EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
ANNEXES 1 to 6  
 
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 methodologies for testing and accepting 
starting substances, compositions and constituents to be included in the European 
positive li sts   
   
EN 0  EN ANNEX I 
IDENTIFICATION OF STARTING SUBSTANCE S, COMPOSITION S AND CONSTITUENT S 
Sufficient information to enable t he identification of starting substance s, composition s and constituent s and characterisation of nanoform s shall be 
generated, including the information set out in the Table. If it is not technically possible or if it does not appear scientifically necessary to give 
information on one or more of the items referred to in the table, the reasons shall be clearly stated.  
For the purpose of this Annex, the following definitions appl y: 
‘organic cementitious constituent s’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, 
including any additive necessary to preserve its stability and any impurity deriving from the process used, but  excluding any solvent which may be 
separated without affecting the stability of the substance or changing its composition.  
‘metallic composition category’ means a group of metallic compositions with the same metallic composition constituents  and the same behaviour when 
they come in contact with water intended for human consumption.  
Table: Standard information and testing with regard to the identification of a starting substance, a composition or a constituent  
  Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
 Standard information and 
testing   
1.1.  Name or any other identifier:   
1.1.1.   Name in the International Union 
of Pure and Applied Chemistry 
(IUPAC) nomenclature and/or 
other international chemical    
EN 1  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
names , if available . 
1.1.2.   Other names (e.g. , usual name, trade name, abbreviation) (if available) . 
1.1.3.   European Inventory of Existing 
Commercial Chemical 
Substances (Einecs), European 
List of Notified Chemical 
Substances (Elincs) or No -
Longer Polymer (NLP) number, 
or the number assigned by 
ECHA  under Regulation 
1907/2006 , if available . European Inventory of  Existing Commercial Chemical Substances 
(Einecs), European List of Notified Chemical Substances (Elincs) or 
the number assigned by the Agency under Regulation 1907/2006 , if 
available . 
 
1.1.4.   Chemical Abstracts Service 
(CAS) name and CAS number , 
if available.   
1.1.5.   European Union Positive List 
number , if available . European Union Positive List 
number , if available .  European Union Positive List 
number, if available . 
1.1.6.    Designation:  
 Standardised material 
designation number  under 
European standard EN 
1412 , if available ; 
 Standardised material 
designation symbol under Name of material category and 
name of enamel , ceramic or 
other inorganic composition .  
EN 2  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
European Standard ISO 
1190 -1, if available . 
1.1.7 .   Identity of existing metal lic 
composition  category that the 
composition belongs to.   
1.1.8 .   Identity and designation of new 
metal lic composition  category 
that the composition belongs to.   
1.1.9 .   Identity of metal constituents of 
the new metal lic composition  
category and corresponding 
concentration ranges (min imum 
and maximum  % w/w) .  
1.1.10 .   Identity of metal impurities of 
the new metal lic composition 
category present above 0 ,02 % 
w/w concentration in the 
composition and corresponding 
maximum percentage by mass 
(% w/w) .  
1.1.11 .   Identity of metal constituents of 
the reference material for the 
new metallic composition   
EN 3  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
category and corresponding 
concentration ranges (min imum 
and maximum  % w/w) . 
1.1.12 .   Identity of metal impurities of 
the reference material for the 
new metallic composition 
category that are present above 
0,02 % w/w concentration in the 
composition and their 
corresponding maximum 
percentage by mass (% w/w) .  
1.2. Information related to 
molecular and structural 
formula or crystal structure:   
1.2.1.   Molecular formula and structural 
formula (including IUPAC 
International Chemical Identifier 
(InChI), Simplified Molecular 
Input Line Entry System 
(SMILES) notation and other 
representation , if available) . Description of crystal structures , 
including crystalline phases , if 
available. . Description of crystal structures , 
including crystalline phases , if 
available. . 
1.2.2.   Information on optical activity 
and typical ratio of 
(stereo)isomers , if available. .    
EN 4  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
1.2.3.   Molecular weight or molecular 
weight range , if available. .   
1.3. Chemical characterisation. 
Where it covers a nanoform, 
this nanoform shall be 
characterised pursuant to 
point 1.4.:   
1.3.1 .  Degree of purity (%), i.e. , 
typical concentration and 
concentration range (in 
percentage, min imum  and 
maximum ) of substance 
constituents .   
1.3.2.  Names  (EC, CAS numbers , and 
other identifiers , if available )  of 
substance constituents present 
above 0,02 % w/w concentration 
in the formulation  and at 
concentration ≥ 0 ,1 % w/w in 
the substance (taking into 
account information submitted 
under points 1.1.1 , 1.1.2 and 
1.1.3 above  and Table 1,  point 
2.4.1 of Annex II). For each of 
these, typical concentration and Names (and other identifiers e.g. 
EC, CAS numbers) of  
constituent s of the composition, 
i.e., the elements in any form 
(e.g., bound  or unbound) and 
corresponding concentration 
ranges ( minimum and maximum 
% w/w) . Names (and other  identifiers e.g. 
EC, CAS numbers) of 
constituent s of the composition, 
i.e., the elements in any form 
(e.g., bound or unbound) and 
corresponding concentration 
ranges (min imum and maximum  
% w/w) . 
  
EN 5  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
concentration range (minimum 
and maximum % w/w).  
1.3.3.  Names (and other identifiers e.g. 
EC, CAS numbers) of impurities 
present above 0 ,02 % w/w 
concentration in the formulation 
of the final material and at 
concentration ≥ 0,1 % w/w in 
the substance  (taking into 
account information submitted 
under point s 2.4.1 . and 2.4.2. of 
Table 1 of Annex II). 
 
For each of these, typical 
concentration and concentration 
range (minimum and maximum 
% w/w).  Names (and other identifiers e.g. 
EC, CAS numbers) of impurities 
present above 0 ,02 % w/w 
concentration in the composition 
and corresponding maximum 
percentage by wei ght (% w/w) .  Names (and other identifiers 
e.g. EC, CAS numbers) of 
impurities , other than 
cadmium ( Cd) and lead (Pb)  
present above 0 ,02 % w/w 
concentration in the 
composition and 
corresponding maximum 
percentage by weight (% 
w/w) ; 
 Information on the 
maximum percentage by 
weight (% w /w) for 
cadmium (Cd) and lead (Pb) . 
1.3.4.  All necessary qualitative and 
quantitative analytical data 
specific for the identification of 
the substance, such as 
ultraviolet, infra -red, nuclear 
magnetic resonance, mass 
spectrum,  chromatographic, 
titrimetric, elemental analysis 
and/or diffraction data . All necessary qualitative and quantitative analytical data specific for 
the identification of the composition and constituents of the 
composition, such as elemental analysis, Inductively Coupled 
Plasma Mass Spectrometry, Atomic Absorption Spectroscopy, Ion 
Chromatography, titrimetric  and/or diffraction data (e.g. , X-Ray 
Fluorescence (XRF) or X -Ray Powder Diffraction (XRD) . 
  
