1990L0128 — EN — 24.12.1999 — 002.002 — 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
of 23 February 1990
relating to plastics materials and articles intended to come into contact with foodstuffs
(90/128/EEC) ◄
(OJ L 75, 21.3.1990, p. 19)
Amended by:
Official Journal
No page date
►M1 Commission Directive 92/39/EEC of 14 May 1992 L 168 21 23.6.1992
►M2 Commission Directive 93/9/EEC of 15 March 1993 L 90 26 14.4.1993
►M3 Commission Directive 95/3/EC of 14 February 1995 L 41 44 23.2.1995
►M4 Commission Directive 96/11/EC of 5 March 1996 L 61 26 12.3.1996
►M5 Commission Directive 1999/91/EC of 23 November 1999 L 310 41 4.12.1999
Corrected by:
►C1 Corrigendum, OJ L 349, 13.12.1990, p. 26 (90/128/EEC)
►C2 Corrigendum, OJ L 249, 4.10.2000, p. 26 (1999/91/EC)
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COMMISSION DIRECTIVE
of 23 February 1990
relating to plastics materials and articles intended to come into
contact with foodstuffs
(90/128/EEC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
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,
Whereas Article 2 of Directive 89/109/EEC lays down that materials and
articles, in their finished state, must not transfer their constituents to
foodstuffs in quantities which could endanger human health or bringabout an unacceptable change in the composition of the foodstuffs;
Whereas, in order to achieve this objective in the case of plastics
materials and articles, a suitable instrument is a specific Directive within
the meaning of Article 3 of Directive 89/109/EEC, the general
provisions of which are also applicable to the case in question;
Whereas the scope of this Directive must coincide with that of Council
Directive 82/711/EEC (
2);
Whereas since the rules established in this Directive are not suitable for
ion-exchange resins, these materials and articles will be covered by a
subsequent specific Directive;
Whereas the establishment of a list of approved substances accompanied
by a limit on overall migration and, where necessary, by other specificrestrictions will be sufficient to achieve the objective laid down inArticle 2 of Directive 89/109/EEC;
Whereas the stage reached in the work at Community level does not yet
permit adoption of a complete list of the authorized substancesapplicable to all types of plastics materials and articles and thereforethe substances which are currently used in at least one Member State cancontinue to be used pending a decision on inclusion in the Community
list; whereas this Directive will accordingly be extended in due course to
the substances and sectors provisionally excluded;
Whereas the overall migration limit is a measure of the inertness of the
material and prevents an unacceptable change in the composition of thefoodstuffs, and, moreover, reduces the need for a large number of
specific migration limits or other restrictions, thus giving effective
control;
Whereas Directive 82/711/EEC lays down the basic rules necessary for
testing migration of the constituents of plastics materials and articles andCouncil Directive 85/572/EEC (
3) establishes the list of simulants to be
used in the migration tests;1990L0128 — EN — 24.12.1999 — 002.002 — 2
(1) OJ No L 40, 11. 2. 1989, p. 38.
(2) OJ No L 297, 23. 10. 1982, p. 26.
(3) OJ No L 372, 31. 12. 1985, p. 14.
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Whereas Council Directive 78/142/EEC (1) lays down limits for the
quantity of vinyl chloride present in plastics materials and articlesprepared with this substance and for the quantity of vinyl chloride
released by these materials and articles, and Commission Directives 80/
766/EEC (
2) and 81/432/EEC (3) establish the Community methods of
analysis for controlling these limits;
Whereas Commission Directive 80/590/EEC (4) determines the symbol
that may accompany any material and article intended to come into
contact with foodstuffs;
Whereas in view of potential liability, there is a need for the written
declaration provided for in Article 6 (5) of Directive 89/109/EECwhenever professional use is made of plastics materials and articleswhich are not by their nature clearly intended for food use;
Whereas, in accordance with Article 3 of Directive 89/109/EEC, the
Scientific Committee for Food has been consulted on the provisions
liable to affect public health;
Whereas the measures provided for in this Directive are in accordance
with the opinion of the Standing Committee on Foodstuffs,
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 plastics 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 that
purpose.
3. For the purposes of this Directive, ‘plastics’ shall mean the organic
macromolecular compounds obtained by polymerization, polycondensa-tion, polyaddition or any other similar process from molecules with alower molecular weight or by chemical alteration of natural macro-
molecules. Silicones and other similar macromolecular compounds shall
also be regarded as plastics. Other substances or matter may be added tosuch macromolecular compounds.
However, the following shall not be regarded as ‘plastics’:
(i) varnished or unvarnished regenerated cellulose film, covered by
Council Directive 83/229/EEC (
5), as amended by Directive 86/388/
EEC (6);
(ii) elastomers and natural and synthetic rubber;
(iii) paper and paperboard, whether modified or not by the addition of
plastics;
(iv) surface coatings obtained from:
— paraffin waxes, including synthetic paraffin waxes, and/or
micro-crystalline waxes,
— mixtures of the waxes listed in the first indent with each other
and/or with plastics;1990L0128 — EN — 24.12.1999 — 002.002 — 3
(1) OJ No L 44, 15. 2. 1978, p. 15.
(2) OJ No L 213, 16. 8. 1980, p. 42.
(3) OJ No L 167, 24. 6. 1981, p. 6.
(4) OJ No L 151, 19. 6. 1980, p. 21.
(5) OJ No L 123, 11. 5. 1983, p. 31.
(6) OJ No L 228, 14. 8. 1986, p. 32.
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(v) ion-exchange resins.
4. This Directive shall not apply, until further action by the
Commission, to materials and articles composed of two or more layers,
one or more of which does not consist exclusively of plastics, even if theone intended to come into direct contact with foodstuffs does consistexclusively of plastics.
Article 2
Plastics materials and articles shall not transfer their constituents to
foodstuffs in quantities exceeding 10 milligrams per square decimetre of
surface area of material or article (mg/dm
2) (overall migration limit).
However, this limit shall be 60 milligrams of the constituents releasedper 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
estimate 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 of plasticsmaterials and articles subject to the restrictions specified.
2. From the date of notification of this Directive, 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.
3. From the date of notification of this Directive no Member State
shall authorize any new substance for use within its territory exceptunder the procedure in Article 4 of Directive 89/109/EEC.
4. As from 1 January 2002, only those monomers and other starting
substances listed in Annex II, Section A, shall be used for themanufacture of plastic materials and articles, subject to the restrictionsspecified therein. However, the substances listed in Annex II, Section B,
may be deleted before the abovementioned date if the data requested for
inclusion in Section A are not supplied in time to permit their evaluationby the Scientific Committee for Food.
5. However the lists appearing in Annex II, Sections A and B do not
yet include monomers and other starting substances used only in themanufacture of:
— surface coatings obtained from resinous or polymerized products in
liquid, powder or dispersion form, such as varnishes, lacquers,paints, etc.,
— silicones,— epoxy resins,
— adhesives and adhesion promoters,— printing inks.1990L0128 — EN — 24.12.1999 — 002.002 — 4
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Article 3a
An incomplete list of additives which may be used for the manufacture
of plastic materials and articles, together with the restrictions on theiruse, is set out in Annex III.
Article 3b
Only the products obtained by means of bacterial fermentation listed in
Annex IV may be used in contact with foodstuffs.
Article 3c
1. The specifications relating to some substances appearing in
Annexes II, III and IV are laid down in Annex V.
2. The meaning of the numbers between brackets appearing in the
Column ‘Restrictions and/or specifications’ is explained in Annex VI.
Article 4
The specific migration limits in the list set out in Annex II are expressed
in mg/kg. However, such limits are expressed in mg/dm
2in 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 areaof such materials and the quantity of foodstuff in contact therewith.
In these cases, the limits set out in Annex II, expressed in mg/kg shall be
divided by the conventional conversion factor of 6 in order to express
them in mg/dm
2.
Article 5
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 Annex I.
2. The verification of compliance with the specific migration limits
provided for in paragraph 1 shall not be compulsory, if it can be
established that compliance with the overall migration limit laid down inArticle 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 beestablished that, by assuming complete migration of the residualsubstance in the material or article, it cannot exceed the specific limit
of migration.
Article 6
1. At the marketing stages other than the retail stages, the plastics
materials and articles which are intended to be placed in contact withfoodstuffs shall be accompanied by a written declaration in accordancewith Article 6 (5) of Directive 89/109/EEC.
