EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
ANNEXES 1 to 4  
 
ANNEXES  
to the  
Commission Implementing Decision  
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   
     
   
EN 1  EN  
ANNEX I  
FINAL ORGANIC MATERIAL  
 
1. GENERAL PROCEDURE FOR  TESTING AND ACCEPTI NG FINAL ORGANIC MAT ERIALS 
AS USED IN A PRODUCT . 
The procedure for testing and accepting final organic material s as used in a product  includes 
the following steps : 
 
Step 1 – Identification of relevant substances  and relevant other parameters depending 
on: 
1. Categori sation of products or components into risk groups  and corresponding testing 
requirements  
2. Formulati on review  
 
Step 2 – Performance of tests  
1. Migration test  
2. Total Organic Carbon (TOC)  
(a) Relevant substances   
(b) Unexpected substances  
(c) Modelling of migration of relevant substances  
3. Migration t est  
(a) Odour and flavour  
(b) Colour  and turbidity  
4. Testing for Enhanc ement of  Microbial Growth (EMG)  
5. Testing residual content of substances  
 
Step 3 – Compliance with pass/fail criteria  
  
EN 2  EN 2.  IDENTIFICATION OF REL EVANT SUBSTANCES AND  RELEVANT OTHER PARAMETERS  
2.1. Categorisation of products or components into risk groups  and corresponding 
testing requirements . 
For each product or component  of an assembled product , a product group and a corresponding 
conversion factor shall be determined  in accordance with Table 5 . Based on the determined 
conversion factor, the product or component is categorised in a risk group (RG) in accordance 
with Table 1.  
The categorisation in a RG determines the corresponding testing requirements including the 
relevant substances and relevant other parameters.  The applicable testing procedure of final 
organic materials results from the use of these materials in products or components of 
assembled products.  
Minor components are considered to be components categoris ed in risk group 3 or 4 (RG3 or 
RG4) and for which reduced testing requirements , as set out in Table 1, may apply in 
comparison with the testing requirements for the risk group 1 or 2 (RG1 or RG2).  
For an assembled product, the components shall be determined. For each component in an 
assembled product, a product group shall be determined. If an assembled product consists of 
components made of the same final materials, then the surface fraction  of the se components 
shall  be cumulatively added for the determination of the product group in accordance with 
Table 5.  
Products or components made of multilayer materials are considered as one final material  
consisting of several layers .  
The test ing shall  be performed on the final materials as used in products in contact with water 
intended for human consumption.  
The specification in Table 1 for testing ‘on product or component’ means that the individual 
product or component of an  assembled product shall be used for the performance of the 
testing .  
The specification in Table 1 for testing on “test piece of the formulation” means that a 
representative test  piece  of the final material as used in a product or component can be 
considered for the testing . In this case it is not required that the individual product or 
component is tested.   
 
   
EN 3  EN Table 1: Risk -based testing requirements for products or components of assembled products  
Risk group  Conversion 
factor (CF)  
in d/dm  Formu -
lation 
review  Relevant 
substances  Screening 
for 
unexpected 
substances  TOC  TON1, 
TFN2, 
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 piec e 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  
1 Threshold odour number  
 2 Threshold flavour number  
  
  
  
2.2. Formulation  review  
A formulation review is required in accordance with the requirements  in Table 1.  
2.2.1 Required information  
For a formulation review of a final organic material  the following information is required:  
(a) list of all starting substances (including their impurities  and other specifications ) used 
to produce the final organic material including all monomers, additives, aids to 
polymerisation , polymer production aids, pigments , colorants  and fillers ; 
(b) the respective percentage by mass  (m/m %) of all starting s ubstances and substances 
used to produce the final material, adding up to 100  %. 
(c) any other information considered relevant for the assessment of the formulation of the 
final organic material.   
EN 4  EN The cut -off value, below which details of the formulation (i.e. the chemical composition of 
starting substances or impurities ) are not required, expressed as mass  percentage in the 
formulation is:  
(a) for one substance : 0.02% for RG1, 0.05% for RG2 and 0.1% for RG3 materials ; and 
(b) for the sum of all such substances : 0.1% for RG1, 0.2% for RG2 and 0.5% for RG3 . 
 
In case of multilayer products with a total barrier, only the layers between  the barrier and the 
surface i n contact with  drinking water shall be considered.  The formulation shall  be specified 
for each layer to be co nsidered.  
 
2.2.2 Relevant substances  
The formulation shall be evaluated and compared with the accepted starting substances of the 
European positive list of starting substances for organic materials  set out in Annex I of 
Commission Implementing Decision (EU) …/… [OP: please fill in the reference of  
C(2023)7001] . One of the objectives of the evaluation is to define the relevant substances, 
which shall be analysed in the migration water.  
The r elevant substances are:  
(a) Starting  substances used in the formulation , listed in the  European positive list 
of starting substances for organic materials  and for which an MTC tap applies ; 
(b) Substances like impurities, degradation or reaction products specified in the  
condition of use of the EU -PL for starting substance of organic materials used 
in the formulation ; 
(c) All substances set out in  Table 4 of Annex I of Commission Implementing 
Decision (EU) …/… [OP: please fill in the reference of  C(2023)7001] of 
starting substances for organic materials  if stabilizers with alkylphenol 
structural moieties are used;  
(d) Starting substances used in the formulation, their impurities , degradation and 
reaction products not listed in the European positive list of starting substances 
for organic materials s et out in Annex I of Commission Implementing Decision 
(EU) …/… [OP: please fill in the reference of  C(2023)7001] , but accepted 
under section 2.2.3  (b) of this Annex ; 
(e) Aluminium, ammonium, barium, cobalt, copper,  europium, gadolinium, iron, 
lanthanum,  lithium, manganese , terbium  and/or zinc , if the respective salts of 
authorised acids, phenols or alcohols , authorised in accordance with note 2. 
"Scope of an authorisation ”, point  ii. of the Annex I of Commission 
Implementing Decision (EU) …/… [OP: please  fill in the reference of  
C(2023)7001] are used ; 
(f) Starting substances of polymeric substances authorised  in accordance with  
note 2. "Scope of an authorisation ”, point  iii. of the Annex I of Commission 
Implementing Decision (EU) …/… [OP: please fill in the reference of  
C(2023)7001] for which an MTC tap applies;    
EN 5  EN (g) Starting substances of pre -polymers and natural or synthetic polymers 
authori sed in accordance with  note 2. “Scope of an authorisation ”, point  v. of 
the Annex I of Commission Implementing Decision (EU ) …/… [OP: please fill 
in the reference of  C(2023)7001]  for which an MTC tap applies ; 
(h) Antimony, arsenic, barium, cadmium  , chromium,  lead, mercur y, selenium  if 
pigments or colorants are used in the formulation not complying with the purity 
requirements in accordance with  section 4.6 of this Annex  or if the purity 
testing was not performed ;  
(i) Primary aromatic amines (PAA) if organic pigments or colorants are used in the 
formulation not complying with the purity requirements in accordance with  
section 4.6 of this Annex  or if the purity testing was not performed ; 
(j) Antimony, arsenic, barium, cadmium  , chromium, lead, mercury, selenium if 
fillers are used in the formulation not complying with the purity requirements 
according to section 4.6 of this Annex or if the purity testing was not 
performed;  
(k) In case additional material -specific criteria apply (see section 2.2.4 ): all 
substances or group of substances for which an MTC tap has been set ; 
(l) In case of migration test with chlorinated test water:  haloacetic acids (HAAs) 
and trihalomethanes  total, as defined in part B of Annex I – to Directive (EU) 
2020/2184.  
For multilayer  materials , the relevant substances shall be  determined for each layer  between 
the total barrier and the drinking water  individu ally. 
 
