1990L0128 — EN — 06.09.2001 — 003.001 — 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
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
►M6 Commission Directive 2001/62/EC of 9 August 2001 L 221 18 17.8.2001
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)
▼B
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 to
materials 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 tofoodstuffs in quantities which could endanger human health or bring
about 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 withinthe meaning of Article 3 of Directive 89/109/EEC, the generalprovisions 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 therefore
the substances which are currently used in at least one Member State can
continue to be used pending a decision on inclusion in the Communitylist; whereas this Directive will accordingly be extended in due course tothe 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 the
foodstuffs, and, moreover, reduces the need for a large number of
specific migration limits or other restrictions, thus giving effectivecontrol;
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 — 06.09.2001 — 003.001 — 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.▼C1
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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 intocontact 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 articles
which 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 of
adhesives or by any other means,
which, in the finished product state, are intended to come into contact or
are brought into contact with foodstuffs and are intended for thatpurpose.
3. For the purposes of this Directive, ‘plastics’ shall mean the organic
macromolecular compounds obtained by polymerisation, polycondensa-tion, polyaddition or any other similar process from molecules with alower molecular weight or by chemical alteration of natural macro-
moles. Other substances or matter may be added to such
macromolecular compounds.
However, the following shall not be regarded as ‘plastics’:
(i) varnished or unvarnished regenerated cellulose film, covered by
Commission Directive 93/10/EEC (
5);
(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;
(v) ion-exchange resins;
(vi) silicones.1990L0128 — EN — 06.09.2001 — 003.001 — 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 L 93, 17.4.1993, p. 27.▼M6
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4. This Directive shall not apply, until further action by the
Commission, to materials and articles composed of two or more layers,one or more of which does not consist exclusively of plastics, even if the
one intended to come into direct contact with foodstuffs does consist
exclusively of plastics.
Article 2
Plastics materials and articles shall not transfer their constituents to
foodstuffs in quantities exceeding 10 milligrams per square decimetre ofsurface 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 toArticle 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. Only those monomers and other starting substances listed in Annex
II, Section A, shall be used for the manufacture of plastic materials and
articles, subject to the restrictions specified therein.
By way of derogation from the first subparagraph, the monomers and
other starting substances listed in Annex II, Section B, may continue tobe used until 31 December 2004 at the latest, pending their evaluation
by the Scientific Committee on Food.
5. 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 polymerised products in
liquid, powder or dispersion form, such as varnishes, lacquers,
paints, etc.,
— epoxy resins,— adhesives and adhesion promoters,— printing inks.
Article 3a
An incomplete list of additives which may be used for the manufacture
of plastic materials and articles, together with restrictions and/orspecifications 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 complianceis carried out in simulant D or in test media of substitute tests as laiddown in Directives 82/711/EEC and 85/572/EEC.1990L0128 — EN — 06.09.2001 — 003.001 — 4
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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. General specifications related to plastics 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.
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 expressthem 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 beestablished 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 limitof migration.
4. The verification of compliance with the specific migration limits
provided for in paragraph 1 may be ensured by the determination of thequantity of a substance in the finished material or article provided that arelationship between that quantity and the value of the specific
migration of the substance has been established either by an adequate
experimentation or by the application of generally recognised diffusionmodels based on scientific evidence. To demonstrate the non-compliance of a material or article, confirmation of the estimatedmigration value by experimental testing is obligatory.
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.1990L0128 — EN — 06.09.2001 — 003.001 — 5
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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 not
later than 31 December 1990. They shall forthwith inform the
Commission thereof.
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 — 06.09.2001 — 003.001 — 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 perlitre 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:
M¼ m: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/EECusing 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.1990L0128 — EN — 06.09.2001 — 003.001 — 7
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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 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,
— 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 migration determined shall not exceed the overall migration
limit.1990L0128 — EN — 06.09.2001 — 003.001 — 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 — 06.09.2001 — 003.001 — 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 perfor-
mance 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 ‘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 — 06.09.2001 — 003.001 — 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’
11530 00999-61-1 Acrylic acid, 2-hydroxy-
propyl esterQMA = 0,05 mg/6 dm2
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 ester
11980 000925-60-0 Acrylic acid, propyl ester
12100 000107-13-1 Acrylonitrile SML = not detectable (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. For use only
as comonomer
12280 002035-75-8 Adipic anhydride12310 Albumin1990L0128 — EN — 06.09.2001 — 003.001 — 11
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PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
12340 Albumin, coagulated by
formaldehyde
12375 Alcohols aliphatic, mono-
hydric, saturated, linear,
primary (C4-C22)
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
12763 00141-43-5 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 84434-12-8 N-(2-aminoethyl)-beta-
alanine, sodium saltSML = 0,05 mg/kg
12788 002432-99-7 11-Aminoundecanoic acid ►M2SML = 5 mg/kg ◄
12789 007664-41-7 Ammonia12820 000123-99-9 Azelaic acid
12970 004196-95-6 Azelaic anhydride
13000 001477-55-0 1,3-Benzenedimethanamine SML = 0,05 mg/kg
13060 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
13395 04767-03-7 2,2-Bis(hydroxymethyl)pro-
pionic acidQMA = 0,05 mg/6 dm2
13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)-
propaneSML = 3 mg/kg1990L0128 — EN — 06.09.2001 — 003.001 — 12
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▼C1
▼M5
▼C1
▼M5
▼C1
▼M6
▼C1
▼C1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
13510 01675-54-3 2,2-Bis(4-hydroxyphenyl)-
propane bis(2,3-
epoxypropyl) ether
(= BADGE)According to Commission Direc-
tive 2001/61/EC of 8 August 2001
on the use of certain epoxy deri-
vatives in materials and articles
intended to come into contact with
foodstuffs (OJ L 215, 9.8.2001, p.
26).