EN 6  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
1.3.5.  Description of the analytical methods or the appropriate bibliographical references that are necessary 
for the identification of the starting substance, organic cementitious constituent (including the 
identification and quantification of impurities and substance  constituents) , metal lic composition 
constituent , and enamel, ceramic, or other inorganic  composition  constituent . The description shall 
consist of the experimental protocols followed and the relevant interpretation of the results reported 
under points 1.3.1 . to 1.3. 4. This information shall be sufficient to allow the methods to be reproduced . 
1.4. Characterisation of a 
nanoform :   
1.4.1.   Names or other identifiers of the 
nanoform of the starting 
substance or organic 
cementitious constituent, if 
applicable .   
1.4.2.   Number based particle size 
distribution with indication of 
the number fraction of nanoform 
particles in the size range 1 nm – 
100 nm .   
1.4.3.   Description of surface 
functionalisation or treatment 
and identification of each agent 
including IUPAC name and 
CAS or EC number .    
EN 7  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
1.4.4.   Shape, aspect ratio and other 
morphological characterisation: 
crystallinity, information on 
assembly structure , including 
e.g., shell like structures or 
hollow structures , if available. .   
1.4.5.   Surface area (specific surface 
area by volume, specific surface 
area by mass or both) .   
1.4.6.   Description of the analytical 
methods or the appropriate 
bibliographical references for 
the information elements in 
point 1.4. This information shall 
be sufficient to allow the 
methods to be reproduced.    
1.5. Additional information 
required for starting 
substances and organic 
cementitious constituents 
which are (a) polymers or (b) 
pre-polymers :  
1.5.1.  Name (and other identifiers e.g. 
EC, CAS numbers ) of    
EN 8  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
monomers and other reactants 
from which the substance is 
produced . 
1.5.2.  Manufacturing process 
description (including 
information on the use of 
monomers and reactants as well 
as their ratio) .   
1.5.3.  Additives to the (pre -)polymer .   
1.5.4.  Structure information of the 
(pre-)polymer .   
1.5.5.  Molecular mass distribution ; test 
report of the molecular mass 
distribution is required .     
1.5.6.  Number averaged molecular 
mass.    
1.5.7.  Molecular mass range 
(min imum  and max imum ).   
1.5.8.  Identities of the substance 
constituents with molecular 
weight < 1000 Da and their    
EN 9  EN   Starting substance for organic 
materials / organic 
cementitious constituent s  Composition of metallic 
material s  Composition of enamel s, 
ceramic, or other inorganic 
material s 
percentage by weight (% w/w) . 
1.5.9.   Residual monomers and their 
concentrations (%) .   
1.5.10.  Viscosity    
1.5.11.  Melt flow index    
   
EN 10  EN ANNEX II 
INTENDED USE  
 
Sufficient information on the intended use of starting substance s, composition s, constituent as well as  of final material s and products shall be 
generated, including the information set out in Table 1. 
 
Table 1: Standard information and testing  with regard to intended use  
 
  Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
 Standard information and 
testing     
2. Use:   
2.1. Material type, category and 
sub-category:  Identification of the material type, material category and material sub -category . 
2.2. Identity and use of final  
material and product:   
2.2.1 .  Specification  of the product/component.  
Definition of area of uses: domestic vs. non -domestic installations . 
2.2.2 .  Relevant product g roups  for 
organic materials or 
cementitious materials (refer to  
Table 5 of Annex I to Relevant product groups for 
metallic compositions  (refer to 
Table 2 of this Annex ). Relevant product g roups  for 
ename l, ceramic or other 
inorganic materials (refer to  
Table  5 of Annex IV to  
EN 11  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
Commission Implementing 
Decision (EU) …/… [OP: 
please fill in the reference of 
C(2023)7003] . Commission Implementing 
Decision (EU) …/… [OP: 
please fill in the  reference of 
C(2023)7003] . 
2.2.3.   Surface to volume ratio  of the 
relevant products of intended 
use. Percentage of exposed surface 
of a metallic composition (as 
indicated by the relevant 
product group under point 
2.2.2.) . Surface to volume ratio  of the 
relevant products of intended 
use. 
2.2.4.   Cold ( ≤ 25 °C) / warm ( 25 - 65 
°C) or hot ( ≥ 65 °C) water use.  Cold ( ≤ 25 °C) / warm ( 25 - 65 
°C) or hot ( ≥ 65 °C) water use.  Cold ( ≤ 25 °C) / warm ( 25 - 65 
°C) or hot ( ≥ 65°C) water use.  
2.3. Technical  function:  Specification of the technical 
function .   
2.4. Conditions of use of the 
starting substance, 
composition or organic 
cementitious constituent; of 
the final material;  and of the 
product:   
2.4.1.   For starting substances for 
organic materials: Maximum 
dosage of the starting substance 
in the formulation to produce the    
EN 12  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
final material.  
2.4.2.   For organic constituents of 
cementitious materials:  
 In case of polymers: 
Dosage of the 
monomers or other 
reactants  to produce the 
polymers  
 Maximum dosage of the 
constituent (polymer) to 
produce a generic 
constituent.  
 Maximum dosage of the 
generic constituent used 
in the formulation to 
produce the final 
material.   
2.4.3.  Proposed restrictions or other conditions of use for the inclusion  of the starting substance, 
composition or constituent on the E uropean positive list.  
2.5. Information on the processing 
and internal structure of the 
material, final material  and 
product:    
EN 13  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
2.5.1 .  Information on the processing of the material, final material and product, including treatment of 
material, final material or product prior to use .  
2.5.2.   Processing temperatures of the 
final material .  Description of the 
manufacturing  and 
processing  steps used to 
produce the final material . 
For bulk materials this 
includes description of any 
processing such as 
mechanical (forming), 
thermal (heat treatment) 
affecting crystallography, 
grain morphologies (size 
and shape), phase structure, 
impurities and their 
distribution, residual 
stresses, microstructure  
and/or surface condition . 
For specifically produced 
surface layers, platings, the 
process type and main 
processing conditions 
should be described ; 
 Appropriate manufacturing 
and processing steps and 
resulting properties, such as Processing temperatures of the 
final material.   
EN 14  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
‘heat treatment to reduce 
beta-phase’ or ‘phase 
distribution in the final 
material’.  
2.5.3 .  Information on the internal structure of the final material . 
2.6. Union and national level 
assessments and 
authorisations:   
2.6.1 .  Details of any authorisation, risk assessment and other relevant regulation at the European Union or 
national level for use in final materials or materials coming into contact with water intended for 
human consumption . 
2.6.2 .  Details of any authorisation , risk assessment and other relevant regulation at the European Union or 
national level for use in final materials or materials coming into contact with food . 
2.7. EU authorisation of biocidal 
active substances:   
2.7.1 .  Approval/ assessment status of 
the starting substance or organic 
cementitious constituent under 
Regulation (EU) No 528/2012 .  
2.7.2 .  Product -type relevant to the 
starting substance or organic   
EN 15  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
cementitious constituent under 
Regulation (EU) No 528/2012 . 
2.7.3 .  Approval start date under 
Regulation (EU) No 528/2012 .  
2.7.4 .  Approval end date under 
Regulation (EU) No 528/2012 .  
3. Identification of non -
intentionally added species  
other than impurities:   
3.1.  Evaluation on the presence of 
non-intentionally added species  
other than impurities and 
substance constituents migrating 
from the material taking into 
account at least the following :  
(a) physico -chemical 
properties ;  
(b) technical functions ; 
(c) interaction with the matrix ;  
(d) water characteristics ; 
(e) results of analysis of testing 
waters by applying an   
EN 16  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
appropriate screening 
method as set out in 
Commission Implementing 
Decision (EU) …/… [OP: 
please fill in the reference of 
C(2023)7003] . 
 
