BAKGRUNN (fra kommisjonsbeslutningen)

(1) Directive (EU) 2020/2184 provides for the establishment of European positive lists of substances, compositions and constituents for each type of materials, namely organic, cementitious, metallic, enamels, ceramic or other inorganic materials, which are authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption and fall within the scope of Article 11 of that Directive. These European positive lists should include, where appropriate, conditions for the use of substances, compositions and constituents and migration limits, which are to be determined on the basis of the methodologies adopted pursuant to Article 11(2), point (a), of Directive (EU) 2020/2184. Such conditions of use may include a purity criterion, a condition on the physico-chemical characteristics of the starting substance, composition or constituent, a condition on its manufacturing process or on the manufacturing process of final materials, their use for certain products, the use of these products, or further testing requirement. Sacrificial anodes, 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) Article 11(3) of the Directive sets out that lists established by the Commission pursuant to Article 5 of Regulation (EC) No 1935/2004 should be used as a source to establish the first European positive lists under the Directive. The list established in Annex I to Regulation (EU) No 10/2011 is one of these lists. However, substances included on this list have only been assessed for their use in plastic food contact materials in accordance Regulation (EU) No 10/2011, subject to specific conditions of use. Moreover, the European Food Safety Authority has indicated that a significant number of the substances should be prioritised for re-evaluation as no specific migration limit was established when they were authorised for use in plastic food contact materials. The inclusion of such substances in Annex I to Regulation (EU) No 10/2011 nevertheless provides a much higher level of certainty over their safety in contact with drinking water when used in the manufacture of drinking water products, than would be the case for unlisted substances. Therefore it is appropriate to add substances originating from lists established by the Commission pursuant to Article 5 of Regulation (EC) No 1935/2004 to the first European list under Article 11(3) of the Directive, provided these additions are only used as a starting point for further conformity assessment in accordance with Article 11(8), and provided their reevaluation by the expiry date set out in the first European positive list takes account of all the conditions and drinking water materials in which they may be used. 

(3) Where applicable, the migration limit, i.e. the maximum tolerable concentration at the tap, should be based on the parametric value set out in Part B or C of Annex I to Directive (EU) 2020/2184 or the specific migration limit set out in Annexes I and II to Commission Regulation (EU) No 10/2011. This should, however, be done after application of an allocation factor to account for the proportion of potential exposure from materials in contact with water intended for human consumption derived from the information provided by Member States. 

(4) Annex I to Regulation (EU) No 10/2011 provides further detail on conditions of use of authorised substances, as well FCM substance reference numbers used in risk assessments. To facilitate further conformity assessment of substances that are added to the first European positive list on the basis of Annex I to Regulation (EU) No 10/2011, it is appropriate to add their FCM reference numbers in the first European positive lists. 

(5) The expiry dates included in the first European positive lists follow the recommendation from European Chemicals Agency (ECHA) in particular on the basis of the hazardous properties of the starting substance, composition or constituent, the quality of the underlying risk assessments, the extent to which those risk assessments are up-to-date and the need for a staggered review of these entries. 

(6) Some entries in the European positive lists should be allowed to be combined, extended to related starting substances, compositions and constituents or extended for use in different material types than the one for which they have been authorised when such combination or extension has no impact on the protection of human health to ensure the proportionality and efficiency of the process. 

(7) Based on notifications from Member States, the first European positive lists include group entries covering multiple starting substances, compositions or constituents. Assessing the safety of each individual starting substance, composition or constituent separately is more appropriate to assess the safety of the groups; however, at the time of adopting the first European positive list it was not possible to identify the starting substances or organic cementitious constituents in those groups. Therefore, group entries should progressively be replaced in the European positive lists by the individual starting substances, compositions or constituents in the group and the 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. 

(8) In order to ensure an orderly and efficient application process, an entry may be renewed provided that notification of intention and, subsequently, an application is submitted to ECHA within a set deadline. 

(9) Member States’ national provisions with regard to starting substances, compositions and constituents and their national positive lists were notified to ECHA by 12 July 2021. In order to allow national authorities sufficient time to prepare for the application of the European positive lists, the application of this act will start from 31 December 2026. The national systems are to apply until 31 December 2026. In addition, transitional measures should be provided for substances, compositions and constituents approved in the national systems from 13 July 2021 to 31 December 2026, provided that in accordance with Part B of Annex I to Directive (EU) 2020/2184, these substances do not exceed the parametric value of 5 µg/l for lead (Pb) at the tap. 

(10) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 22(1) of Directive (EU) 2020/2184.