4-Bis(hydroxymethyl)cyclohexane
13395 004767-03-7 2,2-Bis(hydroxymethyl)propionic acid QMA = 0,05 mg/6 dm
2
13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane SML = 3 mg/kg13510 001675-54-3 2,2-Bis(4-hydroxyphenyl)propane bis(2,3-
epoxypropyl) ether (=BADGE)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)2002L0072 — EN — 02.02.2004 — 001.001 — 13
▼C1
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
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 See ‘Dipropyleneglycol’
13560 0005124-30-1 Bis(4-isocyanatocyclohexyl)methane See ‘Dicyclohexylmethane-
4,4′-diisocyanate’
13600 047465-97-4 3,3-Bis(3-methyl-4-hydroxyphenyl)2-indo-
linoneSML = 1,8 mg/kg
13607 000080-05-7 Bisphenol A See ‘2,2-Bis(4-hydroxyphe-
nyl)propane’
13610 001675-54-3 Bisphenol A bis(2,3-epoxypropyl) ether See ‘2,2-Bis(4-hydroxyphe-
nyl)propane bis(2,3-epoxy-
propyl) ether’
13614 038103-06-9 Bisphenol A bis(phthalic anhydride) See ‘2,2-Bis(4-hydroxyphe-
nyl)propane bis(phthalic
anhydride)’
13617 000080-09-1 Bisphenol S See ‘4,4 ′-Dihydroxydiphenyl
sulphone’
13620 010043-35-3 Boric acid 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).
13630 000106-99-0 Butadiene QM = 1 mg/kg in FP or
SML = not detectable
(DL = 0,020 mg/kg, analy-
tical tolerance included)
13690 000107-88-0 1,3-Butanediol
13720 000110-63-4 1,4-Butanediol SML(T) = 0,05 mg/kg (24)
13780 002425-79-8 1,4-Butanediol bis(2,3-epoxypropyl)ether QM = 1 mg/kg in FP
(expressed as Epoxy group,
Mw = 43)
13810 000505-65-7 1,4-Butanediol formal QMA = 0,05 mg/6 dm2
13840 000071-36-3 1-Butanol13870 000106-98-9 1-Butene
13900 000107-01-7 2-Butene
13932 000598-32-3 3-Buten-2-ol QMA = ND (DL = 0,02 mg/
6d m
2) To be used only as a
comonomer for the prepara-
tion of polymeric additive
14020 000098-54-4 4-tert-Butylphenol SML = 0,05 mg/kg
14110 000123-72-8 Butyraldehyde14140 000107-92-6 Butyric acid
14170 000106-31-0 Butyric anhydride
14200 000105-60-2 Caprolactam SML(T) = 15 mg/kg (
5)2002L0072 — EN — 02.02.2004 — 001.001 — 14
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Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
14230 002123-24-2 Caprolactam, sodium salt SML(T) = 15 mg/kg (5)
(expressed as Caprolactam)
14320 000124-07-2 Caprylic acid14350 000630-08-0 Carbon monoxide14380 000075-44-5 Carbonyl chloride QM = 1 mg/kg in FP14411 008001-79-4 Castor oil14500 009004-34-6 Cellulose14530 007782-50-5 Chlorine14570 000106-89-8 1-Chloro-2,3-epoxypropane See ‘Epichlorohydrin’14650 000079-38-9 Chlorotrifluoroethylene QMA = 0,5 mg/6 dm
2
14680 000077-92-9 Citric acid14710 000108-39-4 m-Cresol
14740 000095-48-7 o-Cresol
14770 000106-44-5 p-Cresol
14841 000599-64-4 4-Cumylphenol SML = 0,05 mg/kg14880 000105-08-8 1,4-Cyclohexanedimethanol See ‘1,4-Bis(hydroxy-
methyl)cyclohexane’
14950 003173-53-3 Cyclohexyl isocyanate QM(T) = 1 mg/kg (expressed
as NCO) (
26)
15030 000931-88-4 Cyclooctene SML = 0,05 mg/kg.For use
only in polymers contacting
foods for which simulant A
is laid down in Directive 85/
572/EEC
15070 001647-16-1 1,9-Decadiene SML = 0,05 mg/kg15095 000334-48-5 Decanoic acid15100 000112-30-1 1-Decanol15130 000872-05-9 1-Decene SML = 0,05 mg/kg15250 000110-60-1 1,4-Diaminobutane15272 000107-15-3 1,2-Diaminoethane See ‘Ethylenediamine’15274 000124-09-4 1,6-Diaminohexane See ‘Hexamethylenediamine’15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazine QMA = 5 mg/6 dm
2
15370 003236-53-1 1,6-Diamino-2,2,4-trimethylhexane QMA = 5 mg/6 dm2
15400 003236-54-2 1,6-Diamino-2,4,4-trimethylhexane QMA = 5 mg/6 dm2
15565 000106-46-7 1,4-Dichlorobenzene SML = 12 mg/kg15610 000080-07-9 4,4 ′-Dichlorodiphenyl sulphone SML = 0,05 mg/kg2002L0072 — EN — 02.02.2004 — 001.001 — 15
▼C1
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
15700 005124-30-1 Dicyclohexylmethane-4,4 ′-diisocyanate QM(T) = 1 mg/kg (expressed
as NCO (26)
15760 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3)
15790 000111-40-0 Diethylenetriamine SML = 5 mg/kg
15820 000345-92-6 4,4 ′-Difluorobenzophenone SML = 0,05 mg/kg
15880 000120-80-9 1,2-Dihydroxybenzene SML = 6 mg/kg15910 000108-46-3 1,3-Dihydroxybenzene SML = 2,4 mg/kg15940 000123-31-9 1,4-Dihydroxybenzene SML = 0,6 mg/kg
15970 000611-99-4 4,4 ′-Dihydroxybenzophenone SML(T) = 6 mg/kg (
15)
16000 000092-88-6 4,4 ′-Dihydroxybiphenyl SML = 6 mg/kg
16090 000080-09-1 4,4 ′-Dihydroxydiphenyl sulphone SML = 0,05 mg/kg
16150 000108-01-0 Dimethylaminoethanol SML = 18 mg/kg16240 000091-97-4 3,3 ′-Dimethyl-4,4 ′-diisocyanatobiphenyl QM(T) = 1 mg/kg (expressed
as NCO) (
26)
16360 000576-26-1 2,6-Dimethylphenol SML = 0,05 mg/kg16390 000126-30-7 2,2-Dimethyl-1,3-propanediol SML = 0,05 mg/kg16450 000646-06-0 1,3-Dioxolane SML = 0,05 mg/kg
16480 000126-58-9 Dipentaerythritol
16570 004128-73-8 Diphenylether-4,4 ′-diisocyanate QM(T) = 1 mg/kg (expressed
as NCO) (
26)
16600 005873-54-1 Diphenylmethane-2,4 ′-diisocyanate QM(T) = 1 mg/kg (expressed
as NCO) (26)
16630 000101-68-8 Diphenylmethane-4,4 ′-diisocyanate QM(T) = 1 mg/kg (expressed
as NCO) (26)
16650 000127-63-9 Diphenyl sulphone SML(T) = 3 mg/kg (25)
16660 000110-98-5 Dipropyleneglycol16690 001321-74-0 Divinylbenzene QMA = 0,01 mg/6 dm
2or
SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included) for the sum of
divinylbenzene and ethylvi-
nylbenzene and in compli-
ance with the specifications
laid down in Annex V
16694 013811-50-2 N,N ′-Divinyl-2-imidazolidinone QM = 5 mg/kg in FP
16697 000693-23-2 n-Dodecanedioic acid16704 000112-41-4 1-Dodecene SML = 0,05 mg/kg16750 000106-89-8 Epichlorohydrin QM = 1 mg/kg in FP
16780 000064-17-5 Ethanol2002L0072 — EN — 02.02.2004 — 001.001 — 16
▼C1
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
16950 000074-85-1 Ethylene
16960 000107-15-3 Ethylenediamine SML = 12 mg/kg
16990 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3)
17005 000151-56-4 Ethyleneneimine SML = ND (DL = 0,01 mg/
kg)
17020 000075-21-8 Ethylene oxide QM = 1 mg/kg in FP
17050 000104-76-7 2-Ethyl-1-hexanol SML = 30 mg/kg
17160 000097-53-0 Eugenol SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included)
17170 061788-47-4 Fatty acids, coco
17200 068308-53-2 Fatty acids, soya
17230 061790-12-3 Fatty acids, tall oil17260 000050-00-0 Formaldehyde SML(T) = 15 mg/kg (
22)
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
18220 068564-88-5 N-Heptylaminoundecanoic acid SML = 0,05 mg/kg (1)
