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Document 32024D0367

Commission Implementing Decision (EU) 2024/367 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption

C/2024/237

OJ L, 2024/367, 23.4.2024, ELI: http://data.europa.eu/eli/dec_impl/2024/367/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/dec_impl/2024/367/oj

European flag

Official Journal
of the European Union

EN

L series


2024/367

23.4.2024

COMMISSION IMPLEMENTING DECISION (EU) 2024/367

of 23 January 2024

laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (1), and in particular Article 11(2), point (b), thereof,

Whereas:

(1)

Directive (EU) 2020/2184 provides for the establishment of European positive lists of substances, compositions and constituents for each type of materials, namely organic, cementitious, metallic, enamels, ceramic or other inorganic materials, which are authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption and fall within the scope of Article 11 of that Directive. These European positive lists should include, where appropriate, conditions for the use of substances, compositions and constituents and migration limits, which are to be determined on the basis of the methodologies adopted pursuant to Article 11(2), point (a), of Directive (EU) 2020/2184. Such conditions of use may include a purity criterion, a condition on the physico-chemical characteristics of the starting substance, composition or constituent, a condition on its manufacturing process or on the manufacturing process of final materials, their use for certain products, the use of these products, or further testing requirement. Sacrificial anodes, membranes and ions exchange resins are water treatment chemicals and/or filter media and are covered by Article 12 of Directive (EU) 2020/2184, therefore they are excluded from the scope of Article 11 of that Directive.

(2)

Article 11(3) of the Directive sets out that lists established by the Commission pursuant to Article 5 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (2) should be used as a source to establish the first European positive lists under the Directive. The list established in Annex I to Commission Regulation (EU) No 10/2011 (3) is one of these lists. However, substances included on this list have only been assessed for their use in plastic food contact materials in accordance with Regulation (EU) No 10/2011, subject to specific conditions of use. Moreover, the European Food Safety Authority has indicated that a significant number of the substances should be prioritised for re-evaluation as no specific migration limit was established when they were authorised for use in plastic food contact materials (4). The inclusion of such substances in Annex I to Regulation (EU) No 10/2011 nevertheless provides a much higher level of certainty over their safety in contact with drinking water when used in the manufacture of drinking water products, than would be the case for unlisted substances. Therefore it is appropriate to add substances originating from lists established by the Commission pursuant to Article 5 of Regulation (EC) No 1935/2004 to the first European list under Article 11(3) of the Directive, provided these additions are only used as a starting point for further conformity assessment in accordance with Article 11(8), and provided their re-evaluation by the expiry date set out in the first European positive list takes account of all the conditions and drinking water materials in which they may be used.

(3)

Where applicable, the migration limit, i.e. the maximum tolerable concentration at the tap, should be based on the parametric value set out in Part B or C of Annex I to Directive (EU) 2020/2184 or the specific migration limit set out in Annexes I and II to Regulation (EU) No 10/2011. This should, however, be done after application of an allocation factor to account for the proportion of potential exposure from materials in contact with water intended for human consumption derived from the information provided by Member States.

(4)

Annex I to Regulation (EU) No 10/2011 provides further detail on conditions of use of authorised substances, as well FCM substance reference numbers used in risk assessments. To facilitate further conformity assessment of substances that are added to the first European positive list on the basis of Annex I to Regulation (EU) No 10/2011, it is appropriate to add their FCM reference numbers in the first European positive lists.

(5)

The expiry dates included in the first European positive lists follow the recommendation from European Chemicals Agency (ECHA) in particular on the basis of the hazardous properties of the starting substance, composition or constituent, the quality of the underlying risk assessments, the extent to which those risk assessments are up-to-date and the need for a staggered review of these entries.

(6)

Some entries in the European positive lists should be allowed to be combined, extended to related starting substances, compositions and constituents or extended for use in different material types than the one for which they have been authorised when such combination or extension has no impact on the protection of human health to ensure the proportionality and efficiency of the process.

(7)

Based on notifications from Member States, the first European positive lists include group entries covering multiple starting substances, compositions or constituents. Assessing the safety of each individual starting substance, composition or constituent separately is more appropriate to assess the safety of the groups; however, at the time of adopting the first European positive list it was not possible to identify the starting substances or organic cementitious constituents in those groups. Therefore, group entries should progressively be replaced in the European positive lists by the individual starting substances, compositions or constituents in the group and the economic operator should only be able to rely on such group entries for the first European positive list if it is able to demonstrate the safety of its starting substance, composition or constituent.

(8)

In order to ensure an orderly and efficient application process, an entry may be renewed provided that notification of intention and, subsequently, an application is submitted to ECHA within a set deadline.

(9)

Member States’ national provisions with regard to starting substances, compositions and constituents and their national positive lists were notified to ECHA by 12 July 2021. In order to allow national authorities sufficient time to prepare for the application of the European positive lists, the application of this act will start from 31 December 2026. The national systems are to apply until 31 December 2026. In addition, transitional measures should be provided for substances, compositions and constituents approved in the national systems from 13 July 2021 to 31 December 2026, provided that in accordance with Part B of Annex I to Directive (EU) 2020/2184, these substances do not exceed the parametric value of 5 μg/l for lead (Pb) at the tap.

(10)

The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 22(1) of Directive (EU) 2020/2184,

HAS ADOPTED THIS DECISION:

Article 1

European positive lists

This Decision establishes the following:

(a)

the European positive list of starting substances for organic materials and groups of starting substances for organic materials as set out in Tables 1 and 2 of Annex I respectively;

(b)

the European positive list of compositions of metallic materials and groups of compositions for metallic materials as set out in Tables 1 and 2 of Annex II respectively;

(c)

the European positive list of organic constituents of cementitious materials and groups of organic constituents for cementitious materials as set out in Tables 2 and 3 of Annex III respectively;

(d)

the European positive list of compositions of enamels, ceramic and other inorganic materials as set out in Table 1 of Annex IV.

Article 2

Definitions

For the purpose of this Decision, the following definitions shall apply:

(1)

‘material’ means a solid, semi-solid or liquid that is used for the manufacturing of a product that is:

(a)

an organic composition prepared from one or more starting substances; or

(b)

a cementitious composition prepared from one or more constituents; or

(c)

a metallic, enamel, ceramic or other inorganic composition;

(2)

‘monomer’ means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

(3)

‘organic material’ means a material that mainly consist of carbon-based substances;

(4)

‘monomer unit’ means the reacted form of a monomer substance in a polymer;

(5)

‘polymer’ means a substance consisting of molecules that are characterised by the sequence of one or more types of monomer units ant that are distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units comprising the following:

(a)

a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;

(b)

less than a simple weight majority of molecules of the same molecular weight;

(6)

‘polymerised part’ means the part of a substance composition consisting of molecules characterised by the sequence of one or more types of monomer units. Molecules such as dimers, trimers contribute also to the polymerised part. However, the term ‘polymerised part’ does not cover unreacted monomer or unreacted other reactants;

(7)

‘pre-polymer’ is a substance resulting from a polymerisation-type of reaction and that is further reacted into a final polymer in a material or product;

(8)

‘organic cementitious constituent’ means an organic substance that is used in the manufacture of cementitious materials;

(9)

‘cement’ means a finely ground inorganic material which, when mixed with water, forms a paste that sets and hardens by means of hydration reactions and processes and which, after hardening, retains its strength and stability even under water;

(10)

‘cementitious material’ means a material that contains a hydraulic cement in sufficient proportion to act as the main binder by forming a hydrate structure which governs the performance of the material;

(11)

‘non-intentionally added species’ means either one of the following:

(a)

an impurity of a starting substance or organic cementitious constituent or composition;

(b)

a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms during the processing or use of the material;

(c)

a reaction product or a degradation product of a starting substance or organic cementitious constituent that forms in contact with water during the use of the material;

(12)

‘metallic material’ means a metal or metal alloy used either in bulk form or as metallic plating;

(13)

‘ceramic materials’ means inorganic poly- or single crystalline, non-metallic solid materials subjected to high temperature in manufacture;

(14)

‘enamel’ means a material that is a vitreous material obtained by melting at temperatures higher than 1 200 °C and fritting of a mixture of inorganic substances;

(15)

‘maximum tolerable concentration at the tap’ (MTCtap) means the maximum permitted concentration of a substance transferred from a specific material into water intended for human consumption.

Article 3

Transitional provision

Starting substances, compositions and constituents which have been approved by a Member State competent authority during the period from 13 July 2021 to 31 December 2026 in accordance with national provisions may be used in the manufacture of materials or products that come into contact with water intended for human consumption until 31 December 2032, provided they comply with the parametric value of 5 μg/l Pb (lead) at the tap as set out in Part B of Annex I to Directive (EU) 2020/2184.

