JAPAN – The Japanese government is set to implement more rigorous standards for milk products that do not require chilling, necessitating additional certificates from the country of origin for entry into the market.

The Ministry of Health, Labour and Welfare (MHLW) unveiled a ministerial proposal, inviting public and industry feedback before the anticipated enforcement in mid-March this year.

The proposed amendment targets milk and dairy products not requiring storage below 10°C or permitted to be stored at room temperature.

This encompasses regular milks, modified milks, low-fat milks, skim milks, processed milks, liquid milk preparations, and other milk-based beverages.

The regulations will apply to products that have undergone sterilization and aseptic packaging or packaging followed by sterilization.

According to the ministerial proposal, products falling into the former category must undergo sterilization by heating at 120°C for four minutes or an equivalent method.

The aseptic filling into pre-sterilized packaging should adhere to a preapproved process, with specific standards for microorganism testing, manufacturing methods, and sterilization records.

Manufacturers will be required to maintain records of sterilization, storing records from self-recording thermometers for a reasonable period, considering the time until consumption.

A significant change includes the extension of certification requirements to all exporters of these milk products to Japan. Previously, certification was mandated only for products not approved by MHLW for room temperature storage.

The new regulation, effective from mid-March 2024, will eliminate the provision excluding products storable at room temperature.

Transitional changes will allow additional time for certain aspects, such as records of self-recording thermometers and the sterilization process, with a six-month implementation period following promulgation.

An essential focus of the amendment revolves around self-recording thermometer records. The ministry has now stipulated specific timeframes, requiring manufacturers to keep records for at least one year for products storable at room temperature and three months for those requiring refrigeration.

MHLW has opened avenues for industry and public comments until the deadline on February 17, 2024. The new regulations aim to enhance food safety along the entire supply chain, ensuring compliance with the evolving standards in the dairy industry.


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