18250 000115-28-6 Hexachloroendomethylenetetrahydroph-
thalic acidSML = ND (DL = 0,01 mg/
kg)
18280 000115-27-5 Hexachloroendomethylenetetrahydroph-
thalic anhydrideSML = ND (DL = 0,01 mg/
kg)
18310 036653-82-4 1-Hexadecanol
18430 000116-15-4 Hexafluoropropylene SML = ND (DL = 0,01 mg/
kg)
18460 000124-09-4 Hexamethylenediamine SML = 2,4 mg/kg
18640 000822-06-0 Hexamethylene diisocyanate QM(T) = 1 mg/kg (expressed
as NCO) (26)
18670 000100-97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (22)
(expressed as Formaldehyde)
18820 000592-41-6 1-Hexene SML = 3 mg/kg
18867 000123-31-9 Hydroquinone See ‘1,4-Dihydroxybenzene’
18880 000099-96-7 p-Hydroxybenzoic acid
18897 016712-64-4 6-Hydroxy-2-naphthalenecarboxylic acid SML = 0,05 mg/kg2002L0072 — EN — 02.02.2004 — 001.001 — 17
▼C1
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
18898 000103-90-2 N-(4-Hydroxyphenyl) acetamide Only to be used in liquid
crystals and behind a barrier
layer in multilayered plastics
19000 000115-11-7 Isobutene
19060 000109-53-5 Isobutyl vinyl ether QM = 5 mg/kg in FP19110 004098-71-9 1-Isocyanato-3-isocyanatomethyl-3,5,5-
trimethylcyclohexaneQM(T) = 1 mg/kg (expressed
as NCO) (
26)
19150 000121-91-5 Isophthalic acid SML = 5 mg/kg
19210 001459-93-4 Isophthalic acid, dimethyl ester SML = 0,05 mg/kg
19243 000078-79-5 Isoprene See ‘2-Methyl-1,3-butadiene’19270 000097-65-4 Itaconic acid
19460 000050-21-5 Lactic acid
19470 000143-07-7 Lauric acid19480 002146-71-6 Lauric acid, vinyl ester
19490 000947-04-6 Laurolactam SML = 5 mg/kg
19510 011132-73-3 Lignocellulose
19540 000110-16-7 Maleic acid SML(T) = 30 mg/kg (
4)
19960 000108-31-6 Maleic anhydride SML(T) = 30 mg/kg (4)
(expressed as maleic acid)
19975 000108-78-1 Melamine See ‘2,4,6-triamino-1,3,5-
triazine’
19990 000079-39-0 Methacrylamide SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included)
20020 000079-41-4 Methacrylic acid20050 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 ester20140 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 SML = 0,05 mg/kg20410 002082-81-7 Methacrylic acid, diester with 1,4-butane-
diolSML = 0,05 mg/kg
20530 002867-47-2 Methacrylic acid, 2-(dimethylamino)-ethyl
esterSML = ND (DL = 0,02 mg/
kg, analytical tolerance
included)
20590 000106-91-2 Methacrylic acid, 2,3-epoxypropyl ester QMA = 0,02 mg/6 dm
2
20890 000097-63-2 Methacrylic acid, ethyl ester2002L0072 — EN — 02.02.2004 — 001.001 — 18
▼C1
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
21010 000097-86-9 Methacrylic acid, isobutyl ester
21100 004655-34-9 Methacrylic acid, isopropyl ester21130 000080-62-6 Methacrylic acid, methyl ester
21190 000868-77-9 Methacrylic acid, monoester with ethylene-
glycol
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, analytical tolerance
included)
21520 001561-92-8 Methallylsulphonic acid, sodium salt SML = 5 mg/kg
21550 000067-56-1 Methanol21640 000078-79-5 2-Methyl-1,3-butadiene QM = 1 mg/kg in FP or
SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included)
21730 000563-45-1 3-Methyl-1-butene QMA = 0,006 mg/6 dm
2.For
use only in Polypropylene
21765 106246-33-7 4,4 ′-Methylenebis(3-chloro-2,6-diethylani-
line)QMA = 0,05 mg/6 dm2
21821 000505-65-7 1,4-(Methylenedioxy)butane See ‘1,4-Butanediol formal’
21940 000924-42-5 N-Methylolacrylamide SML = ND (DL = 0,01 mg/
kg)
22150 000691-37-2 4-Methyl-1-pentene SML = 0,02 mg/kg
22331 025513-64-8 Mixture of (40 % w/w) 1,6-diamino-2,2,4-
trimethylhexane and (60 % w/w) 1,6-
diamino-2,4,4-trimethylhexaneQMA = 5 mg/6 dm2
22332 028679-16-5 Mixture of (40 % w/w) 2,2,4-trimethyl-
hexane-1,6-diisocyanate and (60 % w/w)
2,4,4-trimethylhexane-1,6-diisocyanateQM(T) = 1 mg/kg (expressed
as NCO) (26)
22350 000544-63-8 Myristic acid
22360 001141-38-4 2,6-Naphthalenedicarboxylic acid SML = 5 mg/kg
22390 000840-65-3 2,6-Naphthalenedicarboxylic acid, dimethyl
esterSML = 0,05 mg/kg
22420 003173-72-6 1,5-Naphthalene diisocyanate QM(T) = 1 mg/kg (expressed
as NCO) (26)
22437 000126-30-7 Neopentylglycol See ‘2,2-Dimethyl-1,3-propa-
nediol’
22450 009004-70-0 Nitrocellulose
22480 000143-08-8 1-Nonanol2002L0072 — EN — 02.02.2004 — 001.001 — 19
▼C1
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
22550 000498-66-8 Norbornene See ‘Bicyclo[2.2.1]hept-2-
ene’
22570 000112-96-9 Octadecyl isocyanate QM(T) = 1 mg/kg (expressed
as NCO) (26)
22600 000111-87-5 1-Octanol22660 000111-66-0 1-Octene SML = 15 mg/kg
22763 000112-80-1 Oleic acid
22778 007456-68-0 4,4 ′-Oxybis(benzenesulphonyl azide) QMA = 0,05 mg/6 dm
2
22780 000057-10-3 Palmitic acid
22840 000115-77-5 Pentaerythritol
22870 000071-41-0 1-Pentanol
22900 000109-67-1 1-Pentene SML = 5 mg/kg
22937 001623-05-8 Perfluoropropylperfluorovinyl ether SML = 0,05 mg/kg22960 000108-95-2 Phenol
23050 000108-45-2 1,3-Phenylenediamine SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included)
23155 000075-44-5 Phosgene See ‘Carbonyl chloride’23170 007664-38-2 Phosphoric acid
23175 000122-52-1 Phosphorous acid, triethyl ester QM = ND (DL = 1 mg/kg in
FP)
23187 Phthalic acid See ‘Terephthalic acid’
23200 000088-99-3 o-Phthalic acid23230 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-Pinene23547 009016-00-6
063148-62-9Polydimethylsiloxane (Mw > 6 800) In compliance with the
specifications laid down in
Annex V
23590 025322-68-3 Polyethyleneglycol
23651 025322-69-4 Polypropyleneglycol23740 000057-55-6 1,2-Propanediol
23770 000504-63-2 1,3-Propanediol SML = 0,05 mg/kg
23800 000071-23-8 1-Propanol23830 000067-63-0 2-Propanol2002L0072 — EN — 02.02.2004 — 001.001 — 20
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Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
23860 000123-38-6 Propionaldehyde
23890 000079-09-4 Propionic acid
23920 000105-38-4 Propionic acid, vinyl ester SML(T) = 6 mg/kg (2)
(expressed as Acetaldehyde)
23950 000123-62-6 Propionic anhydride
23980 000115-07-1 Propylene
24010 000075-56-9 Propylene oxide QM = 1 mg/kg in FP
24051 000120-80-9 Pyrocatechol See ‘1,2-Dihydroxybenzene’24057 000089-32-7 Pyromellitic anhydride SML = 0,05 mg/kg
(expressed as Pyromellitic
acid)
24070 073138-82-6 Resin acids and Rosin acids
24072 000108-46-3 Resorcinol See ‘1,3-Dihydroxybenzene’
24073 000101-90-6 Resorcinol diglycidyl ether QMA = 0,005 mg/6 dm
2.Not
for use in polymers
contacting foods for which
simulant D is laid down in
Directive 85/572/EEC and
for indirect food contact
only, behind the PET layer.