Article 4

Entry into force

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 31 December 2026.

Done at Brussels, 23 January 2024.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 435, 23.12.2020, p. 1.

(2)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

(3)  Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).

(4)  EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes andProcessing Aids), Silano V, et. al., 2020. Scientific Opinion on the review and priority setting for substances that are listed without a specific migration limit in Table 1 of Annex 1 of Regulation 10/2011on plastic materials and articles intended to come into contact with food. EFSA Journal 2020;18(6):6124,104 pp. https://doi.org/10.2903/j.efsa.2020.6124.


ANNEX I

EUROPEAN POSITIVE LIST OF STARTING SUBSTANCES FOR ORGANIC MATERIALS

Table 1

European positive lists of individual starting substances for organic materials

EUPL Number

EC Number

CAS Number

FCM substance Number (A)

Starting substance name

Technical function (B)

Drinking water contact materials (C)

Maximum Tolerable Concentration at the tap in organic materials (MTCtap, organics) in μg/l

Total Maximum Tolerable Concentration at the tap (MTC(T)tap, organics) in μg/l (D)

Conditions of use

Expiry date

Value for the starting substance

Values for other relevant chemical species (E)

0001

 

 

1

albumin

Monomer or other reactant

All

 

 

 

 

31 December 2028

0002

 

 

2

albumin, coagulated by formaldehyde

Monomer or other reactant

All

 

 

 

 

31 December 2028

0003

 

 

7

acetylacetic acid, salts

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0004

 

 

18

aluminium calcium hydroxide phosphite, hydrate

Additive or polymer production aid

All

 

 

For aluminium, refer to Annex V.

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0005

 

 

21

carbonic acid, salts

Additive

Polymer production aid

Aid to polymerisation

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0006

 

 

24

cotton fibres

Additive

All

 

 

 

 

31 December 2028

0007

 

 

29

di-n-octyltin bis(ethyl maleate)

Additive or polymer production aid

All

 

 

(10)

 

31 December 2034

0008

 

 

30

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

Additive or polymer production aid

All

 

 

(10)

 

31 December 2028

0009

 

 

32

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

Additive or polymer production aid

All

 

 

(10)

 

31 December 2034

0010

 

 

33

di-n-octyltin thiobenzoate 2-ethylhexyl mercaptoacetate

Additive or polymer production aid

All

 

 

(10)

 

31 December 2028

0011

 

 

34

ethylhydroxymethylcellulose

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0012

 

 

35

ethylhydroxypropylcellulose

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0013

 

 

36

fats and oils, from animal or vegetable food sources

Polymer production aid

Additive

Other (processing aid)

All

 

 

 

 

31 December 2028

0014

 

 

37

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

Polymer production aid

Additive

All

 

 

 

 

31 December 2028

0015

 

 

39

glass microballs

Additive

All

 

 

 

 

31 December 2028

0016

 

 

54

glycerol monooleate, ester with ascorbic acid

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0017

 

 

55

glycerol monooleate, ester with citric acid

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0018

 

 

56

glycerol monopalmitate, ester with ascorbic acid

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0019

 

 

57

glycerol monopalmitate, ester with citric acid

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0020

 

 

58

glycerol monostearate, ester with ascorbic acid

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0021

 

 

59

glycerol monostearate, ester with citric acid

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0022

 

 

60

glycine, salts

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0023

 

 

62

lysine, salts

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0024

 

 

63

manganese pyrophosphite

Additive or polymer production aid

All

 

 

For manganese, refer to Annex V.

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0025

 

 

64

methylhydroxymethylcellulose

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0026

 

 

70

polyacrylic acid, salts

Additive or polymer production aid

All

 

 

(21)

 

31 December 2037

0027

 

 

71

polydimethylsiloxane, γ-hydroxy propylated

Additive or polymer production aid

All

300

 

 

 

31 December 2034

0028

 

 

72

polyester of adipic acid with glycerol or pentaerythritol, esters with even numbered, unbranched C12-C22 fatty acids

Additive or polymer production aid

Plastics

 

 

(31)

Purity of starting substance: the fraction with molecular weight below 1 000 Da shall not exceed 5 % (w/w).

31 December 2034

0029

 

 

74

polyethyleneglycol diricinoleate

Additive or polymer production aid

All

2100

 

 

 

31 December 2034

0030

 

 

75

polyethyleneglycol esters of aliph. monocarb. acids (C6-C22) and their ammonium and sodium sulfates

Additive

Polymer production aid

Other (processing aid)

All

 

 

For ammonium, refer to Annex V.

 

31 December 2037

0031

 

 

76

polyethylene glycol (EO = 1-30, typically 5) ether of butyl 2-cyano 3-(4-hydroxy-3-methoxyphenyl) acrylate

Additive or polymer production aid

Plastics

2,5

 

 

Only for use in PET.

31 December 2034

0032

 

 

77

polyethyleneglycol (EO = 1-30, typically 5) ether of butyl-2-cyano-3-(4-hydroxyphenyl) acrylate

Additive or polymer production aid

Plastics

2,5

 

 

Only for use in PET.

31 December 2034

0033

 

 

79

polyoxyalkyl (C2-C4) dimethyl polysiloxane

Additive

Polymer production aid

All

 

 

 

 

31 December 2034

0034

 

 

81

propylhydroxyethylcellulose

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0035

 

 

82

propylhydroxymethylcellulose

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0036

 

 

83

propylhydroxypropylcellulose

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0037

 

 

84

silicates, natural (with the exception of asbestos)

Additive

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0038

 

 

85

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

Additive

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0039

 

 

86

silicic acid, silylated

Additive

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0040

 

 

87

silicon dioxide, silanated

Additive

All

 

 

 

For synthetic amorphous silicon dioxide, silanated: primary particles of 1–100 nm which are aggregated to a size of 0,1–1 μm and may form agglomerates within the size distribution of 0,3 μm to the mm size.

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0041

 

 

88

sodium monoalkyl dialkylphenoxybenzenedisulfonate

Additive or polymer production aid

All

450

 

 

 

31 December 2028

0042

 

 

90

taurine, salts

Additive or polymer production aid

All

 

 

 

 

31 December 2031

0043

 

 

91

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

Additive or polymer production aid

All

750

 

 

 

31 December 2034

0044

 

 

92

tricyclodecanedimethanol bis(hexahydrophthalate)

Additive or polymer production aid

All

2,5

 

 

 

31 December 2028

0045

 

 

93

waxes, paraffinic, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, low viscosity

Monomer or other reactant (base oil)

Additive

Polymer production aid

Other (processing aid)

All

2,5

 

 

Average molecular weight not less than 350 Da.

Viscosity at 100 °C not less than 2,5 cSt (2,5 × 10-6 m2 /s). Content of hydrocarbons with carbon number less than 25, not more than 40 % (w/w).

31 December 2028

0046

 

 

94

waxes, refined, derived from petroleum based or synthetic hydrocarbon feedstocks, high viscosity

Additive

Polymer production aid

All

 

 

 

Average molecular weight not less than 500 Da.

Viscosity at 100 °C not less than 11 cSt (11 × 10-6 m2 /s).

Content of mineral hydrocarbons with carbon number less than 25, not more than 5 % (w/w).

31 December 2028

0047

 

 

95

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

Monomer or other reactant (base oil)

Additive

Polymer production aid

All

 

 

 

Average molecular weight not less than 480 Da.

Viscosity at 100 °C not less than 8,5 cSt (8,5 × 10-6 m2 /s). Content of mineral hydrocarbons with carbon number less than 25, not more than 5 % (w/w).

31 December 2028

0048

 

 

97

petroleum hydrocarbon resins (hydrogenated)

Monomer or other reactant (resin)

Additive

All

150 (Note: based on a notified national approval)

 

 

Petroleum hydrocarbon resins, hydrogenated are produced by the catalytic or thermal polymerisation of dienes and olefins of the aliphatic, alicyclic and/or monobenzenoidarylalkene types from distillates of cracked petroleum stocks with a boiling range not greater than 220 °C, as well as the pure monomers found in these distillation streams, subsequently followed by distillation, hydrogenation and additional processing.

Properties:

Viscosity at 120 °C: > 3 Pa.s, — Softening point: > 95 °C as determined by ASTM Method E 28-67,

Bromine number: < 40 (ASTM D1159),

The colour of a 50 % solution in toluene < 11 on the Gardner scale,

Residual aromatic monomer ≤50 ppm.