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’
13610 01675-54-3 Bisphenol A bis(2,3-epoxy-
propyl) etherSee ‘2,2-Bis(4-hydroxyphenyl)pro-
pane bis(2,3-epoxypropyl) ether’
13614 038103-06-9 Bisphenol A bis(phthalic
anhydride)See 13530
13617 00080-09-1 Bisphenol S See ‘4,4 ′-Dihydroxydiphenylsul-
phone’
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)
13810 00505-65-7 1,4-Butanediol formal QMA = 0,05 mg/6 dm2
13840 000071-36-3 1-Butanol
13870 000106-98-9 1-Butene
13900 000107-01-7 2-Butene
13932 00598-32-3 3-Buten-2-ol QMA = ND (DL = 0,02 mg/6 dm2)
To be used only as a co-monomer
for the preparation of polmeric
additive
14020 000098-54-4 4-tert-Butylphenol SML = 0,05 mg/kg14110 000123-72-8 Butyraldehyde
14140 000107-92-6 Butyric acid
14170 000106-31-0 Butyric anhydride
14200 0105-60-2 Caprolactam SML(T) = 15 mg/kg (
5)
14230 02123-24-2 Caprolactam, sodium salt SML(T) = 15 mg/kg (5) (expressed
as caprolactam)1990L0128 — EN — 06.09.2001 — 003.001 — 13
▼M6
▼C1
▼M1
▼C1
▼M6
▼M1
▼M6
▼C1
▼M5
▼M6
▼C1
▼M6
▼M5
▼C1
▼M6
▼M6
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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)
15030 00931-88-4 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/kg
15095 000334-48-5 Decanoic acid15100 000112-30-1 1-Decanol
000107-15-3 1,2-Diaminoethane See ‘Ethylenediamine’000124-09-4 1,6-Diaminohexane See ‘Hexamethylenediamine’
15130 000872-05-9 1-Decene SML = 0,05 mg/kg
15250 000110-60-1 1,4-Diaminobutane15370 03236-53-1 1,6-Diamino-2,2,4-trimethyl-
hexaneQMA = 5 mg/6 dm
2
15400 03236-54-2 1,6-Diamino-2,4,4-trimethyl-
hexaneQMA = 5 mg/6 dm2
15565 000106-46-7 1,4-Dichlorobenzene SML = 12 mg/kg
15610 00080-07-9 4,4 ′-Dichlorodiphenyl
sulphoneSML = 0,05 mg/kg
15700 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) ◄1990L0128 — EN — 06.09.2001 — 003.001 — 14
▼C1
▼M3
▼C1
▼M5
▼C1
▼M5
▼C1
▼M6
▼M3
▼M2
▼C1
▼M5
▼M1
▼M6
▼M2
▼M6
▼C1
▼C1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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 00611-99-4 4,4 ′-Dihydroxybenzophe-
noneSML(T) = 6 mg/kg (15)
16000 000092-88-6 4,4 ′-Dihydroxydiphenyl SML = 6 mg/kg
16090 00080-09-1 4,4 ′-Dihydroxydiphenyl
sulphoneSML = 0,05 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
16390 00126-30-7 2,2-Dimethyl-1,3-propane-
diolSML = 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 — 06.09.2001 — 003.001 — 15
▼M2
▼C1
▼M6
▼C1
▼M6
▼C1
▼M5
▼M6
▼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, soya17230 061790-12-3 Fatty acids, tall oil
17260 00050-00-0 Formaldehyde SML(T) = 15 mg/kg (
22)
17290 000110-17-8 Fumaric acid
17530 000050-99-7 Glucose18010 000110-94-1 Glutaric acid
18070 000108-55-4 Glutaric anhydride
18100 000056-81-5 Glycerol
18220 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 00100-97-0 Hexamethylenetetramine SML(T) = 15 mg/kg (
22) (expressed
as formaldehyde)
000123-31-9 Hydroquinone See ‘1,4-Dihydroxybenzene’
18820 000592-41-6 1-Hexene SML = 3 mg/kg
18880 000099-96-7 P-Hydroxybenzoic acid
19000 000115-11-7 Isobutene
19060 000109-53-5 Isobutyl vinyl ether QM = 5 mg/kg in FP
19110 04098-71-9 1-Isocyanato-3-isocyanato-
methyl-3,5,5-trimethylcyclo-
hexaneQM(T) = 1 mg/kg in FP (as NCO)
19150 000121-91-5 Isophthalic acid SML = 5 mg/kg
19210 001459-93-4 Isophthalic acid, dimethyl
esterSML = 0,05 mg/kg
19243 00078-79-5 Isoprene Voir ‘2-Methyl-1,3-butadiene’
19270 000097-65-4 Itaconic acid1990L0128 — EN — 06.09.2001 — 003.001 — 16
▼C1
▼M6
▼C1
▼M1
▼C1
▼M5
▼M1
▼C1
▼M1
▼C1
▼M6
▼C1
▼M5
▼C1
▼M5
▼M6
▼M5
▼M2
▼M6
▼M3
▼M3
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
19460 000050-21-5 Lactic acid
19470 000143-07-7 Lauric acid19480 002146-71-6 Lauric acid, vinyl ester19490 00947-04-6 Laurolactam SML = 5 mg/kg
19510 011132-73-3 Lignocellulose
19540 00110-16-7 Maleic acide SML(T) = 30 mg/kg (
4)
19960 00108-31-6 Maleic anhydride SML(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 acid20050 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
20260 00101-43-9 Methacrylic acid, cyclohexyl
esterSML = 0,05 mg/kg
20410 02082-81-7 Methacrylic acid, diester
with 1,4-butanediolSML = 0,05 mg/kg
20530 002867-47-2 Methacrylic acid, 2-
(dimethylamino)ethyl esterSML = ND (DL = 0,02 mg/kg,
analytical tolerance included)
20590 00106-91-2 Methacrylic acid, 2,3-epoxy-
propyl esterQMA = 0,02 mg/6 dm
2
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
ester1990L0128 — EN — 06.09.2001 — 003.001 — 17
▼M4
▼M1
▼M4
▼M6
▼C1
▼M6
▼C1
▼M5
▼C1
▼M5
▼M2
▼C1
▼M6
▼M5
▼M6
▼C1
▼M1
▼M2
▼M2
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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)
21520 01561-92-8 Methallylsulphonic acid,
sodium saltSML = 5 mg/kg
21550 000067-56-1 Methanol
21640 00078-79-5 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-diethylaniline)QMA = 0,05 mg/6 dm2
21821
00505-65-7 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 ►
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 dm2
22350 000544-63-8 Myristic acid
