Guidance on the Drinking Water Directive. Volume III, Scope.
Date: 2025-05-08
Institutions: European Chemicals Agency
Subjects: biocide, chemical product, chemicals legislation, consumer protection, dangerous substance, directive (EU), drinking water, information analysis, public health, risk management

Guidance on the DWD: Volume III 
Version 1.0 – January 2025 

1 

G U I D A N C E  

Guidance on the Drinking Water Directive 

Volume III: Scope 

Version 1.0 

 
 
 
 
 
 
  
 
 
 
 
 
 
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Guidance on the DWD: Volume III 
Version 1.0 – January 2025 

Legal notice 

This  document  aims  to  assist  users  in  complying  with  their  obligations  under  Directive  (EU) 
2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality 
of water intended for human consumption (recast), hereafter referred to as the ‘drinking water 
directive’ or ‘DWD’. However, users are reminded that the texts of the DWD (Article 11(2)(a)), 
Commission  Delegated  Regulation  (EU)  2024/369,  Commission  Implementing  Decision  (EU) 
2024/367 and Commission Implementing Decision (EU) 2024/365 are the only authentic legal 
references, and that the information in this document does not constitute legal advice. Usage of 
the  information  remains  under  the  sole  responsibility  of  the  user.  The  European  Chemicals 
Agency does not accept any liability with regard to the use that may be made of the information 
contained in this document. 

Guidance on the Drinking Water Directive – Volume III: Scope 

ECHA-24-G-13-EN 

Reference: 
Cat. Number:  ED-01-24-024-EN-N 
978-92-9468-464-6 
ISBN: 
10.2823/8586179 
DoI: 
January 2025 
Publ.date: 
EN 
Language: 

© European Chemicals Agency, 2025 

Luxembourg: Publications Office of the European Union, 2025 

If you have questions or comments in relation to this document, please send them (quoting 
the reference and issue date) using the information request form. The information request 
form can be accessed via the Contact ECHA page at http://echa.europa.eu/contact. 

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, FINLAND 
Visiting address: Telakkakatu 6, FI-00150 Helsinki, FINLAND 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guidance on the DWD: Volume III 
Version 1.0 – January 2025 

Preface 

3 

The Guidance on the Drinking Water Directive – Volume III: Scope is to be used to decide on 
the eligibility of a starting substance, composition or constituent for listing in a European positive 
list (EUPL) and to clarify timelines for applications and the roles of applicant and representative 
of an applicant. 

This document describes the obligations in accordance with Article 11(2)(a) of the DWD and how 
to fulfil them. 

Notes to the reader 

This  guidance  must  be  read  in  conjunction  with  the  relevant  DWD  implementing 
legislation, namely: 

•  Commission Implementing Decision (EU) 2024/365 of 23 January 2024 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; 

•  Commission Implementing Decision (EU) 2024/367 of 23 January 2024 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; 

•  Commission Delegated Regulation (EU) 2024/369 of 23 January 2024 supplementing 
Directive  (EU)  2020/2184  of  the  European  Parliament  and  of  the  Council  by  laying 
down the procedure regarding inclusion in or removal from the European positive lists 
of starting substances, compositions and constituents. 

In addition, this guidance document is part of wider guidance on DWD applications, which 
comprises a total of five volumes. The other volumes are: 

•  DWD  Guidance  Volume I  on  methodologies  for  testing  starting  substances, 
compositions and constituents for use in the manufacture of materials or products in 
contact with water intended for human consumption; 

•  DWD  Guidance  Volume II  on  methodologies  for  accepting  starting  substances, 
compositions and constituents for use in the manufacture of materials or products in 
contact with water intended for human consumption; 

•  DWD Guidance Volume IV on the contents of a notification of intention; 
•  DWD  Guidance  Volume V  on  calibrants  and  representative  samples  of  accepted 
compositions  in  connection  to  applications  submitted  under  Commission  Delegated 
Regulation (EU) 2024/369 (prepared by the European Commission’s Joint Research 
Centre). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Contents 

Guidance on the DWD: Volume III 
Version 1.0 – January 2025 

Legal notice ................................................................................................................ 2 

Preface ....................................................................................................................... 3 

Contents ..................................................................................................................... 4 

List of tables ............................................................................................................... 5 

Abbreviations ............................................................................................................. 6 

1. Aim of this guidance ............................................................................................... 7 

2. General provisions of the drinking water directive and scope of its Article 11 and 

of applications under that article .......................................................................... 8 
2.1. Scope of Article 11 of the drinking water directive ...................................................................... 8 

2.2. Requirements on the scope of a DWD application based on the provisions of the 
implementing legislation .............................................................................................................. 12 

3. Timeline of application of the first EUPLs and role of expiry dates ....................... 27 
3.1. Date of application of the first EUPLs and transitional provisions ................................................ 27 

3.2. Role of expiry dates .............................................................................................................. 27 

3.3. Transitional provisions .......................................................................................................... 27 

4. Potential applicants and the role of ‘representatives’ ........................................... 31 
4.1. Who can the applicant be? .................................................................................................... 31 

4.2. The role of ‘representatives’ .................................................................................................. 31 

4.3. Potential applicants in European Free Trade Association countries .............................................. 34 

 
 
 
 
 
 
 
 
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List of tables 

5 

Table 1. Approvals for the use of entries in an EUPL in materials of a different type ... 14 
Table 2. Selection between a polymer or its monomer(s) as the applied-for substance in the 
case of organic materials .................................................................................... 15 
Table 3. Guidance for the preparation of an application for a monomer (or other reactant) or a 
polymer as a starting substance for organic materials in contact with drinking water . 17 
Table 4. Guidance for selecting the appropriate EUPL and identifying the applied-for entry in an 
application for organic constituent for cementitious materials in contact with drinking water  21 
Table 5. Guidance for the preparation of an application for a monomer or a polymer as an 
organic constituent for cementitious materials in contact with drinking water ............ 25 
Table 6. Timeline of approval status for different types of starting substances, compositions 
and constituents and product certification requirements ......................................... 29 
Table 7. Roles of a ‘representative’ for the purposes of DWD notifications of intention and 
applications ...................................................................................................... 33 

 
 
 
 
 
 
 
 
 
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Abbreviations 

Guidance on the DWD: Volume III 
Version 1.0 – January 2025 

Ctap 

Da 

DWD 

EUPL 

concentration at the tap 

Dalton 

drinking water directive (Directive (EU) 2184/2020) 

European positive list of starting substances, compositions or constituents 

MTCtap 

maximum tolerable concentration at the tap 

MW 

NIAS 

RAC 

molecular weight 

non-intentionally added species 

Committee for Risk Assessment (ECHA) 

 
 
 
 
 
 
 
 
Guidance on the DWD: Volume III 
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1. Aim of this guidance 

7 

Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 
on the quality of water intended for human consumption (the recast DWD) sets specific minimum 
hygiene  requirements  for  the  authorisation  of  starting  substances,  compositions  and  organic 
cementitious  constituents  for  use  in  the  manufacture  of  materials  or  products  in  contact  with 
water  intended  for  human  consumption  on  the  basis  of  the  principles  set  out  in  its  Annex V. 
These requirements ensure the uniform application of paragraph 1 of Article 11 of the DWD. 

This document aims to support potential applicants in the following ways: 

•  establish  whether  the  use  of  a  starting  substance,  composition  or  constituent  and  the 
associated contact material falls under the obligations arising from Article 11 of the DWD; 

•  establish  for  which  starting  substance,  composition  or  constituent  an  application  to  the 
European Chemicals Agency (ECHA) should be prepared and submitted (particularly relevant 
for monomers and other reactants, pre-polymers and polymeric substances for organic and 
cementitious materials in contact with water); 

• 

clarify the role of expiry dates accompanying entries in the EUPLs and the role of transitional 
provisions in the implementing legislation; and 

•  establish who may act as the applicant and the role of representatives. 

