FINAL METALLIC MATERIALS
ANNEX IISupplementary provisions
ANNEX II FINAL METALLIC MATERIALS 1. GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL METALLIC MATERIALS AS USED IN A PRODUCT. The procedure for testing and accepting final metallic materials as used in a product includes the following steps: Step 1 – Identification of relevant substances and relevant other parameters depending on: 1. Metallic compositions of the final materials 2. Composition of applied platings Step 2 – Performance of tests: 1. Testing of the composition 2. Testing of the release of relevant substances Step 3 – Compliance with pass/fail criteria 2. IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS 2.1. Composition review 2.1.1. Required information For the composition review of a metallic product or an assembled product containing metallic components the following information is required: (a) list of all metallic components including the composition of the bulk material as range for all constituents exceeding 0,02 % (m/m), details about the processing to obtain the final metallic materials and the wetted surface fraction of the components in relation to the wetted surface of the assembled product; (b) list of solders applied including details about the soldering process; (c) detailed description of applied plating processes; (d) detailed description of applied impregnations or organic coatings; (e) any other information considered relevant for the assessment of the composition of the final metallic material. 2.1.2. Accepted compositions The compositions of the final metallic materials and platings shall comply with compositions listed in the European positive list of compositions for metallic materials in Annex II of Commission Implementing Decision (EU) 2024/367 established in accordance with Article 11(2) (b) of the Directive and fulfil the limitations set out in the European positive list in respect of their use for certain product groups and the use of these products. Categorisation of products in product groups for metallic materials is set out in Table 2 of Annex II to Commission Implementing Decision (EU) 2024/365 ( 1 ) . Applied organic impregnations and coatings shall comply with the requirements of Annex I. 2.1.3. Relevant substances For plated products, relevant substances shall be identified based on the composition of the plating listed in the European positive list of compositions of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. 3. TESTING REQUIREMENTS 3.1. Composition testing An analysis of the composition of the final metallic materials shall be performed to verify compliance with the compositional requirements of metallic materials included in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. 3.2. Testing of release of relevant substances from plated products Plated products should be tested for the residues on the surface according to indications in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. A suitable test should simulate metallic element release into drinking water at the consumers tap. The methods of analysis shall be validated and documented in accordance with EN ISO/IEC 17025:2017 or other equivalent standards accepted at international level. The testing of the release of organic substances used in the plating process shall be performed in accordance with the requirements set out in Annex I. 4. ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA 4.1. Compliance with the European positive list of metallic compositions The analysed composition of final metallic materials shall comply with the compositional requirements and other limitations specified in the European positive list of metallic compositions in Annex II of Commission Implementing Decision (EU) 2024/367. 4.2. Pass/fail criteria for relevant substances The requirement C tap ≤ MTC tap,metallics shall apply where MTC tap,metallics is listed in the Table 1 of Annex V to Commission Implementing Decision (EU) 2024/367, where in the calculation of C tap the stagnation time and the sampling volume are taken in due consideration. ( 1 ) 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 ( OJ L, 2024/365, 2024.04.23, ELI: http://data.europa.eu/eli/dec_impl/2024/365/oj ).