European Union New Regulations for Water Contact Materials

New Regulations for Materials in Contact with Water

In order to improve the safety and compatibility of materials in contact with water and to protect human health, the European Union has announced comprehensive new regulations for materials and products in contact with water. Directive (EU) 2020/2184 provides for the establishment of European positive lists of substances, compositions and ingredients in regulations covering organic, cementitious, metallic, enamel, ceramic or other inorganic materials.

The new regulations primarily cover plastics, metallic components, ceramics and other inorganic materials in contact with water intended for human consumption. The regulations aim to determine the conditions of use and migration limits. The substances on the list established in Annex I to Commission Regulation (EU) No 10/2011 (3) have been assessed for their use in plastic food contact materials in accordance with Regulation (EU) No 10/2011, subject only to certain conditions of use.

At the same time, the European Food Safety Authority has stated that the re-evaluation of a significant proportion of substances should be prioritized, as no specific migration limits have been set for plastic food contact materials for which their use is permitted.

Testing and Acceptance Methodologies

Part of the regulation by the European Union is the establishment of testing and acceptance methodologies. The aim is to assess the safe use of starting materials, compositions and components. In this context, physical and chemical tests such as migration tests, tests for toxicological properties, identification of relevant chemical species and risk assessment are the analyses to be applied. It is also underlined that tests and analyses should be performed in laboratories applying good laboratory practices (GLP).

The national positive lists of Member States for the regulations have been notified to the European Union Chemicals Agency (ECHA). The national systems will be valid until December 31, 2026. From July 13, 2021 to December 31, 2026, transitional measures will be provided for approved substances. The main objective is to improve the safety and compliance of water contact materials to protect humanity through stronger and more comprehensive regulation in the field of water contact materials.

Hygiene Requirements

Within the scope of the regulations, hygiene requirements will be set for the final materials to be used in products in contact with water, based on Annex V of Directive (EU) 2020/2184 and taken into account in the conformity assessment procedures of the products.

Test Procedures and Requirements

Testing and analysis procedures, including the relevant substances and parameters to be analyzed in the transit water, will be determined in a risk-based approach, proportionate to human health risks and according to the category of the final material, in order to ensure the safety of the final materials.

Tests and Analyses to be Performed on Materials in Contact with Water;

Migration Tests
Sensory Tests (Smell - Taste Test, Color - Turbidity Test)
EMG Tests (Test for Increasing Microbial Growth)
Residue Content Test
NIAS Test
Total Organic Carbon Test

Nanolab Laboratories Group continues to provide services within the scope of Migration Analysis. We also provide services in various Packaging Analysis.

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