22360 01141-38-4 2,6-Naphthalenedicarboxylic
acidSML = 5 mg/kg
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)
22437 00126-30-7 Neopentylglycol See ‘2,2-Dimethyl-1,3-propane-
diol’
22450 009004-70-0 Nitrocellulose
22480 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-Octanol
22660 000111-66-0 1-Octene SML = 15 mg/kg1990L0128 — EN — 06.09.2001 — 003.001 — 18
▼C1
▼M6
▼C1
▼M6
▼M5
▼M6
▼M1
▼C1
▼M5
▼M1
▼M6
▼M2
▼C1
▼M6
▼C1
▼M5
▼C1
▼C1
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
22763 000112-80-1 Oleic acid
22778 07456-68-0 4,4 ′-Oxybis(benzenesul-
phonyl azide)QMA = 0,05 mg/6 dm2
22780 000057-10-3 Palmitic acid
22840 000115-77-5 Pentaerythritol22870 000071-41-0 1-Pentanol
22900 00109-67-1 1-Pentene SML = 5 mg/kg22937 001623-05-8 Perfluoropropyl perfluoro-
vinyl etherSML = 0,05 mg/kg
22960 000108-95-2 Phenol
23050 00108-45-2 1,3-Phenylenediamine SML = ND (DL = 0,02 mg/kg,
analytical tolerance included)
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 Polypropyleneglycol23740 000057-55-6 1,2-Propanediol23770 000504-63-2 1,3-Propanediol SML = 0,05 mg/kg23800 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)1990L0128 — EN — 06.09.2001 — 003.001 — 19
▼M1
▼M6
▼C1
▼M6
▼M5
▼C1
▼M6
▼C1
▼M5
▼M1
▼C1
▼M5
▼C1
▼M4
▼C1
▼M5
▼C1
▼M5
▼M5
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
23950 000123-62-6 Propionic anhydride
23980 000115-07-1 Propylene24010 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’
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 Rosin
24130 008050-09-7 Rosin gum ►M3See ‘Rosin’ ◄
24160 008052-10-6 Rosin tall oil
24190 009014-63-5 Rosin wood24250 009006-04-6 Rubber, natural
24270 000069-72-7 Salicylic acid
24280 000111-20-6 Sebacic acid
24430 002561-88-8 Sebacic anhydride24475 001313-82-2 Sodium sulphide24490 000050-70-4 Sorbitol
24520 008001-22-7 Soybean oil
24540 009005-25-8 Starch, edible
24550 000057-11-4 Stearic acid
24610 000100-42-5 Styrene
24760 026914-43-2 Styrenesulphonic acid SML = 0,05 mg/kg24820 000110-15-6 Succinic acid
24850 000108-30-5 Succinic anhydride
24880 000057-50-1 Sucrose24887 006362-79-4 5-Sulphoisophthalic acid,
monosodium salt►
M3SML = 5 mg/kg ◄
24888 003965-55-7 5-Sulphoisophthalic acid,
monosodium salt, dimethyl
esterSML = 0,05 mg/kg1990L0128 — EN — 06.09.2001 — 003.001 — 20
▼C1
▼M2
▼C1
▼M6
▼C1
▼M1
▼C1
▼M1
▼M2
▼C1
▼M2
▼C1
▼M5
▼C1
▼M1
▼C1
▼M1
▼M2
▼M2
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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/kg
25150 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) ◄
25380 — Trialkyl acetic acid (C7-
C17), vinyl esters (= vinyl
versatate)QMA = 0,05 mg/6 dm2
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/kg25450 26896-48-0 Tricyclodecanedimethanol SML = 0,05 mg/kg
25510 000112-27-6 Triethyleneglycol
25600 000077-99-6 1,1,1-Trimethylolpropane SML = 6 mg/kg
25900 00110-88-3 Trioxane SML = 0,05 mg/kg25910 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 FP1990L0128 — EN — 06.09.2001 — 003.001 — 21
▼C1
▼M2
▼C1
▼M5
▼C1
▼M2
▼C1
▼M6
▼M5
▼C1
▼M6
▼C1
▼M6
▼M1
▼M5
▼C1
▼M3
▼M5
▼M5
PM/REF No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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 FP
SECTION B
LIST OF MONOMERS AND OTHER STARTING SUBSTANCES WHICH MAY CONTINUE
TO BE USED PENDING A DECISION ON INCLUSION IN SECTION A
Ref. No CAS No Name Restrictions and/or specifications
10599/90A 61788-89-4 Acids, fatty, unsaturated
(C18), dimers, distilled
10599/91 61788-89-4 Acids, fatty, unsaturated
(C18), dimers, non-distilled
10599/92A 68783-41-5 Acids, fatty, unsaturated
(C18), dimers, hydrogenated,
distilled
10599/93 68783-41-5 Acids, fatty, unsaturated
(C18), dimers, hydrogenated,
non-distilled
11500 00103-11-7 Acrylic acid, 2-ethylhexyl
ester
13050 00528-44-9 1,2,4-Benzenetricarboxylic
acidSee ‘Trimellitic acid’
13075 00091-76-9 Benzoguanamine See ‘2,4-Diamino-6-phenyl-1,3,5-
triazine’
13720 00110-63-4 1,4-Butanediol
14260 00502-44-3 Caprolactone
14800 03724-65-0 Crotonic acid
15310 00091-76-9 2,4-Diamino-6-phenyl-1,3,5-
triazine
15730 00077-73-6 Dicyclopentadiene
16210 06864-37-5 3,3 ′-Dimethyl-4-4 ′-diamino-
dicyclohexylmethane
16690 01321-74-0 Divinylbenzene
16697 00693-23-2 Dodecanedioic acid
17110 16219-75-3 5-Ethylidenebicyclo[2.2.1]-
hept-2-ene
18370 00592-45-0 1,4-Hexadiene
18700 00629-11-8 1,6-Hexanediol
21370 10595-80-9 Methacrylic acid, 2-
sulphoethyl ester
21400 54276-35-6 Methacrylic acid, sulpho-
propyl ester
21970 00923-02-4 N-methylolmethacrylamide
22210 00098-83-9 Alpha-methylstyrene
25540 00528-44-9 Trimellitic acid QM(T) = 5 mg/kg in FP
25550 00552-30-7 Trimellitic anhydride QM(T) = 5 mg/kg in FP (expressed
as trimellitic acid)1990L0128 — EN — 06.09.2001 — 003.001 — 22
▼M6
▼M6
Ref. No CAS No Name Restrictions and/or specifications
25840 03290-92-4 1,1,1-Trimethylolpropane
trimethacrylate
26230 00088-12-0 Vinylpyrrolidone1990L0128 — EN — 06.09.2001 — 003.001 — 23
▼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 — 06.09.2001 — 003.001 — 24
