5.

Exceptions for assessment of materials used in minor and assembled components For assembled products: minor components, parts and materials shall be described in detail and testing shall be reduced accordingly. For this purpose, ‘minor’ refers to a level of influence on the quality of water intended for human consumption that does not require full testing. Table 1. Testing related to material types N.N.: Not necessary MTCtap: Maximum tolerable concentration at the tap (either derived from the opinion of ECHA for the purposes of inclusion of the substance in the European positive list, or based on a specific migration limit set in Commission Regulation (EU) No 10/2011 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). and considering a 10 % allocation factor and water consumption of 2 litres per day) GCMS: Gas Chromatography – Mass Spectrometry (screening method) Note 1: Specific exceptions to be determined in line with point 5 of this Annex. Note 2: Metals shall not be subject to organoleptic testing because it is generally accepted that if the parametric values set out in Annex I are met, organoleptic problems are unlikely to arise. Note 3: Depending on the existence of organic substances in the composition. Criteria Organic (See Note 1) Metallic (See Note 2) Cementitious Enamels and ceramic materials European positive lists European positive list of starting substances for organic materials X N.N. X N.N. European positive list of accepted metallic compositions N.N. X N.N. N.N. European positive list of constituents for cementitious materials N.N. N.N. X N.N. European positive list of compositions for enamels and ceramic materials N.N. N.N. N.N. X Organoleptic tests Odour and flavour X N.N. X N.N. Colour and Turbidity X N.N. X N.N. General hygiene assessments Leaching of total organic carbon X N.N. X N.N. Surface residues (metals) N.N. X N.N. N.N. Migration testing Relevant parameters of this Directive X X X X MTC_(tap) of PL substances X N.N. X (See Note 3) N.N. Unexpected substances (GCMS) X N.N. X (See Note 3) N.N. Compliance with compositions lists N.N. X N.N. X Enhancement of microbial growth X N.N. X (See Note 3) N.N.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-28 · Text as adopted (Official Journal); later amendments are not incorporated in this text.