Commission Implementing Decision (EU) 2024/368 of 23 January 2024 laying down rul... (32024D0368) - 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 - Seite 28

4.5. Pass/fail criteria for residual content of substances (QM and QMA)

The maximum quantity (QM and QMA) limits of the European positive list of starting substances for organic materials set out in Annex I of Commission Implementing Decision (EU) 2024/367 shall apply independently of the product group of final organic materials.

4.6. Purity pass/fail criteria for pigments, colorants and fillers

Pigments, colorants and fillers shall comply with the purity requirements according to Table 8, if the corresponding substances were not analysed as relevant substances in the migration waters. The extraction with 0,1 N hydrochloric acid shall be performed according to the procedure described in Council of Europe resolution AP(89)1 on the use of colourants in plastic materials coming into contact with food.

Table 8

Requirements on purity of pigments, colorants and fillers

Pigments and colorants

Colorants and pigments shall comply with the following purity requirements:

When extracted with 0,1 N hydrochloric acid, the following elements may dissolve from the colorant or pigment up to the maximum amount, based on the colorant or pigment:

—	antimony 0,05 %

—	arsenic 0,01 %

—	barium 0,01 %

—	cadmium 0,01 %

—	chromium 0,1 %

—	lead 0,01 %

—	mercury 0,005 %

—	selenium 0,01 %

b)	The content of primary aromatic amines soluble in 1 M hydrochloric acid shall not exceed 0,05 % (calculated as aniline). This limit does not apply to primary aromatic amines containing carboxyl- or sulfo-groups,

When extracted with 2 N ethanolic hydrochloric acid, a maximum of 0,05 % aromatic amines (based on the colorant or pigment) may dissolve from the colorant or pigment.

Fillers

Fillers can be contaminated with impurities. For mineral fillers, the following specification applies:

After solution in 0,1 N hydrochloric acid, the concentration of the following elements shall not exceed the maximum amount, based on the filler:

—	antimony 0,005 %

—	arsenic 0,01 %

—	barium 0,01 %

—	cadmium 0,01 %

—	chromium 0,1 %

—	lead 0,01 %

—	mercury 0,0005 %

—	selenium 0,01 %