2. Paragraph 1 does not apply to plastics materials and articles which
by their nature are clearly intended to come into contact with foodstuffs.
Article 7
1. The Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive notlater than 31 December 1990. They shall forthwith inform theCommission thereof.1990L0128 — EN — 24.12.1999 — 002.002 — 5
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2. Member States shall:
— permit the trade in and use of plastics materials and articles
complying with this Directive before 1 January 1991,
— prohibit trade in and use of plastics materials and articles intended to
come into contact with foodstuffs and which do not comply with thisDirective as from 1 January 1993.
Article 8
This Directive is addressed to the Member States.1990L0128 — EN — 24.12.1999 — 002.002 — 6
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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:a2
a1:q:1 000
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 5 of the present Directive,
the sample of the material or article is placed in contact with the foodstuff or
appropriate simulant for a period and at a temperature which are chosen by
reference to the contact conditions in actual use, in accordance with the rules
laid down in Directives 82/711/EEC and 85/572/EEC. At the end of the
prescribed time, the analytical determination of the total quantity of substances
(overall migration) and/or the specific quantity of one or more substances
(specific migration) released by the sample is carried out on the foodstuff or
simulant.
5. Where a material or article is intended to come into repeated contact with
foodstuffs, the migration test(s) shall be carried out three times on a single
sample in accordance with the conditions laid down in Directive 82/711/EEC
using another sample of the food or simulant(s) on each occasion. Its
compliance shall be checked on the basis of the level of the migration found in
the third test. However, if there is conclusive proof that the level of the
migration does not increase in the second and third tests and if the migration
limit(s) is (are) not exceeded on the first test, no further test is necessary.
Special provisions relating to overall migration
6. If the aqueous simulants specified in Directives 82/711/EEC and 85/572/EEC
are used, the analytical determination of the total quantity of substances1990L0128 — EN — 24.12.1999 — 002.002 — 7
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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 determined
quantitatively. The quantity of simulant found is subtracted from the weight of
the sample measured after contact with the simulant. The difference between
the initial and corrected final weights represents the overall migration of the
sample examined.
Where a material or article is intended to come into repeated contact with
foodstuffs and it is technically impossible to carry out the test described in
paragraph 5, modifications to that test are acceptable, provided that they
enable the level of migration occurring during the third test to be determined.
One of these possible modifications is described below.
The test is carried out on three identical samples of the material or article. One
of these shall be subjected to the appropriate test and the overall migration
determined (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—M2do 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,
— 6 mg/kg or 1 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 migration determined shall not exceed the overall migration
limit.1990L0128 — EN — 24.12.1999 — 002.002 — 8
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ANNEX II
LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH
MAY BE USED IN THE MANUFACTURE OF PLASTIC MATERIALS
AND ARTICLES
General introduction
1. This Annex contains the list of monomers or other starting substances. The list
includes:
— substances undergoing polymerization, which includes polycondensation,
polyaddition or any other similar process, to manufacture macromolecules,
— natural or synthetic macromolecular substances used in the manufacture of
modified macromolecules, if the monomers or the other starting substances
required to synthesize 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 authorized acids, phenols or alcohols which are also authorized.
However, names containing ‘… acid(s), salts’ appear in the lists if the
corresponding free acid(s) is (are) not mentioned. In such cases, the meaning
of the term ‘salts’ is ‘salts of aluminium, ammonium, calcium, iron,
magnesium, potassium, sodium and zinc’.
3. The list 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
synthesize them are included in the list;
(c) mixtures of the authorized substances.
The materials and articles which contain the substance indicated under (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 ►
M3as regards the purity
criteria ◄.
5. The list contains the following information:
— column 1 (PM/REF. No): the EEC packaging material references number
of the substance 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 dm2of 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.1990L0128 — EN — 24.12.1999 — 002.002 — 9
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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;
FP = finished material or article;NCO = isocyanate moiety;
ND = not detectable.
For the purpose of this Directive ‘not detectable’ means that the
substance should not be detected by a validated method of analysis
which should detect it at the detection limit (DL) specified.
If such a method does not currently exist, an analytical method
with appropriate performance characteristics at the detection limit
may be used, pending the development of a validated method.
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 ‘QM (T)’ means that the
maximum permitted quantity of the ‘residual’ substance in the
material or article should be determined by a validated method of
analysis at the specified limit. If such a method does not currently
exist, an analytical method with appropriate performance char-
acteristics at the specified limit may be used, pending the
development of a validated method.
SML = specific migration limit in food or in food simulant, unless it is
specified otherwise.
For the purpose of this Directive ‘SML’ means that the specific
migration of the substance should be determined by a validated
method of analysis at the specified limit. 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 (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 ‘SML (T)’ menas that the specific
migration of the substances should be determined by a validated
method of analysis at the specified limit. 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.1990L0128 — EN — 24.12.1999 — 002.002 — 10
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SECTION A
LIST OF AUTHORIZED MONOMERS AND OTHER STARTING SUBSTANCES
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
10030 000514-10-3 Abietic acid
10060 000075-07-0 Acetaldehyde ►M5SML(T) = 6 mg/kg (2) ◄
10090 000064-19-7 Acetic acid
10120 000108-05-4 Acetic acid, vinyl ester SML = 12 mg/kg
10150 000108-24-7 Acetic anhydride
10210 000074-86-2 Acetylene
10630 000079-06-1 Acrylamide SML = ND (DL = 0,01 mg/kg)10660 015214-89-8 2-Acrylamido-2-methylpro-
panesulphonic acidSML = 0,05 mg/kg
10690 000079-10-7 Acrylic acid
10750 002495-35-4 Acrylic acid, benzyl ester10780 000141-32-2 Acrylic acid n-butyl ester
10810 002998-08-5 Acrylic acid, sec-butyl ester
10840 001663-39-4 Acrylic acid tert-butyl ester
11000 050976-02-8 Acrylic acid, dicyclopenta-
dienyl esterQMA = 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
000818-61-1 Acrylic acid hydroxyethyl
esterSee ‘Acrylic acid, monoester with
ethyleneglycol’
11590 00106-63-8 Acrylic acid, isobutyl ester
11680 000689-12-3 Acrylic acid, isopropyl ester
11710 000096-33-3 Acrylic acid, methyl ester
11830 000818-61-1 Acrylic acid, monoester with
ethyleneglycol
11890 002499-59-4 Acrylic acid, n-octyl ester11980 000925-60-0 Acrylic acid, propyl ester
12100 000107-13-1 Acrylonitrile SML = not detectable (DL
= 0,020 mg/kg, analytical toleranceincluded)
12130 000124-04-9 Adipic acid
12265 004074-90-2 Adipic acid, divinyl ester QM = 5 mg/kg in FP. For use only