3.2.  Reactions of the starting 
substance or organic 
cementitious  constituent 
occur ring during the processing 
of the material and final material 
and reaction or degradation 
products formed (also taking 
into account the thermal stability 
as demonstrated by a mandatory 
thermal stability test, of the 
substance)   
3.3.  Reactions of the starting 
substance or organic 
cementitious constituent 
occur ring during the use of the 
final material in contact with 
water intended for human 
consumption  and reaction or 
degradation products formed   
EN 17  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
(also taking into account 
hydrolysis as dem onstrated by a 
mandatory hydrolysis study of 
the substance)  
3.4. Identification of other 
substances that may migrate 
into the drinking water when 
using starting substances and 
organic cementitious 
constituents which are 
monomers or other reactants :  
3.4.1.  Evaluation o f the presence of 
any polymerised part below 
1000 Da that is relevant to the 
use of the starting substance  or 
organic cementitious constituent .  
3.4.2.  Description of process tha t leads 
to the formation of the 
polymerised part below 1000  
Da.  
3.4.3.  Molecular weight distribution 
for polymerised part below 1000 
Da; test report of the molecular 
weight distribution is required.     
EN 18  EN   Starting substance  for organic 
materials / organic 
cementitious constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
3.4.4.  Number averaged molecular 
weight of polymerised part 
below 1000 Da .  
3.4.5.  Molecular mass range (min and 
max) of polymerised part below 
1000 Da .  
3.4.6.  Residual polymerised part below 
1000 Da  and its concentration 
(%).  
3.5.  Name (and other identifiers e.g. 
EC, CAS numbers ) of  non -
intentionally added species  
identified under points 3.1.-3.4.  
 
Table 2: Product groups for metallic compositions  
Product 
group  Examples of metallic products or component s Assumed 
contact surface  
“a” 
A Pipes . 100 % 
B Fittings, ancillaries in buildings installations . 10 %  
EN 19  EN Product 
group  Examples of metallic products or component s Assumed 
contact surface  
“a” 
C 1. Components of products of Product Group B. The sum of the surfaces in contact with water intended for human 
consumption  of all these components shall be less than 10  % of the total wetted surface of the product.  
2. Fittings, ancillaries in water mains and wat er treatment works with permanent flow.  1 % 
D Components of fittings and ancillaries in water mains and in water treatment works as described for product group C 
subcategory 2 above ).  Negligible   
EN 20  EN  
ANNEX III 
PHYSICO -CHEMICAL PROPERTIES  
 
Section 1. No standard information or testing requirement  
No standard information or testing shall be required for starting substances and organic 
cementitious constituents where either of the following conditions are fulfilled : 
(a) a parametric value for the starting substance or organic cementitious  constituent is 
set under Annex I to Directive  (EU) 2020/2184 ;  
(b) a Maximum Tolerable Concentration at the tap ( MTC tap) value for the the starting  
substance or organic cementitious constituent  is set in the corresponding Annex to 
Commission Implementing Decision (EU) …/… [OP: please fill in the reference of 
C(2023)7001]  following a decision by the Commission on an application for a 
starting substance, composition or organic cementitious constituent that has been 
submitted to ECHA under Article 3 of Commission Delegated Regulation  (EU) 
…/…  [OP: please fill in the reference  of C(2023)7002 ] and the applicant submit s at 
least any new or updated  information available as from the date of  the 
Commission’s decision;   
(c) a specific migration limit is set under Commission Regulation (EU) No 10/2011 for 
less than 15 years before the su bmission of an application under Article 3 of 
Commission Delegated Regulation (EU) …/… [OP: please fill in the reference of 
C(2023)7002] .  
 
Section 2. Standard information or testing required  
2.1 Testing under this Section shall be carried out in compliance with the principles of good 
laboratory practice provided for in Directive 2004/10/EC of the European Parliament and of 
the Council2 or other international standards recognised as being equivalen t to Directive 
2004/10/EC by the Commission or ECHA .  
2.2 Testing under this Section shall be carried out in compliance with the test method as 
determined and specified by ECHA and published  on its website , taking into account in 
particular  the requirement s set out in point 2.5. 
2.3 Column 1 of Table  1 establishes the required standard information and testing for a 
starting substance or organic cementitious constituent.  
Column 2 of Table  1 establishes specific rules according to which the standard information 
and testing of column 1 may be omitted, replaced by other information, or adapted in another 
way.  
                                                 
1 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 ). 
2 Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the 
harmonisation of laws, regulations and administrative provisions relating to the application of the principles of 
good laboratory practice and the verification of their applications for test s on chemical substances  (OJ L 50, 
20.2.2004, p. 44 ).  
EN 21  EN  
2.4 Any other relevant physico -chemical information shall be identified and considere d in 
addition.  
2.5 Where a test method offers flexibility in the determination  or choice of the study design, 
including by not prohibiting certain specifications , the chosen study design shall ensure that 
the data generated are adequate for migration testi ng and risk assessment.  
2.6 The general rules for adaptation s set out in  Sections 1 and 2 of Annex XI to Regulation 
(EC) 1907/20063 shall apply mutatis mutandis . 
 
