EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA releva nce)   
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Directive (EU) No 2020/2184 of the European Parliament and of the Council of 16 December 
2020 on the quality of water intended for human consumption includes minimum hygiene 
requirements for materials that come into contact with water intended for human 
consumption.  
This Commission Delegated Regulation establishes the procedure to amend the European 
Positive Lists of substances, compositions or constituents established under Article 11(2)(b) 
of Directive (EU) 2020/2184.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTI ON  OF THE  ACT  
In the context of the development of this Regulation, the Commission carried out targeted 
consultations with stakeholders in the water sector and consulted Member States experts in 
meetings of the expert group on the implementation of the Dri nking Water Directive. The 
Commission also discussed this Regulation with Member States experts in meetings of the 
aforementioned expert group’s subgroup on substances  in contact with drinking water. The 
last Drinking Water Expert Group meeting took place on 16 June 2023, where stakeholders 
were invited to provide comments on this draft act.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
According to Article 11(5) of Directive (EU) 2020/2184, the Commission is to determine the 
conformity assessment procedure applic able to products covered by that Article. That 
procedure is to be used to demonstrate that those products fulfil  the requirements set out in 
Directive (EU) 2020/2184.  
The procedure will start with a notification of intent ion to the European Chemicals Agency 
(ECHA) (Article 2). Articles 3 to 6 set out information and time requirements to be respected 
by applicants, requirements for the consultation of interested parties and for opinions of the 
Committee for Risk Assessment (RA C) on applications. Articles 7 to 10 lay down rules on the 
management of information from applications submitted to ECHA. The application of this 
Regulation will be delayed by 2 years after its entry into force in order to align it with the date 
of applica tion of the drinking water contact materials  package , with the exception of the 
provisions on "notification of intent ion" to allow ECHA to assess the number of applications 
in advance (Article 1 4).  
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(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 2 020 on the quality of water intended for human consumption1, and in particular 
Article 11(5) thereof,  
Whereas:  
(1) Directive (EU) 2020/2184 provides for the establishment of European positive lists of 
starting substances, compositions, or constituents for each  type of materials, namely 
organic, metallic, cementitious, enamels, ceramic or other inorganic materials, which 
are authorised for use in the manufacture of materials or products that come into 
contact with water intended for human consumption. Applicatio ns for inclusion or 
removal and for the purpose of the review of starting substances , compositions or 
constituents from those lists are to be submitted to the European Chemicals Agency 
(ECHA). T he Commission is to establish the procedure for such applications.  
(2) 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. In addition, in order to allow for advance pl anning of the 
processing of applications and for these applications to be processed efficiently and in 
a timely manner, potential applicants must notify their intention to ECHA within  12 
months before submitting the application.   
(3) Persons not established in  the Union should be allowed to apply for inclusion in or 
removal from the European positive lists of a starting substance, composition or 
constituent provided that they appoint a representative established in the Union for that 
purpose.  
(4) In order to protec t human health, it should be possible for the Commission to initiate a 
procedure by request ing the Committee for Risk Assessment  of ECHA  to pre pare an 
opinion  on the inclusion or removal of a starting substance, composition or constituent 
in the European p ositive lists . 
(5) An application should contain all necessary information to assess the application in 
accordance with the testing and acceptance methodologies established in Commission 
Implementing Decision  (EU) …/… [OP: please fill in the reference of  C(202 3)7000 ].  
                                                 
1 OJ L 435, 23.12.2020, p. 1.   
EN 3  EN (6) In the case of a polymer with a high molecular weight which is used as an additive in 
an organic material and is not obtained from microbial fermentation, the application 
should be on the monomer , since the monomer  is expected to be more reactive  and 
thus more relevant for human health . Furthermore, assessing each and every polymer 
manufactured from such monomer would not be proportionate. In the case of a pre -
polymer for some silicones or for coatings, the assessment is more efficiently and 
propo rtionally addressed at the level of the pre -polymer. In the case of an admixture 
for cementitious material, the application should be for the polymer since the polymer 
may be composed of multiple monomers whose interaction can only be assessed if the 
appli cation is for the polymer.  
(7) 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.   
(8) The acco rdance check should ensure that only applications that are complete  and of 
sufficient quality are reviewed by the Committee for Risk Assessment  of ECHA . The 
accordance check should also exclude applications which are outside the scope of 
Article 11 of Dire ctive  (EU) 2020/2184 . Sacrificial anodes, membranes and ions 
exchange resins are water treatment chemicals and/or filter  media and are covered by 
Article 12, therefore they are excluded of the scope of Article 11.  The implementation 
of the accordance check should also allow for grouping of applications that have 
passed the accordance check in order to ensure an efficient evaluation of a potentially 
high number of applications at the same time.   
(9) To facilitate the ve rification of compliance with the c onditions for use and migration 
limits  established in the European positive lists, applications should contain 
information on the relevant analytical methods  for the measurement of migration of 
relevant species  into drink ing water . That information should make it possible to 
verify the identity of and to quantify substances that migrate into water intended for 
human consumption when a starting substance, composition or constituent that is 
listed in the European positive li st is used in the manufacture of materials or products 
that come into contact with such water.  The calibration of the analytical methods and 
the associated measuring equipment might require physical testing of migration  that 
could be conducted only if the  applicant provides a calibrant of the corresponding 
starting substance or organic cementitious  constituent or a sample of the composition . 
Therefore, an applicant shall provide the Commission with a calibrant of its starting 
substance or organic cementiti ous constituent or a representative sample of the 
accepted composition of metallic materials, enamels, ceramic or other inorganic 
materials upon a positive opinion by the Committee for Risk Assessment of ECHA .  
(10) In order to give sufficient time to ECHA but also to economic operators and relevant 
authorities to prepare, the application of this act will start from 31 December 2026, i.e. 
less than two years after its entry into force. However, Article 2 should apply as from 
31 December 2025 . 
 
