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Document 32024D0365
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
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
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
C/2024/239
OJ L, 2024/365, 23.4.2024, ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
Official Journal |
EN L series |
2024/365 |
23.4.2024 |
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (1), and in particular Article 11(2), point (a), thereof,
Whereas:
(1) |
Testing and acceptance methodologies should be established for assessing the safe use of starting substances, compositions and constituents. |
(2) |
Inclusion or removal of an entry in a European positive list should be based on the identification of the starting substance, composition or organic cementitious constituent and the identification of its intended use. The physico-chemical properties of the starting substance, composition or organic cementitious constituent necessary for carrying out migration testing should be established. The starting substance, composition or organic cementitious constituent should be tested for migration. |
(3) |
Inclusion or removal of an entry in a European positive list should be based on the identification of chemical species that are relevant for the acceptance methodology, or risk assessment, because they may have an impact on the safe use of a material or product, such as an impurity, the constituent of a starting substance or a degradation product. These relevant chemical species should be determined on the basis of the information on the identification of the starting substance, composition or constituent and on the basis of its intended use as well as the results of migration testing. The toxicological properties of these relevant chemical species should also be identified. |
(4) |
For proportionality and efficiency reasons, testing for physico-chemical properties and toxicological properties as well as risk assessment should be more limited if a similar assessment has already been carried out at Union level within a reasonable period of time or if the substance has a stringent classification in Part 3 of Annex VI of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) or the applicant proposes such classification. For proportionality reasons, the testing requirements for toxicological properties should be stricter where there is a high exposure to a certain substance through migration. |
(5) |
In order to respect the precautionary principle and in order to cover the potential for significant exposure over a long period of time, the acceptance methodology should be based on a worst-case risk assessment of each relevant chemical species. The risk assessment should consider migration, including release, under the worst foreseeable conditions of use. In particular, the risk assessment should consider the expected long-term exposure to materials or products in contact with water intended for human consumption and, in the case of metallic compositions, the differences in the properties, such as composition and corrosivity, of all water in the Union intended for human consumption. |
(6) |
Economic operators and relevant authorities should be allowed sufficient time to adapt their national methodologies to the methodologies set out in this Decision. 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
Definitions
For the purpose of this Decision, the following definitions apply:
(1) |
‘non-intentionally added species’ means either one of the following:
|
(2) |
‘nanoform’ means a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm–100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm. For the purpose of this definition:
|
(3) |
‘migration’ means transfer of substances from a material into water intended for human consumption. |
Article 2
Testing and acceptance of starting substances, compositions and constituents
1. The methodologies referred to in Article 11(2), point (a), of Directive (EU) 2020/2184 shall apply to the following:
(a) |
starting substance for organic materials; |
(b) |
organic constituent of cementitious materials; |
(c) |
composition of metallic materials; |
(d) |
composition of enamels, ceramic and other inorganic materials. |
2. Where a polymer is intended for use in an organic material or a cementitious material, the testing and acceptance methodologies shall be applied to the monomer, pre-polymer or polymer in accordance with the rules set out in points v to viii of Annex I and points iii and iv of Annex III to Commission Implementing Decision (EU) 2024/367 (3).
Article 3
Testing methodology
1. Starting substances, compositions and organic cementitious constituents shall be identified in accordance with the requirements set out in Annex I.
2. The intended use of starting substances, compositions, constituents, as well as materials and products shall be specified in accordance with the requirements set out in Annex II.
3. The physico-chemical properties of the relevant chemical species shall be determined in accordance with the requirements set out in Annex III.
4. Migration into water intended for human consumption shall be determined in accordance with the requirements set out in Annex IV.
5. The relevant chemical species shall be identified in accordance with Section 3 of Annex IV.
6. The toxicological properties of the relevant chemical species referred to in paragraph 5 shall be determined in accordance with the requirements set out in Annex V.
Article 4
Acceptance methodology in the European positive lists
1. Starting substances, compositions and constituents shall be accepted in accordance with Annex VI on the basis of an assessment of the risks raised by the relevant chemical species identified for the corresponding starting substance, composition or organic cementitious constituent.