Table 1: Standard information and testing, and specific rules for the adaptation of such 
information and testing, with regard to physico -chemical properties  
 Column 1  
Standard information 
and testing  Column 2  
Specific rules for adaptation of the standard 
information and testing  
4.1. Appearance at 20 °C and 
101,3 kPa   
4.1.1. Physical state   
4.1.2. Aggregate state (e.g., 
viscous, crystalline, 
powder)   
4.1.3. Colour   
4.1.4. Odour   
4.2. Melting/freezing point  No need to provide information below a lower limit 
of −20 °C.  
4.3. Boiling point  No need to provide information  for the following : 
(a) gases;  
(b) solids which either melt above 300 °C or 
decompose before boiling , in which case 
the boiling point under reduced pressure 
may be estimated or measured;  
(c) substances which decompose before 
boiling (e.g. auto -oxidation, 
rearrangeme nt, degradation, 
decomposition, etc.).  
4.4. Density  The study for density does not need to be 
conducted in the following cases : 
(a) the substance is only stable in solution in a 
particular solvent and the solution density 
is similar to that of the solvent , in which 
                                                 
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006  
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishin g a 
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 
793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2 000/21/EC)   
EN 22  EN  Column 1  
Standard information 
and testing  Column 2  
Specific rules for adaptation of the standard 
information and testing  
case an indication of whether the solution 
density is higher or lower than the solvent 
density is sufficient;  
(b) the substance is a gas , in which case an 
estimation based on calculation shall be 
made from its molecular weight and the 
Ideal Gas Laws.  
4.5. Vapour pressure  No need to provide information if the melting point 
is above 300 °C.  
If the melting point is between 200 °C and 300 °C, 
a limit value based on measurement or a recognised 
calculation method is sufficient.  
4.5.1. Henry’s law constant  
must always be stated for 
solids and liquids if it can 
be calculated .  
4.6. Surface tension of an 
aqueous solution  The information need only be provided in the 
following cases : 
(a) based on structure, surface activity is 
expected or can be predicted;  
(b) surface activity is a desired property of the 
material;  
If the water solubility is below 1  mg/l at 20 °C , the 
test does not need to be conducted.  
4.7. Water solubility  No need to provide information  in the following 
cases : 
(a) the substance is hydrolytically unstable at 
pH 4, 7 and 9 (half -life less than 12 hours);  
(b) the substance is readily oxidisable in 
water.  
 
If the substance appears ‘insoluble’ in water, a limit 
test up to the detection limit of the analytical 
method shall be pe rformed.  
 
For metals and sparingly soluble metal compounds, 
information on transformation/dissolution in 
aqueous media shall be provided.  
4.8. Partition coefficient ( n-
octanol/water) and its pH 
dependency  No need to provide information if the substance is 
inorganic.  
 
If the test cannot be performed (e.g. , the substance 
decomposes, has a high surface activity, reacts 
violently during the performance of the test or does  
EN 23  EN  Column 1  
Standard information 
and testing  Column 2  
Specific rules for adaptation of the standard 
information and testing  
not dissolve in water or in octanol, o r it is not 
possible to obtain a sufficiently pure substance), a 
calculated value for the partition coefficient  as well 
as details of the calculation method shall be 
provided.  
4.9. Granulometry  The study does not need to be conducted if the 
substance is marketed or used in a non -solid or 
non-granular form.  
4.10. Dissociation constant  No need to provide information in the following 
cases : 
(a) the substance is hydrolytically unstable 
(half -life less t han 12 hours) or is readily 
oxidisable in water;  
(b) it is scientifically not possible to perform 
the test , for instance if the analytical 
method is not sensitive enough;  
(c) based on the structure, the substance does 
not have any chemical group that can 
dissociate.  
 
  
EN 24  EN ANNEX IV 
MIGRATION  AND CONFIRMATION OF RELEVANT SPECIES  
 
Section 1. General r equirements , 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 fo r 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 ade quate 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, 1.4 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 metal lic 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 metal lic composition  constituent is phosphorus, silicon, sul fur 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, magnesi um, 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 1.4(b).  
EN 25  EN 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 
constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
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 m igration 
methods or 
electrochemical Test method for factory -made 
products and site applied 
products made from or 
incorporating  organic materials  (a) All m etallic compositions: 
Test method for dynamic 
rig test established in  
standa rd EN 15664 -1 for Test method for products made 
from or incorporating glassy 
(porcelain/vitreous enamel) 
materials  according to the standard  
EN 26  EN   Starting substance or organic 
materials / organic cementitious 
constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
methods  according to standards referred 
to in Annex I to  Commission 
Implementing Decision (EU) 
…/… [OP: please fill in the 
reference of C(2023)7003] . 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 metal lic 
compositions . 
(c) Platings:  
 - Either one of the tests methods 
referred to in points (a) and (b) , as 
applicable ; or 
- the test method established in  
standard EN 16058 , with 3 tests 
and 3 test waters . described in Annex IV 
Commission Implementing 
Decision (EU) …/… [OP: please 
fill in the reference of 
C(2023)7003] . 
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 metal lic compositions ): 
Description and details of analytical methods and techniques used to analyse concentrations  of potentially 
relevant species or elements from migration and/or contact water resulting from migration testing. For surface 
layers (coatings, platings) this includes relevant species or elements  from the surface layer and from the  
EN 27  EN   Starting substance or organic 
materials / organic cementitious 
constituent s Composition of metallic 
material s Composition of enamels, 
ceramic, or other inorganic 
material s 
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 me thods to be reproduced.  
 
Section 2. General rules for adaptation of information and testing with regard to the migration  
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) …/… [OP: please fill in the reference of  C(2023)7003]  may replace testing for a starting substance used in 
an organic material whe re, on the basis of a scientific explanation, any of the following con ditions 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 te chnique;  
(c) the test substance rapidly degrades  in water.  
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 ferrou s composition s, 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 s imilar corrosion behaviour ; 
(ii) the representative test piece belong s 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 . 
  
EN 28  EN  
(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) adequa cy for the purpose of concentration at the t ap (Ctap ) determination  and identification of relevant species has been 
demonstrated ;  
(iii) the Ctap and identification of relevant 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 just ify such explanation.  
 
Section 3. Criteria for the i dentification of relevant species 
1. Relevant 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 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, point 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 constit uent which do not fall under point (a) or (b) and which have been tested in accordance with Table 5 
and have been found to migrate into water intended for human consumption  with a concentration at the tap (Ctap) 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.  
EN 29  EN ANNEX V 
TOXICOLOGICAL  PROPERTIES  
 
