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Japanese Chemical Substance Control Law (CSCL) stipulates that potential revisions or amendments to the Law should be assessed every 5 years to align legislation with industry status quo. The last amendments to the CSCL finished in Apr 2011. The Japanese government held 3 conferences in late 2016 and consulted with stakeholders on potential amendments to the current CSCL. In Jan 2017, Japanese Ministry of Economy, Trade and Industry (METI) and Ministry of Environment (MOE) issued the draft amendments for public opinion. On Mar 7th 2017, Japanese government voted and passed the amendments to CSCL.
The amendments address 2 major issues raised by stakeholders during the conferences. The first one is made by industry. According to CSCL, the new chemical substances to be manufactured or imported with a total amount less than 1 ton/year across the nation are regarded as small volume substances and can avail of an exemption from prior notification and evaluation, after receiving confirmation from the Ministry of Health, Labor and Welfare (MHLW), METI and MOE. Similarly, substances imported/manufactured in volumes of less than 10 ton/year are regarded as low volume substances and can also enjoy favorable regulatory compliance policies. However, the industry complained that the volume threshold was set too low. When multiple enterprises applied for a small amount exemption for the same substance, the aggregated tonnage usually exceeded the exemption threshold. As a result, enterprises had to negotiate and cut down on the manufacture or import volumes with a negative impact on business.
To resolve this issue the new amendments introduce a new concept called “Environmental Release Amount”. The environmental release amount of a substance is calculated by the formula: [Environmental Release Amount] = [Manufacture or Import Amount] × [Release Factor]. The release factor is decided based on the specific use and application of the substance and varies among different industries. For identical substances, the release factor can vary depending on respective usage. For example, when a certain substance is used in aromatics, its release factor is set as 1.0, which means all of it will be released into the environment. However, when it is used in the production of LCD panels, the release factor is 0.0012 because very little of it will be released into the environment. The criteria for small volume substances and low volume substances will remain 1 ton/year and 10 ton/year. However, it will be based on the environmental release amount, instead of the previously used total manufacture or import amount.
Another major issue that the amendments attempt to address relates to the management of some very toxic new chemical substances. These substances pose huge health and environmental risks to human beings, animals and plants. However, based on the current new chemical evaluation and assessment standards under CSCL, they may only be regarded as “General Chemicals” instead of “Priority Assessment Chemicals” or “Class 2 Specified Chemicals”, because of their low residual effect in the environment. Obviously the previous classification of these substances didn’t reflect their hazards or risk level.
The 2017 amendments designate these substances as “Specified General Chemicals”, which is a new category. This category of new chemicals will be subject to more regulatory compliance requirements than general chemicals. These compliance requirements will continue even after their notifications are complete and they are announced as general chemicals.
The official document of the amendments will be published soon. However, the implementation of these amendments will be place on hold until detailed implementation rules are released. According to the timeline set by authorities, the amendment on environmental release factor will be put into effect within 3 years of the publication of official documents and the Specific General Chemicals regulations in 1 year.
