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Japan: Alcohol Regulation Tentatively Eased for Disinfectant Production due to COVID-19 Pandemic

(June 15, 2020) Between the middle of March and the beginning of May 2020, government agencies in Japan instituted regulations to ease restrictions on the production, storage, sale, and use of alcohol to make more disinfectants available for medical institutions and general consumers because of the COVID-19 health emergency.

Background

In January 2020, Japan began experiencing a shortage of alcohol used for disinfectants that to date has not been completely resolved. Breweries in Japan have the capacity to produce alcohol, but regulations prevented them from producing and selling alcohol for use as a disinfectant. Japan has four laws covering the use and sale of alcohol: the Alcohol Business Act, the Alcohol Tax Act, the Pharmaceutical and Medical Devices Act, and the Fire Service Act. Consumers started using beverages with a high alcohol content for disinfection after alcohol-based disinfection products disappeared from stores. In late February, some vodka with a high alcohol content sold out, and breweries subsequently have received many inquiries from consumers regarding the availability of beverages with a high alcohol content.

Fire and Disaster Management Agency Circular

Products with more than 60% alcoholic content by weight are classified as dangerous flammable materials under the Fire Services Act (Act No. 186 of 1948). Its handling and storage is subject to regulations under the act. On March 18, 2020, the Fire and Disaster Management Agency issued a circular stating that it was allowing exceptions to facility standards for producers of alcohol to increase alcohol production for disinfection. (Shobo-ki No. 77 of 2020.)

On April 3, 2020, the Agency issued another circular that allowed delayed safety inspection of storage facilities for dangerous material. (Shobo-ki No. 92 of 2020.)

Ministry of Health, Labour and Welfare Announcement

In March, some breweries in Japan began marketing beverages with high alcoholic content. Because they were beverages, they were subject to the Alcohol Tax and could not be advertised for use as disinfectants. The manufacturing and marketing of disinfectants are strictly regulated by the Pharmaceutical and Medical Devices Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Act No. 145 of 1960).

Because of the high demand for beverages with high alcoholic content to be used as disinfectants, the Ministry of Health, Labour and Welfare (MHLW) allowed an emergency exception to the Pharmaceutical and Medical Devices Act. The MHLW notified local health departments on March 23, 2020, that it was instituting an emergency measure that allows the use of methanol-free products with 70–83% ethanol by volume for use as disinfectants by medical institutions even though they were not manufactured as pharmaceutical or quasi-pharmaceutical products.

After the MHLW issued the notice, more breweries planned to produce and sell products with high alcoholic content. On April 10, 2020, the MHLW further loosened the regulations to allow the labels of such products and their advertisements to state that the products are not pharmaceutical or quasi-pharmaceutical products but can be substituted for them as disinfectants. Further, on April 22, 2020, the MHLW allowed products with more than 60% ethanol by volume to be used as disinfectants.

National Tax Agency Measures

On April 21, 2020, the National Tax Agency (NTA) simplified the distilled–spirits production licensing process and accelerated processing time as a temporary measure to increase the production of alcohol for use as a disinfectant.

On May 1, 2020, the NTA decided to exempt from the Alcohol Tax any alcohol disinfectants that the MHLW approved as substitutes for pharmaceutical products. To qualify for this exemption, the products must have a label that states “not for drinking” and a control number. For example, the alcohol tax for 500 ml (about 16.9 US fluid ounces) of products with a 60% alcoholic content is 300 yen (about US$2.80).