Section 1 . No standard information or testin g 
1.1. No standard information or testing  is required for a relevant species where either of  the 
following conditions are fulfilled : 
(a) a parametric value for the relevant species  is set under Annex I to Directive  (EU) 
2020/2184 ; 
(b) a MTCtap value  for the relevant s species  in the applicable material type  is set in the 
corresponding Annex to Commission Implementing Decision (EU) …/… [OP: 
please fill in the reference of C(2023)7001]  following a decision by the 
Commission on an applicati on for a starting substance, composition or constituent 
that has been submitted to ECHA under Article 4 of Commission Delegated 
Regulation  (EU) …/… [OP: please fill in the reference of C(2023)7002]  and the 
applicant submit s at least  any new or updated information available as from the 
date of  the Commission’s decision ;  
(c) the relevant s pecies  is classifi ed Regulation (EU) 1272/2008 of the European 
Parliament and of the Council4 as one of the following:  
i. carcinogenic, mutagenic or reproductive toxicity,  categories 1A or 1B  or 
endocrine disruptor for human health category 1 ; 
ii. persistent bioaccumulative and toxic ;  
iii. very persistent and very bioaccumulative ;  
iv. persistent mobile and toxic ; 
v. very persistent and very mobile . 
(d) the relevant s pecies  is identifi ed as a substance of very high concern in the Candidate 
List established under Article 59 of Regulation (EC) 1907/2006 , except those 
identified on the basis of Article 57(f) of Regulation (EC) 1907/2006 only for the 
environment ;  
(e) the relevant species  is authoris ed as an active substance under Regulation (EU) 
528/2012 on the basis of an  opinion of the Commitee of the Risk Assessment of 
ECHA setting a defined safety threshold for the oral route and used as such in 
material s in contact with water under Product -type 6. 
1.2. No standard information or testing is required for a relevant  species , to the extent that  a 
specific migration limit is set under  Commission Regulation (EU) No 10/2011 for less than 1 5 
years from the date of submission of the application under Art icle 3 of Commission Delegated 
Regulation (EU) …/… [OP: please fill in the reference of C(2023)7002]  and the information 
that would otherwise have to be generated under Section 2 of this Annex for the 
                                                 
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/ EC, and amending Re gulation (EC) No 1907/2006  (OJ L 353, 31.12.2008, p. 1 ).  
EN 30  EN corresponding Ctap is covered by the scientific opinion underlying th at specific migration 
limit .  
 
Section 2 . Standard information or testing required  
Part 1. General and specific rules  
1.1. Testing under this Section shall be carried out in compliance with the principles of good 
laboratory practice provided for in Directive 2004/10/EC or other international standards 
recognised as being equivalent by the Commission or ECHA and with the provisions of 
Directive 2010/63/EU  of the European Parliament and of the Council 5, if applicable.  
1.2. Any applicant shall ensure that t esting on vertebrate animals is carried ou t only when no 
alternative method s, identified under this Section , is available.  If testing on vertebrate animals 
is unavoidable, such testing shall be design ed, where appropriate, by taking into account the 
possibility to explore several parameters within the framework of one study (e.g. kinetic data 
generation, micronucleus formation, neurotoxicity, immunotoxicity) or to combine two 
studies  (e.g. long -term to xicity study and carcinogenicity study)  to the extent permitted by the 
corresponding test method . 
1.3. Testing under this Section shall be carried out in compliance with the appropriate  test 
guideline determined and specified by ECHA and published  on its website, taking into 
account  in particular the requirements set out in point 1.6.  
1.4. A stepwise  approach for toxicological testing shall be applied based on the C tap of a 
relevant species  in water intended for human consumption . For the lowest migration 
concentration band , the standard information is set out in Table 1, and every time a new 
migration  band is reached, the standard information set out in the corresponding Tables 2 and 
3 shall be added.  
Column 1 of Tables 1, 2 and 3 establishes the standard information for relevant species . Any 
other relevant toxicological information shall be considered in addition.  
Column 2 of Tables 1, 2 and 3 lists specific rules according to which the standard information  
and testing  may be omitt ed.  
Standard information and testing may be adapted according to the general rule set out  in Part 
2. 
1.5. Any other relevant toxicological information that is available shall be identified and 
considered.  
1.6. Where a test method offers flexibility in the  determination  or choice of the  study design, 
including by not prohibiting certain study specifications, for example in relation to the choice 
of dose levels, the chosen study design shall ensure that the data generated are adequate for 
hazard identificati on and risk assessment. To this end, testing shall be performed at 
appropriately high dose levels. If dose (concentration) selection is limited by the physico -
chemical properties or biological effects of the test substance, the applicant shall provide a 
scientifically robust justification . 
 
 
                                                 
5 Directive  2010/63/EU of the European Parliament and of the Council of 22 September 2010. on the protection 
of animals used for scientific purposes  (OJ L 276, 20.10.2010, p. 33 ).  
EN 31  EN Table 1: Standard information and testing - Ctap below 2 ,5 µg/l  
 Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information  and testing  
6.1. Mutagenicity :  
6.1.1. In vitro  genetic toxicity   
6.1.1.1. In vitro  gene mutation study in 
bacteria  The in vitro  gene mutation study in 
bacteria does not need to be 
conducted if this test is not applicable 
for the relevant species . In this case, 
the applicant shall provide a 
justification and perform an in vitro  
study referred to in point 6.1.1.3.  
The study does not need to be 
conducted for nanoforms where it is 
not appropriate. In this case , other 
studies involving one or more in vitro  
mutagenicity studies in mammalian 
cells shall be provided . 
6.1.1.2. In vitro  mammalian chromosomal 
aberration study or in vitro  
mammalian micronucleus study  The study does not need to be carried 
out if an adequate data from an in 
vivo cytogenicity test is available  
 
6.1.1.3. In vitro  gene mutation test in 
mammalian cells  The study shall be carried out in the 
following cases : 
(a) there are negative results in 
both in vitro  studies referred 
to in points 6.1.1.1. and 
6.1.1.2.;    
(b) the in vitro  study referred to 
in point 6.1.1.1.  is 
inapplicable to the relevant 
species . 
 
The study does not need to be carried 
out if there are adequate data from a 
reliable in vivo  mammalian gene 
mutation test.  
6.1.2. In vivo  genetic toxicity   
6.1.2.1.  An appropriate in vivo  mammalian 
somatic cell genotoxicity study  The study shall be carried out if there 
is a positive result in any of the in 
vitro  genotoxicity study referred to in 
point 6.1.1. which give s rise to a 
concern.  
 
The study shall address the 
chromosomal aberration concern or 
the gene mutation concern or both, as  
EN 32  EN  Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information  and testing  
appropriate.  
6.1.2.2.  An appropriate in vivo  mammalian 
germ cell genotoxicity study  The study shall be carried out if there 
is a positive result in an available in 
vivo mammalian soma tic cell 
genotoxicity study, which gives rise 
to concern.  
 
The study shall address the 
chromosomal aberration concern or 
the gene mutation concern or both, as 
appropriate.  
 
The study does not need to be 
conducted if there is clear evidence 
that neither the relevant species nor its 
metabolites reach the germ cells.  
6.2. Appropriate toxicokinetic and 
metabolism studies in mammals, 
appropriate repeated dose toxicity 
study, appro priate reproductive 
toxicity study, appropriate 
carcinogenicity study or 
appropriate additional studies 
referred to in Tables  7 and 8 The study shall be carried out if there 
is any of the information available , 
raises a concern for at least one of the 
following hazard classes defined in 
Annex I to Regulation (EC) No 
1272/2008: Specific Target Organ 
Toxicity – Repeat Exposure ( STOT 
RE), Carcinogenic ity, Mutagenic ity 
or Reprotoxic ity (CMR ) or endocrine 
disruption for human health . 
 
