Address https://gelex.eu/eli/EU/decision/2024/368@2024-01-23/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2 Definitions
   3. Article 3
3. ANNEX
4. ANNEX I FINAL ORGANIC MATERIAL
5. 1.
6. pt_1
7. pt_2
8. 1.
9. 3.
10. 2.
11. 2.1. Table 1 Risk-based testing requirements for products or components of assembled products
12. 2.2.
13. 2.2.1
14. 2.2.2
15. 2.2.3
16. 2.2.4 Table 2 Table 3 Table 4 Requirement for polyamides and polyurethane resin coatings Requirements on amines and nitrosamines for rubbers Requirements on nitrosamines for final materials other than rubbers made of starting substances bearing N-functionalities when tested with chlorinated test water
17. 3.
18. 3.1.
19. 3.1.1.
20. 3.2.
21. 3.2.3.
22. 3.3.
23. 4.
24. 4.1.
25. 4.2.
26. 4.2.1. Table 5 (2,3,4) Product groups and their conversion factor (CF)
27. 4.2.2.
28. 4.2.3. Table 6 MTCtap for unexpected substances
29. 4.2.3.
30. 4.2.4.
31. 4.3.
32. 4.3.1.
33. 4.4. Table 7 Acceptance criteria for EMG
34. 4.6. Table 8 Requirements on purity of pigments, colorants and fillers
35. ANNEX II FINAL METALLIC MATERIALS
36. 1.
37. pt_1
38. pt_2
39. 2.
40. 2.1.2.1.1.
41. 3.
42. 4.
43. ANNEX III FINAL CEMENTITIOUS MATERIALS
44. 1.
45. pt_1
46. pt_2
47. 1.
48. 2.
49. 2.1. Table 1 Risk-based testing requirements for products or components of assembled products
50. 2.2.
51. 2.2.1.
52. 2.2.2.
53. 2.2.3.
54. 3.
55. 3.1.
56. 3.1.1.
57. 3.2.
58. 4.
59. 4.1.
60. 4.2.
61. 4.2.2.
62. 4.2.4.
63. 4.3.
64. 4.3.1.
65. ANNEX IV FINAL ENAMELS, CERAMIC MATERIALS AND OTHER INORGANIC MATERIALS (INCLUDING GLASS)
66. 1.
67. pt_1
68. pt_2
69. 2.
70. 2.1. Table 1 Risk-based testing requirements for products or components of assembled products
71. 2.2.
72. 3.
73. 3.2.
74. 3.3.
75. 4.
76. 4.2.
77. 4.2.2.

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, and in particular Article 11(2), point (c), thereof,

Whereas:

(1) In order to be able to test and accept final materials to be used in products that come into contact with water intended for human consumption, hygiene requirements should be set out for each category of final material, namely organic, cementitious, metallic, enamels and ceramic, or other inorganic materials. The methodologies to be used should be based, inter alia, on Annex V to Directive (EU) 2020/2184 and should be taken into account in the performance of the conformity assessment procedures of products.

(2) The testing of final materials requires the identification of relevant substances and other relevant parameters. Those substances and parameters should be analysed in the migration water. It is necessary to establish the requirements for such testing procedure and analysis.

(3) This Decision should lay down the testing requirements in order to ensure the performance of the testing. For organic, cementitious, enamel and ceramic materials, the testing requirements should be subject to a risk-based approach by categorising the product that comes into contact with water intended for human consumption. The risk-based approach ensures proportionate testing in relation to the human health risk of the final material.

(4) The testing for each final material should be carried out in accordance with the determined testing requirements to ensure that the water intended for human consumption is wholesome and clean. In order to determine whether the final material should be accepted and approved, it is necessary to set out pass/fail criteria that the results of the testing have to meet.

(5) In order to ensure proportionate testing, it should be possible to reduce testing for materials used in minor components and minor components of assembled products.

(6) National competent authorities or bodies should be allowed sufficient time to adapt their national system to the new requirements for testing and acceptance of final materials. The application of this Decision should therefore be deferred.

(7) 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

The procedures and methods for testing and accepting final materials as used in a product as provided for in Article 11(2), point (c), of Directive (EU) 2020/2184 on the quality of water intended for human consumption are set out in the Annexes I to IV.

Article 2 Definitions

For the purposes of this Decision, the following definitions apply: (1) starting substance means a substance that has been intentionally added in the production of organic materials or of admixtures for cementitious materials; (a) a substance that has been intentionally used to manufacture a cementitious material; (b) an alloying element present in a composition of metallic materials; (c) an element or a combination of elements present in a composition of enamels, ceramic or other inorganic materials; (d) a substance present in a mixture of substances. (2) constituent means: any of the following: (3) product means an object that comes into contact with water intended for human consumption, which is made of final materials and with the intention to be placed on the market; (4) assembled product means a product that consists of two or more components, that are joined together and function as a whole unit and can be disassembled without destroying the components; (5) component means an identifiable part of an assembled product consisting of one or more materials; (6) multilayer product means a product that consist of two or more layers of final materials bonded together and cannot be non-destructively disassembled for the testing; (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. (7) material means a solid, semi-solid or liquid that is used for the manufacturing of a product that is: (8) organic material means a material that mainly consists of carbon-based substances; (9) metallic material means a metal or metal alloy, and that is used either in bulk form or as metallic plating; (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) enamel means a material that is a vitreous material obtained by melting at temperatures higher than 1200 °C and fritting of a mixture of inorganic substances; (12) ceramic material means inorganic poly or single crystalline, non-metallic solid materials subjected to high temperature in manufacture; (13) final material means a material which is subject to testing and acceptance in accordance with the testing requirements and acceptance requirements set out in the respective Annexes I, II, III and IV to this Decision; (14) site applied material means a final material to be produced on a construction site; (15) test piece means a representative object of the final material that is used for the carrying out of testing in accordance with the procedures and methods for testing set out in the respective Annexes I, II, III and IV of this Decision; (16) unexpected substance means a substance that has migrated from a product, a final organic material or a final cementitious material into water intended for human consumption, that was not intentionally added during the production process of the material or product, and that was not included in the information provided in the application referred to in Article 11(5) of Directive (EU) 2020/2184; (17) formulation means the list of all substances or constituents used in the preparation of an organic material or of a cementitious material and their relative quantities; (18) total barrier means a barrier layer that prevents the diffusion of any substances towards the side of the final material in contact with the water intended for human consumption; (19) enhancement of microbial growth (EMG) means the ability of final organic or cementitious materials to enhance the multiplication of micro-organisms under specified conditions; (20) migration water means the test water that has been in contact with the test piece under the specified conditions set out in the respective Annexes I, II, III and IV.

(1) starting substance means a substance that has been intentionally added in the production of organic materials or of admixtures for cementitious materials;

(2) constituent means: any of the following: (a) a substance that has been intentionally used to manufacture a cementitious material; (b) an alloying element present in a composition of metallic materials; (c) an element or a combination of elements present in a composition of enamels, ceramic or other inorganic materials; (d) a substance present in a mixture of substances.

(a) a substance that has been intentionally used to manufacture a cementitious material;

(b) an alloying element present in a composition of metallic materials;

(c) an element or a combination of elements present in a composition of enamels, ceramic or other inorganic materials;

(d) a substance present in a mixture of substances.

(3) product means an object that comes into contact with water intended for human consumption, which is made of final materials and with the intention to be placed on the market;

(4) assembled product means a product that consists of two or more components, that are joined together and function as a whole unit and can be disassembled without destroying the components;

(5) component means an identifiable part of an assembled product consisting of one or more materials;

(6) multilayer product means a product that consist of two or more layers of final materials bonded together and cannot be non-destructively disassembled for the testing;

(7) 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.

(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.

(8) organic material means a material that mainly consists of carbon-based substances;

(9) metallic material means a metal or metal alloy, and that is used either in bulk form or as metallic plating;

(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) enamel means a material that is a vitreous material obtained by melting at temperatures higher than 1200 °C and fritting of a mixture of inorganic substances;

(12) ceramic material means inorganic poly or single crystalline, non-metallic solid materials subjected to high temperature in manufacture;

(13) final material means a material which is subject to testing and acceptance in accordance with the testing requirements and acceptance requirements set out in the respective Annexes I, II, III and IV to this Decision;

(14) site applied material means a final material to be produced on a construction site;

(15) test piece means a representative object of the final material that is used for the carrying out of testing in accordance with the procedures and methods for testing set out in the respective Annexes I, II, III and IV of this Decision;

(16) unexpected substance means a substance that has migrated from a product, a final organic material or a final cementitious material into water intended for human consumption, that was not intentionally added during the production process of the material or product, and that was not included in the information provided in the application referred to in Article 11(5) of Directive (EU) 2020/2184;

(17) formulation means the list of all substances or constituents used in the preparation of an organic material or of a cementitious material and their relative quantities;

(18) total barrier means a barrier layer that prevents the diffusion of any substances towards the side of the final material in contact with the water intended for human consumption;

(19) enhancement of microbial growth (EMG) means the ability of final organic or cementitious materials to enhance the multiplication of micro-organisms under specified conditions;

(20) migration water means the test water that has been in contact with the test piece under the specified conditions set out in the respective Annexes I, II, III and IV.

Article 3

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

ANNEX

(1) Categorisation of products or components into risk groups and corresponding testing requirements (2) Formulation review (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (a) Total Organic Carbon (TOC) (b) Relevant substances (c) Unexpected substances (1) Migration test for (2) Modelling of migration of relevant substances (a) Odour and flavour (b) Colour and turbidity (3) Migration test for (4) Testing for Enhancement of Microbial Growth (EMG) (5) Testing residual content of substances (2) Step 2 – Performance of tests (3) Step 3 – Compliance with pass/fail criteria Grp. 1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL ORGANIC MATERIALS AS USED IN A PRODUCT. The procedure for testing and accepting final organic materials as used in a product includes the following steps: Grp_21_table. 1. Categorisation of products or components into risk groups and corresponding testing requirements. For each product or component of an assembled product, a product group and a corresponding conversion factor (CF) shall be determined in accordance with Table 5. Based on the determined CF, the product or component is categorised in a risk group (RG) in accordance with Table 1. The categorisation in a RG determines the corresponding testing requirements including the relevant substances and relevant other parameters. The applicable testing procedure of final organic materials results from the use of these materials in products or components of assembled products. Minor components are considered to be components categorised in risk group 3 or 4 (RG3 or RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1 or 2 (RG1 or RG2). For an assembled product, the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same main polymer, then the surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5. Products or components made of multilayer materials are considered as one final material consisting of several layers. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. The specification in Table 1 for testing on product or component means that the individual product or component of an assembled product shall be used for the performance of the testing. The specification in Table 1 for testing on test piece of the formulation means that a representative test piece of the final material as used in a product or component can be considered for the testing. In this case it is not required that the individual product or component is tested. Risk group CF in d/dm Formu-lation review Relevant substances Screening for unexpected substances TOC TON, TFN, colour, turbidity EMG RG1 ≥ 4 Yes Yes, on product Yes, on product Yes, on product Yes, on product Yes, on product for pipes with CF >10 d/dm or test piece of the formulation RG2 ≥ 0,4 and < 4 Yes Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product or component Yes, on (assembled) product or component Yes, on component or test piece of the formulation RG3 ≥ 0,04 and < 0,4 Yes Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on component or test piece of the formulation RG4 < 0,04 No No Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on component or test piece of the formulation (a) list of all starting substances (including their impurities and other specifications) used to produce the final organic material including all monomers, additives, aids to polymerisation, polymer production aids, pigments, colorants and fillers; (b) the respective percentage by mass (m/m %) of all starting substances and substances used to produce the final material, adding up to 100 %. (c) any other information considered relevant for the assessment of the formulation of the final organic material. Pt_a_. 2. for one substance: 0,02 % for RG1, 0,05 % for RG2 and 0,1 % for RG3 materials; and Pt_b_. 2. for the sum of all such substances: 0,1 % for RG1, 0,2 % for RG2 and 0,5 % for RG3. Grp. 221. Required information For a formulation review of a final organic material the following information is required: The cut-off value, below which details of the formulation (i.e. the chemical composition of starting substances or impurities) are not required, expressed as mass percentage in the formulation is: In case of multilayer products with a total barrier, only the layers between the barrier and the surface in contact with drinking water shall be considered. The formulation shall be specified for each layer to be considered. (a) Starting substances used in the formulation, listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (b) Substances like impurities, degradation or reaction products specified in the condition of use of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 used in the formulation; (c) All substances set out in Table 4 of Annex I of Commission Implementing Decision (EU) 2024/367 of starting substances for organic materials if stabilizers with alkylphenol structural moieties are used; (d) Starting substances used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 (b) of this Annex; (e) Aluminium, ammonium, barium, cobalt, copper, europium, gadolinium, iron, lanthanum, lithium, manganese, terbium and/or zinc, if the respective salts of authorised acids, phenols or alcohols, authorised in accordance with note 2. Scope of an authorisation, point ii. of the Annex I of Commission Implementing Decision (EU) 2024/367 are used; (f) Starting substances of polymeric substances authorised in accordance with note 2. Scope of an authorisation, point iii. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (g) Starting substances of pre-polymers and natural or synthetic polymers authorised in accordance with note 2. Scope of an authorisation, point v. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (h) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (i) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (j) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if fillers are used in the formulation not complying with the purity requirements according to section 4.6 of this Annex or if the purity testing was not performed; (k) In case additional material-specific criteria apply (see section 2.2.4): all substances or group of substances for which an MTCtap has been set; (l) In case of migration test with chlorinated test water: haloacetic acids (HAAs) and trihalomethanes total, as defined in part B of Annex I – to Directive (EU) 2020/2184. Grp. 222. Relevant substances The formulation shall be evaluated and compared with the accepted starting substances of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367. One of the objectives of the evaluation is to define the relevant substances, which shall be analysed in the migration water. The relevant substances are: For multilayer materials, the relevant substances shall be determined for each layer between the total barrier and the drinking water individually. (a) starting substances listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367; or (1) substances classified as carcinogenic, mutagenic, toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006 (REACH) for the ED, PBT or vPvB properties; (2) substances intentionally added in nanoform; (3) monomers of the main polymers in the material. (b) starting substances for which no migration of the substance, its impurities and/or its reaction and degradation products into drinking water occurs at levels exceeding 0,1 μg/l at the consumer’s tap. This only applies to substances that do not belong to either one of the following categories: Grp. 223. Acceptance of starting substances Organic materials shall only be made of : The relevant notes of the Annex I to Commission Implementing Decision (EU) 2024/367 establishing the European positive list of starting substances for organic materials shall be considered in the acceptance of starting substances. Grp_224_table_2_table_3_table. 4. Material-specific requirements For polyamide or polyurethane resin coatings, requirements on the release of primary aromatic amines (PAA) apply, as specified in Table 2. Requirements for rubbers are listed in Table 3. Requirements for organic materials other than rubbers made of starting substances bearing N-functionalities, such as aminic, amidic or quaternary, when tested with chlorinated test water are listed in Table 4. Parameter Restriction Sum of Primary Aromatic Amines (PAA) MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of Primary Aromatic Amines (PAA) (a.o. aniline, o-toluidine) MTC tap = N.D. (LOD = 0,1 μg/l) Sum of secondary amines MTC tap = 250 μg/l Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l) Grp. 22. Formulation review A formulation review is required in accordance with the requirements in Table 1. Grp. 2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS (a) For factory-made products: EN 12873-1:2014; (b) For site-applied materials: EN 12873-2:2021. Grp. 311. Standards For testing the release of relevant substances, unexpected substances and TOC, the following standards shall be used to obtain the migration waters: For testing odour and flavour, colour and turbidity, standard EN 1420:2016 shall be used to obtain the migration waters. The mentioned EN standards leave options for testing. The following provisions in sections 3.1.2, 3.1.3, 3.1.4 and 3.1.5 substantiate these standards. Grp. 312. Test piece For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece. Grp. 313. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. Multilayer products shall always be tested at 60 °C ± 2 °C or 85 °C ± 2 °C additionally, even when not used at these temperatures. Grp. 314. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, this test shall only be performed with non-chlorinated test water. Grp. 315. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria set out in sections 4.2 and 4.3 are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria set out in sections 4.2 and 4.3 are not met at the 7th migration period the testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day). For multilayer products an extended warm or hot water migration test is always required to ensure that substances originating from different layers appear in the migration water. To ensure sufficient substance diffusion and equilibration across layer boundaries, it is required that the multilayer product has undergone a storage period at room temperature for at least 30 days. Grp. 31. Migration testing Grp. 321. Relevant Substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters (see section 3.1.5). The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 322. Unexpected Substances Unexpected substances are only determined in the migration waters of the cold water test. For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening shall be conducted according to EN 15768:2015. (a) Total Organic Carbon (TOC) shall be determined according to EN 1484:1997 as non-purgeable organic carbon; (b) Odour shall be determined as Threshold Odour Number (TON) according to EN 1420:2016 and EN 1622:2006; (c) Flavour shall be determined as Threshold Flavour Number (TFN) according to EN 1420:2016 and EN 1622:2006; (d) Colour shall be determined according to EN ISO 7887:2011 – method C; (e) Turbidity shall be determined according to EN ISO 7027-1:2016 - nephelometry. Grp. 323. Relevant other parameters The relevant other parameters shall be analysed in the migration waters according to the following standards: Grp. 32. Analysis of migration waters (a) Migration modelling according to CEN/TR 16364:2012 or other equivalent standards accepted at international level, simulating a migration test according to the EN 12873-1:2014 and EN 12873-2:2021; (b) Full transfer calculation, simulating full transfer of substances from the product into the migration water. Grp. 33. Mathematical modelling Where generally recognised diffusion models exist on the basis of experimental data, mathematical modelling for estimation of migration levels may be used as alternative to the migration testing of relevant substances for certain types of final organic materials. If these recognised diffusion models predict that the migration of the substance complies with the maximum tolerable concentration at the tap (MTCtap), migration testing for these substances is not necessary. For the assessment of some parameters and for modelling, the content of the respective substances in the final material shall be determined. If compliance is not shown by using the models, migration testing shall be performed. The following mathematical modelling approaches may be used: Grp. 34. Enhancement of Microbial Growth (EMG) testing For the EMG testing, standard EN 16421:2015 – method 1 or 2 shall be used. Grp. 35. Testing residual content of substances (QM/QMA) For starting substances with a maximum quantity (QM or QMA) restriction set out in the European positive list of starting substances for organic materials of Annex I of Commission Implementing Decision (EU) 2024/367, its residual content in the product shall be analysed. Grp. 3. TESTING REQUIREMENTS (a) shall be used according to the technical function specified in the European positive list of starting substances for organic materials; (b) shall be used in compliance with conditions of use established under the European positive list of starting substances for organic materials. Grp. 41. Formulation Starting substances of the formulation listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367. Grp_421_table_5. 234. Conversion of test results In accordance with the migration standards EN 12873-1:2014 and EN 12873-2:2021, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to this Annex. Components (sum of components made of same main polymer or same composition) of assembled products with a wetted surface fraction Product group CF (in d/dm) A Pipes and pipe linings 1 ID < 80 mm (domestic installations, buildings) 20 2 80 mm ≤ ID < 300 mm (service piping) 10 3 ID ≥ 300 mm (mains piping) 5 B Fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 2 2 80 mm ≤ ID < 300 mm (service piping) 1 3 ID ≥ 300 mm (mains piping) 0,5 C Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,2 2 80 mm ≤ ID < 300 mm (service piping) 0,1 3 ID ≥ 300 mm (mains piping) 0,05 D Small Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,02 2 80 mm ≤ ID < 300 mm (service piping) 0,01 3 ID ≥ 300 mm (mains piping) 0,005 E Storage systems (reservoirs) 1 In domestic installations, buildings, water volume < 10 l 4 2 In domestic installations, buildings, water volume ≥ 10 l 2 3 In water supply 1 F Components of storage systems 1 In domestic installations, buildings, water volume < 10 l 0,4 2 In domestic installations, buildings; water volume ≥ 10 l 0,2 3 In water supply 0,1 G Small Components storage systems 1 In domestic installations, buildings; water volume < 10 l 0,04 2 In domestic installations, buildings; water volume ≥ 10 l 0,02 3 In water supply 0,01 (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. For ions, the MTCtap,organics of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing). Grp. 423. Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test: The MTCtap for the unexpected substances are set out in Table 6. Parameter MTCtap Identified substances with a known MTCtap MTCtap of the substance Identified substance without a known MTCtap 1,0 μg/l Unidentified substances 1,0 μg/l per unidentified substance 1 5,0 μg/l for the sum of the unidentified substances (a) Ctap ≤ 0,5 mg/l for the 3rd migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 9th migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 3rd migration period (10th day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 22nd migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 7th migration period (10th day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 424. Pass/fail criteria for TOC The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required. Grp. 42. Relevant substances, unexpected substances, TOC (i) Pass/fail criteria for TON and TFN for pipes with internal diameter (ID) < 80 mm: (a) TON, TFN ≤ 8,0 for the 3rd migration period (10th day of testing); or (b) TON, TFN ≤ 8,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 16 for the 3rd migration period (10th day of testing). Pt_a_. 2. TON, TFN ≤ 8,0 for the 7th migration period (10th day of testing); or Pt_b_. 2. TON, TFN ≤ 8,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 16 for the 7th migration period (10th day of testing). (ii) Pass/fail criteria for TON and TFN for all other products: Pt_a_. 3. TON, TFN ≤ 2,0 for the 3rd migration period (10th day of testing); or Pt_b_. 3. TON, TFN ≤ 2,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 3rd migration period (10th day of testing). Pt_a_. 4. TON, TFN ≤ 2,0 for the 7th migration period (10th day of testing); or Pt_b_. 4. TON, TFN ≤ 2,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 7th migration period (10th day of testing). Grp. 431. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: Grp. 432. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing). Grp. 433. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing). Grp. 43. Odour, flavour, colour and turbidity Grp_44_table. 7. Enhancement of Microbial Growth (EMG) The pass/fail criteria for the parameter Enhancement of Microbial Growth (EMG) are listed in Table 7. Additionally, the surface of the products or components shall not have any biocidal effects on water intended for human consumption. Therefore, test pieces without surface colonisation (comparison of contact culture/test sample smear with that of the negative control) do not satisfy this requirement. Standard Non-elastomers Elastomers (CF > 1 d/dm) Elastomers (1 d/dm ≥ CF > 0,1 d/dm) Elastomers (CF ≤ 0,1 d/dm) EN 16421 Method 1 Biomass production potential (BPP) in pg ATP/ cm2 ≤ 1000 ≤ 1000 ≤ 1000 ≤ 1000 EN 16421 Method 2 Vbiofilm in ml/800 cm2 ≤ 0,05 ± 0,02 ≤ 0,05 ± 0,02 ≤ 0,12 ± 0,03 ≤ 0,20 ± 0,03 Grp. 45. Pass/fail criteria for residual content of substances (QM and QMA) The maximum quantity (QM and QMA) limits of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 shall apply independently of the product group of final organic materials. (1) antimony 0,05 % (2) arsenic 0,01 % (3) barium 0,01 % (4) cadmium 0,01 % (5) chromium 0,1 % (6) lead 0,01 % (7) mercury 0,005 % (8) selenium 0,01 % (a) When extracted with 0,1 N hydrochloric acid, the following elements may dissolve from the colorant or pigment up to the maximum amount, based on the colorant or pigment: (b) The content of primary aromatic amines soluble in 1 M hydrochloric acid shall not exceed 0,05 % (calculated as aniline). This limit does not apply to primary aromatic amines containing carboxyl- or sulfo-groups, (3) When extracted with 2 N ethanolic hydrochloric acid, a maximum of 0,05 % aromatic amines (based on the colorant or pigment) may dissolve from the colorant or pigment. (4) antimony 0,005 % (5) arsenic 0,01 % (6) barium 0,01 % (7) cadmium 0,01 % (8) chromium 0,1 % (9) lead 0,01 % (10) mercury 0,0005 % (11) selenium 0,01 % Grp_46_table. 8. Purity pass/fail criteria for pigments, colorants and fillers Pigments, colorants and fillers shall comply with the purity requirements according to Table 8, if the corresponding substances were not analysed as relevant substances in the migration waters. The extraction with 0,1 N hydrochloric acid shall be performed according to the procedure described in Council of Europe resolution AP(89)1 on the use of colourants in plastic materials coming into contact with food. Pigments and colorants Colorants and pigments shall comply with the following purity requirements: or Fillers Fillers can be contaminated with impurities. For mineral fillers, the following specification applies: After solution in 0,1 N hydrochloric acid, the concentration of the following elements shall not exceed the maximum amount, based on the filler: Grp. 4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA

ANNEX I FINAL ORGANIC MATERIAL

1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL ORGANIC MATERIALS AS USED IN A PRODUCT. The procedure for testing and accepting final organic materials as used in a product includes the following steps: (1) Categorisation of products or components into risk groups and corresponding testing requirements (2) Formulation review (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (a) Total Organic Carbon (TOC) (b) Relevant substances (c) Unexpected substances (1) Migration test for (2) Modelling of migration of relevant substances (a) Odour and flavour (b) Colour and turbidity (3) Migration test for (4) Testing for Enhancement of Microbial Growth (EMG) (5) Testing residual content of substances (2) Step 2 – Performance of tests (3) Step 3 – Compliance with pass/fail criteria

Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Categorisation of products or components into risk groups and corresponding testing requirements (2) Formulation review

1.

pt_1

1. Categorisation of products or components into risk groups and corresponding testing requirements

2. Formulation review

Step 2 – Performance of tests (a) Total Organic Carbon (TOC) (b) Relevant substances (c) Unexpected substances (1) Migration test for (2) Modelling of migration of relevant substances (a) Odour and flavour (b) Colour and turbidity (3) Migration test for (4) Testing for Enhancement of Microbial Growth (EMG) (5) Testing residual content of substances

pt_2

1. Migration test for (a) Total Organic Carbon (TOC) (b) Relevant substances (c) Unexpected substances

1.

(a) Total Organic Carbon (TOC)

(b) Relevant substances

(c) Unexpected substances

2. Modelling of migration of relevant substances

3. Migration test for (a) Odour and flavour (b) Colour and turbidity

3.

(a) Odour and flavour

(b) Colour and turbidity

4. Testing for Enhancement of Microbial Growth (EMG)

5. Testing residual content of substances

Step 3 – Compliance with pass/fail criteria

2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS Grp_21_table. 1. Categorisation of products or components into risk groups and corresponding testing requirements. For each product or component of an assembled product, a product group and a corresponding conversion factor (CF) shall be determined in accordance with Table 5. Based on the determined CF, the product or component is categorised in a risk group (RG) in accordance with Table 1. The categorisation in a RG determines the corresponding testing requirements including the relevant substances and relevant other parameters. The applicable testing procedure of final organic materials results from the use of these materials in products or components of assembled products. Minor components are considered to be components categorised in risk group 3 or 4 (RG3 or RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1 or 2 (RG1 or RG2). For an assembled product, the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same main polymer, then the surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5. Products or components made of multilayer materials are considered as one final material consisting of several layers. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. The specification in Table 1 for testing on product or component means that the individual product or component of an assembled product shall be used for the performance of the testing. The specification in Table 1 for testing on test piece of the formulation means that a representative test piece of the final material as used in a product or component can be considered for the testing. In this case it is not required that the individual product or component is tested. Risk group CF in d/dm Formu-lation review Relevant substances Screening for unexpected substances TOC TON, TFN, colour, turbidity EMG RG1 ≥ 4 Yes Yes, on product Yes, on product Yes, on product Yes, on product Yes, on product for pipes with CF >10 d/dm or test piece of the formulation RG2 ≥ 0,4 and < 4 Yes Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product or component Yes, on (assembled) product or component Yes, on component or test piece of the formulation RG3 ≥ 0,04 and < 0,4 Yes Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on component or test piece of the formulation RG4 < 0,04 No No Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on component or test piece of the formulation (a) list of all starting substances (including their impurities and other specifications) used to produce the final organic material including all monomers, additives, aids to polymerisation, polymer production aids, pigments, colorants and fillers; (b) the respective percentage by mass (m/m %) of all starting substances and substances used to produce the final material, adding up to 100 %. (c) any other information considered relevant for the assessment of the formulation of the final organic material. Pt_a_. 2. for one substance: 0,02 % for RG1, 0,05 % for RG2 and 0,1 % for RG3 materials; and Pt_b_. 2. for the sum of all such substances: 0,1 % for RG1, 0,2 % for RG2 and 0,5 % for RG3. Grp. 221. Required information For a formulation review of a final organic material the following information is required: The cut-off value, below which details of the formulation (i.e. the chemical composition of starting substances or impurities) are not required, expressed as mass percentage in the formulation is: In case of multilayer products with a total barrier, only the layers between the barrier and the surface in contact with drinking water shall be considered. The formulation shall be specified for each layer to be considered. (a) Starting substances used in the formulation, listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (b) Substances like impurities, degradation or reaction products specified in the condition of use of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 used in the formulation; (c) All substances set out in Table 4 of Annex I of Commission Implementing Decision (EU) 2024/367 of starting substances for organic materials if stabilizers with alkylphenol structural moieties are used; (d) Starting substances used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 (b) of this Annex; (e) Aluminium, ammonium, barium, cobalt, copper, europium, gadolinium, iron, lanthanum, lithium, manganese, terbium and/or zinc, if the respective salts of authorised acids, phenols or alcohols, authorised in accordance with note 2. Scope of an authorisation, point ii. of the Annex I of Commission Implementing Decision (EU) 2024/367 are used; (f) Starting substances of polymeric substances authorised in accordance with note 2. Scope of an authorisation, point iii. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (g) Starting substances of pre-polymers and natural or synthetic polymers authorised in accordance with note 2. Scope of an authorisation, point v. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (h) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (i) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (j) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if fillers are used in the formulation not complying with the purity requirements according to section 4.6 of this Annex or if the purity testing was not performed; (k) In case additional material-specific criteria apply (see section 2.2.4): all substances or group of substances for which an MTCtap has been set; (l) In case of migration test with chlorinated test water: haloacetic acids (HAAs) and trihalomethanes total, as defined in part B of Annex I – to Directive (EU) 2020/2184. Grp. 222. Relevant substances The formulation shall be evaluated and compared with the accepted starting substances of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367. One of the objectives of the evaluation is to define the relevant substances, which shall be analysed in the migration water. The relevant substances are: For multilayer materials, the relevant substances shall be determined for each layer between the total barrier and the drinking water individually. (a) starting substances listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367; or (1) substances classified as carcinogenic, mutagenic, toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006 (REACH) for the ED, PBT or vPvB properties; (2) substances intentionally added in nanoform; (3) monomers of the main polymers in the material. (b) starting substances for which no migration of the substance, its impurities and/or its reaction and degradation products into drinking water occurs at levels exceeding 0,1 μg/l at the consumer’s tap. This only applies to substances that do not belong to either one of the following categories: Grp. 223. Acceptance of starting substances Organic materials shall only be made of : The relevant notes of the Annex I to Commission Implementing Decision (EU) 2024/367 establishing the European positive list of starting substances for organic materials shall be considered in the acceptance of starting substances. Grp_224_table_2_table_3_table. 4. Material-specific requirements For polyamide or polyurethane resin coatings, requirements on the release of primary aromatic amines (PAA) apply, as specified in Table 2. Requirements for rubbers are listed in Table 3. Requirements for organic materials other than rubbers made of starting substances bearing N-functionalities, such as aminic, amidic or quaternary, when tested with chlorinated test water are listed in Table 4. Parameter Restriction Sum of Primary Aromatic Amines (PAA) MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of Primary Aromatic Amines (PAA) (a.o. aniline, o-toluidine) MTC tap = N.D. (LOD = 0,1 μg/l) Sum of secondary amines MTC tap = 250 μg/l Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l) Grp. 22. Formulation review A formulation review is required in accordance with the requirements in Table 1.

2.

2.1. Table 1 Risk-based testing requirements for products or components of assembled products

Categorisation of products or components into risk groups and corresponding testing requirements. For each product or component of an assembled product, a product group and a corresponding conversion factor (CF) shall be determined in accordance with Table 5. Based on the determined CF, the product or component is categorised in a risk group (RG) in accordance with Table 1. The categorisation in a RG determines the corresponding testing requirements including the relevant substances and relevant other parameters. The applicable testing procedure of final organic materials results from the use of these materials in products or components of assembled products. Minor components are considered to be components categorised in risk group 3 or 4 (RG3 or RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1 or 2 (RG1 or RG2). For an assembled product, the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same main polymer, then the surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5. Products or components made of multilayer materials are considered as one final material consisting of several layers. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. The specification in Table 1 for testing on product or component means that the individual product or component of an assembled product shall be used for the performance of the testing. The specification in Table 1 for testing on test piece of the formulation means that a representative test piece of the final material as used in a product or component can be considered for the testing. In this case it is not required that the individual product or component is tested. Risk group CF in d/dm Formu-lation review Relevant substances Screening for unexpected substances TOC TON, TFN, colour, turbidity EMG RG1 ≥ 4 Yes Yes, on product Yes, on product Yes, on product Yes, on product Yes, on product for pipes with CF >10 d/dm or test piece of the formulation RG2 ≥ 0,4 and < 4 Yes Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product or component Yes, on (assembled) product or component Yes, on component or test piece of the formulation RG3 ≥ 0,04 and < 0,4 Yes Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on component or test piece of the formulation RG4 < 0,04 No No Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on (assembled) product, component or test piece of the formulation Yes, on component or test piece of the formulation

2.2. Formulation review A formulation review is required in accordance with the requirements in Table 1. (a) list of all starting substances (including their impurities and other specifications) used to produce the final organic material including all monomers, additives, aids to polymerisation, polymer production aids, pigments, colorants and fillers; (b) the respective percentage by mass (m/m %) of all starting substances and substances used to produce the final material, adding up to 100 %. (c) any other information considered relevant for the assessment of the formulation of the final organic material. Pt_a_. 2. for one substance: 0,02 % for RG1, 0,05 % for RG2 and 0,1 % for RG3 materials; and Pt_b_. 2. for the sum of all such substances: 0,1 % for RG1, 0,2 % for RG2 and 0,5 % for RG3. Grp. 221. Required information For a formulation review of a final organic material the following information is required: The cut-off value, below which details of the formulation (i.e. the chemical composition of starting substances or impurities) are not required, expressed as mass percentage in the formulation is: In case of multilayer products with a total barrier, only the layers between the barrier and the surface in contact with drinking water shall be considered. The formulation shall be specified for each layer to be considered. (a) Starting substances used in the formulation, listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (b) Substances like impurities, degradation or reaction products specified in the condition of use of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 used in the formulation; (c) All substances set out in Table 4 of Annex I of Commission Implementing Decision (EU) 2024/367 of starting substances for organic materials if stabilizers with alkylphenol structural moieties are used; (d) Starting substances used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 (b) of this Annex; (e) Aluminium, ammonium, barium, cobalt, copper, europium, gadolinium, iron, lanthanum, lithium, manganese, terbium and/or zinc, if the respective salts of authorised acids, phenols or alcohols, authorised in accordance with note 2. Scope of an authorisation, point ii. of the Annex I of Commission Implementing Decision (EU) 2024/367 are used; (f) Starting substances of polymeric substances authorised in accordance with note 2. Scope of an authorisation, point iii. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (g) Starting substances of pre-polymers and natural or synthetic polymers authorised in accordance with note 2. Scope of an authorisation, point v. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (h) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (i) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (j) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if fillers are used in the formulation not complying with the purity requirements according to section 4.6 of this Annex or if the purity testing was not performed; (k) In case additional material-specific criteria apply (see section 2.2.4): all substances or group of substances for which an MTCtap has been set; (l) In case of migration test with chlorinated test water: haloacetic acids (HAAs) and trihalomethanes total, as defined in part B of Annex I – to Directive (EU) 2020/2184. Grp. 222. Relevant substances The formulation shall be evaluated and compared with the accepted starting substances of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367. One of the objectives of the evaluation is to define the relevant substances, which shall be analysed in the migration water. The relevant substances are: For multilayer materials, the relevant substances shall be determined for each layer between the total barrier and the drinking water individually. (a) starting substances listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367; or (1) substances classified as carcinogenic, mutagenic, toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006 (REACH) for the ED, PBT or vPvB properties; (2) substances intentionally added in nanoform; (3) monomers of the main polymers in the material. (b) starting substances for which no migration of the substance, its impurities and/or its reaction and degradation products into drinking water occurs at levels exceeding 0,1 μg/l at the consumer’s tap. This only applies to substances that do not belong to either one of the following categories: Grp. 223. Acceptance of starting substances Organic materials shall only be made of : The relevant notes of the Annex I to Commission Implementing Decision (EU) 2024/367 establishing the European positive list of starting substances for organic materials shall be considered in the acceptance of starting substances. Grp_224_table_2_table_3_table. 4. Material-specific requirements For polyamide or polyurethane resin coatings, requirements on the release of primary aromatic amines (PAA) apply, as specified in Table 2. Requirements for rubbers are listed in Table 3. Requirements for organic materials other than rubbers made of starting substances bearing N-functionalities, such as aminic, amidic or quaternary, when tested with chlorinated test water are listed in Table 4. Parameter Restriction Sum of Primary Aromatic Amines (PAA) MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of Primary Aromatic Amines (PAA) (a.o. aniline, o-toluidine) MTC tap = N.D. (LOD = 0,1 μg/l) Sum of secondary amines MTC tap = 250 μg/l Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l)

2.2.

