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 by establishing the European positive lists of starting 
substances, compositions and constituents authorised for use in the manufacture of 
mater ials or 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 by establishing the European positive lists of starting 
substances, compositions and constituents authorised for use in the manufacture of 
materials or products that come into contact with water intended for human 
consumption  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard 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 int ended for human consumption1, and in particular 
Article 11(2) , point (b), thereof , 
Whereas:  
(1) Directive (EU) 2020/2184  provides for the establishment of European positive lists of 
substances, compositions and constituents for each type of materials, namely organic, 
cementitious, metallic, enamels, ceramic or other inorganic  materials, which are 
authorised for use in the manufacture of materials or products that come into con tact 
with water intended for human consumption  and fall within the scope of Article 11 of 
that Directive. These European positive lists should include, where appropriate, 
conditions for the use of substances, compositions and constituents  and migration 
limits, which are to be determined on the basis of the methodologies adopted pursuant 
to Article 11(2) , point (a) , of Directive  (EU) 2020/2184 . Such conditions of use may 
include a purity criterion, a condition on the physico -chemical characteristics of the 
starting substance, composition or constituent, a condition on its manufacturing 
process  or on the manufacturing process of final materials, their use for certain 
products, the use of these products, or  further testing requirement . Sacrificial anodes , 
membr anes and ions exchange resins are water treatment chemicals and/or filter media 
and are covered by Article 12  of Directive (EU) 2020/2184 , therefore they are 
excluded from the scope of Article 11  of that Directive .  
(2) Article 11(3) of the Directive sets out that lists established by the Commission 
pursuant to Article 5  of Regulation (EC) No 1935/2004  should be used as a source to 
establish t he first European positive lists under the Directive . The list established in 
Annex I to Regulation (EU) No 10/2011 is one of these lists. However, substances 
included on this list have only been assessed for their use in plastic food contact 
materials in accordance Regulation (EU) No 10/2011, subject to spe cific conditions of 
use. Moreover, the European Food Safety Authority has indicated that a significant 
number of the substances should be prioritised for re -evaluation as no specific 
migration limit was established when they were authorised for use in plas tic food 
                                                 
1 OJ L 435, 23.12.2020, p. 1.   
EN 2  EN contact materials2. The inclusion of such substances in Annex I to Regulation (EU) No 
10/2011 nevertheless provides a much higher level of certainty over their safety in 
contact with drinking water when used in the manufacture of drinking water pr oducts, 
than would be the case for unlisted substances. Therefore it is appropriate to add 
substances originating from lists established by the Commission pursuant to Article 5 
of Regulation (EC) No 1935/2004 to the first European list under Article 11(3) of the 
Directive, provided these additions are only used as a starting point for further 
conformity assessment in accordance with Article 11(8), and provided their re -
evaluation by the expiry date set out in the first European positive list takes account o f 
all the conditions and drinking water materials in which they may be used.   
(3) Where applicable, the migration limit, i.e. the maximum tolerable concentration at the 
tap, should be based on the parametric value set out in Part B or C  of Annex I to 
Directive  (EU) 2020/2184  or the specific  migration limit set out in Annex es I and II to 
Commission Regulation (EU) No 10/20113. This should, however, be done after 
application of an allocation factor to account for the proportion of potential exposure 
from material s in contact with water derived from the information provided by 
Member States.  
(4) Annex I to Regulation (EU) No 10/2011 provides further detail on conditions of use of 
authorised substances, as well FCM substance reference numbers used in risk 
assessments. T o facilitate further conformity assessment of substances that are added 
to the first European positive list on the basis of Annex I to Regulation (EU) No 
10/2011, it is appropriate to add their FCM reference numbers in the first European 
positive lists.  
(5) The expiry dates included  in the first European positive lists follow the 
recommendation from European Chemicals Agency ( ECHA ) in particular on the basis 
of the hazardous properties of the  starting  substance , composition or constituent , the 
quality of the underlying risk assessments , the extent to which those risk assessments 
are up -to-date and the need for a staggered review of these entries .  
(6) Some entries in the European positive lists should be allowed to be combined, 
extended to rela ted starting substances, compositions and constituents or extended for 
use in different material types than the one for which they have been authorised when 
such combination or extension has no impact  on the protection of  human health  to 
ensure the proport ionality and efficiency of the process .  
(7) Based on notifications from Member States , the first European positive lists include  
group entries covering multiple starting substances , compositions  or constituents.  
Assessing the safety of each individual starti ng substance, composition or constituent 
separately is more  appropriate to assess the safety  of the groups ; however, at the time 
of adopting the first European positive list it was not possible to identify the  starting 
substances or organic  cementitious co nstituents in th ose group s. Therefore, group  
entries should progressively be replaced in the European positive lists by the 
individual starting substances, compositions  or constituents  in the group and the 
                                                 