24100 008050-09-7 Rosin24130 008050-09-7 Rosin gum See ‘Rosin’
24160 008052-10-6 Rosin tall oil
24190 009014-63-5 Rosin wood
24250 009006-04-6 Rubber, natural
24270 000069-72-7 Salicylic acid24280 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 oil24540 009005-25-8 Starch, edible
24550 000057-11-4 Stearic acid
24610 000100-42-5 Styrene
24760 026914-43-2 Styrenesuphonic acid SML = 0,05 mg/kg
24820 000110-15-6 Succinic acid24850 000108-30-5 Succinic anhydride2002L0072 — EN — 02.02.2004 — 001.001 — 21
▼C1
Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
24880 000057-50-1 Sucrose
24887 006362-79-4 5-Sulphoisophthalic acid, monosodium salt SML = 5 mg/kg24888 003965-55-7 5-Sulphoisophthalic acid, monosodium salt,
dimethyl esterSML = 0,05 mg/kg
24910 000100-21-0 Terephthalic acid SML = 7,5 mg/kg
24940 000100-20-9 Terephthalic acid dichloride SML(T) = 7,5 mg/kg
(expressed as Terephthalic
acid)
24970 000120-61-6 Terephthalic acid, dimethyl ester25080 001120-36-1 1-Tetradecene SML = 0,05 mg/kg25090 000112-60-7 Tetraethyleneglycol
25120 000116-14-3 Tetrafluoroethylene SML = 0,05 mg/kg
25150 000109-99-9 Tetrahydrofuran SML = 0,6 mg/kg25180 000102-60-3 N,N,N ′,N′,-Tetrakis(2-hydroxypropyl)ethy-
lenediamine
25210 000584-84-9 2,4-Toluene diisocyanate QM(T) = 1 mg/kg (expressed
as NCO) (
26)
25240 000091-08-7 2,6-Toluene diisocyanate QM(T) = 1 mg/kg (expressed
as NCO) (26)
25270 026747-90-0 2,4-Toluene diisocyanate dimer QM(T) = 1 mg/kg (expressed
as NCO) (26)
25360 Trialkyl(C5-C15)acetic acid, 2,3-epoxy-
propyl esterQM = 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 In compliance with the
specifications laid down in
Annex V
25420 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg25450 026896-48-0 Tricyclodecanedimethanol SML = 0,05 mg/kg25510 000112-27-6 Triethyleneglycol25600 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg25840 003290-92-4 1,1,1-Trimethylolpropane trimethacrylate SML = 0,05 mg/kg
25900 000110-88-3 Trioxane SML = 0,05 mg/kg
25910 024800-44-0 Tripropyleneglycol25927 027955-94-8 1,1,1-Tris(4-hydroxyphenol)ethane QM= 0,5 mg/kg in FP.For
use only in polycarbonates
25960 000057-13-6 Urea2002L0072 — EN — 02.02.2004 — 001.001 — 22
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Ref.
No.CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
26050 000075-01-4 Vinyl chloride See Council Directive 78/
142/EEC
26110 000075-35-4 Vinylidene chloride QM = 5 mg/kg in FP or
SML = ND (DL = 0,05 mg/
kg)
26140 000075-38-7 Vinylidene fluoride SML = 5 mg/kg
26155 001072-63-5 1-Vinylimidazole QM = 5 mg/kg in FP26170 003195-78-6 N-Vinyl-N-methylacetamide QM = 2 mg/kg in FP
26320 002768-02-7 Vinyltrimethoxysilane QM = 5 mg/kg in FP
26360 007732-18-5 Water In compliance with Directive
98/83/EC2002L0072 — EN — 02.02.2004 — 001.001 — 23
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Section B
List of monomers and other starting substances which may continue to be used pending a deci-
sion on inclusion in Section A
Ref.No CAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
10599/90A 061788-89-4 Acids, fatty, unsaturated (C18), dimers,
distilled
10599/91 061788-89-4 Acids, fatty, unsaturated (C18), dimers,
non-distilled
10599/92A 068783-41-5 Acids, fatty, unsaturated (C18), dimers,
hydrogenated, distilled
10599/93 068783-41-5 Acids, fatty, unsaturated (C18), dimers,
hydrogenated, non-distilled
11500 000103-11-7 Acrylic acid, 2-ethylhexyl ester13050 000528-44-9 1,2,4-Benzenetricarboxylic acid See ‘Trimellitic acid’
14260 000502-44-3 Caprolactone
14800 003724-65-0 Crotonic acid
15730 000077-73-6 Dicyclopentadiene
16210 006864-37-5 3,3 ′-Dimethyl-4,4 ′-diaminodicyclohexyl-
methane
17110 016219-75-3 5-Ethylidenebicyclo[2.2.1]hept-2-ene
18370 000592-45-0 1,4-Hexadiene18700 000629-11-8 1,6-Hexanediol
21370 010595-80-9 Methacrylic acid, 2-sulphoethyl ester
21400 054276-35-6 Methacrylic acid, sulphopropyl ester
21970 000923-02-4 N-Methylolmethacrylamide
22210 000098-83-9 alpha-Methylstyrene25540 000528-44-9 Trimellitic acid QM(T) = 5 mg/kg in FP
25550 000552-30-7 Trimellitic anhydride QM(T) = 5 mg/kg in FP
(expressed as Trimellitic
acid)
26230 000088-12-0 Vinylpyrrolidone2002L0072 — EN — 02.02.2004 — 001.001 — 24
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ANNEX III
INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE
MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES
GENERAL INTRODUCTION
1.This Annex contains the list of:
(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 forma-
tion 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 corre-
sponding 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 dm
2of 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.2002L0072 — EN — 02.02.2004 — 001.001 — 25
▼C1
Section A
Incomplete list of additives fully harmonised at Community level
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
30000 000064-19-7 Acetic acid
30045 000123-86-4 Acetic acid, butyl ester
30080 004180-12-5 Acetic acid, copper salt SML(T) = 30 mg/kg (7)
(expressed as Copper)
30140 000141-78-6 Acetic acid, ethyl ester
30280 000108-24-7 Acetic anhydride30295 000067-64-1 Acetone
30370 — Acetylacetic acid, salts
30400 — Acetylated glycerides30610 — Acids, C
2-C24, aliphatic, linear, monocar-
boxylic from natural oils and fats, and their
mono-, di- and triglycerol esters (branched
fatty acids at naturally occuring levels are
included)
30612 — Acids, C2-C24, aliphatic, linear, monocar-
boxylic, synthetic and their mono-, di- and
triglycerol esters
30960 — Acids, aliph., monocarb. (C6-C22), esters
with polyglycerol
31328 — Acids, fatty, from animal or vegetable food
fats and oils
31530 123968-25-2 Acrylic acid, 2,4-di-tert-pentyl-6-(1-(3,5-di-
tert-pentyl-2-hydroxyphenyl)ethyl)phenyl
esterSML = 5 mg/kg
31730 000124-04-9 Adipic acid
33120 — Alcohols, aliph, monoh., sat., linear,
primary (C4-C24)
33350 009005-32-7 Alginic acid
33801 — n-Alkyl(C10-C13)benzenesulphonic acid SML = 30 mg/kg
34240 — Alkyl(C10-C20)sulphonic acid, esters with
phenolsSML = 6 mg/kg.Authorised
until 1 January 2002
34281 — Alkyl(C8-C22)sulphuric acids, linear,
primary with an even number of carbon
atoms
34475 — Aluminum calcium hydroxide phosphite,
hydrate
34480 — Aluminium fibers, flakes and powders34560 021645-51-2 Aluminium hydroxide
34690 011097-59-9 Aluminium magnesium carbonate hydro-
xide2002L0072 — EN — 02.02.2004 — 001.001 — 26
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
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 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 indirect
food contact only, behind the
PET layer
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 indirect
food contact only, behind the
PET layer.
