EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
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 
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
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 lists  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functio ning of the European Union,  
Having regard to Directive (EU) 2020/2184 of the European Parliament and of the Council of 
16 December 2020 on the quality of water intended for human consumption1, and in particular 
Article 11(2) , point (a), thereof,  
Whereas:  
(1) Testing and acceptance methodologies should be established for assessing the safe use 
of starting substances, compositions and constituents.  
(2) Inclusion or removal of  an entry in a European positive list should  be based on  the 
identif ication of the  starting substance , composition or organic  cementitious  
constituent and the identif ication of  its intended use. The physico -chemical properties 
of the starting substance , composition  or organic cementitious constituent necessary 
for carrying out migration testing  should  be established . The starting substance, 
composition or organic cementitious constituent should  be tested for migration .  
(3) Inclusion or removal of  an entry in a European positive list  should be based on the 
identification of  species  that are relevant for the acceptance methodology, or risk 
assessment, because they  may have an impact on the safe use of a material  or product , 
such as an impurity, the constituent of a starting substance or a degradation product . 
These relevant species  should be determined  on the basis of the information on the 
identification of the starting substance, composition or constituent and on the basis of 
its intended use as well as the results of migration testing . The toxicological properties 
of these relevant species should  also be identified . 
(4) For proportionality and efficiency  reasons, testing  for physico -chemical properties and 
toxicological properties  as well as risk assessment should be more limited if a similar 
assessment has already been carried out at Union level within a  reasonable period of 
time or if the substance has a stringent classification in Part 3 of Annex VI of 
Regulation (EU) 1272/2008 or the applicant proposes such classification. For 
proportionality  reasons, the testing requirements for toxicological propert ies should 
be stricter where there is a high exposure to a certain substance through migration.  
                                                 
1 OJ L 435, 23.12.2020, p. 1.   
EN 2  EN (5) In order to  respect the precautionary principle  and in order to cover the potential for 
significant exposure over  a long period of time , the acceptance methodology should be 
based on a worst -case risk assessment of each relevant species . The risk assessment 
should  consider migration , including  release , under the worst foreseeable  conditions of 
use. In particular, the risk assessment should cons ider the expected long-term exposure 
to materials or products in contact with water  intended for human consumption  and, in 
the case of metallic compositions, the differen ces in the  properties, such as  
composition  and corrosiv ity, of all water  in the Union intended for human 
consumption .    
(6) Economic operators and relevant authorities should be allowed sufficient  time to adapt 
their national methodologies  to the methodologies set out in this Decision . The 
application of this Decision should therefore be defer red. 
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Committee referred to in Article 22(1) of Directive  (EU) 2020/2184 . 
 
HAS ADOPTED THIS DECISION:  
Article 1  
Definitions  
For the purpose of this Decision, the following definition s apply:  
(1) ‘non-intentionally added species ’ means either one of the following:   
(a) an impurity of a starting substance or of an organic cementitious constituent or 
composition ;   
(b) a reaction product or a degradation product of a starting sub stance or organic 
cementitious constituent that forms during the processing or use of the 
material ;  
(c) a reaction product or a degradation product of a starting substance or organic 
cementitious constituent  that forms in contact with water during the use of the 
material . 
(2) ‘nanoform’ means a form of a natural or manufactured substance containing particles, in 
an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of 
the particles in the number size distribution, one or more external dimensions is in the 
size range 1 nm -100 nm, including also by derogation fullerenes, graphene flakes and 
single wall carbon nanotubes with one or more external dimensions below 1 nm;  
(3) ‘particle’ means a minute piece of matter with defined physical  boundaries;  
(4) ‘aggregate’ means a particle comprising strongly bound or fused particles;  
(5) ‘agglomerate’  means a collection of weakly bound particles or aggregates where the 
resulting external surface area is similar to the sum of the surface areas of the individual 
components ;   
(6) ‘migration’  means transfer of substances from a material into water intended for human 
consumption .  
  
EN 3  EN Article 2 
Testing and acceptance of starting substances, compositions and constituents  
1. The methodologies referred to in Article 11(2), point (a), of Directive (EU) 
2020/2184  shall apply to  the following :  
(a) starting substance for organic materials;  
(b) organic constituent of cementitious materials;  
(c) composition of metallic materials;  
(d) composition of enamels, ceramic and other inorganic m aterials.  
2. Where a polymer is intended for use in an organic material or a cementitious 
material, the testing and acceptance methodologies shall be applied to the monomer, 
pre-polymer or polymer in accordance with the rules set out in Points iv to vii of 
Annex I and Point s iii and iv of Annex III to Decision Commission Implementing 
Decision (EU) …/… [OP: please fill in the reference of C(2023)7001] . 
Article 3  
Testing methodology  
1. Starting substance s, compositions and organic cementitious constituent s shall be  
identified in accordance with  the requirements set out in  Anne x I. 
2. The intended use of starting substance s, compositions, constituents, as well as  
material s and product s shall be specified in  accordance with the requirements set out 
in Annex  II.  
3. The physico -chemical properties of s tarting substances and organic cementitious 
constituents shall be determine d in accordance with the requirements set out in 
Annex III. 
4. Migration into water  intended for human consumption shall be determined in 
accordance with the requirements set out in Annex IV.  
5. The r elevant species shall be identified in accordance with Section 3 of Annex IV.   
6. The toxicological properties of the relevant specie s referred to in paragraph 5 shall be 
determine d in accordance with the requirements set out in  Annex  V.  
   
EN 4  EN Article 4 
Acceptance methodology  in the European positive lists  
1. Starting substances, compositions and constituents shall be accepted  in accordance 
with Annex VI on the basis of an assessment of the risks raised by the relevant 
species  identified  for the  corresponding  starting substance, composition or organic 
cementitious constituent . 
2. Starting substances and organic cementitious constituents which have a biocidal  
function and which are subject to Regulation (EU) No 528/2012 of the European 
Parliament and of the Council2 shall only be accepted if they belong to product -type 
6 (preservatives for products during storage) as set out in Annex V to that 
Regulation.   
 
 
Article 5  
Entry into force  
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 31 December 2026.   
Done at Brussels,  
 For the Commission  
 Virginijus SINKEVIČIUS  
 Member of the Commission  
  
 
                                                 
2 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the 
making available on the market and use of biocidal products  (OJ L 167 27.6.2012, p. 1 ).