2.2.1 Required information For a formulation review of a final organic material the following information is required: The cut-off value, below which details of the formulation (i.e. the chemical composition of starting substances or impurities) are not required, expressed as mass percentage in the formulation is: In case of multilayer products with a total barrier, only the layers between the barrier and the surface in contact with drinking water shall be considered. The formulation shall be specified for each layer to be considered. (a) list of all starting substances (including their impurities and other specifications) used to produce the final organic material including all monomers, additives, aids to polymerisation, polymer production aids, pigments, colorants and fillers; (b) the respective percentage by mass (m/m %) of all starting substances and substances used to produce the final material, adding up to 100 %. (c) any other information considered relevant for the assessment of the formulation of the final organic material. Pt_a_. 2. for one substance: 0,02 % for RG1, 0,05 % for RG2 and 0,1 % for RG3 materials; and Pt_b_. 2. for the sum of all such substances: 0,1 % for RG1, 0,2 % for RG2 and 0,5 % for RG3.

2.2.1

(a) list of all starting substances (including their impurities and other specifications) used to produce the final organic material including all monomers, additives, aids to polymerisation, polymer production aids, pigments, colorants and fillers;

(b) the respective percentage by mass (m/m %) of all starting substances and substances used to produce the final material, adding up to 100 %.

(c) any other information considered relevant for the assessment of the formulation of the final organic material.

(a) for one substance: 0,02 % for RG1, 0,05 % for RG2 and 0,1 % for RG3 materials; and

(b) for the sum of all such substances: 0,1 % for RG1, 0,2 % for RG2 and 0,5 % for RG3.

2.2.2 Relevant substances The formulation shall be evaluated and compared with the accepted starting substances of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367. One of the objectives of the evaluation is to define the relevant substances, which shall be analysed in the migration water. The relevant substances are: For multilayer materials, the relevant substances shall be determined for each layer between the total barrier and the drinking water individually. (a) Starting substances used in the formulation, listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (b) Substances like impurities, degradation or reaction products specified in the condition of use of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 used in the formulation; (c) All substances set out in Table 4 of Annex I of Commission Implementing Decision (EU) 2024/367 of starting substances for organic materials if stabilizers with alkylphenol structural moieties are used; (d) Starting substances used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 (b) of this Annex; (e) Aluminium, ammonium, barium, cobalt, copper, europium, gadolinium, iron, lanthanum, lithium, manganese, terbium and/or zinc, if the respective salts of authorised acids, phenols or alcohols, authorised in accordance with note 2. Scope of an authorisation, point ii. of the Annex I of Commission Implementing Decision (EU) 2024/367 are used; (f) Starting substances of polymeric substances authorised in accordance with note 2. Scope of an authorisation, point iii. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (g) Starting substances of pre-polymers and natural or synthetic polymers authorised in accordance with note 2. Scope of an authorisation, point v. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies; (h) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (i) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed; (j) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if fillers are used in the formulation not complying with the purity requirements according to section 4.6 of this Annex or if the purity testing was not performed; (k) In case additional material-specific criteria apply (see section 2.2.4): all substances or group of substances for which an MTCtap has been set; (l) In case of migration test with chlorinated test water: haloacetic acids (HAAs) and trihalomethanes total, as defined in part B of Annex I – to Directive (EU) 2020/2184.

2.2.2

(a) Starting substances used in the formulation, listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies;

(b) Substances like impurities, degradation or reaction products specified in the condition of use of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 used in the formulation;

(c) All substances set out in Table 4 of Annex I of Commission Implementing Decision (EU) 2024/367 of starting substances for organic materials if stabilizers with alkylphenol structural moieties are used;

(d) Starting substances used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 (b) of this Annex;

(e) Aluminium, ammonium, barium, cobalt, copper, europium, gadolinium, iron, lanthanum, lithium, manganese, terbium and/or zinc, if the respective salts of authorised acids, phenols or alcohols, authorised in accordance with note 2. Scope of an authorisation, point ii. of the Annex I of Commission Implementing Decision (EU) 2024/367 are used;

(f) Starting substances of polymeric substances authorised in accordance with note 2. Scope of an authorisation, point iii. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies;

(g) Starting substances of pre-polymers and natural or synthetic polymers authorised in accordance with note 2. Scope of an authorisation, point v. of the Annex I of Commission Implementing Decision (EU) 2024/367 for which an MTCtap applies;

(h) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed;

(i) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements in accordance with section 4.6 of this Annex or if the purity testing was not performed;

(j) Antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium if fillers are used in the formulation not complying with the purity requirements according to section 4.6 of this Annex or if the purity testing was not performed;

(k) In case additional material-specific criteria apply (see section 2.2.4): all substances or group of substances for which an MTCtap has been set;

(l) In case of migration test with chlorinated test water: haloacetic acids (HAAs) and trihalomethanes total, as defined in part B of Annex I – to Directive (EU) 2020/2184.

2.2.3 Acceptance of starting substances Organic materials shall only be made of : The relevant notes of the Annex I to Commission Implementing Decision (EU) 2024/367 establishing the European positive list of starting substances for organic materials shall be considered in the acceptance of starting substances. (a) starting substances listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367; or (1) substances classified as carcinogenic, mutagenic, toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006 (REACH) for the ED, PBT or vPvB properties; (2) substances intentionally added in nanoform; (3) monomers of the main polymers in the material. (b) starting substances for which no migration of the substance, its impurities and/or its reaction and degradation products into drinking water occurs at levels exceeding 0,1 μg/l at the consumer’s tap. This only applies to substances that do not belong to either one of the following categories:

2.2.3

(a) starting substances listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367; or

(b) starting substances for which no migration of the substance, its impurities and/or its reaction and degradation products into drinking water occurs at levels exceeding 0,1 μg/l at the consumer’s tap. This only applies to substances that do not belong to either one of the following categories: (1) substances classified as carcinogenic, mutagenic, toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006 (REACH) for the ED, PBT or vPvB properties; (2) substances intentionally added in nanoform; (3) monomers of the main polymers in the material.

(b)

(1) substances classified as carcinogenic, mutagenic, toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006 (REACH) for the ED, PBT or vPvB properties;

(2) substances intentionally added in nanoform;

(3) monomers of the main polymers in the material.

2.2.4 Table 2 Table 3 Table 4 Requirement for polyamides and polyurethane resin coatings Requirements on amines and nitrosamines for rubbers Requirements on nitrosamines for final materials other than rubbers made of starting substances bearing N-functionalities when tested with chlorinated test water

Material-specific requirements For polyamide or polyurethane resin coatings, requirements on the release of primary aromatic amines (PAA) apply, as specified in Table 2. Requirements for rubbers are listed in Table 3. Requirements for organic materials other than rubbers made of starting substances bearing N-functionalities, such as aminic, amidic or quaternary, when tested with chlorinated test water are listed in Table 4. Parameter Restriction Sum of Primary Aromatic Amines (PAA) MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of Primary Aromatic Amines (PAA) (a.o. aniline, o-toluidine) MTC tap = N.D. (LOD = 0,1 μg/l) Sum of secondary amines MTC tap = 250 μg/l Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l) Parameter Restriction Sum of N-nitrosamines MTC tap = N.D. (LOD = 0,1 μg/l)

3. TESTING REQUIREMENTS (a) For factory-made products: EN 12873-1:2014; (b) For site-applied materials: EN 12873-2:2021. Grp. 311. Standards For testing the release of relevant substances, unexpected substances and TOC, the following standards shall be used to obtain the migration waters: For testing odour and flavour, colour and turbidity, standard EN 1420:2016 shall be used to obtain the migration waters. The mentioned EN standards leave options for testing. The following provisions in sections 3.1.2, 3.1.3, 3.1.4 and 3.1.5 substantiate these standards. Grp. 312. Test piece For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece. Grp. 313. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. Multilayer products shall always be tested at 60 °C ± 2 °C or 85 °C ± 2 °C additionally, even when not used at these temperatures. Grp. 314. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, this test shall only be performed with non-chlorinated test water. Grp. 315. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria set out in sections 4.2 and 4.3 are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria set out in sections 4.2 and 4.3 are not met at the 7th migration period the testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day). For multilayer products an extended warm or hot water migration test is always required to ensure that substances originating from different layers appear in the migration water. To ensure sufficient substance diffusion and equilibration across layer boundaries, it is required that the multilayer product has undergone a storage period at room temperature for at least 30 days. Grp. 31. Migration testing Grp. 321. Relevant Substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters (see section 3.1.5). The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 322. Unexpected Substances Unexpected substances are only determined in the migration waters of the cold water test. For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening shall be conducted according to EN 15768:2015. (a) Total Organic Carbon (TOC) shall be determined according to EN 1484:1997 as non-purgeable organic carbon; (b) Odour shall be determined as Threshold Odour Number (TON) according to EN 1420:2016 and EN 1622:2006; (c) Flavour shall be determined as Threshold Flavour Number (TFN) according to EN 1420:2016 and EN 1622:2006; (d) Colour shall be determined according to EN ISO 7887:2011 – method C; (e) Turbidity shall be determined according to EN ISO 7027-1:2016 - nephelometry. Grp. 323. Relevant other parameters The relevant other parameters shall be analysed in the migration waters according to the following standards: Grp. 32. Analysis of migration waters (a) Migration modelling according to CEN/TR 16364:2012 or other equivalent standards accepted at international level, simulating a migration test according to the EN 12873-1:2014 and EN 12873-2:2021; (b) Full transfer calculation, simulating full transfer of substances from the product into the migration water. Grp. 33. Mathematical modelling Where generally recognised diffusion models exist on the basis of experimental data, mathematical modelling for estimation of migration levels may be used as alternative to the migration testing of relevant substances for certain types of final organic materials. If these recognised diffusion models predict that the migration of the substance complies with the maximum tolerable concentration at the tap (MTCtap), migration testing for these substances is not necessary. For the assessment of some parameters and for modelling, the content of the respective substances in the final material shall be determined. If compliance is not shown by using the models, migration testing shall be performed. The following mathematical modelling approaches may be used: Grp. 34. Enhancement of Microbial Growth (EMG) testing For the EMG testing, standard EN 16421:2015 – method 1 or 2 shall be used. Grp. 35. Testing residual content of substances (QM/QMA) For starting substances with a maximum quantity (QM or QMA) restriction set out in the European positive list of starting substances for organic materials of Annex I of Commission Implementing Decision (EU) 2024/367, its residual content in the product shall be analysed.

3.

3.1. Migration testing (a) For factory-made products: EN 12873-1:2014; (b) For site-applied materials: EN 12873-2:2021. Grp. 311. Standards For testing the release of relevant substances, unexpected substances and TOC, the following standards shall be used to obtain the migration waters: For testing odour and flavour, colour and turbidity, standard EN 1420:2016 shall be used to obtain the migration waters. The mentioned EN standards leave options for testing. The following provisions in sections 3.1.2, 3.1.3, 3.1.4 and 3.1.5 substantiate these standards. Grp. 312. Test piece For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece. Grp. 313. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. Multilayer products shall always be tested at 60 °C ± 2 °C or 85 °C ± 2 °C additionally, even when not used at these temperatures. Grp. 314. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, this test shall only be performed with non-chlorinated test water. Grp. 315. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria set out in sections 4.2 and 4.3 are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria set out in sections 4.2 and 4.3 are not met at the 7th migration period the testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day). For multilayer products an extended warm or hot water migration test is always required to ensure that substances originating from different layers appear in the migration water. To ensure sufficient substance diffusion and equilibration across layer boundaries, it is required that the multilayer product has undergone a storage period at room temperature for at least 30 days.

3.1.

3.1.1. Standards For testing the release of relevant substances, unexpected substances and TOC, the following standards shall be used to obtain the migration waters: For testing odour and flavour, colour and turbidity, standard EN 1420:2016 shall be used to obtain the migration waters. The mentioned EN standards leave options for testing. The following provisions in sections 3.1.2, 3.1.3, 3.1.4 and 3.1.5 substantiate these standards. (a) For factory-made products: EN 12873-1:2014; (b) For site-applied materials: EN 12873-2:2021.

3.1.1.

(a) For factory-made products: EN 12873-1:2014;

(b) For site-applied materials: EN 12873-2:2021.

3.1.2 Test piece For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece.

3.1.3. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. Multilayer products shall always be tested at 60 °C ± 2 °C or 85 °C ± 2 °C additionally, even when not used at these temperatures.

3.1.4. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, this test shall only be performed with non-chlorinated test water.

3.1.5. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria set out in sections 4.2 and 4.3 are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria set out in sections 4.2 and 4.3 are not met at the 7th migration period the testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day). For multilayer products an extended warm or hot water migration test is always required to ensure that substances originating from different layers appear in the migration water. To ensure sufficient substance diffusion and equilibration across layer boundaries, it is required that the multilayer product has undergone a storage period at room temperature for at least 30 days.

3.2. Analysis of migration waters Grp. 321. Relevant Substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters (see section 3.1.5). The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 322. Unexpected Substances Unexpected substances are only determined in the migration waters of the cold water test. For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening shall be conducted according to EN 15768:2015. (a) Total Organic Carbon (TOC) shall be determined according to EN 1484:1997 as non-purgeable organic carbon; (b) Odour shall be determined as Threshold Odour Number (TON) according to EN 1420:2016 and EN 1622:2006; (c) Flavour shall be determined as Threshold Flavour Number (TFN) according to EN 1420:2016 and EN 1622:2006; (d) Colour shall be determined according to EN ISO 7887:2011 – method C; (e) Turbidity shall be determined according to EN ISO 7027-1:2016 - nephelometry. Grp. 323. Relevant other parameters The relevant other parameters shall be analysed in the migration waters according to the following standards:

3.2.

3.2.1. Relevant Substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters (see section 3.1.5). The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level.

3.2.2. Unexpected Substances Unexpected substances are only determined in the migration waters of the cold water test. For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening shall be conducted according to EN 15768:2015.

3.2.3. Relevant other parameters The relevant other parameters shall be analysed in the migration waters according to the following standards: (a) Total Organic Carbon (TOC) shall be determined according to EN 1484:1997 as non-purgeable organic carbon; (b) Odour shall be determined as Threshold Odour Number (TON) according to EN 1420:2016 and EN 1622:2006; (c) Flavour shall be determined as Threshold Flavour Number (TFN) according to EN 1420:2016 and EN 1622:2006; (d) Colour shall be determined according to EN ISO 7887:2011 – method C; (e) Turbidity shall be determined according to EN ISO 7027-1:2016 - nephelometry.

3.2.3.

(a) Total Organic Carbon (TOC) shall be determined according to EN 1484:1997 as non-purgeable organic carbon;

(b) Odour shall be determined as Threshold Odour Number (TON) according to EN 1420:2016 and EN 1622:2006;

(c) Flavour shall be determined as Threshold Flavour Number (TFN) according to EN 1420:2016 and EN 1622:2006;

(d) Colour shall be determined according to EN ISO 7887:2011 – method C;

(e) Turbidity shall be determined according to EN ISO 7027-1:2016 - nephelometry.

3.3. Mathematical modelling Where generally recognised diffusion models exist on the basis of experimental data, mathematical modelling for estimation of migration levels may be used as alternative to the migration testing of relevant substances for certain types of final organic materials. If these recognised diffusion models predict that the migration of the substance complies with the maximum tolerable concentration at the tap (MTCtap), migration testing for these substances is not necessary. For the assessment of some parameters and for modelling, the content of the respective substances in the final material shall be determined. If compliance is not shown by using the models, migration testing shall be performed. The following mathematical modelling approaches may be used: (a) Migration modelling according to CEN/TR 16364:2012 or other equivalent standards accepted at international level, simulating a migration test according to the EN 12873-1:2014 and EN 12873-2:2021; (b) Full transfer calculation, simulating full transfer of substances from the product into the migration water.

3.3.

(a) Migration modelling according to CEN/TR 16364:2012 or other equivalent standards accepted at international level, simulating a migration test according to the EN 12873-1:2014 and EN 12873-2:2021;

(b) Full transfer calculation, simulating full transfer of substances from the product into the migration water.

3.4. Enhancement of Microbial Growth (EMG) testing For the EMG testing, standard EN 16421:2015 – method 1 or 2 shall be used.

3.5. Testing residual content of substances (QM/QMA) For starting substances with a maximum quantity (QM or QMA) restriction set out in the European positive list of starting substances for organic materials of Annex I of Commission Implementing Decision (EU) 2024/367, its residual content in the product shall be analysed.