2.2.3 Acceptance of starting substances  
Organic materials shall only be made of : 
(a) starting substances listed in the European positive list of starting substances for 
organic materials set out in Annex I of Commission Implementing Decision (EU) 
…/… [OP: please fill in the reference of  C(2023)7001] ; or  
(b) starting substances for which no migration of the substance, its impurities and/or its 
reaction and degradation products into drinking water occurs at levels exceeding 
0.1 µg/l at the consumer’s tap. T his only applies to substances that do not belong to 
either one of the following categories:  
(1) substances classified as carcinogenic, mutagenic , toxic for reproduction 
category 1A or 1B, endocrine disrupters (ED) for human health category 1, 
persistent, bioa ccumulative and toxic substances (PBT) or very persistent and 
very bioaccumulative substances (vPvB) in accordance with Regulation No. 
1272/2008  (CLP);  or being  included in the candidate list as substances of very 
high concern (SVHC) under Regulation (EC) No 1907/2006  (REACH) for the 
ED, PBT or vPvB properties ; 
(2) substances intentionally added in nanoform;   
EN 6  EN (3) monomers of the main polymer s in the material . 
The relevant notes of the Annex I to Commission Implementing Decision (EU) …/… [OP: 
please fill in the reference of  C(2023)7001] establishing the European positive list of starting 
substances for organic materials shall  be considered in the acceptance of starting substances.  
 
2.2.4 Material -specific requirements  
For polyamide or polyurethane resin coatings , requirements on the release of primary aromatic 
amines (PAA) apply, as spe cified in Table 2. 
Requirements for rubbers are listed in Table 3.  
Requirements for organic materials  other than rubbers made of starting substances bearing N -
functionalities, such  as aminic, amidic or quaternary, when tested with  chlorinated test water 
are listed in Table 4.  
 
Table 2 Requirement for polyamides and polyurethane resin coatings  
Parameter  Restriction  
Sum of Primary Aromatic Amines (PAA)  MTC tap = N.D. ( LOD = 0.1 µg/l)1 
Method should be improved to have a Limit Of Detection ( LOD ) of 0.1 µg/l.  
 
 
Table 3: Requirements on amines and nitrosamines for rubbers  
Parameter  Restriction  
Sum of Primary Aromatic Amines (PAA) (a.o.  aniline, o -toluidine)  MTC tap = N.D. ( LOD  = 0.1  µg/l)1 
Sum of secondary amines2 MTC tap = 250 µg/l  
Sum of N -nitrosamines3 MTC tap = N.D. (LOD = 0.1 µg/l ) 
1 Method should be improved to have a Limit Of Detection (LOD) of 0.1 µg/l.  
2 sum of dibutylamine (CAS 111 -92-2), diethylamine (CAS 109-89-7), dimethylamine (CAS 124 -40-3), dicyclohexylamine 
(CAS 101 -83-7), cyclohexylethylamine (CAS 5459 -93-8), diphenylamine (CAS 122 -39-4), dibenzylamine (CAS 103 -49-
1), benzyl -N-methylamine (CAS 103 -67-3), benzylidenebenzylamine (CAS,780 -25-6) N -methyl aniline (CAS 100 -61-8), 
N-ethylaniline (CAS 103 -69-5), N -butylaniline (CAS  1126 -78-9) 
3  sum of N-Nitroso -di-n-butylamine (CAS 924 -16-3), N -Nitroso -diethanolamine (CAS 1116 -54-7), N -Nitroso -diethylamine 
(CAS 55 -18-5), N -Nitroso -diisopropylamine (CAS 601-77-4), N -Nitroso -dimethylamine (CAS 62 -75-9), N -Nitroso -di-
n-propylamine (CAS 621 -64-7), N -Nitroso -ethyl phenylamine (CAS 612 -64-6), N -Nitroso -methyl ethylamine (CAS 
10595 -95-6) N-Nitroso -methyl phenylamine (CAS 614 -00-6), N -Nitroso -morpholine (CAS 59 -89-2), N -Nitroso -piperidine 
(CAS 100 -75-4), N -Nitroso -pyrrolidine (CAS 930 -55-2) 
  
EN 7  EN Table 4: Requirements on nitrosamines for final materials other than rubbers made of starting substances bearing N -
functionalities when tested with chlorinated test water  
Parameter  Restriction  
Sum of N -nitrosamines1 MTC tap = N.D. (LOD = 0.1 µg/l ) 
1  sum of N-Nitroso -di-n-butylamine (CAS 924 -16-3), N -Nitroso -diethanolamine (CAS 1116 -54-7), N -Nitroso -diethylamine 
(CAS 55 -18-5), N -Nitroso -diisopropylamine (CAS 601 -77-4), N-Nitroso -dimethylamine (CAS 62 -75-9), N -Nitroso -di-
n-propylamine (CAS 621 -64-7), N -Nitroso -ethyl phenylamine (CAS 612 -64-6), N -Nitroso -methyl ethylamine (CAS 
10595 -95-6) N-Nitroso -methyl phenylamine (CAS 614 -00-6), N -Nitroso -morpholine (CAS 59 -89-2), N -Nitroso -piperidine 
(CAS 100 -75-4), N -Nitroso -pyrrolidine (CAS 930 -55-2) 
   
EN 8  EN 3. TESTING  REQUIREMENTS  
3.1. Migration testing  
3.1.1. Standards  
For testing the release of relevant substances , unexpected substances  and TOC , the following 
standards shall  be used  to obtain the migration waters : 
(a) For factory made products: EN 12873 -1:2014 ; 
(b) For site applied materials: EN 12873 -2:2021 . 
For testing odour  and flavour , colour and turbidity , standard EN 1420:2016  shall be used to  
obtain the migration waters .  
The mentione d EN standards leave options for testing. The following provisions in  sections 
3.1.2, 3.1.3, 3.1.4 and 3.1.5 substantiate these standards.  
3.1.2. Test piece  
For a product or a component of which the size does not allow the practical application of the 
testing, a representative test piece for the testing shall be provided.  
Special attention shall be given to the production of the test piece.  
 