as comonomer
12280 002035-75-8 Adipic anhydride12310 Albumin
12340 Albumin, coagulated by
formaldehyde
12375 Alcohols aliphatic, mono-
hydric, saturated, linear,
primary (C4-C22)1990L0128 — EN — 24.12.1999 — 002.002 — 11
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PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
12670 002855-13-2 1-Amino-3-aminomethyl-
3,5,5-trimethylcyclohexaneSML = 6 mg/kg
12761 000693-57-2 12-Aminododecanoic acid SML = 0,05 mg/kg
12788 002432-99-7 11-Aminoundecanoic acid ►M2SML = 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/kg13060 004422-95-1 1,3,5-Benzenetricarboxylic
acid trichlorideQMA = 0,05 mg/6 dm
2(measured
as 1,3,5-benzenetricarboxylic acid)
13090 000065-85-0 Benzoic acid
13150 000100-51-6 Benzyl alcohol
000111-46-6 Bis(2-hydroxyethyl) ether See ‘Diethyleneglycol’
000077-99-6 2,2-Bis(hydroxymethyl)-1-
butanolSee ‘1,1,1-Trimethylolpropane’
13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene
(= norbornene)SML = 0,05 mg/kg
13210 001761-71-3 Bis(4-aminocyclohexyl)-
methaneSML = 0,05 mg/kg
13390 000105-08-8 1,4-Bis(hydroxymethyl)cy-
clohexane
13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)-
propaneSML = 3 mg/kg
13510 001675-54-3 2,2 Bis(4-hydroxyphenyl)-
propane bis(2,3-
epoxypropyl) ether►M5SML(T) = 1 mg/kg (9)
Authorised until 1 January
2005◄
000110-98-5 Bis(hydroxypropyl) ether See ‘Dipropyleneglycol’
005124-30-1 Bis(4-isocyanatocyclohexyl)-
methaneSee ‘Dicyclohexylmethane-4,4 ′-
diisocyanate’
13530 038103-06-9 2,2-Bis(4-hydroxyphenyl)-
propane bis(phthalic
anhydride)SML = 0,05 mg/kg
13600 047465-97-4 3,3-Bis(3-methyl-4-hydroxy-
phenyl)-2-indolinoneSML = 1,8 mg/kg
000080-05-7 Bisphenol A See ‘2,2-Bis(4-hydroxyphenyl)
propane’
001675-54-3 Bisphenol A bis(2,3-epoxy-
propyl) etherSee ‘2,2-Bis(4-hydroxyphenyl)
propane-bis(2,3-epoxypropyl)
ether’
13614 038103-06-9 Bisphenol A bis(phthalic
anhydride)See 135301990L0128 — EN — 24.12.1999 — 002.002 — 12
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▼M1
▼M1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
13630 000106-99-0 Butadiene QM = 1 mg/kg in FP or SML = not
detectable (DL = 0,020 mg/kg,
analytical tolerance included)
13690 000107-88-0 1,3-Butanediol
13780 002425-79-8 1,4-Butanediol bis(2,3-epox-
ypropyl) etherQM = 1 mg/kg in FP (expressed as
epoxy group, molecular
weight = 43)
13840 000071-36-3 1-Butanol
13870 000106-98-9 1-Butene
13900 000107-01-7 2-Butene
14020 000098-54-4 4-tert-Butylphenol SML = 0,05 mg/kg14110 000123-72-8 Butyraldehyde
14140 000107-92-6 Butyric acid14170 000106-31-0 Butyric anhydride
14200 000105-60-2 Caprolactam ►
M5SML(T) = 15 mg/kg (5) ◄
14230 002123-24-2 Caprolactam, sodium salt ►M5SML(T) = 15 mg/kg (5)
(expressed as caprolactam) ◄
14320 000124-07-2 Caprylic acid
14350 000630-08-0 Carbon monoxide14380 000075-44-5 Carbonyl chloride QM = 1 mg/kg in FP
14411 008001-79-4 Castor oil
14500 009004-34-6 Cellulose
14530 007782-50-5 Chlorine
000106-89-8 1-Chloro-2,3-epoxypropane See ‘Epichlorhydrin’
14650 000079-38-9 Chlorotrifluoroethylene QMA = 0,05 mg/6 dm2
14680 000077-92-9 Citric acid
14710 000108-39-4 m-Cresol
14740 000095-48-7 o-Cresol
14770 00106-44-5 p-Cresol
000105-08-8 1,4-Cyclohexanedimethanol See ‘1,4-Bis(hydroxymethyl)cy-
clohexane’
14841 000599-64-4 4-Cumylphenol SML = 0,05 mg/kg
14950 003173-53-3 Cyclohexyl isocyanate QM(T) = 1 mg/kg in FP (expressed
as NCO)
15070 001647-16-1 1,9-Decadiene SML = 0,05 mg/kg15095 000334-48-5 Decanoic acid
15100 000112-30-1 1-Decanol
000107-15-3 1,2-Diaminoethane See ‘Ethylenediamine’
000124-09-4 1,6-Diaminohexane See ‘Hexamethylenediamine’1990L0128 — EN — 24.12.1999 — 002.002 — 13
▼C1
▼M5
▼C1
▼M5
▼C1
▼M3
▼C1
▼M5
▼C1
▼M5
▼C1
▼M3
▼M2
▼C1
▼C1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
15130 000872-05-9 1-Decene SML = 0,05 mg/kg
15250 000110-60-1 1,4-Diaminobutane15565 000106-46-7 1,4-Dichlorobenzene SML = 12 mg/kg15700 005124-30-1 Dicyclohexylmethane-4,4 ′-
diisocyanateQM(T) = 1 mg/kg in FP (expressed
as NCO)
15760 000111-46-6 Diethyleneglycol ►
M5SML(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/kg
15910 000108-46-3 1,3-Dihydroxybenzene SML = 2,4 mg/kg
15940 000123-31-9 1,4-Dihydroxybenzene SML = 0,6 mg/kg
15970 000611-99-4 4,4 ′-Dihydroxybenzophe-
noneSML = 6 mg/kg
16000 000092-88-6 4,4 ′-Dihydroxydiphenyl SML = 6 mg/kg
16150 000108-01-0 Dimethylaminoethanol SML = 18 mg/kg
16240 000091-97-4 3,3 ′-Dimethyl-4,4 ′-diisocya-
natobiphenylQM(T) = 1 mg/kg in FP (expressed
as NCO)
16360 000576-26-1 2,6-Dimethylphenol SML = 0,05 mg/kg
16450 000646-06-0 1,3-Dioxolane SML = 0,05 mg/kg
16480 000126-58-9 Dipentaerythritol
16570 004128-73-8 Diphenyl ether 4,4 ′-diisocya-
nateQM(T) = 1 mg/kg in FP (expressed
as NCO)
16600 005873-54-1 Diphenylmethane 2,4 ′-diiso-
cyanateQM(T) = 1 mg/kg in FP (expressed
as NCO)
16630 000101-68-8 Diphenylmethane 4,4 ′-diiso-
cyanateQM(T) = 1 mg/kg in FP (expressed
as NCO)
16660 000110-98-5 Dipropyleneglycol
16694 013811-50-2 N,N ′-Divinyl-2-imidazolidi-
noneQM = 5 mg/kg in FP
16704 000112-41-4 1-Dodecene SML = 0,05 mg/kg16750 000106-89-8 Epichlorohydrin QM = 1 mg/kg in FP
16780 000064-17-5 Ethanol
16950 000074-85-1 Ethylene
16960 000107-15-3 Ethylenediamine SML = 12 mg/kg
16990 000107-21-1 Ethyleneglycol ►
M5SML(T) = 30 mg/kg (3) ◄
17005 000151-56-4 Ethyleneimine ►M1SML = 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/kg17160 000097-53-0 Eugenol ►
M5SML = ND (DL = 0,02 mg/
kg, analytical tolerance
included) ◄1990L0128 — EN — 24.12.1999 — 002.002 — 14
▼M5
▼M1
▼M2
▼C1
▼M2
▼C1
▼M5
▼C1
▼M5
▼C1
▼M3
▼M2
▼M2
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
17170 061788-47-4 Fatty acids, coco
17200 068308-53-2 Fatty acids, soya
17230 061790-12-3 Fatty acids, tall oil
17260 000050-00-0 Formaldehyde SML = 15 mg/kg
17290 000110-17-8 Fumaric acid
17530 000050-99-7 Glucose
18010 000110-94-1 Glutaric acid
18070 000108-55-4 Glutaric anhydride18100 000056-81-5 Glycerol18220 068564-88-5 N-Heptylaminoundecanoic
acidSML = 0,05 mg/kg (1)
18250 000115-28-6 Hexachloroendomethylenete-
trahydrophthalic acidSML = ND (DL = 0,01 mg/kg)
18280 000115-27-5 Hexachloroendomethylenete-
trahydrophthalic anhydrideSML = ND (DL = 0,01 mg/kg)
18310 036653-82-4 1-Hexadecanol
18430 000116-15-4 Hexafluoropropylene SML = ND (LD = 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 in FP (expressed
as NCO)
18670 000100-97-0 Hexamethylenetetramine ►
M1SML (T) = 15 mg/kg
(expressed as formaldehyde) ◄
000123-31-9 Hydroquinone See ‘1,4-Dihydroxybenzene’
18820 000592-41-6 1-Hexene SML = 3 mg/kg18880 000099-96-7 P-Hydroxybenzoic acid
19000 000115-11-7 Isobutene
19060 000109-53-5 Isobutyl vinyl ether QM = 5 mg/kg in FP
19150 000121-91-5 Isophthalic acid SML = 5 mg/kg
19210 001459-93-4 Isophthalic acid, dimethyl
esterSML = 0,05 mg/kg
19270 000097-65-4 Itaconic acid
19460 000050-21-5 Lactic acid19470 000143-07-7 Lauric acid19480 002146-71-6 Lauric acid, vinyl ester19510 011132-73-3 Lignocellulose
19540 000110-16-7 Maleic acid ►
M5SML(T) = 30 mg/kg (4) ◄1990L0128 — EN — 24.12.1999 — 002.002 — 15
▼C1
▼M1
▼C1
▼M5
▼M1
▼C1
▼M1
▼C1
▼M5
▼C1
▼M5
▼M2
▼M3
▼M4
▼M1
▼M4
▼C1
▼C1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
19960 000108-31-6 Maleic anhydride ►M5SML(T) = 30 mg/kg (4)
(expressed as maleic acid) ◄
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 acid
20050 000096-05-9 Methacrylic acid, allyl ester SML = 0,05 mg/kg20080 002495-37-6 Methacrylic acid, benzyl
ester
20110 000097-88-1 Methacrylic acid, butyl ester
20140 002998-18-7 Methacrylic acid, sec-butyl
ester
20170 000585-07-9 Methacrylic acid, tert-butyl
ester
20530 002867-47-2 Methacrylic acid, 2-
(dimethylamino)ethyl esterSML = ND (DL = 0,02 mg/kg,
analytical tolerance included)
20890 000097-63-2 Methacrylic acid, ethyl ester
21010 000097-86-9 Methacrylic acid, isobutyl
ester
21100 004655-34-9 Methacrylic acid, isopropyl
ester
21130 000080-62-6 Methacrylic acid, methyl
ester
21190 000868-77-9 Methacrylic acid, monoester
with ethyleneglycol
21280 002177-70-0 Methacrylic acid, phenyl
ester
21340 002210-28-8 Methacrylic acid, propyl
ester
21460 000760-93-0 Methacrylic anhydride21490 000126-98-7 Methacrylonitrile SML = non detectable (DL
= 0,020 mg/kg, analytical tolerance
included)
21550 000067-56-1 Methanol
21730 000563-45-1 3-Methyl-1-butene QMA = 0,006 mg/6 dm
2. For use
only in polypropylene.