HAS ADOPTED THIS REGULATION:  
CHAPTER I  
GENERAL PROVISIONS   
EN 4  EN Article 1 
Definition  
For the purpose of this Regulation, the following definition shall apply:  
(1) ‘calibrant’ means a representative physical sample of a starting substance, or 
organic cementitiou s constituent subject to an application in accordance with  this 
Regulation which is used in the calibration of equipment or a measurement 
procedure . 
 
CHAPTER II  
NOTIFICATION OF INTE NTION  
Article 2 
Notification of intention  
1. A potential applicant shall submi t to ECHA  a notification of its intention to submit 
within a determined period of time an application for the inclusion of a starting 
substance, composition or constituent in the European positive lists. Unless the 
potential applicant is a competent releva nt authority for an application justified by 
urgency, this notification shall be made within 12 months prior to the submission of 
the application.  
2. ECHA  shall acknowledge receipt of the notification of the intention.  
 
CHAPTER III  
APPLICATION PROCEDUR E 
Article 3 
Application  
1. ECHA shall acknowledge receipt of the application submitted for the inclusion or 
removal of a starting substance, composition or constituent in the European positive 
lists to the applicant without undue delay.  
2. The Commission may also initiate the application procedure by requesting t he 
Committee for Risk Assessment of ECHA  to issue an opinion on the inclusion or 
removal of a starting substance, composition or constituent in the European positive 
lists.  
3. Applicant s not established in th e Union shall appoint a representative established in 
the Union . Applicant s established in the Union, other than a relevant  authority, may 
also appoint a representative.  
4. In the case of a polymer intended as a starting substance or as organic cementitious 
constituent in the manufacture of cementitious materials other than admixtures , the 
application shall be made for  any of the following : 
(a) the monomer in the case of a po lymer not used as an additive;   
EN 5  EN (b) the monomer or other reactant in the case of a polymer with out a 
polymerised part below  1000 Da which is used as an additive and is not 
obtained from microbial fermentation;  
(c) the pre -polymer, in the case of organopolys iloxanes used in the 
manufacture of silicones, rubbers, lubricants and surface treatment for fillers or 
in the case of coatings;   
(d) the polymer in all other cases.  
5. In the case of a polymer intended for use as organic cementitious constituent in the 
manuf acture of admixtures, the application shall cover all the monomers included in 
that polymer.  
6. An application from a relevant authority may cover several starting substances, 
compositions, organic cementitious constituents, nanoforms or entries.   
An applicat ion from a person other than a relevant authority  shall cover only one 
starting substance, composition, organic cementitious constituent  or nanoform.  
7. The application shall contain the information listed in the Annex.  
8. Where an application concerning an exis ting entry in one of the European positive 
lists is made after the first review referred to in Article 11(4), fourth subparagraph of 
Directive (EU) 2020/2184 is completed, the following shall apply:  
(a) by way of derogation from points 3 and 4 of the Annex , the information 
may be limited to a reference to the existing entry;  
(b) by way of derogation from points 4 to 9 of the Annex , in relation to already 
submitted information, the applicant is only required to submit any new or 
updated information.  
9. In the case of an application by a relevant authority that concerns the review of an 
existing entry on a European positive list and that is justified by a concern for human 
health, the following shall apply:  
(a) by way of derogation from points 3 and  4 of the Ann ex, the information 
may be limited to a reference to the existing entry;  
(b) by way of derogation from points 4 to 9 of the Annex , the applicant is only 
required to address the concern for human health and submit any available 
information relevant to that  concern.  
10. The information referred to in point 8 of the Annex shall be submitted in the form of 
a robust study summary.  
The information referred to in point 5 of the Annex , shall be submitted in the form of 
a study summary.   
The information referred to in point 6 of the Annex  shall be submitted in the form of 
a full study report complying with reporting requirements established by the 
corresponding EN standard or the standard determined by ECHA in accordance with 
Section 1, point 1.2 of Annex IV to Commission Implementing Decision  (EU) …/… 
[OP: please fill in the reference of  C(2023)7000 ]. 
 
