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

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (1), 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. Applications 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). The 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 planning 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 protect human health, it should be possible for the Commission to initiate a procedure by requesting the Committee for Risk Assessment of ECHA to prepare an opinion on the inclusion or removal of a starting substance, composition or constituent in the European positive 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) 2024/365 (2).

(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 proportionally addressed at the level of the pre-polymer. In thecase 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 application 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 accordance 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 Directive (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 verification of compliance with the conditions 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 chemical species into drinking 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 list 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 cementitious 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. However, Article 2 should apply as from 31 December 2025.

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

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 cementitious 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 INTENTION

Article 2

Notification of intention

CHAPTER III

APPLICATION PROCEDURE

Article 3

Application

Applicants established in the Union, other than a relevant authority, may also appoint a representative.

(a) the monomer in the case of a polymer not used as an additive;

(b) the monomer or other reactant in the case of a polymer without a polymerised part below 1 000 Da which is used as an additive and is not obtained from microbial fermentation;

(c) the pre-polymer, in the case of organopolysiloxanes 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.

An application from a person other than a relevant authority shall cover only one starting substance, composition, organic cementitious constituent or nanoform.

(a) by way of derogation from points (c) and (d) of the Annex, the information may be limited to a reference to the existing entry;

(b) by way of derogation from points (e) to (i) of the Annex, in relation to already submitted information which complies with Implementing Decision (EU) 2024/365 the applicant is only required to submit any new or updated information.

(a) by way of derogation from points (c) and (d) of the Annex, the information may be limited to a reference to the existing entry;

(b) by way of derogation from points (e) to (i) of the Annex, the applicant is only required to address the concern for human health and submit any available information relevant to that concern.

The information referred to in point (e) of the Annex, shall be submitted in the form of a study summary.

The information referred to in point (f) 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 Implementing Decision (EU) 2024/365.

Article 4

Accordance check

(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 (EU) 2020/2184 and complies with Article 3(3) to (6).

Where the application does not fulfil the criterion 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.

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

The Committee for Risk Assessment shall prepare a draft opinion taking into account any information submitted by 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 applications 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.

CHAPTER IV

TREATMENT OF INFORMATION

Article 7

Submission of information

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

Article 9

Publication

ECHA shall publish the following without delay:

(a) the notifications of intention;

(b) the date of submission of an application;

(c) the applications which passed the accordance check;

(d) the opinions 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;