China Consults on Technical Guidance for Aquatic Toxicity Testing for Difficult Test Chemicals

The Chinese Ministry of Ecology and Environment (MEE) recently invited the public to comment on the Technical Guidance for Aquatic Toxicity Testing of Difficult Test Chemicals (Draft). Comments are welcome before February 17, 2025. Once officially issued and implemented, this guidance is expected to play an important role in further standardizing and enhancing the aquatic toxicity testing levels along domestic ecological testing institutions.

Background

The Action Plan for New Pollutants Treatment emphasizes the need to establish a comprehensive system of technical standards for chemical environment risk assessment and control, formulating or revising standards on environment risk assessment of chemicals, socio-economic impact analysis, and hazard testing methods. Moreover, if applying for simplified or regular registration of new chemical substances under the MEE Order No.12, specific tests on their health, physical and environmental hazards must be conducted prior to registration, along with submission of relevant test reports.

To guide environmental hazard testing, except for the HJ/T 153-2004 The guidelines for the testing of chemicals, several national standards for aquatic toxicity testing have been established, covering several trophic levels, typically, algae, daphnia, and fish. These include:

While these standards significantly aid in the testing of conventional chemical substances, there are currently no standards detailing testing methods for difficult test chemicals, such as those that are poorly soluble, easily volatile, prone to photodegradation, hydrolysis, oxidation, or multi-component mixtures.

In practice, these challenging testing attributes may lead to operational difficulties in processes such as preparing test solutions, selecting and maintaining exposure systems, sample collection and preservation, exposure concentration analysis, and characterization of toxicity results, causing technical troubles for testers. Therefore, to enhance the reliability of testing data and to address the shortcomings of existing testing methods, the MEE initiated the development of the technical guidance for aquatic toxicity testing of difficult-to-test chemical substances in 2020. On December 26, 2024, the MEE issued this draft guidance for public comments.

Insights

In 2024, the MEE has been actively taking action to ensure the quality of testing data required for new chemical registration and to support the establishment of a robust systematic framework in this area.

For instance, in November 2024, the SCC-MEE organized an expert review meeting in Beijing themed on the ecological toxicology testing reports of new chemical substances. This meeting featured experienced experts who reviewed fifteen test reports formulated by institutions that had identified multiple issues during the registration process, specifically examining the authenticity, reliability, scientific validity, and relevance of the testing data.

This expert review concluded that ten of the fifteen test reports had serious quality issues in areas such as experimental design, test concentration analysis methods, test results, and the validity of the test reports, rendering them unsuitable for the new chemical registration compliance under MEE Order No.12.

ChemLinked advises relevant enterprises that testing data is a crucial foundation for compliance with the new chemical registration in China. Selecting professional testing institutions is essential to ensure data quality, as it's a critical prerequisite for new chemical registration. Enterprises should be cautious not to let minor issues result in significant losses which may severely affect registration progress and reputation. For assistance in this matter, please feel free to contact us.