REACH24H Consulting Group

Author Biography

Linda Lee

REACH24H China, Senior expert of Regulatory Compliance Dept with expertise in chemical safety report preparation and data analysis

This article was recently published in Chemical Watch, the global chemical regulatory portal.

Following the introduction last year of China's new notification regime for new chemical substances, companies must prepare risk assessment reports. REACH24H experts Linda Lee, MSc and Caroline Currid, PhD here address to the question of risk assessment report in China New Chemical Substance Notification (NCSN).

Since a major revision of China's Measures on Environment Management of New Chemical Substances came into force last October, companies wishing to manufacture or import a new substance in China have been obliged to first notify new chemical substances - those not listed on the Inventory of Existing Chemical Substances in China (IECSC) - to the Chemical Registration Centre (CRC). Under the regime, regular notifications for substances must include a risk assessment report.

Because China previously relied on other regulatory frameworks for chemical risk assessment, the development of a comprehensive risk assessment programme for chemicals by the authorities is still at an early stage, and this is reflected in the lack of standardised approaches and guidance. The Ministry of Health (MoH) has led the way with its Guidelines for Risk Assessment of Cosmetic Raw Materials. Now the MEP is in the process of developing the strong specialised knowledge base and guidelines required to manage and supervise risks for chemicals. Indigenous chemical manufacturers are also becoming increasingly aware of the everyday risks of dealing with their chemicals. Therefore the risk assessment report has become a critical tool for the authorities, manufacturers and downstream users to manage chemical safety concerns effectively. An overview on whether a risk assessment report is required under China new chemical substance notification (NCSN) is provided in Figure 1.

Figure 1: When is a risk assessment report required under China NCSN?

Report format and tonnage volume

The format of the risk assessment report required under China NCSN was published in the MEP's NCSN guidance document in September 2010. It details the main cmponents of the risk assessment report – classification and labelling, hazard assessment, exposure prediction and risk characterisation, which are similar to the REACH chemical safety report (CSR). However, in contrast to REACH, where a CSR is required for substances produced in annual quantities above ten tonnes, a risk assessment report under China NCSN must be provided for those produced in annual quantities above one tonne.

Use collection and exposure prediction tools

For a REACH CSR, five use descriptors are widely accepted for collection of uses used in the exposure assessment: sector of use (SU); process category (PROC); chemical product category (PC); article category (AC); and environmental release category (ERC). But these terminologies are not obligatory for risk assessment reports in China. However, detailed information about the method of use, technical function, process steps and so on are required and a process flow diagram and the material balance can be provided if necessary. To date, no models have been developed by China’s authorities to predict the potential environmental exposure for quantitative assessment. However, equation methods and model predictions using software tools such as the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC)'s Targeted Risk Assessment (TRA) tools or the European Commission’s EU System for the Evaluation of Substances (EUSES) are currently acceptable.

Methods of risk characterisation

The area of risk characterisation also demonstrates a divergent approach under REACH and China NCSN. It is only necessary to qualitatively characterise the potential risks to human health, irrespective of the tonnage volume under China NCSN. The toxicological test results and levels of exposure will be given individual scores in order to indicate the level of damage to human health. The combination of scores corresponds to a human health qualitative risk characterisation phrase: extremely high, high, medium, and low. For potential environmental risks, whether a qualitative or (semi-) quantitative assessment is required will depend on the tonnage volume of the substance. If the tonnage volume is 1-10 t/a, a qualitative risk characterisation is sufficient, while a quantitative or semi-quantitative risk characterisation is obligatory when the tonnage volume is above 10 t/a. The quantitative environmental risk assessment is communicated using the Risk Characterization Ratio (RCR; RCR = predicted environmental concentration (PEC)/predicted no-effect concentration (PNEC); the RCR is also used in the REACH environmental risk assessment.

Classification system

For classification purposes, new chemical substances must be classified using China's system based on the UN Globally Harmonized System (GHS), which differs in some aspects from the CLP classification system applied under REACH. China GHS standards are drawn up by the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the Standardization Administration, and are supervised by several government departments together.

Overall, there are substantial differences in the format and information required when preparing a risk assessment report under China NCSN and it is not sufficient just to refer to an available REACH CSR. An overview of the differences in risk assessment of EU REACH and China NCSN is provided in Table 1. The MEP is developing the Guidelines for Risk Assessment of Chemical Substances, which will be available in draft format in English shortly.

Table 1: Overview of differences in risk assessment of EU REACH and China NCSN