  
EN 6  EN Article 4 
Accordance check  
1. ECHA  shall assess  whether the application from an applicant complies with the 
following : 
(a) it provides the information which is necessary and sufficient to be in 
accordance with Article 3(7); 
(b) it falls within the scope of Article 11 (5) of Directive 2020/2184 and 
complies with  Article 3(3) to (6).  
2. Where  the application does not fulfil the crite rion of Article 4(1), point (a), ECHA  
shall notify the reasons to the applicant. The applicant shall bring its application into 
accordance within six months of the date of receipt of the reasons from ECHA .  
Where  the application does not fulfil the criteri on of Article 4(1), point (b), ECHA  
shall notify this conclusion to the applicant. The applicant shall provide its comment 
within one month of the date of receipt of the reasons from ECHA .  
3. Where  the applica tion does not comply with the requirements set out in Article 4(1), 
the procedure shall be terminated and ECHA  shall notify it to the applicant.   
Where  the application does not fulfil the criterion of Article 5(1) , point (a), the 
applicant may submit a new app lication within six months from the notification of 
the termination of the procedure. In such case, Article 2(1) shall not apply.  
4. ECHA  shall inform the applicant of the accordance of its application without undue 
delay, indicating the date of completion of  the accordance check.  
5. Passing the accordance check is without prejudice to the opinion of the Committee 
for Risk Assessment in accordance with Article 6. 
6. Where  an application for review of an existing entry limited to the indication of the 
adoption of a harmonised classification  and labelling under Section 3 of Annex VI to 
Regulation (EC) 1272/2008 or the inclusion of a substance in the Candidate List 
established under Article 59 of Regulation (EC) 1907/2006 ECHA  may address that 
application directly to t he Commission upon completion of the accordance check . In 
such case, Articles 5 and 6 of this Regulation shall not apply.  
7. Where  an application under Article 3(9)  for which no updated information is 
available, ECHA  may address that application directly to the Commission upon 
completion of the accordance check . In such case, Article  6 shall not apply .  
8. Where  applications to which Annex VI, Section 1 , point  3 of Commission 
Implementing Decision  (EU) …/… [OP: please fill in the reference of  C(2023)7000 ] 
may apply, ECHA  may address the corresponding parts of that application directly to 
the Committee for Risk Assessment . In such case, Article  5 shall not apply.   
9. Where  an application is submitted to ECHA to review an entry from one of the 
positive lists r eferred to in Article 1 of  Commission Implementing Decision  (EU) 
…/… [OP: please fill in the reference of  C(2023)700 1], that entry shall remain valid 
after its expiry date until the Commission decides on the application to review that 
entry provided that t he application is submitted to ECHA no later than 18 months 
prior to the expiry date . 
  
EN 7  EN Article 5 
Consultation of interested parties  
Within four weeks of the publication of an application on ECHA ’s website , ECHA  shall 
invite  interested parties to submit scientific information.  
Article 6 
Consultation of the applicant and opinion  
1. The Committee for Risk Assessment shall provide an opinion on the risks to human 
health arising from the uses of the starting substance, composition or organic 
cementitious constit uent covered by the application for on the basis of Commission 
Implementing Decision  (EU) …/… [OP: please fill in the reference of  
C(2023)7000 ]. 
The Committee for Risk Assessment shall prepare a draft opinion taking into account 
any information submitted b y interested parties within 10 months from the 
publication of the application or within 13 months from that publication in the case 
of a joint opinion in accordance with the below .  
The draft opinion may be a joint draft opinion covering several applicatio ns in the 
following cases:  
(a) where they cover the same starting substance, composition or organic 
cementitious constituent ; 
(b) where they cover the same non -intentionally added species ;  
(c) where they are based on similar toxicological information;  
(d) where they raise similar considerations, in particular in case of absence of 
adverse effect identified;  
(e) in any other duly justified case.  
2. ECHA  shall send the draft opinion of the Committee for Risk Assessment to the 
applicant without undue delay.  ECHA  shall at the same time  inform the applicant of 
the right to comment within 30 days.  
3. The Committee for Risk Assessment shall finalise its opinion taking into account the 
comments from the applicant on the draft opinion, if any.  
4. ECHA  shall forward the opinion of the Committee for Risk Assessment to the 
applicant and the Commission without undue delay.  
5. The Commission shall without undue delay, taking into account the opinion of the 
Committee for Risk Assessment , decide on the application in accordance wi th 
Article 11(4) of the Directive.  
 