4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA (a) shall be used according to the technical function specified in the European positive list of starting substances for organic materials; (b) shall be used in compliance with conditions of use established under the European positive list of starting substances for organic materials. Grp. 41. Formulation Starting substances of the formulation listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367. Grp_421_table_5. 234. Conversion of test results In accordance with the migration standards EN 12873-1:2014 and EN 12873-2:2021, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to this Annex. Components (sum of components made of same main polymer or same composition) of assembled products with a wetted surface fraction Product group CF (in d/dm) A Pipes and pipe linings 1 ID < 80 mm (domestic installations, buildings) 20 2 80 mm ≤ ID < 300 mm (service piping) 10 3 ID ≥ 300 mm (mains piping) 5 B Fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 2 2 80 mm ≤ ID < 300 mm (service piping) 1 3 ID ≥ 300 mm (mains piping) 0,5 C Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,2 2 80 mm ≤ ID < 300 mm (service piping) 0,1 3 ID ≥ 300 mm (mains piping) 0,05 D Small Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,02 2 80 mm ≤ ID < 300 mm (service piping) 0,01 3 ID ≥ 300 mm (mains piping) 0,005 E Storage systems (reservoirs) 1 In domestic installations, buildings, water volume < 10 l 4 2 In domestic installations, buildings, water volume ≥ 10 l 2 3 In water supply 1 F Components of storage systems 1 In domestic installations, buildings, water volume < 10 l 0,4 2 In domestic installations, buildings; water volume ≥ 10 l 0,2 3 In water supply 0,1 G Small Components storage systems 1 In domestic installations, buildings; water volume < 10 l 0,04 2 In domestic installations, buildings; water volume ≥ 10 l 0,02 3 In water supply 0,01 (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. For ions, the MTCtap,organics of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing). Grp. 423. Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test: The MTCtap for the unexpected substances are set out in Table 6. Parameter MTCtap Identified substances with a known MTCtap MTCtap of the substance Identified substance without a known MTCtap 1,0 μg/l Unidentified substances 1,0 μg/l per unidentified substance 1 5,0 μg/l for the sum of the unidentified substances (a) Ctap ≤ 0,5 mg/l for the 3rd migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 9th migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 3rd migration period (10th day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 22nd migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 7th migration period (10th day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 424. Pass/fail criteria for TOC The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required. Grp. 42. Relevant substances, unexpected substances, TOC (i) Pass/fail criteria for TON and TFN for pipes with internal diameter (ID) < 80 mm: (a) TON, TFN ≤ 8,0 for the 3rd migration period (10th day of testing); or (b) TON, TFN ≤ 8,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 16 for the 3rd migration period (10th day of testing). Pt_a_. 2. TON, TFN ≤ 8,0 for the 7th migration period (10th day of testing); or Pt_b_. 2. TON, TFN ≤ 8,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 16 for the 7th migration period (10th day of testing). (ii) Pass/fail criteria for TON and TFN for all other products: Pt_a_. 3. TON, TFN ≤ 2,0 for the 3rd migration period (10th day of testing); or Pt_b_. 3. TON, TFN ≤ 2,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 3rd migration period (10th day of testing). Pt_a_. 4. TON, TFN ≤ 2,0 for the 7th migration period (10th day of testing); or Pt_b_. 4. TON, TFN ≤ 2,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 7th migration period (10th day of testing). Grp. 431. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: Grp. 432. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing). Grp. 433. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing). Grp. 43. Odour, flavour, colour and turbidity Grp_44_table. 7. Enhancement of Microbial Growth (EMG) The pass/fail criteria for the parameter Enhancement of Microbial Growth (EMG) are listed in Table 7. Additionally, the surface of the products or components shall not have any biocidal effects on water intended for human consumption. Therefore, test pieces without surface colonisation (comparison of contact culture/test sample smear with that of the negative control) do not satisfy this requirement. Standard Non-elastomers Elastomers (CF > 1 d/dm) Elastomers (1 d/dm ≥ CF > 0,1 d/dm) Elastomers (CF ≤ 0,1 d/dm) EN 16421 Method 1 Biomass production potential (BPP) in pg ATP/ cm2 ≤ 1000 ≤ 1000 ≤ 1000 ≤ 1000 EN 16421 Method 2 Vbiofilm in ml/800 cm2 ≤ 0,05 ± 0,02 ≤ 0,05 ± 0,02 ≤ 0,12 ± 0,03 ≤ 0,20 ± 0,03 Grp. 45. Pass/fail criteria for residual content of substances (QM and QMA) The maximum quantity (QM and QMA) limits of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 shall apply independently of the product group of final organic materials. (1) antimony 0,05 % (2) arsenic 0,01 % (3) barium 0,01 % (4) cadmium 0,01 % (5) chromium 0,1 % (6) lead 0,01 % (7) mercury 0,005 % (8) selenium 0,01 % (a) When extracted with 0,1 N hydrochloric acid, the following elements may dissolve from the colorant or pigment up to the maximum amount, based on the colorant or pigment: (b) The content of primary aromatic amines soluble in 1 M hydrochloric acid shall not exceed 0,05 % (calculated as aniline). This limit does not apply to primary aromatic amines containing carboxyl- or sulfo-groups, (3) When extracted with 2 N ethanolic hydrochloric acid, a maximum of 0,05 % aromatic amines (based on the colorant or pigment) may dissolve from the colorant or pigment. (4) antimony 0,005 % (5) arsenic 0,01 % (6) barium 0,01 % (7) cadmium 0,01 % (8) chromium 0,1 % (9) lead 0,01 % (10) mercury 0,0005 % (11) selenium 0,01 % Grp_46_table. 8. Purity pass/fail criteria for pigments, colorants and fillers Pigments, colorants and fillers shall comply with the purity requirements according to Table 8, if the corresponding substances were not analysed as relevant substances in the migration waters. The extraction with 0,1 N hydrochloric acid shall be performed according to the procedure described in Council of Europe resolution AP(89)1 on the use of colourants in plastic materials coming into contact with food. Pigments and colorants Colorants and pigments shall comply with the following purity requirements: or Fillers Fillers can be contaminated with impurities. For mineral fillers, the following specification applies: After solution in 0,1 N hydrochloric acid, the concentration of the following elements shall not exceed the maximum amount, based on the filler:

4.

4.1. Formulation Starting substances of the formulation listed in the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367. (a) shall be used according to the technical function specified in the European positive list of starting substances for organic materials; (b) shall be used in compliance with conditions of use established under the European positive list of starting substances for organic materials.

4.1.

(a) shall be used according to the technical function specified in the European positive list of starting substances for organic materials;

(b) shall be used in compliance with conditions of use established under the European positive list of starting substances for organic materials.

4.2. Relevant substances, unexpected substances, TOC Grp_421_table_5. 234. Conversion of test results In accordance with the migration standards EN 12873-1:2014 and EN 12873-2:2021, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to this Annex. Components (sum of components made of same main polymer or same composition) of assembled products with a wetted surface fraction Product group CF (in d/dm) A Pipes and pipe linings 1 ID < 80 mm (domestic installations, buildings) 20 2 80 mm ≤ ID < 300 mm (service piping) 10 3 ID ≥ 300 mm (mains piping) 5 B Fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 2 2 80 mm ≤ ID < 300 mm (service piping) 1 3 ID ≥ 300 mm (mains piping) 0,5 C Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,2 2 80 mm ≤ ID < 300 mm (service piping) 0,1 3 ID ≥ 300 mm (mains piping) 0,05 D Small Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,02 2 80 mm ≤ ID < 300 mm (service piping) 0,01 3 ID ≥ 300 mm (mains piping) 0,005 E Storage systems (reservoirs) 1 In domestic installations, buildings, water volume < 10 l 4 2 In domestic installations, buildings, water volume ≥ 10 l 2 3 In water supply 1 F Components of storage systems 1 In domestic installations, buildings, water volume < 10 l 0,4 2 In domestic installations, buildings; water volume ≥ 10 l 0,2 3 In water supply 0,1 G Small Components storage systems 1 In domestic installations, buildings; water volume < 10 l 0,04 2 In domestic installations, buildings; water volume ≥ 10 l 0,02 3 In water supply 0,01 (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. For ions, the MTCtap,organics of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing). Grp. 423. Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test: The MTCtap for the unexpected substances are set out in Table 6. Parameter MTCtap Identified substances with a known MTCtap MTCtap of the substance Identified substance without a known MTCtap 1,0 μg/l Unidentified substances 1,0 μg/l per unidentified substance 1 5,0 μg/l for the sum of the unidentified substances (a) Ctap ≤ 0,5 mg/l for the 3rd migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 9th migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 3rd migration period (10th day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 22nd migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 7th migration period (10th day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 424. Pass/fail criteria for TOC The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required.

4.2.

4.2.1. Table 5 (2,3,4) Product groups and their conversion factor (CF)

Conversion of test results In accordance with the migration standards EN 12873-1:2014 and EN 12873-2:2021, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to this Annex. Components (sum of components made of same main polymer or same composition) of assembled products with a wetted surface fraction Product group CF (in d/dm) A Pipes and pipe linings 1 ID < 80 mm (domestic installations, buildings) 20 2 80 mm ≤ ID < 300 mm (service piping) 10 3 ID ≥ 300 mm (mains piping) 5 B Fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 2 2 80 mm ≤ ID < 300 mm (service piping) 1 3 ID ≥ 300 mm (mains piping) 0,5 C Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,2 2 80 mm ≤ ID < 300 mm (service piping) 0,1 3 ID ≥ 300 mm (mains piping) 0,05 D Small Components of fittings, ancillaries 1 ID < 80 mm (domestic installations, buildings) 0,02 2 80 mm ≤ ID < 300 mm (service piping) 0,01 3 ID ≥ 300 mm (mains piping) 0,005 E Storage systems (reservoirs) 1 In domestic installations, buildings, water volume < 10 l 4 2 In domestic installations, buildings, water volume ≥ 10 l 2 3 In water supply 1 F Components of storage systems 1 In domestic installations, buildings, water volume < 10 l 0,4 2 In domestic installations, buildings; water volume ≥ 10 l 0,2 3 In water supply 0,1 G Small Components storage systems 1 In domestic installations, buildings; water volume < 10 l 0,04 2 In domestic installations, buildings; water volume ≥ 10 l 0,02 3 In water supply 0,01

4.2.2. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. For ions, the MTCtap,organics of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time.

4.2.2.

(a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing);

(b) there shall be no increasing trend of Ctap in time.

(a) Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing);

(b) there shall be no increasing trend of Ctap in time.

4.2.3. Table 6 MTCtap for unexpected substances

Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test: The MTCtap for the unexpected substances are set out in Table 6. Parameter MTCtap Identified substances with a known MTCtap MTCtap of the substance Identified substance without a known MTCtap 1,0 μg/l Unidentified substances 1,0 μg/l per unidentified substance 1 5,0 μg/l for the sum of the unidentified substances (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing).

4.2.3.

(a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing).

4.2.4. Pass/fail criteria for TOC The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required. (a) Ctap ≤ 0,5 mg/l for the 3rd migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 9th migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 3rd migration period (10th day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 22nd migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 7th migration period (10th day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time.

4.2.4.

(a) Ctap ≤ 0,5 mg/l for the 3rd migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 9th migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 3rd migration period (10th day of testing);

(b) there shall be no increasing trend of Ctap in time.

(a) Ctap ≤ 0,5 mg/l for the 7th migration period (10th day of testing) or, Ctap ≤ 0,5 mg/l for the 22nd migration period (31st day of testing) and Ctap ≤ 2,0 mg/l for the 7th migration period (10th day of testing);

(b) there shall be no increasing trend of Ctap in time.

4.3. Odour, flavour, colour and turbidity (i) Pass/fail criteria for TON and TFN for pipes with internal diameter (ID) < 80 mm: (a) TON, TFN ≤ 8,0 for the 3rd migration period (10th day of testing); or (b) TON, TFN ≤ 8,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 16 for the 3rd migration period (10th day of testing). Pt_a_. 2. TON, TFN ≤ 8,0 for the 7th migration period (10th day of testing); or Pt_b_. 2. TON, TFN ≤ 8,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 16 for the 7th migration period (10th day of testing). (ii) Pass/fail criteria for TON and TFN for all other products: Pt_a_. 3. TON, TFN ≤ 2,0 for the 3rd migration period (10th day of testing); or Pt_b_. 3. TON, TFN ≤ 2,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 3rd migration period (10th day of testing). Pt_a_. 4. TON, TFN ≤ 2,0 for the 7th migration period (10th day of testing); or Pt_b_. 4. TON, TFN ≤ 2,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 7th migration period (10th day of testing). Grp. 431. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: Grp. 432. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing). Grp. 433. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing).

4.3.

4.3.1. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: (i) Pass/fail criteria for TON and TFN for pipes with internal diameter (ID) < 80 mm: (a) TON, TFN ≤ 8,0 for the 3rd migration period (10th day of testing); or (b) TON, TFN ≤ 8,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 16 for the 3rd migration period (10th day of testing). Pt_a_. 2. TON, TFN ≤ 8,0 for the 7th migration period (10th day of testing); or Pt_b_. 2. TON, TFN ≤ 8,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 16 for the 7th migration period (10th day of testing). (ii) Pass/fail criteria for TON and TFN for all other products: Pt_a_. 3. TON, TFN ≤ 2,0 for the 3rd migration period (10th day of testing); or Pt_b_. 3. TON, TFN ≤ 2,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 3rd migration period (10th day of testing). Pt_a_. 4. TON, TFN ≤ 2,0 for the 7th migration period (10th day of testing); or Pt_b_. 4. TON, TFN ≤ 2,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 7th migration period (10th day of testing).

4.3.1.

(i) Pass/fail criteria for TON and TFN for pipes with internal diameter (ID) < 80 mm:

(a) TON, TFN ≤ 8,0 for the 3rd migration period (10th day of testing); or

(b) TON, TFN ≤ 8,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 16 for the 3rd migration period (10th day of testing).

(a) TON, TFN ≤ 8,0 for the 7th migration period (10th day of testing); or

(b) TON, TFN ≤ 8,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 16 for the 7th migration period (10th day of testing).

(ii) Pass/fail criteria for TON and TFN for all other products:

(a) TON, TFN ≤ 2,0 for the 3rd migration period (10th day of testing); or

(b) TON, TFN ≤ 2,0 for the 9th migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 3rd migration period (10th day of testing).

(a) TON, TFN ≤ 2,0 for the 7th migration period (10th day of testing); or

(b) TON, TFN ≤ 2,0 for the 22nd migration period (31st day of testing) and TON, TFN ≤ 4,0 for the 7th migration period (10th day of testing).

4.3.2. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing).

4.3.3. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU. The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing (10th day of testing) or, in case of extended testing, for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing (31st day of testing).

4.4. Table 7 Acceptance criteria for EMG

Enhancement of Microbial Growth (EMG) The pass/fail criteria for the parameter Enhancement of Microbial Growth (EMG) are listed in Table 7. Additionally, the surface of the products or components shall not have any biocidal effects on water intended for human consumption. Therefore, test pieces without surface colonisation (comparison of contact culture/test sample smear with that of the negative control) do not satisfy this requirement. Standard Non-elastomers Elastomers (CF > 1 d/dm) Elastomers (1 d/dm ≥ CF > 0,1 d/dm) Elastomers (CF ≤ 0,1 d/dm) EN 16421 Method 1 Biomass production potential (BPP) in pg ATP/ cm2 ≤ 1000 ≤ 1000 ≤ 1000 ≤ 1000 EN 16421 Method 2 Vbiofilm in ml/800 cm2 ≤ 0,05 ± 0,02 ≤ 0,05 ± 0,02 ≤ 0,12 ± 0,03 ≤ 0,20 ± 0,03

4.5. Pass/fail criteria for residual content of substances (QM and QMA) The maximum quantity (QM and QMA) limits of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 shall apply independently of the product group of final organic materials.

4.6. Table 8 Requirements on purity of pigments, colorants and fillers

Purity pass/fail criteria for pigments, colorants and fillers Pigments, colorants and fillers shall comply with the purity requirements according to Table 8, if the corresponding substances were not analysed as relevant substances in the migration waters. The extraction with 0,1 N hydrochloric acid shall be performed according to the procedure described in Council of Europe resolution AP(89)1 on the use of colourants in plastic materials coming into contact with food. Pigments and colorants Colorants and pigments shall comply with the following purity requirements: or Fillers Fillers can be contaminated with impurities. For mineral fillers, the following specification applies: After solution in 0,1 N hydrochloric acid, the concentration of the following elements shall not exceed the maximum amount, based on the filler: (1) antimony 0,05 % (2) arsenic 0,01 % (3) barium 0,01 % (4) cadmium 0,01 % (5) chromium 0,1 % (6) lead 0,01 % (7) mercury 0,005 % (8) selenium 0,01 % (a) When extracted with 0,1 N hydrochloric acid, the following elements may dissolve from the colorant or pigment up to the maximum amount, based on the colorant or pigment: (b) The content of primary aromatic amines soluble in 1 M hydrochloric acid shall not exceed 0,05 % (calculated as aniline). This limit does not apply to primary aromatic amines containing carboxyl- or sulfo-groups, (3) When extracted with 2 N ethanolic hydrochloric acid, a maximum of 0,05 % aromatic amines (based on the colorant or pigment) may dissolve from the colorant or pigment. (4) antimony 0,005 % (5) arsenic 0,01 % (6) barium 0,01 % (7) cadmium 0,01 % (8) chromium 0,1 % (9) lead 0,01 % (10) mercury 0,0005 % (11) selenium 0,01 %

a)

When extracted with 0,1 N hydrochloric acid, the following elements may dissolve from the colorant or pigment up to the maximum amount, based on the colorant or pigment: (1) antimony 0,05 % (2) arsenic 0,01 % (3) barium 0,01 % (4) cadmium 0,01 % (5) chromium 0,1 % (6) lead 0,01 % (7) mercury 0,005 % (8) selenium 0,01 %

antimony 0,05 %

arsenic 0,01 %

barium 0,01 %

cadmium 0,01 %

chromium 0,1 %

lead 0,01 %

mercury 0,005 %

selenium 0,01 %

b)

The content of primary aromatic amines soluble in 1 M hydrochloric acid shall not exceed 0,05 % (calculated as aniline). This limit does not apply to primary aromatic amines containing carboxyl- or sulfo-groups,

When extracted with 2 N ethanolic hydrochloric acid, a maximum of 0,05 % aromatic amines (based on the colorant or pigment) may dissolve from the colorant or pigment.