This  guidance  is  primarily  addressed  to  applicants  seeking  approval  for  a  starting  substance, 
composition or organic cementitious constituent to be included in the EUPL, and those seeking 
the removal or update of an existing entry in the EUPL. 

Applicants  should  note  that  issues  of  scope  in  terms  of  starting  substance,  composition  or 
constituent, but also the  eligibility  of applicants,  are issues that may  be addressed under the 
accordance check (Article 4 of Commission Delegated Decision (EU) 2024/369). 

 
 
 
 
 
 
 
 
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2. General provisions of the drinking water directive and 
scope of its Article 11 and of applications under that article 

2.1. Scope of Article 11 of the drinking water directive 

The elements to be included in an EUPL must be determined on the basis of a combination of 
the following provisions: 

• 

• 

• 

• 

• 

scope of the DWD as defined under Articles 2 and 3 of the DWD; 

scope of Article 11 as defined under Article 11(1) of the DWD; 

scope of Article 12, which precludes applications submitted to ECHA for starting substances 
and compositions or constituents for products that fall under that article; 

scope of the EUPLs as defined under Article 11(2)(b) and Annex V of the DWD; 

specific rules provided in Commission Implementing Decision (EU) 2024/367. 

These various provisions are addressed in turn below. 

As a general remark, the provisions of the DWD should be interpreted in line with its objective 
of protection of human health. 

2.1.1. Materials falling under Article 11(1) of the drinking water directive 

Article 11(1) of the DWD defines its scope by relying on three criteria: 

•  Materials; 

•  That  are  intended  to  be  used  in  new  installations  or,  in  the  case  of  repair  works  or 
reconstruction, in existing installations for the abstraction, treatment, storage or distribution 
of water intended for human consumption; and 

•  That come into contact with such water. 

These aspects are discussed in turn below. 

2.1.1.1. Materials 

‘Materials’ means a solid, semi-solid or liquid that is used in the manufacturing process of a 
product in contact with water intended for human consumption, and that is: 

•  either prepared from one or more starting substances or cementitious constituents; or 

•  a metallic, enamel, ceramic or other inorganic composition (see Article 2(1) of Commission 

Implementing Decision (EU) 2024/367). 

Therefore, for example, ultraviolet light used to purify water would not be subject to Article 11. 

2.1.1.2. Areas of water supply 

The minimum hygienic requirements established under Article 11 of the DWD apply to materials 
that are intended to be used (Article 11(1)): 

 
 
 
 
 
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• 

• 

• 

in new installations; 

for repair works or reconstruction, in existing installations; 

for  the  abstraction,  treatment,  storage  or  distribution  of  water  intended  for  human 
consumption. 

The intended use should be determined considering the material supplier’s instructions for use, 
promotional materials and reasonable expectations of how such materials could be used. 

The  terms  ‘installation’,  ‘repair’  and  ‘reconstruction’  are  not  defined  in  the  DWD.  Considering 
that these terms are intended to define the scope of Article 11, which aims to protect human 
health, they should be broadly construed. An installation may be the combination of two pieces 
of equipment. This would include drinking water systems in boats, mobile homes and temporary 
installations. Further, the terms ‘repair’ and ‘reconstruction’, broadly construed, should include 
any change and improvement. 

The  terms  ‘abstraction,  treatment,  storage  or  distribution’  are  also  not  defined  in  the  DWD. 
Considering that these terms are intended to define the scope of Article 11, which aims to protect 
human health, they should be broadly construed. In other words, Article 11 covers everything 
from the water catchment to the tap. 

On the other hand, materials coming into contact with drinking water after it leaves the tap (e.g. 
bottles, containers, kettles, cooking pots) fall outside the scope and are considered food contact 
materials. Similarly, products such as a kitchen sink are not relevant to the scope of Article 11. 

2.1.2. Materials falling under the scope of Article 12 

Article 11 of the DWD regulates materials in contact with drinking water, with the exclusion of 
treatment chemicals and filter media, which are regulated by another provision, Article 12 of the 
DWD.  In  practical  terms,  sacrificial  anodes,  filtering  membranes  and  ion  exchange  resins  are 
considered treatment chemicals and/or filter media and are covered by Article 12, therefore they 
are outside the scope of Article 11. This is established in recital (1) of Commission Implementing 
Regulation (EU) 2024/367: ‘Sacrificial anodes, membranes 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’. 

2.1.3. Scope of the EUPLs as defined under Article 11(2)(b) and Annex V of 
the DWD 

2.1.3.1. Article 11(2)(b) of the DWD 

Article 11(2)(b) of the DWD sets three criteria: 

1. 

2. 

3. 

starting substances, compositions or organic cementitious constituents; 

for  each  group ( 1)  of  materials,  namely  organic,  cementitious,  metallic,  enamels, 
ceramic or other inorganic; 

for use in the manufacture of materials or products in contact with water intended for 
human consumption. 

(1)  Note that the DWD guidance documents generally refer to these four as material ‘types’, not groups. 

 
 
 
 
 
 
 
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These aspects are discussed in turn below. 

2.1.3.1.1. Starting substance, composition or organic cementitious constituent 

The  concepts  of  starting  substance,  composition  and  organic  cementitious  constituent  are 
defined as follows: 

•  starting substance is a substance that has been intentionally added in the production of 

organic materials or of admixtures for cementitious materials; 

•  composition  is  the  chemical  composition  of  a  metal,  enamel,  ceramic  or  other  inorganic 

material; and 

•  organic  cementitious  constituent  is  an  organic  substance  intentionally  used  in  the 
manufacture  of  cementitious  materials  (e.g.  starting  substance  intentionally  used  in  the 
formulation of admixtures). 

The  first  two  definitions  appear  in  Article 2  of  the  DWD;  the  third  appears  in  Article 2(8)  of 
Commission Implementing Decision (EU) 2024/367. 

2.1.3.1.2. Material types 

Article 11(2)(b)  of  the  DWD  defines  four  material  types:  organic,  cementitious,  metallic  and 
enamels, ceramic or other inorganic. These are exhaustive in the sense that any material that 
is  intended  to  come  into  contact  with  water  intended  for  human  consumption,  and  is  not  a 
treatment chemical / filter medium, must fall under one of these material types. 

A material may also fall under  only  one material type. In case of uncertainty, an assessment 
must be made case-by-case to determine under which material type a material falls, taking into 
account,  among  other  things:  its  composition  (the  respective  percentage  of  the  material’s 
constituents),  function  (the  contribution  of  each  material’s  constituent  to  the  function  of  the 
material:  e.g.  is  a  material’s  constituent  an  impurity?),  and  testing  requirements  (e.g.  if  the 
material (or product) contains both organic and metallic material constituents, which migration 
testing methodology is more appropriate: the one for organic materials or the one for metallic 
materials?). 

2.1.3.1.3. Use in the manufacture of materials or products and impurities 

Article 11(2)(b)  of  the  DWD  covers  any  starting  substance,  composition  and  organic 
cementitious  constituent  used  in  the  manufacture  of  materials  or  products  in  contact  with 
drinking  water.  That  provision  does  not  distinguish  between  intentionally  and  unintentionally 
used substances. Impurities fall under the scope of Article 11 and the following are noted. 

•  The  definition  of  starting  substance  is  limited  to  intentionally  added  substance.  An 
intentionally added substance may have various constituents, including impurities which are 
still part of that substance. 

•  The  terms  ‘composition’  and  ‘organic  cementitious  constituent’  themselves  do  not  exclude 

impurities. 

•  Further, impurities may negatively impact human health if they migrate into drinking water. 

Therefore, impurities are covered within the scope of Article 11 of the directive. 