31 December 2028

0049

 

50-00-0

98

formaldehyde

Monomer or other reactant

All

 

 

(15)

 

31 December 2028

0050

 

50-70-4

100

sorbitol

Monomer or other reactant

Additive

All

 

 

 

 

31 December 2037

0051

 

50-81-7

101

ascorbic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0052

 

56-81-5

103

glycerol

Monomer or other reactant

Additive

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2037

0053

 

57-09-0

104

hexadecyltrimethylammonium bromide

Additive

Polymer production aid

All

300

 

 

 

31 December 2034

0054

 

57-10-3

105

palmitic acid

Monomer or other reactant

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2037

0055

 

57-11-4

106

stearic acid

Monomer or other reactant

Additive

Polymer production aid

Aid to polymerisation

Other (processing aid)

All

 

 

 

 

31 December 2037

0056

 

57-13-6

107

urea

Monomer or other reactant

Additive

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2037

0057

 

57-50-1

108

sucrose

Monomer or other reactant

All

 

 

 

 

31 December 2037

0058

 

60-00-4

111

ethylenediaminetetraacetic acid (EDTA)

Additive

Polymer production aid

All

60

 

 

 

31 December 2034

0059

 

60-33-3

112

linoleic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0060

 

64-17-5

113

ethanol

Monomer or other reactant

Additive

Polymer production aid

All

 

 

 

 

31 December 2034

0061

 

64-18-6

114

formic acid

Monomer or other reactant

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2034

0062

 

64-19-7

115

acetic acid

Monomer or other reactant

Additive

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2037

0063

 

65-85-0

116

benzoic acid

Monomer or other reactant

Polymer production aid

Aid to polymerisation

All

 

 

 

 

31 December 2034

0064

 

67-56-1

117

methanol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0065

 

67-63-0

118

2-propanol

Monomer or other reactant

Polymer production aid

All

 

 

 

 

31 December 2034

0066

 

67-64-1

119

acetone

Polymer production aid

All

 

 

 

 

31 December 2034

0067

 

67-68-5

120

dimethyl sulfoxide

Polymer production aid

All

 

 

 

 

31 December 2034

0068

 

69-72-7

121

salicylic acid

Monomer or other reactant, aid to polymerisation, Other (processing aid)

Coatings

Rubber

 

 

 

 

31 December 2028

0069

 

71-23-8

122

1-propanol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0070

 

71-36-3

123

1-butanol

Monomer or other reactant

Polymer production aid

All

 

 

 

 

31 December 2034

0071

 

71-41-0

124

1-pentanol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0072

 

74-85-1

125

ethylene

Monomer or other reactant

All

 

 

 

 

31 December 2034

0073

 

74-86-2

126

acetylene

Monomer or other reactant

All

 

 

 

 

31 December 2034

0074

 

75-01-4

127

vinyl chloride

Monomer or other reactant

All

0,5

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product.

31 December 2028

0075

 

75-07-0

128

acetaldehyde

Monomer or other reactant

All

 

 

(1)

 

31 December 2028

0076

 

75-21-8

129

ethylene oxide

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product.

Verification of compliance by residual content per water contact surface area (QMA) in case of reaction with water.

31 December 2028

0077

 

75-35-4

130

vinylidene chloride

Monomer or other reactant

All

0,1

 

 

Verification of compliance by residual content per water contact surface area (QMA) pending the availability of an analytical method.

31 December 2028

0078

 

75-37-6

131

1,1-difluoroethane

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0079

 

75-38-7

132

vinylidene fluoride

Monomer or other reactant

All

250

 

 

 

31 December 2034

0080

 

75-44-5

133

carbonyl chloride

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product.

Verification of compliance by residual content per water contact surface area (QMA) in case of reaction with water.

31 December 2034

0081

 

75-45-6

134

chlorodifluoromethane

Additive or polymer production aid

All

300

 

 

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

31 December 2034

0082

 

76-22-2

136

camphor

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0083

 

77-62-3

137

2,2′-methylenebis(4-methyl-6-(1- methylcyclohexyl)phenol)

Additive

All

 

 

(5)

 

31 December 2034

0084

 

77-90-7

138

tri-n-butyl acetyl citrate

Additive or polymer production aid

All

 

 

(31)

 

31 December 2034

0085

 

77-92-9

139

citric acid

Monomer or other reactant

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2037

0086

 

77-93-0

140

citric acid, triethyl ester

Additive or polymer production aid

All

 

 

(31)

 

31 December 2034

0087

 

77-99-6

141

1,1,1-trimethylolpropane

Monomer or other reactant

Additive

All

300

 

 

 

31 December 2034

0088

 

78-08-0

142

vinyltriethoxysilane

Additive

Other (processing aid)

All

2,5

 

 

Only to be used as a surface treatment agent.

31 December 2034

0089

 

78-78-4

143

isopentane

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0090

 

78-79-5

144

2-methyl–1,3-butadiene (isoprene)

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product.

31 December 2028

0091

 

79-06-1

145

acrylamide

Monomer or other reactant

All

0,1

 

 

 

31 December 2028

0092

 

79-09-4

146

propionic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0093

 

79-10-7

147

acrylic acid

Monomer or other reactant

All

 

 

(21)

 

31 December 2034

0094

 

79-38-9

148

chlorotrifluoroethylene

Monomer or other reactant

All

0,1

 

 

Verification of compliance by residual content per water contact surface area (QMA) pending the availability of an analytical method.

31 December 2034

0095

 

79-39-0

149

methacrylamide

Monomer or other reactant

All

0,1

 

 

 

31 December 2034

0096

 

79-41-4

150

methacrylic acid

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0097

 

80-05-7

151

2,2-bis(4-hydroxyphenyl)propane

Monomer or other reactant

Additive

All

2,5

 

 

Technical function as additive is only accepted for plastics.

31 December 2028

0098

 

80-07-9

152

4,4′-dichlorodiphenyl sulfone

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0099

 

80-08-0

153

4,4′-diaminodiphenyl sulfone

Monomer or other reactant

All

250

 

 

 

31 December 2034

0100

 

80-09-1

154

4,4′-dihydroxydiphenyl sulfone

Monomer or other reactant

All

2,5

 

 

 

31 December 2028

0101

 

80-56-8

155

α-pinene

Monomer or other reactant

All

 

 

 

 

31 December 2034

0102

 

80-62-6

156

methacrylic acid, methyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0103

 

84-74-2

157

phthalic acid, dibutyl ester ('DBP')

Additive

All

6,0

 

(31)

(35)

Only to be used as:

(a)

plasticiser;

(b)

technical support agent in polyolefins in concentrations up to 0,05 % in the product.

31 December 2028

0104

 

85-44-9

158

phthalic anhydride

Monomer or other reactant

Aid to polymerisation

All

 

 

 

 

31 December 2034

0105

 

85-68-7

159

phthalic acid, benzyl butyl ester ('BBP')

Additive

All

300

 

(31)

(35)

Only to be used as

(a)

plasticiser;

(b)

technical support agent in concentrations up to 0,1 % in the product.

≤ 5% as sum of all phthalates.

31 December 2028

0106

 

87-18-3

160

salicylic acid, 4-tert-butylphenyl ester

Additive or polymer production aid

All

600

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2028

0107

 

87-69-4

161

L-(+)-tartaric acid

Monomer or other reactant

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2034

0108

 

87-78-5

162

mannitol

Monomer or other reactant

Polymer production aid

All

 

 

 

 

31 December 2028

0109

 

88-24-4

163

2,2′-methylene bis(4-ethyl-6-tert-butylphenol)

Additive

All

 

 

(13)

 

31 December 2034

0110

 

88-68-6

164

2-aminobenzamide

Additive or polymer production aid

Plastics

2,5

 

 

Only for use in PET.