3.1.3. Temperature of testing  
All products shall be tested at 23  °C ± 2  °C (cold water test condition).  
Additionally, products that are normally used for warm or hot applications shall be tested at 
60 °C ± 2  °C or 85  °C ± 2  °C, respectively. For this purpose, warm water corresponds to 
normal operating temperatures between 30  °C and 70  °C and hot water corres ponds to 
operating temperatures exceeding 70  °C.  
Multilayer products shall always be tested at 60  °C ± 2  °C or 85  °C ± 2  °C additionally, even 
when not  used at these temperatures.  
 
3.1.4. Type of test water  
Cold water test (23  °C ± 2  °C) shall  be performed with chlorinated and non -chlorinated test 
water.  
In case a warm or a hot water test is required , this test shall only be performed with non -
chlorinated test water.  
 
3.1.5. Migration periods  
For cold water  tests the migration samples of the 1st, 2nd and 3rd migration period according to 
standards shall be analy sed. The compliance with the pass/fail criteria shall be assessed at the 
3rd migration period (10th day of testing). If the pass/fail criteria set out in  sections 4.2 and 4.3 
are not met  at the 3rd migration period the testing can be extended and  the 5th, 7th and 9th  
EN 9  EN period shall be analy sed additionally . In this case the pass/fail criteria shall be assessed  at the 
9th migration period (31st day of testing ).  
For warm or hot water  tests the migration samples of the 1st, 6th and 7th migration period shall  
be analysed . The compliance with the pass/fail criteria shall be assessed at the 7th migration 
period (10th day). If the pass/ fail criteria set out in sections 4.2 and 4.3  are not met a t the 7th 
migration period the testing can be extended and the 12th, 17th and 22nd period shall  be 
analysed  additionally . In this case the pass/fail criteria shall be assessed  at the 22nd migration 
period (31st day).  
For multilayer products an extended warm or hot water migration test is always required to 
ensure that  substances originating from different layers appear in the migration water . To 
ensure sufficient substance diffusion and equilibration across layer boundaries, it is required 
that t he multilayer product has undergone a storage period at room temperature for at least 30 
days.  
 
3.2. Analysis of migration water s 
3.2.1. Relevant Substances  
The relevant substances defined in section 2.2.2 shall be analysed in the migration waters (see 
section 3.1.5). 
The methods for analysis of relevant substances in  migration waters shall be  validated and 
documented in accordance with EN ISO/IEC 17025 :2017  or other equivalent standards 
accepted at international level.  
3.2.2. Unexpected Substances  
Unexpected substances are only determined in the migration waters of the cold  water test.  
For the identification and semi -quantitate analysis of u nexpected substances a GC-MS 
screening shall be conducted according to EN  15768 :2015.  
3.3.3. Relevant o ther parameters  
The relevant other parameters shall be analysed in the migration waters according to the 
following standards:  
(a) Total Organic Carbon ( TOC ) shall be determined according to EN 1484 :1997  
as non -purgeable organic carbon ; 
(b) Odour shall be determined as Threshold Odour Number (TON) according to 
EN 1420 :2016  and EN 1622 :2006 ; 
(c) Flavour shall be determined as Threshold Flavour Number (TNF)  according to 
EN 1420 :2016  and EN 1622 :2006 ; 
(d) Colour shall be determined according to EN  ISO 7887 :2011 ; 
(e) Turbidity shall be determined  according to EN ISO 7027 -1:2016 . 
  
EN 10  EN 3.3. Mathematical modelling  
Where generally recognised diffusion models exist on the basis of experimental data, 
mathematical modelling for estimation of migration levels may be used as alternative to the 
migration testing of relevant substances for certain types of final organic mat erials.  
If these recognised diffusion models predict that the migration of the substance complies with 
the maximum tolerable concentration at the tap (MTC tap), migration testing for these 
substances is not necessary. For the assessment of some parameters and for modelling, the 
concentration of the respective substances in the final material shall be determined.  
If compliance is not shown by using the models, migration testing shall be performed.  
The following mathematical modelling  approaches may  be used : 
(a) Migration modelling according to CEN/TR 16364 :2012 , simulating a migration 
test according to the EN  12873 -1:2014  and EN  12873 -2:2021 ; 
(b) Full transfer calculation, simulating full transfer of substances from the product 
into the migration water .  
 
3.4. Enhancement  of Microbial Growth (EMG) testing  
For the enhancement of microbial growth (EMG) testing, standard EN 16421 :2015 – method 1 
or 2 shall be used.  
  
3.5. Testing residual content of substances (QM/QMA ) 
For starting substances with a  maximum quantity  (QM or QMA)  restriction set out in the 
European positive list of starting substances for organic materials of Annex I of Commission 
Implementing Decision (EU) …/… [OP: please fill in the reference of  C(2023)7001] , its 
residual content in the product shall be analysed.  
 
   
EN 11  EN 4. 4. ACCEPTANCE REQUIREMEN TS: PASS/FAIL CRITERIA  
4.1. Formulation  
Starting substances of the formulation listed in the European positive list of starting substances 
for organic materials set out in Annex I of Commission Implementing Decision (EU) …/… 
[OP: please fill in the reference of  C(2023)7001] . 
(a) shall  be used accord ing to the technical function  specified in the European 
positive list  of starting substances for organic materials ; 
(b) shall  be used in compliance with condition s of use  established under the 
European positive list  of starting substances for organic materials .  
(c)  
4.2. Relevant substances, unexpected substances, TOC  
4.2.1. Conversion of test results  
In accordance with  the migration standards EN 12873 -1:2014  and EN 12873 -2:2021 , the test 
results are ex pressed as migration rates  (M) in µg/(dm² .d). The se results shall be converted to 
estimate the concentrations at the tap  (Ctap), defined as Ctap = M * CF , where CF is the 
corresponding conversion factor  in d/dm .  
The conversion factors for the different product groups  are listed in Table 5  to this Anne x. 
   
EN 12  EN Table 5: Product group s and their  conversion factor (CF)  
Product group  CF (in 
day/dm)  
A Pipes and pipe linings   
1 ID < 80 mm (domestic installations, buildings) 1 20 
2 80 mm ≤ ID < 300 mm (service piping)  10 
3 ID ≥ 300 mm (mains piping)  5 
B Fittings, ancillaries 2  
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 3  
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 4  
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 3  
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 4  
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 
1 If from a series of different diameter pipes made from the same pre-product  under the same manufacturing process (a so -
called product family) the smallest diameter pipe is assessed and approved, then the whole series of different diameter pipes  is 
allowed to be used for all application areas within the product group without furth er testing.  
2,3,4 Components (sum of components made of similar materials) of assembled products with a wetted surface fraction  
2   ≥ 10 % of the assembled product  
3  < 10 % of the assembled product  
4  < 1 % of the assembled product  
   
EN 13  EN 4.2.2. Pass/fail  criteria for relevant substances  
The following requirements shall apply to the cold water migration test:  
(a) Ctap ≤ MTC tap for the 3rd migration period (10th day of testing)  or, in case 
extended testing is needed, at the 9th migration period (31st day of tes ting) ; 
(b) there shall be no increasing trend of Ctap in time.  
The following requirements  shall apply to the warm/hot water migration test:  
(a) Ctap ≤ MTC tap for the 7th migration period (10th day of testing ) or, in case 
extended testing is needed, at the 22nd migration period (31st day of testing);   
(b) there shall be no increasing trend of Ctap in time.  
The measured substance concentrations in the migration water from the successive migration 
periods shall be used to assess the trend. However, if Ctap in the rel evant migration period is 
below 1/10 of MTC tap, no trend analysis is required.  
For ions, the MTC tap,organics  of Table 1 in Annex V to Commission Implementing Decision 
(EU) …/… [OP: please fill in the reference of  C(2023)7001] shall apply.  
 