antimony 0,005 %

arsenic 0,01 %

barium 0,01 %

cadmium 0,01 %

chromium 0,1 %

lead 0,01 %

mercury 0,0005 %

selenium 0,01 %

(1) Metallic compositions of the final materials (2) Composition of applied platings (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Testing of the composition (2) Testing of the release of relevant substances (2) Step 2 – Performance of tests: (3) Step 3 – Compliance with pass/fail criteria (a) list of all metallic components including the composition of the bulk material as range for all constituents exceeding 0,02 % (m/m), details about the processing to obtain the final metallic materials and the wetted surface fraction of the components in relation to the wetted surface of the assembled product; (b) list of solders applied including details about the soldering process; (c) detailed description of applied plating processes; (d) detailed description of applied impregnations or organic coatings; (e) any other information considered relevant for the assessment of the composition of the final metallic material. Grp. 21211. Composition review Required information For the composition review of a metallic product or an assembled product containing metallic components the following information is required: Grp. 212. Accepted compositions The compositions of the final metallic materials and platings shall comply with compositions listed in the European positive list of compositions for metallic materials in Annex II of Commission Implementing Decision (EU) 2024/367 established in accordance with Article 11(2) (b) of the Directive and fulfil the limitations set out in the European positive list in respect of their use for certain product groups and the use of these products. Categorisation of products in product groups for metallic materials is set out in Table 2 of Annex II to Commission Implementing Decision (EU) 2024/365. Applied organic impregnations and coatings shall comply with the requirements of Annex I. Grp. 213. Relevant substances For plated products, relevant substances shall be identified based on the composition of the plating listed in the European positive list of compositions of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. Grp. 2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS Grp. 1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL METALLIC MATERIALS AS USED IN A PRODUCT. The procedure for testing and accepting final metallic materials as used in a product includes the following steps: Grp. 31. Composition testing An analysis of the composition of the final metallic materials shall be performed to verify compliance with the compositional requirements of metallic materials included in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 32. Testing of release of relevant substances from plated products Plated products should be tested for the residues on the surface according to indications in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. A suitable test should simulate metallic element release into drinking water at the consumers tap. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. The testing of the release of organic substances used in the plating process shall be performed in accordance with the requirements set out in Annex I. Grp. 3. TESTING REQUIREMENTS Grp. 41. Compliance with the European positive list of metallic compositions The analysed composition of final metallic materials shall comply with the compositional requirements and other limitations specified in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. Grp. 42. Pass/fail criteria for relevant substances The requirement Ctap ≤ MTCtap,metallics shall apply where MTCtap,metallics is listed in the Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367, where in the calculation of Ctap the stagnation time and the sampling volume are taken in due consideration. Grp. 4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA

ANNEX II FINAL METALLIC MATERIALS

1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL METALLIC MATERIALS AS USED IN A PRODUCT. The procedure for testing and accepting final metallic materials as used in a product includes the following steps: (1) Metallic compositions of the final materials (2) Composition of applied platings (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Testing of the composition (2) Testing of the release of relevant substances (2) Step 2 – Performance of tests: (3) Step 3 – Compliance with pass/fail criteria (a) list of all metallic components including the composition of the bulk material as range for all constituents exceeding 0,02 % (m/m), details about the processing to obtain the final metallic materials and the wetted surface fraction of the components in relation to the wetted surface of the assembled product; (b) list of solders applied including details about the soldering process; (c) detailed description of applied plating processes; (d) detailed description of applied impregnations or organic coatings; (e) any other information considered relevant for the assessment of the composition of the final metallic material. Grp. 21211. Composition review Required information For the composition review of a metallic product or an assembled product containing metallic components the following information is required: Grp. 212. Accepted compositions The compositions of the final metallic materials and platings shall comply with compositions listed in the European positive list of compositions for metallic materials in Annex II of Commission Implementing Decision (EU) 2024/367 established in accordance with Article 11(2) (b) of the Directive and fulfil the limitations set out in the European positive list in respect of their use for certain product groups and the use of these products. Categorisation of products in product groups for metallic materials is set out in Table 2 of Annex II to Commission Implementing Decision (EU) 2024/365. Applied organic impregnations and coatings shall comply with the requirements of Annex I. Grp. 213. Relevant substances For plated products, relevant substances shall be identified based on the composition of the plating listed in the European positive list of compositions of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. Grp. 2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS

Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Metallic compositions of the final materials (2) Composition of applied platings

1.

pt_1

1. Metallic compositions of the final materials

2. Composition of applied platings

Step 2 – Performance of tests: (1) Testing of the composition (2) Testing of the release of relevant substances

pt_2

1. Testing of the composition

2. Testing of the release of relevant substances

Step 3 – Compliance with pass/fail criteria

2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS (a) list of all metallic components including the composition of the bulk material as range for all constituents exceeding 0,02 % (m/m), details about the processing to obtain the final metallic materials and the wetted surface fraction of the components in relation to the wetted surface of the assembled product; (b) list of solders applied including details about the soldering process; (c) detailed description of applied plating processes; (d) detailed description of applied impregnations or organic coatings; (e) any other information considered relevant for the assessment of the composition of the final metallic material. Grp. 21211. Composition review Required information For the composition review of a metallic product or an assembled product containing metallic components the following information is required: Grp. 212. Accepted compositions The compositions of the final metallic materials and platings shall comply with compositions listed in the European positive list of compositions for metallic materials in Annex II of Commission Implementing Decision (EU) 2024/367 established in accordance with Article 11(2) (b) of the Directive and fulfil the limitations set out in the European positive list in respect of their use for certain product groups and the use of these products. Categorisation of products in product groups for metallic materials is set out in Table 2 of Annex II to Commission Implementing Decision (EU) 2024/365. Applied organic impregnations and coatings shall comply with the requirements of Annex I. Grp. 213. Relevant substances For plated products, relevant substances shall be identified based on the composition of the plating listed in the European positive list of compositions of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367.

2.

2.1.2.1.1. Composition review Required information For the composition review of a metallic product or an assembled product containing metallic components the following information is required: (a) list of all metallic components including the composition of the bulk material as range for all constituents exceeding 0,02 % (m/m), details about the processing to obtain the final metallic materials and the wetted surface fraction of the components in relation to the wetted surface of the assembled product; (b) list of solders applied including details about the soldering process; (c) detailed description of applied plating processes; (d) detailed description of applied impregnations or organic coatings; (e) any other information considered relevant for the assessment of the composition of the final metallic material.

2.1.2.1.1.

(a) list of all metallic components including the composition of the bulk material as range for all constituents exceeding 0,02 % (m/m), details about the processing to obtain the final metallic materials and the wetted surface fraction of the components in relation to the wetted surface of the assembled product;

(b) list of solders applied including details about the soldering process;

(c) detailed description of applied plating processes;

(d) detailed description of applied impregnations or organic coatings;

(e) any other information considered relevant for the assessment of the composition of the final metallic material.

2.1.2. Accepted compositions The compositions of the final metallic materials and platings shall comply with compositions listed in the European positive list of compositions for metallic materials in Annex II of Commission Implementing Decision (EU) 2024/367 established in accordance with Article 11(2) (b) of the Directive and fulfil the limitations set out in the European positive list in respect of their use for certain product groups and the use of these products. Categorisation of products in product groups for metallic materials is set out in Table 2 of Annex II to Commission Implementing Decision (EU) 2024/365. Applied organic impregnations and coatings shall comply with the requirements of Annex I.

2.1.3. Relevant substances For plated products, relevant substances shall be identified based on the composition of the plating listed in the European positive list of compositions of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367.

3. TESTING REQUIREMENTS Grp. 31. Composition testing An analysis of the composition of the final metallic materials shall be performed to verify compliance with the compositional requirements of metallic materials included in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 32. Testing of release of relevant substances from plated products Plated products should be tested for the residues on the surface according to indications in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. A suitable test should simulate metallic element release into drinking water at the consumers tap. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. The testing of the release of organic substances used in the plating process shall be performed in accordance with the requirements set out in Annex I.

3.

3.1. Composition testing An analysis of the composition of the final metallic materials shall be performed to verify compliance with the compositional requirements of metallic materials included in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level.

3.2. Testing of release of relevant substances from plated products Plated products should be tested for the residues on the surface according to indications in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. A suitable test should simulate metallic element release into drinking water at the consumers tap. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. The testing of the release of organic substances used in the plating process shall be performed in accordance with the requirements set out in Annex I.

4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA Grp. 41. Compliance with the European positive list of metallic compositions The analysed composition of final metallic materials shall comply with the compositional requirements and other limitations specified in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. Grp. 42. Pass/fail criteria for relevant substances The requirement Ctap ≤ MTCtap,metallics shall apply where MTCtap,metallics is listed in the Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367, where in the calculation of Ctap the stagnation time and the sampling volume are taken in due consideration.

4.

4.1. Compliance with the European positive list of metallic compositions The analysed composition of final metallic materials shall comply with the compositional requirements and other limitations specified in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367.

4.2. Pass/fail criteria for relevant substances The requirement Ctap ≤ MTCtap,metallics shall apply where MTCtap,metallics is listed in the Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367, where in the calculation of Ctap the stagnation time and the sampling volume are taken in due consideration.

(1) Categorisation of products or components into risk groups and corresponding testing requirements. (2) Formulation review. (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (a) Relevant substances (b) Unexpected substances (c) Odour and flavour (d) Colour and turbidity (e) Total Organic Carbon (TOC) (1) Migration test for: (2) Testing for enhancement of microbial growth (emg) (2) Step 2 – Performance of tests (3) Step 3 – Compliance with pass/fail criteria Grp. 1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL CEMENTITIOUS MATERIALS AS USED IN A PRODUCT. The procedure for testing and accepting final cementitious materials as used in a product includes the following steps: Grp_21_table. 1. Categorisation of products into risk groups and corresponding testing requirements The applicable testing procedure of final cementitious materials results from the use of these materials in products. In accordance with Table 5 of Annex I, a product group and a corresponding conversion factor (CF) shall be determined for the product or the component. Based on the determined CF, the product or component is categorised in a risk group (RG). In accordance with Table 1 of this Annex, the categorisation in a RG determines the corresponding testing requirements and relevant other parameters. For an assembled product, the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same final materials, then the surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5 of Annex I. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. Minor components are considered to be components categorised in risk group 4 (RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1, 2 or 3 (RG1, RG2, RG3). Risk Group CF in d/dm Formulation review Relevant substances Screening for unexpected substances TOC TON, TFN, colour, turbidity EMG RG1 ≥ 4 Yes Yes, on product or test piece Yes, on product or test piece if organic constituents are used Yes, on product or test piece Yes, on product or test piece Yes, on product or test piece if organic constituents are used RG2 ≥ 0,4 and < 4 RG3 ≥ 0,04 and < 0,4 RG4 < 0,04 No No No Yes, on product or test piece Yes, on product or test piece Yes, on product or test piece if organic constituents are used (a) list of all constituents (including information on their impurities) used to produce the final cementitious material; (b) the respective percentage by mass (m/m %) of constituents with respect to cement content used to produce the final cementitious material; (c) any other information considered relevant for the assessment of the formulation of the final cementitious material. Grp. 221. Required Information The following information in the formulation review is required for each final cementitious material: The cut-off value, below which details of the formulation of the final material are not required, expressed as mass percentage in the formulation is 0,02 % (w/w) related to the cement content for one constituent. The formulation shall be evaluated and compared with the accepted constituents of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and with the accepted starting substances of the European positive list for organic materials, when relevant in accordance with Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The evaluation shall define the relevant substances that shall be analysed in the migration water. (1) Organic cementitious constituents used in the formulation of the final cementitious material, listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or listed in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (2) Impurities, degradation or reaction products specified in the condition of use of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or specified in the condition of the use of the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 used in the formulation; (3) Organic cementitious constituents used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 of this Annex; (4) Metals for which MTCtap,cementitious exist according to Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367; (5) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements according to section 4.6 of Annex I or when purity testing was not performed. Grp. 222. Relevant substances The relevant substances to be analysed in the migration water are: (a) Inorganic constituents; (i) Substances classified as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006; and (REACH) for their ED, PBT or vPvB properties; (ii) Substances intentionally added in nanoform. (b) Organic cementitious constituents for which there is no possibility that they, including their reaction products, migrate at levels exceeding 0,1 μg/l in water intended for human consumption. This only applies to substances that do not belong to either one of the following categories: Grp. 223. Accepted constituents Final cementitious materials shall only contain organic cementitious constituents listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and in the European positive list of starting substances for organic materials as further specified in Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The use of the following additional constituents is allowed: The relevant notes of Annex III to Commission Implementing Decision (EU) 2024/367 establishing the European Positive List of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 shall be considered in the acceptance of constituents of cementitious materials. Grp. 224. Material-specific requirements If used, pigments and colorants shall comply with purity criteria as defined in Table 8 of Annex I, and not migrate at levels exceeding 0,1 μg/l. Grp. 22. Formulation review A formulation review shall be performed in accordance with the requirements in Table 1. Grp. 2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS (a) Test pieces (b) Preconditioning of test pieces (c) Migration test (i) Migration test water for odour, flavour, colour, turbidity and TOC (ii) Migration test water for migration of relevant and unexpected substances (iii) Migration test water temperature (iv) Duration of migration test periods (v) Surface-to-volume ratio (S/V) (vi) Additional specifications Grp. 311. Specifications for testing final cementitious materials for migration of organoleptic parameters (odour, flavour, colour and turbidity), TOC, relevant and unexpected substances For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece. Test pieces shall be preconditioned by immersion in demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1) and sodium hydrogen carbonate ((336 ± 2) NaHCO3 mg L-1) adjusted to a pH of (7.4 ± 0,1) by air or CO2 bubbling. Test pieces shall be preconditioned at (23 ± 2) °C in three successive periods of (24 ± 1) h followed by one period of (72 ± 1) h and one period of (24 ± 1) h. After each period the water is discarded and the test piece is not rinsed. If the pH of the last preconditioning water exceeds 9,5 then the preconditioning shall be repeated with new test pieces. After the fifth preconditioning the test piece shall immediately be subjected to the migration test. Test pieces shall be immersed in migration test water with a specified temperature and for a specified period of time. Non-chlorinated migration test water shall be natural water without gas or demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1), sodium hydrogen carbonate ((482 ± 2) NaHCO3 mg L-1) and sodium silicate ((71 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7.4 ± 0,1) by air or CO2 bubbling, a conductivity of (500 ± 50) μS cm -1, an alkalinity of (350 ± 50) mg HCO3- L-1, a concentration of calcium of (80 ± 10) mg -1 L and a concentration of silica of (15 ± 5) mg SiO2 L-1. Non-chlorinated migration test water shall have no odour (< 2 TON), flavour (< 2 TFN), colour (< 0,1 m-1), turbidity (< 0,1 FNU) and TOC (<0,2 mg C L-1). Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. Non-chlorinated migration test water shall be demineralised water containing anhydrous calcium chloride ((110 ± 1) mg CaCl2 L-1), sodium hydrogen carbonate ((140 ± 1) NaHCO3 mg L-1) and sodium silicate ((48 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7,0 ± 0,1) by air or CO2 bubbling. Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. The test piece for cold water application shall be in contact with test water for 72 h ± 1 h. The test piece for elevated temperature applications shall be in contact with water for 24h. The test shall be repeated at least two more times using fresh test water each time. For cold water tests, the migration samples of the 1st, 2nd and 3rd migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period. For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 7th migration period the testing can be extended and 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period. The largest S/V representative of the product group shall be selected. For further details on testing organoleptic parameters, TOC, relevant and unexpected substances relevant European standards or, in the absence thereof, an internationally recognised methods shall be used. Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water. Grp. 31. Migration testing Testing of organic coatings with inorganic fillers should be performed according to section 3.1 of Annex I. If pH > 9.5 in the final migration water, the test should be considered invalid and the product should be evaluated as a cementitious product and testing will be performed according to section 3.1 of Annex III. Grp. 321. Relevant substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters. The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 322. Unexpected substances For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening or screening by other analytical techniques can be used. Unexpected substances are only determined in the migration waters of the cold water test. Grp. 323. Relevant other parameters The methods for analysis of relevant other parameters in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 32. Analysis of migration waters Grp. 33. Mathematical modelling Where generally recognised diffusion models exist on the basis of experimental data, mathematical modelling for estimation of migration levels may be used as alternative to the migration testing of relevant substances for certain types of final cementitious materials. If these recognised diffusion models predict that the migration of the substance complies with the maximum tolerable concentration at the tap (MTCtap), migration testing for these substances is not necessary. For the assessment of some parameters and for modelling, the content of the respective substances in the final material shall be determined. If compliance is not shown by using the models, migration testing shall be performed. Only validated mathematical models applicable to cementitious materials shall be used to determine the concentration of a relevant substance in migration water. Grp. 34. Enhancement of Microbial Growth (EMG) testing Tests for Enhancement of Microbial Growth shall be performed if organic constituents are used according to the formulation. For the Enhancement of Microbial Growth testing, standard EN 16421:2015 – method 1 or 2 shall be used. Grp. 3. TESTING REQUIREMENTS (a) in accordance with the technical function specified in the relevant European positive lists; (b) in compliance with conditions of use established under the relevant European positive lists. Grp. 41. Formulation Organic cementitious constituents of the formulation listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and in the European positive list of starting substances for organic materials as further specified in Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367 shall be used: Grp. 421. Conversion of migration test results The migration test results are expressed as migration rates (M) in μg/(dm2d). These results shall be converted to estimate the concentrations at the tap (Ctap) , defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to Annex I. (a) Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period or, in case extended testing is needed, at the 22nd migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration test water from the successive migration periods shall be used to assess the trend. However, if the Ctap in the relevant migration period is below 1/10th of the MTCtap, then no trend analysis is required. For metals, MTCtap,cementitious of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. Grp. 423. Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test:Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period. The MTCtap for the unexpected substances are set out in Table 6 of Annex I. For certain cementitious products the S/V ratio does not allow to meet the limit of MTCtap = 1 μg/L as established for organic materials. In this case MTCtap < Limit of Quantification for the highest S/V ratio shall apply. (a) Ctap ≤ 0,5 mg/l for the 3rd migration period or Ctap ≤ 0,5 mg/l for the 9th migration period and Ctap ≤ 2,0 mg/l for the 3rd migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period or Ctap ≤ 0,5 mg/l for the 22nd migration period and Ctap ≤ 2,0 mg/l for the 7th migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 424. Pass/fail criteria for Total Organic Carbon (TOC) The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required. Grp. 42. Relevant substances, unexpected substances (a) TON, TFN ≤ 2,0 for the 3rd migration period; or (b) TON, TFN ≤ 2,0 for the 9th migration period and TON ≤ 4,0 for the 3rd migration period. Pt_a_. 2. TON, TFN ≤ 2,0 for the 7th migration period; or Pt_b_. 2. TON, TFN ≤ 2,0 for the 22nd migration period and TON, TFN ≤ 4,0 for the 7th migration period. Grp. 431. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: Grp. 432. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing. Grp. 433. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing. Grp. 43. Odour, flavour, colour and turbidity Grp. 44. Enhancement of Microbial Growth (EMG) The pass/fail criteria for Enhancement of Microbial Growth (EMG) for method 1 (EN 16421:2015) is < 1000 pg ATP/ cm2 and for method 2 (EN 16421:2015) is ≤ (0,05 ± 0,02) ml/800 cm2. Additionally, the surface of the products or components shall not have any biocidal effects on water intended for human consumption. Therefore, test pieces without surface colonisation (comparison of contact culture/test sample smear with that of the negative control) do not satisfy this requirement. Grp. 4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA

ANNEX III FINAL CEMENTITIOUS MATERIALS

1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL CEMENTITIOUS MATERIALS AS USED IN A PRODUCT. The procedure for testing and accepting final cementitious materials as used in a product includes the following steps: (1) Categorisation of products or components into risk groups and corresponding testing requirements. (2) Formulation review. (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (a) Relevant substances (b) Unexpected substances (c) Odour and flavour (d) Colour and turbidity (e) Total Organic Carbon (TOC) (1) Migration test for: (2) Testing for enhancement of microbial growth (emg) (2) Step 2 – Performance of tests (3) Step 3 – Compliance with pass/fail criteria

Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Categorisation of products or components into risk groups and corresponding testing requirements. (2) Formulation review.