35320 007664-41-7 Ammonia
35440 001214-97-9 Ammonium bromide35600 001336-21-6 Ammonium hydroxide
35840 000506-30-9 Arachidic acid
35845 007771-44-0 Arachidonic acid36000 000050-81-7 Ascorbic acid
36080 000137-66-6 Ascorbyl palmitate
36160 010605-09-1 Ascorbyl stearate36640 000123-77-3 Azodicarbonamide ►
M1 For use only as
blowing agent.Use prohib-
ited as from 2 August
2005.◄
36840 012007-55-5 Barium tetraborate SML(T) = 1 mg/kg
expressed 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).
36880 008012-89-3 Beeswax36960 003061-75-4 Behenamide
37040 000112-85-6 Behenic acid
37280 001302-78-9 Bentonite
37360 000100-52-7 Benzaldehyde In compliance with note 9 in
Annex VI
37600 000065-85-0 Benzoic acid
37680 000136-60-7 Benzoic acid, butyl ester2002L0072 — EN — 02.02.2004 — 001.001 — 27
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
37840 000093-89-0 Benzoic acid, ethyl ester
38080 000093-58-3 Benzoic acid, methyl ester
38160 002315-68-6 Benzoic acid, propyl ester
38320 005242-49-9 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzox-
azolyl)stilbeneIn 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-tetramethyl-
4-piperidinamine and 2,4,6-trichloro-1,3,5-
triazineSML = 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)pen-
taerythritol diphosphiteSML = 5 mg/kg (sum of
phosphite and phosphate)
38840 154862-43-8 Bis(2,4-dicumylphenyl)pentaerythritol-
diphosphiteSML = 5 mg/kg (as sum of
the substance itself, its
oxidised form bis(2,4-dicu-
mylphenyl)pentaerythritol-
phosphate and its hydrolysis
product (2,4-dicumyl-
phenol)).
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 chlorideSML = 1,8 mg/kg
39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene QMA = 0,05 mg/6 dm2
39890 087826-41-3
069158-41-4054686-97-4081541-12-0Bis(methylbenzylidene)sorbitol
39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5-dimethyl-
hexaneSML = 0,05 mg/kg
40120 068951-50-8 Bis(polyethyleneglycol)hydroxymethylpho-
sphonateSML = 0,6 mg/kg
40320 010043-35-3 Boric acid 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).
40400 010043-11-5 Boron nitride
40570 000106-97-8 Butane40580 000110-63-4 1,4-Butanediol SML(T) = 0,05 mg/kg (
24)
41040 005743-36-2 Calcium butyrate
41120 010043-52-4 Calcium chloride2002L0072 — EN — 02.02.2004 — 001.001 — 28
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
41280 001305-62-0 Calcium hydroxide
41520 001305-78-8 Calcium oxide
41600 012004-14-7
037293-22-4Calcium sulphoaluminate
41680 000076-22-2 Camphor In compliance with note 9 in
Annex VI
41760 008006-44-8 Candelilla wax
41840 000105-60-2 Caprolactam SML(T) = 15 mg/kg (5)
41960 000124-07-2 Caprylic acid42160 000124-38-9 Carbon dioxide42320 007492-68-4 Carbonic acid, copper salt SML(T) = 30 mg/kg (
7)
(expressed as Copper)
42500 — Carbonic acid, salts
42640 009000-11-7 Carboxymethylcellulose
42720 008015-86-9 Carnauba wax42800 009000-71-9 Casein42960 064147-40-6 Castor oil, dehydrated43200 — Castor oil, mono- and diglycerides43280 009004-34-6 Cellulose43300 009004-36-8 Cellulose acetate butyrate43360 068442-85-3 Cellulose, regenerated43440 008001-75-0 Ceresin43515 — Chlorides of choline esters of coconut oil
fatty acidsQMA = 0,9 mg/6 dm
2
44160 000077-92-9 Citric acid
44640 000077-93-0 Citric acid, triethyl ester45195 007787-70-4 Copper bromide SML(T) = 30 mg/kg (
7)
(expressed as Copper)
45200 001335-23-5 Copper iodide SML(T) = 30 mg/kg (7)
(expressed as Copper) and
SML = 1 mg/kg (11)
(expressed as Iodine)
45280 — Cotton fibers45450 068610-51-5 p-Cresol-dicyclopentadiene - isobutylene,
copolymerSML = 0,05 mg/kg
45560 014464-46-1 Cristobalite
45760 000108-91-8 Cyclohexylamine2002L0072 — EN — 02.02.2004 — 001.001 — 29
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
45920 009000-16-2 Dammar
45940 000334-48-5 n-Decanoic acid
46070 010016-20-3 alpha-Dextrin
46080 007585-39-9 beta-Dextrin46375 061790-53-2 Diatomaceous earth46380 068855-54-9 Diatomaceous earth, soda ash flux-calcined46480 032647-67-9 Dibenzylidene sorbitol46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxybenzoic acid,
2,4-di-tert-butylphenyl ester
46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxybenzoic acid,
hexadecyl ester
46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylpho-
sphonic acid, dioctadecyl ester
46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzylpho-
sphonic acid, monoethyl ester, calcium saltSML = 6 mg/kg
47210 026427-07-6 Dibutylthiostannoic acid polymer [= Thio-
bis(butyl-tin sulphide), polymer]In compliance with the
specifications laid down in
Annex V.
47440 000461-58-5 Dicyanodiamide
47540 027458-90-8 Di-tert-dodecyl disulphide SML = 0,05 mg/kg
47680 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (
3)
48460 000075-37-6 1,1-Difluoroethane48620 000123-31-9 1,4-Dihydroxybenzene SML = 0,6 mg/kg48720 000611-99-4 4,4'-Dihydroxybenzophenone SML(T) = 6 mg/kg (
15)
49485 134701-20-5 2,4-Dimethyl-6-(1-methylpentadecyl)-
phenolSML = 1 mg/kg
49540 000067-68-5 Dimethyl sulphoxide
51200 000126-58-9 Dipentaerythritol51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexy-
loxy)phenolSML = 0,05 mg/kg
51760 025265-71-8
000110-98-5Dipropyleneglycol
52640 016389-88-1 Dolomite
52645 010436-08-5 cis-11-Eicosenamide52720 000112-84-5 Erucamide52730 000112-86-7 Erucic acid52800 000064-17-5 Ethanol2002L0072 — EN — 02.02.2004 — 001.001 — 30
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
53270 037205-99-5 Ethylcarboxymethylcellulose
53280 009004-57-3 Ethylcellulose
53360 000110-31-6 N,N'-Ethylenebisoleamide
53440 005518-18-3 N,N'-Ethylenebispalmitamide
53520 000110-30-5 N,N'-Ethylenebisstearamide
53600 000060-00-4 Ethylenediaminetetraacetic acid53610 054453-03-1 Ethylenediaminetetraacetic acid, copper
saltSML(T) = 30 mg/kg (
7)
(expressed as Copper)
53650 000107-21-1 Ethyleneglycol SML(T) = 30 mg/kg (3)
54005 005136-44-7 Ethylene-N-palmitamide-N'-stearamide
54260 009004-58-4 Ethylhydroxyethylcellulose
54270 — Ethylhydroxymethylcellulose
54280 — Ethylhydroxypropylcellulose54300 118337-09-0 2,2'-Ethylidenebis(4,6-di-tert-butylphenyl)
fluorophosphoniteSML = 6 mg/kg
54450 — Fats and oils, from animal or vegetable
food sources
54480 — Fats and oils, hydrogenated, from animal or
vegetable food sources
54930 025359-91-5 Formaldehyde-1-naphthol, copolymer
[=poly(1-hydroxynaphthylmethane)]SML = 0,05 mg/kg
55040 000064-18-6 Formic acid
55120 000110-17-8 Fumaric acid
55190 029204-02-2 Gadoleic acid
55440 009000-70-8 Gelatin
55520 — Glass fibers
55600 — Glass microballs55680 000110-94-1 Glutaric acid
55920 000056-81-5 Glycerol
56020 099880-64-5 Glycerol dibehenate
56360 — Glycerol, esters with acetic acid
56486 — Glycerol, esters with acids, aliph., sat.,
linear, with an even number of carbon
atoms (C
14-C18) and with acids, aliph.,
unsat., linear, with an even number of
carbon atoms (C16-C18)
56487 — Glycerol, esters with butyric acid2002L0072 — EN — 02.02.2004 — 001.001 — 31
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
56490 — Glycerol, esters with erucic acid
56495 — Glycerol, esters with 12-hydroxystearic
acid
56500 — Glycerol, esters with lauric acid
56510 — Glycerol, esters with linoleic acid56520 — Glycerol, esters with myristic acid
56540 — Glycerol, esters with oleic acid