4.2.3. Pass/fail  criteria for unexpected  substances  
The following requirement shall apply to the cold water migration test:  
(a) Ctap ≤ MTC tap for the 3rd migration period (10th day of testing)  or, in case 
extended testing is needed, at the 9th migration period (31st day of testing).  
The MTC tap for the unexpected substances are set out  in Table 6. 
 
Table 6 - MTCtap  for unexpected substances1 
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 substance1 
5.0 µg/l for the sum of the unidentified substan ces 
 1 Based on the response of the closest internal standard.  
 
   
EN 14  EN 4.2.4. Pass/fail  criteria for TOC  
The following  requirement s shall apply to the cold water migration test:  
(a) Ctap ≤ 0.5 mg/l for the 3rd migration period (10th day of testing)  or, Ctap ≤ 
0.5 mg/l for the 9th migration period (31st day of testing) and Ctap ≤ 2.0 mg/l for 
the 3rd migration period (10th day of testing) ; 
(b) there shall be no increasing trend of Ctap in time.  
The following requirement s shall apply to the warm/hot water migration test:  
(a) Ctap ≤ 0.5 mg/l for the 7th migration period (10th day of testing)  or, Ctap ≤ 
0.5 mg/l for the 22nd migration period (31st day of testing) and Ctap ≤ 2.0 mg/l 
for the 7th migration period (10th day of testing) ;  
(b) there shall be no increasing trend of Ctap in time.  
The measured TOC in the migration water from the successive migration periods shall be used  
to assess the trend. However, if the TOC in the relevant migration period is below 0 .2 mg/l no 
trend analysis is required.  
 
4.3. Odour , flavour , colour and turbidity  
4.3.1. Pass/fail  criteria for TON , TFN  
(i) Pass/fail criteria for TON and TFN for  pipes with internal diameter (ID) < 80  mm:  
The following requirement s shall apply to the cold water migration test:  
(a) TON, TFN ≤ 8.0 for the 3rd migration period (10th day of testing); or  
(b) TON, TFN ≤ 8.0 for the 9th migration period (31st day of testing)  
and TON, TFN ≤ 16 for the 3rd migration period (10th day of testing).  
The following requirement s shall apply to the warm/hot  water migration test:  
(a) TON, TFN ≤ 8.0 for the 7th migration period (10th day of testing); or  
(b) TON,  TFN  ≤ 8.0 for the 22nd migration period (31st day of testing)  
and TON, TFN ≤ 16 for the 7th migration period (10th day of testing).  
(ii)  Pass/fail criteria for TON and TFN for a ll other products:  
The following requirement s shall apply to the cold water migration test:  
(a) TON, TFN ≤ 2.0 for the 3rd migration period (10th day of testing); or  
(b) TON, TFN ≤ 2.0 for the 9th migration period (31st day of testing)  
AND TON, TFN ≤ 4.0 for the 3rd migration period (10th day of testing).  
The following requirement s shall apply to the warm/hot  water m igration test:  
(a) TON, TFN ≤ 2.0 for the 7th migration period (10th day of testing); or  
(b) TON,  TFN ≤ 2.0 for the 22nd migration period (31st day of testing)  
AND TON, TFN ≤ 4.0 for the 7th migration period (10th day of testing).  
  
EN 15  EN 4.3.2. Pass/fail  criteria f or colour  
The acce ptance criterion for colour is ≤ 5  mg/l Pt/Co . 
The criterion shall  be met for the 3rd migration period for cold water migration testing / 7th 
migration period for warm /hot water testing (10th day of testing) or , in case of extended 
testing , for the 9th migration period for cold water migration testing / 22nd migration period for 
warm /hot water testing (31st day of testing).  
 
4.3.3. Pass/fail  criteria for turbidity  
The acceptance criterion for turbidity is ≤ 0.5 NFU . 
The criterion shall  be met for the 3rd migration period for cold water migration testing / 7th 
migration period for warm /hot water testing (10th day of testing) or , in case of extended 
testing , for the 9th migration period for cold water migration testing / 22nd migration pe riod for 
warm /hot water testing (31st day of testing).  
 
4.4. Enhancement of Microbial Growth (EMG)  
The pass/fail  criteria for the parameter Enhancement of Microbial Growth (EMG)  are listed in 
Table 7.  
Additionally, the surface of the products or compo nents  shall  not have any biocidal effects on 
drinking water. Therefore, test pieces  without surface colonisation (comparison of contact 
culture/test sample smear with that of the negative control) do not satisfy this requirement.  
 
Table 7 – Acceptance criteria for 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  ≤ 1000  ≤ 1000  ≤ 1000  ≤ 1000  
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)  
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) …/… [OP: please fill in the reference of  C(2023)7001] shall apply independently of the 
product group of final organic materials.   
 
4.6. Dw Purity pass/fail criteria for pigments, colorants and fillers   
EN 16  EN 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:  
a) 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,  
 or 
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%  
  
EN 17  EN ANNEX II  
 FINAL METALLIC MATERIALS  
 
1. GENERAL PROCEDURE FOR  TESTING AND ACCEPTI NG FINAL METALLIC MA TERIALS 
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 REL EVANT 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) detaile d 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 compo sitions 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) …/… [OP: please fill in the reference of  
C(2023)7001] established in accordance with Article 11(2) (b) of the Directive and fulfil the  
EN 18  EN limitations set out  in the European positive list in respect of their use for certain product 
groups and the use of these products.   
Categori sation of products in product groups for metallic materials is set out  in Table 2 of 
Annex II to  Commission Implementing Decision (EU) …/… [OP: please fill in the reference 
of C(2023)7000]. 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) …/… [OP: please fill in the reference of  
C(2023)7001].  
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 composi tional requirements of metallic materials included in the 
European positive list  of metallic compositions  in Annex II of Commission Implementing 
Decision (EU) …/… [OP: please fill in the reference of  C(2023)7001] . 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 plat ed products  
Plated products should be tested for the residues on the surface accord ing to indications in the 
European positive list  of metallic compositions  in Annex II of Commission Implementing 
Decision (EU) …/… [OP: please fill in the reference of  C(2023)7001] . 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 plati ng process shall  be performed 
in accordance with the requirements set out in Annex I. 
 