1.

pt_1

1. Categorisation of products or components into risk groups and corresponding testing requirements.

2. Formulation review.

Step 2 – Performance of tests (a) Relevant substances (b) Unexpected substances (c) Odour and flavour (d) Colour and turbidity (e) Total Organic Carbon (TOC) (1) Migration test for: (2) Testing for enhancement of microbial growth (emg)

pt_2

1. Migration test for: (a) Relevant substances (b) Unexpected substances (c) Odour and flavour (d) Colour and turbidity (e) Total Organic Carbon (TOC)

1.

(a) Relevant substances

(b) Unexpected substances

(c) Odour and flavour

(d) Colour and turbidity

(e) Total Organic Carbon (TOC)

2. Testing for enhancement of microbial growth (emg)

Step 3 – Compliance with pass/fail criteria

2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS Grp_21_table. 1. Categorisation of products into risk groups and corresponding testing requirements The applicable testing procedure of final cementitious materials results from the use of these materials in products. In accordance with Table 5 of Annex I, a product group and a corresponding conversion factor (CF) shall be determined for the product or the component. Based on the determined CF, the product or component is categorised in a risk group (RG). In accordance with Table 1 of this Annex, the categorisation in a RG determines the corresponding testing requirements and relevant other parameters. For an assembled product, the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same final materials, then the surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5 of Annex I. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. Minor components are considered to be components categorised in risk group 4 (RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1, 2 or 3 (RG1, RG2, RG3). Risk Group CF in d/dm Formulation review Relevant substances Screening for unexpected substances TOC TON, TFN, colour, turbidity EMG RG1 ≥ 4 Yes Yes, on product or test piece Yes, on product or test piece if organic constituents are used Yes, on product or test piece Yes, on product or test piece Yes, on product or test piece if organic constituents are used RG2 ≥ 0,4 and < 4 RG3 ≥ 0,04 and < 0,4 RG4 < 0,04 No No No Yes, on product or test piece Yes, on product or test piece Yes, on product or test piece if organic constituents are used (a) list of all constituents (including information on their impurities) used to produce the final cementitious material; (b) the respective percentage by mass (m/m %) of constituents with respect to cement content used to produce the final cementitious material; (c) any other information considered relevant for the assessment of the formulation of the final cementitious material. Grp. 221. Required Information The following information in the formulation review is required for each final cementitious material: The cut-off value, below which details of the formulation of the final material are not required, expressed as mass percentage in the formulation is 0,02 % (w/w) related to the cement content for one constituent. The formulation shall be evaluated and compared with the accepted constituents of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and with the accepted starting substances of the European positive list for organic materials, when relevant in accordance with Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The evaluation shall define the relevant substances that shall be analysed in the migration water. (1) Organic cementitious constituents used in the formulation of the final cementitious material, listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or listed in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (2) Impurities, degradation or reaction products specified in the condition of use of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or specified in the condition of the use of the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 used in the formulation; (3) Organic cementitious constituents used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 of this Annex; (4) Metals for which MTCtap,cementitious exist according to Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367; (5) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements according to section 4.6 of Annex I or when purity testing was not performed. Grp. 222. Relevant substances The relevant substances to be analysed in the migration water are: (a) Inorganic constituents; (i) Substances classified as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006; and (REACH) for their ED, PBT or vPvB properties; (ii) Substances intentionally added in nanoform. (b) Organic cementitious constituents for which there is no possibility that they, including their reaction products, migrate at levels exceeding 0,1 μg/l in water intended for human consumption. This only applies to substances that do not belong to either one of the following categories: Grp. 223. Accepted constituents Final cementitious materials shall only contain organic cementitious constituents listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and in the European positive list of starting substances for organic materials as further specified in Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The use of the following additional constituents is allowed: The relevant notes of Annex III to Commission Implementing Decision (EU) 2024/367 establishing the European Positive List of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 shall be considered in the acceptance of constituents of cementitious materials. Grp. 224. Material-specific requirements If used, pigments and colorants shall comply with purity criteria as defined in Table 8 of Annex I, and not migrate at levels exceeding 0,1 μg/l. Grp. 22. Formulation review A formulation review shall be performed in accordance with the requirements in Table 1.

2.

2.1. Table 1 Risk-based testing requirements for products or components of assembled products

Categorisation of products into risk groups and corresponding testing requirements The applicable testing procedure of final cementitious materials results from the use of these materials in products. In accordance with Table 5 of Annex I, a product group and a corresponding conversion factor (CF) shall be determined for the product or the component. Based on the determined CF, the product or component is categorised in a risk group (RG). In accordance with Table 1 of this Annex, the categorisation in a RG determines the corresponding testing requirements and relevant other parameters. For an assembled product, the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same final materials, then the surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5 of Annex I. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. Minor components are considered to be components categorised in risk group 4 (RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1, 2 or 3 (RG1, RG2, RG3). Risk Group CF in d/dm Formulation review Relevant substances Screening for unexpected substances TOC TON, TFN, colour, turbidity EMG RG1 ≥ 4 Yes Yes, on product or test piece Yes, on product or test piece if organic constituents are used Yes, on product or test piece Yes, on product or test piece Yes, on product or test piece if organic constituents are used RG2 ≥ 0,4 and < 4 RG3 ≥ 0,04 and < 0,4 RG4 < 0,04 No No No Yes, on product or test piece Yes, on product or test piece Yes, on product or test piece if organic constituents are used

2.2. Formulation review A formulation review shall be performed in accordance with the requirements in Table 1. (a) list of all constituents (including information on their impurities) used to produce the final cementitious material; (b) the respective percentage by mass (m/m %) of constituents with respect to cement content used to produce the final cementitious material; (c) any other information considered relevant for the assessment of the formulation of the final cementitious material. Grp. 221. Required Information The following information in the formulation review is required for each final cementitious material: The cut-off value, below which details of the formulation of the final material are not required, expressed as mass percentage in the formulation is 0,02 % (w/w) related to the cement content for one constituent. The formulation shall be evaluated and compared with the accepted constituents of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and with the accepted starting substances of the European positive list for organic materials, when relevant in accordance with Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The evaluation shall define the relevant substances that shall be analysed in the migration water. (1) Organic cementitious constituents used in the formulation of the final cementitious material, listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or listed in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (2) Impurities, degradation or reaction products specified in the condition of use of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or specified in the condition of the use of the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 used in the formulation; (3) Organic cementitious constituents used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 of this Annex; (4) Metals for which MTCtap,cementitious exist according to Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367; (5) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements according to section 4.6 of Annex I or when purity testing was not performed. Grp. 222. Relevant substances The relevant substances to be analysed in the migration water are: (a) Inorganic constituents; (i) Substances classified as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006; and (REACH) for their ED, PBT or vPvB properties; (ii) Substances intentionally added in nanoform. (b) Organic cementitious constituents for which there is no possibility that they, including their reaction products, migrate at levels exceeding 0,1 μg/l in water intended for human consumption. This only applies to substances that do not belong to either one of the following categories: Grp. 223. Accepted constituents Final cementitious materials shall only contain organic cementitious constituents listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and in the European positive list of starting substances for organic materials as further specified in Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The use of the following additional constituents is allowed: The relevant notes of Annex III to Commission Implementing Decision (EU) 2024/367 establishing the European Positive List of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 shall be considered in the acceptance of constituents of cementitious materials. Grp. 224. Material-specific requirements If used, pigments and colorants shall comply with purity criteria as defined in Table 8 of Annex I, and not migrate at levels exceeding 0,1 μg/l.

2.2.

2.2.1. Required Information The following information in the formulation review is required for each final cementitious material: The cut-off value, below which details of the formulation of the final material are not required, expressed as mass percentage in the formulation is 0,02 % (w/w) related to the cement content for one constituent. The formulation shall be evaluated and compared with the accepted constituents of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and with the accepted starting substances of the European positive list for organic materials, when relevant in accordance with Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The evaluation shall define the relevant substances that shall be analysed in the migration water. (a) list of all constituents (including information on their impurities) used to produce the final cementitious material; (b) the respective percentage by mass (m/m %) of constituents with respect to cement content used to produce the final cementitious material; (c) any other information considered relevant for the assessment of the formulation of the final cementitious material.

2.2.1.

(a) list of all constituents (including information on their impurities) used to produce the final cementitious material;

(b) the respective percentage by mass (m/m %) of constituents with respect to cement content used to produce the final cementitious material;

(c) any other information considered relevant for the assessment of the formulation of the final cementitious material.

2.2.2. Relevant substances The relevant substances to be analysed in the migration water are: (1) Organic cementitious constituents used in the formulation of the final cementitious material, listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or listed in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies; (2) Impurities, degradation or reaction products specified in the condition of use of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or specified in the condition of the use of the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 used in the formulation; (3) Organic cementitious constituents used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 of this Annex; (4) Metals for which MTCtap,cementitious exist according to Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367; (5) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements according to section 4.6 of Annex I or when purity testing was not performed.

2.2.2.

(1) Organic cementitious constituents used in the formulation of the final cementitious material, listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or listed in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 and for which an MTCtap applies;

(2) Impurities, degradation or reaction products specified in the condition of use of the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or specified in the condition of the use of the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367 used in the formulation;

(3) Organic cementitious constituents used in the formulation, their impurities, degradation and reaction products not listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 or in the European positive list of starting substances for organic materials, of Annex I to Commission Implementing Decision (EU) 2024/367, but accepted under section 2.2.3 of this Annex;

(4) Metals for which MTCtap,cementitious exist according to Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367;

(5) Primary aromatic amines (PAA) if organic pigments or colorants are used in the formulation not complying with the purity requirements according to section 4.6 of Annex I or when purity testing was not performed.

2.2.3. Accepted constituents Final cementitious materials shall only contain organic cementitious constituents listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and in the European positive list of starting substances for organic materials as further specified in Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367. The use of the following additional constituents is allowed: The relevant notes of Annex III to Commission Implementing Decision (EU) 2024/367 establishing the European Positive List of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 shall be considered in the acceptance of constituents of cementitious materials. (a) Inorganic constituents; (i) Substances classified as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006; and (REACH) for their ED, PBT or vPvB properties; (ii) Substances intentionally added in nanoform. (b) Organic cementitious constituents for which there is no possibility that they, including their reaction products, migrate at levels exceeding 0,1 μg/l in water intended for human consumption. This only applies to substances that do not belong to either one of the following categories:

2.2.3.

(a) Inorganic constituents;

(b) Organic cementitious constituents for which there is no possibility that they, including their reaction products, migrate at levels exceeding 0,1 μg/l in water intended for human consumption. This only applies to substances that do not belong to either one of the following categories: (i) Substances classified as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006; and (REACH) for their ED, PBT or vPvB properties; (ii) Substances intentionally added in nanoform.

(b)

(i) Substances classified as carcinogenic, mutagenic or toxic for reproduction category 1A or 1B, endocrine disrupters (ED) for human health category 1, persistent, bioaccumulative and toxic substances (PBT) or very persistent and very bioaccumulative substances (vPvB) in accordance with Regulation No. 1272/2008 (CLP); or being included in the candidate list as substances of very high concern (SVHC) under Regulation (EC) No 1907/2006; and (REACH) for their ED, PBT or vPvB properties;

(ii) Substances intentionally added in nanoform.

2.2.4. Material-specific requirements If used, pigments and colorants shall comply with purity criteria as defined in Table 8 of Annex I, and not migrate at levels exceeding 0,1 μg/l.

3. TESTING REQUIREMENTS (a) Test pieces (b) Preconditioning of test pieces (c) Migration test (i) Migration test water for odour, flavour, colour, turbidity and TOC (ii) Migration test water for migration of relevant and unexpected substances (iii) Migration test water temperature (iv) Duration of migration test periods (v) Surface-to-volume ratio (S/V) (vi) Additional specifications Grp. 311. Specifications for testing final cementitious materials for migration of organoleptic parameters (odour, flavour, colour and turbidity), TOC, relevant and unexpected substances For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece. Test pieces shall be preconditioned by immersion in demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1) and sodium hydrogen carbonate ((336 ± 2) NaHCO3 mg L-1) adjusted to a pH of (7.4 ± 0,1) by air or CO2 bubbling. Test pieces shall be preconditioned at (23 ± 2) °C in three successive periods of (24 ± 1) h followed by one period of (72 ± 1) h and one period of (24 ± 1) h. After each period the water is discarded and the test piece is not rinsed. If the pH of the last preconditioning water exceeds 9,5 then the preconditioning shall be repeated with new test pieces. After the fifth preconditioning the test piece shall immediately be subjected to the migration test. Test pieces shall be immersed in migration test water with a specified temperature and for a specified period of time. Non-chlorinated migration test water shall be natural water without gas or demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1), sodium hydrogen carbonate ((482 ± 2) NaHCO3 mg L-1) and sodium silicate ((71 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7.4 ± 0,1) by air or CO2 bubbling, a conductivity of (500 ± 50) μS cm -1, an alkalinity of (350 ± 50) mg HCO3- L-1, a concentration of calcium of (80 ± 10) mg -1 L and a concentration of silica of (15 ± 5) mg SiO2 L-1. Non-chlorinated migration test water shall have no odour (< 2 TON), flavour (< 2 TFN), colour (< 0,1 m-1), turbidity (< 0,1 FNU) and TOC (<0,2 mg C L-1). Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. Non-chlorinated migration test water shall be demineralised water containing anhydrous calcium chloride ((110 ± 1) mg CaCl2 L-1), sodium hydrogen carbonate ((140 ± 1) NaHCO3 mg L-1) and sodium silicate ((48 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7,0 ± 0,1) by air or CO2 bubbling. Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. The test piece for cold water application shall be in contact with test water for 72 h ± 1 h. The test piece for elevated temperature applications shall be in contact with water for 24h. The test shall be repeated at least two more times using fresh test water each time. For cold water tests, the migration samples of the 1st, 2nd and 3rd migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period. For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 7th migration period the testing can be extended and 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period. The largest S/V representative of the product group shall be selected. For further details on testing organoleptic parameters, TOC, relevant and unexpected substances relevant European standards or, in the absence thereof, an internationally recognised methods shall be used. Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water. Grp. 31. Migration testing Testing of organic coatings with inorganic fillers should be performed according to section 3.1 of Annex I. If pH > 9.5 in the final migration water, the test should be considered invalid and the product should be evaluated as a cementitious product and testing will be performed according to section 3.1 of Annex III. Grp. 321. Relevant substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters. The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 322. Unexpected substances For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening or screening by other analytical techniques can be used. Unexpected substances are only determined in the migration waters of the cold water test. Grp. 323. Relevant other parameters The methods for analysis of relevant other parameters in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 32. Analysis of migration waters Grp. 33. Mathematical modelling Where generally recognised diffusion models exist on the basis of experimental data, mathematical modelling for estimation of migration levels may be used as alternative to the migration testing of relevant substances for certain types of final cementitious materials. If these recognised diffusion models predict that the migration of the substance complies with the maximum tolerable concentration at the tap (MTCtap), migration testing for these substances is not necessary. For the assessment of some parameters and for modelling, the content of the respective substances in the final material shall be determined. If compliance is not shown by using the models, migration testing shall be performed. Only validated mathematical models applicable to cementitious materials shall be used to determine the concentration of a relevant substance in migration water. Grp. 34. Enhancement of Microbial Growth (EMG) testing Tests for Enhancement of Microbial Growth shall be performed if organic constituents are used according to the formulation. For the Enhancement of Microbial Growth testing, standard EN 16421:2015 – method 1 or 2 shall be used.

3.

3.1. Migration testing Testing of organic coatings with inorganic fillers should be performed according to section 3.1 of Annex I. If pH > 9.5 in the final migration water, the test should be considered invalid and the product should be evaluated as a cementitious product and testing will be performed according to section 3.1 of Annex III. (a) Test pieces (b) Preconditioning of test pieces (c) Migration test (i) Migration test water for odour, flavour, colour, turbidity and TOC (ii) Migration test water for migration of relevant and unexpected substances (iii) Migration test water temperature (iv) Duration of migration test periods (v) Surface-to-volume ratio (S/V) (vi) Additional specifications Grp. 311. Specifications for testing final cementitious materials for migration of organoleptic parameters (odour, flavour, colour and turbidity), TOC, relevant and unexpected substances For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece. Test pieces shall be preconditioned by immersion in demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1) and sodium hydrogen carbonate ((336 ± 2) NaHCO3 mg L-1) adjusted to a pH of (7.4 ± 0,1) by air or CO2 bubbling. Test pieces shall be preconditioned at (23 ± 2) °C in three successive periods of (24 ± 1) h followed by one period of (72 ± 1) h and one period of (24 ± 1) h. After each period the water is discarded and the test piece is not rinsed. If the pH of the last preconditioning water exceeds 9,5 then the preconditioning shall be repeated with new test pieces. After the fifth preconditioning the test piece shall immediately be subjected to the migration test. Test pieces shall be immersed in migration test water with a specified temperature and for a specified period of time. Non-chlorinated migration test water shall be natural water without gas or demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1), sodium hydrogen carbonate ((482 ± 2) NaHCO3 mg L-1) and sodium silicate ((71 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7.4 ± 0,1) by air or CO2 bubbling, a conductivity of (500 ± 50) μS cm -1, an alkalinity of (350 ± 50) mg HCO3- L-1, a concentration of calcium of (80 ± 10) mg -1 L and a concentration of silica of (15 ± 5) mg SiO2 L-1. Non-chlorinated migration test water shall have no odour (< 2 TON), flavour (< 2 TFN), colour (< 0,1 m-1), turbidity (< 0,1 FNU) and TOC (<0,2 mg C L-1). Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. Non-chlorinated migration test water shall be demineralised water containing anhydrous calcium chloride ((110 ± 1) mg CaCl2 L-1), sodium hydrogen carbonate ((140 ± 1) NaHCO3 mg L-1) and sodium silicate ((48 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7,0 ± 0,1) by air or CO2 bubbling. Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. The test piece for cold water application shall be in contact with test water for 72 h ± 1 h. The test piece for elevated temperature applications shall be in contact with water for 24h. The test shall be repeated at least two more times using fresh test water each time. For cold water tests, the migration samples of the 1st, 2nd and 3rd migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period. For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 7th migration period the testing can be extended and 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period. The largest S/V representative of the product group shall be selected. For further details on testing organoleptic parameters, TOC, relevant and unexpected substances relevant European standards or, in the absence thereof, an internationally recognised methods shall be used. Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water.

