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)
Article 1
Definitions
Article 2
Testing and acceptance of starting substances, compositions and constituents
Article 3
Testing methodology
Article 4
Acceptance methodology in the European positive lists
Article 5
Entry into force
ANNEX I
IDENTIFICATION OF STARTING SUBSTANCES, COMPOSITIONS AND CONSTITUENTS
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Starting substance for organic materials/organic cementitious constituents |
Composition of metallic materials |
Composition of enamels, ceramic, or other inorganic materials |
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Standard information and testing |
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1.1. |
Name or any other identifier: |
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1.1.1. |
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Name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature and/or other international chemical names, if available. |
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1.1.2. |
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Other names (e.g., usual name, trade name, abbreviation) (if available). |
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1.1.3. |
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European Inventory of Existing Commercial Chemical Substances (Einecs), European List of Notified Chemical Substances (Elincs) or No-Longer Polymer (NLP) number, or the number assigned by ECHA under Regulation (EC) No 1907/2006, if available. |
European Inventory of Existing Commercial Chemical Substances (Einecs), European List of Notified Chemical Substances (Elincs) or the number assigned by the Agency under Regulation (EC) 1907/2006, if available. |
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1.1.4. |
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Chemical Abstracts Service (CAS) name and CAS number, if available. |
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1.1.5. |
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European Union Positive List number, if available. |
European Union Positive List number, if available. |
European Union Positive List number, if available. |
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1.1.6. |
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Designation:
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Name of material category and name of enamel, ceramic or other inorganic composition. |
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1.1.7. |
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Identity of existing metallic composition category that the composition belongs to. |
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1.1.8. |
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Identity and designation of new metallic composition category that the composition belongs to. |
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1.1.9. |
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Identity of metal constituents of the new metallic composition category and corresponding concentration ranges (minimum and maximum % w/w). |
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1.1.10. |
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Identity of metal impurities of the new metallic composition category present above 0,02 % w/w concentration in the composition and corresponding maximum percentage by mass (% w/w). |
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1.1.11. |
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Identity of metal constituents of the reference material for the new metallic composition category and corresponding concentration ranges (minimum and maximum % w/w). |
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1.1.12. |
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Identity of metal impurities of the reference material for the new metallic composition category that are present above 0,02 % w/w concentration in the composition and their corresponding concentration ranges (minimum and maximum, % w/w). |
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1.2. |
Information related to molecular and structural formula or crystal structure: |
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1.2.1. |
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Molecular formula and structural formula (including IUPAC International Chemical Identifier (InChI), Simplified Molecular Input Line Entry System (SMILES) notation and other representation, if available). |
Description of crystal structures, including crystalline phases, if available.. |
Description of crystal structures, including crystalline phases, if available.. |
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1.2.2. |
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Information on optical activity and typical ratio of (stereo)isomers, if available. |
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1.2.3. |
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Molecular weight or molecular weight range, if available. |
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1.3. |
Chemical characterisation. Where it covers a nanoform, this nanoform shall be characterised pursuant to point 1.4.: |
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1.3.1. |
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Degree of purity (%), i.e., typical concentration and concentration range (in percentage, minimum and maximum) of substance constituents. |
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1.3.2. |
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Names (EC, CAS numbers, and other identifiers, if available) of substance constituents present above 0,02 % w/w concentration in the formulation and at concentration ≥ 0,1 % w/w in the substance (taking into account information submitted under points 1.1.1, 1.1.2 and 1.1.3 above and Table 1, point 2.4.1 of Annex II). For each of these, typical concentration and concentration range (minimum and maximum % w/w). |
Names (and other identifiers e.g. EC, CAS numbers) of constituents of the composition, i.e., the elements in any form (e.g., bound or unbound) and corresponding concentration ranges (minimum and maximum % w/w). |
Names (and other identifiers e.g. EC, CAS numbers) of constituents of the composition, i.e., the elements in any form (e.g., bound or unbound) and corresponding concentration ranges (minimum and maximum % w/w). |
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1.3.3. |
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Names (and other identifiers e.g. EC, CAS numbers) of impurities present above 0,02 % w/w concentration in the formulation of the final material and at concentration ≥ 0,1 % w/w in the substance (taking into account information submitted under points 2.4.1. and 2.4.2. of Table 1 of Annex II). For each of these, typical concentration and concentration range (minimum and maximum % w/w). |
