(Sept. 6, 2017) Japan’s Chemical Substances Control Law (CSCL) aims to prevent environmental pollution caused by chemical substances that pose a risk to human health and interfere with the habitat and healthy development of flora and fauna. (Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture etc., Act No. 117 of 1973, art. 1 (provisional translation, for version in effect as of Apr. 1, 2011), Ministry of Economy, Trade and Industry (METI) website.) The CSCL regulates chemicals that are not regulated by other laws such as the Poisonous and Deleterious Substitute Control Law and Pharmaceutical Affairs Law. The CSCL was recently amended and the amendment was promulgated on June 7, 2017. (KANPO [OFFICIAL GAZETTE] (June 7, 2017), No. 7034, at 2, KANPO website.)
The CSCL requires prior risk assessment of new chemicals before they can be manufactured or imported. (CSCL, art. 4.) Currently, if the quantities of new chemicals to be manufactured or imported are below an amount set by Cabinet order and the chemicals are not harmful based on available knowledge, they will be exempted from all or part of the risk assessment process. (Id. art. 5 ¶ 5.) The amended law changes the calculation of the maximum permissible quantities. The new measurement of quantity will be based on the level of harmful emissions released by the chemicals into the environment, not on the manufacturing or import of chemicals. (Id. new art. 5 ¶ 5.) This increases the upper limit of the quantities of certain new chemicals that can be manufactured or imported without full assessment. (Summary of the Bill to Amend a Part of the CSCL, METI website (last visited Aug. 31, 2017) (in Japanese).)
Chemicals are currently classified into the following categories based on their level of persistency, bio-accumulativeness, and toxicity upon continuous exposure to the environment. (CSCL, art. 2.)
- Class I Specified Chemicals are persistent, bio-accumulative, and toxic after continuous exposure;
- Class II Specified Chemicals are accumulated or will be accumulated to some extent in the environment and are toxic after continuous exposure;
- Monitored? Chemicals are persistent and bio-accumulative, but whose toxicity after continuous exposure is unknown;
- Priority Assessment Chemicals are accumulated or will be accumulated to some extent in the environment, but whose toxic after continuous exposure is unknown; and
- General Chemicals.
The amendment adds a new category of chemicals, “Specified General Chemicals,” that are toxic after continuous exposure to the environment, to the above list. (Id. art. 2 new ¶ 8.)
The government takes measures to control risks associated with a chemical after it is on the market. General Chemicals are the ones least regulated under the CSCL. The amended CSCL adds the following management measures to be applied to Specified General Chemicals:
- the government will send a notification of the risk assessment to businesses that report holding them (id. art. 4 ¶ 4);
- the government will make public the results of assessments of the chemicals (id. art. 4 ¶ 6);
- the competent ministries will instruct and give advice to the businesses under their jurisdiction (id. art. 39); and
- the businesses dealing with such chemicals are obligated to expend effort inproviding information on the chemicals to their clients (id. art. 8-2).