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
(Text with EEA relevance)
Article 1
Article 2
Definitions
Article 3
ANNEX I
FINAL ORGANIC MATERIAL
1.
GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL ORGANIC MATERIALS AS USED IN A PRODUCT.
2.
IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS
2.1.
Categorisation of products or components into risk groups and corresponding testing requirements.
Risk group |
CF in d/dm |
Formu-lation review |
Relevant substances |
Screening for unexpected substances |
TOC |
TON (1) , TFN (2) , colour, turbidity |
EMG |
RG1 |
≥ 4 |
Yes |
Yes, on product |
Yes, on product |
Yes, on product |
Yes, on product |
Yes, on product for pipes with CF >10 d/dm or test piece of the formulation |
RG2 |
≥ 0,4 and < 4 |
Yes |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on (assembled) product or component |
Yes, on (assembled) product or component |
Yes, on component or test piece of the formulation |
RG3 |
≥ 0,04 and < 0,4 |
Yes |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on component or test piece of the formulation |
RG4 |
< 0,04 |
No |
No |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on (assembled) product, component or test piece of the formulation |
Yes, on component or test piece of the formulation |
2.2.
Formulation review
2.2.1
Required information
2.2.2
Relevant substances
2.2.3
Acceptance of starting substances
2.2.4
Material-specific requirements
Parameter |
Restriction |
Sum of Primary Aromatic Amines (PAA) |
MTC tap = N.D. (LOD = 0,1 μg/l)(4) |
Parameter |
Restriction |
Sum of Primary Aromatic Amines (PAA) (a.o. aniline, o-toluidine) |
MTC tap = N.D. (LOD = 0,1 μg/l)(5) |
Sum of secondary amines(6) |
MTC tap = 250 μg/l |
Sum of N-nitrosamines(7) |
MTC tap = N.D. (LOD = 0,1 μg/l) |
Parameter |
Restriction |
Sum of N-nitrosamines(8) |
MTC tap = N.D. (LOD = 0,1 μg/l) |
3.
TESTING REQUIREMENTS
3.1.
Migration testing
3.1.1.
Standards
3.1.2
Test piece
3.1.3.
Temperature of testing
3.1.4.
Type of test water
3.1.5.
Migration periods
3.2.
Analysis of migration waters
3.2.1.
Relevant Substances
3.2.2.
Unexpected Substances
3.2.3.
Relevant other parameters
3.3.
Mathematical modelling
3.4.
Enhancement of Microbial Growth (EMG) testing
3.5.
Testing residual content of substances (QM/QMA)
4.
ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA
4.1.
Formulation
4.2.
Relevant substances, unexpected substances, TOC
4.2.1.
Conversion of test results
Product group |
CF (in d/dm) |
|||
A |
Pipes and pipe linings |
|
||
1 |
ID < 80 mm (domestic installations, buildings)(9) |
20 |
||
2 |
80 mm ≤ ID < 300 mm (service piping) |
10 |
||
3 |
ID ≥ 300 mm (mains piping) |
5 |
||
B |
Fittings, ancillaries (10) |
|
||
1 |
ID < 80 mm (domestic installations, buildings) |
2 |
||
2 |
80 mm ≤ ID < 300 mm (service piping) |
1 |
||
3 |
ID ≥ 300 mm (mains piping) |
0,5 |
||
C |
Components of fittings, ancillaries (11) |
|
||
1 |
ID < 80 mm (domestic installations, buildings) |
0,2 |
||
2 |
80 mm ≤ ID < 300 mm (service piping) |
0,1 |
||
3 |
ID ≥ 300 mm (mains piping) |
0,05 |
||
D |
Small Components of fittings, ancillaries (12) |
|
||
1 |
ID < 80 mm (domestic installations, buildings) |
0,02 |
||
2 |
80 mm ≤ ID < 300 mm (service piping) |
0,01 |
||
3 |
ID ≥ 300 mm (mains piping) |
0,005 |
||
E |
Storage systems (reservoirs) |
|
||
1 |
In domestic installations, buildings, water volume < 10 l |
4 |
||
2 |
In domestic installations, buildings, water volume ≥ 10 l |
2 |
||
3 |
In water supply |
1 |
||
F |
Components of storage systems (11) |
|
||
1 |
In domestic installations, buildings, water volume < 10 l |
0,4 |
||
2 |
In domestic installations, buildings; water volume ≥ 10 l |
0,2 |
||
3 |
In water supply |
0,1 |
||
G |
Small Components storage systems (12) |
|
||
1 |
In domestic installations, buildings; water volume < 10 l |
0,04 |
||
2 |
In domestic installations, buildings; water volume ≥ 10 l |
0,02 |
||
3 |
In water supply |
0,01 |
||
|
4.2.2.
Pass/fail criteria for relevant substances
4.2.3.
Pass/fail criteria for unexpected substances
Parameter |
MTCtap |
Identified substances with a known MTCtap |
MTCtap of the substance |
Identified substance without a known MTCtap |
1,0 μg/l |
Unidentified substances |
1,0 μg/l per unidentified substance 1 5,0 μg/l for the sum of the unidentified substances |
4.2.4.
Pass/fail criteria for TOC
4.3.
Odour, flavour, colour and turbidity
4.3.1.