Names (and other identifiers e.g. EC, CAS numbers) of impurities present above 0,02 % w/w concentration in the composition and corresponding maximum percentage by weight (% w/w). |
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1.3.4. |
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All necessary qualitative and quantitative analytical data specific for the identification of the substance, such as ultraviolet, infra-red, nuclear magnetic resonance, mass spectrum, chromatographic, titrimetric, elemental analysis and/or diffraction data. |
All necessary qualitative and quantitative analytical data specific for the identification of the composition and constituents of the composition, such as elemental analysis, Inductively Coupled Plasma Mass Spectrometry, Atomic Absorption Spectroscopy, Ion Chromatography, titrimetric and/or diffraction data (e.g., X-Ray Fluorescence (XRF) or X-Ray Powder Diffraction (XRD). |
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1.3.5. |
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Description of the analytical methods or the appropriate bibliographical references that are necessary for the identification of the starting substance, organic cementitious constituent (including the identification and quantification of impurities and substance constituents), metallic composition constituent, and enamel, ceramic, or other inorganic composition constituent. The description shall consist of the experimental protocols followed and the relevant interpretation of the results reported under points 1.3.1. to 1.3.4. This information shall be sufficient to allow the methods to be reproduced. |
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1.4. |
Characterisation of a nanoform: |
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1.4.1. |
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Names or other identifiers of the nanoform of the starting substance or organic cementitious constituent, if applicable. |
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1.4.2. |
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Number based particle size distribution with indication of the number fraction of nanoform particles in the size range 1 nm – 100 nm. |
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1.4.3. |
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Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number. |
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1.4.4. |
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Shape, aspect ratio and other morphological characterisation: crystallinity, information on assembly structure, including e.g., shell like structures or hollow structures, if available. |
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1.4.5. |
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Surface area (specific surface area by volume, specific surface area by mass or both). |
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1.4.6. |
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Description of the analytical methods or the appropriate bibliographical references for the information elements in point 1.4. This information shall be sufficient to allow the methods to be reproduced. |
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1.5. |
Additional information required for starting substances and organic cementitious constituents which are (a) polymers or (b) pre-polymers: |
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1.5.1. |
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Name (and other identifiers e.g. EC, CAS numbers) of monomers and other reactants from which the substance is produced. |
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1.5.2. |
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Manufacturing process description (including information on the use of monomers and reactants as well as their ratio). |
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1.5.3. |
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Additives to the (pre-)polymer. |
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1.5.4. |
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Structure information of the (pre-)polymer. |
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1.5.5. |
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Molecular mass distribution; test report of the molecular mass distribution is required. |
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1.5.6. |
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Number averaged molecular mass. |
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1.5.7. |
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Molecular mass range (minimum and maximum). |
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1.5.8. |
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Identities of the substance constituents with molecular weight < 1000 Da and their percentage by weight (% w/w). |
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1.5.9. |
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Residual monomers and their concentrations (%). |
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1.5.10. |
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Viscosity |
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1.5.11. |
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Melt flow index |
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ANNEX II
INTENDED USE
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Starting substance for organic materials/organic cementitious constituents |
Composition of metallic materials |
Composition of enamels, ceramic, or other inorganic materials |
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Standard information and testing |
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2. |
Use: |
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2.1. |
Material type, category and sub-category: |
Identification of the material type, material category and material sub-category. |
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2.2. |
Identity and use of final material and product: |
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2.2.1. |
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Specification of the product/component. Definition of area of uses: domestic vs. non-domestic installations. |
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2.2.2. |
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Relevant product groups for organic materials or cementitious materials (refer to Table 5 of Annex I to Commission Implementing Decision (EU) 2024/368(1). |
Relevant product groups for metallic compositions (refer to Table 2 of this Annex). |
Relevant product groups for enamel, ceramic or other inorganic materials (refer to Table 5 of Annex IV to Commission Implementing Decision (EU) 2024/368. |
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2.2.3. |