56550 — Glycerol, esters with palmitic acid56565 — Glycerol, esters with nonanoic acid
56570 — Glycerol, esters with propionic acid
56580 — Glycerol, esters with ricinoleic acid56585 — 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 monooctanoate57040 — Glycerol monooleate, ester with ascorbic
acid
57120 — Glycerol monooleate, ester with citric acid57200 — Glycerol monopalmitate, ester with
ascorbic acid
57280 — Glycerol monopalmitate, ester with citric
acid
57600 — Glycerol monostearate, ester with ascorbic
acid
57680 — Glycerol monostearate, ester with citric
acid
57800 018641-57-1 Glycerol tribehenate57920 000620-67-7 Glycerol triheptanoate
58300 — Glycine, salts
58320 007782-42-5 Graphite58400 009000-30-0 Guar gum
58480 009000-01-5 Gum arabic
58720 000111-14-8 Heptanoic acid59360 000142-62-1 Hexanoic acid
59760 019569-21-2 Huntite2002L0072 — EN — 02.02.2004 — 001.001 — 32
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
59990 007647-01-0 Hydrochloric acid
60030 012072-90-1 Hydromagnesite
60080 012304-65-3 Hydrotalcite60160 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
60480 003864-99-1 2-(2'-Hydroxy-3,5'-di-tert-butylphenyl)-5-
chlorobenzotriazoleSML(T) = 30 mg/kg (
19)
60560 009004-62-0 Hydroxyethylcellulose
60880 009032-42-2 Hydroxyethylmethylcellulose61120 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 acid62140 006303-21-5 Hypophosphorous acid
62240 001332-37-2 Iron oxide
62450 000078-78-4 Isopentane62640 008001-39-6 Japan wax
62720 001332-58-7 Kaolin
62800 — Kaolin, calcined62960 000050-21-5 Lactic acid
63040 000138-22-7 Lactic acid, butyl ester
63280 000143-07-7 Lauric acid63760 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 acid64500 — Lysine, salts
64640 001309-42-8 Magnesium hydroxide
64720 001309-48-4 Magnesium oxide2002L0072 — EN — 02.02.2004 — 001.001 — 33
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
64800 00110-16-7 Maleic acid SML(T) = 30 mg/kg (4)
65020 006915-15-7 Malic acid
65040 000141-82-2 Malonic acid
65520 000087-78-5 Mannitol65920 066822-60-4 N-Methacryloyloxyethyl-N,N-dimethyl-N-
carboxymethylammonium chloride, sodium
salt -octadecyl methacrylate-ethyl metha-
crylate-cyclohexyl methacrylate-N-vinyl-2-
pyrrolidone, copolymers
66200 037206-01-2 Methylcarboxymethylcellulose
66240 009004-67-5 Methylcellulose66560 004066-02-8 2,2'-Methylenebis(4-methyl-6-cyclohexyl-
phenol)SML(T) = 3 mg/kg (
6)
66580 000077-62-3 2,2'-Methylenebis(4-methyl-6-(1-methylcy-
clohexyl)phenol)SML(T) = 3 mg/kg (6)
66640 009004-59-5 Methylethylcellulose
66695 — Methylhydroxymethylcellulose
66700 009004-65-3 Methylhydroxypropylcellulose
66755 002682-20-4 2-Methyl-4-isothiazolin-3-one SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included)
67120 012001-26-2 Mica
67170 — Mixture of (80 to 100 % w/w) 5,7-di-tert-
butyl-3-(3,4-dimethylphenyl)-2(3H)-benzo-
furanone and (0 to 20 % w/w)5,7-di-tert-
butyl-3-(2,3-dimethylphenyl)-2(3H)-benzo-
furanoneSML = 5 mg/kg
67180 — 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 esterSML = 5 mg/kg (1)
67200 001317-33-5 Molybdenum disulphide
67840 — Montanic acids and/or their esters with
ethyleneglycol and/or with 1,3-butanediol
and/or with glycerol
67850 008002-53-7 Montan wax67891 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)pho-
sphite)SML =5 mg/kg (sum of
phosphite and phosphate)2002L0072 — EN — 02.02.2004 — 001.001 — 34
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
68960 000301-02-0 Oleamide
69040 000112-80-1 Oleic acid
69760 000143-28-2 Oleyl alcohol70000 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 acid71440 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-diphe-
nylacrylate)SML = 0,05 mg/kg
71680 006683-19-8 Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-
4-hydroxyphenyl)-propionate]
71720 000109-66-0 Pentane72640 007664-38-2 Phosphoric acid
73160 — Phosphoric acid, mono- and di-n-alkyl (C
16and C18) estersSML = 0,05 mg/kg
73720 000115-96-8 Phosphoric acid, trichloroethyl ester SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included)
74010 145650-60-8 Phosphorous acid, bis(2,4-di-tert-butyl-6-
methylphenyl) ethyl esterSML =5 mg/kg (sum of
phosphite and phosphate)
74240 031570-04-4 Phosphorous acid, tris(2,4-di-tert-butylphe-
nyl)ester
74480 000088-99-3 o-Phthalic acid
76320 000085-44-9 Phthalic anhydride76721 009016-00-6
063148-62-9Polydimethylsiloxane (Mw > 6800) In compliance with the
specifications laid down in
Annex V
76730 — Polydimethylsiloxane, gamma-hydroxypro-
pylatedSML = 6 mg/kg
76865 — Polyesters of 1,2-propanediol and/or 1,3-
and/or 1,4-butanediol and/or polypropyle-
neglycol with adipic acid, also end-capped
with acetic acid or fatty acids C
10-C18or n-
octanol and/or n-decanolSML = 30 mg/kg
76960 025322-68-3 Polyethyleneglycol2002L0072 — EN — 02.02.2004 — 001.001 — 35
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
77600 061788-85-0 Polyethyleneglycol ester of hydrogenated
castor oil
77702 — Polyethyleneglycol esters of aliph.mono-
carb.acids (C6-C22) and their ammonium
and sodium sulphates
77895 068439-49-6 Polyethyleneglycol(EO = 2-6) monoalkyl
(C16-C18) etherSML = 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 tristearate80240 029894-35-7 Polyglycerol ricinoleate
80640 — Polyoxyalkyl (C
2-C4) dimethylpolysiloxane
80720 008017-16-1 Polyphosphoric acids
80800 025322-69-4 Polypropyleneglycol
81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperi-
dinyl)-n-butylamino]-1,3,5-triazine-2,4-
diyl][(2,2,6,6-tetramethyl-4-piperidinyl)i-
mino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-
4-piperidinyl)imino]]-alpha-[N,N,N',N'-
tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperi-
dinyl)-N"-[6-(2,2,6,6-tetramethyl-4-piperi-
dinylamino)-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 hydroxide81760 — Powders, flakes and fibres of brass, bronze,
copper, stainless steel, tin and alloys of
copper, tin and ironSML(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 dipalmitate2002L0072 — EN — 02.02.2004 — 001.001 — 36
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
82720 006182-11-2 1,2-Propyleneglycol distearate
82800 027194-74-7 1,2-Propyleneglycol monolaurate
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 — Propylhydroxyethylcellulose
83325 — Propylhydroxymethylcellulose
83330 — 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-mercap-
toethyl ester, with dichlorodimethyltin,
sodium sulphide and trichloromethyltinSML(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 pentaery-
thritol
84560 009006-04-6 Rubber, natural
84640 000069-72-7 Salicylic acid
85360 000109-43-3 Sebacic acid, dibutyl ester
85600 — Silicates, natural
85610 — Silicates, natural, silanated (with the
exception of asbestos)
85680 001343-98-2 Silicic acid
85840 053320-86-8 Silicic acid, lithium magnesium sodium
saltSML(T) = 0,6 mg/kg (8)
(expressed as Lithium)
86000 — Silicic acid, silylated
86160 000409-21-2 Silicon carbide2002L0072 — EN — 02.02.2004 — 001.001 — 37
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
86240 007631-86-9 Silicon dioxide
86285 — Silicon dioxide, silanated
86560 007647-15-6 Sodium bromide86720 001310-73-2 Sodium hydroxide
87040 001330-43-4 Sodium tetraborate 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).