4. ACCEPTANCE REQUIREMEN TS: PASS/FAIL CRITERIA  
4.1. Compliance with the European positive list  of metallic compositions  in Annex II 
of Commission Implementing Decision (EU) …/… [OP: please fill in the 
reference of  C(2023)7001]  
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) …/… [OP: please fill 
in the reference of  C(2023)7001] .    
4.2.  Pass/fail criteria for relevant substances  
The requirement Ctap ≤  MTC tap,metallics shall apply where MTC tap,metallics  is listed in the Table 1 
of Annex V to Commission Implementing Decision (EU) …/… [OP: please fill in the 
reference of  C(2023)7001] , where in the calculation of Ctap the stagnation time and the 
sampling volume are taken in due consideration.   
EN 19  EN  
   
EN 20  EN ANNEX III  
FINAL CEMENTITIOUS MATERIALS  
1. GENERAL PROCEDURE FOR TESTIN G AND ACCEPTING FINA L CEMENTITIOUS 
MATERIALS AS USED IN  A PRODUCT . 
The procedure for testing and accepting final cementitious materials as used in a product 
includes the following steps:  
 
Step 1 – Identification of relevant substances a nd relevant other parameters depending 
on: 
1. Categorisation of products or components into risk groups and corresponding testing 
requirements . 
2. Formulation review .  
 
Step 2 – Performance of tests  
1. Migration test for: 
(a) Relevant substances  
(b) Unexpected substances  
(c) Odour and flavour  
(d) Colour and turbidity  
(e) Total Organic Carbon (TOC)  
 
2. Testing for Enhancement of Microbial Growth (EMG)  
 
Step 3 – Compliance with pass/fail criteria  
   
EN 21  EN 2. IDENTIFICATION OF REL EVANT SUBSTANCES AND  RELEVANT OTHER PARAMETERS  
2.1. Categorisation of products into risk groups and corresponding testing 
requirements  
The applicable testing procedure of final cementitious materials results from the use of these 
materials in products.  
In accordance with Table 5 of Annex I , a product group and a corresponding conversion 
factor (CF) shall be determined for the product or the component. Based on the determined 
CF, the product or component is categorised in a risk group (RG). In accordance with Table 1 
of this Annex , the categ orisation in a RG determines the corresponding testing requirements 
and relevant other parameters.  
For an assembled product, the components shall be determined. For each component in an 
assembled product, a product group shall be determined. If an assembled product consists of 
components made of the same final materials, then the surface fraction of the se components 
shall be cumulatively added for the determination of the product group in accordance with 
Table 5.  
The testing shall be performed on the final materials as used in products in contact with water 
intended for human consumption.  
Minor componen ts are considered to be components categorised in risk group 3 or 4 (RG3 or 
RG4) and for which reduced testing requirements, as set out in Table 1, may apply in 
comparison with the testing requirements for the risk group 1 or 2 (RG1 or RG2).  
 
Table 1: Risk -based testing requirements for products or components of assembled products  
Risk 
Group  CF 
in d/dm  Formulation 
review  Relevant 
substances  Screening for 
release of 
unexpected 
substances  TOC  TON1, TFN2, 
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  
1 Threshold odour number  
2 Threshold flavour number  
   
EN 22  EN  
2.2. Formulation review  
A formulation review shall be performed in accordance with the requirements in Table 1.  
2.2.1.  Required Information  
The following information in the formulation review is required for each final cementitious 
material:  
(a) list of all constituents (including information on their impurities) used to 
produce the final cementitious material;  
(b) the respective percentage by mass (m/m %) of constituents with respect to 
cement content used to produce the final cementitious material;  
(c) any other information considered rel evant for the assessment of the formulation 
of the final cementitious material.  
The cut -off value, below which details of the formulation of the final material are not 
required, expressed as mass percentage in the formulation is  0.02% (w/w) related to the 
cement content for one constituent . 
The formulation shall be evaluated and compared with the accepted constituents of the 
European positive list  of constituents for cementitious materials in Annex III of Commission 
Implementing Decision (EU) …/… [OP: pleas e fill in the reference of  C(2023)7001] and 
with the accepted starting substances of the European positive list  for organic materials, when 
relevant in accordance with Table 1 of Annex II I to Commission Implementing Decision (EU) 
…/… [OP: please fill in the reference of  C(2023)7001] . The evaluation shall define the 
relevant substances that  shall be analysed in the migration water.  
 
2.2.2.  Relevant substances  
The relevant substances to be analysed in the migration water are:  
(2) Organic cementitious constituents use d in the formulation of the final cementitious 
material, listed in the European positive list  in Annex III of Commission 
Implementing Decision (EU) …/… [OP: please fill in the reference of  C(2023)7001] 
and for which an MTC tap applies;  
(3) Impurities, degradati on or reaction products specified in the condition of use of the 
European positive list of cementitious materials for organic constituents in Annex III 
of Commission Implementing Decision (EU) …/… [OP: please fill in the reference 
of C(2023)7001] used in t he formulation;  
(4) Organic cementitious constituents   used in the formulation, their impurities, 
degradation and reaction products not listed in the European positive list of 
cementitious materials  in Annex III of Commission Implementing Decision (EU) 
…/… [OP: please fill in the reference of  C(2023)7001] , but accepted under section 
2.2.3 of this Annex ;  
(5) Metals for which MTC tap ,cementitious exist  according to Table 1 in Annex V to 
Commission Implementing Decision (EU) …/… [OP: please fill in the reference o f 
C(2023)7001] ; 
(6) Primary aromatic amines (PAA) if organic pigments or colorants are used in the 
formulation not complying with the purity requirements according to section 4.6  of 
Annex I or when purity testing was not performed.   
EN 23  EN  
2.2.3.  Accepted constituents  
Final cementitious materials shall only contain  organic cementitious constituents listed in the 
European positive list  for constituents of cementitious materials and in the European positive 
list of starting substances for organic materials as further specified in Table 1 of Annex  III to 
Commission Implementing Decision (EU) …/… [OP: please fill in the reference of  
C(2023)7001] .   
The use of the following additional constituents is allowed:  
(a) Inorg anic constituents;  
(b) Organic cementitious constituents for which there is no possibility that they, 
including their reaction products, migrate at levels exceeding 0.1  μg/l in water 
intended for human consumption. This only applies to substances that do not 
belong to either one of the following categories:  
(i) Substances classified as carcinogenic, mutagenic or toxic for 
reproduction category 1A or 1B, endocrine disrupters (ED) for human 
health category 1, persistent, bioaccumulative and toxic substances 
(PBT) or very persistent and very bioaccumulative substances (vPvB) 
in accordance with Regulation No. 1272/2008  (CLP);  or being included 
in the candidat e list as substances of very high concern (SVHC) under 
Regulation (EC) No 1907/2006; and  (REACH) for their ED, PBT or 
vPvB properties;  
(ii) Substances  intentionally added in nanoform .  
 