 
 
 
 
 
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2.1.3.2. Exemptions stipulated by Annex V of the DWD 

Annex V of the DWD provides exemptions from listing starting substances for organic materials 
and organic constituents for cementitious materials as shown below. 

•  For  organic  materials:  ‘substances  in  relation  to  which  there  is  no  possibility  that  the 
substance and its reaction products are present at levels exceeding 0.1 μg/l in water intended 
for  human  consumption,  unless  for  specific  substances  a  more  stringent  value  is  needed 
taking into account their toxicity’. 

•  For  cementitious  materials:  ‘(ii)  organic  constituents  in  relation  to  which  there  is  no 
possibility that the constituents and their reaction products are present at levels exceeding 
0.1 μg/l in water intended for human consumption and (iii) inorganic constituents’. 

In practice, if the use of a starting substance results in the migration of relevant chemical species 
into  drinking  water  at  concentrations  below  0.1 μg/l  and  there  is  no  toxicological  information 
(including a parametric value in Annex I of the directive or a maximum tolerable concentration 
at the tap (MTCtap) value adopted by the Commission in Implementing Decision (EU) 2024/367) 
which  supports  the  adoption  of  an  MTCtap  value  lower  than  0.1 μg/l,  economic  operators  and 
authorities should consider the available information to determine if there is toxicity and, if so, 
apply at ECHA. Otherwise, that starting substance would be used in the manufacture of contact 
materials  without  it  being  listed  in  the  corresponding  EUPL  and  without  a  risk  assessment  to 
protect human health. 

In  the  context  of  an  application  for  an  applied-for  entry,  it  should  be  noted  that  a  stringent 
acceptance  methodology  applies  to  substances  of  known  severe  hazard,  as  prescribed  in 
Section 1.1  of  Annex VI  of  Commission  Implementing  Decision  (EU)  2024/365.  Starting 
substances and organic cementitious constituents (in accordance with Annex V to the DWD, only 
if migrating at > 0.1 µg/l) which are: 

(a) classified as (i) Category 1A or 1B for carcinogenicity, mutagenicity or reproductive 
toxicity,  (ii)  Category  1  for  endocrine  disruption  for  human  health,  (iii)  persistent 
bioaccumulative  and  toxic,  (iv)  very  persistent  and  very  bioaccumulative ( 2),  (v) 
persistent mobile and toxic, or (vi) very persistent and very mobile under Regulation 
(EU) 1272/2008; or 

(b) identified  as  substances  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, 

should in principle be avoided from use in the manufacture of drinking water contact materials. 
For them to be allowed in the corresponding EUPL, and thus allowed to be used, they must meet 
specific  strict  requirements,  as  prescribed  in  Section 1.1  of  Annex VI  of  Commission 
Implementing Decision (EU) 2024/365: 

(a) they are a monomer of a main polymer of the contact material; and 

(b) their concentration at the tap (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  to  account  for 
multiple routes of exposure to the substance, besides exposure via materials used in 

(2)  As  provided  in  the  mirror  provision  of  Annex V  to  the  same  regulation  (Section 1.1(c)(iii);  Commission 
Implementing Decision (EU) 2024/365 erroneously refers to ‘very persistent and very toxic’, which does not exist 
under Regulation (EU) No 1272/2008. 

 
 
 
 
 
 
 
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Guidance on the DWD: Volume III 
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products in contact with water intended for human consumption; and 

(c) their concentration 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); 

In the case of a relevant chemical species that is a non-intentionally added species (NIAS) or a 
substance constituent of a starting substance or of an organic cementitious constituent, where 
the relevant chemical species shows one of the severe hazards presented above, for the applied-
for  entry  to  be  allowed  in  the  corresponding  EUPL,  and  thus  to  allow  its  use,  the  NIAS  or  a 
substance  constituent  must  meet  strict  requirement  (b)  regarding  their  Ctap  value  and,  in  the 
case of an impurity or a substance constituent, they must in addition meet strict requirement 
(c) regarding their concentration in the final material. 

Finally, in the context of an application for an applied-for entry, it should be noted that specific 
rules apply to the identification of relevant chemical species in relation to monomers or other 
reactant of a main polymer, as set out in Section 3 of Annex IV of Commission Implementing 
Decision  (EU)  2024/365.  Starting  substances  and  organic  cementitious  constituents  which 
function as a monomer or other reactant of a main polymer in the material are always considered 
relevant chemical species, irrespective of their human health hazard properties. In such a case, 
even  if  the  starting  substance  migrates  below  0.1 μg/l,  it  must  be  applied  for  at  ECHA.  The 
reason  for  this  is  that  Section 2.2.3  of  Annex I  to  Commission  Implementing  Decision  (EU) 
2024/368 on the testing of final materials as used in products requires that organic materials 
shall be made of starting substances listed in the EUPL for organic materials, including monomers 
which are not exempt from listing even if accompanied by migration into water that is lower than 
0.1 μg/l. 

In contrast to starting substances and organic cementitious constituents, no exemption from the 
requirement for listing on the EUPL is provided for metallic compositions or enamels, ceramic or 
other  inorganic  compositions.  In  other  words,  a  metallic,  enamel,  ceramic  or  other  inorganic 
composition can only be used in the manufacture of materials in contact with water intended for 
human consumption if they are present in the corresponding EUPL. 

2.2. Requirements on the scope of a DWD application based on the 
provisions of the implementing legislation 

2.2.1. Requirement for applications for an individual starting substance, 
composition or constituent or a single nanoform 

According  to  Article 3(3)  of  Commission  Delegated  Regulation  (EU)  2024/369,  ‘an  application 
from  a  relevant  authority  may  cover  several  starting  substances,  compositions,  organic 
cementitious constituents, nanoforms or entries. On the other hand, an application from a person 
other  than  a  relevant  authority  shall  cover  only  one  starting  substance,  composition,  organic 
cementitious constituent or nanoform’. In practice, this means that where a material is made of 
several  substances  (for  example,  a  polymer  material  made  of  monomers,  additives,  polymer 
production  aids,  aids  to  polymerisation,  etc.),  an  economic  operator  will  submit  separate 
applications for the approvals of each one of the substances; certain information, however, may 
be  common  in  the  submitted  dossiers,  for  example  the  description  of  uses  or  the  migration 
assessment. 

2.2.2. Review applications for group entries 

Recital  (7)  of  Commission  Implementing  Decision  (EU)  2024/367  explains  that  ‘Based  on 
notifications from Member States, the first European positive lists include group entries covering 
multiple  starting  substances,  compositions  or  constituents’  and  that  ‘group  entries  should 

 
 
 
 
 
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progressively  be  replaced  in  the  European  positive  lists  by  the  individual  starting  substances, 
compositions or constituents in the group and the economic operator should only be able to rely 
on such group entries for the first European positive list if it is able to demonstrate the safety of 
its starting substance, composition or constituent.’ 

Group entries in the first EUPL can be found in: 

•  Table 2  of  Annex I  of  Commission  Implementing  Decision  (EU)  2024/367,  for  organic 

materials; 

•  Table 2  of  Annex II  of  Commission  Implementing  Decision  (EU)  2024/367,  for  metallic 

materials; and 

•  Table 3 of Annex III of Commission Implementing Decision (EU) 2024/367, for cementitious 

materials. 

In practical terms, review applications for entire group entries cannot be submitted by economic 
operators. What is allowed to be submitted to ECHA are review applications for individual starting 
substances, compositions or constituents which fall within the boundaries of an existing group 
entry. 

Exceptionally and theoretically, if the applicant could demonstrate and justify that an existing 
group entry had been incorrectly identified as a group one, they might submit an application for 
the individual entry which has been incorrectly labelled as a group. 