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Cold (≤ 25 °C)/warm (25 – 65 °C) or hot (≥ 65 °C) water use. |
Cold (≤ 25 °C)/warm (25 – 65 °C) or hot (≥ 65 °C) water use. |
Cold (≤ 25 °C)/warm (25 – 65 °C) or hot (≥ 65 °C) water use. |
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2.3. |
Technical function: |
Specification of the technical function. |
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2.4. |
Conditions of use of the starting substance, composition or organic cementitious constituent; of the final material; and of the product: |
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2.4.1. |
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For starting substances for organic materials: Maximum dosage of the starting substance in the formulation to produce the final material. |
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2.4.2. |
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For organic constituents of cementitious materials:
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2.4.3. |
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Proposed restrictions or other conditions of use for the inclusion of the starting substance, composition or constituent on the European positive list. |
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2.5. |
Information on the processing and internal structure of the material, final material and product: |
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2.5.1. |
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Information on the processing of the material, final material and product, including treatment of material, final material or product prior to use. |
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2.5.2. |
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Processing temperatures of the final material. |
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Processing temperatures of the final material. |
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2.5.3. |
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Information on the internal structure of the final material. |
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2.6. |
Union and national level assessments and authorisations: |
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2.6.1. |
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Details of any authorisation, risk assessment and other relevant regulation at the European Union or national level for use in final materials or materials coming into contact with water intended for human consumption. |
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2.6.2. |
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Details of any authorisation, risk assessment and other relevant regulation at the European Union or national level for use in final materials or materials coming into contact with food. |
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2.7. |
EU authorisation of biocidal active substances: |
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2.7.1. |
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Approval/assessment status of the starting substance or organic cementitious constituent under Regulation (EU) No 528/2012. |
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2.7.2. |
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Product-type relevant to the starting substance or organic cementitious constituent under Regulation (EU) No 528/2012. |
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2.7.3. |
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Approval start date under Regulation (EU) No 528/2012. |
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2.7.4. |
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Approval end date under Regulation (EU) No 528/2012. |
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3. |
Identification of non-intentionally added species other than impurities: |
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3.1. |
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Evaluation on the presence of non-intentionally added species other than impurities and substance constituents migrating from the material taking into account at least the following:
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3.2. |
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Reactions of the starting substance or organic cementitious constituent occurring during the processing of the material and final material and reaction or degradation products formed (also taking into account the thermal stability as demonstrated by a mandatory thermal stability test, of the substance) |
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3.3. |
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Reactions of the starting substance or organic cementitious constituent occurring during the use of the final material in contact with water intended for human consumption and reaction or degradation products formed (also taking into account hydrolysis as demonstrated by a mandatory hydrolysis study of the substance). |
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3.4. |
Identification of other substances that may migrate into the drinking water when using starting substances and organic cementitious constituents which are monomers or other reactants: |
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3.4.1. |
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Evaluation of the presence of any polymerised part below 1000 Da that is relevant to the use of the starting substance or organic cementitious constituent. |
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3.4.2. |
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Description of process that leads to the formation of the polymerised part below 1000 Da. |
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3.4.3. |
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Molecular weight distribution for polymerised part below 1000 Da; test report of the molecular weight distribution is required. |
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3.4.4. |
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Number averaged molecular weight of polymerised part below 1000 Da. |
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3.4.5. |
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Molecular mass range (min and max) of polymerised part below 1000 Da. |
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3.4.6. |
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Residual polymerised part below 1000 Da and its concentration (%). |
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3.5. |
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Name (and other identifiers e.g. EC, CAS numbers) of non-intentionally added species identified under points 3.1.–3,4. |
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Product group |
Examples of metallic products or components |
Assumed contact surface ‘a’ |