2. Starting substances and organic cementitious constituents which have a biocidal function and which are subject to Regulation (EU) No 528/2012 of the European Parliament and of the Council (4) shall only be accepted if they belong to product-type 6 (preservatives for products during storage) as set out in Annex V to that Regulation.
Article 5
Entry into force
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 31 December 2026.
Done at Brussels, 23 January 2024.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 435, 23.12.2020, p. 1.
(2) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(3) 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 (OJ L, 2024/367, 23.04.2024, ELI: http://data.europa.eu/eli/dec_impl/2024/367/oj).
(4) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
ANNEX I
IDENTIFICATION OF STARTING SUBSTANCES, COMPOSITIONS AND CONSTITUENTS
Sufficient information to enable the identification of starting substances, compositions and constituents and characterisation of nanoforms shall be generated, including the information set out in the Table. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items referred to in the table, the reasons shall be clearly stated.
Table
Standard information and testing with regard to the identification of a starting substance, a composition or a constituent
|
|
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
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.
Table 1
Standard information and testing with regard to intended use
|
|
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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Table 2
Product groups for metallic compositions
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 |
|
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 % |
(1) Commission Implementing Decision (EU) 2024/368 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 the procedures and methods for testing and accepting final materials as used in products that come into contact with water intended for human consumption (OJ L, 2024/368, 23.04.2024, ELI: http://data.europa.eu/eli/dec_impl/2024/368/oj).
ANNEX III
PHYSICO-CHEMICAL PROPERTIES
Section 1. No standard information or testing requirement
No standard information or testing shall be required for starting substances and organic cementitious constituents where either of the following conditions are fulfilled:
(a) |
a parametric value for the starting substance or organic cementitious constituent is set under Annex I to Directive (EU) 2020/2184; |
(b) |
a Maximum Tolerable Concentration at the tap (MTCtap) value for the starting substance or organic cementitious constituent is set in the corresponding Annex to Commission Implementing Decision (EU) 2024/367 (1) following a decision by the Commission on an application for a starting substance, composition or organic cementitious constituent that has been submitted to ECHA under Article 3 of Commission Delegated Regulation (EU) 2024/369 (2) and the applicant submits at least any new or updated information available as from the date of the Commission’s decision; |
(c) |
a specific migration limit is set under Commission Regulation (EU) No 10/2011 (3) for less than 15 years before the submission of an application under Article 3 of Delegated Regulation (EU) 2024/369. |
Section 2. Standard information or testing required
2.1. |
Testing under this Section shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament and of the Council (4) or other international standards recognised as being equivalent to Directive 2004/10/EC by the Commission or ECHA. |
2.2. |
Testing under this Section shall be carried out in compliance with the test method as determined and specified by ECHA and published on its website, taking into account in particular the requirements set out in point 2.5. |
2.3. |
Column 1 of Table 1 establishes the required standard information and testing for a starting substance or organic cementitious constituent.
Column 1 of Table 1, points 4.7 and 4.8 establish the required standard information and testing for relevant chemical species other than a starting substance or organic cementitious constituent. Column 1 of Table 1, points 4.1.3, 4.2 and 4.4 establish the required standard information and testing for a metallic, enamel, ceramic or other inorganic composition. Column 2 of Table 1 establishes specific rules according to which the standard information and testing of column 1 may be omitted, replaced by other information, or adapted in another way. |
2.4. |
Any other relevant physico-chemical information shall be identified and considered in addition. |
2.5. |
Where a test method offers flexibility in the determination or choice of the study design, including by not prohibiting certain specifications, the chosen study design shall ensure that the data generated are adequate for migration testing and risk assessment. |
2.6. |
The general rules for adaptations set out in Sections 1 and 2 of Annex XI to Regulation (EC) No 1907/2006 (5) shall apply mutatis mutandis.