If review applications are submitted for one or more specified members of a group entry, upon 
approval of the authorisation of such members of the group, these members of the group will 
replace the previous group entry in the EU positive list. Thereafter, only those specific members 
of the original group shall be considered authorised for use in the manufacture of materials in 
contact with drinking water. 

2.2.3. Starting substances and organic cementitious constituents considered 
authorised by Annexes I and III of Commission Implementing Decision (EU) 
2024/367 

In the case of starting substances for organic materials and organic constituents for cementitious 
materials,  Annexes I  and  III  of  Commission  Implementing  Decision  (EU)  2024/367  consider 
certain substances as approved for use in the respective materials without a need for their listing 
in the EUPL. More specifically, the salts of acids, phenols and alcohols which are authorised in 
the organic EUPL or cementitious EUPL are considered covered by that authorisation:  

•  aluminium 

•  europium 

•  manganese 

•  ammonium 

•  gadolinium 

•  potassium 

•  barium 

• 

• 

• 

calcium 

cobalt 

copper 

• 

• 

• 

iron 

lanthanum 

lithium 

•  magnesium 

•  podium 

• 

• 

terbium 

zinc. 

This is subject to compliance with the corresponding MTCtap values for the element or ion shown 
for organic and cementitious materials in Annex V of Commission Implementing Decision (EU) 

 
 
 
 
 
 
 
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2024/367.  Where  the  corresponding  acid,  phenol  or  alcohol  is  not  present  in  the  EUPL,  the 
presence of a specific salt of it does not extend its approval to either the acid, phenol or alcohol 
or any other of its salts. 

Furthermore, in the case of organic materials, mixtures obtained by mixing authorised starting 
substances  without  a  chemical  reaction  of  the  components  are  considered  covered  by  that 
authorisation. 

2.2.4. Water as a starting substance for organic materials 

Water may be used as a starting substance in the manufacture of organic materials that come 
into contact with water intended for human consumption and is considered as covered by any 
entry for a starting substance with which it is used without a need for it to be listed in the organic 
materials EUPL. 

2.2.5. Cross-approvals among the different EUPLs 

Annexes I and III of Commission Implementing Decision (EU) 2024/367 allow the use of certain 
entries of one EUPL in contact materials of another type. More specifically, this applies to the 
approval of entries in the metallics, cementitious and inorganic EUPLs for use in organic materials 
under certain conditions, and the use of fibres of compositions listed in the metallics EUPL as 
additives  in  cementitious  materials.  The  details  of  these  cross-approvals  are  summarised  in 
Table 1. 

Table 1. Approvals for the use of entries in an EUPL in materials of a different type 

Approved for use in organic materials 

Entries in the 
organics 
EUPL 

N/A 

Entries in the 
metallics 
EUPL 

Fibres made of metallic compositions 
approved in the metallic materials EUPL may 
be used in organic materials and shall adhere 
to the requirements of Annex II of 
Commission Implementing Decision (EU) 
2024/367 

Approved for use in cementitious 
materials 

Stating substances approved in the 
organic materials EUPL for use in the 
manufacture of (i) coatings, which 
are also authorised to be used as 
organic additions, or (ii) organic 
fibres (polymer fibres or bunding 
aids) in cementitious materials 

Fibres made of metallic compositions 
approved in the metallic materials 
EUPL are also authorised for use in 
cementitious materials 

Entries in the 
cementitious 
EUPL 

Organic cementitious constituents approved 
in the cementitious materials EUPL may be 
used in organic materials when used as 
constituents in cementitious fillers 

— 

 
 
 
 
 
 
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Approved for use in organic materials 

Approved for use in cementitious 
materials 

Entries in the 
enamels, 
ceramic and 
other 
inorganics 
EUPLs 

Ceramic compositions approved in enamels, 
ceramic and other inorganic materials EUPL 
may be used as fillers in organic materials 
and shall adhere to the requirements of 
Annex IV of Commission Implementing 
Decision (EU) 2024/367 

— 

Fibres and microballs made of glass 
compositions approved in the enamels, 
ceramics and other inorganic materials 
EUPLs may be used in organic materials, 
provided that each filament has a diameter 
above 1 µm and the average diameter of the 
filaments in the organic material is above 
5 µm and shall adhere to the requirements 
of Annex IV of Commission Implementing 
Decision (EU) 2024/367 

2.2.6. Applications for monomers and polymeric substances for organic 
materials 

In the case of organic materials, polymers may be present in the material in contact with drinking 
water. However, under certain conditions, the substance to be listed in the corresponding EUPL 
and thus any application submitted to ECHA should be for the monomer rather than the polymer 
itself. Table 2 explains the conventions that should be followed to establish the requirements on 
the  polymer  and  monomer.  Table 3  further  explains  the  information  requirements  for  the 
monomer, the polymer and other relevant chemical species when submitting an application for 
a starting substance. 

Table 2. Selection between a polymer or its monomer(s) as the applied-for substance in the 
case of organic materials 

Scenario 

Important parameters 

Polymer is 
used as main 
structural 
component of 
the material 

An application to the agency shall 
evaluate the presence of 
polymerised parts (< 1 000 Da) that 
are relevant to the use of the 
monomer or other reactant (see 
point 3.4. of Annex II to Commission 
Implementing Decision (EU) 
2024/365) 

Polymer used 
as an additive 

• 

• 

Polymeric additive has a 
molecular weight > 1 000 Da 
and 
Polymeric additive is not 
obtained from microbial 
fermentation 

Required entry in 
the EUPL 

Applied-for entry in an 
application to the 
agency 

Monomer or other 
reactant 

Monomer or other 
reactant 

Monomer or other 
reactant 

Monomer or other 
reactant 

 
 
 
 
 
 
 
 
 
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Required entry in 
the EUPL 

Applied-for entry in an 
application to the 
agency 

Polymeric additive 

Polymeric additive 

Pre-polymer 

Pre-polymer 

Scenario 

Important parameters 

Pre-polymer 

• 

• 

• 

• 

• 

Polymeric additive has a 
molecular weight < 1 000 Da 
or 
Polymeric additive is obtained 
from microbial fermentation 

Pre-polymer is an 
organopolysiloxane used in the 
manufacture of silicones, 
rubbers, lubricants and surface 
treatment for fillers 
or 
Pre-polymer is used in the 
manufacture of organic coatings 

Pre-polymer is not relevant to 
organopolysiloxanes or coatings 

Monomer or other 
reactant 

Monomer or other 
reactant 

 
 
 
 
 
 
 
 
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Table 3. Guidance for the preparation of an application for a monomer (or other reactant) or a polymer as a starting substance for organic materials in 
contact with drinking water 

Legal 
act 

Relevant aspect 
of an application 
to ECHA 

Organopolysiloxane pre-
polymers (3) in: 
• 
silicones, 
• 
rubbers, 
• 
lubricants, 
• 
surface treatment for fillers. 

Coatings (
4) 

Polymer not intended to be 
used as an additive (5) 

Polymer intended to be used as an additive 

No microbial fermentation 

Microbial 
fermentation (6) 

MW ≥ 1 000 Da 

MW 
< 1 000 Da 

2024/
367 

EUPL entry 
applied for (the 
‘starting 
substance’) 

MTCtap and 
specific 
conditions of use 

EUPL entry 
extended to 
include 

2024/
369 

Application 
(Article 3(4)) 

2024/
365 

Set of SID 
information 
(Annex I, in 
particular 
point 1.5.) 