▼M5
▼M3
▼M6
SECTION A
Incomplete list of additives fully harmonised at Community level
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 hydroxide1990L0128 — EN — 06.09.2001 — 003.001 — 25
▼M3
▼M5
▼M3
▼M5
▼M3
▼M5
▼M3
▼M5
▼M4
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
34690 011097-59-9 Aluminium magnesium
carbonate hydroxide
34720 001344-28-1 Aluminium oxide
35120 013560-49-1 3-Aminocrotonic acid,
diester with thiobis (2-
hydroxyethyl) ether
35160 06642-31-5 6-Amino-1,3-dimethyluracil SML = 5 mg/kg
35170 00141-43-5 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 00111-41-1 N-(2-aminoethyl)ethanola-
mineSML = 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 012124-97-9 Ammonium bromide
35600 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 stearate
36640 000123-77-3 Azodicarbonamide For use only as a blowing agent36880 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 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-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)1990L0128 — EN — 06.09.2001 — 003.001 — 26
▼M6
▼M3
▼M5
▼M3
▼M5
▼M3
▼M5
▼C2
▼C2
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
38810 080693-00-1 Bis(2,6-di-tert-butyl-4-
methylphenyl)pentaerythritol
diphosphiteSML = 5 mg/kg (sum of phosphite
and phosphate)
38840 154862-43-8 Bis(-2,4-dicumylphenyl)pen-
taerythritoldiphosphiteSML = 5 mg/kg (as sum of the
substance itself, its oxidised form
bis (2,4-dicumylphenyl)pentaery-
thritol-phosphate and its hydrolysis
product (2,4-dicumylphenol)
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 dm2
39890 ►M5
087826-41-3
◄Bis (methylbenzylidene)
sorbitol
►M5
069158-41-4
◄
►M5
054686-97-4
◄
►M5
081541-12-0
◄
39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5
-dimethyl hexaneSML = 0,05 mg/kg
40020 110553-27-0 2,4-Bis(octylthiomethyl)-6-
methylphenolSML = 6 mg/kg
40120
— Bis (polyethyleneglycol)hy-
droxymethylphosphonateSML = 0,6 mg/kg and authorised
until 1 January 2004
40400 010043-11-5 Boron nitride
40570 000106-97-8 Butane
41040 005743-36-2 Calcium butyrate
41120 10043-52-4 Calcium chloride41280 001305-62-0 Calcium hydroxide
41520 001305-78-8 Calcium oxide
41600 012004-14-7 Calcium sulphoaluminate
41680 000076-22-2 Camphor In compliance with note 10 in
Annex VI
037293-22-41990L0128 — EN — 06.09.2001 — 003.001 — 27
▼M5
▼M6
▼M5
▼M3
▼M5
▼C2
▼M3
▼M6
▼M3
▼M6
▼M3
▼M5
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
41760 008006-44-8 Candelilla wax
41840 00105-60-2 Caprolactam SML(T) = 15 mg/kg (5)
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 wax42800 009000-71-9 Casein
42960 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 acid
44640 000077-93-0 Citric acid, triethyl ester
45195 007787-70-4 Copper bromide SML(T) = 30 mg/kg (7) (expressed
as copper)
45200 01335-23-5 Copper iodide SML(T) = 30 mg/kg (7) (expressed
as copper) and SML = 1 mg/kg (11)
(expressed as iodine)
45280 — Cotton fibers
45450 068610-51-5 p-Cresol-dicyclopentadiene-
isobutylene, copolymerSML = 0,05 mg/kg (1)
45560 014464-46-1 Cristobalite
45760 000108-91-8 Cyclohexylamine45920 009000-16-2 Dammar
45940 000334-48-5 n-Decanoic acid
46070 010016-20-3 alpha-Dextrin46080 007585-39-9 beta-Dextrin
46375 061790-53-2 Diatomaceous earth
46380 068855-54-9 Diatomaceous earth, soda ash
flux-calcined1990L0128 — EN — 06.09.2001 — 003.001 — 28
▼M6
▼M3
▼M5
▼C2
▼M3
▼M5
▼M3
▼M5
▼M6
▼M3
▼M5
▼M3
▼M4
▼M4
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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
47210 26427-07-6 Dibutylthiostannoic acid
polymer [= thiobis(butyl-tin
sulphide), polymer]In compliance with the specifica-
tions laid down in Annex V
47440 000461-58-5 Dicyanodiamide
47540 27458-90-8 Di-tert-dodecyl disulfide SML = 0,05 mg/kg
47680 000111-46-6 Diethyleneglycol SML(T) = 30 mg/kg (3)
48460 000075-37-6 1,1-Difluoroethane48620 00123-31-9 1,4-Dihydroxybenzene SML = 0,6 mg/kg
48720 00611-99-4 4,4 ′-Dihydroxybenzophe-
noneSML(T) = 6 mg/kg (
15)
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/kg
51760 025265-71-8 Dipropyleneglycol
000110-98-5
52640 016389-88-1 Dolomite
52645 10436-08-5 Cis-11-eicosenamide
52720 000112-84-5 Erucamide
52730 000112-86-7 Erucic acid
52800 000064-17-5 Ethanol
53270 037205-99-5 Ethylcarboxymethylcellulose53280 009004-57-3 Ethylcellulose53360 000110-31-6 N,N ′-Ethylenebisoleamide1990L0128 — EN — 06.09.2001 — 003.001 — 29
▼M3
▼M5
▼M6
▼M3
▼M6
▼M5
▼C2
▼M5
▼M6
▼M5
▼M3
▼M5
▼C2
▼M3
▼M6
▼M4
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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 Ethylhydroxyethylcellulose
54270 — Ethylhydroxymethylcellulose54280 — 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 acid
55440 009000-70-8 Gelatin
55520 — Glass fibres
55600 — Glass microballs
55680 000110-94-1 Glutaric acid
55920 000056-81-5 Glycerol56020 099880-64-5 Glycerol dibehenate
56360 — Glycerol, esters with acetic
acid
56486 — Glycerol, esters with acids,
aliphatic, saturated, linear,
