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The first draft revision to the 2011 Measures for the Environmental Management Registration of Hazardous Chemicals (Trial) (MEP Order 22) was published for public consultation recently (see CL news). During REACH24h’S Chemical Regulatory Affairs Conference 2015 an updated revised edition was introduced and interpreted by Ms. Jinye SUN from the Solid Waste and Chemicals Management Center of MEP (SCC-MEP) on CRAC 2015.
Regulatory Rationale
The government clarified that the regulation has been developed in a bid to collect information about chemicals, assess risks to human health and the environment and prevent or mitigate potential hazards. Therefore, the environmental management registration for HCs and PRTR for HCPECs are established as record filing schemes instead of administrative approval schemes. The authorities will only be responsible for technical review of the paperwork and will not be responsible for investigating the authenticity. Therefore, it will be the enterprises that bear all the legal liability in the case of environmental pollution.
Scope
In addition to the low quantity exemption (HC < 1 ton/yr, HCPEC < 100 kg/yr) and the exemption granted to pesticide formulation, the exemption will be extended to:
Using HCs for scientific R&D
Using HCs for inspection and testing
Using HCs for waste/pollution treatment and disposal
Using HCs for other purposes excluding manufacturing (e.g. using organic solvents to clean machines)
The previous plan of issuing a list of hazardous chemicals exempted from environmental management registration, as spoken of during CRAC 2014 (see CL news), has been cancelled. But with the implementation of simplified registration and issuance of the annual report form, a more feasible guidance, scraping of the administration fee and cancellation of the registration certificate and the 3-year validity period, industry stakeholders will be less burdened by compliance requirements.
The regulation also applies to enterprises manufacturing or using HCs in the bonded areas, export processing zones, free trade zones, etc.
Major Technical Revisions
Changes to the technical requirements are presented in the supporting documents shown in Fig 1.
The registration form is simplified by removing information related to the product composition (which is under CBI protection in most cases), production line, process and techniques. After revision, only three parts remain including basic information of the enterprise, information of the hazardous chemical (SDS should be attached) and information on the release of particular pollutants.
The revised Guidance for Environmental Risk Assessment of HCPECs develops quantitative method to assess the environmental risk brought by daily production/use and determines whether the risk is at an acceptable level. While the chemical flow analysis requires calculation of the HCPECs released or transferred to the atmosphere, water and soil, the ecological risk assessment only focuses on the risk to surface aquatic environment.
The Environmental Risk Control Plan is an essential section of the HCPEC Environmental Risk Assessment Report of HCPEC. In addition, the Plan should be updated and submitted separately from the Report for annual record filing.
