BAKGRUNN (fra kommisjonsforordningen)

(1) Article 11 of Directive (EU) 2020/2184 requires Member States to ensure that certain materials that come into contact with water intended for human consumption do not directly or indirectly compromise the protection of human health, adversely affect the colour, odour or taste of the water, enhance microbial growth, or leach contaminants into the water at levels that are higher than necessary in view of the intended purpose of the material.
 

(2) For the purpose of ensuring uniform application of Article 11 of Directive (EU) 2020/2184, minimum hygiene requirements for materials that come into contact with water intended for human consumption have been established in Commission Implementing Decision (EU) …/… [OP: please fill in the reference of C(2024)238 ].
 

(3) According to Article 11(8) of Directive (EU) 2020/2184, the Commission is to determine the conformity assessment procedures applicable to products covered by that Article. Those conformity assessment procedures are to be used to demonstrate that those products fulfil the requirements set out in Directive (EU) 2020/2184, thereby ensuring that only products that use final materials approved in accordance with Directive (EU) 2020/2184 are placed on the market, as required by Article 11(7) of that Directive.
 

(4) In order to ensure that the information regarding conformity of products with the minimum hygiene requirements established under Article 11 of Directive (EU) 2020/2184 is provided in a uniform manner for all products, that information should be provided in the form of a single EU declaration of conformity. By drawing up the EU declaration of conformity, the manufacturer, importer or authorised representative should assume responsibility for the compliance of the product with the minimum hygiene requirements set out in Commission Implementing Decision (EU) …/… [OP: please fill in the reference of C(2024)238].
 

(5) Since accreditation is an essential means of verifying the competence of conformity assessment bodies, conformity assessment bodies should be accredited by a national accreditation body in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council in order to be authorised as a notified body and allowed to carry out the conformity assessment procedures set out in this Regulation.
 

(6) To ensure a consistent level of quality in the performance of conformity assessment, it is necessary to set requirements for notifying authorities involved in the assessment of notified bodies. In particular, it should be ensured that the notifying authority is objective and impartial with regard to its activity. Furthermore, notifying authorities should be required to safeguard the confidentiality of the information they obtain, but should nonetheless be able to exchange information on notified bodies with national authorities, the notifying authorities of other Member States and the Commission to ensure consistency in the conformity assessment.
 

(7) Having regard to the resources necessary for setting up the required organisation by Member States and conformity assessment bodies, and to ensure that conformity assessment bodies meet the requirements for notification, the application of this Regulation should be deferred. It is necessary to avoid a situation where all applications for conformity assessments of products have to be processed by the notified bodies at the same time and to ensure that notified bodies can progressively build up appropriate capacity for the carrying out of conformity assessment of products. Therefore, the application of this Regulation should be further deferred for products that have been found in conformity with national hygiene requirements for products that come into contact with water intended for human consumption before the date of entry into force of this Regulation and for which the national conformity certificate of the product expires after that date,