with an even number of
carbon atoms(C
14-C18) and
with acids, aliphatic, unsatu-
rated, linear, with an even
number of carbon atoms (C16-
C18)
56487 — Glycerol, esters with butyric
acid1990L0128 — EN — 06.09.2001 — 003.001 — 30
▼M5
▼C2
▼M5
▼M3
▼M5
▼M3
▼M5
▼M3
▼M4
▼M3
▼M4
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(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
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 monobehenate56720 026402-23-3 Glycerol monohexanoate56800 030899-62-8 Glycerol monolaurate diace-
tate
56880 026402-26-6 Glycerol monooctanoate57040 — 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 tribehenate57920 000620-67-7 Glycerol triheptanoate
58300 — Glycine, salts58320 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 acid59760 019569-21-2 Huntite
59990 007647-01-0 Hydrochloric acid
60030 012072-90-1 Hydromagnesite60080 012304-65-3 Hydrotalcite1990L0128 — EN — 06.09.2001 — 003.001 — 31
▼M5
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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 03864-99-1 2-(2 ′-Hydroxy-3,5 ′-di-tert-
butylphenyl)-5-chlorobenzo-
triazoleSML(T) = 30 mg/kg (19)
60560 009004-62-0 Hydroxyethylcellulose
60880 009032-42-2 Hydroxyethylmethylcellulose61120 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 Wax62720 001332-58-7 Kaolin
62800 — Kaolin, calcined
62960 000050-21-5 Lactic acid63040 000138-22-7 Lactic acid, butyl ester63280 000143-07-7 Lauric acid63760 008002-43-5 Lecithin63840 000123-76-2 Levulinic acid63920 000557-59-5 Lignoceric acid
64015 000060-33-3 Linoleic acid
64150 028290-79-1 Linolenic acid64500 — Lysine, salts64640 001309-42-8 Magnesium hydroxide64720 001309-48-4 Magnesium oxide
64800 00110-16-7 Maleic acid SML(T) = 30 mg/kg (
4)
65020 006915-15-7 Malic acid
65040 000141-82-2 Malonic acid65520 000087-78-5 Mannitol
65920 66822-60-4 [N-methacryloyloxyethyl-
N,N-dimethyl-N-carboxy-
methylammonium chloride,
sodium salt-octadecyl
methacrylate-ethyl methacry-
late-cyclohexyl methacry-
late-N-vinyl-2-pyrrolidone,
copolymers1990L0128 — EN — 06.09.2001 — 003.001 — 32
▼M6
▼M3
▼M6
▼M3
▼M6
▼M6
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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 wax67891 000544-63-8 Myristic acid68040 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)
68960 000301-02-0 Oleamide1990L0128 — EN — 06.09.2001 — 003.001 — 33
▼M3
▼M5
▼M3
▼M5
▼C2
▼M3
▼M5
▼M3
▼M5
▼M4
▼M4
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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-hydroxy-
phenyl)propionate]
70240 012198-93-5 Ozokerite70400 000057-10-3 Palmitic acid71020 000373-49-9 Palmitoleic acid71440 009000-69-5 Pectin71600 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 Pentane72640 007664-38-2 Phosphoric acid
73160 — Phosphoric acid, mono- and
di-n-alkyl (C16 and C18)
estersSML = 0,05 mg/kg
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
76730 — Polydimethylsiloxane,
gamma-hydroxypropylatedSML = 6 mg/kg
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 Polyethyleneglycol1990L0128 — EN — 06.09.2001 — 003.001 — 34
▼M3
▼M5
▼M3
▼M6
▼M5
▼C2
▼M5
▼M3
▼M5
▼M6
▼C2
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
77600 061788-85-0 Polyethyleneglycol ester of
hydrogenated castor oil
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 Polypropyleneglycol81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetra-
methyl-4-piperidinyl)-n-
butylamino]-1,3,5-triazine-
2,4-diyl][2,2,6,6-tetramethyl-
4-piperidinyl)imino]-1,6-
hexanediyl[2,2,6,6-tetra-
methyl-4-piperidinyl)i-
mino]]-alpha-[N,N,N ′,N′-
tetrabutyl-N ″″-(2,2,6,6-tetra-
methyl-4-piperidinylamino)-
hexyl][1,3,5-triazine-2,4,6-
triamine]-omega-N,N,N ′,N′-
tetrabutyl-1,3,5-triazine-2,4-
diamine]SML = 5 mg/kg
81515 087189-25-1 Poly(zinc glycerolate)
81520 007758-02-3 Potassium bromide
81600 001310-58-3 Potassium hydroxide
81760 — Powders, flakes and fibres of
brass, bronze, copper, 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 alginate1990L0128 — EN — 06.09.2001 — 003.001 — 35
▼M5
▼M3
▼M4
▼M6
▼M5
▼M3
▼M5
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
82240 022788-19-8 1,2-Propyleneglycol dilaurate
82400 000105-62-4 1,2-Propyleneglycol dioleate82560 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-
stearate
83320 — Propylhydroxyethylcellulose83325 — Propylhydroxymethylcellu-
lose
83330 — Propylhydroxypropylcellu-
lose
83440 002466-09-3 Pyrophosphoric acid83455 013445-56-2 Pyrophosphorous acid
83460 012269-78-2 Pyrophyllite
83470 014808-60-7 Quartz
83599 68442-12-6 Reaction products of oleic
acid, 2-mercaptoethyl 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 Rosin84000 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)
85680 01343-98-2 Silicic acid1990L0128 — EN — 06.09.2001 — 003.001 — 36
▼M6
▼M3
▼M5
▼M3
▼M5
▼M6
▼M6
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
85840 53320-86-8 Silicic acid, lithium magne-
sium sodium saltSML(T) = 0,6 mg/kg (8) (expressed
