EU Draft Commission Implementing Decision laying down rules for the application of Directive (EU) 2020/2184 as regards methodologies for testing and accepting starting substances to be included in the European positive lists

The European Commission has issued an implementing decision on the application of Directive (EU) 2020/2184, concerning the quality of water intended for human consumption. The decision outlines rules for testing and accepting starting substances, compositions, and constituents to be included in European positive lists.

Under this decision:

1. Testing Methodologies: The decision calls for the establishment of testing and acceptance methodologies to assess the safe use of starting substances, compositions, and constituents.

2. Inclusion or Removal Criteria: Inclusion or removal from a European positive list will be based on identifying the starting substance, composition, or organic cementitious constituent and its intended use, along with necessary physico-chemical properties and migration testing.

3. Identification of Relevant Species: Relevant species affecting material or product safety will be determined based on information about the starting substance, composition, or constituent, as well as the results of migration testing. Toxicological properties of these relevant species will also be identified.

4. Proportionality and Efficiency: The decision emphasizes proportionality and efficiency, reducing testing requirements when assessments have been conducted at the Union level or when substances have a stringent classification. Stricter testing will apply with higher exposure to certain substances through migration.

5. Worst-Case Risk Assessment: The acceptance methodology will be based on a worst-case risk assessment of each relevant species, considering migration under foreseeable usage conditions, especially long-term exposure to water intended for human consumption.

6. Adaptation Period: Economic operators and relevant authorities will have time to adapt their national methodologies to align with the decision.

The decision defines key terms such as "non-intentionally added species," "nanoform," "particle," "aggregate," and "agglomerate."

Testing and acceptance methodologies apply to various substances, including starting substances for organic materials, organic constituents of cementitious materials, and compositions of metallic, enamel, ceramic, and other inorganic materials. For polymers intended for use in organic or cementitious materials, testing applies to monomers, pre-polymers, or polymers following specific rules.

The decision also outlines detailed requirements for testing methodologies, identification of substances, physico-chemical properties, migration testing, and toxicological properties.

Starting substances, compositions, and constituents will be accepted in European positive lists based on risk assessments of relevant species. Biocidal substances subject to Regulation (EU) No 528/2012 will only be accepted for product-type 6 (preservatives for products during storage).

The decision will enter into force on the twentieth day following its publication in the Official Journal of the European Union and will apply from December 31, 2026.

Title of document
Draft Commission Implementing Decision laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council as regards methodologies for testing and accepting starting substances, compositions and constituents to be included in the European positive lists

Description
This draft Commission decision will establish methodologies to test and accept substances, constituents and compositions that are safe to be used in materials that come into contact with drinking water. 

Notifying member: European Union

Notification: G/TBT/N/EU/1015

Objective tag
Protection of human health or safety (TBT)

Documents

• 23_12652_00_e.pdf
• 23_12652_01_e.pdf

Timing:

• Submission: N/A
• Reception: N/A
• Distribution: 27/09/2023
• Final date for comments: N/A
• Proposed date of adoption: N/A