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Japan Revises the Enforcement Regulation of the Food Sanitation Act

16 types of foods are exempted from obtaining the manufacture permit for sealed packaged food.

On January 19, 2023, Japan the Ministry of Health, Labour and Welfare (MHLW) released an amendment to the Enforcement Regulation of the Food Sanitation Act. According to the amendment, MHLW newly specified 16 types of foods exempted from sealed packaged food manufacture permit, because these foods do not have the risk of reproducing spore-forming heat-resistant anaerobic bacteria such as Clostridium botulinum under normal storage conditions. The amendments became effective upon its publication on January 19, 2023.

16 types of new food items are included:

1. Substitutes for tea (limited to dried products)

It is used as a substitute for tea such as mate and rooibos. However, dried fruits are not included in this type.

2. Dried mushrooms* (including the previously defined as “dried shiitake mushrooms”).

3. Dried cereals. Dried grains such as foxtail millet, quinoa, and proso millet.

4. Dried nuts and seeds

5. Dried beans

6. Dried potatoes

It refers to potato that has been steamed, peeled, and dried.

7. Dried seaweeds* (including the previously defined as “toasted laver”)

8. Liquid sugar

It refers to liquid products mainly composed of sucrose, or liquid products manufactured by enzymatically decomposing starch contained in grains (malt, rice, sweet potato, etc.).

9. Processed sesames

It refers to the products and processed products of sesame seeds after selection, heat treatment (drying, roasting), pulverized, grinding, etc. Washed sesame, kneaded sesame, ground sesame, etc. are also included.

10. Dried kudzu starch noodles

11. Dried soups

It refers to dried powder, granular or solid products from "boiled soup of meat, seafood, vegetables, seaweed, etc. or those mentioned above crushed and filtered products", "hydrolyzed protein", "binding agent", "ingredient" or "floats" added with seasoning, sugar, edible oil, spices, etc. The soup is cooked or restored with water or milk.

12. Dried spices

It refers to dried fragrant bark/roots/rhizomes/buds/seeds/fruits/pericarp derived from various plants used in relatively small amounts for the purpose of flavoring foods.

13. Dried tapioca

14. Dried herbs

It refers to dried leaves, stems, roots or flowers of various herbaceous plants used in relatively small amounts as condiments for the purpose of flavoring food.

15. Salt. (Contains rock salt)

16. Cooking roux

It refers to products manufactured by mixing ingredients such as salt, sugar, seasonings, dairy products, dried vegetable powder, and meat extract into roux made by frying wheat flour in edible oil, heating and mixing, as well as cooling. This includes solid and flake curry roux, stew roux, hayashi roux, etc.

*Notably, "dried shiitake mushrooms" and "toasted laver" were deleted from Article 66-10 as they are included in the above newly added foods.

Stakeholders may conduct self-inspection in the scope of the new 16 kinds of food, confirming whether they still need to apply for a production license for sealed packaged food.

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