as lithium)
86000 — Silicic acid, silylated
86160 000409-21-2 Silicon carbide86240 007631-86-9 Silicon dioxide
86285 — Silicon dioxide, silanated
86560 007647-15-6 Sodium bromide
86720 001310-73-2 Sodium hydroxide87200 000110-44-1 Sorbic acid87280 029116-98-1 Sorbitan dioleate87520 062568-11-0 Sorbitan monobehenate87600 001338-39-2 Sorbitan monolaurate87680 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 trioleate88160 054140-20-4 Sorbitan tripalmitate88240 026658-19-5 Sorbitan tristearate88320 000050-70-4 Sorbitol88600 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 Stearamide
89040 000057-11-4 Stearic acid
89200 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 isobutyrate91360 000126-14-7 Sucrose octaacetate91840 007704-34-9 Sulphur91920 007664-93-9 Sulphuric acid1990L0128 — EN — 06.09.2001 — 003.001 — 37
▼M3
▼M5
▼M3
▼M5
▼M3
▼M4
▼M3
▼M5
▼M3
▼M3
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
92030 010124-44-4 Sulphuric acid, copper salt SML(T) = 30 mg/kg (7) (expressed
as copper)
92080 014807-96-6 Talc92150 01401-55-4 Tannic acids According to the JECFA specifi-
cations
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
010191-41-0
93680 009000-65-1 Tragacanth gum
93720 00108-78-1 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/kg
95200 001709-70-2 1,3,5-Trimethyl-2,4,6-
tris(3,5-di-tert-butyl-4-hydro-
xybenzyl)benzene
95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl
2-butyl-2-ethyl-1,3-propane-
diol phosphateSML = 2 mg/kg (as sum of
phosphite, phosphate and the
hydrolysis 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/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 V1990L0128 — EN — 06.09.2001 — 003.001 — 38
▼M5
▼M3
▼M6
▼M3
▼M5
▼M3
▼M6
▼M3
▼M5
▼C2
▼M3
▼M6
▼M5
▼M5
PM/Ref No CAS No Name►M5Restrictions and/or
specifications ◄
(1) (2) (3) (4)
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 sulphide
SECTION B
Incomplete list of additives referred to in Article 3a, second paragraph
Ref. No CAS No Name Restrictions and/or specifications
30180 02180-18-9 Acetic acid, manganese salt SML(T) = 0,6 mg/kg (10)
(expressed as manganese)
31520 61167-58-6 Acrylic acid, 2-tert-butyl-6-
(3-tert-butyl-2-hydroxy-5-
methylbenzyl)-4-methyl-
phenyl esterSML = 6 mg/kg
31920 00103-23-1 Adipic acid, bis(2-ethyl-
hexyl) esterSML = 18 mg/kg (1)
34230 — Alkyl(C8-C22)sulphonic
acidsSML = 6 mg/kg
35760 01309-64-4 Antimony trioxide SML = 0,02 mg/kg (expressed as
antimonium and analytical toler-
ance included)
36720 17194-00-2 Barium hydroxide SML(T) = 1 mg/kg (12) (expressed
as barium)
36800 10022-31-8 Barium nitrate SML(T) = 1 mg/kg (12) (expressed
as barium)
38240 00119-61-9 Benzophenone SML = 0,6 mg/kg
38560 07128-64-5 2,5-Bis(5-tert-butyl-2-
benzoxazolyl)thiopheneSML = 0,6 mg/kg
38700 63397-60-4 Bis(2-carbobutoxyethyl)tin-
bis(isooctyl mercaptoacetate)SML = 18 mg/kg
38800 32687-78-8 N,N ′-Bis(3-(3,5-di-tert-butyl-
4-hydroxyphenyl)propionyl)-
hydrazideSML = 15 mg/kg
38820 26741-53-7 Bis(2,4-di-tert-butylphenyl)
pentaerythritol diphosphiteSML = 0,6 mg/kg
39060 35958-30-6 1,1-Bis(2-hydroxy-3,5-di-
tert-butylphenyl)ethaneSML = 5 mg/kg
39090 — N,N-Bis(2-hydroxyethy-
l)alkyl(C8-C18)amineSML(T) = 1,2 mg/kg (13)
39120 — N,N-bis(2-hydroxyethy-
l)alkyl(C8-C18)amine hydro-
chloridesSML(T) = 1,2 mg/kg (13)
(expressed as N,N-bis(2-hydro-
xyethyl)alkyl(C8-C18)amine)
40000 00991-84-4 2,4-Bis(octylmercapto)-6-(4-
hydroxy-3,5-di-tert-butylani-
lino)-1,3,5-triazineSML = 30 mg/kg
40020 110553-27-0 2,4-Bis(octylthiomethyl)-6-
methylphenolSML = 6 mg/kg1990L0128 — EN — 06.09.2001 — 003.001 — 39
▼M3
▼M6
▼M6
Ref. No CAS No Name Restrictions and/or specifications
40160 61269-61-2 N,N ′-bis(2,2,6,6-tetramethyl-
4-piperidyl)hexamethylene-
diamine-1,2-dibromoethane,
copolymerSML = 2,4 mg/kg
40800 13003-12-8 4,4 ′-Butylidene-bis(6-tert-
butyl-3-methylphenyl-ditri-
decyl phosphite)SML = 6 mg/kg
40980 19664-95-0 Butyric acid, manganese salt SML(T) = 0,6 mg/kg (10)
(expressed as manganese)
42000 63438-80-2 (2-Carbobutoxyethyl)tin-
tris(isooctyl mercaptoacetate)SML = 30 mg/kg
42400 10377-37-4 Carbonic acid, lithium salt SML(T) = 0,6 mg/kg (8) (expressed
as lithium)
42480 00584-09-8 Carbonic acid, rubidium salt SML = 12 mg/kg43600 04080-31-3 1-(3-Chloroallyl)-3,5,7-
triaza-1-azoniaadamantane
chlorideSML = 0,3 mg/kg
43680 00075-45-6 Chlorodifluoromethane SML = 6 mg/kg and in compliance
with the specifications laid down
in Annex V
44960 11104-61-3 Cobalt oxide SML(T) = 0,05 mg/kg (
14)
(expressed as cobalt)
45440 — Cresols, butylated, styrenated SML = 12 mg/kg46720 04130-42-1 2,6-Di-tert-butyl-4-ethyl-
phenolQMA = 4,8 mg/6 dm
2
47600 84030-61-5 Di-n-dodecyltin bis(isooctyl
mercaptoacetate)SML = 12 mg/kg
48640 00131-56-6 2,4-Dihydroxybenzophenone SML(T) = 6 mg/kg (15)
48800 00097-23-4 2,2 ′-Dihydroxy-5,5 ′-dichlor-
odiphenylmethaneSML = 12 mg/kg
48880 00131-53-3 2,2 ′-Dihydroxy-4-methoxy-
benzophenoneSML(T) = 6 mg/kg (15)
49600 26636-01-1 Dimethyltin bis(isooctyl