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A |
Pipes. |
100 % |
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B |
Fittings, ancillaries in buildings installations. |
10 % |
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C |
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1 % |
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D |
Components of fittings and ancillaries in water mains and in water treatment works as described for product group C subcategory 2 above). |
< 0,1 % |
ANNEX III
PHYSICO-CHEMICAL PROPERTIES
Section 1. No standard information or testing requirement
Section 2. Standard information or testing required
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Column 1 Standard information and testing |
Column 2 Specific rules for adaptation of the standard information and testing |
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4.1. |
Appearance at 20 °C and 101,3 kPa |
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4.1.1. |
Physical state |
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4.1.2. |
Aggregate state (e.g., viscous, crystalline, powder) |
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4.1.3. |
Colour |
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4.1.4. |
Odour |
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4.2. |
Melting/freezing point |
No need to provide information below a lower limit of – 20 °C. |
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4.3. |
Boiling point |
No need to provide information for the following:
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4.4. |
Density |
The study for density does not need to be conducted in the following cases:
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4.5. |
Vapour pressure |
No need to provide information if the melting point is above 300 °C. If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recognised calculation method is sufficient. |
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4.5.1. |
Henry’s law constant must always be stated for solids and liquids if it can be calculated. |
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4.6. |
Surface tension of an aqueous solution |
The information need only be provided in the following cases:
If the water solubility is below 1 mg/l at 20 °C, the test does not need to be conducted. |
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4.7. |
Water solubility |
No need to provide information in the following cases:
If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analytical method shall be performed. For metals and sparingly soluble metal compounds, information on transformation/dissolution in aqueous media shall be provided. |
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4.8. |
Partition coefficient (n-octanol/water) and its pH dependency |
No need to provide information if the substance is inorganic. If the test cannot be performed (e.g., the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for the partition coefficient as well as details of the calculation method shall be provided. |
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4.9. |
Granulometry |
The study does not need to be conducted if the substance is marketed or used in a non-solid or non-granular form. |
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4.10. |
Dissociation constant |
No need to provide information in the following cases:
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ANNEX IV
MIGRATION AND CONFIRMATION OF RELEVANT CHEMICAL SPECIES
Section 1. General requirements, standard information and testing for the determination of migration
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Starting substance or organic materials/organic cementitious constituents |
Composition of metallic materials |
Composition of enamels, ceramic, or other inorganic materials |
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5. |
Migration: |
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5.1. |
Test pieces |
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5.1.1. |
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Detailed description of the test pieces including dimensions, the production of the test pieces and the storage of the test pieces between the production and the sampling including the name of the producer of the test pieces. |
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5.1.2. |
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Dosage of the starting substance/organic cementitious constituent to produce the test pieces. |
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5.1.3. |
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Concentration of the starting substance/organic cementitious constituent in the test pieces. |
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5.1.4. |
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Composition of the test pieces. |
Composition of the test pieces. |
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5.1.5. |
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Roughness of the inner surface of the test pieces. |
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5.2. |
Testing for hygienic safety via migration methods or electrochemical methods of the substances as specified in Annex IV Section 1.4. |
Test method for factory-made products and site applied products made from or incorporating organic materials according to standards referred to in Annex I to Commission Implementing Decision (EU) 2024/368. |
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Test method for products made from or incorporating glassy (porcelain/vitreous enamel) materials according to the standard described in Annex IV Commission Implementing Decision (EU) 2024/368. |
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5.3. |
Analytical methods and techniques |
For testing in accordance with point 5.2. (excluding the test method to evaluate the passive behaviour of stainless steels and other passive metallic compositions): Description and details of analytical methods and techniques used to analyse concentrations of potentially relevant chemical species or elements from migration and/or contact water resulting from migration testing. For surface layers (coatings, platings) this includes relevant chemical species or elements from the surface layer and from the substrate. The methods and techniques shall be validated and shall comply with minimum performance criteria. The description shall consist of the experimental protocols followed and the relevant interpretation of the results. This information shall be sufficient to allow the methods to be reproduced. |
Section 2. General rules for adaptation of information and testing with regard to the migration
Section 3.Criteria for the identification of relevant chemical species
ANNEX V
TOXICOLOGICAL PROPERTIES
Section 1. No standard information or testing
Section 2. Standard information or testing required
Part 1.