Table 1 Standard information and testing, and specific rules for the adaptation of such information and testing, with regard to physico-chemical properties
|
(1) 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 (OJ L, 2024/367, 23.04.2024, ELI: http://data.europa.eu/eli/dec_impl/2024/367/oj).
(2) Commission Delegated Regulation (EU) 2024/369 of 23 January 2024 supplementing Directive (EU) 2020/2184 of the European Parliament and of the Council by laying down the procedure regarding inclusion in or removal from the European positive lists of starting substances, compositions and constituents (OJ L, 2024/369, 23.04.2024, ELI: http://data.europa.eu/eli/reg_del/2024/369/oj).
(3) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).
(4) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
(5) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1-849).
ANNEX IV
MIGRATION AND CONFIRMATION OF RELEVANT CHEMICAL SPECIES
Section 1. General requirements, standard information and testing for the determination of migration
1.1. |
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. |
1.2. |
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 determination based on worst foreseeable conditions of use. |
1.3. |
Any testing or modelling under this Section shall be carried out on the basis of the intended use for the starting substance, composition or constituent and the test piece shall be representative of worst foreseeable conditions of use. |
1.4. |
Sufficient information on the determination of the migration of all the following substances, at least including the information set out in Table 1, shall be generated:
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1.5. |
In case of starting substances which are metals or alloys that are not included in the European positive list of compositions as metallic materials, the migration waters resulting from testing of a representative test piece of the final material shall be analysed in accordance with the rules set out in point Section 1.4(b). |
1.6. |
Any other relevant migration information that is available shall be identified and considered.
Table 1 Standard information and testing with regard to migration
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Section 2. General rules for adaptation of information and testing with regard to the migration
2.1. |
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:
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2.2. |
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 conditions are met:
In all cases, adequate and reliable documentation of the applied method shall be provided. Such documentation shall include an explanation why the migration of the metallic composition may be determined based on the information on the similar metallic composition and supporting information to scientifically justify such explanation. |
Section 3.Criteria for the identification of relevant chemical species
Relevant chemical species are those that are covered by the requirements set out in Annex V in order to demonstrate that the starting substance, composition or constituent meets the acceptance criteria set out in Annex VI. Relevant chemical species include the following:
(a) |
starting substances and organic cementitious constituents which function as a monomer or other reactant of a main polymer in the material; |
(b) |
starting substances, organic cementitious constituents, substance constituents and non-intentionally added species originating from the starting substance or organic cementitious constituent which show one of the human health hazards referred to in Section 1.1 of Annex VI irrespective of their levels of migration; |
(c) |
starting substances, organic cementitious constituents, substance constituents and non-intentionally added species originating from a starting substance or organic cementitious constituent which do not fall under point (a) or (b) and which have been tested in accordance with Table 1 and have been found to migrate into water intended for human consumption with a concentration at the tap (Ctap) exceeding 0,1 μg/l; |
(d) |
metallic composition constituents or impurities, which have been tested in accordance with Table 1; |
(e) |
enamel, ceramic or other inorganic composition constituents or impurities of an enamel, ceramic or other inorganic composition which have been tested in accordance with Table 1. |
ANNEX V
TOXICOLOGICAL PROPERTIES
Section 1. No standard information or testing
1.1. |
No standard information or testing is required for a relevant chemical species where either of the following conditions are fulfilled:
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1.2. |
No standard information or testing is required for a relevant chemical species, to the extent that a specific migration limit is set under Commission Regulation (EU) No 10/2011 for less than 15 years from the date of submission of the application under Article 3 of Delegated Regulation (EU) 2024/369. |
Section 2. Standard information or testing required
Part 1. General and specific rules
1.1. |
Testing under this Section shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or ECHA and with the provisions of Directive 2010/63/EU of the European Parliament and of the Council (2), if applicable. |
1.2. |
Any applicant shall ensure that testing on vertebrate animals is carried out only when no alternative methods, identified under this Section, is available. If testing on vertebrate animals is unavoidable, such testing shall be designed, where appropriate, by taking into account the possibility to explore several parameters within the framework of one study (e.g. kinetic data generation, micronucleus formation, neurotoxicity, immunotoxicity) or to combine two studies (e.g. long-term toxicity study and carcinogenicity study) to the extent permitted by the corresponding test method. |
1.3. |
Testing under this Section shall be carried out in compliance with the appropriate test guideline determined and specified by ECHA and published on its website, taking into account in particular the requirements set out in Section 1.6. |
1.4. |
A stepwise approach for toxicological testing shall be applied based on the Ctap of a relevant chemical species in water intended for human consumption. For the lowest migration concentration band, the standard information is set out in Table 1, and every time a new migration band is reached, the standard information set out in the corresponding Tables 2 and 3 shall be added.