3.1.

3.1.1. Specifications for testing final cementitious materials for migration of organoleptic parameters (odour, flavour, colour and turbidity), TOC, relevant and unexpected substances For a product or a component of which the size does not allow the practical application of the testing, a representative test piece for the testing shall be provided. Special attention shall be given to the production of the test piece. Test pieces shall be preconditioned by immersion in demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1) and sodium hydrogen carbonate ((336 ± 2) NaHCO3 mg L-1) adjusted to a pH of (7.4 ± 0,1) by air or CO2 bubbling. Test pieces shall be preconditioned at (23 ± 2) °C in three successive periods of (24 ± 1) h followed by one period of (72 ± 1) h and one period of (24 ± 1) h. After each period the water is discarded and the test piece is not rinsed. If the pH of the last preconditioning water exceeds 9,5 then the preconditioning shall be repeated with new test pieces. After the fifth preconditioning the test piece shall immediately be subjected to the migration test. Test pieces shall be immersed in migration test water with a specified temperature and for a specified period of time. Non-chlorinated migration test water shall be natural water without gas or demineralised water containing anhydrous calcium chloride ((222 ± 2) mg CaCl2 L-1), sodium hydrogen carbonate ((482 ± 2) NaHCO3 mg L-1) and sodium silicate ((71 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7.4 ± 0,1) by air or CO2 bubbling, a conductivity of (500 ± 50) μS cm -1, an alkalinity of (350 ± 50) mg HCO3- L-1, a concentration of calcium of (80 ± 10) mg -1 L and a concentration of silica of (15 ± 5) mg SiO2 L-1. Non-chlorinated migration test water shall have no odour (< 2 TON), flavour (< 2 TFN), colour (< 0,1 m-1), turbidity (< 0,1 FNU) and TOC (<0,2 mg C L-1). Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. Non-chlorinated migration test water shall be demineralised water containing anhydrous calcium chloride ((110 ± 1) mg CaCl2 L-1), sodium hydrogen carbonate ((140 ± 1) NaHCO3 mg L-1) and sodium silicate ((48 ± 1) Na2SiO3·9·H2O mg L-1). It shall have a pH of (7,0 ± 0,1) by air or CO2 bubbling. Chlorinated migration test water shall consist of non-chlorinated test water containing (1,0 ± 0,2) mg L-1 of free chlorine. All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. The test piece for cold water application shall be in contact with test water for 72 h ± 1 h. The test piece for elevated temperature applications shall be in contact with water for 24h. The test shall be repeated at least two more times using fresh test water each time. For cold water tests, the migration samples of the 1st, 2nd and 3rd migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 3rd migration period the testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period. For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 7th migration period the testing can be extended and 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period. The largest S/V representative of the product group shall be selected. For further details on testing organoleptic parameters, TOC, relevant and unexpected substances relevant European standards or, in the absence thereof, an internationally recognised methods shall be used. Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non-chlorinated test water. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water. (a) Test pieces (b) Preconditioning of test pieces (c) Migration test (i) Migration test water for odour, flavour, colour, turbidity and TOC (ii) Migration test water for migration of relevant and unexpected substances (iii) Migration test water temperature (iv) Duration of migration test periods (v) Surface-to-volume ratio (S/V) (vi) Additional specifications

3.1.1.

(a) Test pieces

(b) Preconditioning of test pieces

(c) Migration test

(i) Migration test water for odour, flavour, colour, turbidity and TOC

(ii) Migration test water for migration of relevant and unexpected substances

(iii) Migration test water temperature

(iv) Duration of migration test periods

(v) Surface-to-volume ratio (S/V)

(vi) Additional specifications

3.2. Analysis of migration waters Grp. 321. Relevant substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters. The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 322. Unexpected substances For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening or screening by other analytical techniques can be used. Unexpected substances are only determined in the migration waters of the cold water test. Grp. 323. Relevant other parameters The methods for analysis of relevant other parameters in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level.

3.2.

3.2.1. Relevant substances The relevant substances defined in section 2.2.2 shall be analysed in the migration waters. The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level.

3.2.2. Unexpected substances For the identification and semi-quantitative analysis of unexpected substances a GC-MS screening or screening by other analytical techniques can be used. Unexpected substances are only determined in the migration waters of the cold water test.

3.2.3. Relevant other parameters The methods for analysis of relevant other parameters in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level.

3.3. Mathematical modelling Where generally recognised diffusion models exist on the basis of experimental data, mathematical modelling for estimation of migration levels may be used as alternative to the migration testing of relevant substances for certain types of final cementitious materials. If these recognised diffusion models predict that the migration of the substance complies with the maximum tolerable concentration at the tap (MTCtap), migration testing for these substances is not necessary. For the assessment of some parameters and for modelling, the content of the respective substances in the final material shall be determined. If compliance is not shown by using the models, migration testing shall be performed. Only validated mathematical models applicable to cementitious materials shall be used to determine the concentration of a relevant substance in migration water.

3.4. Enhancement of Microbial Growth (EMG) testing Tests for Enhancement of Microbial Growth shall be performed if organic constituents are used according to the formulation. For the Enhancement of Microbial Growth testing, standard EN 16421:2015 – method 1 or 2 shall be used.

4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA (a) in accordance with the technical function specified in the relevant European positive lists; (b) in compliance with conditions of use established under the relevant European positive lists. Grp. 41. Formulation Organic cementitious constituents of the formulation listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and in the European positive list of starting substances for organic materials as further specified in Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367 shall be used: Grp. 421. Conversion of migration test results The migration test results are expressed as migration rates (M) in μg/(dm2d). These results shall be converted to estimate the concentrations at the tap (Ctap) , defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to Annex I. (a) Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period or, in case extended testing is needed, at the 22nd migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration test water from the successive migration periods shall be used to assess the trend. However, if the Ctap in the relevant migration period is below 1/10th of the MTCtap, then no trend analysis is required. For metals, MTCtap,cementitious of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. Grp. 423. Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test:Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period. The MTCtap for the unexpected substances are set out in Table 6 of Annex I. For certain cementitious products the S/V ratio does not allow to meet the limit of MTCtap = 1 μg/L as established for organic materials. In this case MTCtap < Limit of Quantification for the highest S/V ratio shall apply. (a) Ctap ≤ 0,5 mg/l for the 3rd migration period or Ctap ≤ 0,5 mg/l for the 9th migration period and Ctap ≤ 2,0 mg/l for the 3rd migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period or Ctap ≤ 0,5 mg/l for the 22nd migration period and Ctap ≤ 2,0 mg/l for the 7th migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 424. Pass/fail criteria for Total Organic Carbon (TOC) The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required. Grp. 42. Relevant substances, unexpected substances (a) TON, TFN ≤ 2,0 for the 3rd migration period; or (b) TON, TFN ≤ 2,0 for the 9th migration period and TON ≤ 4,0 for the 3rd migration period. Pt_a_. 2. TON, TFN ≤ 2,0 for the 7th migration period; or Pt_b_. 2. TON, TFN ≤ 2,0 for the 22nd migration period and TON, TFN ≤ 4,0 for the 7th migration period. Grp. 431. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: Grp. 432. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing. Grp. 433. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing. Grp. 43. Odour, flavour, colour and turbidity Grp. 44. Enhancement of Microbial Growth (EMG) The pass/fail criteria for Enhancement of Microbial Growth (EMG) for method 1 (EN 16421:2015) is < 1000 pg ATP/ cm2 and for method 2 (EN 16421:2015) is ≤ (0,05 ± 0,02) ml/800 cm2. Additionally, the surface of the products or components shall not have any biocidal effects on water intended for human consumption. Therefore, test pieces without surface colonisation (comparison of contact culture/test sample smear with that of the negative control) do not satisfy this requirement.

4.

4.1. Formulation Organic cementitious constituents of the formulation listed in the European positive list of organic constituents for cementitious materials in Annex III of Commission Implementing Decision (EU) 2024/367 and in the European positive list of starting substances for organic materials as further specified in Table 1 of Annex III to Commission Implementing Decision (EU) 2024/367 shall be used: (a) in accordance with the technical function specified in the relevant European positive lists; (b) in compliance with conditions of use established under the relevant European positive lists.

4.1.

(a) in accordance with the technical function specified in the relevant European positive lists;

(b) in compliance with conditions of use established under the relevant European positive lists.

4.2. Relevant substances, unexpected substances Grp. 421. Conversion of migration test results The migration test results are expressed as migration rates (M) in μg/(dm2d). These results shall be converted to estimate the concentrations at the tap (Ctap) , defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to Annex I. (a) Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period or, in case extended testing is needed, at the 22nd migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration test water from the successive migration periods shall be used to assess the trend. However, if the Ctap in the relevant migration period is below 1/10th of the MTCtap, then no trend analysis is required. For metals, MTCtap,cementitious of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. Grp. 423. Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test:Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period. The MTCtap for the unexpected substances are set out in Table 6 of Annex I. For certain cementitious products the S/V ratio does not allow to meet the limit of MTCtap = 1 μg/L as established for organic materials. In this case MTCtap < Limit of Quantification for the highest S/V ratio shall apply. (a) Ctap ≤ 0,5 mg/l for the 3rd migration period or Ctap ≤ 0,5 mg/l for the 9th migration period and Ctap ≤ 2,0 mg/l for the 3rd migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period or Ctap ≤ 0,5 mg/l for the 22nd migration period and Ctap ≤ 2,0 mg/l for the 7th migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 424. Pass/fail criteria for Total Organic Carbon (TOC) The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required.

4.2.

4.2.1. Conversion of migration test results The migration test results are expressed as migration rates (M) in μg/(dm2d). These results shall be converted to estimate the concentrations at the tap (Ctap) , defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 to Annex I.

4.2.2. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration test water from the successive migration periods shall be used to assess the trend. However, if the Ctap in the relevant migration period is below 1/10th of the MTCtap, then no trend analysis is required. For metals, MTCtap,cementitious of Table 1 in Annex V to Commission Implementing Decision (EU) 2024/367 shall apply. (a) Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period or, in case extended testing is needed, at the 22nd migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time

4.2.2.

(a) Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period;

(b) there shall be no increasing trend of Ctap in time.

(a) Ctap ≤ MTCtap for the 7th migration period or, in case extended testing is needed, at the 22nd migration period.

(b) there shall be no increasing trend of Ctap in time

4.2.3. Pass/fail criteria for unexpected substances The following requirement shall apply to the cold water migration test:Ctap ≤ MTCtap for the 3rd migration period or, in case extended testing is needed, at the 9th migration period. The MTCtap for the unexpected substances are set out in Table 6 of Annex I. For certain cementitious products the S/V ratio does not allow to meet the limit of MTCtap = 1 μg/L as established for organic materials. In this case MTCtap < Limit of Quantification for the highest S/V ratio shall apply.

4.2.4. Pass/fail criteria for Total Organic Carbon (TOC) The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured TOC in the migration water from the successive migration periods shall be used to assess the trend. However, if the TOC in the relevant migration period is below 0,2 mg/l no trend analysis is required. (a) Ctap ≤ 0,5 mg/l for the 3rd migration period or Ctap ≤ 0,5 mg/l for the 9th migration period and Ctap ≤ 2,0 mg/l for the 3rd migration period; (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ 0,5 mg/l for the 7th migration period or Ctap ≤ 0,5 mg/l for the 22nd migration period and Ctap ≤ 2,0 mg/l for the 7th migration period. Pt_b_. 2. there shall be no increasing trend of Ctap in time.

4.2.4.

(a) Ctap ≤ 0,5 mg/l for the 3rd migration period or Ctap ≤ 0,5 mg/l for the 9th migration period and Ctap ≤ 2,0 mg/l for the 3rd migration period;

(b) there shall be no increasing trend of Ctap in time.

(a) Ctap ≤ 0,5 mg/l for the 7th migration period or Ctap ≤ 0,5 mg/l for the 22nd migration period and Ctap ≤ 2,0 mg/l for the 7th migration period.

(b) there shall be no increasing trend of Ctap in time.

4.3. Odour, flavour, colour and turbidity (a) TON, TFN ≤ 2,0 for the 3rd migration period; or (b) TON, TFN ≤ 2,0 for the 9th migration period and TON ≤ 4,0 for the 3rd migration period. Pt_a_. 2. TON, TFN ≤ 2,0 for the 7th migration period; or Pt_b_. 2. TON, TFN ≤ 2,0 for the 22nd migration period and TON, TFN ≤ 4,0 for the 7th migration period. Grp. 431. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: Grp. 432. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing. Grp. 433. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing.

4.3.

4.3.1. Pass/fail criteria for TON, TFN The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: (a) TON, TFN ≤ 2,0 for the 3rd migration period; or (b) TON, TFN ≤ 2,0 for the 9th migration period and TON ≤ 4,0 for the 3rd migration period. Pt_a_. 2. TON, TFN ≤ 2,0 for the 7th migration period; or Pt_b_. 2. TON, TFN ≤ 2,0 for the 22nd migration period and TON, TFN ≤ 4,0 for the 7th migration period.

4.3.1.

(a) TON, TFN ≤ 2,0 for the 3rd migration period; or

(b) TON, TFN ≤ 2,0 for the 9th migration period and TON ≤ 4,0 for the 3rd migration period.

(a) TON, TFN ≤ 2,0 for the 7th migration period; or

(b) TON, TFN ≤ 2,0 for the 22nd migration period and TON, TFN ≤ 4,0 for the 7th migration period.

4.3.2. Pass/fail criteria for colour The acceptance criterion for colour is ≤ 5 mg/l Pt/Co The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing.

4.3.3. Pass/fail criteria for turbidity The acceptance criterion for turbidity is ≤ 0,5 NFU The criterion shall be met for the 3rd migration period for cold water migration testing / 7th migration period for warm/hot water testing or in case of extended testing for the 9th migration period for cold water migration testing / 22nd migration period for warm/hot water testing.

4.4. Enhancement of Microbial Growth (EMG) The pass/fail criteria for Enhancement of Microbial Growth (EMG) for method 1 (EN 16421:2015) is < 1000 pg ATP/ cm2 and for method 2 (EN 16421:2015) is ≤ (0,05 ± 0,02) ml/800 cm2. Additionally, the surface of the products or components shall not have any biocidal effects on water intended for human consumption. Therefore, test pieces without surface colonisation (comparison of contact culture/test sample smear with that of the negative control) do not satisfy this requirement.

(1) Categorisation of products or components into risk groups and corresponding testing requirements. (2) Composition review (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Testing of composition (2) Migration test for relevant substances (2) Step 2 – Performance of tests (3) Step 3 – Compliance with pass/fail criteria Grp. 1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING The procedure for testing and accepting final enamels, other glass materials, ceramic materials and other inorganic materials as used in a product includes the following steps: Grp_21_table. 1. Categorisation of products or components into risk groups and corresponding testing requirements. For each product or component of an assembled product, a product group and a corresponding conversion factor (CF) shall be determined in accordance with Table 5 of Annex I. Based on the determined CF, the product or component is categorised in a risk group (RG) in accordance with Table 1. The categorisation in a RG determines the corresponding testing requirements including the relevant other parameters. The applicable testing procedure of final materials results from the use of these materials in products or components of assembled products. Minor components are considered to be components categorised in risk group 4 (RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1, 2 or 3 (RG1, RG2, RG3). For an assembled product the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same final material, then the wetted surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5 of Annex I. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. Risk group Conversion factor CF in d/dm Composition review & testing Specific migration testing RG 1 ≥ 4 Yes Yes, on product or component. Enamels: test piece(s) produced by enameller RG 2 ≥ 0,4 and < 4 RG 3 ≥ 0,04 and < 0,4 Yes Yes, on product or component. Enamels: test pieces(s) produced by enamel manufacturer RG 4 < 0,04 Yes No Grp. 221. Required information For the final materials the complete composition with the range for all constituents exceeding 0,02 % (m/m) is required. The content of lead and cadmium shall be declared. Grp. 222. Accepted compositions The compositions of the final materials shall comply with compositions listed in the European positive lists of compositions of enamels, ceramics and other inorganic materials set out in Table 1 of Annex IV of Commission Implementing Decision (EU) 2024/367, and fulfil the limitations set out in this European positive list in respect of their use for certain product groups and the use of these products. The content of lead and cadmium shall be less than 0,02 % (m/m). Grp. 223. Relevant substances The relevant substances to be analysed in migration waters are specified for each composition set out in the Annex IV to Commission Implementing Decision (EU) 2024/367. Grp. 22. Composition review Grp. 2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS Grp. 31. Testing of the composition An analysis of the composition of the final materials shall be performed to verify compliance with the compositional requirements of compositions of enamels, ceramics or other inorganic materials included in the Annex IV to Commission Implementing Decision (EU) 2024/367. Grp. 321. Standards For testing the release of relevant substances, the following standard shall be used to obtain the migration waters: EN 12873-1:2014. The following sections 3.2.2, 3.2.3, 3.2.4 and 3.2.5 substantiate this standard. Grp. 322. Test piece Special attention shall be given to the production of the test piece. The respective component or product is to be used as test piece(s). A specifically produced test piece shall only be used if the product cannot be tested. Grp. 323. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. For materials that can be subjected to high temperature variation (for example, in solar water heaters), the test should be carried out at 85 °C. Grp. 324. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with non-chlorinated test water. In the case PAH analysis is required the test shall be performed with chlorinated test water additionally. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water. Grp. 325. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria (see 4.2 and 4.3) are not met at the 3rd migration period, testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 2nd, 3rd and 7th, migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria (see 4.2 and 4.3) are not met at the 7th migration period, testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day). Grp. 32. Migration testing Grp. 331. Relevant Substances The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 33. Analysis of migration waters Grp. 3. TESTING REQUIREMENTS Grp. 41. Composition The analysed composition of the final material shall comply with the compositional requirements and other limitations specified in the respective European positive list of compositions. Grp. 421. Conversion of test results In accordance with the standard EN 12873-1:2014, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 of Annex I. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. The MTCtap,inorganic to be applied are defined in the Annex IV and Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367. Grp. 42. Relevant substances Grp. 4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA

ANNEX IV FINAL ENAMELS, CERAMIC MATERIALS AND OTHER INORGANIC MATERIALS (INCLUDING GLASS)

1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING The procedure for testing and accepting final enamels, other glass materials, ceramic materials and other inorganic materials as used in a product includes the following steps: (1) Categorisation of products or components into risk groups and corresponding testing requirements. (2) Composition review (1) Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Testing of composition (2) Migration test for relevant substances (2) Step 2 – Performance of tests (3) Step 3 – Compliance with pass/fail criteria

Step 1 – Identification of relevant substances and relevant other parameters depending on: (1) Categorisation of products or components into risk groups and corresponding testing requirements. (2) Composition review

1.

pt_1

1. Categorisation of products or components into risk groups and corresponding testing requirements.

2. Composition review

Step 2 – Performance of tests (1) Testing of composition (2) Migration test for relevant substances

pt_2

1. Testing of composition

2. Migration test for relevant substances

Step 3 – Compliance with pass/fail criteria

2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS Grp_21_table. 1. Categorisation of products or components into risk groups and corresponding testing requirements. For each product or component of an assembled product, a product group and a corresponding conversion factor (CF) shall be determined in accordance with Table 5 of Annex I. Based on the determined CF, the product or component is categorised in a risk group (RG) in accordance with Table 1. The categorisation in a RG determines the corresponding testing requirements including the relevant other parameters. The applicable testing procedure of final materials results from the use of these materials in products or components of assembled products. Minor components are considered to be components categorised in risk group 4 (RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1, 2 or 3 (RG1, RG2, RG3). For an assembled product the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same final material, then the wetted surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5 of Annex I. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. Risk group Conversion factor CF in d/dm Composition review & testing Specific migration testing RG 1 ≥ 4 Yes Yes, on product or component. Enamels: test piece(s) produced by enameller RG 2 ≥ 0,4 and < 4 RG 3 ≥ 0,04 and < 0,4 Yes Yes, on product or component. Enamels: test pieces(s) produced by enamel manufacturer RG 4 < 0,04 Yes No Grp. 221. Required information For the final materials the complete composition with the range for all constituents exceeding 0,02 % (m/m) is required. The content of lead and cadmium shall be declared. Grp. 222. Accepted compositions The compositions of the final materials shall comply with compositions listed in the European positive lists of compositions of enamels, ceramics and other inorganic materials set out in Table 1 of Annex IV of Commission Implementing Decision (EU) 2024/367, and fulfil the limitations set out in this European positive list in respect of their use for certain product groups and the use of these products. The content of lead and cadmium shall be less than 0,02 % (m/m). Grp. 223. Relevant substances The relevant substances to be analysed in migration waters are specified for each composition set out in the Annex IV to Commission Implementing Decision (EU) 2024/367. Grp. 22. Composition review

2.

2.1. Table 1 Risk-based testing requirements for products or components of assembled products

Categorisation of products or components into risk groups and corresponding testing requirements. For each product or component of an assembled product, a product group and a corresponding conversion factor (CF) shall be determined in accordance with Table 5 of Annex I. Based on the determined CF, the product or component is categorised in a risk group (RG) in accordance with Table 1. The categorisation in a RG determines the corresponding testing requirements including the relevant other parameters. The applicable testing procedure of final materials results from the use of these materials in products or components of assembled products. Minor components are considered to be components categorised in risk group 4 (RG4) and for which reduced testing requirements, as set out in Table 1, may apply in comparison with the testing requirements for the risk group 1, 2 or 3 (RG1, RG2, RG3). For an assembled product the components shall be determined. For each component in an assembled product, a product group shall be determined. If an assembled product consists of components made of the same final material, then the wetted surface fraction of these components shall be cumulatively added for the determination of the product group in accordance with Table 5 of Annex I. The testing shall be performed on the final materials as used in products in contact with water intended for human consumption. Risk group Conversion factor CF in d/dm Composition review & testing Specific migration testing RG 1 ≥ 4 Yes Yes, on product or component. Enamels: test piece(s) produced by enameller RG 2 ≥ 0,4 and < 4 RG 3 ≥ 0,04 and < 0,4 Yes Yes, on product or component. Enamels: test pieces(s) produced by enamel manufacturer RG 4 < 0,04 Yes No

2.2. Composition review Grp. 221. Required information For the final materials the complete composition with the range for all constituents exceeding 0,02 % (m/m) is required. The content of lead and cadmium shall be declared. Grp. 222. Accepted compositions The compositions of the final materials shall comply with compositions listed in the European positive lists of compositions of enamels, ceramics and other inorganic materials set out in Table 1 of Annex IV of Commission Implementing Decision (EU) 2024/367, and fulfil the limitations set out in this European positive list in respect of their use for certain product groups and the use of these products. The content of lead and cadmium shall be less than 0,02 % (m/m). Grp. 223. Relevant substances The relevant substances to be analysed in migration waters are specified for each composition set out in the Annex IV to Commission Implementing Decision (EU) 2024/367.

2.2.

2.2.1. Required information For the final materials the complete composition with the range for all constituents exceeding 0,02 % (m/m) is required. The content of lead and cadmium shall be declared.

2.2.2. Accepted compositions The compositions of the final materials shall comply with compositions listed in the European positive lists of compositions of enamels, ceramics and other inorganic materials set out in Table 1 of Annex IV of Commission Implementing Decision (EU) 2024/367, and fulfil the limitations set out in this European positive list in respect of their use for certain product groups and the use of these products. The content of lead and cadmium shall be less than 0,02 % (m/m).

2.2.3. Relevant substances The relevant substances to be analysed in migration waters are specified for each composition set out in the Annex IV to Commission Implementing Decision (EU) 2024/367.

3. TESTING REQUIREMENTS Grp. 31. Testing of the composition An analysis of the composition of the final materials shall be performed to verify compliance with the compositional requirements of compositions of enamels, ceramics or other inorganic materials included in the Annex IV to Commission Implementing Decision (EU) 2024/367. Grp. 321. Standards For testing the release of relevant substances, the following standard shall be used to obtain the migration waters: EN 12873-1:2014. The following sections 3.2.2, 3.2.3, 3.2.4 and 3.2.5 substantiate this standard. Grp. 322. Test piece Special attention shall be given to the production of the test piece. The respective component or product is to be used as test piece(s). A specifically produced test piece shall only be used if the product cannot be tested. Grp. 323. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. For materials that can be subjected to high temperature variation (for example, in solar water heaters), the test should be carried out at 85 °C. Grp. 324. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with non-chlorinated test water. In the case PAH analysis is required the test shall be performed with chlorinated test water additionally. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water. Grp. 325. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria (see 4.2 and 4.3) are not met at the 3rd migration period, testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 2nd, 3rd and 7th, migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria (see 4.2 and 4.3) are not met at the 7th migration period, testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day). Grp. 32. Migration testing Grp. 331. Relevant Substances The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. Grp. 33. Analysis of migration waters

3.

3.1. Testing of the composition An analysis of the composition of the final materials shall be performed to verify compliance with the compositional requirements of compositions of enamels, ceramics or other inorganic materials included in the Annex IV to Commission Implementing Decision (EU) 2024/367.

3.2. Migration testing Grp. 321. Standards For testing the release of relevant substances, the following standard shall be used to obtain the migration waters: EN 12873-1:2014. The following sections 3.2.2, 3.2.3, 3.2.4 and 3.2.5 substantiate this standard. Grp. 322. Test piece Special attention shall be given to the production of the test piece. The respective component or product is to be used as test piece(s). A specifically produced test piece shall only be used if the product cannot be tested. Grp. 323. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. For materials that can be subjected to high temperature variation (for example, in solar water heaters), the test should be carried out at 85 °C. Grp. 324. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with non-chlorinated test water. In the case PAH analysis is required the test shall be performed with chlorinated test water additionally. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water. Grp. 325. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria (see 4.2 and 4.3) are not met at the 3rd migration period, testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 2nd, 3rd and 7th, migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria (see 4.2 and 4.3) are not met at the 7th migration period, testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day).

3.2.

3.2.1. Standards For testing the release of relevant substances, the following standard shall be used to obtain the migration waters: EN 12873-1:2014. The following sections 3.2.2, 3.2.3, 3.2.4 and 3.2.5 substantiate this standard.

3.2.2. Test piece Special attention shall be given to the production of the test piece. The respective component or product is to be used as test piece(s). A specifically produced test piece shall only be used if the product cannot be tested.

3.2.3. Temperature of testing All products shall be tested at 23 °C ± 2 °C (cold water test condition). Additionally, products that are normally used for warm or hot applications shall be tested at 60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to normal operating temperatures between 30 °C and 70 °C and hot water corresponds to operating temperatures exceeding 70 °C. For materials that can be subjected to high temperature variation (for example, in solar water heaters), the test should be carried out at 85 °C.

3.2.4. Type of test water Cold water test (23 °C ± 2 °C) shall be performed with non-chlorinated test water. In the case PAH analysis is required the test shall be performed with chlorinated test water additionally. In case a warm or a hot water test is required, the test shall only be performed with non-chlorinated test water.

3.2.5. Migration periods For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to standards shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 3rd migration period (10th day of testing). If the pass/fail criteria (see 4.2 and 4.3) are not met at the 3rd migration period, testing can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 9th migration period (31st day of testing). For warm or hot water tests the migration samples of the 1st, 2nd, 3rd and 7th, migration period shall be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration period (10th day). If the pass/ fail criteria (see 4.2 and 4.3) are not met at the 7th migration period, testing can be extended and the 12th, 17th and 22nd period shall be analysed additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period (31st day).

3.3. Analysis of migration waters Grp. 331. Relevant Substances The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level.

3.3.

3.3.1. Relevant Substances The methods for analysis of relevant substances in migration waters shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level.

4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA Grp. 41. Composition The analysed composition of the final material shall comply with the compositional requirements and other limitations specified in the respective European positive list of compositions. Grp. 421. Conversion of test results In accordance with the standard EN 12873-1:2014, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 of Annex I. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. The MTCtap,inorganic to be applied are defined in the Annex IV and Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367. Grp. 42. Relevant substances

4.

4.1. Composition The analysed composition of the final material shall comply with the compositional requirements and other limitations specified in the respective European positive list of compositions.

4.2. Relevant substances Grp. 421. Conversion of test results In accordance with the standard EN 12873-1:2014, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 of Annex I. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time. Grp. 422. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. The MTCtap,inorganic to be applied are defined in the Annex IV and Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367.

4.2.

4.2.1. Conversion of test results In accordance with the standard EN 12873-1:2014, the test results are expressed as migration rates (M) in μg/(dm2.d). These results shall be converted to estimate the concentrations at the tap (Ctap), defined as Ctap = M * CF, where CF is the corresponding conversion factor in d/dm. The conversion factors for the different product groups are listed in Table 5 of Annex I.

4.2.2. Pass/fail criteria for relevant substances The following requirements shall apply to the cold water migration test: The following requirements shall apply to the warm/hot water migration test: The measured substance concentrations in the migration water from the successive migration periods shall be used to assess the trend. However, if Ctap in the relevant migration period is below 1/10 of MTCtap, no trend analysis is required. The MTCtap,inorganic to be applied are defined in the Annex IV and Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367. (a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing); (b) there shall be no increasing trend of Ctap in time. Pt_a_. 2. Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing); Pt_b_. 2. there shall be no increasing trend of Ctap in time.

4.2.2.

(a) Ctap ≤ MTCtap for the 3rd migration period (10th day of testing) or, in case extended testing is needed, at the 9th migration period (31st day of testing);

(b) there shall be no increasing trend of Ctap in time.

(a) Ctap ≤ MTCtap for the 7th migration period (10th day of testing) or, in case extended testing is needed, at the 22nd migration period (31st day of testing);

(b) there shall be no increasing trend of Ctap in time.

Versions

1. 2024-01-23

Cited by

• Commission Implementing Decision (EU) 2024/365 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive lists (Text with EEA relevance) Decision · Grade B

  results of analysis of testing waters by applying an appropriate screening method as set out in Commission Implementing Decision (EU) 2024/368

• Commission Implementing Decision (EU) 2024/365 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive lists (Text with EEA relevance) Decision · Grade B

  Sufficient information on the intended use of starting substances, compositions, constituent as well as of final materials and products shall be generated, including the information set out in Table 1. Starting substance for organic materials/organic cementitious constituents Composition of metallic materials Composition of enamels, ceramic, or other inorganic materials Standard information and testing 2. Use: 2.1. Material type, category and sub-category: Identification of the material type, material category and material sub-category. 2.2. Identity and use of final material and product: 2.2.

• Commission Implementing Decision (EU) 2024/365 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive lists (Text with EEA relevance) Decision · Grade B

  Any testing under this Section shall be carried out in compliance with the principles of good laboratory practice provided for in standard EN ISO/IEC 17025 or other international standards recognised as being equivalent by the Commission or ECHA. Any testing or modelling shall follow the appropriate test method determined by ECHA and published on its website or identified below. Such testing or modelling shall also follow the specifications determined by ECHA and published on its website to ensure adequate and reliable conclusion on migration, taking into account the requirement for migration

• Commission Implementing Decision (EU) 2024/365 of 23 January 2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive lists (Text with EEA relevance) Decision · Grade B

  A prediction of migration in organic materials using mathematical modelling in accordance with the migration testing standard set out in Annex I of Commission Implementing Decision (EU) 2024/368 may replace testing for a substances as specified in Annex IV, Section 1.4 used in an organic material where, on the basis of a scientific explanation, any of the following conditions is met: Physical testing of a metallic composition may be waived if its migration is likely to be similar, as a result of compositional and structural similarities, to another metallic composition and the following condit

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  For the purpose of ensuring uniform application of Article 11 of Directive (EU) 2020/2184, minimum hygiene requirements for materials that come into contact with water intended for human consumption have been established in Commission Implementing Decision (EU) 2024/368.

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  In order to ensure that the information regarding conformity of products with the minimum hygiene requirements established under Article 11 of Directive (EU) 2020/2184 is provided in a uniform manner for all products, that information should be provided in the form of a single EU declaration of conformity. By drawing up the EU declaration of conformity, the manufacturer, importer or authorised representative should assume responsibility for the compliance of the product with the minimum hygiene requirements set out in Implementing Decision (EU) 2024/368.

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  final material means material which is subject to testing and acceptance in accordance with the testing requirements and acceptance criteria set out in Implementing Decision (EU) 2024/368;

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  test piece means a representative object of the final material that is used for the carrying out of testing in accordance with the procedures and methods for testing set out in Implementing Decision (EU) 2024/368;

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  minimum hygiene requirements means the hygiene requirements set out in Implementing Decision (EU) 2024/368;

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  reduced testing means carrying out a test where only a part of the procedures and methods for testing set out in Implementing Decision (EU) 2024/368 are applied on test pieces which have been withdrawn by the notified body during the initial or annual inspection.

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  all relevant tests referred to in Implementing Decision (EU) 2024/368 shall be performed by the notified body or on behalf of the notified body;

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  Where the product is categorised in risk group 1 or 2 under Implementing Decision (EU) 2024/368 or, in the case of a metallic composition, in product group A or B in Table 2 Product group for metallic compositions of Annex II to Commission Implementing Decision (EU) 2024/365, both of the following conformity assessment procedures shall apply: Where the conformity assessment procedures referred to in the first subparagraph demonstrate that the product complies with the minimum hygiene requirements, the notified body shall issue a certificate for both conformity assessment procedures referred to

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  all relevant tests referred to in Implementing Decision (EU) 2024/368 shall be performed by the notified body or on behalf of the notified body;

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  Where the product is categorised in risk group 3 or 4 under Implementing Decision (EU) 2024/368 or, in the case of a metallic composition, in product group C or D in Table 2 Product group for metallic compositions of Annex II to Implementing Decision (EU) 2024/365, both of the following conformity assessment procedures shall apply: Where the conformity assessment procedures referred to in the first subparagraph demonstrate that the product complies with the minimum hygiene requirements, the notified body shall issue a certificate for the conformity assessment procedure referred to in that subp

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  Where the product is an assembled product, the applicable conformity assessment procedure shall be determined by the individual component with the highest risk group categorisation (RG1 is the highest risk group, RG4 is the lowest risk group) under Implementing Decision (EU) 2024/368 or, in the case of metallic compositions, the highest categorised product group in Table 2 Product group for metallic compositions of Annex II to Implementing Decision (EU) 2024/365.

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  The applicable conformity assessment procedure for the manufacture of an individual component of an assembled product shall be determined by the risk group of that individual component under Implementing Decision (EU) 2024/368 or, in the case of metallic compositions, the product group of the individual component in Table 2 Product group for metallic compositions of Annex II to Implementing Decision (EU) 2024/365.

• Commission Delegated Regulation (EU) 2024/370 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down conformity assessment procedures for products that come into contact with water intended for human consumption and the rules for the designation of conformity assessment bodies involved in those procedures (Text with EEA relevance) Regulation · Grade B

  appropriate knowledge and understanding of the minimum hygiene requirements and their standards set out in Implementing Decision (EU) 2024/368; and

• 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) Decision · Grade B

  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 ac

• 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) Decision · Grade B

  Table 1 sets out (1) the different categories of generic constituents of cementitious materials that may be used in the preparation of cementitious mixtures and (2) establishes conditions of use for each category. Generic constituent category Types of specific organic cementitious constituents within the scope of the European positive lists European positive list requirements Condition of use Cement Organic grinding aids or other organic substances used for the preparation of cement European positive list for cementitious materials Inorganic additions Organic grinding aids or other organic sub