2 EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes andProcessing Aids), Silano V,  et. 
al., 2020. Scientific Opinion on the review and priority setting for  substances that are listed without a 
specific migration limi t in Table 1 of Annex 1 of Regulation 10/2011on plastic materials and articles 
intended to come into contact with food. EFSA Journal 2020;18(6):6124,104 pp.  
https://doi.org/10.2903/j.efsa.2020.6124 . 
3 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to come into contact wi th food ( OJ L 12, 15.1.2011, p. 1 ).  
EN 3  EN economic operator should only be able to rely on such group entr ies for the first 
European positive list  if it is  able to demonstrate the safety of its starting substance, 
composition  or constituent .   
(8) In order to ensure an orderly and efficient  application process, an entry may be 
renewed provided that notification of intention and , subsequently, an application is 
submitted to ECHA within a set deadline.  
(9) Member States ’ national provisions with regard to starting substances, compositions 
and constituents and their national positive lists were notified to  ECHA by 12 July 
2021. In order to allow national authorities sufficient time to prepare for the 
application of the European positive lists, the application of this act will start from 31 
December 2026, i.e. less than  two years after its entry into force . The national systems 
are to apply until 31 December 2026 . In addition , transitional measures should be 
provided for substances , compositions and constituents  approved in the national 
system s from 13  July 2021 to 31 December 2026 , provided that in accordance with 
Part B of Annex I  to Directive  (EU) 2020/2184 , these substances do not exceed the 
parametric value of 5 µg/l for lead (Pb) at the tap.     
(10) The measures provided for in this Decision are in accordance with the opinion of th e 
Committee referred to in Article 22(1) of Directive  (EU) 2020/ 2184 . 
   
EN 4  EN HAS ADOPTED THIS DECISION:  
 
Article 1 
European positive lists  
This Decision establishes the following:  
(a) the European positive list of  starting substances  for organic materials and gro ups of 
starting substances for organic materials as set out in Tables 1 and 2 of Annex I  
respectively ; 
(b) the European positive list of  compositions of metallic materials and groups of 
compositions for metallic materials as set out in Tables 1 and 2 of Annex II 
respectively ; 
(c) the European positive list of  organic constituents of cementitious materials and 
groups of organic constituents for cementitious materials as set out in Tables 2 and 3 
of Annex III  respectively ;  
(d) the European positive list of  compositions of enamels, ceramic and other inorganic 
materials as set out in Table 1 of Annex IV . 
Article 2 
Definitions  
For the purpose of this Decision, the following definitions shall apply:  
(1) ‘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 .  
(2) ‘monomer ’ means a substance which is capable of forming covalent bonds with a 
sequence of additional like or unlike molecules under the conditions of the relevant 
polymer -forming reaction used for the particular process ;  
(3) ‘organic material’ means  a material that m ainly consist of carbon -based substances ; 
(4) ‘monomer unit’ means the reacted form of a monomer substance in a polymer ; 
(5) ‘polymer’ means a substance consisting of molecules that are characterised by the 
sequence of one or more types of monomer units  ant that a re distributed over a range of 
molecular weights wherein differences in the molecular weight are primarily attributable 
to differences in the number of monomer units  comprising the following:  
(a) a simple weight majority of molecules containing at least three monomer units 
which are covalently bound to at least one other monomer unit or other 
reactant;  
(b) less than a simple weight majority of molecules of the same molecular weight ; 
(6) ‘polymerised part ’ means the part of a substance composition consisting of molecule s 
characterised by the sequence of one or more types of monomer units. Molecules such as  
EN 5  EN dimers, trimers contribute also to the polymerised part. However, the term “polymerised 
part” does not cover unreacted monomer or unreacted other reactants ; 
(7) ‘pre-polym er’ is a substance resulting from a polymerisation -type of reaction and that is 
further reacted into a final polymer in a material or product ; 
(8) ‘organic cementitious constituent’ means an organic substance that used in the 
manufacture of cementitious materials;  
(9) ‘cement’ means a  finely ground inorganic material which, when mixed with water, forms 
a paste that sets and hardens by means of hydration reactions and processes and which, 
after hardening, retains its strength and stability even under water;  
(10) ‘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;  
(11) ‘non-intentionally added species ’ means  either  of the f ollowing : 
(a) an impurity of a starting substance or organic cementitious constituent or 
composition;  
(b) a reaction product or a degradation product of a starting substance or organic 
cementitious constituent that forms during the processing or use of the 
materi al;  
(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;  
(12) ‘metallic material’ means a metal or metal alloy used either in bulk form or as m etallic 
plating;  
(13) ‘ceramic materials’ means inorganic poly - or single crystalline, non -metallic solid 
materials subjected to high temperature in manufacture;  
(14) ‘enamel’ means a vitreous material obtained by melting at temperatures above 1200 °C, 
and fritting of a mixture of inorganic substances. The fritted material may be applied to a 
metal substrate by melting at a temperature above 480 °C;  
(15) ‘maximum tolerable concentration at the tap’ (MTC tap) means the maximum permitted 
concentration of a substance transferred from a specific material into water intended for 
human consumption.  
  
Article 3 
Transitional  provision   
Starting substances, compositions and constituents which have been approved by a Member 
State competent authority during the period from 13 July 2021 to 31 December 2026  in 
accordance with national provisions may be used in the manufacture of materials or products 
that come into contact with water intended for human consumption until 31 December 2030 , 
provided  they comply with the parametri c value of 5  µg/l Pb (lead) at the tap as set out in Part 
B of Annex I to Directive  (EU) 2020/2184 .  
  
EN 6  EN Article 4 
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  
  
  
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 The President  
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