The relevant notes of Annex III to Commission Implementing Decision ( EU) …/… [OP: 
please fill in the reference of  C(2023)7001] establishing the European Positive List of organic 
constituents of cementitious materials in Annex III of Commission Implementing Decision 
(EU) …/… [OP: please fill in the reference of  C(2023)7001]  shall  be considered in the 
acceptance of constituents of cementitious materials.  
 
 
2.2.4.  Material -specific requirements  
If used, pigments and colorants shall comply with purity criteria as defined in Table 8 of 
Annex I, and not migrate at levels exceeding 0.1 µg /l. 
   
EN 24  EN 3. TESTING REQUIREMENTS  
3.1. Migration testing  
Testing of organic coating with inorganic fillers should be  performed according to section 3.1 
of Annex I. If pH > 9.5 in the final migration water, the test should be considered invalid and 
the product should be evaluated as a cementitious product and testing will be performed 
according to section 3.1 of this Annex.  
3.1.1.  Specifications for testing final  cementitious materials for migration of organoleptic 
parameters (odour, flavour, colour and turbidity), TOC, relevant and unexpected 
substances  
 
(a) Test pieces  
For a product or a component of which the size does not allow the practical application of the 
testing, a representative test piece for the testing shall be provided.  
Special attention shall be given to the production of the test piece.  
 
(b) Preconditioning of test pieces  
Test pieces shall be preconditioned by immersion in demineralised water containing  
anhydrous calcium chloride ((222 ± 2) mg CaCl 2 L-1) and sodium hydrogen carbonate ((336 ± 
2) NaHCO 3 mg L-1) adjusted to a pH of (7.4 ± 0.1) by air or CO 2 bubbling.  
Test pieces shall be preconditioned at (23 ± 2) °C in three successive periods of (24 ± 1)  h 
followed by one period of (72 ± 1) h and one period of (24 ± 1) h. After each period the water 
is discarded and the test piece is not rinsed. If the pH of the last preconditioning water 
exceeds 9.5 then the preconditioning shall  be repeated with new tes t pieces.  
After the fifth preconditioning the test piece shall immediately be subjected to the migration 
test.  
(c) Migration test  
 
Test pieces shall be immersed in migration test water with a specified temperature and for a 
specified period of time.  
 
(i) Migration test water for odour, flavour, colour, turbidity and TOC  
 
Non-chlorinated migration test water shall be natural water without gas or demineralised 
water containing anhydrous calcium chloride ((222 ± 2) mg CaCl 2 L-1), sodium hydrogen 
carbonate (( 482 ± 2) NaHCO 3 mg L-1) and sodium silicate ((71 ± 1) Na 2SiO 3·9·H 2O mg  L-1). 
It shall have a pH of (7.4 ± 0.1)  by air or CO 2 bubbling , a conductivity of (500 ± 50) µS cm -1, 
an alkalinity of (350 ± 50) mg HCO 3- L-1, a concentration of calcium of (80 ± 10) mg -1 L and 
a concentration of silica of (15 ± 5) mg SiO 2 L-1. Non -chlorinated migration test water shall 
have no odour (< 2 TON), flavour (< 2 TFN), colour (< 0.1 m-1), turbidity (< 0.1 FNU) and 
TOC (<0.2 mg C L-1).  
Chlorinated migration test water shall  consist of non -chlorinated test water containing (1.0 ± 
0.2) mg L-1 of free chlorine.   
  
EN 25  EN (ii) Migration test water for migration of relevant and unexpected 
substances  
Non-chlorinated migration test water shall be demineralised water containing anhydrous 
calcium chloride ((110 ± 1) mg CaCl 2 L-1), sodium hydrogen carbonate ((140 ± 1) 
NaHCO 3 mg L-1) and sodium silicate ((48 ± 1) Na 2SiO 3·9·H 2O mg  L-1). It shall have a pH 
of (7.0 ± 0.1)  by air or CO 2 bubbling.  
Chlorinated migration test water shall consist of non-chlorinated test water containing (1.0 
± 0.2) mg L-1 of free chlorine.   
 
    (iii) Migration test water temperature  
 
All products shall be tested at 23 °C ± 2 °C (cold water test condition).  
Additionally, products that are normally used for warm or h ot applications shall be tested at 
60 °C ± 2 °C or 85 °C ± 2 °C, respectively. For this purpose, warm water corresponds to 
normal operating temperatures between 30 °C and 70 °C and hot water corresponds to 
operating temperatures exceeding 70 °C.  
 
    (iv) Duration of migration test periods  
 
The test piece for cold water application shall be in contact with test water for 72  h ± 1  h. The 
test piece for elevated temperature applications shall be in contact with water for 24h. The test 
shall be repeated at le ast two more times using fresh test water each time . For cold water tests, 
the migration samples of the 1st, 2nd and 3rd migration period shall be analysed. The 
compliance with the pass/fail criteria shall be assessed at the 3rd migration period.  If the 
pass/fail criteria (see sections 4.2 and 4.3) are not met at the 3rd migration period the testing 
can be extended and the 5th, 7th and 9th period shall be analysed additionally. In this case the 
pass/fail criteria shall be assessed at the 9th migrat ion period.  
 
For warm or hot water tests the migration samples of the 1st, 6th and 7th migration period shall 
be analysed. The compliance with the pass/fail criteria shall be assessed at the 7th migration 
period. If the pass/fail criteria (see sections 4.2 and 4.3) are not met at the 3rd migration period 
the testing can be extended and 12th, 17th and 22nd period shall be analysed additionally. In 
this case the pass/fail criteria shall be assessed at the 22nd migration period.  
 
(v) Surface -to-volume ratio (S /V) 
The largest S/V representative of the product group shall be selected.  
    (vi) Additional specifications  
For further details on testing organoleptic parameters, TOC, relevant and unexpected 
substances relevant European standards or, in the absence th ereof, an internationally 
recognised methods shall be used.  
Cold water test (23 °C ± 2 °C) shall be performed with chlorinated and non -chlorinated 
test water. In case a warm or a hot water test is required, the test shall only be performed 
with non -chlorin ated test water.  
3.2. Analysis of migration water s  
EN 26  EN 3.2.1.  Relevant substances  
The relevant substances defined in section 2.2.2  shall be analysed in the migration waters.  
The methods for analysis of relevant substances in migration waters shall be validated and 
documented in accordance with EN ISO/IEC 17025 :2017  or other equivalent standards 
accepted at international level.  
3.2.2.  Unexpected substances  
For the identification and semi -quantitative analysis of unexpected substances a GC -MS 
screening or screening by other  analytical techniques can be used.  
Unexpected substances are only determined in the migration waters of the cold water test.  
3.2.3.  Relevant o ther parameters  
The methods for analysis of relevant other parameters in migration waters shall be validated 
and docume nted in accordance with EN ISO/IEC 17025 :2017  or other equivalent standards 
accepted at international level.  
 