Pass/fail criteria for TON, TFN
4.3.2.
Pass/fail criteria for colour
4.3.3.
Pass/fail criteria for turbidity
4.4.
Enhancement of Microbial Growth (EMG)
Standard |
|
|
Non-elastomers |
Elastomers (CF > 1 d/dm) |
Elastomers (1 d/dm ≥ CF > 0,1 d/dm) |
Elastomers (CF ≤ 0,1 d/dm) |
EN 16421 |
Method 1 |
Biomass production potential (BPP) in pg ATP/ cm2 |
≤ 1 000 |
≤ 1 000 |
≤ 1 000 |
≤ 1 000 |
EN 16421 |
Method 2 |
Vbiofilm in ml/800 cm2 |
≤ 0,05 ± 0,02 |
≤ 0,05 ± 0,02 |
≤ 0,12 ± 0,03 |
≤ 0,20 ± 0,03 |
4.5.
Pass/fail criteria for residual content of substances (QM and QMA)
4.6.
Purity pass/fail criteria for pigments, colorants and fillers
Pigments and colorants |
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Colorants and pigments shall comply with the following purity requirements: |
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|
or
|
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Fillers |
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Fillers can be contaminated with impurities. For mineral fillers, the following specification applies: |
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After solution in 0,1 N hydrochloric acid, the concentration of the following elements shall not exceed the maximum amount, based on the filler:
|
ANNEX II
FINAL METALLIC MATERIALS
1.
GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL METALLIC MATERIALS AS USED IN A PRODUCT.
2.
IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS
2.1.
Composition review
2.1.2.
Accepted compositions
2.1.3.
Relevant substances
3.
TESTING REQUIREMENTS
3.1.
Composition testing
3.2.
Testing of release of relevant substances from plated products
4.
ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA
4.1.
Compliance with the European positive list of metallic compositions
4.2.
Pass/fail criteria for relevant substances
ANNEX III
FINAL CEMENTITIOUS MATERIALS
1.
GENERAL PROCEDURE FOR TESTING AND ACCEPTING FINAL CEMENTITIOUS MATERIALS AS USED IN A PRODUCT.
2.
IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS
2.1.
Categorisation of products into risk groups and corresponding testing requirements
Risk Group |
CF in d/dm |
Formulation review |
Relevant substances |
Screening for unexpected substances |
TOC |
TON(1), TFN(2), colour, turbidity |
EMG |
RG1 |
≥ 4 |
Yes |
Yes, on product or test piece |
Yes, on product or test piece if organic constituents are used |
Yes, on product or test piece |
Yes, on product or test piece |
Yes, on product or test piece if organic constituents are used |
RG2 |
≥ 0,4 and < 4 |
||||||
RG3 |
≥ 0,04 and < 0,4 |
||||||
RG4 |
< 0,04 |
No |
No |
No |
Yes, on product or test piece |
Yes, on product or test piece |
Yes, on product or test piece if organic constituents are used |
2.2.
Formulation review
2.2.1.
Required Information
2.2.2.
Relevant substances
2.2.3.
Accepted constituents
2.2.4.
Material-specific requirements
3.
TESTING REQUIREMENTS
3.1.
Migration testing
3.1.1.
Specifications for testing final cementitious materials for migration of organoleptic parameters (odour, flavour, colour and turbidity), TOC, relevant and unexpected substances
3.2.
Analysis of migration waters
3.2.1.
Relevant substances
3.2.2.
Unexpected substances
3.2.3.
Relevant other parameters
3.3.
Mathematical modelling
3.4.
Enhancement of Microbial Growth (EMG) testing
4.
ACCEPTANCE REQUIREMENTS: PASS/FAIL CRITERIA
4.1.
Formulation
4.2.
Relevant substances, unexpected substances
4.2.1.
Conversion of migration test results
4.2.2.
Pass/fail criteria for relevant substances
4.2.3.
Pass/fail criteria for unexpected substances
4.2.4.
Pass/fail criteria for Total Organic Carbon (TOC)
4.3.
Odour, flavour, colour and turbidity
4.3.1.
Pass/fail criteria for TON, TFN
4.3.2.
Pass/fail criteria for colour
4.3.3.
Pass/fail criteria for turbidity
4.4.
Enhancement of Microbial Growth (EMG)
ANNEX IV
FINAL ENAMELS, CERAMIC MATERIALS AND OTHER INORGANIC MATERIALS (INCLUDING GLASS)
1.
GENERAL PROCEDURE FOR TESTING AND ACCEPTING
2.
IDENTIFICATION OF RELEVANT SUBSTANCES AND RELEVANT OTHER PARAMETERS
2.1.
Categorisation of products or components into risk groups and corresponding testing requirements.
Risk group |
Conversion factor CF in d/dm |
Composition review & testing |
Specific migration testing |
RG 1 |
≥ 4 |
Yes |
Yes, on product or component. Enamels: test piece(s) produced by enameller |
RG 2 |
≥ 0,4 and < 4 |
||
RG 3 |
≥ 0,04 and < 0,4 |
Yes |
Yes, on product or component. Enamels: test pieces(s) produced by enamel manufacturer |
RG 4 |
< 0,04 |
Yes |
No |