The study shall address each of the 
concern s identified . 
 
Table 2: Standard information and testing - Ctap equal to or above 2 ,5 µg/L and 
below 250 µg/L  
 Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
7.1. Toxicokinetics and metabolism 
studies in mammals :  
7.1.1. Data to demonstrate the absence of  
potential for accumulation in human  
  
7.2. Repeated dose toxicity :  
7.2.1. Sub-chronic repeated dose toxicity 
study (90 -days) in one species 
(rodents), male and female, via oral 
route of administration  The study does not need to be 
conducted  where any of the following 
conditions are fulfilled :  
(a) a reliable short -term toxicity 
study (28 days) or a repeated  
EN 33  EN  Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
dose toxicity study with the  
reproduction/developmental 
toxicity screening test  is 
available showing severe 
toxicity effects according to 
the criteria for classifying the 
relevant species  as STOT RE  
(Regulation (EC) No 
1272/2008), for which the 
observed No Observed 
Adverse Effect Lev el 
(NOAEL )-28 days, with the 
application of an appropriate 
uncertainty factor allows the 
extrapolation towards the 
NOAEL -90 days for the same 
route of exposure;   
(b) a reliable chronic toxicity 
study is available, in which 
an appropriate species and 
route of a dministration were 
used;  
(c) the relevant species  is 
unreactive, insoluble, not 
bioaccumulative and there is 
no evidence of absorption and 
no evidence of toxicity in a 
28-day “limit test ”. 
7.3. Reproductive toxicity :  
7.3.1. Reproduction/toxicity screening study  The study does not need to be 
conducted  where any of the following 
conditions are fulfilled : 
(a) a reliable extended one -
generation reproductive 
toxicity study is available, in 
which an appropriate species 
and route of administration 
were used ;  
(b) the relevant species  is of low 
toxicological activity (no 
evidence of toxicity seen in 
any of the tests available 
provided that the dataset is 
sufficiently comprehensive 
and informative), it can be  
EN 34  EN  Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
proven from toxicokinetic 
data that no systemic 
absorption occ urs via the oral 
route of exposure, e.g. , 
plasma/blood concentrations 
below detection limit using a 
sensitive method and the 
relevant species  and its 
metabolites are absent in 
urine  or bile. 
7.4. Appropriate toxicokinetic and 
metabolism studies, appropriate 
repeated dose toxicity study, 
appropriate reproductive toxicity 
study, appropriate carcinogenicity 
study or appropriate additional 
studies referred to under Table 8  The study shall be carried ou t if any 
information available raises a concern 
for at least one of the following 
hazard classes defined in Annex I to 
Regulation (EC) No 1272/2008: 
STOT RE  or CMR or endocrine 
disruption  for human health . 
 
The study shall address each of the 
concern s identified.  
 
Table 3: Standard information and testing - Ctap equal or above 250 µg/L  
 Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
8.1. Toxicokinetics and metabolism 
studies in mammals :  
8.1.1. Study on absorption, distribution, 
metabolism and excretion   
8.1.2. Considerations on the potential need 
for additional toxicokinetic 
information  Additional information might be 
needed based on the outcome of the 
toxicokinetic and metabolism study 
conducted in rats or based on the 
evaluation of the toxicological and 
physicochemical profile of the 
relevant species . 
8.2. Repeated dose toxicity :  
8.2.1. Long -term repeated dose toxicity (≥ 
12 months)  This study does not need to be 
conducted  if a combined long -term 
repeated dose/carcinogenicity study is 
undertaken  
8.3. Reproductive toxicity : The studies do not need to be 
conducted  where the relevant species  
is of low toxicological activity (no 
evidence of toxicity seen in any of the 
tests available , in which a sufficiently  
EN 35  EN  Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
comprehensive and informative  
dataset has been used ), it can be 
proven from toxicokinetic data that no 
systemic absorption occurs via the 
oral route of exposure, e.g. , 
plasma/blood concentrations below 
detection limit using a sensitive 
method and the relevant species  and 
its metabolites are absent in urine  or 
bile. 
8.3.1.  Extended one -generation 
reproductive toxicity study, oral route 
of administration  An Extended One -Generation 
Reproductive Toxicity Study with the 
extension of cohort 1B to include the 
F2 generation where any of the 
following conditions are met:  
(a) the relevant species  displays 
genotoxic effects in somatic 
cell mutagenicity tests in vivo 
which could lead to its 
classif ication as mutagen 
category 2;  
(b) there are indications that the 
internal dose for the relevan t 
species  and/or any of its 
metabolites will reach a 
steady state in the test 
animals only after an 
extended exposure ;   
(c) there are indications of one or 
more relevant modes of 
action related to endocrine 
disruption from available in 
vivo studies or non -animal 
approaches.  
 
An Extended One -Generation 
Reproductive Toxicity Study 
including cohorts 2A/2B 
(developmental neurotoxicity) and/or 
cohort 3 (developmental 
immunotoxicity) shall be included in 
case of particular concerns on 
(developmental) neurotoxicity o r 
(developmental) immunotoxicity 
justified by any of the following : 
   
EN 36  EN  Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
(a) existing information on the 
relevant species  itself derived 
from relevant available in 
vivo or non -animal 
approaches (e.g. , 
abnormalities of the central 
nervous system  (CNS), 
evidence of adverse effects 
on the nervous or immune 
system in studies on adult 
animals or animals exposed 
prenatally );   
(b) specific mechanisms/modes 
of action of the relevant 
species  with an association to 
(developmental) 
neurotoxicity and/or 
(devel opmental) 
immunotoxicity (e.g. , 
cholinesterase inhibition or 
relevant changes in thyroidal 
hormone levels associated to 
adverse effects );  
(c) existing information on 
effects caused by substances  
analogous to the relevant 
species  being studied, 
suggesting such effects or 
mechanisms/modes of action.  
 