Column 1 of Tables 1, 2 and 3 establishes the standard information for relevant chemical species. Column 2 of Tables 1, 2 and 3 lists specific rules according to which the standard information and testing may be omitted. Standard information and testing may be adapted according to the general rule set out in Part 2. |
1.5. |
Any other relevant toxicological information that is available shall be identified and considered. |
1.6. |
Where a test method offers flexibility in the determination or choice of the study design, including by not prohibiting certain study specifications, for example in relation to the choice of dose levels, the chosen study design shall ensure that the data generated are adequate for hazard identification and risk assessment. To this end, testing shall be performed at appropriately high dose levels. If dose (concentration) selection is limited by the physico-chemical properties or biological effects of the test substance, the applicant shall provide a scientifically robust justification.
Table 1 Standard information and testing – Ctap below 2,5 μg/l
Table 2 Standard information and testing – Ctap equal to or above 2,5 μg/L and below 250 μg/L
Table 3 Standard information and testing – Ctap equal or above 250 μg/L
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Part 2. General rules for adaptation of Column 1 of Tables 1, 2 and 3
2.1. |
The general rules for adaptation set under Sections 1 and 2 of Annex XI to Regulation (EC) No 1907/2006 shall apply mutatis mutandis with the exception set out in Section 2.2. |
2.2. |
The general rules for adaptation under Sections 1.3 (Qualitative or Quantitative structure-activity relationship ((Q)SAR)) and 1.5 (Grouping of substances and read-across approach) of Annex XI to Regulation (EC) No 1907/2006 shall apply to the standard information and testing referred to in Table 1, point 6.1.1., only in the case of a substance constituent or a non-intentionally added species for which experimental testing is not technically possible (e.g., it cannot be isolated and tested as such). |
(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(2) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010. on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
ANNEX VI
ACCEPTANCE METHODOLOGY
Section 1. Limited acceptance methodology
1.1. |
Section 2 shall not apply to a relevant chemical species which is a starting substance, or an organic cementitious constituent, or a substance constituent or a non-intentionally added species where such substance or constituent is:
In either case, the starting substances or organic cementitious constituents referred to in the first paragraph shall be accepted in the European positive list under the following conditions of use: |
(a) |
The relevant chemical species is:
|
(b) |
Ctap is lower than the generic limit of 0,1 μg/l or the relevant MTCtap calculated from a parametric value set under Annex I to Directive (EU) 2020/2184 by application of an appropriate allocation factor (ALF) to take into account multiple routes of exposure to the relevant chemical species, besides exposure via materials used in products in contact with water intended for human consumption; |
(c) |
The concentration of the starting substance, organic cementitious constituent, substance constituent or non-intentionally added species in the final material is lower than 0,1 % (weight/weight), except if physical migration testing is uncertain in which case the concentration in the final material is lower than 0,02 % (weight/weight). |
1.2. |
Part 2.4 of Section 2 shall not apply in the case of any concern that a relevant chemical species which is a starting substance, or an organic cementitious constituent, or a substance constituent, or a non-intentionally added species may have genotoxicity, carcinogenicity or endocrine disruption properties for human health with non-threshold mode of action.