3.3. Mathematical modelling  
Where generally recognised diffusion models exist on the basis of experimental data, 
mathematical modelling for estimation of migration levels may be used as alternative to the 
migration testing of relevant substances for certain types of final organic materials.  
If these recognised diffusion models predict that the migration of the substance complies with 
the maximum tolerab le concentration at the tap (MTC tap), migration testing for these 
substances is not necessary. For the assessment of some parameters and for modelling, the 
concentration of the respective substances in the final material shall be determined.  
If compliance is not shown by using the models, migration testing shall be performed.  
Only validated mathematical models applicable to cementitious materials shall be used to 
determine the concentration of a relevant substance in migration water.  
 
3.4. Enhancement of Microb ial Growth (EMG) testing  
Tests for Enhancement of Microbial Growth shall be performed if organic constituents are 
used according to the formulation. For the Enhancement of Microbial Growth testing, 
standard EN 16421:2015 – method 1 or 2 shall be used.  
 
   
EN 27  EN 4. ACCEPTANCE REQUIREMEN TS: PASS/FAIL CRITERIA  
4.1. Formulation  
Organic cementitious constituents of the formulation listed in the European positive list of 
cementitious materials  in Annex III of Commission Implementing Decision (EU) …/… [OP: 
please fill in the re ference of  C(2023)7001] and in the European positive list of starting 
substances for organic materials  in Annex I of Commission Implementing Decision (EU) 
…/… [OP: please fill in the reference of  C(2023)7001]  shall be used : 
(7) in accordance with the technical function specified in the European positive list s; 
(8) in compliance with conditions of use established under the European positive list s.  
 
4.2. Relevant substances, unexpected substances  
4.2.1.  Conversion of migration test results  
The migration test results are expressed as migration rates (M ) in µg /(dm2.d). These results 
shall be converted to estimate the concentrations at the tap ( Ctap) , defined as Ctap = M * CF, 
where CF is the corresponding conversion factor in d/dm.  
The conversio n factors  for the different product groups are listed in Table 5 to Annex I. 
 
4.2.2.  Pass/fail criteria for relevant substances   
The following requirements shall apply to the cold water migration test:  
(a) Ctap ≤ MTC tap for the 3rd migration period  or, in case extended testing is 
needed, at the 9th migration period;  
(b) there shall be no increasing trend of Ctap in time.  
 
The following requirement s shall apply to the warm/hot water migration test:  
(a) Ctap ≤ MTC tap for the 7th migration period  or, in case extended testi ng is 
needed, at the 22nd migration period.  
(b) there shall be no increasing trend of Ctap in time  
 
The measured substance  concentrations in the migration test water from the successive 
migration periods shall be used to assess the trend. However, if the Ctap in the relevant 
migration period is below 1/10th of the MTC tap, then no trend analysis is required.  
For metals, MTC tap,cementitious  of Table 1 in Annex V to Commission Implementing Decision 
(EU) …/… [OP: please fill in the reference of  C(2023)7001]  shall apply.  
 
4.2.3.   Pass/fail criteria for unexpected substances  
The following requirement shall apply to the cold water migration test:  
(9) Ctap ≤ MTC tap for the 3rd migration period  or, in case extended testing is needed, at 
the 9th migration period.   
EN 28  EN The MTC tap for the unexpected substances are set out in Table 6 of Annex I. For certain 
cementitious products the S/V ratio does not allow to meet the limit of MTC tap = 1 µg/L as 
established for organic materials.  
In this case MTC tap < Limit of Quantification  for the worst S/V ratio shall apply.  
 
4.2.4.  Pass/fail criteria for Total Organic Carbon (TOC)  
The following requirements shall apply to the cold water migration test:  
(a) Ctap ≤ 0.5  mg/l for the 3rd migration period  or C tap ≤ 0.5  mg/l for the 9th 
migration period and Ctap ≤ 2.0  mg/l for the 3rd migration period;  
(b) there shall be no increasing trend of Ctap in time.  
The following requirement s shall apply to the warm/hot water migration test:  
(a) Ctap ≤ 0,5 mg/l for the 7th migration period  or C tap ≤ 0,5 mg/l for the 22nd 
migration period and Ctap ≤ 2,0 mg/l for the 7th migration period.  
(b) there shall be no increasing trend of Ctap in time.  
The measured TOC in the migration water from the successive migration periods shall be 
used to assess the trend. However, if the TOC in  the relevant migration period is below 
0.2 mg/l no trend analysis is required.  
   
EN 29  EN 4.3. Odour, flavour, colour and turbidity  
4.3.1.  Pass/fail criteria for TON, TFN  
The following requirement s shall apply to the cold water migration test:  
(a) TON, TFN ≤ 2.0 for the 3rd migra tion period ; or  
(b) TON, TFN ≤ 2.0 for the 9th migration period  and TON ≤ 4.0 for the 3rd 
migration period.  
The following requirements shall apply to the warm/hot water migration test:  
(a) TON, TFN ≤ 2.0 for the 7th migration period ; or 
(b) TON, TFN ≤ 2.0 for the 22nd migration period and TON, TFN ≤ 4.0 for the 7th 
migration period.  
 
4.3.2.  Pass/fail criteria for colour  
The acceptance criterion for colour is ≤ 5  mg/l Pt/Co  
The criterion shall  be met for the 3rd migration period for cold water migration testing / 7th 
migration period for warm /hot water testing or  in case of extended testing for the 9th 
migration period for cold water migration testing / 22nd migration period for warm /hot water 
testing . 
 
4.3.3.  Pass/fail criteria for turbidity  
The acceptance criterion for tur bidity is ≤ 0.5 NFU   
The criterion shall  be met for the 3rd migration period for cold water migration testing / 7th 
migration period for warm /hot water testing or in case of extended testing for the 9th 
migration period for cold water migration testing / 22nd migration period for warm /hot water 
testing . 
 
4.4. Enhancement of Microbial Growth (EMG)  
The pass/fail criteria for Enhancement of Microbial Growth (EMG) for method 1 (EN 
16421 :2015 ) is < 1000 pg ATP/ cm ²and for method 2 (EN 16421 :2015 ) is ≤ (0.05 ± 0.02) 
ml/800 cm2. 
Additionally, the surface of the products or components shall  not have any biocidal effects on 
drinking water. Therefore, test pieces without surface colonisation (comparison of contact 
cultu re/test sample smear with that of the negative control) do not satisfy this requirement.  
 