31 December 2034

0111

 

88-99-3

165

o-phthalic acid

Monomer or other reactant

All

 

 

 

 

31 December 2034

0112

 

89-32-7

166

pyromellitic anhydride

Monomer or other reactant

All

2,5 – expressed as the sum of pyromellitic anhydride and pyromellitc acid

 

 

 

31 December 2034

0113

 

91-08-7

167

2,6-toluene diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0114

 

91-76-9

168

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

Monomer or other reactant

All

250

 

 

 

31 December 2034

0115

 

91-97-4

169

3,3′-dimethyl–4,4′-diisocyanato biphenyl

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0116

 

92-88-6

170

4,4′-dihydroxybiphenyl

Monomer or other reactant

All

300

 

 

 

31 December 2034

0117

 

93-58-3

171

benzoic acid, methyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0118

 

93-89-0

172

benzoic acid, ethyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0119

 

94-13-3

173

4-hydroxybenzoic acid, propyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0120

 

95-48-7

174

o-cresol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0121

 

96-05-9

175

methacrylic acid, allyl ester

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0122

 

96-33-3

176

acrylic acid, methyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2034

0123

 

96-49-1

177

ethylene carbonate

Monomer or other reactant

All

1500 - expressed as ethyleneglycol

 

 

 

31 December 2034

0124

 

96-69-5

178

4,4′-thiobis(6-tert-butyl-3-methyl phenol)

Additive

All

24

 

 

 

31 December 2034

0125

 

97-23-4

179

2,2′-dihydroxy–5,5′-dichlorodiphenylmethane

Additive or polymer production aid

All

600

 

 

 

31 December 2028

0126

 

97-53-0

180

eugenol

Monomer or other reactant

All

 

 

(32)

 

31 December 2034

0127

 

97-63-2

181

methacrylic acid, ethyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0128

 

97-65-4

182

itaconic acid

Monomer or other reactant

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2034

0129

 

97-86-9

183

methacrylic acid, isobutyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0130

 

97-88-1

184

methacrylic acid, butyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0131

 

97-90-5

185

methacrylic acid, diester with ethyleneglycol

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0132

 

98-54-4

186

4-tert-butylphenol

Monomer or other reactant

All

2,5

 

 

 

31 December 2028

0133

 

98-83-9

187

α-methylstyrene

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0134

 

99-63-8

188

isophthalic acid dichloride

Monomer or other reactant

All

 

 

(26)

 

31 December 2034

0135

 

99-76-3

189

4-hydroxybenzoic acid, methyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0136

 

99-96-7

190

p-hydroxybenzoic acid

Monomer or other reactant

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2034

0137

 

100-20-9

191

terephthalic acid dichloride

Monomer or other reactant

All

 

 

(27)

 

31 December 2034

0138

 

 

192

phthalic acid

Monomer or other reactant

Additive

All

 

 

(27)

 

31 December 2034

0139

 

100-42-5

193

styrene

Monomer or other reactant

All

 

 

 

 

31 December 2028

0140

 

100-51-6

194

benzyl alcohol

Monomer or other reactant

Additive

Polymer production aid

All

 

 

 

 

31 December 2034

0141

 

100-52-7

195

benzaldehyde

Additive or polymer production aid

All

 

 

 

There is a risk that the migration of the substance deteriorates the organoleptic characteristics of the drinking water and then, that the product does not comply with Commission Implementing Decision (EU) 2024/368.

31 December 2034

0142

 

100-97-0

196

hexamethylenetetramine

Monomer or other reactant

Aid to polymerisation

All

 

 

(15)

 

31 December 2034

0143

 

101-43-9

197

methacrylic acid, cyclohexyl ester

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0144

 

101-68-8

198

diphenylmethane–4,4′-diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0145

 

101-90-6

199

resorcinol diglycidyl ether

Monomer or other reactant

All

0,1

 

 

For indirect water contact only, behind a PET layer.

Verification of compliance by residual content per water contact surface area (QMA); QMA = 0,0083 dm-1.

31 December 2028

0146

 

102-08-9

200

N,N′-diphenylthiourea

Additive or polymer production aid

All

150

 

 

 

31 December 2034

0147

 

102-09-0

201

diphenyl carbonate

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0148

 

102-39-6

202

(1,3-phenylenedioxy)diacetic acid

Monomer or other reactant

All

2,5

 

 

 

31 December 2028

0149

 

102-40-9

203

1,3-bis(2-hydroxyethoxy)benzene

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0150

 

102-60-3

204

N,N,N′,N′-tetrakis(2-hydroxypropyl)ethylenediamine

Monomer or other reactant

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0151

 

103-11-7

206

acrylic acid, 2-ethylhexyl ester

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0152

 

103-23-1

207

adipic acid, bis(2-ethylhexyl) ester

Additive

All

900

 

(31)

 

31 December 2034

0153

 

103-90-2

208

N-(4-hydroxyphenyl) acetamide

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0154

 

104-76-7

209

2-ethyl-1-hexanol

Monomer or other reactant

All

1500

 

 

 

31 December 2034

0155

 

105-08-8

210

1,4-bis(hydroxymethyl)cyclohexane

Monomer or other reactant

All

 

 

 

 

31 December 2034

0156

 

105-38-4

211

propionic acid, vinyl ester

Monomer or other reactant

All

 

 

(1)

 

31 December 2034

0157

 

105-60-2

212

caprolactam

Monomer or other reactant

Additive

Aid to polymerisation

All

 

 

(4)

When used for coatings, only for hot curing coatings.

31 December 2034

0158

 

105-62-4

213

1,2-propyleneglycol dioleate

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0159

 

106-14-9

214

12-hydroxystearic acid

Monomer or other reactant

Additive

Other (processing aid)

All

 

 

 

 

31 December 2034

0160

 

106-31-0

215

butyric anhydride

Monomer or other reactant

All

 

 

 

 

31 December 2034

0161

 

106-44-5

216

p-cresol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0162

 

106-46-7

217

1,4-dichlorobenzene

Monomer or other reactant

All

600

 

 

 

31 December 2028

0163

 

106-63-8

218

acrylic acid, isobutyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2034

0164

 

106-89-8

219

epichlorohydrin

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product.

Verification of compliance by residual content per water contact surface area (QMA) in case of reaction with water.

31 December 2028

0165

 

106-91-2

220

methacrylic acid, 2,3-epoxypropyl ester

Monomer or other reactant

All

1,0

 

 

Verification of compliance by residual content per water contact surface area (QMA) in case of reaction with water.

31 December 2028

0166

 

106-97-8

221

butane

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0167

 

106-98-9

222

1-butene

Monomer or other reactant

All

 

 

 

 

31 December 2034

0168

 

106-99-0

223

butadiene

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product.

31 December 2028

0169

 

107-13-1

225

acrylonitrile

Monomer or other reactant

All

0,1

 

 

 

31 December 2028

0170

 

107-15-3

226

ethylenediamine

Monomer or other reactant

Polymer production aid

All

600

 

 

 

31 December 2034

0171

 

107-21-1

227

ethyleneglycol

Monomer or other reactant

All

 

 

(2)

 

31 December 2034

0172

 

107-92-6

229

butyric acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0173

 

108-01-0

230

dimethylaminoethanol

Monomer or other reactant

All

900

 

 

 

31 December 2034

0174

 

108-05-4

231

acetic acid, vinyl ester

Monomer or other reactant

All

600

 

 

 

31 December 2028

0175

 

108-24-7

232

acetic anhydride

Monomer or other reactant

Additive

Polymer production aid

All

 

 

 

 

31 December 2034

0176

 

108-30-5

233

succinic anhydride

Monomer or other reactant

All

 

 

 

 

31 December 2034

0177

 

108-31-6

234

maleic anhydride

Monomer or other reactant

Additive

Polymer production aid

Other (processing aid)

All

 

 

(3)

 

31 December 2034

0178

 

108-39-4

235

m-cresol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0179

 

108-45-2

236

1,3-phenylenediamine

Monomer or other reactant

All

0,1

 

 

A detection limit of 0,1 μg/l applies.

31 December 2028

0180

 

108-46-3

237

1,3-dihydroxybenzene (resorcinol)

Monomer or other reactant

Other (processing aid)

All

120

 

 

 

31 December 2034

0181

 

108-55-4

238

glutaric anhydride

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2034

0182

 

108-78-1

239

2,4,6-triamino-1,3,5-triazine (melamine)

Monomer or other reactant

All

125

 

 

 

31 December 2028

0183

 

108-91-8

240

cyclohexylamine

Monomer or other reactant

Aid to polymerisation

All

 

 

 

 

31 December 2028

0184

 

108-95-2

241

phenol

Monomer or other reactant

All

150

 

 

 

31 December 2028

0185

 

109-43-3

242

sebacic acid, dibutyl ester

Additive

Polymer production aid

All

 

 

(31)

 

31 December 2034

0186

 

109-53-5

243

isobutyl vinyl ether

Monomer or other reactant

All

2,5

 

 

Verification of compliance by residual content per water contact surface area (QMA) in case of reaction with water.