General and specific rules
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Column 1 Standard information and testing |
Column 2 Specific rules for adaptation of the standard information and testing |
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6.1. |
Genotoxicity/Mutagenicity: |
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6.1.1. |
In vitro genetic toxicity |
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6.1.1.1. |
In vitro gene mutation study in bacteria |
The in vitro gene mutation study in bacteria does not need to be conducted if this test is not applicable for the relevant chemical species. In this case, the applicant shall provide a justification and perform an in vitro study referred to in point 6.1.1.3. The study does not need to be conducted for nanoforms where it is not appropriate. In this case, other studies involving one or more in vitro mutagenicity studies in mammalian cells shall be provided. |
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6.1.1.2. |
In vitro mammalian chromosomal aberration study or in vitro mammalian micronucleus study |
The study does not need to be carried out if an adequate data from an in vivo cytogenicity test is available. |
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6.1.1.3. |
In vitro gene mutation test in mammalian cells |
The study shall be carried out in the following cases:
The study does not need to be carried out if there are adequate data from a reliable in vivo mammalian gene mutation test. |
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6.1.2. |
In vivo genetic toxicity |
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6.1.2.1. |
An appropriate in vivo mammalian somatic cell genotoxicity study |
The study shall be carried out if there is a positive result in any of the in vitro genotoxicity study referred to in point 6.1.1. which gives rise to a concern. The study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate. |
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6.1.2.2. |
An appropriate in vivo mammalian germ cell genotoxicity study |
The study shall be carried out if there is a positive result in an available in vivo mammalian somatic cell genotoxicity study, which gives rise to concern. The study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate. The study does not need to be conducted if there is clear evidence that neither the relevant chemical species nor its metabolites reach the germ cells. |
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6.2. |
Appropriate toxicokinetic and metabolism studies in mammals, appropriate repeated dose toxicity study, appropriate reproductive toxicity study, appropriate carcinogenicity study or appropriate additional studies referred to in Tables 2 and 3 |
The study shall be carried out if there is any of the information available, raises a concern for at least one of the following hazard classes defined in Annex I to Regulation (EC) No 1272/2008: Specific Target Organ Toxicity – Repeat Exposure (STOT RE), Carcinogenicity, Mutagenicity or Reprotoxicity (CMR) or endocrine disruption for human health. The study shall address each of the concerns identified. |
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Column 1 Standard information and testing |
Column 2 Specific rules for adaptation of the standard information and testing |
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7.1. |
Toxicokinetics and metabolism studies in mammals: |
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7.1.1. |
Data to demonstrate the absence of potential for accumulation in human |
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7.2. |
Repeated dose toxicity: |
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7.2.1. |
Sub-chronic repeated dose toxicity study (90-days) in one animal species (rodents), male and female, via oral route of administration |
The study does not need to be conducted where any of the following conditions are fulfilled:
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7.3. |
Reproductive toxicity: |
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7.3.1. |
Reproduction/Developmental toxicity screening study |
The study does not need to be conducted where any of the following conditions are fulfilled:
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7.4. |
Appropriate toxicokinetic and metabolism studies, appropriate repeated dose toxicity study, appropriate reproductive toxicity study, appropriate carcinogenicity study or appropriate additional studies referred to under Table 3 |
The study shall be carried out if any information available raises a concern for at least one of the following hazard classes defined in Annex I to Regulation (EC) No 1272/2008: STOT RE or CMR or endocrine disruption for human health. The study shall address each of the concerns identified. |
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Column 1 Standard information and testing |
Column 2 Specific rules for adaptation of the standard information and testing |
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8.1. |
Toxicokinetics and metabolism studies in mammals: |
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8.1.1. |
Study on absorption, distribution, metabolism and excretion |
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8.1.2. |
Considerations on the potential need for additional toxicokinetic information |