One for each pre-polymer  

One for the monomer (or one 
other reactant) 

One for each monomer and 
one for each other reactant 

One for the polymer 

One MTCtap for each entry applied for and one MTCtap for each of its relevant chemical species, potentially conditions of use (e.g. use only within the 
manufacture of a certain (co-)polymer) 

If the EUPL entry names the monomer, then all polymerised parts < 1 000 Da and polymers are covered by that 
EUPL entry (and may be accompanied by their own conditions of use, e.g. an MTCtap value) 

/ 

One pre-polymer  

One monomer or other reactant  One monomer or other 

One polymer 

reactant 

One for each pre-polymer 
(with data on monomer and other reactants, 
additives to (pre-)polymer, polymerised part 
(< 1 000 Da), etc.) 

One for the monomer (or other 
reactant) 
(No data on polymer, which is 
addressed under the description 
of the ‘intended use’) 

One for each monomer / 
other reactant 
(No data on polymer, which 
is addressed under the 
description of the ‘intended 
use’) 

One for the polymer 
(with data on monomer and other 
reactants, polymerised parts 
(< 1 000 Da), etc.) 

(3)  Regardless of molecular weight. 
(4)  Regardless of molecular weight. 
(5)  Regardless of molecular weight or microbial fermentation. 
(6)  Regardless of molecular weight. 

 
 
 
 
 
 
 
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Legal 
act 

Relevant aspect 
of an application 
to ECHA 

Organopolysiloxane pre-
polymers (3) in: 
• 
silicones, 
• 
rubbers, 
• 
lubricants, 
• 
surface treatment for fillers. 

Guidance on the DWD: Volume III 
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Coatings (
4) 

Polymer not intended to be 
used as an additive (5) 

Polymer intended to be used as an additive 

No microbial fermentation 

Microbial 
fermentation (6) 

MW ≥ 1 000 Da 

MW 
< 1 000 Da 

Intended use 
(Annex II, point 2) 

NIAS other than 
impurities 
(Annex II, point 3) 

• 
• 

• 

Intended use and technical function of the monomer and the polymer 
Conditions of use: maximum dosage of the starting substance and other conditions of use for the polymer 

Any NIAS that originates from / links to the starting substance 

Test material for 
migration 
testing/modelling 

Potentially 
relevant chemical 
species 
(Annex IV, 
Section 1.4(a)) 

The polymer 

• 
• 
• 

Pre-polymer 
Any pre-polymer’s substance constituent 
Any NIAS 

NB: NIAS, may include monomer / polymerised 
part 

•  Monomer (or other 

•  Monomer or other 

reactant) 
Any monomer’s (or other 
reactant’s) substance 
constituent 
Any NIAS 

• 

• 

reactant 
Any monomer’s or 
other reactant’s 
substance constituent 
Any NIAS 

• 

• 

NB: NOT polymerised part 
(unless it is a degradation 
product and thus a NIAS) and 
NOT polymer 

NB: NOT polymerised part 
(unless it is a degradation 
product and thus a NIAS) 
and NOT polymer 

• 
• 

• 

Polymer 
Any polymer’s substance 
constituent 
Any NIAS 

NB: NOT monomer / other 
reactant and NOT polymerised 
part (unless the monomer / 
polymerised part qualifies as a 
degradation product and thus a 
NIAS) 

 
 
 
 
 
 
 
 
 
 
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Legal 
act 

Relevant aspect 
of an application 
to ECHA 

Organopolysiloxane pre-
polymers (3) in: 
• 
silicones, 
• 
rubbers, 
• 
lubricants, 
• 
surface treatment for fillers. 

Coatings (
4) 

Polymer not intended to be 
used as an additive (5) 

Polymer intended to be used as an additive 

No microbial fermentation 

Microbial 
fermentation (6) 

MW ≥ 1 000 Da 

MW 
< 1 000 Da 

19 

Relevant 
chemical species 
(Annex IV, 
Section 3,) 

• 

Any pre-polymer, its substance constituent 
and NIAS with: 
o  one of the human health hazards referred 

to in Section 1.1 of Annex VI of 
Commission Implementing Decision (EU) 
2024/365, irrespective of their levels of 
migration; or 
o  Ctap > 0.1 µg/l. 

NB: NOT monomer, NOT polymerised part 
(< 1 000 Da) and NOT polymer (unless, for 
monomer/polymerised part (< 1 000 Da), it is a 
degradation product and thus a NIAS which fulfils 
one of the two conditions above) 

Toxicity testing 
and risk 
assessment 

One set for each relevant chemical species 

•  Monomer (or other 

• 

• 

reactant) 
Any of its substance 
constituents and NIAS 
with: 
o 

one of the human 
health hazards 
referred to in 
Section 1.1 of 
Annex VI of 
Commission 
Implementing Decision 
(EU) 2024/365, 
irrespective of their 
levels of migration; or 

o  Ctap > 0.1 µg/l. 

NB: NOT polymerised part 
(unless it is a degradation 
product and thus a NIAS which 
fulfils one of the two conditions 
above) and NOT polymer 

Any monomer or other 
reactant, its substance 
constituent and NIAS 
with: 
o 

one of the human 
health hazards 
referred to in 
Section 1.1 of 
Annex VI of 
Commission 
Implementing 
Decision (EU) 
2024/365, 
irrespective of 
their levels of 
migration; or 
o  Ctap > 0.1 µg/l. 

NB: NOT polymerised part 
(unless it is a degradation 
product and thus a NIAS 
which fulfils one of the two 
conditions above) and NOT 
polymer 

• 

Any polymer, its substance 
constituent and NIAS with: 
o  CLH for CMR 1A/1B, ED 
one of the human health 
hazards referred to in 
Section 1.1 of Annex VI 
of Commission 
Implementing Decision 
(EU) 2024/365, 
irrespective of their 
levels of migration; or 

o  Ctap > 0.1 µg/l. 

NB: NOT monomer / other 
reactant and NOT polymerised 
part (unless the monomer / 
polymerised part qualifies as a 
degradation product and thus a 
NIAS which fulfils one of the two 
conditions above) 

 
 
 
 
 
 
 
 
 
 
 
 
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2.2.7. Identification of the applied-for organic cementitious constituent and 
the appropriate EUPL 

In the case of cementitious materials, constituents used in the manufacture of the material may 
be  listed  (and  applied-for)  either  in  the  cementitious  materials  EUPL  or  the  organic  materials 
EUPL. Table 4 explains which EUPL applies for different organic cementitious constituents, and 
which should be assumed the applied-for entry to be. The issues surrounding admixtures are of 
particular importance. 

•  What  is  an  admixture  for  the  purposes  of  a  DWD  application?  On  one  hand, 
Article 2(10)  of  the  directive  defines  starting  substance  as  ‘a  substance  that  has  been 
intentionally added in the production of organic materials or of admixtures for cementitious 
materials’.  On the other hand, Annex V, Section 3 of the directive only refers to (organic) 
constituents. For the purposes of DWD applications, substances (which are components) in 
admixtures are treated as organic cementitious constituents and are to be applied for listing 
in the EUPL (similarly to a starting substance for organic materials). 

•  What  requirements  apply  for  polymeric components  of  admixtures? In the  specific 
case  of  these  chemicals,  the  polymer  is  the  organic  cementitious  constituent  and  is  the 
applied-for entry. However, exceptionally, for reasons of regulatory clarity and practicality, 
the EUPL will list the individual monomer(s) that are used to manufacture the polymer. The 
conditions of use of the monomers will describe their use as monomers in the manufacture 
of specific polymeric components of admixtures. 

Table 5 explains the information requirements for the monomer, the polymer and other relevant 
chemical species when applying for an organic cementitious constituent. 

