#SFHP2615616ANotification Rules for Bodies Assessing Materials in Contact with Drinking Water
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This order sets the rules for which conformity assessment bodies may be officially notified to assess materials and products that come into contact with drinking water. Only accredited bodies can carry out these activities, and they must submit a detailed application to the health minister showing their scope of work, accreditation certificate, and commitment to EU requirements. The order also controls subcontracting. Assessment bodies may use subcontractors or subsidiaries only with the client's agreement and only if those partners meet equivalent standards of competence, impartiality, and independence. Laboratories carrying out tests must be accredited under ISO/IEC 17025. Bodies must also promptly report any suspension or withdrawal of their accreditation, which can affect their notification status.
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Key Changes
- Requires conformity assessment bodies for drinking-water contact materials to be accredited before they can be notified
- Sets the application file that bodies must submit to the health minister, including scope of activities and accreditation proof
- Allows subcontracting only under strict conditions, with accredited laboratories required for testing and analysis
Obligations
What this law requires
Conformity assessment activities for materials and products in contact with drinking water may only be carried out by bodies accredited for notification by COFRAC or another national accreditation body recognized under Regulation (EC) No 765/2008.
A conformity assessment body seeking notification must submit an application to the minister responsible for health before being notified under Delegated Regulation (EU) 2024/370.
The notification application must include a description of the conformity assessment activities, assessment modules, and products for which the body considers itself competent.
The notification application must include an accreditation certificate for notification issued by COFRAC or another recognized national accreditation body, covering the relevant certification scope.
The notification application must include the body's commitment to comply with paragraph 12 of Article 5 of Delegated Regulation (EU) 2024/370.