21940 000924-42-5 N-Methylolacrylamide SML = ND (DL = 0,01 mg/kg)22150 000691-37-2 4-Methyl-1-pentene ►
M1SML = 0,02 mg/kg ◄
22331 025513-64-8 Mixture of (40 % w/w) 1,6-
diamino-2,2,4-trimethyl-
hexane and (60 % w/w) 1,6-
diamino-2,4,4-trimethyl-
hexaneQMA = 5 mg/6 dm21990L0128 — EN — 24.12.1999 — 002.002 — 16
▼M5
▼C1
▼M5
▼M2
▼C1
▼M5
▼C1
▼M1
▼M2
▼C1
▼M5
▼M1
▼C1
▼M5
▼M5
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
22350 000544-63-8 Myristic acid
22390 000840-65-3 2,6-Naphthalenedicarboxylic
acid, dimethyl esterSML = 0,05 mg/kg
22420 003173-72-6 1,5-Napthalene diisocyanate QM(T) = 1 mg/kg in FP (expressed
as NCO)
22450 009004-70-0 Nitrocellulose22480 000143-08-8 1-Nonanol
22550 000498-66-8 Norbornene See ‘Bicyclo[2.2.1]hept-2-ene’22570 000112-96-9 Octadecyl isocyanate QM(T) = 1 mg/kg in FP (expressed
as NCO)
22600 000111-87-5 1-Octanol22660 000111-66-0 1-Octene SML = 15 mg/kg
22763 000112-80-1 Oleic acid22780 000057-10-3 Palmitic acid
22840 000115-77-5 Pentaerythritol22870 000071-41-0 1-Pentanol
22937 001623-05-8 Perfluoropropyl perfluoro-
vinyl etherSML = 0,05 mg/kg
22960 000108-95-2 Phenol
23050 000108-45-2 1,3-Phenylenediamine QM = 1 mg/kg in FP
000075-44-5 Phosgene See ‘Carbonyl chloride’
23170 007664-38-2 Phosphoric acid
Phthalic acid See ‘Terephthalic acid’
23175 000122-52-1 Phosphorous acid, triethyl
esterQM = ND (DL = 1 mg/kg in FP)
23200 000088-99-3 o-Phthalic acid
23230
000131-17-9 Phthalic acid, diallyl ester SML = ND (DL = 0,01 mg/kg)
23380 000085-44-9 Phthalic anhydride
23470 000080-56-8 alpha-Pinene
23500 000127-91-3 beta-Pinene
23547 009016-00-6
063148-62-9Polydimethylsiloxane (MW
> 6800)In compliance with the specifica-
tions laid down in Annex V
23590 025322-68-3 Polyethyleneglycol
23650 025322-69-4 Polypropyleneglycol (Mole-
cular weight greater than
400)
23651 025322-69-4 Polypropyleneglycol
23740 000057-55-6 1,2-Propanediol1990L0128 — EN — 24.12.1999 — 002.002 — 17
▼M1
▼M2
▼C1
▼M5
▼C1
▼M1
▼C1
▼M5
▼C1
▼M5
▼M1
▼C1
▼M5
▼C1
▼M4
▼C1
▼C1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
23770 000504-63-2 1,3-Propanediol SML = 0,05 mg/kg
23800 000071-23-8 1-Propanol
23830 000067-63-0 2-Propanol
23860 000123-38-6 Propionaldehyde
23890 000079-09-4 Propionic acid
23920 000105-38-4 Propionic acid, vinyl ester 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
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
000108-46-3 Resorcinol See ‘1,3-Dihydroxybenzene’
24100 008050-09-7 Rosin24130 008050-09-7 Rosin gum ►
M3See ‘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 acid24430 002561-88-8 Sebacic anhydride
24475 001313-82-2 Sodium sulphide
24490 000050-70-4 Sorbitol
24520 008001-22-7 Soybean oil
24540 009005-25-8 Starch, edible24550 000057-11-4 Stearic acid
24610 000100-42-5 Styrene
24760 026914-43-2 Styrenesulphonic acid SML = 0,05 mg/kg24820 000110-15-6 Succinic acid24850 000108-30-5 Succinic anhydride24880 000057-50-1 Sucrose24887 006362-79-4 5-Sulphoisophthalic acid,
monosodium salt►
M3SML = 5 mg/kg ◄1990L0128 — EN — 24.12.1999 — 002.002 — 18
▼M5
▼C1
▼M5
▼C1
▼M2
▼C1
▼M1
▼C1
▼M1
▼M2
▼C1
▼M2
▼C1
▼M5
▼C1
▼M1
▼C1
▼M1
▼M1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
24888 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 Terephtalic acid dichloride SML(T) = 7,5 mg/kg (expressed as
terephtalic acid)
24970 000120-61-6 Terephthalic acid, dimethyl
ester
25080 001120-36-1 1-Tetradecene SML = 0,05 mg/kg25090 000112-60-7 Tetraethyleneglycol25120 000116-14-3 Tetrafluoroethylene SML = 0,05 mg/kg25150 000109-99-9 Tetrahydrofuran SML = 0,6 mg/kg
25180 000102-60-3 N,N,N ′,N′-Tetrakis(2-hydro-
xypropyl)ethylenediamine
25210 000584-84-9 2,4-Toluene diisocyanate QM(T) = 1 mg/kg in FP (expressed
as NCO)
25240 000091-08-7 2,6-Toluene diisocyanate QM(T) = 1 mg/kg in FP (expressed
as NCO)
25270 026747-90-0 2,4-Toluene diisocyanate
dimerQM(T) = 1 mg/kg in FP (expressed
as NCO)
25360 Trialkyl(C5-C15)acetic acid,
2,3-epoxypropyl ester►
M5QM = 1 mg/kg in FP
(expressed as epoxy group, mole-
cular weight = 43) ◄
25385 000102-70-5 Triallylamine In compliance with the specifica-
tions laid down in Annex V
25420 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML = 30 mg/kg
25510 000112-27-6 Triethyleneglycol
25600 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg
25910 024800-44-0 Tripropyleneglycol25927 027955-94-8 1,1,1-Tris(4-hydroxypheny-
l)ethaneQM = 0,5 mg/kg in FP. For use
only in polycarbonates
25960 000057-13-6 Urea
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 = not
detectable (DL = 0,05 mg/kg)
26140 000075-38-7 Vinylidene fluoride SML = 5 mg/kg26155 001072-63-5 1-Vinylimidazole QM = 5 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/EC
26170
003195-78-6 N-Vinyl-N-methylacetamide QM = 2 mg/kg in FP1990L0128 — EN — 24.12.1999 — 002.002 — 19
▼M2
▼C1
▼M2
▼C1
▼M5
▼C1
▼M2
▼C1
▼M5
▼C1
▼M1
▼M5
▼C1
▼M3
▼M5
▼M5
SECTION B
LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY CONTINUE
TO BE USED PENDING A DECISION ON INCLUSION IN SECTION A
PM/REF No CAS No Name Restrictions
(1) (2) (3) (4)
000542-02-9 Acetoguanamine See ‘2,4-Diamino-6-methyl-1,3,5-
