INTENDED USE
ANNEX IISupplementary provisions
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 Standard information and testing 2. Use: 2.1. Material type, category and sub-category: Identification of the material type, material category and material sub-category. 2.2. Identity and use of final material and product: 2.2.1. Specification of the product/component. Definition of area of uses: domestic vs. non-domestic installations. 2.2.2. 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. 2.2.3. 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. 2.3. Technical function: Specification of the technical function. 2.4. Conditions of use of the starting substance, composition or organic cementitious constituent; of the final material; and of the product: 2.4.1. For starting substances for organic materials: Maximum dosage of the starting substance in the formulation to produce the final material. 2.4.2. For organic constituents of cementitious materials: • In case of polymers: Dosage of the monomers or other reactants to produce the polymers • Maximum dosage of the constituent (polymer) to produce a generic constituent. • Maximum dosage of the generic constituent used in the formulation to produce the final material. 2.4.3. Proposed restrictions or other conditions of use for the inclusion of the starting substance, composition or constituent on the European positive list. 2.5. Information on the processing and internal structure of the material, final material and product: 2.5.1. Information on the processing of the material, final material and product, including treatment of material, final material or product prior to use. 2.5.2. Processing temperatures of the final material. • Description of the manufacturing and processing steps used to produce the final material. For bulk materials this includes description of any processing such as mechanical (forming), thermal (heat treatment) affecting crystallography, grain morphologies (size and shape), phase structure, impurities and their distribution, residual stresses, microstructure and/or surface condition. For specifically produced surface layers, platings, the applied surface of the plating, process type and main processing conditions as well as plating properties should be described; • Appropriate manufacturing and processing steps and resulting properties, such as ‘heat treatment to reduce beta-phase’ or ‘phase distribution in the final material’. Processing temperatures of the final material. 2.5.3. Information on the internal structure of the final material. 2.6. Union and national level assessments and authorisations: 2.6.1. 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. 2.6.2. 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. 2.7. EU authorisation of biocidal active substances: 2.7.1. Approval/assessment status of the starting substance or organic cementitious constituent under Regulation (EU) No 528/2012. 2.7.2. Product-type relevant to the starting substance or organic cementitious constituent under Regulation (EU) No 528/2012. 2.7.3. Approval start date under Regulation (EU) No 528/2012. 2.7.4. Approval end date under Regulation (EU) No 528/2012. 3. Identification of non-intentionally added species other than impurities: 3.1. 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: (a) physico-chemical properties; (b) technical functions; (c) interaction with the matrix; (d) water characteristics; (e) results of analysis of testing waters by applying an appropriate screening method as set out in Commission Implementing Decision (EU) 2024/368 3.2. 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) 3.3. 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). 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: 3.4.1. 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. 3.4.2. Description of process that leads to the formation of the polymerised part below 1000 Da. 3.4.3. Molecular weight distribution for polymerised part below 1000 Da; test report of the molecular weight distribution is required. 3.4.4. Number averaged molecular weight of polymerised part below 1000 Da. 3.4.5. Molecular mass range (min and max) of polymerised part below 1000 Da. 3.4.6. Residual polymerised part below 1000 Da and its concentration (%). 3.5. Name (and other identifiers e.g. EC, CAS numbers) of non-intentionally added species identified under points 3.1.–3,4. Table 2 Product groups for metallic compositions Product group Examples of metallic products or components Assumed contact surface ‘a’ A Pipes. 100 % B Fittings, ancillaries in buildings installations. 10 % C 1. Components of products of Product Group B. The sum of the surfaces in contact with water intended for human consumption of all these components shall be less than 10 % of the total wetted surface of the product. 2. Fittings, ancillaries in water mains and water treatment works with permanent flow. 1 % 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 ).