On November 18, 2021, Japan MHLW released an amendment for "Ordinance for Enforcement of the Food Sanitation Act". According to the amendment, 19 types of foods are newly added as designated food, for which has no need to obtain a sealed packaged food manufacturing industry license.
Revision
As revealed by Article 55 of Food Sanitation Act, anyone who intends to run a "sealed packaged food manufacturing business (A business that manufactures sealed packaged foods and do not require freezing or refrigeration for storage)" must obtain permission from the prefectural governor. However, if there is no risk of breeding botulinum toxin or other anaerobic bacteria that can form heat-resistant spores when stored by a method other than freezing or refrigeration, the food will be specified by MHLW and exempted from permission.
Designated food that exempted from manufacturing permission are as follows:
Before | After |
Vinegar and honey | Brown rice, milled rice, wheat, buckwheat's seed, green coffee bean, roasted coffee bean, tea, roasted wheat, dried Lentinus edodes, peanut(excluding fresh and boiled), dried and fermented fish, flakes of boiled fish meat, toasted laver, dried bread crumbs, gelatin, yakifu(a light, breadlike food made from baked wheat gluten), granular or powdered food, compressed foods made from granular or powdered foods, foods in capsules of granular or powdered foods and mixed food of the above, vinegar, honey |
For the specific requirements of these designated foods, please refer to the attachment. (Feel free to contact ChemLinked if you need translation service) | |
Implementation Date
The amendments became effective upon its publication on November 18, 2021. A 6-month grace period which will end on May 31, 2022, was granted for stakeholders .
If the product has been submitted to the prefectural governor for approval before November 18, 2021, the product shall be dealt with in accordance with the previous regulations.
Designated Food Application
MHLW also announced that it will continue to accept additional applications for designated foods.
Pre-conditions for Designated Food Application
The food shall meet the following conditions.
1. Food that does not require a sealed package food manufacturing license, and is not a MHLW-designated food;
2. It should supported by scientific evidence that there is no risk of breeding botulinum toxin or other anaerobic bacteria that can form heat-resistant spores when stored by a method other than freezing or refrigeration.
Documents to be submitted
1. explanatory materials related to the food
Explanatory materials shall be submitted when citing other laws, ordinances, or regulations, such as Japanese Agricultural Standards and Food Labeling Standards
2. Documents, or inspection results indicating that the food "if stored in a non-freezing or non-refrigerated situation, botulinum toxin or other anaerobic bacteria that can form heat-resistant spores will not proliferate".
For example,
・Water activity (less than 0.85 generally)
・PH (4.6 or less without pH adjustment)
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