 
 
 
 
 
 
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Table 4. Guidance for selecting the appropriate EUPL and identifying the applied-for entry in an application for organic constituent for cementitious 
materials in contact with drinking water 

Generic constituent 
category 

(category of ingredient 
of a cement-based 
mixture) 

Types of specific organic cementitious 
constituents within the scope of the 
EUPLs 

(specific types of ingredient of a cement-
based mixture that need to be approved 
in the EUPL) 

Cement 

Organic grinding aids or other organic 
substances used for the preparation of 
cement 

NB: For the purposes of product certification 
under Commission Delegated Regulation (EU) 
2024/370, if the grinding aid is present at 
< 0.2 % wt. in the cement, the material will 
be considered as organic-free (no GC-MS 
screening and no specific migration testing 
will take place); however, if an organic 
substance is present at ≥ 0.02 % wt. in the 
grinding aid constituent, it must be declared 
in the formulation and be listed in the EUPL 

EUPL the application should be 
submitted for 

Identification of the applied-for entry 

Cementitious materials EUPL only 

An organic substance which: 

(a)  has the technical function of a grinding aid; 

or 

(b)  is a component of a mixture which acts as 

a grinding aid; or 

(c)  is another organic substance used in the 

preparation of cement. 

Inorganic additions 

Organic grinding aids or other organic 
substances used for the preparation of 
inorganic additions 

NB: See note above 

Cementitious materials EUPL only 

An organic substance which: 

(a)  has the technical function of a grinding aid; 

or 

(b)  is a component of a mixture which acts as 

a grinding aid; 

(c)  is another organic substance used in the 

preparation of inorganic additions. 

Aggregates 

Not relevant 

Not relevant 

Not relevant 

 
 
 
 
 
 
 
 
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Generic constituent 
category 

(category of ingredient 
of a cement-based 
mixture) 

Types of specific organic cementitious 
constituents within the scope of the 
EUPLs 

(specific types of ingredient of a cement-
based mixture that need to be approved 
in the EUPL) 

EUPL the application should be 
submitted for 

Identification of the applied-for entry 

Mixing water 

Not relevant 

Not relevant 

Not relevant 

Organic additions 

(> 5 % by mass of the 
inorganic binder (cement) 
content of the 
cementitious material) 

Organic substances, assumed to be polymeric 
dispersions or powders 

No application is to be 
submitted if the organic addition is 
made of starting substances which 
are all authorised in the organic 
materials EUPL for use in the 
manufacture of coatings 

A separate application for the approval of the 
substance on the cementitious EUPL in relation to 
its use of the substance in cementitious mixtures is 
not necessary; however, potential applicants need 
to be aware of the conditions of use and the expiry 
date presented within the relevant starting 
substances in the organics EUPL 

Cementitious materials EUPL if 
at least one the starting substances 
that are used to make the organic 
addition is not already authorised in 
the organics EUPL for use in the 
manufacture of coatings, and there 
is no interest such coatings use 

Organic materials EUPL for use 
in coatings if there is a wish for 
the starting substances of the 
organic addition to also be allowed 
to use in the manufacture of 
coatings 

For the inclusion of an organic addition (typically a 
polymeric dispersion or powder) into the 
cementitious EUPL, the application must be made 
for the polymer itself 

For the inclusion of the starting substances of the 
organic addition into the organics EUPL, the 
application must be made for all required starting 
substances individually 

 
 
 
 
 
 
 
 
 
 
 
 
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Generic constituent 
category 

(category of ingredient 
of a cement-based 
mixture) 

Types of specific organic cementitious 
constituents within the scope of the 
EUPLs 

(specific types of ingredient of a cement-
based mixture that need to be approved 
in the EUPL) 

Admixtures 

(< 5 % by mass of the 
inorganic binder (cement) 
content of the 
cementitious material) 

Organic substances intentionally added in the 
production of admixtures for cementitious 
materials 

EUPL the application should be 
submitted for 

Identification of the applied-for entry 

Cementitious materials EUPL only 

(a)  An organic substance that (i) is a 

component of an admixture, and (ii) has an 
auxiliary role in the admixture, and (iii) is 
typically not the polymeric component 
which delivers the key technical 
functionality of the admixture 

(b)  Exceptionally, for polymeric components of 
admixtures which deliver the key technical 
functionality of the admixture, the applied-
for substance will be the polymer, but for 
reasons of regulatory clarity and 
practicality, the individual monomer(s) will 
be listed in the EUPL for cementitious 
materials and the polymer will be 
considered to be covered by the entries for 
the monomer(s) 

(c)  If the polymeric component is made of pre-

polymers, the pre-polymer does not need to 
be applied for if its monomer(s) are already 
listed in the EUPL. If the monomer(s) are 
not listed, the application will be made for 
the pre-polymer but the individual 
monomer(s) will be listed in the EUPL for 
cementitious materials and the pre-polymer 
will be considered to be covered by the 
entries for the monomer(s) 

 
 
 
 
 
 
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Generic constituent 
category 

(category of ingredient 
of a cement-based 
mixture) 

Types of specific organic cementitious 
constituents within the scope of the 
EUPLs 

(specific types of ingredient of a cement-
based mixture that need to be approved 
in the EUPL) 

EUPL the application should be 
submitted for 

Identification of the applied-for entry 

Organic fibres 

Organic substances 

Organic materials EUPL only 

Metallic fibres 

Not relevant 

Metallic materials EUPL only 

A separate application for the approval of the 
substance on the cementitious EUPL in relation to 
its use of the substance in cementitious mixtures is 
not necessary; if any of the starting substances 
required for the manufacture of the fibre used in 
cementitious materials is not listed in the organic 
materials EUPL, an application for its inclusion into 
that list will be required. The organic materials 
EUPL is similarly relevant for the listing of organic 
substances which are used for banding aids and 
surface treatment (sizing) 

If the metallic composition is not listed in the 
metallic materials EUPL, an application for its 
inclusion into that list will be required 

Formwork release agents 

Organic substances 

Cementitious materials EUPL only 

An organic substance which: 

(a)  has the technical function of a formwork 

release agent; or 

(b)  is a component of a mixture which acts as 

a formwork release agent. 

Curing compounds 

Organic substances 

Cementitious materials EUPL only 

An organic substance which: 

(a)  has the technical function of a curing 

compound; or 

(b)  is a component of a mixture which acts as 

a curing compound. 

 
 
 
 
 
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Table 5. Guidance for the preparation of an application for a monomer or a polymer as an organic constituent for cementitious materials 
in contact with drinking water 

Legal act 

Relevant aspect of an application to ECHA  Admixture 

2024/367 

Applied-for entry (the ‘organic 
cementitious constituent’) 

The polymer 

Other generic constituent 
categories  

Same as for a starting 
substance 

Listed entry in the EUPL table  

One entry for each monomer  

MTCtap and specific conditions of use  

•  One MTCtap for each monomer and one MTCtap for 

2024/369 

2024/365 

Application 
(Article 3(2)) 

Set of SID information 
(Annex I) 

Intended use (point 2, Annex II) 

NIAS other than impurities (point 3, 
Annex II) 

each of its relevant chemical species 

•  Specific conditions of use: only for use with the 
other monomer(s) covered by the application to 
generate a specific polymeric substance 

For the polymer covering all monomers used to 
manufacture it 

• 
For the polymer (points 1.1 to 1.5. of Annex I) 
•  One for each monomer (points 1.1. and 1.2. of 

Annex I) 

• 

Intended use and technical function of the 
monomer(s) and the polymer 

•  Conditions of use: maximum dosage of the 

starting substance and other conditions of use for 
the polymer 

•  Any NIAS, linked to either the monomers or 

• 

polymer 
Each NIAS should be linked to a specific monomer 
(for determining in which entry to include it in the 
EUPL; otherwise, it would be listed in each one) 

Test material for migration 

The cementitious material that contains the polymer 

 
 
 
 
 
 
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Relevant aspect of an application to ECHA  Admixture 

Guidance on the DWD: Volume III 
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Other generic constituent 
categories  

testing/modelling 

Potentially relevant chemical species 
(Section 1.1.4(a), Annex IV) 

Relevant chemical species 
(Section 3, Annex IV) 

•  Monomers 
•  Any monomer’s substance constituent 
•  Any NIAS 

NB: NOT a polymerised part (unless it is a degradation 
product and thus a NIAS) and NOT the polymer 

•  Any monomer, its substance constituent and NIAS 

with: 
o  one of the human health hazards referred to in 

Section 1.1. of Annex VI of Commission 
Implementing Decision (EU) 2024/365, 
irrespective of their levels of migration; or 

o  Ctap > 0.1 µg/l. 