In such case, the starting substances or organic cementitious constituents referred to in the first paragraph may be accepted in the European positive list if Ctap is lower than a generic limit of 0,1 μg/l or the relevant MTCtap value calculated from a parametric value set under Annex I to Directive (EU) 2020/2184 by application of an appropriate ALF to take into account multiple routes of exposure to the relevant chemical species, besides exposure via material used in products in contact with water intended for human consumption. |
1.3. |
Part 2 of Section 2 shall not apply to a relevant chemical species in any of the following cases:
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1.4. |
Part 2.4 of Section 2 shall not apply in the following cases:
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Section 2. Comprehensive acceptance methodology
Part 1. Introduction
1.1. |
The acceptance methodology for starting substances, compositions and constituents shall be based on a risk assessment. Such risk assessment shall result in:
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1.2. |
In addition to the information required under Annexes I, II and III, a risk assessment shall take into account any other relevant technical or scientific information which is available addressing worst foreseeable conditions of use. Where appropriate, conditions of use shall be implemented. |
1.3. |
The information provided in the risk assessment shall allow the Committee for Risk Assessment of ECHA to evaluate and reach an opinion on whether the starting substance, composition or constituent complies with the criteria set out under Article 11(1) of Directive (EU) 2020/2184. |
Part 2. Hazard assessment
2.1. |
Principles |
2.1.1. |
For accepting a starting substance, composition or constituent, the hazard assessment process, in relation to human health shall entail assessment of effects, comprising the following steps:
|
2.1.2. |
The hazard assessment for human health shall address the following potential toxic effects for the general human population and exposure by the oral route:
|
2.1.3. |
The hazard identification shall address the properties and potential adverse effects of the relevant chemical species that migrate from the material. |
2.2. |
Dose-response assessment |
2.2.1. |
The establishment of a quantitative dose (concentration)-response (effect) relationship is required and, where possible, a no observed adverse effect level (NOAEL) shall be identified. If it is not possible to identify a NOAEL, the lowest observed adverse effect level (LOAEL) shall be identified. Where appropriate, other dose-effect descriptors may be used as reference values. |
2.2.2. |
When carrying out the hazard assessment, special consideration shall be given to toxicity data derived from observations of human exposure where such data are available, e.g. information gained from manufacture, from poison centres or epidemiology surveys. |
2.3. |
Derived no effect level |
2.3.1. |
The derivation of a derived no effect level (DNEL) shall be carried out in accordance with Section 1.4 of Annex I to Regulation (EC) No 1907/2006. |
2.4. |
Maximum Tolerable Concentration at the tap (MTCtap) |
2.4.1. |
Subject to Part 2.4.2, the MTCtap is equal to a value calculated on the basis of the safe oral dose (DNEL), the body weight (60 kg), the drinking water ingestion rate of 2 l (litres) per day and an appropriate ALF (expressed as a percentage) to take into account multiple routes of exposure to the relevant chemical species, besides exposure via material used in products in contact with water intended for human consumption.
MTCtap (μg/l) = |
2.4.2. |
By way of exception to Part 2.4.1:
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Part 3. Migration assessment
3.1. |
The Ctap to be compared against the MTCtap value shall be determined based on the worst foreseeable conditions of use, including in terms of representativeness of the concentration in the material matrix, water, surface area to water volume, and temperature, as determined by ECHA and published on its website for each test method taking into account, in particular, the requirements for determination based on the worst foreseeable conditions of use and the appropriate EN standard. |
Part 4. Risk acceptance
4.1. |
Risk acceptance for starting substances for organic materials, organic cementitious constituents and compositions for enamels, ceramic and other inorganic materials
The starting substance, composition or constituent shall be accepted if Ctap < MTCtap for each relevant chemical species on the 10th day of testing according to point 5.2 in Table 1 of Annex IV. |
4.2. |
Risk acceptance for metallic materials
For the assessment of the test rig results (according to standard EN 15664-1) the arithmetic mean of the equivalent pipe concentrations MEPn(T) analysed from relevant contact waters (see Annex IV, Section 1.1) shall be considered. The composition can be accepted for a product group with the assumed contact surface a (see Table 2 of Annex II), if the following criteria are met for all required test waters:
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ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj
ISSN 1977-0677 (electronic edition)