31 December 2034

0187

 

109-66-0

244

pentane

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0188

 

109-67-1

245

1-pentene

Monomer or other reactant

All

250

 

 

 

31 December 2034

0189

 

109-99-9

246

tetrahydrofuran

Monomer or other reactant

Polymer production aid

All

30

 

 

 

31 December 2028

0190

 

110-15-6

247

succinic acid

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2037

0191

 

110-16-7

248

maleic acid

Monomer or other reactant

Other (processing aid)

All

 

 

(3)

 

31 December 2034

0192

 

110-17-8

249

fumaric acid

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2034

0193

 

110-30-5

250

N,N′-ethylenebisstearamide

Additive

Polymer production aid

All

 

 

 

 

31 December 2034

0194

 

110-31-6

251

N,N′-ethylenebisoleamide

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0195

 

110-44-1

252

sorbic acid

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0196

 

110-60-1

253

1,4-diaminobutane

Monomer or other reactant

All

 

 

 

 

31 December 2034

0197

 

110-63-4

254

1,4-butanediol

Monomer or other reactant

Additive

All

 

 

(29)

 

31 December 2034

0198

 

110-88-3

255

trioxane

Monomer or other reactant

All

250

 

 

 

31 December 2034

0199

 

110-94-1

256

glutaric acid

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2037

0200

 

111-06-8

258

palmitic acid, butyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0201

 

111-14-8

259

heptanoic acid

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0202

 

111-20-6

260

sebacic acid

Monomer or other reactant

Additive

Other (processing aid)

All

 

 

 

 

31 December 2034

0203

 

111-40-0

261

diethylenetriamine

Monomer or other reactant

All

250

 

 

 

31 December 2034

0204

 

111-41-1

262

N-(2-aminoethyl)ethanolamine

Additive or polymer production aid

All

2,5

 

 

For indirect water contact only, behind a PET layer.

31 December 2028

0205

 

111-46-6

263

diethyleneglycol

Monomer or other reactant

Aid to polymerisation

All

 

 

(2)

 

31 December 2034

0206

 

111-66-0

264

1-octene

Monomer or other reactant

All

750

 

 

 

31 December 2034

0207

 

111-87-5

265

1-octanol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0208

 

112-27-6

266

triethyleneglycol

Monomer or other reactant

Additive

Other (processing aid)

All

 

 

 

 

31 December 2034

0209

 

112-30-1

267

1-decanol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0210

 

112-41-4

268

1-dodecene

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0211

 

112-60-7

269

tetraethyleneglycol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0212

 

112-80-1

270

oleic acid

Monomer or other reactant

Additive

Other (processing aid)

All

 

 

 

 

31 December 2028

0213

 

112-84-5

271

erucamide

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2034

0214

 

112-85-6

272

behenic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0215

 

112-86-7

273

erucic acid

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2028

0216

 

112-96-9

274

octadecyl isocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0217

 

115-07-1

275

propylene

Monomer or other reactant

All

 

 

 

 

31 December 2034

0218

 

115-11-7

276

isobutene

Monomer or other reactant

All

 

 

 

 

31 December 2034

0219

 

115-27-5

277

hexachloroendomethylenetetrahydrophthalic anhydride

Monomer or other reactant

Other (processing aid)

All

0,1

 

 

 

31 December 2034

0220

 

115-28-6

278

hexachloroendomethylenetetrahydrophthalic acid

Monomer or other reactant

Other (processing aid)

All

0,1

 

 

 

31 December 2028

0221

 

115-77-5

279

pentaerythritol

Monomer or other reactant

Additive

All

 

 

 

 

31 December 2034

0222

 

115-96-8

280

phosphoric acid, trichloroethyl ester

Additive or polymer production aid

All

0,1

 

 

 

31 December 2028

0223

 

116-14-3

281

tetrafluoroethylene

Monomer or other reactant

All

2,5

 

 

When used for coatings, only as monomer for polymeric additives.

31 December 2028

0224

 

116-15-4

282

hexafluoropropylene

Monomer or other reactant

All

0,1

 

(38)

 

31 December 2028

0225

 

117-81-7

283

phthalic acid, bis(2-ethylhexyl) ester ('DEHP')

Additive

Polymer production aid

All

30

 

(31)

(35)

Only to be used as:

(a)

plasticiser; or

(b)

technical support agent in concentrations up to 0,1 % in the product.

31 December 2028

0226

 

119-36-8

284

salicylic acid, methyl ester

Additive or polymer production aid

All

1500

 

 

 

31 December 2028

0227

 

119-47-1

285

2,2′-methylene bis(4-methyl-6-tert-butylphenol)

Additive

All

 

 

(13)

 

31 December 2028

0228

 

119-61-9

286

benzophenone

Aid to polymerisation

All

30

 

 

 

31 December 2028

0229

 

120-47-8

287

4-hydroxybenzoic acid, ethyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0230

 

120-61-6

288

terephthalic acid, dimethyl ester

Monomer or other reactant

All

 

 

 

 

31 December 2034

0231

 

120-80-9

289

1,2-dihydroxybenzene

Monomer or other reactant

All

300

 

 

 

31 December 2028

0232

 

121-79-9

290

gallic acid, propyl ester

Additive

All

 

 

(19)

 

31 December 2034

0233

 

121-91-5

291

isophthalic acid

Monomer or other reactant

Other (processing aid)

All

 

 

(26)

 

31 December 2034

0234

 

122-20-3

292

triisopropanolamine

Monomer or other reactant

Aid to polymerisation

All

250

 

 

 

31 December 2034

0235

 

122-52-1

293

phosphorous acid, triethyl ester

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product.

31 December 2034

0236

 

123-28-4

294

thiodipropionic acid, didodecyl ester

Additive or polymer production aid

All

 

 

(14)

 

31 December 2034

0237

 

123-31-9

295

1,4-dihydroxybenzene

Monomer or other reactant

All

30

 

 

 

31 December 2028

0238

 

123-38-6

296

propionaldehyde

Monomer or other reactant

All

 

 

 

 

31 December 2034

0239

 

123-62-6

297

propionic anhydride

Monomer or other reactant

All

 

 

 

 

31 December 2034

0240

 

123-72-8

298

butyraldehyde

Monomer or other reactant

All

 

 

 

 

31 December 2034

0241

 

123-76-2

299

levulinic acid

Additive or polymer production aid

All

 

 

 

 

31 December 2037

0242

 

123-86-4

300

acetic acid, butyl ester

Polymer production aid

All

 

 

 

 

31 December 2034

0243

 

123-95-5

301

stearic acid, butyl ester

Additive

All

 

 

 

 

31 December 2028

0244

 

123-99-9

302

azelaic acid

Monomer or other reactant

All

 

 

 

 

31 December 2034

0245

 

124-04-9

303

adipic acid

Monomer or other reactant

All

 

 

 

 

31 December 2034

0246

 

124-07-2

304

caprylic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0247

 

124-09-4

305

hexamethylenediamine

Monomer or other reactant

All

120

 

 

 

31 December 2034

0248

 

124-26-5

306

stearamide

Other (processing aid)

All

 

 

 

 

31 December 2034

0249

 

124-38-9

307

carbon dioxide

Additive or polymer production aid

All

 

 

 

 

31 December 2037

0250

 

126-13-6

308

sucrose acetate isobutyrate

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0251

 

126-14-7

309

sucrose octaacetate

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0252

 

126-30-7

310

2,2-dimethyl–1,3-propanediol (neopentylglycol)

Monomer or other reactant

All

2,5 - expressed as mono and diethylene glycols

 

 

 

31 December 2034

0253

 

126-58-9

311

dipentaerythritol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0254

 

126-98-7

312

methacrylonitrile

Monomer or other reactant

All

0,1

 

 

 

31 December 2034

0255

 

127-63-9

313

diphenyl sulfone

Monomer or other reactant

All

150

 

 

 

31 December 2034

0256

 

127-91-3

314

β-pinene

Monomer or other reactant

All

 

 

 

 

31 December 2028

0257

 

128-37-0

315

2,6-di-tert-butyl-p-cresol

Additive

Polymer production aid

All

150

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2034

0258

 

131-17-9

316

phthalic acid, diallyl ester

Monomer or other reactant

All

0,1

 

 

 

31 December 2034

0259

 

131-53-3

317

2,2′-dihydroxy-4-methoxybenzophenone

Additive or polymer production aid

All

 

 

(8)

 

31 December 2034

0260

 

131-56-6

318

2,4-dihydroxybenzophenone

Aid to polymerisation

All

 

 

(8)

 

31 December 2034

0261

 

131-57-7

319

2-hydroxy-4-methoxybenzophenone

Additive or polymer production aid

All

 

 

(8)

 

31 December 2034

0262

 

136-60-7

320

benzoic acid, butyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0263

 

137-66-6

321

ascorbyl palmitate

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0264

 

140-88-5

323

acrylic acid, ethyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2034

0265

 

141-22-0

324

ricinoleic acid

Monomer or other reactant

All

2100

 

 

 

31 December 2028

0266

 

141-32-2

325

acrylic acid, n-butyl ester

Monomer or other reactant

All, except rubber

 

 

(21)

 

31 December 2034

0267

 

141-43-5

326

2-aminoethanol

Monomer or other reactant

All

2,5

 

 

For indirect water contact only, behind a PET layer, except when used for coatings.