triazine’
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
ester
11530 000999-61-1 Acrylic acid, 2-hydroxy-
propyl ester
12910 001732-10-1 Azelaic acid, dimethyl ester
13030 000528-44-9 1,2,4-Benzenetricarboxylic
acidSee ‘Trimellitic acid’
000091-76-9 Benzoguanamine See ‘2,4-Diamino-6-phenyl-1,3,5-
triazine’
13570 000080-09-1 Bisphenol S See ‘4,4-Dihydroxydiphenyl
sulphone’
13720 000110-63-4 1,4-Butanediol
13810 000505-65-7 1,4-Butanediol formal
13932 000598-32-3 3-Buten-2-ol
14260 000502-44-3 Caprolactone
14470 000115-28-6 Chlorendic acid See ‘Hexachloroendo-methylene-
tetrahydrophthalic acid’
14800 003724-65-0 Crotonic acid
15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5-
triazine
15370 003236-53-1 1,6-Diamino-2,2,4-trimethyl-
hexane1990L0128 — EN — 24.12.1999 — 002.002 — 20
▼C1
▼M2
▼M5
▼C1
▼M5
▼C1
▼M5
▼C1
▼M5
▼C1
▼M1
▼M5
▼C1
▼M5
▼C1
▼C1
PM/REF No CAS No Name Restrictions
(1) (2) (3) (4)
15400 003236-54-2 1,6-Diamino-2,4,4-trimethyl-
hexane
15610 000080-07-9 4,4 ′-Dichlorodiphenyl
sulphone
15730 000077-73-6 Dicyclopentadiene16090 000080-09-1 4,4 ′-Dihydroxydiphenyl
sulphone
16210 006864-37-5 3,3 ′-Dimethyl-4,4 ′-diamino-
dicyclohexylmethane
16390 000126-30-7 2,2-Dimethyl-1,3-propane-
diol
16540 000102-09-0 Diphenyl carbonate
16690 001321-74-0 Divinylbenzene ►M5QM = 1 mg/kg in FP or
SML = ND (DL = 0,02 mg/kg,
analytical tolerance included) ◄
16697 000693-23-2 Dodecanedioic acid
17110 016219-75-3 5-Ethylidenebicyclo[2.2.1]-
hept-2-ene
18370 000592-45-0 1,4-Hexadiene
18441 000085-42-7 Hexahydrophthalic anhy-
dride
18700 000629-11-8 1,6-Hexanediol
19180 000099-63-8 Isophthalic acid dichloride
19240 000078-79-5 Isoprene See ‘2-Methyl-1,3-butadiene’
19490 000947-04-6 Laurolactam
19570 000999-21-3 Maleic acid, diallyl ester
19600 000105-76-0 Maleic acid, dibutyl ester
20260 000101-43-9 Methacrylic acid, cyclohexyl
ester
20380 001189-08-8 Methacrylic acid, diester
with 1,3-butanediol
20410 002082-81-7 Methacrylic acid, diester
with 1,4-butanediol
20440 000097-90-5 Methacrylic acid, diester
with ethyleneglycol1990L0128 — EN — 24.12.1999 — 002.002 — 21
▼M5
▼C1
▼M5
▼C1
▼M1
▼C1
▼M5
▼C1
▼M1
▼C1
▼M5
▼C1
▼M1
▼C1
▼M5
▼C1
▼C1
PM/REF No CAS No Name Restrictions
(1) (2) (3) (4)
20590 000106-91-2 Methacrylic acid, 2,3-epoxy-
propyl ester►M5QM(T) = 5 mg/kg in FP
(expressed as epoxy group, mole-
cular weight = 43) ◄
21370 010595-80-9 Methacrylic acid, 2-
sulphoethyl ester
21400 054276-35-6 Methacrylic acid, sulpho-
propyl ester
21520 001561-92-8 Methallylsulphonic acid,
sodium saltQM = 5 mg/kg in FP
21640 000078-79-5 2-Methyl-1,3-butadiene
21820 000505-65-7 1,4-(Methylenedioxy)butane See ‘1,4-Butanediol formal’
21970 000923-02-4 N-Methylolmethacrylamide22210 000098-83-9 alpha-Methylstyrene22360 001141-38-4 2,6-Naphtalenedicarboxylic
acid
000126-30-7 Neopentylglycol See ‘2,2-Dimethyl-1,3-propane-
diol’
22540 000498-66-8 Norbornene See ‘Bicyclo[2.2.1]hept-2-ene’
22720 000140-66-9 4-tert-Octylphenol ►M5See ‘4-(1,1,3,3-Tetra-
methylbutyl)phenol’ ◄
22900 000109-67-1 1-Pentene
23140 000092-69-3 Phthalic acids See ‘Iso- or o-phthalic acid’
24370 000106-79-6 Sebacic acid, dimethyl ester
25380 Trialkyl (C5-C15) acetic
acid, vinyl ester (= vinyl
versatate)
25390 000101-37-1 Triallyl cyanurate
25450 026896-48-0 Tricyclodecanedimethanol
25540 000528-44-9 Trimellitic acid QM(T) = 5 mg/kg in FP25550 000552-30-7 Trimellitic anhydride QM(T) = 5 mg/kg in FP (expressed
as trimellitic acid)
25810 015625-89-5 1,1,1-Trimethylolpropane
triacrylate
25840 003290-92-4 1,1,1-Trimethylolpropane
trimethacrylate
25900 000110-88-3 Trioxane
000102-71-6 Tris(2-hydroxyethyl)amine See ‘Triethanolamine’1990L0128 — EN — 24.12.1999 — 002.002 — 22
▼M5
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▼M5
▼C1
▼M5
▼C1
▼M5
▼C1
▼M5
▼C1
▼M5
▼M1
▼C1
▼C1
PM/REF No CAS No Name Restrictions
(1) (2) (3) (4)
26230 000088-12-0 Vinylpyrrolidone
26290 000622-97-9 p-Vinyltoluene See ‘ p-Methylstyrene’
26320 000105-67-9 m-Xylenol See ‘2,4-Dimethylphenol’
000526-75-0 o-Xylenol See ‘2,3-Dimethylphenol’
000095-87-4 p-Xylenol See ‘2,5-Dimethylphenol’1990L0128 — EN — 24.12.1999 — 002.002 — 23
▼M5
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▼M1
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▼M3
ANNEX III
INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE
MANUFACTURE OF PLASTICS 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 polymerization
occurs (e.g. emulsifiers, surfactants, buffering agents etc.).
The list does not include the substances which directly influence the formation
of polymers (e.g. the catalytic system).
2. The list does not include the salts (including double salts and acid salts) of
aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and
zinc of the authorized acids, phenols or alcohols which are also authorized.
However, names containing ‘…acid(s), salts’ appear in the lists if the
corresponding free acid(s) is (are) not mentioned. In such cases, the meaning
of the term ‘salts’ is ‘salts of aluminium, ammonium, calcium, iron,
magnesium, potassium, sodium and zinc’.