NB: NOT polymerised part (unless it is a degradation 
product and thus a NIAS which fulfils one of the two 
conditions above) and NOT polymer 

Toxicity testing and risk assessment 

One set for each relevant chemical species 

 
 
 
 
 
 
 
 
 
 
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3. Timeline of application of the first EUPLs and role of 
expiry dates 

3.1. Date of application of the first EUPLs and transitional provisions 

According  to  Article 4  of  Commission  Implementing  Decision  (EU)  2024/367,  the  first  EUPLs 
apply from 31 December 2026. Until then, national rules and provisions apply. This also means 
that until 31 December 2026, the presence or absence of a starting substance, composition or 
constituent in the first EUPLs does not play a limiting role to its use in the manufacture of drinking 
water contact materials. 

Further, according to Article 3  of  Commission  Implementing Decision  (EU) 2024/367, starting 
substances,  compositions  and  constituents  which  have  been  approved  by  a  Member  State 
competent  authority  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 
drinking water intended for human consumption until 31 December 2032 provided they comply 
with the parametric value of 5 μg/l Pb (lead) at the tap as set out in Part B of Annex I to Directive 
(EU) 2020/2184. Their  use during this transitional period beyond the territory  of the  Member 
State which approved the starting substance, composition or constituent will be subject to any 
applicable national provisions as of the end of 2026, since the EU approval system will still not 
apply  to  the  affected  products.  Consequently,  for  their  use  to  be  allowed  across  the  EU  from 
1 January 2033, they must be listed in the corresponding EUPL. If such authorisation on an EUPL 
is not valid on 1 January 2033, the use of that starting substance, composition or constituent 
must be stopped. 

3.2. Role of expiry dates 

Each entry in the EUPLs is accompanied by an expiry date. For an entry already present in the 
EUPL for which a review application is successfully submitted to ECHA no later than 18 months 
prior to the expiry date, including a review application for a substance that is a member of an 
already listed group entry, in accordance with Article 4(9) of Commission Delegated Regulation 
(EU) 2024/369, the entry shall remain valid after its expiry date until the Commission decides 
on the application to review. 

Conversely, for a starting substance, composition or constituent that is not present on the EUPL, 
its use can only be allowed in the manufacture of drinking water contact materials that are placed 
on the EU market upon the adoption of a positive decision by the Commission for the addition 
of that new entry into the relevant EUPL. Therefore, applicants are advised to consider the time 
that may be required for (a) submitting their notification of intention and their application, and 
(b) the subsequent assessment of their application by ECHA’s Committee for Risk Assessment 
(RAC)  and  the  Commission’s  decision  before  the  new  entry  may  be  allowed  into  the  relevant 
EUPL. 

3.3. Transitional provisions 

According  to  Article 3  of  Commission  Implementing  Decision  (EU)  2024/367,  ‘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  2032,  provided  they 
comply with the parametric value of 5 µg/l Pb (lead) at the tap as set out in Part B of Annex I to 
Directive (EU) 2020/2184’. 

27 

 
 
 
 
 
 
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Starting substances, compositions and constituents that meet the requirements allowing them 
to  continue  to  be  used  during  the  transitional  period  between  the  adoption  of  Commission 
Implementing Decision (EU) 2024/367 and 31 December 2032 would be required to be listed in 
the  relevant  EUPL  in  order  for  their  use  to  be  allowed  in  the  EU  after  31 December  2032.  In 
order to avoid interruption to the approval status of such a starting substance, composition or 
constituent, applicants are advised to consider the time that may be required for submitting their 
notification of intention and their application, and the subsequent assessment of their application 
by the RAC and the Commission, so that a positive decision by the Commission may be adopted 
by the end of the transitional period. 

In this context, it is also relevant to consider the date of application and the delayed application 
of the rules on the conformity assessment procedures for the certification of products that come 
into contact with drinking water prescribed by Commission Delegated Regulation (EU) 2024/370. 
Article 11 of that regulation states: ‘For products which are assessed to be in conformity with 
national  hygiene  requirements  for  products  that  come  into  contact  with  water  intended  for 
human  consumption  and  for  which  the  national  certificate  of  conformity  is  still  valid  on 
31 December 2026, it shall apply from 31 December 2032’. There is no definition of ‘certificate’ 
in  this  regulation,  but  a  certificate  should  be  understood  to  be  a  written  assurance  that  the 
product complies with the relevant national hygiene requirements. There is also no definition of 
‘national conformity certificate’ under the regulation. Nevertheless, according to Article 11 and 
the associated  recital (7) of the regulation, the ‘national conformity certificate’  of the product 
should be understood as a (written) assurance establishing that the product complies with the 
relevant national hygiene requirements. 

Table 6 explains the timeline of validity and expiration status for different starting substances 
compositions and constituents, depending on their listing on the first EUPL while referring to the 
provisions of the legislation on the certification of products. 

 
 
 
 
 
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Table 6. Timeline of approval status for different types of starting substances, compositions and constituents and product certification requirements 

Scenarios for different 
starting substances, 
compositions and 
constituents 

Period: until 31.12.2026 (at 
23:59) 

Period: 1.1.2027 (at 00:00) to 
31.12.2032 (at 23:59) 

Period: from 1.1.2033 (at 
00:00) onwards 

Approval status of a 
starting substance, 
composition or 
constituent 

Present in the first EUPL 
(on its own or as a 
member of a listed group 
entry) 

The provisions of the first EUPL do 
not apply. Approval of the starting 
substance, composition or 
constituent depends on national 
provisions which continue to be 
valid 

The starting substance, composition or constituent is approved for use until 
its expiry date. Exceptionally, the entry will not expire if an applicant 
successfully submits a review application to ECHA at least 18 months before 
the expiry date shown in the EUPL. Thereafter, the entry will expire by the 
date indicated in the decision of the Commission 

Not present in the first 
EUPL and no Member 
State approval in the 
period 13.7.2021 to 
31.12.2026 

The provisions of the first EUPL do 
not apply. Approval of the starting 
substance, composition or 
constituent depends on national 
provisions which continue to be 
valid 

The starting substance, composition or constituent is not approved for use. 
It may only be approved for use after a positive decision by the Commission 
as a result of an application submitted to ECHA. Applications to ECHA can 
only be submitted on 31/12/2026 at the earliest and should be preceded by 
the submission to ECHA of a notification of intention to apply (see Articles 2 
and 3 of Commission Delegated Regulation (EU) 2024/369) 

Not present in the first 
EUPL, but approved by a 
Member State under 
national rules in the period 
13.7.2021 to 31.12.2026 

Approval for use depends on national provisions which continue to apply, as 
long as the materials and products comply with the parametric value of 
5 μg/l Pb (lead) at the tap. as set out in Part B of Annex I to the DWD 

The starting substance, composition 
or constituent is not approved for 
use. It may only be approved for 
use after a positive decision by the 
Commission as a result of an 
application submitted to ECHA 

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Validity status of 
certificates of 
conformity for 
products 

Guidance on the DWD: Volume III 
Version 1.0 – January 2025 

Scenarios for different 
starting substances, 
compositions and 
constituents 

Period: until 31.12.2026 (at 
23:59) 

Period: 1.1.2027 (at 00:00) to 
31.12.2032 (at 23:59) 

Period: from 1.1.2033 (at 
00:00) onwards 

The provisions of Commission 
Delegated Regulation (EU) 
2024/370 do not apply. Until 
31 December 2026, national 
product certificates continue to be 
valid 

Products require an EU-wide 
certificate of conformity that reflects 
the status of the EUPL, with the 
following exception: 
• 

for products for which the 
national conformity certificate is 
still valid on 31 December 2026, 
the provisions of Commission 
Delegated Regulation (EU) 
2024/370 do not apply. 