87200 000110-44-1 Sorbic acid
87280 029116-98-1 Sorbitan dioleate87520 062568-11-0 Sorbitan monobehenate
87600 001338-39-2 Sorbitan monolaurate
87680 001338-43-8 Sorbitan monooleate87760 026266-57-9 Sorbitan monopalmitate
87840 001338-41-6 Sorbitan monostearate
87920 061752-68-9 Sorbitan tetrastearate88080 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 monostearate88640 008013-07-8 Soybean oil, epoxidised In compliance with the
specifications laid down in
Annex V
88800 009005-25-8 Starch, edible
88880 068412-29-3 Starch, hydrolysed88960 000124-26-5 Stearamide
89040 000057-11-4 Stearic acid
89200 007617-31-4 Stearic acid, copper salt SML(T) = 30 mg/kg (
7)
(expressed as Copper)
89440 — Stearic acid, esters with ethyleneglycol SML(T) = 30 mg/kg (3)
90720 058446-52-9 Stearoylbenzoylmethane
90800 005793-94-2 Stearoyl-2-lactylic acid, calcium salt
90960 000110-15-6 Succinic acid91200 000126-13-6 Sucrose acetate isobutyrate2002L0072 — EN — 02.02.2004 — 001.001 — 38
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
91360 000126-14-7 Sucrose octaacetate
91840 007704-34-9 Sulphur91920 007664-93-9 Sulphuric acid92030 010124-44-4 Sulphuric acid, copper salt SML(T) = 30 mg/kg (
7)
(expressed as Copper)
92080 014807-96-6 Talc92150 001401-55-4 Tannic acids According to the JECFA
specifications
92160 000087-69-4 Tartaric acid
92195 — Taurine, salts
92205 057569-40-1 Terephthalic acid, diester with 2,2'-methy-
lenebis(4-methyl-6-tert-butylphenol)
92350 000112-60-7 Tetraethyleneglycol
92640 000102-60-3 N,N,N',N'-Tetrakis(2-hydroxypropyl)ethyle-
nediamine
92700 078301-43-6 2,2,4,4-Tetramethyl-20-(2,3-epoxypropyl)-
7-oxa-3,20-diazadispiro-[5.1.11.2]-henei-
cosan-21-one, polymerSML = 5 mg/kg
92930 120218-34-0 Thiodiethanolbis(5-methoxycarbonyl-2,6-
dimethyl-1,4-dihydropyridine-3-carboxy-
late)SML = 6 mg/kg
93440 013463-67-7 Titanium dioxide
93520 000059-02-9
010191-41-0alpha-Tocopherol
93680 009000-65-1 Tragacanth gum
93720 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg
94320 000112-27-6 Triethyleneglycol
94960 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-
4-hydroxybenzyl)benzene
95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-
1,3-propanediol phosphiteSML = 2 mg/kg (as sum of
phosphite, phosphate and thehydrolysis product = TTBP)
95725 110638-71-6 Vermiculite, reaction product with citric
acid, lithium saltSML(T) = 0,6 mg/kg (
8)
(expressed as Lithium)
95855 007732-18-5 Water In compliance with Directive
98/83/EEC
95859 — Waxes, refined, derived from petroleum
based or synthetic hydrocarbon feedstocksIn compliance with the
specifications laid down in
Annex V2002L0072 — EN — 02.02.2004 — 001.001 — 39
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
95883 — White mineral oils, paraffinic, derived from
petroleum based hydrocarbon feedstocksIn compliance with the
specifications laid down in
Annex V
95905 013983-17-0 Wollastonite
95920 — Wood flour and fibers, untreated95935 011138-66-2 Xanthan gum
96190 020427-58-1 Zinc hydroxide
96240 001314-13-2 Zinc oxide96320 001314-98-3 Zinc sulphide2002L0072 — EN — 02.02.2004 — 001.001 — 40
▼C1
Section B
Incomplete list of additives referred to in Article 4, second paragraph
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
30180 002180-18-9 Acetic acid, manganese salt SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
31520 061167-58-6 Acrylic acid, 2-tert-butyl-6-(3-tert-butyl-2-
hydroxy-5-methylbenzyl)-4-methylphenyl
esterSML = 6 mg/kg
31920 000103-23-1 Adipic acid, bis(2-ethylhexyl) ester SML = 18 mg/kg (1)
34230 — Alkyl(C8-C22)sulphonic acids SML = 6 mg/kg
35760 001309-64-4 Antimony trioxide SML = 0,02 mg/kg
(expressed as Antimony and
analytical tolerance included)
36720 017194-00-2 Barium hydroxide SML(T) = 1 mg/kg (12)
(expressed as Barium)
36800 010022-31-8 Barium nitrate SML(T) = 1 mg/kg (12)
(expressed as Barium)
38240 000119-61-9 Benzophenone SML = 0,6 mg/kg
38560 007128-64-5 2,5-Bis(5-tert-butyl-2-benzoxazolyl)thio-
pheneSML = 0,6 mg/kg
38700 063397-60-4 Bis(2-carbobutoxyethyl)tin-bis(isooctyl
mercaptoacetate)SML = 18 mg/kg
38800 032687-78-8 N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphe-
nyl)propionyl)hydrazideSML = 15 mg/kg
38820 026741-53-7 Bis(2,4-di-tert-butylphenyl) pentaerythritol
diphosphiteSML = 0,6 mg/kg
39060 035958-30-6 1,1-Bis(2-hydroxy-3,5-di-tert-butylpheny-
l)ethaneSML = 5 mg/kg
39090 — N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine SML(T) = 1,2 mg/kg (13)
39120 — N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine
hydrochloridesSML(T) = 1,2 mg/kg (13)
expressed as Tertiary amine
(expressed excluding HCl)
40000 000991-84-4 2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-
di-tert-butylanilino)-1,3,5-triazineSML = 30 mg/kg
40020 110553-27-0 2,4-Bis(octylthiomethyl)-6-methylphenol SML = 6 mg/kg
40160 061269-61-2 N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)-
hexamethylenediamine-1,2-dibromoethane,
copolymerSML = 2,4 mg/kg
40800 013003-12-8 4,4'-Butylidene-bis(6-tert-butyl-3-methyl-
phenyl-ditridecyl phosphite)SML = 6 mg/kg
40980 019664-95-0 Butyric acid, manganese salt SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
42000 063438-80-2 (2-Carbobutoxyethyl)tin-tris(isooctyl
mercaptoacetate)SML = 30 mg/kg
42400 010377-37-4 Carbonic acid, lithium salt SML(T) = 0,6 mg/kg (8)
(expressed as Lithium)2002L0072 — EN — 02.02.2004 — 001.001 — 41
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
42480 000584-09-8 Carbonic acid, rubidium salt SML = 12 mg/kg
43600 004080-31-3 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaada-
mantane chlorideSML = 0,3 mg/kg
43680 000075-45-6 Chlorodifluoromethane SML = 6 mg/kg and in
compliance with the specifi-
cations laid down in Annex
V
44960 011104-61-3 Cobalt oxide SML(T) = 0,05 mg/kg (14)
(expressed as Cobalt)
45440 — Cresols, butylated, styrenated SML = 12 mg/kg
45650 006197-30-4 2-Cyano-3,3-diphenylacrylic acid, 2-ethyl-
hexyl esterSML = 0,05 mg/kg
46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol QMA = 4,8 mg/6 dm2
47600 084030-61-5 Di-n-dodecyltin bis(isooctyl mercaptoace-
tate)SML = 12 mg/kg
48640 000131-56-6 2,4-Dihydroxybenzophenone SML(T) = 6 mg/kg (15)
48800 000097-23-4 2,2'-Dihydroxy-5,5'-dichlorodiphenyl-
methaneSML = 12 mg/kg
48880 000131-53-3 2,2'-Dihydroxy-4-methoxybenzophenone SML(T) = 6 mg/kg (15)
49600 026636-01-1 Dimethyltin bis(isooctyl mercaptoacetate) SML(T) = 0,18 mg/kg (16)
(expressed as Tin)