3. The list does not include the following substances although they may be
present:
(a) substances which could be present in the finished product such as:
— impurities in the substances used,
— reaction intermediates,
— decomposition products;
(b) mixtures of the authorized 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 (PM-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 materil 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 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.1990L0128 — EN — 24.12.1999 — 002.002 — 24
▼M5
▼M3
▼M3
Incomplete list of additives
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(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 anhydride
30295 000067-64-1 Acetone
30370 — Acetylacetic acid, salts
30400 — Acetylated glycerides
30610 — Acids, C2-C24, aliphatic,
linear, monocarboxylic, from
natural oils and fats, and their
mono-, di- and triglycerol
esters (branched fatty acids at
naturally occurring levels are
included)
30612 — Acids, C2-C24, aliphatic,
linear, monocarboxylic,
synthetic, and their mono-,
di- and triglycerol esters
30960 — Acids aliphatic monocar-
boxylic (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-hydroxypheny-
l)ethyl]phenyl esterSML = 5 mg/kg
31730 000124-04-9 Adipic acid
33120 — Alcohols, aliphatic, mono-
hydric, saturated, linear,
primary (C4-C24)
33350 009005-32-7 Alginic acid
33801 — n-Alkyl(C10-C13)benzene-
sulphonic acidSML = 30 mg/kg
34240 — Alkyl(C10-C20)sulphonic
acid,SML = 6 mg/kg. Authorised until 1
January 2002
34281 — Alkyl(C8-C22) sulphoric
acids, linear, primary, with
an even number of carbon
atoms
34475 — Aluminium calcium hydro-
xide phosphite, hydrate
34480 — Aluminium fibers, flakes and
powders
34560 021645-51-2 Aluminium hydroxide
34690 011097-59-9 Aluminium magnesium
carbonate hydroxide1990L0128 — EN — 24.12.1999 — 002.002 — 25
▼M5
▼M3
▼M5
▼M3
▼M5
▼M3
▼M5
▼M4
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
34720 001344-28-1 Aluminium oxide
35120 013560-49-1 3-Aminocrotonic acid,
diester with thiobis (2-
hydroxyethyl) ether
35320 007664-41-7 Ammonia35440 012124-97-9 Ammonium bromide35600 001336-21-6 Ammonium hydroxide35840 000506-30-9 Arachidic acid
35845 007771-44-0 Arachidonic acid
36000 000050-81-7 Ascorbic acid36080 000137-66-6 Ascorbyl palmitate36160 010605-09-1 Ascorbyl stearate
36640 000123-77-3 Azodicarbonamide For use only as a blowing agent
36880 008012-89-3 Beeswax
36960 003061-75-4 Behenamide
37040 000112-85-6 Behenic acid
37280 001302-78-9 Bentonite
37360 000100-52-7 Benzaldehyde In compliance with note 10 in
Annex VI
37600 000065-85-0 Benzoic acid
37680 000136-60-7 Benzoic acid, butyl ester
37840 000093-89-0 Benzoic acid, ethyl ester38080 000093-58-3 Benzoic acid, methyl ester38160 002315-68-6 Benzoic acid, propyl ester
38320 005242-49-9 4-(2-Benzoxazolyl)-4 ′-(5-
methyl-2-benzoxazolyl)stil-
beneIn compliance with the specifica-
tions laid down in Annex V
38510 136504-96-6 1,2-Bis(3-aminopropyl)ethy-
lenediamine, polymer with
N-butyl-2,2,6,6-tetramethyl-
4-piperidinamine and2,4,6-
trichloro-1,3,5-triazineSML = 5 mg/kg
38515 001533-45-5 4,4'-Bis(2-benzoxazolyl)stil-
beneSML = 0,05 mg/kg (1)
38810 080693-00-1 Bis(2,6-di-tert-butyl-4-
methylphenyl)pentaerythritol
diphosphiteSML = 5 mg/kg (sum of phosphite
and phosphate)
38879 135861-56-2 Bis(3,4-dimethylbenzylide-
ne)sorbitol
38950 079072-96-1 Bis (4-ethylbenzylidene)
sorbitol
39200 006200-40-4 Bis(2-hydroxyethyl)-2-
hydroxypropyl-3-(dodecylox-
y)methylammonium chlorideSML = 1,8 mg/kg
39815 182121-12-6 9,9-Bis(methoxymethyl)-
fluoreneQMA = 0,05 mg/6 dm
21990L0128 — EN — 24.12.1999 — 002.002 — 26
▼M5
▼M3
▼M5
▼M3
▼M5
▼C2
▼M5
▼M3
▼M5
▼C2
▼C2
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
39890 ►M5
087826-41-3
◄Bis (methylbenzylidene)
sorbitol
►M5
069158-41-4
◄
►M5
054686-97-4
◄
►M5
081541-12-0
◄
40120 — Bis(polyethyleneglycol)hy-
droxymethylphosphonateSML = 0,6 mg/kg. Authorised until
1 January 2002
40400 010043-11-5 Boron nitride
40570 000106-97-8 Butane
41040 005743-36-2 Calcium butyrate
41280 001305-62-0 Calcium hydroxide41520 001305-78-8 Calcium oxide
41600 012004-14-7 Calcium sulphoaluminate
41680 000076-22-2 Camphor In compliance with note 10 in
Annex VI
037293-22-4
41760 008006-44-8 Candelilla wax
41960 000124-07-2 Caprylic acid
42160 000124-38-9 Carbon dioxide
42320 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 wax
42800 009000-71-9 Casein42960 064147-40-6 Castor oil, dehydrated
43200 — Castor oil, mono- and digly-
cerides
43280 009004-34-6 Cellulose
43300 009004-36-8 Cellulose acetate butyrate43360 068442-85-3 Cellulose, regenerated
43440 008001-75-0 Ceresin
43515 — Chlorides of choline esters of
coconut oil fatty acidsQMA = 0,9 mg/6 dm
2
44160 000077-92-9 Citric acid1990L0128 — EN — 24.12.1999 — 002.002 — 27
▼M3
▼M5
▼M3
▼M5
▼M3
▼M5
▼C2
▼M3
▼M5
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
44640 000077-93-0 Citric acid, triethyl ester
45195 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
(expressed as iodine)
45280 — Cotton fibers45450 068610-51-5 p-Cresol-dicyclopentadiene-
isobutylene, copolymerSML = 0,05 mg/kg (1)
45560 014464-46-1 Cristobalite
45760 000108-91-8 Cyclohexylamine
45920 009000-16-2 Dammar
45940 000334-48-5 n-Decanoic acid
46070 010016-20-3 alpha-Dextrin
46080 007585-39-9 beta-Dextrin
46375 061790-53-2 Diatomaceous earth
46380 068855-54-9 Diatomaceous earth, soda ash
flux-calcined
46480 032647-67-9 Dibenzylidene sorbitol
46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxy-
benzoic acid, 2,4-di-tert-
butylphenyl ester
46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxy-
benzoic acid, hexadecyl ester
46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxy-
benzylphosphonic acid,
dioctadecyl ester
46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxy-
benzyl phosphonic acid,
monoethyl ester, calcium saltSML = 6 mg/kg
47440 000461-58-5 Dicyanodiamide
47680 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3)
48460 000075-37-6 1,1-Difluoroethane
49485 134701-20-5 2,4-Dimethyl-6-(1-methyl-
pentadecyl)phenolSML = 1 mg/kg
49540 000067-68-5 Dimethyl sulphoxide
51200 000126-58-9 Dipentaerythritol
51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-
triazin-2-yl)-5-(hexyloxy)-
phenolSML = 0,05 mg/kg1990L0128 — EN — 24.12.1999 — 002.002 — 28
▼M5
▼M3
▼M5
▼M3
▼M4
▼M3
▼M5
▼M3
▼M5
▼C2
▼M5
▼M3
▼M5
▼C2
▼C2
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
51760 025265-71-8 Dipropyleneglycol
000110-98-5
52640 016389-88-1 Dolomite
52720 000112-84-5 Erucamide52730 000112-86-7 Erucic acid
52800 000064-17-5 Ethanol53270 037205-99-5 Ethylcarboxymethylcellulose53280 009004-57-3 Ethylcellulose
53360 000110-31-6 N,N ′-Ethylenebisoleamide
53440 005518-18-3 N,N ′-Ethylenebispalmita-
mide
53520 000110-30-5 N,N ′-Ethylenebisstearamide
53600 000060-00-4 Ethylenediaminetetraacetic
acid
53610 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 Ethylhydroxyethylcellulose54270 — Ethylhydroxymethylcellulose
54280 — Ethylhydroxypropylcellulose
54300 118337-09-0 2,2 ′Ethylidenebis(4,6-di-tert-
butylphenyl) fluorophospho-
niteSML = 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-hydro-
xynaphthyl-methane)]SML = 0,05 mg/kg
55040 000064-18-6 Formic acid