31 December 2034

0268

 

141-78-6

327

acetic acid, ethyl ester

Additive

All

 

 

 

 

31 December 2034

0269

 

141-82-2

328

malonic acid

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2034

0270

 

142-62-1

329

hexanoic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0271

 

143-07-7

330

lauric acid

Monomer or other reactant

Additive

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2037

0272

 

143-08-8

331

1-nonanol

Monomer or other reactant

All

 

 

 

 

31 December 2034

0273

 

143-28-2

332

oleyl alcohol

Monomer or other reactant

Additive

Polymer production aid

All

 

 

 

 

31 December 2034

0274

 

144-62-7

333

oxalic acid

Monomer or other reactant

Other (processing aid)

All

300

 

 

 

31 December 2034

0275

 

151-56-4

334

ethyleneimine

Monomer or other reactant

All

0,1

 

 

 

31 December 2028

0276

 

301-02-0

335

oleamide

Additive

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2028

0277

 

334-48-5

336

n-decanoic acid

Monomer or other reactant

Additive

Other (processing aid)

All

 

 

 

 

31 December 2037

0278

 

345-92-6

337

4,4′-difluorobenzophenone

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0279

 

373-49-9

338

palmitoleic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0280

 

409-21-2

339

silicon carbide

Monomer or other reactant

Additive

All

 

 

 

 

31 December 2028

0281

 

461-58-5

340

dicyanodiamide

Monomer or other reactant

All

3000

 

 

 

31 December 2034

0282

 

498-66-8

341

bicyclo[2.2.1]hept-2-ene

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0283

 

502-44-3

342

caprolactone

Monomer or other reactant

All

 

 

(28)

 

31 December 2034

0284

 

504-63-2

343

1,3-propanediol

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0285

 

505-65-7

344

1,4-butanediol formal

Monomer or other reactant

All

2,5

 

(15)

(29)

 

31 December 2034

0286

 

506-30-9

345

arachidic acid

Monomer or other reactant

All

 

 

 

 

31 December 2037

0287

 

514-10-3

346

abietic acid

Monomer or other reactant

All

 

 

 

 

31 December 2028

0288

 

528-44-9

347

trimellitic acid

Monomer or other reactant

All

 

 

(20)

 

31 December 2028

0289

 

544-63-8

348

myristic acid

Monomer or other reactant

Polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2028

0290

 

552-30-7

349

trimellitic anhydride

Monomer or other reactant

All

 

 

(20)

 

31 December 2034

0291

 

557-59-5

350

lignoceric acid

Monomer or other reactant

All

 

 

 

 

31 December 2028

0292

 

563-45-1

351

3-methyl-1-butene

Monomer or other reactant

Plastics

0,1

 

 

Only to be used in polypropylene.

Verification of compliance by residual content per water contact surface area (QMA) pending the availability of an analytical method.

31 December 2028

0293

 

576-26-1

352

2,6-dimethylphenol

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0294

 

584-09-8

353

carbonic acid, rubidium salt

Additive or polymer production aid

All

600

 

 

 

31 December 2028

0295

 

584-84-9

354

2,4-toluene diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0296

 

585-07-9

355

methacrylic acid, tert-butyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0297

 

592-41-6

356

1-hexene

Monomer or other reactant

All

150

 

 

 

31 December 2034

0298

 

599-64-4

358

4-cumylphenol

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0299

 

611-99-4

359

4,4′-dihydroxybenzophenone

Aid to polymerisation

All

 

 

(8)

 

31 December 2034

0300

 

620-67-7

360

glycerol triheptanoate

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0301

 

629-11-8

361

1,6-hexanediol

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0302

 

630-08-0

362

carbon monoxide

Monomer or other reactant

All

 

 

 

 

31 December 2028

0303

 

646-06-0

363

1,3-dioxolane

Monomer or other reactant

All

250

 

 

 

31 December 2034

0304

 

689-12-3

365

acrylic acid, isopropyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2028

0305

 

691-37-2

366

4-methyl-1-pentene

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0306

 

693-23-2

367

n-dodecanedioic acid

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2034

0307

 

693-36-7

368

thiodipropionic acid, dioctadecyl ester

Additive or polymer production aid

All

 

 

(14)

 

31 December 2034

0308

 

693-57-2

369

12-aminododecanoic acid

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0309

 

760-93-0

370

methacrylic anhydride

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0310

 

818-61-1

371

acrylic acid, monoester with ethyleneglycol

Monomer or other reactant

All

 

 

(21)

 

31 December 2034

0311

 

822-06-0

372

hexamethylene diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0312

 

840-65-3

373

2,6-naphthalenedicarboxylic acid, dimethyl ester

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0313

 

868-77-9

374

methacrylic acid, monoester with ethyleneglycol

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0314

 

872-05-9

375

1-decene

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0315

 

872-50-4

376

N-methylpyrrolidone

Additive or polymer production aid

All

3000

 

 

 

31 December 2028

0316

 

919-30-2

377

3-aminopropyltriethoxysilane

Additive

Polymer production aid

All

2,5

 

 

Residual extractable content of 3-aminopropyltriethoxysilane to be less than 3 mg/kg filler when used for the reactive surface treatment of inorganic fillers.

MTCtap = 2,5 μg/l when used for the surface treatment of materials and products.

31 December 2034

0317

 

923-02-4

378

N-methylolmethacrylamide

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0318

 

924-42-5

379

N-methylolacrylamide

Monomer or other reactant

All

0,1

 

 

 

31 December 2028

0319

 

925-60-0

380

acrylic acid, propyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2028

0320

 

931-88-4

381

cyclooctene

Monomer or other reactant

All

2,5

 

 

 

31 December 2028

0321

 

947-04-6

382

laurolactam

Monomer or other reactant

All

250

 

 

 

31 December 2034

0322

 

948-65-2

383

2-phenylindole

Additive or polymer production aid

All

750

 

 

 

31 December 2028

0323

 

991-84-4

384

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

Additive

All

1500

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2034

0324

 

999-61-1

385

acrylic acid, 2-hydroxypropyl ester

Monomer or other reactant

All

2,5 - expressed as the sum of acrylic acid, 2-hydroxypropyl ester and acrylic acid, 2-hydroxyisopropyl ester

 

 

It may contain up to 25 % (w/w) of acrylic acid, 2-hydroxyisopropyl ester (CAS No. 2918-23-2).

Verification of compliance by residual content per water contact surface area (QMA) pending the availability of an analytical method.

31 December 2028

0325

 

1034-01-1

386

gallic acid, octyl ester

Additive

All

 

 

(19)

 

31 December 2028

0326

 

1072-63-5

387

1-vinylimidazole

Monomer or other reactant

All

2,5

 

 

 

31 December 2028

0327

 

1120-36-1

388

1-tetradecene

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0328

 

1141-38-4

389

2,6-naphthalenedicarboxylic acid

Monomer or other reactant

All

250

 

 

 

31 December 2034

0329

 

1166-52-5

390

gallic acid, dodecyl ester

Additive

All

 

 

(19)

 

31 December 2028

0330

 

1187-93-5

391

perfluoromethyl perfluorovinyl ether

Monomer or other reactant

Plastics, coatings, rubber

0,1

 

(38)

Only to be used in:

coatings; or

rubber; or

-fluoro- and perfluoropolymers intended for products with a CF (S/V ratio) of ≤ 0,0067 dm-1.

31 December 2028

0331

 

1241-94-7

392

phosphoric acid, diphenyl 2-ethylhexyl ester

Additive

All

120

 

 

 

31 December 2034

0332

 

1302-78-9

393

bentonite

Additive

Polymer production aid

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0333

 

1305-62-0

394

calcium hydroxide

Additive

Polymer production aid

Aid to polymerisation

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0334

 

1305-78-8

395

calcium oxide

Additive

Aid to polymerisation

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0335

 

1309-42-8

396

magnesium hydroxide

Additive

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0336

 

1309-48-4

397

magnesium oxide

Additive

Aid to polymerisation

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0337

 

1309-64-4

398

antimony trioxide

Additive or polymer production aid

All

 

 

For antimony, refer to Annex V.