Two-generation reproductive toxicity 
studies that were initiated before 13 
May 2015 shall be considered 
appropriate to address this standard 
information requirement . 
8.3.2.  Prenatal developmental toxicity 
study , in rat, unless another species is 
justified to be more appropriate , oral 
route of administration   
8.3.3.  Further pre -natal developmental 
toxicity study, in a second species, 
oral route of administration or 
mechanistic study  A decision on the need to perform 
additional studies on a second species 
or mechanistic studies shall be based 
on the outcome of the first test (point 
8.3.2.) and all other relevant available 
data (in particular rodent reproductive 
toxicity studies).   
EN 37  EN  Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
8.4. Carcinogenicity :  
8.4.1 Carcinogenicity study , in rat, oral 
route of administration  
 
See 8.4.2 for new study requirements  The study does not need to be 
conducted where all of the following 
conditions are fulfilled : 
(a) no genotoxic potential is 
identified in  genotoxicity 
tests;  
(b) the sub-chronic andlong -term 
(≥ 12 months) toxicity studies  
show no evidence of toxicity  
at the limit dose level.   
8.4.2  Combined carcinogenicity study and 
long-term repeated dose toxicity   
8.5. Additional toxicity properties : If there is an indication for one or 
more mechanisms/modes of action of 
the relevant species  with an 
association to (developmental) 
neurotoxicity and/or endocrine 
disruption and/or (developmental) 
immunotoxicity, corresponding 
additional data shall be generated in 
accordance with this point, unless 
already fully covered by the 
information under point 8.3.1.  
8.5.1. Appropriate n eurotoxicity 
information or study, including 
developmental neurotoxicity, in rat , 
unless  another species is justified to 
be more appropriate  (e.g. adult hen 
for delayed neurotoxicity study) , oral 
route of exposure  If anticholinesterase activity is 
detected , a test for response to 
reactivating agents shall be generated.  
 
8.5.2. Appropriate in formation or study on 
endocrine disruption, oral route of 
exposure if relevant  This standard information or study 
shall be generated if there is any 
evidence from in vitro  studies  or from 
repeated dose or reproduction toxicity 
studies, that the relevant species may 
have endocrine disrupting properties  
for human health , in order to  elucidate 
the mode/mechanism of action and  
provide sufficient evidence for 
relevant adverse effects.  
8.5.3. Appropriate immunotoxicity 
information or study, including 
developmen tal immunotoxicity  This standard information or study 
shall be generated if there is any 
evidence, from skin sensitisation, 
repeated dose or reproductive toxicity 
studies, that the relevant species  may  
EN 38  EN  Column 1  
Standard information and testing  Column 2  
Specific rules for adaptation of the 
standard information and testing  
have immunotoxic properties, in order 
to elucidate the mode/mechanism of 
action and  provide sufficient evidence 
for relevant adverse effects.  
8.5.4. Appropriate mechanistic data or 
studies  This standard information or testing  
shall be generated if necessary to 
clarify any effects reported in toxicity 
studies . 
 
Part 2. General rules for adaptation of Column 1 of Tables 1, 2 and 3 
 
2.1 The general rules for adaptation set under Sections 1 and 2 of Annex XI to Regulation 
(EC) 1907/2006 shall apply mutatis mutandi s with the exception  set out in point 2.2.  
2.2 The general rules for adaptation under Section s 1.3 (Qualitative or Quantitative structure -
activity relationship ((Q)SAR) ) and 1.5 ( Grouping of substances and read -across approach ) of 
Annex XI to Regulation (EC) 1907/2006 shall apply to the standard inform ation and testing 
referred to in Table 1, point 6.1.1., only in the case of a substance constituent  or a non-
intentionally added species  for which experimental testing is not technically possible (e.g. , it 
cannot be isolated and tested as such ).  
 
   
EN 39  EN ANNEX VI 
ACCEPTANCE METHODOLOGY  
 
Section 1 . Limited acceptance methodology   
1. Section 2 shall not apply to a relevant species  which  is a starting substance, or an organic 
cementitious constituent , or a substance constituent  or a non-intentionally added species  
where such substance or constituent is : 
(a) classifi ed as (i) carcinogenic, mutagenic or reproductive toxicity, categories 1A or 
1B, (ii) endocrine disrupter  for human health  category 1 , (iii) persistent 
bioaccumulative and toxic, ( iv) very persistent and ver y toxic, (v) persistent 
mobile and toxic, or (vi) very persistent and very mobile under Regulation (EU) 
1272/2008; or 
(b) identified as a substance of very high concern under the Candidate List established 
under Article 59 of Regulation (EC) 1907/2006 , except those identified on the 
basis of Article 57(f) of Regulation (EC) 1907/2006 only for the environment . 
In either case, the starting substance s or organic cementitious constituent s referred to in the 
first paragraph shall be accepted in the European positive  list under the following conditions 
of use : 
(a) The relevant species  is:  
a non -intentionally added species , or  
 substance constituent,  or  
starting substance or organic cementitious constituent which is monomer of a main polymer 
of the contact material . 
(b) Ctap is lower than the generic limit of 0,1 µg/l or the relevant MTCtap calculated 
from a parametric value set under Annex I to Directive (EU) 2020/2184 by 
application  of an appropriate allocation factor (A LF) to take into account multiple 
routes of exposu re to the relevant species , besides exposure via material s used in 
products in contact with water intended for human consumption ;  
(c) The concentration of the starting substance, organic cementitious constituent , 
substance constituent  or non -intentionally add ed species  in the final material is 
lower than 0 ,1 % (weight/weight) , except if physical migration testing is uncertain 
in which case the concentration in the final material is lower than 0 ,02 % 
(weight/weight).  
2. Part 2 of Section 2 shall not apply in the case of any concern that a relevant species  which 
is a starting substance, or an organic cementitious  constituent , or a substance constituent , or a 
non-intentionally added species  may have genotoxicity , carcinogenicity  or endocrine 
disruption properties  for human health with non -threshold mode of action .  
In such case,  the starting substance s or organic cementitious constituent s referred to in the 
first paragraph  may be accepted in the European positive list if Ctap is lower than a generic 
limit of 0 ,1 µg/l or the relevant MTC tap value calculated from a parametric value set under 
Annex I to Directive (EU) 2020/2184 by application of an appropriate A LF to take into 
account multiple routes of exposure to the relevant species , besides exposure via material 
used in products in contact with water intended for human consumption .  
EN 40  EN  
3. Part 2 of Section 2 shall not apply to a relevant  species  in any of the following cases :  
(a) a parametric value for the relevant species  in the applicable material type  is set 
under Annex I to Directive (EU) 2020/218 4, in which case the MTCtap value  
shall be calculated  by application of an appropriate A LF to take into account 
multiple routes of exposure to the relevant species , besides ex posure via material 
used in products in contact with water intended for human consumption , in which 
case that MTCtap value shall be used for the purpose of Part 4 of Section 2 ;  
(b) a MTCtap value for the relevant species  in the applicable  material type is set 
under the corresponding Annex of Commission Implementing Decision (EU) 
…/… [OP: please fill in the reference of C(2023)7001] following a decision by 
the Commission on an application for a starting substance, composition or organic 
cementitious constituent that has been submitted to ECHA under Article 4 of  
Commission Delegated Regulation  (EU) …/… [OP: please fill in the reference of 
C(2023)7002] , in which case t hat MTCtap value may be used for the purpose of 
Part 4 of Section 2 provided that it m ay not be impacted by information not 
included in the previous application for the concerned starting substance, 
composition or organic cementitious constituent ; 
(c) an authorisation for an active substance has been granted under Regulation (EU) 
528/2012 on th e basis of an ECHA opinion setting  a defined safety threshold for 
the oral route and used as such in material in contact with water under product -
type 6, in which case that safety threshold shall be used for the purpose of  Part 4 
of Section 2 ;  
(d) a specific  migration limit has been  set under Commission Regulation (EU) 
10/2011 in less than 15 years from the date of submission of the application under 
Article 4 of Commission Delegated Regulation (EU) …/… [OP: please fill in the 
reference of C(2023)7002] and th at specific migration limit was derived based on 
the same data as required under Annex V considering the Ctap of the 
corresponding relevant  species , in which case that specific migration limit divided 
by 20  l/kg shall be used for the purpose of Part 4 of S ection 2 . 
 