mercaptoacetate)SML(T) = 0,18 mg/kg (16)
(expressed as tin)
49840 02500-88-1 Dioctadecyl disulphide SML = 3 mg/kg50160 — Di-n-octyltin bis(n-
alkyl(C10-C16) mercapto
acetate)SML(T) = 0,04 mg/kg (
17)
(expressed as tin)
50240 10039-33-5 Di-n-octyltin bis(2-ethyl-
hexyl maleate)SML(T) = 0,04 mg/kg (17)
(expressed as tin)
50320 15571-58-1 Di-n-octyltin bis(2-ethyl-
hexyl mercaptoacetate)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 33568-99-9 Di-n-octyltin bis(isooctyl
maleate)SML(T) = 0,04 mg/kg (17)
(expressed as tin)
50480 26401-97-8 Di-n-octyltin bis(isooctyl
mercaptoacetate)SML(T) = 0,04 mg/kg (17)
(expressed as tin)
50560 — Di-n-octyltin 1,4-butanediol
bis(mercaptoacetate)SML(T) = 0,04 mg/kg (17)
(expressed as tin)
50640 03648-18-8 Di-n-octyltin dilaurate SML(T) = 0,04 mg/kg (17)
(expressed as tin)
50720 15571-60-5 Di-n-octyltin dimaleate SML(T) = 0,04 mg/kg (17)
(expressed as tin)
50800 — Di-n-octylin dimaleate,
esterifiedSML(T) = 0,04 mg/kg (17)
(expressed as tin)
50880 — Di-n-octyltin dimaleate,
polymers (n = 2-4)SML(T) = 0,04 mg/kg (17)
(expressed as tin)1990L0128 — EN — 06.09.2001 — 003.001 — 40
▼M6
Ref. No CAS No Name Restrictions and/or specifications
50960 69226-44-4 Di-n-octyltin ethyleneglycol
bis(mercaptoacetate)SML(T) = 0,04 mg/kg (17)
(expressed as tin)
51040 15535-79-2 Di-n-octyltin mercaptoace-
tateSML(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 00127-63-9 Diphenyl sulphone SML = 3 mg/kg
51680 00102-08-9 N,N ′-diphenylthiourea SML = 3 mg/kg
52000 27176-87-0 Dodecylbenzenesulphonic
acidSML = 30 mg/kg
52320 52047-59-3 2-(4-Dodecylphenyl)indole SML = 0,06 mg/kg
52880 23676-09-7 4-Ethoxybenzoic acid, ethyl
esterSML = 3,6 mg/kg
53200 23949-66-8 2-Ethoxy-2 ′-ethyloxanilide SML = 30 mg/kg
58960 00057-09-0 Hexadecyltrimethylammo-
nium bromideSML = 6 mg/kg
59120 23128-74-7 1,6-Hexamethylene-bis(3-
(3,5-di-tert-butyl-4-hydroxy-
phenyl)propionamide)SML = 45 mg/kg
59200 35074-77-2 1,6-Hexamethylene-bis(3-
(3,5-di-tert-butyl-4-hydroxy-
phenyl)propionate)SML = 6 mg/kg
60320 70321-86-7 2-(2-Hydroxy-3,5-bis(1,1-
dimethylbenzyl)phenyl)ben-
zotriazoleSML = 1,5 mg/kg
60400 03896-11-5 2-(2 ′-Hydroxy-3 ′-tert-butyl-
5′-methylphenyl)-5-chloro-
benzotriazoleSML(T) = 30 mg/kg (19)
60800 65447-77-0 1-(2-Hydroxyethyl)-4-
hydroxy-2,2,6,6-tetramethyl
piperidine-succinic acid,
dimethyl ester, copolymerSML = 30 mg/kg
61280 03293-97-8 2-Hydroxy-4-n-hexyloxyben-
zophenoneSML(T) = 6 mg/kg (15)
61360 00131-57-7 2-Hydroxy-4-methoxybenzo-
phenoneSML(T) = 6 mg/kg (15)
61440 02440-22-4 2-(2-Hydroxy-5-methylphe-
nyl)benzotriazoleSML(T) = 30 mg/kg (19)
61600 01843-05-6 2-Hydroxy-4-n-octyloxyben-
zophenoneSML(T) = 6 mg/kg (15)
63200 51877-53-3 Lactic acid, manganese salt SML(T) = 0,6 mg/kg (10)
(expressed as manganese)
64320 10377-51-2 Lithium iodide SML(T) = 1 mg/kg (11) (expressed
as iodium) and SML(T) = 0,6 mg/
kg (8) (expressed as lithium)
65120 07773-01-5 Manganese chloride SML(T) = 0,6 mg/kg (10)
(expressed as manganese)
65200 12626-88-9 Manganese hydroxide SML(T) = 0,6 mg/kg (10)
(expressed as manganese)
65280 10043-84-2 Manganese hypophosphite SML(T) = 0,6 mg/kg (10)
(expressed as manganese)
65360 11129-60-5 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 85209-91-2 2-2 ′-Methylene bis(4,6-di-
tert-butylphenyl)sodium
phosphateSML = 5 mg/kg
66400 00088-24-4 2,2 ′-Methylenebis(4-ethyl-6-
tert-butylphenol)SML(T) = 1,5 mg/kg (20)1990L0128 — EN — 06.09.2001 — 003.001 — 41
▼M6
Ref. No CAS No Name Restrictions and/or specifications
66480 00119-47-1 2,2 ′-Methylenebis(4-methyl-
6-tert-butylphenol)SML(T) = 1,5 mg/kg (20)
67360 67649-65-4 Mono-n-dodecyltin tris(i-
sooctyl mercaptoacetate)SML = 24 mg/kg
67520 54849-38-6 Monomethyltin tris(isooctyl
mercaptoacetate)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 27107-89-7 Mono-n-octyltin tris(2-ethyl-
hexyl mercaptoacetate)SML(T) = 1,2 mg/kg (18)
(expressed as tin)
67760 26401-86-5 Mono-n-octyltin tris(isooctyl
mercaptoacetate)SML(T) = 1,2 mg/kg (18)
(expressed as tin)
68078 27253-31-2 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 02082-79-3 Octadecyl 3-(3,5-di-tert-
butyl-4-hydroxylphenyl)pro-
pionateSML = 6 mg/kg
68400 10094-45-8 Octadecylerucamide SML = 5 mg/kg
69840 16260-09-6 Oleylpalmitamide SML = 5 mg/kg72160 00948-65-2 2-Phenylindole SML = 15 mg/kg72800 01241-94-7 Phosphoric acid, diphenyl 2-
ethylhexyl esterSML = 2,4 mg/kg
73040 13763-32-1 Phosphoric acid, lithium salts SML(T) = 0,6 mg/kg (
8) (expressed
as lithium)
73120 10124-54-6 Phosphoric acid, manganese
saltSML(T) = 0,6 mg/kg (10)
(expressed as manganese)
74400 — Phosphorous acid, tris(nonyl-
and/or dimonylphenyl) esterSML = 30 mg/kg
77440 — Polyethyleneglycol dirici-
noleateSML = 42 mg/kg
77520 61791-12-6 Polyethyleneglycol ester of
castor oilSML = 42 mg/kg
78320 09004-97-1 Polyethyleneglycol monori-
cinoleateSML = 42 mg/kg
81200 71878-19-8 Poly[6-[(1,1,3,3-tetramethyl-
butyl)amino]-1,3,5-triazine-
2,4-diyl][(2,2,6,6-tetra-
methyl-4-piperidyl)imino]-