55120 000110-17-8 Fumaric acid55190 029204-02-2 Gadoleic acid55440 009000-70-8 Gelatin
55520 — Glass fibres
55600 — Glass microballs
55680 000110-94-1 Glutaric acid
55920 000056-81-5 Glycerol
56020 099880-64-5 Glycerol dibehenate1990L0128 — EN — 24.12.1999 — 002.002 — 29
▼M3
▼M4
▼M3
▼M5
▼C2
▼M5
▼M3
▼M5
▼M3
▼M5
▼M3
▼M4
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
56360 — Glycerol, esters with acetic
acid
56486 — Glycerol, esters with acids,
aliphatic, saturated, linear,
with an even number of
carbon atoms(C14-C18) and
with acids, aliphatic, unsatu-
rated, linear, with an even
number of carbon atoms (C16-
C18)
56487 — Glycerol, esters with butyric
acid
56490 — Glycerol, esters with erucic
acid
56495 — Glycerol, esters with 12-
hydroxystearic acid
56500 — Glycerol, esters with lauric
acid
56510 — Glycerol, esters with linoleic
acid
56520 — Glycerol, esters with myristic
acid
56540 — Glycerol, esters with oleic
acid
56550 — Glycerol, esters with palmitic
acid
56565 — Glycerol, esters with nona-
noic acid
56570 — Glycerol, esters with
propionic acid
56580 — Glycerol, esters with ricino-
leic acid
56585 — Glycerol, esters with stearic
acid
56610 030233-64-8 Glycerol monobehenate
56720 026402-23-3 Glycerol monohexanoate
56800 030899-62-8 Glycerol monolaurate diace-
tate
56880 026402-26-6 Glycerol monooctanoate
57040 — Glycerol monooleate, ester
with ascorbic acid
57120 — Glycerol monooleate, ester
with citric acid
57200 — 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 tribehenate
57920 000620-67-7 Glycerol triheptanoate1990L0128 — EN — 24.12.1999 — 002.002 — 30
▼M4
▼M3
▼M5
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
58300 — Glycine, salts
58320 007782-42-5 Graphite58400 009000-30-0 Guar gum58480 009000-01-5 Gum arabic58720 000111-14-8 Heptanoic acid
59360 000142-62-1 Hexanoic acid
59760 019569-21-2 Huntite59990 007647-01-0 Hydrochloric acid60030 012072-90-1 Hydromagnesite60080 012304-65-3 Hydrotalcite
60160 000120-47-8 4-Hydroxybenzoic acid,
ethyl ester
60180 004191-73-5 4-Hydroxybenzoic acid,
isopropyl ester
60200 000099-76-3 4-Hydroxybenzoic acid,
methyl ester
60240 000094-13-3 4-Hydroxybenzoic acid,
propyl ester
60480 003864-99-1 2-(2-Hydroxy-3,5-di-tert-
butyl-phenyl)-5-chlorobenzo-
triazoleSML = 30 mg/kg
60560 009004-62-0 Hydroxyethylcellulose
60880 009032-42-2 Hydroxyethylmethylcellulose
61120 009005-27-0 Hydroxyethyl starch61390 037353-59-6 Hydroxymethylcellulose61680 009004-64-2 Hydroxypropylcellulose61800 009049-76-7 Hydroxypropyl starch
61840 000106-14-9 12-Hydroxystearic acid
62140 006303-21-5 Hypophosphorous acid62240 001332-37-2 Iron oxide62450 000078-78-4 Isopentane62640 008001-39-6 Japan Wax
62720 001332-58-7 Kaolin
62800 — Kaolin, calcined62960 000050-21-5 Lactic acid63040 000138-22-7 Lactic acid, butyl ester63280 000143-07-7 Lauric acid
63760 008002-43-5 Lecithin
63840 000123-76-2 Levulinic acid63920 000557-59-5 Lignoceric acid64015 000060-33-3 Linoleic acid64150 028290-79-1 Linolenic acid
64500 — Lysine, salts
64640 001309-42-8 Magnesium hydroxide64720 001309-48-4 Magnesium oxide1990L0128 — EN — 24.12.1999 — 002.002 — 31
▼M5
▼C2
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
65020 006915-15-7 Malic acid
65040 000141-82-2 Malonic acid
65520 000087-78-5 Mannitol
66200 037206-01-2 Methylcarboxymethylcellu-
lose
66240 009004-67-5 Methylcellulose
66560 004066-02-8 2,2 ′Methylenebis(4-methyl-
6-cyclohexylphenol)SML(T) = 3 mg/kg (6)
66580 000077-62-3 2,2 ′Methylenebis[4-methyl-
6-(1-methylcyclo-hexyl)-
phenol]SML(T) = 3 mg/kg (6)
66640 009004-59-5 Methylethylcellulose
66695 — Methylhydroxymethylcellu-
lose
66700 009004-65-3 Methylhydroxypropylcellu-
lose
66755 002682-20-4 2-Methyl-4-isothiazolin-3-
oneSML = 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-
dimethyphenyl)-2(3H)-
benzofuranone and (0 to
20 %w/w)5,7-di-tert-butyl-3-
(2,3-di-methylphenyl)-2(3H)-
benzofuranoneSML = 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 wax
67891 000544-63-8 Myristic acid
68040 003333-62-8 7-[2-H-Naphto-(1,2-
D)triazol-2-yl]-3-phenylcou-
marin
68125 ►M5
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)1990L0128 — EN — 24.12.1999 — 002.002 — 32
▼M5
▼M3
▼M5
▼C2
▼M3
▼M5
▼M3
▼M5
▼M5
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
68960 000301-02-0 Oleamide
69040 000112-80-1 Oleic acid
69760 000143-28-2 Oleyl alcohol
70000 070331-94-1 2,2 ′-Oxamidobis[ethyl-3-
(3,5-di-tert-butyl-4-hydroxy-
phenyl)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
71680 006683-19-8 Pentaerythritol tetrakis[3-
(3,5-di-tert-butyl-4-hydroxy-
phenyl)propionate]
71720 000109-66-0 Pentane
72640 007664-38-2 Phosphoric acid
73720 0000115-96-8 Phosphoric acid, trichlor-
oethyl esterSML = 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-butylphenyl)ester
74480 000088-99-3 o-Phthalic acid76320 000085-44-9 Phthalic anhydride
76721 009016-00-6
063148-62-9Polydimethylsiloxane (MW
> 6800)In compliance with the specifica-
tions laid down in Annex V
76865 — Polyesters of 1,2-propanediol
and/or 1,3- and 1,4-butane-
diol and/or
polypropyleneglycol with
adipic acid, also end-capped
with acetic acid or fatty acids
C10-C18 or n-octanol and/or
n-decanolSML = 30 mg/kg
76960 025322-68-3 Polyethyleneglycol
77600 061788-85-0 Polyethyleneglycol ester of
hydrogenated castor oil1990L0128 — EN — 24.12.1999 — 002.002 — 33
▼M4
▼M3
▼M5
▼M3
▼M5
▼C2
▼M5
▼M3
▼M5
▼C2
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
77702 — Polyethyleneglycol esters of
aliphatic monocarboxylic
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
monolaureate
79120 009005-65-6 Polyethyleneglycol sorbitan
monooleate
79200 009005-66-7 Polyethyleneglycol sorbitan
monopalmitate
79280 009005-67-8 Polyethyleneglycol sorbitan
monostearate
79360 009005-70-3 Polyethyleneglycol sorbitan
trioleate
79440 009005-71-4 Polyethyleneglycol sorbitan
tristearate
80240 029894-35-7 Polyglycerol ricinoleate
80640 — Polyoxyalkyl(C2-
C4)dimethylpolysiloxane
80720 008017-16-1 Polyphosphoric acids
80800 025322-69-4 Polypropyleneglycol81515 087189-25-1 Poly(zinc glycerolate)81520 007758-02-3 Potassium bromide
81600 001310-58-3 Potassium hydroxide
81760 — Powders, flakes and fibres of
brass, bronze, copper, stain-
less 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 dipalmi-
tate
82720 006182-11-2 1,2-Propyleneglycol distea-
rate
82800 027194-74-7 1,2-Propyleneglycol mono-
laurate
82960 001330-80-9 1,2-Propyleneglycol mono-
oleate
83120 029013-28-3 1,2-Propyleneglycol mono-
palmitate
83300 001323-39-3 1,2-Propyleneglycol mono-
stearate1990L0128 — EN — 24.12.1999 — 002.002 — 34
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▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
83320 — Propylhydroxyethylcellulose
83325 — Propylhydroxymethylcellu-
lose
83330 — Propylhydroxypropylcellu-
lose
83440 002466-09-3 Pyrophosphoric acid
83455 013445-56-2 Pyrophosphorous acid
83460 012269-78-2 Pyrophyllite
83470 014808-60-7 Quartz
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 pentaery-
thritol
84210 065997-06-0 Rosin, hydrogenated
84240 065997-13-9 Rosin, hydrogenated, ester
with glycerol
84320 008050-15-5 Rosin, hydrogenated, ester
with methanol
84400 064365-17-9 Rosin, hydrogenated, ester
with pentaerythritol
84560 009006-04-6 Rubber, natural