 
 
 
   
EN 30  EN ANNEX IV  
FINAL ENAMELS, CERAMIC MATERIALS AND OTHER INORGANIC 
MATERIALS (INCLUDING GLASS)  
 
1. GENERAL PROCEDURE FOR  TESTING AND ACCEPTI NG  
The procedure for testing and accepting final  enamels, other glass materials, ceramic 
materials and other inorganic materials as used in a product includes the following steps:  
 
Step 1 – Identification of relevant substances and relevant other parameters depending 
on: 
1. Categorisation of products or components into risk groups and corresponding testing 
requirements . 
2. Composition review  
 
Step 2 – Performance of tests  
1. Testing of composition  
2. Migration test for relevant substances  
 
 
Step 3 – Compliance with pass/fail criteria  
   
EN 31  EN 2. IDENTIFICATION OF REL EVANT SUBSTANCES AND  RELEVANT OTHER PARAMETERS  
2.1. Categorisation of products or components into risk groups and corresponding 
testing requirements . 
For each product or component of an assembled product, a product group and a co rresponding 
conversion factor shall be determined in accordance with Table 5 of Annex I. Based on the 
determined conversion factor, the product or component is categorised in a risk group (RG) in 
accordance with Table 1.  
The categorisation in a RG determi nes the corresponding testing requirements including the 
relevant other parameters. The applicable testing procedure of final materials results from the 
use of these materials in products or components of assembled products.  
Minor components are considere d to be components categorised in risk group 3 or 4 (RG3 or 
RG4) and for which reduced testing requirements, as set out in Table 1, may apply in 
comparison with the testing requirements for the risk group 1 or 2 (RG1 or RG2).  
For an assembled product the components shall be determined. For each component in an 
assembled product, a product group shall be determined. If an assembled product consists of 
components made of the same final material, then the wetted surface fraction o f these 
components shall be cumulatively added for the determination of the product group in 
accordance with Table 5 of Annex I .  
The testing shall be performed on the final materials as used in products in contact with water 
intended for human consumption.    
EN 32  EN Table 1: Risk -based testing requirements for products or components of assembled products  
 
2.2. Composition review  
2.2.1.  Required information  
For the final materials the complete composition with the range for all constituents exceeding 
0.02 % (m/m) is required. The content of lead and cadmium shall be  declared.  
 
2.2.2.  Accepted compositions  
The compositions of the final materials shall  comply with compositions listed in the 
respective European positive list of compositions for enamels and other glass materials  in 
Annex IV of Commission Implementing Decision (EU) …/… [OP: please fill in the reference 
of C(2023)7001] , of compositions  for ceramic materials and of compositions for other 
inorganic materials established in accordance with Article 11(2) (b) of the Directive  and fulfil 
the limitations s et out  in these European positive lists in respect of their use for certain 
product group s and the use of these products.  
The content of lead and cadmium shall  be less than 0.02% (m/m).  
 
2.2.3.  Relevant substances  
The relevant substances to be analysed in migration waters are specified for each composition 
set out in the Annex IV to Commission Implem enting Decision (EU) …/… [OP: please fill in 
the reference of  C(2023)7001] . 
 
 
  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  
EN 33  EN 3. TESTING REQUIREMENTS  
3.1. Testing of the composition  
An analysis of the composition of the final materials shall be performed to verify compliance 
with the compositional requirement s of compositions of enamels, ceramics or other inorganic 
materials included in the Annex IV to Commission Implementing Decision (EU) …/… [OP: 
please fill in the reference of  C(2023)7001] .  
 
3.2. Migration testing  
3.2.1.  Standards  
For testing the release of relevant substances, the following standard shall be  used to obtain 
the migration waters: EN 12873 -1:2014.  
The following sections 3.2. 2, 3.2. 3, 3.2. 4 and 3.2. 5 substantiate this standard.  
 
3.2.2.  Test piece  
Special attention shall be gi ven to the production of the test piece. The respective component 
or product is to be used as test piece(s).  
A test piece shall only be used if the product cannot be tested.  
 
3.2.3.  Temperature of testing  
All products shall be tested at 23  °C ± 2  °C (cold water test condition).  
Additionally, products that are normally used for warm or hot applications shall be tested at 
60 °C ± 2  °C or 85  °C ± 2  °C, respectively. For this purpose, warm water corresponds to  
normal operating temperatures between 30  °C and 70  °C and hot water corresponds to 
operating temperatures exceeding 70  °C.  
For materials that can be subjected to high temperature variation (for example, in solar water 
heaters), the test should be carried  out at 85°C.  
 
3.2.4.  Type of test water  
Cold water test (23  °C ± 2  °C) shall be performed with non-chlorinated test water. In the case 
PAH analysis is required the test shall be performed with and chlorinated test water 
additionally . 
In case a warm or a hot wate r test is required, the test shall only be performed with non -
chlorinated test water.  
 
3.2.5.  Migration periods  
For cold water tests the migration samples of the 1st, 2nd and 3rd migration period according to 
standards shall be analysed. The compliance with the p ass/fail criteria shall be assessed at the 
3rd migration period (10th day of testing). If the pass/fail criteria (see 4.2 and 4.3) are not met 
at the 3rd migration period, testing can be extended and the 5th, 7th and 9th period shall be 
analysed additional ly. In this case the pass/fail criteria shall be assessed at the 9th migration 
period (31st day of testing).   
EN 34  EN For warm or hot water tests the migration samples of the 1st, 2nd, 3rd and 7th, migration period 
shall be analysed. The compliance with the pass/f ail criteria shall be assessed at the 7th 
migration period (10th day). If the pass/ fail criteria (see 4.2 and 4.3) are not met at the 7th 
migration period, testing can be extended and the 12th, 17th and 22nd period shall be analysed 
additionally. In this case the pass/fail criteria shall be assessed at the 22nd migration period 
(31st day).  
 
3.3. Analysis of migration waters  
3.3.1.  Relevant Substances  
The methods for analysis of relevant substances in migration waters sha ll be validated and 
documented in accordance with EN ISO/IEC 17025 :2017  or other equivalent standards 
accepted at international level.  
4. ACCEP TANCE  REQUIREMENTS : PASS/FAIL CRITERIA  
4.1. Composition  
The analysed composition of the final material shall  comply with  the compositional 
requirements and other limitations specified in the respective European positive list  of 
compositions.    
 
4.2. Relevant substances  
4.2.1.  Conversion of test results  
In accordance with  the standard EN 12873 -1:2014 , the test results are expressed as migration 
rates (M) in µg/(dm² .d). These results shall be converted to estimate the concentrations at the 
tap (Ctap), defined as Ctap = M * CF , where  CF is the corresponding conversion factor in d/dm.  
The conversion fact ors for the different product groups are listed in Table 5 of Annex I. 
4.2.2.  Pass/fail criteria for relevant substances  
The following requirements shall apply to the cold water migration test:  
(a) Ctap ≤ MTC tap for the 3rd migration period (10th day of testing)  or, in case 
extended testing is needed, at the 9th migration period (31st day of testing);  
(b) there shall be no increasing trend of Ctap in time.  
The following requirements  shall apply to the warm/hot water migration test:  
(a) Ctap ≤ MTC tap for the 7th migration per iod (10th day of testing ) or, in case 
extended testing is needed, at the 22nd migration period (31st day of testing);  
(b) there shall be no increasing trend of Ctap in time.  
   
EN 35  EN The measured substance concentrations in the migration water from the successive mi gration 
periods shall be used to assess the trend. However, if Ctap in the relevant migration period is 
below 1/10 of MTC tap, no trend analysis is required.  
The MTC tap,inorganic  to be applied are defined in the Annex IV and Table 1 of Annex V to 
Commission Implementing Decision (EU) …/… [OP: please fill in the reference of  
C(2023)7001 ].