49840 002500-88-1 Dioctadecyl disulphide SML = 3 mg/kg
50160 — Di-n-octyltin bis(n-alkyl(C10-C16) mercap-
toacetate)SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50240 010039-33-5 Di-n-octyltin bis(2-ethylhexyl maleate) SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50320 015571-58-1 Di-n-octyltin bis(2-ethylhexyl mercaptoa-
cetate)SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50360 — Di-n-octyltin bis(ethyl maleate) SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50400 033568-99-9 Di-n-octyltin bis(isooctyl maleate) SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50480 026401-97-8 Di-n-octyltin bis(isooctyl mercaptoacetate) SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50560 — Di-n-octyltin 1,4-butanediol bis(mercaptoa-
cetate)SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50640 003648-18-8 Di-n-octyltin dilaurate SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50720 015571-60-5 Di-n-octyltin dimaleate SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50800 — Di-n-octyltin dimaleate, esterified SML(T) = 0,04 mg/kg (17)
(expressed as Tin)2002L0072 — EN — 02.02.2004 — 001.001 — 42
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
50880 — Di-n-octyltin dimaleate, polymers (n = 2-4) SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
50960 069226-44-4 Di-n-octyltin ethyleneglycol bis(mercaptoa-
cetate)SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
51040 015535-79-2 Di-n-octyltin mercaptoacetate SML(T) = 0,04 mg/kg (17)
(expressed as Tin)
51120 — Di-n-octyltin thiobenzoate 2-ethylhexyl
mercaptoacetateSML(T) = 0,04 mg/kg (17)
(expressed as Tin)
51570 000127-63-9 Diphenyl sulphone SML(T) = 3 mg/kg (25)
51680 000102-08-9 N,N'-diphenylthiourea SML = 3 mg/kg
52000 027176-87-0 Dodecylbenzenesulphonic acid SML = 30 mg/kg52320 052047-59-3 2-(4-Dodecylphenyl)indole SML = 0,06 mg/kg
52880 023676-09-7 4-Ethoxybenzoic acid, ethyl ester SML = 3,6 mg/kg
53200 023949-66-8 2-Ethoxy-2'-ethyloxanilide SML = 30 mg/kg58960 000057-09-0 Hexadecyltrimethylammonium bromide SML = 6 mg/kg
59120 023128-74-7 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-
4-hydroxyphenyl)propionamide)SML = 45 mg/kg
59200 035074-77-2 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-
4-hydroxyphenyl)propionate)SML = 6 mg/kg
60320 070321-86-7 2-[2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)-
phenyl]benzotriazoleSML = 1,5 mg/kg
60400 003896-11-5 2-(2'-Hydroxy-3'-tert-butyl-5'-methyl-
phenyl)-5-chlorobenzotriazoleSML(T) = 30 mg/kg (
19)
60800 065447-77-0 1-(2-Hydroxyethyl)-4-hydroxy-2,2,6,6-
tetramethyl piperidine-succinic acid,
dimethyl ester, copolymerSML = 30 mg/kg
61280 003293-97-8 2-Hydroxy-4-n-hexyloxybenzophenone SML(T) = 6 mg/kg (15)
61360 000131-57-7 2-Hydroxy-4-methoxybenzophenone SML(T) = 6 mg/kg (15)
61440 002440-22-4 2-(2'-Hydroxy-5'-methylphenyl)benzotria-
zoleSML(T) = 30 mg/kg (19)
61600 001843-05-6 2-Hydroxy-4-n-octyloxybenzophenone SML(T) = 6 mg/kg (15)
63200 051877-53-3 Lactic acid, manganese salt SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
64320 010377-51-2 Lithium iodide SML(T) = 1 mg/kg (11)
(expressed as Iodine) and
SML(T) = 0,6 mg/kg (8)
(expressed as Lithium)
65120 007773-01-5 Manganese chloride SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
65200 012626-88-9 Manganese hydroxide SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)2002L0072 — EN — 02.02.2004 — 001.001 — 43
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
65280 010043-84-2 Manganese hypophosphite SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
65360 011129-60-5 Manganese oxide SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
65440 — Manganese pyrophosphite SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
66360 085209-91-2 2,2'-Methylene bis(4,6-di-tert-butylphenyl)
sodium phosphateSML = 5 mg/kg
66400 000088-24-4 2,2'-Methylene bis(4-ethyl-6-tert-butyl-
phenol)SML(T) = 1,5 mg/kg (20)
66480 000119-47-1 2,2'-Methylene bis(4-methyl-6-tert-butyl-
phenol)SML(T) = 1,5 mg/kg (20)
67360 067649-65-4 Mono-n-dodecyltin tris(isooctyl mercaptoa-
cetate)SML = 24 mg/kg
67520 054849-38-6 Monomethyltin tris(isooctyl mercaptoace-
tate)SML(T) = 0,18 mg/kg (16)
(expressed as Tin)
67600 — Mono-n-octyltin tris(alkyl(C10-C16) mercap-
toacetate)SML(T) = 1,2 mg/kg (18)
(expressed as Tin)
67680 027107-89-7 Mono-n-octyltin tris(2-ethylhexyl mercap-
toacetate)SML(T) = 1,2 mg/kg (18)
(expressed as Tin)
67760 026401-86-5 Mono-n-octyltin tris(isooctyl mercaptoace-
tate)SML(T) = 1,2 mg/kg (18)
(expressed as Tin)
68078 027253-31-2 Neodecanoic acid, cobalt salt SML(T) = 0,05 mg/kg
(expressed as Neodecanoic
acid) and SML(T) = 0,05 mg/
kg (14) (expressed as Cobalt).
Not for use in polymers
contacting foods for which
simulant D is laid down in
Directive 85/572/EEC.
68320 002082-79-3 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxy-
phenyl)propionateSML = 6 mg/kg
68400 010094-45-8 Octadecylerucamide SML = 5 mg/kg
68860 004724-48-5 n-Octylphosphonic acid SML = 0,05 mg/kg69840 016260-09-6 Oleylpalmitamide SML = 5 mg/kg72160 000948-65-2 2-Phenylindole SML = 15 mg/kg
72800 001241-94-7 Phosphoric acid, diphenyl 2-ethylhexyl
esterSML = 2,4 mg/kg
73040 013763-32-1 Phosphoric acid, lithium salts SML(T) = 0,6 mg/kg (
8)
(expressed as Lithium)
73120 010124-54-6 Phosphoric acid, manganese salt SML(T) = 0,6 mg/kg (10)
(expressed as Manganese)
74400 — Phosphorous acid, tris(nonyl-and/or dino-
nylphenyl) esterSML = 30 mg/kg
77440 — Polyethyleneglycol diricinoleate SML = 42 mg/kg2002L0072 — EN — 02.02.2004 — 001.001 — 44
▼C1
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
77520 061791-12-6 Polyethyleneglycol ester of castor oil SML = 42 mg/kg
78320 009004-97-1 Polyethyleneglycol monoricinoleate SML = 42 mg/kg
81200 071878-19-8 Poly[6-[(1,1,3,3-tetramethylbutyl)amino]-
1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetra-
methyl-4-piperidyl)-imino]hexamethy-
lene[(2,2,6,6-tetramethyl-4-piperidyl)
imino]SML = 3 mg/kg
81680 007681-11-0 Potassium iodide SML(T) = 1 mg/kg (11)
(expressed as Iodium)
82020 019019-51-3 Propionic acid, cobalt salt SML(T) = 0,05 mg/kg (14)
(expressed as Cobalt)
83595 119345-01-6 Reaction product of di-tert-butylphospho-
nite with biphenyl, obtained by condensa-
tion of 2,4-di-tert-butylphenol with Friedel
Craft reaction product of phosphorous
trichloride and biphenylSML = 18 mg/kg and in
compliance with the specifi-
cations mentioned in Annex
V.