 

31 December 2028

0338

 

1310-58-3

399

potassium hydroxide

Additive or polymer production aid

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0339

 

1310-73-2

400

sodium hydroxide

Additive or polymer production aid

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0340

 

1313-82-2

401

sodium sulfide

Monomer or other reactant

All

 

 

 

 

31 December 2034

0341

 

1314-13-2

402

zinc oxide

Additive

Aid to polymerisation

All

 

 

For zinc, refer to Annex V.

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0342

 

1314-98-3

403

zinc sulfide

Polymer production aid

Additive

All

 

 

For zinc, refer to Annex V.

 

31 December 2034

0343

 

1317-33-5

404

molybdenum disulfide

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0344

 

1321-74-0

405

divinylbenzene

Monomer or other reactant

All

0,1 - expressed as the sum of divinylbenzene and ethylvinylbenzene

 

 

It may contain up to 45 % (w/w) of ethylvinylbenzene.

Verification of compliance by residual content per water contact surface area (QMA) pending the availability of an analytical method.

31 December 2034

0345

 

1323-39-3

406

1,2-propyleneglycol monostearate

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0346

 

1330-80-9

408

1,2-propyleneglycol monooleate

Additive or polymer production aid

All

 

 

 

 

31 December 2037

0347

 

1332-58-7

410

kaolin

Additive

All

 

 

 

Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the drinking water provides a functional barrier preventing migration of particles into the water.

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0348

 

1333-86-4

411

carbon black

Additive

All

 

Polycyclic aromatic hydrocarbons MTCtap = 0,1 μg/l

 

Primary particles of 10 – 300 nm which are aggregated to a size of 100 – 1 200 nm which may form agglomerates within the size distribution of 300 nm – mm. Toluene extractables: maximum 0,1 %, determined according to ISO method 6209.

UV absorption of cyclohexane extract at 386 nm: < 0,02 AU for a 1 cm cell or < 0,1 AU for a 5 cm cell, determined according to a generally recognised method of analysis.

Benzo(a)pyrene content: max 0,25 mg/kg carbon black. Maximum use level of carbon black in plastics: 2,5 % w/w.

31 December 2034

0349

 

1335-23-5

412

copper iodide

Additive or polymer production aid

All

 

 

(6)

For copper, refer to Annex V.

 

31 December 2028

0350

 

1336-21-6

413

ammonium hydroxide

Additive

Polymer production aid

All

 

 

For ammonium, refer to Annex V.

 

31 December 2034

0351

 

1338-39-2

414

sorbitan monolaurate

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0352

 

1338-41-6

415

sorbitan monostearate

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0353

 

1338-43-8

416

sorbitan monooleate

Additive

Polymer production aid

All

 

 

 

 

31 December 2037

0354

 

1343-98-2

417

silicic acid

Monomer or other reactant

Additive

Polymer production aid

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0355

 

1344-28-1

418

aluminium oxide

Additive

Polymer production aid

All

 

 

For aluminium, refer to Annex V.

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0356

 

1401-55-4

419

tannic acids

Additive or polymer production aid

All

 

 

 

According to the JECFA specifications.

31 December 2034

0357

 

1459-93-4

420

isophthalic acid, dimethyl ester

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0358

 

1477-55-0

421

1,3-benzenedimethanamine

Monomer or other reactant

All

 

 

(33)

 

31 December 2034

0359

 

1533-45-5

422

4,4′-bis(2-benzoxazolyl)stilbene

Additive or polymer production aid

All

2,5

 

 

 

31 December 2034

0360

 

1623-05-8

423

perfluoropropylperfluorovinyl ether

Monomer or other reactant

All

2,5

 

(38)

 

31 December 2028

0361

 

1647-16-1

424

1,9-decadiene

Monomer or other reactant

All

2,5

 

 

 

31 December 2028

0362

 

1663-39-4

425

acrylic acid, tert-butyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2034

0363

 

1675-54-3

426

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

Monomer or other reactant (resin)

All

450 - expressed as BADGE and its hydrolysis products

BADGE chlorohydrins MTCtap = 50 μg/l

bisphenol-A MTCtap = 2,5 μg/l

epichlorohydrin MTCtap = 0,1 μg/l

(49)

In compliance with Commission Regulation (EC) No 1895/2005 (OJ L 302, 19.11.2005, p. 28.).

31 December 2034

0364

 

1679-51-2

427

4-(hydroxymethyl)-1-cyclohexene

Monomer or other reactant

All

2,5

 

 

 

31 December 2028

0365

 

1709-70-2

428

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

Additive

All

 

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2034

0366

 

1761-71-3

429

bis(4-aminocyclohexyl)methane

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0367

 

1843-03-4

430

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

Additive or polymer production aid

All

250

 

 

 

31 December 2034

0368

 

1843-05-6

431

2-hydroxy-4-n-octyloxybenzophenone

Additive

Polymer production aid

All

 

 

(8)

 

31 December 2034

0369

 

2035-75-8

432

adipic anhydride

Monomer or other reactant

All

 

 

 

 

31 December 2028

0370

 

2082-79-3

433

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

Additive

Polymer production aid

All

300

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2034

0371

 

2082-81-7

434

methacrylic acid, diester with 1,4-butanediol

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0372

 

2123-24-2

435

caprolactam, sodium salt

Monomer or other reactant

All

 

 

(4)

 

31 December 2034

0373

 

2146-71-6

436

lauric acid, vinyl ester

Monomer or other reactant

All

 

 

 

 

31 December 2034

0374

 

2156-97-0

437

acrylic acid, dodecyl ester

 

All

2,5

 

 

 

31 December 2034

0375

 

2162-74-5

438

bis(2,6-diisopropylphenyl) carbodiimide

Monomer or other reactant

All

2,5 - expressed as the sum of bis(2,6-diisopropylphenyl)carbodiimide and its hydrolysis product 2,6-diisopropylaniline

 

 

 

31 December 2037

0376

 

2177-70-0

439

methacrylic acid, phenyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0377

 

2210-28-8

440

methacrylic acid, propyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2028

0378

 

2315-68-6

441

benzoic acid, propyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0379

 

2425-79-8

442

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

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 1 mg/kg in the product expressed as epoxy group. Molecular weight of epoxy group is 43 Da.

Verification of compliance by residual content per water contact surface area (QMA) in case of reaction with water.

31 December 2034

0380

 

2432-99-7

443

11-aminoundecanoic acid

Monomer or other reactant

All

250

 

 

 

31 December 2034

0381

 

2440-22-4

444

2-(2′-hydroxy-5′-methylphenyl)benzotriazole

Additive or polymer production aid

All

 

 

(12)

 

31 December 2034

0382

 

2466-09-3

445

pyrophosphoric acid

Monomer or other reactant

Polymer production aid

All

 

 

 

 

31 December 2028

0383

 

2495-35-4

446

acrylic acid, benzyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2034

0384

 

2495-37-6

447

methacrylic acid, benzyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2034

0385

 

2499-59-4

448

acrylic acid, n-octyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2028

0386

 

2500-88-1

449

dioctadecyl disulfide

Additive or polymer production aid

All

2,5

 

 

 

31 December 2034

0387

 

2561-88-8

450

sebacic anhydride

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2028

0388

 

2682-20-4

451

2-methyl-4-isothiazolin-3-one

Additive

Polymer production aid

All

25

 

 

Only to be used in aqueous polymer dispersions and emulsions.

31 December 2034

0389

 

2725-22-6

452

2,4-bis(2,4-dimethylphenyl)-6-(2- hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine

Additive or polymer production aid

All

250

 

 

 

31 December 2034

0390

 

2768-02-7

453

vinyltrimethoxysilane

Additive

Other (processing aid)

All

2,5

 

 

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0391

 

2855-13-2

454

1-amino-3-aminomethyl-3,5,5- trimethylcyclohexane

Monomer or other reactant

All

300

 

 

 

31 December 2034

0392

 

2867-47-2

455

methacrylic acid, 2-(dimethylamino)-ethyl ester

Monomer or other reactant

All

0,1

 

 

 

31 December 2034

0393

 

2998-08-5

456

acrylic acid, sec-butyl ester

Monomer or other reactant

All

 

 

(21)

 

31 December 2028

0394

 

2998-18-7

457

methacrylic acid, sec-butyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2028

0395

 

3061-75-4

458

behenamide

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0396

 

3135-18-0

459

3,5-di-tert-butyl-4-hydroxybenzyl-phosphonic acid, dioctadecyl ester

Additive or polymer production aid

All

 

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2028

0397

 

3173-53-3

460

cyclohexyl isocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0398

 

3173-72-6

461

1,5-naphthalene diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0399

 

3195-78-6

462

N-vinyl-N-methylacetamide

Monomer or other reactant

All

1,0

 

 

 

31 December 2034

0400

 

3290-92-4

463

1,1,1-trimethylolpropane trimethacrylate

Aid to polymerisation

All

2,5

 

 

 

31 December 2034

0401

 

3293-97-8

464

2-hydroxy-4-n-hexyloxybenzophenone

Additive or polymer production aid

All

 

 

(8)

 

31 December 2028

0402

 

3333-62-8

465

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

Additive

All

 

 

 

Requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2028

0403

 

3648-18-8

466

di-n-octyltin dilaurate

Additive

Polymer production aid

All

 

 

(10)

 

31 December 2028

0404

 

3825-26-1

468

perfluorooctanoic acid, ammonium salt

Additive or polymer production aid

All

 

 

(38)

(39)

Only to be used in repeated use articles, sintered at high temperatures.