hexamethylene[(2,2,6,6-tetra-
methyl-4-piperidyl)imino]SML = 3 mg/kg
81680 07681-11-0 Potassium iodide SML(T) = 1 mg/kg (11) (expressed
as iodium)
82020 19019-51-3 Propionic acid, cobalt salt SML(T) = 0,05 mg/kg (14)
(expressed as cobalt)
83595 119345-01-6 Reaction product of di-tert-
butylphosphonite with
biphenyl, obtained by
condensation of 2,4-di-tert-
butylphenol with friedel craft
reaction product of phos-
phorus trichloride and
biphenylSML = 18 mg/kg and in compli-
ance with the specifications
mentioned in Annex V
83700 00141-22-0 Ricinoleic acid SML = 42 mg/kg
84800 00087-18-3 Salicylic acid, 4-tert-butyl-
phenyl esterSML = 12 mg/kg1990L0128 — EN — 06.09.2001 — 003.001 — 42
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Ref. No CAS No Name Restrictions and/or specifications
84880 00119-36-8 Salicylic acid, methyl ester SML = 30 mg/kg
85760 12068-40-5 Silicic acid, lithium alumi-
nium salt (2:1:1)SML(T) = 0,6 mg/kg (8) (expressed
as lithium)
85920 12627-14-4 Silicic, acid, lithium salt SML(T) = 0,6 mg/kg (8) (expressed
as lithium)
86800 07681-82-5 Sodium iodide SML(T) = 1 mg/kg (11) (expressed
as iodium)
86880 — Sodium monoalkyl dialkyl-
phenoxybenzenedisulphonateSML = 9 mg/kg
89170 13586-84-0 Stearic acid, cobalt salt SML(T) = 0,05 mg/kg (14)
(expressed as cobalt)
92000 07727-43-7 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 38613-77-3 Tetrakis(2,4-di-tert-butyl-
phenyl)-4-4 ′-biphenylylene
diphosphoniteSML = 18 mg/kg
92800 00096-69-5 4,4 ′-Thiobis(6-tert-butyl-3-
methylphenol)SML = 0,48 mg/kg
92880 41484-35-9 Thiodiethanol bis(3-(3-5-di-
tert-butyl-4-hydroxyphenyl)-
propionate)SML = 2,4 mg/kg
93120 00123-28-4 Thiodipropionic acid, dido-
decyl esterSML(T) = 5 mg/kg (21)
93280 00693-36-7 Thiodipropionic acid, diocta-
decyl esterSML(T) = 5 mg/kg (21)
94560 00122-20-3 Triisopropanolamine SML = 5 mg/kg
95280 40601-76-1 1,3,5-Tris(4-tert-butyl-3-
hydroxy-2,6-dimethyl-
benzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trioneSML = 6 mg/kg
95360 27676-62-6 1,3,5-Tris(3,5-di-tert-butyl-4-
hydroxybenzyl)-1,3,5-tria-
zine-2,4,6-(1H,3H,5H)-trioneSML = 5 mg/kg
95600 01843-03-4 1,1,3-Tris(2-methyl-4-
hydroxy-5-tert-butylphenyl)-
butaneSML = 5 mg/kg1990L0128 — EN — 06.09.2001 — 003.001 — 43
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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 — 06.09.2001 — 003.001 — 44
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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
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.1990L0128 — EN — 06.09.2001 — 003.001 — 45
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PM/Ref No Other specifications
— Migration The migration of crotonic acid should not exceed
0,05 mg/kg food.
— 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 PHOSPHORUS 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 (1))
— 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[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-
butylphenyl)phosphonite
(CAS No 112949-97-0) < 5 % w/w)
Other specifications
— Phosphor content of minimum 5,4 % to 5,9 %
— Acid value of maximum 10 mg KOH per gram— Melt range of 85-110 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 ºC1990L0128 — EN — 06.09.2001 — 003.001 — 46
▼M6
▼C2
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▼M5
▼M5
PM/Ref No Other specifications
— 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 480
(1) Quantity of substance used/quantity of formulation.1990L0128 — EN — 06.09.2001 — 003.001 — 47
▼M6
▼M6
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 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 PM/
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 PM/
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 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 levels of the following substances mentioned as
PM/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
PM/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
PM/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
PM/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
PM/REF Nos: 36720, 36800 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
PM/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
PM/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
PM/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
PM/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
PM/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
PM/REF Nos: 67600, 67680 and 67760.1990L0128 — EN — 06.09.2001 — 003.001 — 48
▼M6
(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
PM/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
PM/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
PM/REF Nos: 93120 and 93280.
(22) SML(T) in this specific case means that the restriction shall not be exceeded
by the sum of the migration levels of the following substances mentioned as
PM/REF Nos: 17260 and 18670.1990L0128 — EN — 06.09.2001 — 003.001 — 49