BAKGRUNN (fra kommisjonsforordningen)

(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) …/… [OP: please fill in the reference of C(2024)239].

(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 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 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.