31 December 2028

0405

 

3864-99-1

469

2-(2′-hydroxy–3,5′-di-tert-butylphenyl)-5-chlorobenzotriazole

Additive

Polymer production aid

All

 

For the MTCtap values of degradation products, refer to Table 4.

(12)

 

31 December 2028

0406

 

3896-11-5

470

2-(2′-hydroxy-3′-tert-butyl-5′-methylphenyl)-5-chlorobenzotriazole

Additive or polymer production aid

All

 

 

(12)

 

31 December 2034

0407

 

3965-55-7

471

5-sulfoisophthalic acid, monosodium salt, dimethyl ester

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0408

 

4066-02-8

472

2,2′-methylenebis(4-methyl-6-cyclohexylphenol)

Additive

All

 

 

(5)

 

31 December 2034

0409

 

4074-90-2

473

adipic acid, divinyl ester

Monomer or other reactant

All

0,1

 

 

Maximum residual content in the final material (QM) = 5 mg/kg in the product.

Only to be used as co-monomer.

Verification of compliance by residual content per water contact surface area (QMA) pending the availability of an analytical method.

31 December 2028

0410

 

4098-71-9

475

1-isocyanato-3-isocyanatomethyl- 3,5,5-trimethylcyclohexane

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0411

 

4128-73-8

476

diphenylether–4,4′-diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2028

0412

 

4130-42-1

477

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

Polymer production aid

Other (processing aid)

All

240

For the MTCtap values of degradation products, refer to Table 4.

 

Verification of compliance by residual content per water contact surface area (QMA) pending the availability of an analytical method.

31 December 2028

0413

 

4191-73-5

478

4-hydroxybenzoic acid, isopropyl ester

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0414

 

4196-95-6

479

azelaic anhydride

Monomer or other reactant

All

 

 

 

 

31 December 2028

0415

 

4221-80-1

480

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

Additive or polymer production aid

All

 

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2034

0416

 

4422-95-1

481

1,3,5-benzenetricarboxylic acid trichloride

Monomer or other reactant

All

2,5 - expressed as 1,3,5-benzenetricarboxylic acid

 

 

 

31 December 2037

0417

 

4655-34-9

482

methacrylic acid, isopropyl ester

Monomer or other reactant

All

 

 

(22)

 

31 December 2028

0418

 

4724-48-5

483

n-octylphosphonic acid

Additive or polymer production aid

All

2,5

 

 

 

31 December 2034

0419

 

4767-03-7

484

2,2-bis(hydroxymethyl)propionic acid

Monomer or other reactant

All

2,5

 

 

Verification of compliance by residual content per drinking water contact surface area (QMA) pending the availability of an analytical method.

When used for coatings, only as monomer for polymeric additives.

31 December 2034

0420

 

5124-30-1

485

dicyclohexylmethane–4,4′-diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0421

 

5136-44-7

486

ethylene-N-palmitamide-N′-stearamide

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0422

 

5232-99-5

487

2-cyano–3,3-diphenylacrylic acid, ethyl ester

Additive

Polymer production aid

All

2,5

 

 

 

31 December 2034

0423

 

5518-18-3

488

N,N′-ethylenebispalmitamide

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0424

 

5873-54-1

490

diphenylmethane–2,4′-diisocyanate

Monomer or other reactant

All

 

 

(16)

Maximum residual content in the final material (QM) = 1 mg/kg in the product, expressed as isocyanate moiety.

Verification of compliance by residual content per water contact surface area (QMA).

31 December 2034

0425

 

6182-11-2

491

1,2-propyleneglycol distearate

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0426

 

6197-30-4

492

2-cyano–3,3-diphenylacrylic acid, 2-ethylhexyl ester

Additive or polymer production aid

All

2,5

 

 

 

31 December 2034

0427

 

6200-40-4

493

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

Additive or polymer production aid

All

90

 

 

 

31 December 2028

0428

 

6303-21-5

494

hypophosphorous acid

Additive

Polymer production aid

All

 

 

 

 

31 December 2034

0429

 

6642-31-5

495

6-amino–1,3-dimethyluracil

Additive or polymer production aid

All

250

 

 

 

31 December 2034

0430

 

6683-19-8

496

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

Additive

Polymer production aid

All

 

For the MTCtap values of degradation products, refer to Table 4.

 

 

31 December 2034

0431

 

6846-50-0

497

2,2,4-trimethyl–1,3-pentanediol diisobutyrate

Additive

Polymer production aid

Coatings

250

 

 

Only to be used in coatings.

31 December 2034

0432

 

6864-37-5

498

3,3′-dimethyl–4,4′-diaminodicyclohexylmethane

Monomer or other reactant

Plastics

2,5

 

 

Only to be used in polyamides.

31 December 2034

0433

 

6915-15-7

499

malic acid

Monomer or other reactant

Other (processing aid)

All

 

 

 

In case of use as a monomer only to be used as a co-monomer in aliphatic polyesters up to maximum level of 1 % on a molar basis, except when used for coatings.

31 December 2034

0434

 

7128-64-5

500

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

Additive

Polymer production aid

All

30

 

 

Requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex 1 of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0435

 

7456-68-0

502

4,4′-oxybis(benzenesulfonyl azide)

Monomer or other reactant

All

2,5

 

 

 

31 December 2034

0436

 

7585-39-9

503

β-dextrin

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0437

 

7631-90-5

505

sodium bisulfite

Additive or polymer production aid

All

 

 

(18)

 

31 December 2034

0438

 

7632-00-0

506

sodium nitrite

Additive or polymer production aid

All

30

 

 

 

31 December 2034

0439

 

7647-01-0

507

hydrochloric acid

Additive or polymer production aid

Other (processing aid)

All

 

 

 

 

31 December 2034

0440

 

7647-15-6

508

sodium bromide

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0441

 

7664-38-2

509

phosphoric acid

Monomer or other reactant

Polymer production aid

All

 

 

 

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0442

 

7664-41-7

510

ammonia

Monomer or other reactant

Other (processing aid)

All

 

 

For ammonium, refer to Annex V.

 

31 December 2037

0443

 

7681-11-0

512

potassium iodide

Additive or polymer production aid

All

 

 

(6)

 

31 December 2034

0444

 

7681-82-5

513

sodium iodide

Additive or polymer production aid

All

 

 

(6)

 

31 December 2034

0445

 

7757-83-7

516

sodium sulfite

Additive or polymer production aid

All

 

 

(18)

If used as filler or pigment (additive) the requirements on purity of pigments, colorants and fillers apply; refer to Section 4.6, Annex I of Commission Implementing Decision (EU) 2024/368.

31 December 2034

0446

 

7758-02-3

517

potassium bromide

Additive or polymer production aid

All

 

 

 

 

31 December 2034

0447

 

7782-42-5

521

graphite

Additive

All

 

Polycyclic aromatic hydrocarbons MTCtap = 0,1 μg/l

 

Graphites according to EUPL Number 2039, Annex IV.

31 December 2034

0448

 

7782-50-5

522

chlorine

Monomer or other reactant

All

 

 

 

 

31 December 2034

0449

 

7787-70-4

523

copper bromide

Additive or polymer production aid

All

 

 

(6)

For copper, refer to Annex V.

 

31 December 2034

0450

 

8001-22-7

524

soybean oil

Monomer or other reactant

Other (processing aid)

All

 

 

 

 

31 December 2028

0451

 

8001-39-6

525

Japan wax

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0452

 

8001-75-0

526

ceresin

Additive or polymer production aid

All

 

 

 

 

31 December 2028

0453

 

8001-79-4

527

castor oil

Monomer or other reactant (base oil)

All

 

 

 

 

31 December 2028

0454

 

8002-43-5

528

lecithin