83700 000141-22-0 Ricinoleic acid SML = 42 mg/kg
84800 000087-18-3 Salicylic acid, 4-tert-butylphenyl ester SML = 12 mg/kg
84880 000119-36-8 Salicylic acid, methyl ester SML = 30 mg/kg
85760 012068-40-5 Silicic acid, lithium aluminium salt(2:1:1) SML(T) = 0,6 mg/kg (8)
(expressed as Lithium)
85920 012627-14-4 Silicic acid, lithium salt SML(T) = 0,6 mg/kg (8)
(expressed as Lithium)
86800 007681-82-5 Sodium iodide SML(T) = 1 mg/kg (11)
(expressed as Iodine)
86880 — Sodium monoalkyl dialkylphenoxybenze-
nedisulphonateSML = 9 mg/kg
89170 013586-84-0 Stearic acid, cobalt salt SML(T) = 0,05 mg/kg (14)
(expressed as Cobalt)
92000 007727-43-7 Sulphuric acid, barium salt SML(T) = 1 mg/kg (12)
(expressed as Barium)
92320 — Tetradecyl-polyethyleneglycol(EO=3-8)
ether of glycolic acidSML = 15 mg/kg
92560 038613-77-3 Tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-
biphenylylene diphosphoniteSML = 18 mg/kg
92800 000096-69-5 4,4'-Thiobis(6-terc-butyl-3-methylphenol) SML = 0,48 mg/kg
92880 041484-35-9 Thiodiethanol bis(3-(3,5-di-tert-butyl-4-
hydroxy phenyl) propionate)SML = 2,4 mg/kg
93120 000123-28-4 Thiodipropionic acid, didodecyl ester SML(T) = 5 mg/kg (21)
93280 000693-36-7 Thiodipropionic acid, dioctadecyl ester SML(T) = 5 mg/kg (21)
94560 000122-20-3 Triisopropanolamine SML = 5 mg/kg
95000 028931-67-1 Trimethylolpropane trimethacrylate-methyl
methacrylate copolymer2002L0072 — EN — 02.02.2004 — 001.001 — 45
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Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
95280 040601-76-1 1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-
dimethylbenzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trioneSML = 6 mg/kg
95360 027676-62-6 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxy-
benzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-
trioneSML = 5 mg/kg
95600 001843-03-4 1,1,3-Tris(2-methyl-4-hydroxy-5-tert-butyl-
phenyl) butaneSML = 5 mg/kg2002L0072 — EN — 02.02.2004 — 001.001 — 46
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ANNEX IV
PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION
Ref.
NoCAS No NameRestrictions and/or specifica-
tions
(1) (2) (3) (4)
18888 080181-31-3 3-Hydroxybutanoic acid-3-hydroxypenta-
noic acid, copolymerSML = 0,05 mg/kg for
Crotonic acid (as impurity)
and in compliance with the
specifications laid down in
Annex V2002L0072 — EN — 02.02.2004 — 001.001 — 47
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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
ofAlcaligenes 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 microscopically and for
any changes in colonial morphology on a variety of agars at
different temperatures.The copolymers are isolated from heat
treatment bacteria by controlled digestion of the other cellular
components, washing and drying.These copolymers are
normally offered as formulated, melt formed granules
containing additives such as nucleating agents, plasticisers,
fillers, stabilisers and pigments which all conform to the
general and individual specifications.
Chemical name Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
CAS number 080181-31-3
Structural formula
where n/(m + n) greater than 0 and less or equal to 0,25
Average molecular weight Not less than 150 000 Daltons (measured by gel permeation
chromotography).
Assay Not less than 98 % poly(3-D-hydroxybutanoate-co-3-D-
hydroxypentanoate) analysed after hydrolysis as a mixture of
3-D-hydroxybutanoic and 3-D-hydroxypentanoic acids.
Description White to off-white powder after isolation
Characteristics
Identification tests:
Solubility Soluble in chlorinated hydrocarbons such as chloroform or
dichloromethane but practically insoluble in ethanol, aliphatic
alkanes and water.
Migration The migration of crotonic acid should not exceed 0,05 mg/kg
food.2002L0072 — EN — 02.02.2004 — 001.001 — 48
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Ref.No OTHER SPECIFICATIONS
Purity Prior to granulation the raw material copolymer powder must
contain:
— Nitrogen Not more than 2 500 mg/kg of plastic
— Zinc Not more than 100 mg/kg of plastic
— Copper Not more than 5 mg/kg of plastic
— Lead Not more than 2 mg/kg of plastic— Arsenic Not more than 1 mg/kg of plastic
— Chromium Not more than 1 mg/kg of plastic
23547 Polydimethylsiloxane (Mw > 6 800)
Minimum viscosity 100 × 10
–6m2/s (= 100 centistokes) at 25 ºC
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 ′-(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
Molecular unit = (C8H18S3Sn2)n (n = 1,5-2)
76721 Polydimethylsiloxane (Mw > 6 800)
Minimum viscosity 100 × 10–6m2/s (= 100 centistokes) at 25 ºC
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′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 38613-77-
3) (36-46 % w/w (*)),
— 4,3′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 118421-
00-4 (17-23 % w/w (*)),
— 3,3′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 118421-
01-5) (1-5 % w/w (*)),
— 4-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS.No 91362-37-7) (11-
19 % w/w (*)),
— Tris(2,4-di-tert-butylphenyl)phosphite (CAS.No 31570-04-4) (9-18 % w/w (*)),— 4,4′-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butyl-
phenyl)phosphonite (CAS.No 112949-97-0) (< 5 % w/w (*)).
Other specifications:
— Phosphor content of min.5,4 % to max.5,9 %
— Acid value of max.10 mg KOH per gram— Melt range of 85-110 ºC
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
–6m2/s (= 11 centistokes) at 100 ºC
— Average molecular weight not less than 500.
95883 White mineral oils, paraffinic derived from petroleum based hydrocarbon feedstocks2002L0072 — EN — 02.02.2004 — 001.001 — 49
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Ref.No OTHER SPECIFICATIONS
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 × 10–6m2/s (= 8,5 centistokes) at 100 ºC
— Average molecular weight not less than 480
(*) Quantity of substance used /quantity of formulation2002L0072 — EN — 02.02.2004 — 001.001 — 50
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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 67760.2002L0072 — EN — 02.02.2004 — 001.001 — 51
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(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 specificcase 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.
(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 25270.2002L0072 — EN — 02.02.2004 — 001.001 — 52
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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))
DirectiveDeadlines
For transposi-
tionTo permit trade
in those
products which
comply with
this DirectiveTo prohibit
trade in those
products which
do not comply
with this Direc-
tive
90/128/EEC (OJ L 349,
13.12.1990, p. 26)31 December
19901 January
19911 January 1993
92/39/EEC (OJ L 168,
23.6.1992, p. 21)31 December
199231 March
19941 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
19971 January
19971 January 1999
1999/91/EC (OJ L 310,
4.12.1999, p. 41)31 December
20001 January
20021 January 2003
2001/62/EC (OJ L 221,
17.8.2001, p. 18)30 November
20021 December
20021 December
2002
2002/17/EC (OJ L 58,
28.2.2002, p. 19)28 February
20031 March 2003 1 March 2004
1 March 2003
for materials
and articles
which containDivinylbenzene2002L0072 — EN — 02.02.2004 — 001.001 — 53
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ANNEX VIII
CORRELATION TABLE
Directive 90/128/EEC This Directive
Article 1 Article 1
Article 2 Article 2Article 3 Article 3
Article 3a Article 4
Article 3b Article 5
Article 3c Article 6
Article 4 Article 7
Article 5 Article 8
Article 6 Article 9
- Article 10
- Article 11
- Article 12
ANNEX I ANNEX I
ANNEX II ANNEX II
ANNEX III ANNEX III
ANNEX IV ANNEX IV
ANNEX V ANNEX V
ANNEX VI ANNEX VI
- ANNEX VII- ANNEX VIII2002L0072 — EN — 02.02.2004 — 001.001 — 54