EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
laying down rules for the application of Directive (EU) 2020/2184 of the European 
Parliament and of the Council as regards the procedures and methods for testing and 
accepting final materials as used in products that come into contact with water intended 
for human consumption  
 
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
laying down rules for the application of Directive (EU) 2020/2184 of the European 
Parliament and of the Council as regards the procedures and methods for testing and 
accepting final materials as used in products that come into contact with water intended 
for human consumption  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having re gard to the Treaty on the Functioning 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 (c), thereof,  
Whereas:  
(1) In order to be able to test and accept final materials to be used in products that come 
into contact with water intended for human consumption, hygiene requirements should 
be set out for each category of final material , namely  organic, cementitious, metallic, 
enamels and ceramic , or other inorganic materials. The methodol ogies to be used 
should be  based, inter alia , on Annex V to Directive (EU) 2020/2184  and should be 
taken into account in the performance of the conformi ty assessment procedures of 
products.  
(2) The testing of final materials requires the identification of relevant substances and 
other relevant parameters . Those substances and parameters  should be analysed in the 
migration water. It is necessary to establish the requirements for such testing 
procedure and analysis . 
(3) This Decision should lay down the testing requirement s in order to ensure th e 
performance of the testing. For organic, cementitious, enamel and ceramic materials, 
the testing requirements should be  subject to a risk -based approach by categorising the 
product that comes into contact with water intended for human consumption. The risk -
based approach ensures proportionate testing in relation to the human health risk of the 
final material.  
(4) The testing fo r each final material should be carried out in accordance with the 
determined testing requirements  to ensure that the water intended for human 
consumption wholesome and clean . In order to determine whether the final material 
should be accepted and approved , it is necessary to set out pass/fail criteria that t he 
results of the testing have to meet.  
                                                 
1 OJ L 435, 23.12.2020, p. 1 –62.   
EN 2  EN (5) In order to ensure proportionate testing, it should be possible to reduce testing for 
materials  used in minor components and  minor  components of assembled product s. 
(6) National competent authorities or bodies  should be allowed sufficient  time to adapt 
their national system to the new requirements for testing and acceptance of final 
materials . The application of this Decision should therefore be deferred . 
(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  
The procedures and methods for testing and accepting  final materials  as used  in a product as 
provided for in Article 11(2 ), point (c), of Directive (EU) 2020/2184  on the quality of water 
intended for human consumption  are set out in the Annexes I to IV.  
 
Article 2  
Definitions  
For the purposes of this Decision , the following defini tions apply:  
(1) ‘starting substance’ means a substance that has been intentionally added in the production 
of organic materials or of admixtures for cementitious materials ; 
(2) ‘constituent’ means :  any of the following:  
(a) a substance that has been intentionally used to manufacture a cementitious 
material;  
(b) an alloying element present in  a composition of metallic materials;  
(c) an element or a combination of elements present in a composition of enamels, 
ceramic or other inorganic materials;  
(d) a substance present in a mixture of substances.  
(3) ‘product’ means an object  that comes  into contact with water intended for human 
consumption , which is made  of final materials and with the intention to be placed on the 
market ; 
(4) ‘assembled product’ means a product that consist s of two or more components, that are 
joined together and function as a whole unit and cannot be disassembled  without 
destroying the function of the product ;  
(5) ‘multilayer product’ means a  product that consi st of two or more layers of final materials 
bonded together and can not be non-destructively disassembled for the testing ; 
(6) ‘material’ means a solid, semi -solid or liquid that is used for the manufacturing of a 
product that is:  
(a) an organic composition prepared from one or more starting substances ; or 
(b) a cementitious composition prepared from one or more constituents ; or 
(c) a metallic, enamel, ceramic or other inorganic composition.    
EN 3  EN (7) ‘organic material’ mean s a material  that mainly consist s of carbon -based substances ;  
(8) ‘metallic material’ mean s a material  that is a metal or metal alloy , and that is used either in 
bulk form or as metallic plating ; 
(9) ‘cementitious material’ means a material that contains a hydraulic cement in sufficient 
proportion to act as the main binder by forming a hydrate structure which governs the 
performance of the material ; 
(10) ‘enamel ’ mean s a material  that is a vitreous material obtained by melting  at temperatures 
higher than 1200°C  and fritting of a mixture o f inorganic substances ;  
(11) ‘ceramic material’ means inorganic poly or single crystalline, non -metallic solid materials 
subjected to high temperature in manufacture ;  
(12) ‘final material’ means a material  which is subject to testing and acceptance in accordance 
with the testing requirements and acceptance requirements set out in the respective 
Annexes  I, II, III and IV  to this Decision ;  
(13) ‘site applied material’ means a final material to be produced on a construction site ; 
(14) ‘test piece’ means a  representative  object of the final material that is used for the carrying 
out of testing in accordance with the procedures and methods for testing set out in the 
respective Annexes I, II, III and IV  of this Decision ; 
(15) ‘unexpected substance’ mean s a substance that has migrat ed from a product , a final 
organic material or a final cementitious material  into water intended for human 
consumption , that was not intentionally added during the production p rocess of the 
material or product, and that was not included in the information provided in the 
application referred to in  Article 11(5) of Directive (EU) 2020/2184 ; 
(16) ‘formulation’ means the list of all substances  used in the preparation of an organic 
material or of a cementitious material  and their relative quantities ;  
(17) ‘total barrier’ means a barrier layer that prevents the diffusion of any substances towards 
the side of the final material in contact with the water intended for human consumption ;  
 (18)‘ enhancement of microbial growth (EMG)’ means  the ability of  final organic or 
cementitious material s to enhance the multiplication of micro -organisms  under specified 
conditions ;  
(19) ‘migration water’ means the test water that has been in contact with the test piece under 
the specified conditions  set out in the respective Annexes I, II, III and IV . 
   
EN 4  EN Article  3 
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.   
 
This Decision  shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
  
  
 (PE/PO)  
 The President  
 […]