CHAPTER IV  
TREATMENT OF INFORMA TION  
Article 7 
Submission of information   
EN 8  EN Any information shall be submitted to ECHA  using the format and the submission tools made 
available for free by ECHA  as well as  the International Uniform Chemical Information 
Database for notifications of intention and applications.  
Article 8 
Access to information by the Committee for Risk Assessment  
1. For the purpose of preparing its opinion under this Regulation, the Committee for 
Risk Assessment ma y, if it considers necessary,  refer to  any relevant information 
submitted to ECHA , the Commission, other Union bodies and agencies or Member 
States for the purpose of other Regulations or Directives, taking into account in 
particular the latest scientific and technological developments. Union bodies and 
agencies as well as Member States in possession of the requested information  shall 
provide it to ECHA  upon request informing it of any valid confidentiality claims 
with regard to the information at the same time.  
2. The information referred in paragraph 1, may not be used to substitute missing 
standard testing or information required by Commission Implementing Decision  
(EU) …/… [OP: please fill in the reference of  C(2023)7000 ] in the application.  
Article 9 
Publ ication  
ECHA  shall publish the following without delay:  
(a) the notification s of intention;  
(b) the date of submission of an application;  
(c) the application s which passed the accordance check;  
(d) the opinion s of the Committee for Risk Assessment;  
(e) a notice of withdrawal of an application for a duration of 30 days;  
(f) the date of termination of any application process;  
(g) following the decision of the Commission on an application, a description of the 
analytical method described by the applica nt in its application for each relevant 
species  as identified under Section 3 of Annex IV of Commission Implementing 
Decision  (EU) …/… [OP: please fill in the reference of  C(2023)7000 ]. 
Article 10 
Confidentiality  
1. Information submitted to ECHA  shall be cons idered as non -confidential and may be 
made publicly available . 
2. By way of derogation to paragraph 1, the following shall be considered confidential 
and may not be made publicly available:   
(a) information concerning the identification of an applicant in cas e of a 
designated third party representative;   
EN 9  EN (b) information on the manufacturing process of a starting substance, 
composition or organic cementitious constituent or the manufacturing process 
into which it is involved;  
(c) information on any link between  any operators  in the same supply chain ;  
(d) information received from another Union body, agency or a Member State, 
for which  confidentiality has been granted  by the body which has provided this 
information to ECHA . 
 
CHAPTER V  
FINAL PROVISIONS  
Article 11 
Change of notifier or applicant  
1. The role of a notifier under Article 2 may be taken over by mutual agreement 
between an existing and a prospective notifier prior to the submission of the 
application.  
2. The role of an applicant may be taken over by mutual ag reement between an existing 
and a prospective applicant until the draft opinion is received by  the applicant 
pursuant to Article 6(2). 
3. A notification referred to in paragraphs 1 or 2  shall be submitted jointly to ECHA  by 
the prospective and the existing notifiers or applicants.  
Article 12 
Withdrawal of application  
In case of withdrawal of an application before the draft opinion has been received by  the 
applicant, the withdrawal shall be notified to ECHA . The withdrawa l shall take effect 60 days 
after the publication of the notice of withdrawal referred to in Article 9, point (e), unless a 
change of applicant in accordance with Article 11(3) is notified prior to the expiration of th at 
time limit.  
Article 13 
Additional o bligations of the applicant  
1. The applicant shall cooperate with ECHA. U pon request  from ECHA , the applicant 
shall provid e a full study report for any study covered in the application . It shall also 
answer questions from ECHA  without undue delay . 
2. Within 2 m onths from the publication of an opinion of the Committee for Risk 
Assessment  to include , maintain  or amend  an entry  in one of the European positive 
lists, the applicant shall provide the Commission with a calibrant of its starting 
substance or organic cementitious constituent or a representative sample of the 
accepted composition of metallic materials, enamels, ceramic or other inorganic 
materials .   
EN 10  EN 3. After a decision of the Commission to include an entry in one of the European 
positive list s, the applica nt shall keep available all the information it required to carry 
out its duties under this Regulation for a period of at least 20 years from the date on 
which the authorisation was removed or expired.  
The applicant shall submit th e information referred to  in the first subparagraph or 
make it available without delay upon request to any relevant  authority of the country 
in which he is established or to ECHA . 
Where  an applicant ceas es activity, or transfer s part or all of its operations to a third 
party, the party responsible for liquidating the applicant’s undertaking or assuming 
responsibility for the operations concerned shall be bound by the obligation s set out  
in paragraphs 1 and 2 in place of the applicant.  
 
Article 14 
Entry into force  
This Regulation 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 . 
However, Article  2 shall apply from 31 Dec ember 2025 . 
 
Done at Brussels,  
 For the Commission  
 The President  
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