When a prefectural governor discovers food, additives, apparatus, or containers and packages stated in the following items, and finds that the food, additives, apparatus, or containers and packages that the person produced or processed are likely to continue to fall under those stated in the following items in view of the capability, etc. for conducting inspections of the person who produced or processed them and necessary for preventing occurrence of food sanitation hazards, the prefectural governor may order that the person should undergo an inspection by the prefectural governor or a registered conformity assessment body on the food, additives, apparatus, or containers and packages, in accordance with the requirements and procedures specified by Cabinet Order:
food or additives that do not conform to the standards established pursuant to the provisions of Article 13, paragraph (1);
food for which additives are used in a method that does not conform to the criteria established pursuant to the provisions of Article 13, paragraph (1);
food prescribed in Article 13, paragraph (3);
apparatus, or containers and packages prescribed in Article 16;
apparatus, or containers and packages that do not conform to standards established pursuant to the provisions of Article 18, paragraph (1); and
apparatus, or containers and packages violating Article 18, paragraph (3).
When the Minister of Health, Labour and Welfare finds it necessary for preventing the occurrence of food sanitation hazards, the Minister may order a person who imports food, additives, apparatus, or containers and packages that are the same type as those produced or processed by a person who has produced or processed food, additives, apparatus, or containers and packages stated in each item of the preceding paragraph or food prescribed in Article 12 to undergo an inspection conducted by the Minister or a registered conformity assessment body on the food, additives, apparatus, or containers and packages.
When the Minister of Health, Labour and Welfare finds it necessary for preventing the occurrence of food sanitation hazards, the Minister may order a person who imports food, additives, apparatus, or containers and packages that are found to be likely to fall under food, additives, apparatus, or containers and packages stated in each item of paragraph (1) or food prescribed in Article 12, in view of circumstances at production sites and other circumstances to undergo an inspection conducted by the Minister or a registered conformity assessment body on the food, additives, apparatus, or containers and packages.
A person who has received the order referred to in the preceding three paragraphs must not sell the food, additives, apparatus, or containers and packages, display them for the purpose of selling, or use them for business until after the person has undergone the inspection and has received the notice of the results of the inspection.
The notice referred to in the preceding paragraph which is given by a registered conformity assessment body is to be given through the prefectural governor or the Minister of Health, Labour and Welfare who has ordered that the person should undergo the inspection.
A person who intends to undergo an inspection conducted by the Minister of Health, Labour and Welfare or a registered conformity assessment body under the provisions of paragraphs (1) through (3), must pay a fee specified by the Minister in consideration of the actual costs of the inspections for an inspection conducted by the Minister, and must pay a fee specified by the registered conformity assessment body by obtaining an approval from the Minister in consideration of the actual costs of the inspections for an inspection conducted by a registered conformity assessment body.
第一項から第三項までの規定による厚生労働大臣又は登録検査機関の行う検査を受けようとする者は、検査に要する実費の額を考慮して、厚生労働大臣の行う検査にあつては厚生労働大臣が定める額の、登録検査機関の行う検査にあつては当該登録検査機関が厚生労働大臣の認可を受けて定める額の手数料を納めなければならない。
The provisions of paragraphs (3) through (5) of the preceding Article apply mutatis mutandis to inspections referred to in paragraphs (1) through (3).
前条第三項から第五項までの規定は、第一項から第三項までの検査について準用する。
food
「食品」
All food and drink, except the pharmaceutical products, quasi-pharmaceutical products and regenerative medicine products defined in the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Defined inArticle 4, paragraph (1)· applies throughout the law
additives
「添加物」
A substance used in or on food, by adding, mixing, soaking or any other method, in the course of producing food or to process or preserve it.
Defined inArticle 4, paragraph (2)· applies throughout the law
apparatus
「器具」
Tableware, kitchen utensils and other machines, equipment and articles that are used in collecting, producing, processing, cooking, storing, transporting, displaying, handing over or consuming food or additives and that touch the food or additives directly; those used to harvest food in farming and fisheries are not included.
Defined inArticle 4, paragraph (4)· applies throughout the law
containers and packages
「容器包装」
Anything that holds or wraps food or additives and is handed over with them, as it is, when the food or additives change hands.
Defined inArticle 4, paragraph (5)· applies throughout the law
registered conformity assessment body
「登録検査機関」
A corporation registered by the Minister of Health, Labour and Welfare under Article 33, paragraph (1) as a body that carries out product inspections (製品検査).
Defined inArticle 4, paragraph (9)· applies throughout the law