MIGRATION AND CONFIRMATION OF RELEVANT CHEMICAL SPECIES
ANNEX IVSupplementary provisions
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: (a) the starting substance, organic cementitious constituent, substance constituent, and each non-intentionally added species identified in accordance with points 1.3 and 1.5, in the table of Annex I and point 3 in Table 1 of Annex II as well as any starting substance or an organic cementitious constituent which functions as a monomer or other reactant of a main polymer in the material; (b) each metallic composition constituent and impurity identified in accordance with points 1.3.2 and 1.3.3 in the table of Annex I, unless: (i) the metallic composition constituent is phosphorus, silicon, sulfur or tin; or (ii) the metallic composition impurity is aluminium, iron, manganese, phosphorus, silicon, tin or zinc; (c) each inorganic composition constituent and impurity identified in accordance with points 1.3.2 and 1.3.3 in the table of Annex I, unless the inorganic composition constituent is carbon, calcium, fluorine, iron, magnesium, nitrogen, phosphorus, potassium, silicon, sodium, tin or zinc. 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 Starting substance or organic materials/organic cementitious constituents Composition of metallic materials Composition of enamels, ceramic, or other inorganic materials 5. Migration: 5.1. Test pieces 5.1.1. 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. 5.1.2. Dosage of the starting substance/organic cementitious constituent to produce the test pieces. 5.1.3. Concentration of the starting substance/organic cementitious constituent in the test pieces. 5.1.4. Composition of the test pieces. Composition of the test pieces. 5.1.5. Roughness of the inner surface of the test pieces. 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. (a) All metallic compositions: Test method for dynamic rig test established in standard EN 15664-1 for assessment of metal release. (b) Metallic compositions which exhibit passive behaviour in contact with water intended for human consumption: Test method established in standard EN 16056 to evaluate the passive behaviour of stainless steels and other passive metallic compositions. (c) Platings: • Tests method referred to in point (a); or • The test method established in standard EN 16058, with 3 different test pieces. 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. 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 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: (a) testing is demonstrated to be not technically possible; (b) testing would require a concentration of the substance in water below the limit of quantification, using the best available technique; (c) the test substance rapidly degrades in water. 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: (a) For ferrous compositions, the compositions are used under permanent water flow and the supporting explanation takes into account water compositions and, in particular, oxygen concentration; (b) For copper alloys: (i) the alloys have similar corrosion behaviour; (ii) the representative test piece belongs to the same metallic composition category; (iii) the alloys have identical alloying elements, impurities and microstructure; (iv) the constituents and impurities of the similar metallic composition have MTC tap values higher than 100 μg/l. (c) For both ferrous compositions and copper alloys (a) and (b): (i) an adequate and reliable migration test for the similar metallic composition has been carried out; (ii) adequacy for the purpose of concentration at the tap (C tap ) determination and identification of relevant chemical species has been demonstrated; (iii) the C tap and identification of relevant chemical species of that similar metallic composition have been used. 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 (C tap ) 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.