Additional information might be needed based on the outcome of the toxicokinetic and metabolism study conducted in rats or based on the evaluation of the toxicological and physicochemical profile of the relevant chemical species. |
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8.2. |
Repeated dose toxicity: |
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8.2.1. |
Long-term repeated dose toxicity (≥ 12 months), oral route of administration |
This study does not need to be conducted if the combined chronic toxicity/carcinogenicity study referred to in point 8.4.1. is provided. |
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8.3. |
Reproductive toxicity: |
The studies do not need to be conducted where the relevant chemical species is of low toxicological activity (no evidence of toxicity seen in any of the tests available, in which a sufficiently comprehensive and informative dataset has been used), it can be proven from toxicokinetic data that no systemic absorption occurs via the oral route of exposure, e.g., plasma/blood concentrations below detection limit using a sensitive method and the relevant chemical species and its metabolites are absent in urine or bile. |
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8.3.1. |
Extended one-generation reproductive toxicity study, oral route of administration |
An Extended One-Generation Reproductive Toxicity Study with the extension of cohort 1B to include the F2 generation where any of the following conditions are met:
An Extended One-Generation Reproductive Toxicity Study including cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental immunotoxicity) shall be included in case of particular concerns on (developmental) neurotoxicity or (developmental) immunotoxicity justified by any of the following:
Two-generation reproductive toxicity studies that were initiated before 13 May 2015 shall be considered appropriate to address this standard information requirement. |
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8.3.2. |
Prenatal developmental toxicity study, in rat, unless another animal species is justified to be more appropriate, oral route of administration |
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8.3.3. |
Further pre-natal developmental toxicity study, in a second animal species, oral route of administration or mechanistic study |
A decision on the need to perform additional studies on a second animal species or mechanistic studies shall be based on the outcome of the first test (point 8.3.2.) and all other relevant available data (in particular rodent reproductive toxicity studies). |
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8.4. |
Carcinogenicity: See 8.4.1 for new study requirements |
The study does not need to be provided where all of the following conditions are fulfilled:
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8.4.1 |
Combined Chronic Toxicity/Carcinogenicity study oral route of administration |
The study does not need to be conducted if adequate data from a reliable carcinogenicity study, oral route of administration is available: in such circumstances the long term repeated dose toxicity study referred to in point 8.2.1. must be provided. |
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8.5. |
Additional toxicity properties: |
If there is an indication for one or more mechanisms/modes of action of the relevant chemical species with an association to (developmental) neurotoxicity and/or endocrine disruption and/or (developmental) immunotoxicity, corresponding additional data shall be generated in accordance with this point, unless already fully covered by the information under point 8.3.1. |
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8.5.1. |
Appropriate neurotoxicity information or study, including developmental neurotoxicity, in rat, unless another animal species is justified to be more appropriate (e.g. adult hen for delayed neurotoxicity study), oral route of exposure |
If anticholinesterase activity is detected, a test for response to reactivating agents shall be generated. |
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8.5.2. |
Appropriate information or study on endocrine disruption, oral route of exposure if relevant |
This standard information or study shall be generated if there is any evidence from in vitro studies or from repeated dose or reproduction toxicity studies, that the relevant chemical species may have endocrine disrupting properties for human health, in order to elucidate the mode/mechanism of action and provide sufficient evidence for relevant adverse effects. |
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8.5.3. |
Appropriate immunotoxicity information or study, including developmental immunotoxicity |
This standard information or study shall be generated if there is any evidence, from skin sensitisation, repeated dose or reproductive toxicity studies, that the relevant chemical species may have immunotoxic properties, in order to elucidate the mode/mechanism of action and provide sufficient evidence for relevant adverse effects. |
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8.5.4. |
Appropriate mechanistic data or studies |
This standard information or testing shall be generated if necessary to clarify any effects reported in toxicity studies. |