Products need an EU-wide 
certificate of conformity that 
reflects the status of the EUPL. 
National product certificates are no 
longer valid 

 
 
 
 
 
 
 
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4. Potential applicants and the role of ‘representatives’ 

4.1. Who can the applicant be? 

According  to  Article 11(5)  of  the  DWD,  applicants  can  be  ‘economic  operators  or  relevant 
authorities’.  The  term  ‘economic  operator’  is  not  defined  in  the  DWD  or  the  implementing 
legislation ( 7). 

Recital (2) of Commission Delegated Regulation (EU) 2024/369 says that ‘potential applicants 
should be encouraged to group their efforts and avoid unnecessary animal testing by preparing 
a  single  application  for  the  same  starting  substance,  composition  or  constituent’.  Since  the 
implementing  legislation  encourages  the  grouping  of  efforts  among  potential  applicants,  the 
role of an applicant should support the goal of collaboration. This goal can be supported if the 
applicant’s role can thus be played by a variety of natural and legal persons established in the 
EU. For example, an applicant may be: 

•  a manufacturer or importer of the applied-for entry; 

•  a distributor of the applied-for entry; 

•  an industrial or professional user of the applied-for entry; 

•  a manufacturer, importer, distributor or user of a material or product that is manufactured 

by using the applied-for entry; but also 

•  a  natural  or  legal  person  that  acts  on  behalf  of  a  group  of  economic  operators,  for 
example an industry consortium, an industry association or a consultant. In such a case, 
this  natural  or  legal  person  shall  submit  a  DWD  application  and  take  over  the  tasks  and 
responsibilities of the DWD application process on behalf of the group. 

Guidance  on  intellectual  property  rights  and  data  sharing  among  economic  operators  is 
provided in section 1.5. of DWD Guidance Volume I. 

Beyond economic operators, a relevant (competent) authority of a Member State may also play 
the role of the applicant. 

4.2. The role of ‘representatives’ 

According  to  Article 3(3)  of  Commission  Delegated  Regulation  (EU)  2024/369,  ‘applicants 
established in the Union, other than a relevant authority, may also appoint a representative’. 

Recital (7) of the same regulation explains that ‘in order to protect confidential information, an 
applicant other than a relevant authority  should be allowed to appoint a representative that 
can be named instead of that economic operator in any public communication purpose’. 

(7)  Other legislation may be considered to infer the scope of the term ‘economic operator’, for example Article 3(22) 
of  the  batteries  regulation  (Regulation  (EU)  2023/1542,  https://eur-lex.europa.eu/eli/reg/2023/1542/oj), 
(EU)  2023/988,  https://eur-
Article 3(13)  of 
lex.europa.eu/eli/reg/2023/988/oj)  or  Annex I,  Article R1.6(7)  of  Decision  No 768/2008/EC  (https://eur-
lex.europa.eu/eli/dec/2008/768(1)/oj). 

the  general  product  safety 

(Regulation 

regulation 

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Thus, in the case of EU applicants for DWD applications, the role of representatives is to be 
considered as follows: 

• 

• 

• 

• 

the use of a representative is optional; 

the representative can be used only with the intention to not disclose the applicant’s identity 
in any public communication (e.g. ECHA would publish the name and contact email address 
of the representative in connection to a notification of intention); 

the role of a representative may be assumed by a natural or legal person established in the 
EU; 

the  legal  obligations  arising  from  the  DWD  implementing  legislation  remain  with  the  EU 
applicant and any communications with ECHA or requests for information will be addressed 
to the applicant, not their representative. 

On the other hand, Article 3(3) of Commission Delegated Regulation (EU) 2024/369 requires 
that ‘applicants not established in the Union shall appoint a representative established in the 
Union’. Thus, in the case of non-EU applicants for DWD applications, the role of ‘representatives’ 
is to be considered as shown below. 

•  The use of a representative is mandatory. 

•  The role of a representative must be assumed by a natural or legal person established in 
the EU, that has been appointed to act on behalf of one or more natural or legal persons 
not  established  in  the  EU  and  that  is/are  a  manufacturer,  importer,  distributor  or 
professional user  of  starting substances, compositions,  organic cementitious constituents 
or materials or products in contact with water intended for human consumption. 

•  The  role  of  the  representative  is  to  submit  the  application  on  behalf  of  the  non-EU 
company/ies and be responsible for cooperating with and responding to any communication 
from ECHA and the Commission throughout and after the DWD application process (e.g. 
respond to technical and administrative questions from ECHA; provide a full study report 
for any study referred to in the application or provide comments on the draft RAC opinion; 
keep  records  and  make  them  available  upon  request  under  Article 13  of  Commission 
Delegated Regulation (EU) 2024/369). 

•  The representative must be a natural or legal entity officially established in the EU according 
to national legislation and must have an EU official address where they can be contacted 
by  the  enforcement  authorities  and  ECHA.  Most  Member  States  require  that  the  official 
address  of  a  representative  is  in  the  Member  State  where  they  are  established.  A 
representative  should  have  sufficient  background  in  the  information  relating  to  starting 
substances, compositions and constituents. 

The key characteristics of representatives in both cases are summarised in Table 7. 

 
 
 
 
 
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Table 7. Roles of a ‘representative’ for the purposes of DWD notifications of intention and applications 

Applicant 
type 

Necessity of a 
representative 

Role of a representative 

Legal status of the 
representative 

Notification about the 
representative role to ECHA 

Contact information to be 
published  

Optional 

EU-based 
economic 
operator(s) 

•  Conceal the applicant’s 
identity from the public 
•  Act as initial contact point 
for potential applicants of 
the same starting 
substance, composition or 
constituent who may want 
to group efforts for an 
application 

Natural or legal person 
established in the EU 

The EU-based applicant will 
provide the information of the 
representative to ECHA 

Natural or legal person 
established in the EU 

Mandatory 

•  Act as an application 

submitter; communicate 
with ECHA for all application 
purposes; assume the legal 
obligations of the applicant 
•  Act as initial contact point 
for potential applicants of 
the same starting 
substance, composition or 
constituent who may want 
to group efforts for an 
application 

The EU-based representative 
will interact with ECHA 
and will identify both 
themselves and the non-EU 
economic operator(s) they 
represent. Proof of the 
contractual relationship 
between the non-EU economic 
operator(s) and the EU-based 
representative needs to be 
available upon request 

Non-EU-
based 
economic 
operator(s) 

EU-based 
relevant 
authority 

EU-based economic operator 
name and email address unless 
a representative is used; in the 
latter case, the representative’s 
name and email address are 
published 

EU-based representative’s 
name and email address 

Not relevant 

Not relevant 

Not relevant 

Not relevant 

EU-based relevant authority’s 
name and email address 

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4.3. Potential applicants in European Free Trade Association countries 

For  the  purposes  of  applications  submitted  to  ECHA  under  Article 11  of  the  DWD,  economic 
operators established in European Free Trade Association (8) countries (Iceland, Liechtenstein, 
Norway and Switzerland) or Northern Ireland are considered to be non-EU applicants and the 
approach described for non-EU applicants above applies. 

(8)  The European Free Trade Association is an intergovernmental organisation set up for the promotion of free trade 
and economic integration to the benefit of its four Member States: Iceland, Liechtenstein, Norway and Switzerland.