New EU Hygiene Requirements for Materials in Contact with Drinking Water Published
The European Union’s new minimum hygiene requirements for materials and products that come into contact with drinking water were published in the Official Journal of the European Union on April 23, 2024. The new measures (three Implementing Decisions and three Delegated Regulations) will apply to materials and products intended to be used in new installations for the abstraction, treatment, storage, distribution of water or for repair works, such as supply pipes, valves, pumps, water meters, fittings, and taps. Materials and products that comply with the new EU measures will receive an EU declaration of conformity and an EU specific marking.
The Implementing Decisions lay down rules for the application of the Drinking Water Directive[1]:
- Establish a Positive List of starting substances, compositions, and constituents authorized for use in the manufacture of materials or products that come into contact with drinking water intended for human consumption (Decision (EU) 2024/367);
- Set forth the methodologies for testing and accepting starting substances, compositions, and constituents to be included in the European Positive Lists (Decision (EU) 2024/368); and
- Establish methodologies for testing and accepting final materials as used in products that come into contact with drinking water (Decision (EU) 2024/365).
In addition, the Delegated Regulations supplement the Drinking Water Directive by:
- Including a procedure for including a new substance in the Positive List of starting substances, compositions, or constituents to be used in the manufacture of materials or products intended to be used in contact with drinking water (Regulation (EU) 2024/369);
- Laying down conformity assessment procedures for products and the rules for the designation of conformity assessment bodies involved in those procedures (Regulation (EU) 2024/370); and
- Establishing harmonized specifications for the marking of products that come into contact with water intended for human consumption (Regulation (EU) 2024/371).
With respect to the first item, the applicant must notify the European Chemicals Agency (ECHA) about the intention to submit an application (and typically this must be done at least 12 months prior to the submission of the application). Once the application is submitted and ECHA determines that it includes all the necessary information, ECHA will publish the application on its website and invite interested parties to submit scientific information. Finally, the ECHA’s Committee for Risk Assessment will provide an opinion on the risks to human health arising from the uses of the starting substance, composition, or organic cementitious constituent covered by the application.
All six measures will enter into force on May 15, 2024, and will generally apply from December 31, 2026, although there are some transitional provisions.
[1] 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.