4.  Part 2 of Section 2 shall not apply in the following cases : 
(a) the available information for the relevant species  is insufficient to exclude 
genotoxicity , in which case the generic limit MTCtap of 0,1 µg/l  shall apply for 
the purpose of Part 4 of Section 2 ; 
(b) the available information for the relevant species  is sufficient to exclude 
genotoxicity  but does not  fulfil the information requirements set out in Table s 2 
and 3 of Annex V, or is not sufficient for DNEL derivation  in accordance with 
Part 2  of Section 2, in which case the generic limit MTCtap of 2,5 µg/l shall apply 
for the purpose of Part 4 of Section 2 .  
   
EN 41  EN Section 2 . Comprehensive acceptance methodology  
Part 1. Introduction  
 
1.1. The acceptance methodology for starting substances, compositions and constituents shall 
be based on a risk assessment. Such risk assessment shall result in:  
(a) determining the maximum tolerable concentration at tap water (MTCtap)  for 
each relevant species ;  
(b) ensuring that Ctap for each relevant species  is lower than its MTCtap.  
 
1.2. In addition to the information required under Annexes I, II and III , a risk assessment shall 
take into account any other relevant technical or scientific information which is available  
addressing worst foreseeable conditions  of use . Where appropriate,  conditions of use shall be 
implemented . 
1.3. The information provided in the risk assessment shall allow the Committee for Risk 
Assessment of ECHA to evaluate and reach a n opinion on whether the starting substance, 
composition or constituent complies with the criteria set out  under Article 11(1) of Directive  
(EU) 2020/218 4. 
 
Part 2. Hazard assessment  
2.1. Principles  
 
2.1.1. For accepting a  starting substance, composition or constit uent, the hazard assessment 
process, in relation to human health shall entail assessment of effects, comprising  the 
following steps :  
(a) hazard identification: identification of the adverse effects which the 
relevant species  have an inherent capacity to cause ;  
(b) hazard characterisation: dose (concentration) - response (effects) 
assessment: estimation of the relationship between dose, or level of 
exposure to the relevant species , and the incidence and severity of an 
effect, where appropriate.  
2.1.2. The hazard  assessment for human health shall address the following potential toxic 
effects for the general human population  and exposure by the oral route:  
(a) mutagenicity ; 
(b) systemic (target -organ) toxicity after repeated dose administration ;  
(c) toxicity for reproduction ; 
(d) carcinogenicity ; 
(e) neurotoxicity ;  
(f) immunotoxicity ;  
(g) endocrine disruption  for human health . 
  
EN 42  EN 2.1.3. The hazard identification shall address the properties and potential adverse effects of 
the relevant species  that migrate from  the material.  
 
2.2. Dose -response  assessment  
2.2.1. The establishment of a quantitative dose (concentration) -response (effect) relationship 
is required and, where possible, a no observed adverse effect level (NOAEL) shall be 
identified. If it is not possible to identify a NOAEL, the lowes t observed  adverse  effect level 
(LOAEL) shall be identified. Where appropriate, other dose -effect descriptors may be used as 
reference values.  
2.2.2. When carrying out the hazard  assessment , special consideration shall be given to 
toxicity data derived from observations of human exposure where such data are available, e.g. 
information gained from manufacture, from poison centres or epidemiology surveys.  
 
2.3. Derived no effect level  
2.3.1. The derivation of a  derived no effect level (DNEL) shall be carried out in accordance 
with Section 1.4 of Annex I to Regulation (EC) 1907/2006.  
 
2.4. Maximum Tolerable Concentration at the tap (MTC tap) 
2.4.1 If the C tap < 2,5 µg/l and screening genotoxicity tests are negative: MTC tap = 2,5 µg/l.  
As an exception, if duly justified and the application fulfils the requirements of Table 2 of 
Annex V, Section 2.4.2 may apply.   
2.4.2 If the C tap is equal or above 2 ,5 µg/l  but below 250 µg/l : the MTC tap is equal to a value  
calculated on the basis of the safe oral dose (DNEL), the body weight (60 kg), the drinking 
water ingestion rate of 2 l (litres) per day and an appropriate ALF (expressed as a percentage) 
to take into account multiple routes of exposure to  the relevant species , besides exposure via 
material used in products in contact with water intended for human consumption . The MTC tap 
shall  not be higher than 250 µg/l.  
 
MTC tap (µg/l) = DNEL (mg/kg/d) × 60 (kg)  × 𝟏𝟎𝟎𝟎  (µ𝐠/𝐦𝐠) 
𝟐 (l/d) ×𝑨𝑳𝑭 
 
2.4.3. If the C tap is above 250 µg/l: the MTC tap shall be set in accordance with the equation 
above.  
 
Part 3. Migration assessment  
 
3.1. The Ctap to be compared against the MTC tap value shall be determined based on the worst 
foreseeable  conditions of use , including in terms of representativeness of the concentration  in 
the material matrix , water , surface area to water volume,  and temperature,  as determined by 
ECHA and published on its website for each test method  taking into a ccount, in particular, the 
requirements for determination based on the worst foreseeable conditions of use and the 
appropriate EN standard .  
EN 43  EN  
Part 4. Risk acceptance  
 
4.1. Risk acceptance for starting substances for organic materials, organic cementitious  
constituents  and compositions  for enamels, ceramic and other inorganic materials  
 
The starting substance, composition or constituent shall be accepted if Ctap < MTC tap for 
each relevant species . 
 
4.2. Risk acceptance for metallic materials  
 
For the assessment of the test rig results (according to standard  EN 15664 -1) the 
arithmetic mean of the equivalent pipe concentrations MEP n(T) analysed from relevant 
contact waters (see Annex IV, point 1.1.) shall be considered.  
 
The composition can be accepted for a product group with the assumed contact surface a 
(see Table  2 of Annex II), if the following criteria are met for all required test waters:  
(a) MTCtap values are met for all analy sed elements ;  
(b) analysed metal concentrations are not showing incre asing trend .