84640 000069-72-7 Salicylic acid
85360 000109-43-3 Sebacic acid, dibutyl ester
85600 — Silicates, natural85610 — Silicates, natural, silanated
(with the exception of
asbestos)
85840 053320-86-8 Silicic acid, lithium magne-
sium sodium saltSML(T) = 0,6 mg/kg (8)
(expressed s lithium)
85980 — Silicic acid, salts
86000 — Silicic acid, silylated
86160 000409-21-2 Silicon carbide
86240 007631-86-9 Silicon dioxide
86285 — Silicon dioxide, silanated86560 007647-15-6 Sodium bromide
86720 001310-73-2 Sodium hydroxide
87200 000110-44-1 Sorbic acid
87280 029116-98-1 Sorbitan dioleate
87520 062568-11-0 Sorbitan monobehenate
87600 001338-39-2 Sorbitan monolaurate
87680 001338-43-8 Sorbitan monooleate
87760 026266-57-9 Sorbitan monopalmitate
87840 001338-41-6 Sorbitan monostearate
87920 061752-68-9 Sorbitan tetrastearate1990L0128 — EN — 24.12.1999 — 002.002 — 35
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▼M3
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▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
88080 026266-58-0 Sorbitan trioleate
88160 054140-20-4 Sorbitan tripalmitate88240 026658-19-5 Sorbitan tristearate
88320 000050-70-4 Sorbitol
88600 026836-47-5 Sorbitol monostearate
88640 008013-07-8 Soybean oil, epoxidised In compliance with the specifica-
tins laid down in Annex V
88800 009005-25-8 Starch, edible
88880 068412-29-3 Starch, hydrolysed
88960 000124-26-5 Stearamide89040 000057-11-4 Stearic acid89200 007617-31-4 Stearic acid, copper salt SML(T) = 30 mg/kg (7) (expresed
as copper)
89440 — Stearic acid, esters with
ethyleneglycolSML(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 isobutyrate
91360 000126-14-7 Sucrose octaacetate
91840 007704-34-9 Sulphur91920 007664-93-9 Sulphuric acid
92030 010124-44-4 Sulphuric acid, copper salt SML(T) = 30 mg/kg (7) (expressed
as copper)
92080 014807-96-6 Talc
92160 000087-69-4 Tartaric acid
92195 — Taurine, salts92205 057569-40-1 Terephthalic acid, diester
with 2,2 ′-methylenebis(4-
methyl-6-tert-butylphenol)
92350 000112-60-7 Tetraethyleneglycol
92640 000102-60-3 N,N,N ′,N′-Tetrakis(2-hydro-
xypropyl)ethylenediamine
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-methoxy-
carbonyl-2,6-dimethyl-1,4-
dihydropyri- dine-3-carboxy-
late)SML = 6 mg/kg
93440 013463-67-7 Titanium dioxide
93520 000059-02-9 alpha-Tocopherol
010191-41-01990L0128 — EN — 24.12.1999 — 002.002 — 36
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▼M3
▼M5
▼M3
▼M5
▼M3
▼M5
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
93680 009000-65-1 Tragacanth gum
94320 000112-27-6 Triethyleneglycol
94960 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg
95200 001709-70-2 1,3,5-Trimethyl-2,4,6-
tris(3,5-di-tert-butyl-4-hydro-
xybenzyl)benzene
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/EC
95859 — Waxes, refined, derived from
petroleum based or synthetic
hydrocarbon feedstocksIn compliance with the specifica-
tions laid down in Annex V
95883 — White mineral oils, paraf-
finic, derived from petroleum
based hydrocarbon feed-
stocksIn compliance with the specifica-
tions laid down in Annex V
95905 013983-17-0 Wollastonite
95920 — Wood flour and fibres,
untreated
95935 011138-66-2 Xanthan gum
96190 020427-58-1 Zinc hydroxide
96240 001314-13-2 Zinc oxide
96320 001314-98-3 Zinc sulphide1990L0128 — EN — 24.12.1999 — 002.002 — 37
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ANNEX IV
PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION
PM/REf No CAS No Name Restrictions and/or specifications
(1) (2) (3) (4)
18888 80181-31-3 3-hydroxybutanoic acid-3-
hydro xypentanoic acid,
copolymerSML = 0,05 mg/kg for crotonic
acid (as impurity) and in compli-
ance with the specifications laid
down in Annex IV1990L0128 — EN — 24.12.1999 — 002.002 — 38
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ANNEX V
SPECIFICATIONS
Part A: General specifications
(to be fixed later)
Part B: Other specifications
PM/Ref No Other specifications
18888 3-HYDROXYBUTANOIC ACID-3-HYDROXYPENTANOIC ACID, COPO-
LYMER
Definition These copolymers are produced by the controlled
fermentation of Alcaligenes eutrophus using
mixtures of glucose and propanoic acid as carbon
sources. The organism used has not been geneti-
cally engineered and has been derived from a
single wild-type organism Alcaligenes eutrophus
strain H16 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-hydroxypen-
tanoate)
— CAS No 80181-31-3
— Structural formula
— Average molecular weight Not less than 150 000 daltons (measured by gel
permeation chromatography).
— Assay Not less than 98 % poly(3-D-hydroxybutanoato-
co-3-D-hydroxypentanoate) analysed after hydro-
lysis 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.1990L0128 — EN — 24.12.1999 — 002.002 — 39
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PM/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)
76721 POLYDIMETHYLSILOXANE (Mw > 6 800)
Minimum viscosity 100 × 10–6m2/s (= 100 centistokes at 25 ºC
88640 SOYBEAN OIL, EPOXIDISED
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 FEEDSTOCKS
The product should have the following specifications:
— Content of mineral hydrocarbons with carbon number less than 25: not more than
5 % (w/w)
— Viscosity not less than 8,5 × 10-6m2/s (= 8,5 centistokes) at 100 ºC
— Average molecular weight not less than 4801990L0128 — EN — 24.12.1999 — 002.002 — 40
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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 PM/
REF Nos: 10060 and 23920.
(3) SML(T) in this specific case means that the restriction shall not be exceeded
by the sum of the migration of the following substances mentioned as PM/
REF Nos: 15760, 16990, 47680, 53650, 89440.
(4) SML(T) in this specific case means that the restriction shall not be exceeded
by the sum of the migration of the following substances mentioned as PM/
REF Nos: 19540, 19960.
(5) SML(T) in this specific case means that the restriction shall not be exceeded
by the sum of the migration of the following substances mentioned as PM/
REF Nos: 14200, 14230.
(6) SML(T) in this specific case means that the restriction shall not be exceeded
by the sum of the migration of the following substances mentioned as PM/
REF Nos: 66560 and 66580.
(7) SML(T) in this specific case means that the restriction shall not be exceeded
by the sum of the migration of the following substances mentioned as PM/
REF Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200, 92030.
(8) SML(T) in this specific case means that the restriction shall not be exceeded
by the sum of the migration of the following substances mentioned as PM/
REF Nos: 85840 and 95725.
(9) 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:
(a) Badge (=2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether:
(b) Badge.H2O.
(d) Badge.HCl.
(e) Badge.2HCl
(f) Badge.H2O.HCl
However in aqueous food simulants, the SML(T) should also include
Badge.2H2O (c) unless the material or article is labelled for use in contact
only with those foods and/or beverages for which it has been demonstrated
that the sum of the migration levels of the five abovementioned substances
(a)(b)(d)(e)(f) cannot exceed 1 mg/kg.
(10) 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.1990L0128 — EN — 24.12.1999 — 002.002 — 41