Chapter I Food, Additives, Apparatus, and Containers and Packaging

Article 1 Cases in which there is no risk of endangering human health under the provisions of the proviso to Article 6, item (ii) of the Food Sanitation Act (Act No. 233 of 1947; hereinafter referred to as "the Act") are as follows: (i) toxic or harmful substances that are naturally contained in or attached to food or additives and are not generally considered hazardous to human health depending on the dose or through treatment; (ii) when it is unavoidable to mix or add toxic or harmful substances in the process of producing food or additives and it is found to generally involve no risk to human health.

Article 2 An application for cancellation under the provisions of Article 7, paragraph (4) of the Act is to be filed by submitting a written application to the Minister of Health, Labour and Welfare stating the matters set forth in the following items, attaching documents proving that there is no longer any risk of food sanitation hazards resulting from the food or objects for which the application for the cancellation is filed: (i) the address and name of the applicant (for a corporation, its name, the location of its principal office, and the name of its representative); (ii) the scope of the food or objects for which the application for cancellation is filed; (iii) the reason that there is no risk of food sanitation hazards resulting from the food or objects related to the prohibition, and other matters that the Minister of Health, Labour and Welfare finds necessary.

Article 2-2 (1) A person who seeks to make a notification under the provisions of Article 8, paragraph (1) of the Act is to make the notification by submitting a written notification to a prefectural governor, mayor of a city establishing health centers, or director of a special ward (hereinafter referred to as "prefectural governor, etc.") stating the following matters (excluding items (iv) through (vii) in the case of making a notification when food containing designated ingredients, etc. is likely to cause harm to human health); provided, however, that when it is difficult to obtain the information on the person who has suffered damage to their health due to refusal to provide the information or other circumstances, statment of the matters set forth in items (iv) through (vii) is not required. (i) the date on which information that food containing designated ingredients, etc., has caused or is likely to cause harm to human health has been obtained; (ii) the product name of the food containing designated ingredients, etc.; (iii) the content of designated ingredients, etc.; (iv) the sex, age, consumption status of food containing designated ingredients, etc., and symptoms related to the damage to the health of the person who has suffered damage; (v) if the person who has suffered damage to their health is visiting a medical institution, the name and location of the medical institution; (vi) the results of diagnosis at the medical institution referred to in the preceding item; (vii) the names of the pharmaceuticals, etc., used when consuming food containing designated ingredients, etc., if any; and (viii) other necessary matters. (2) The notification referred to in Article 8, paragraph (1) of the Act may be made through a person responsible for the content of the labeling of food containing designated ingredients, etc.

Article 3 (1) The grounds specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9, paragraph (1) of the Act are as follows: (i) regarding specific food or additives which are collected, produced, processed, cooked, or stored in a specific country or region, or which are collected, produced, processed, cooked, or stored by a specific person (hereinafter referred to as "specific foods, etc."), the results of inspections under Article 26, paragraphs (1) through (3) of the Act or Article 28, paragraph (1) of the Act, or inspections conducted by a business person in accordance with the administrative guidance (meaning administrative guidance provided for in Article 2, item (vi) of the Administrative Procedure Act (Act No. 88 of 1993); the same applies in Article 17, paragraph (1), item (i)) provided by the State, prefectures, cities specified by Cabinet Order based on the provisions of Article 5, paragraph (1) of the Community Health Act (Act No. 101 of 1947) (hereinafter referred to as "cities establishing health centers") or special wards show that the total number of objects falling under food or additives set forth in each item of Article 9, paragraph (1) of the Act accounts for approximately 5% or more of the total number of food or additives covered by the inspections; (ii) the content of regulations and measures concerning food sanitation for specific foods, etc., in a country or region where the specific foods, etc., are collected, produced, processed, cooked, or stored, the inspection system and other systems for food sanitation management related to the specific foods, etc., by the government of the country or region, or local public entities, etc., the results of inspections of the specific foods, etc., conducted by the government of the country or region, or local public entities, etc., and other status of food sanitation management related to the specific foods, etc., in the country or region; (iii) regarding specific foods, etc., the fact that food poisoning or other damage caused to the health or suspected to have been caused by the specific foods, etc., has occurred; (iv) regarding specific foods, etc., a situation in which the specific foods, etc., have been contaminated or are likely to be contaminated has occurred. (2) The provisions of the preceding paragraph apply mutatis mutandis to the grounds specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act. In such a case, the term "food or additives" in item (i) of the preceding paragraph is deemed to be replaced with "toys", the term "specific foods, etc." in that item and items (ii) and (iv) of that paragraph is deemed to be replaced with "specific toys", the term "regarding specific foods, etc." in item (iii) of that paragraph is deemed to be replaced with "regarding specific toys", and the term "food poisoning or other damage caused to the health or suspected to have been caused by the specific foods, etc." in that item is deemed to be replaced with "other damage caused by or suspected to have been caused by the specific toys".

Article 4 (1) The matters specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 9, paragraph (1) of the Act are as follows: (i) the level of risk that specific foods, etc. may have in harming human health; (ii) the matters set forth in each item of paragraph (1) of the preceding Article; (iii) the possibility that specific foods, etc., falling under food or additives set forth in each item of Article 9, paragraph (1) of the Act may continue to be sold, or collected, produced, imported, processed, used, or cooked for the purpose of sale; and (iv) the effects that methods other than the prohibition under the provisions of Article 9, paragraph (1) of the Act are expected to have for preventing food sanitation hazards resulting from specific foods, etc. (2) The provisions of the preceding paragraph apply mutatis mutandis to the matters specified by the Ministry of Health, Labour and Welfare provided for in Article 9, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act. In such a case, the term "specific foods, etc." in items (i), (iii) and (iv) of the preceding paragraph is deemed to be replaced with "specific toys", and the term "food or additives" in item (iii) of that paragraph is deemed to be replaced with "toys".

Article 5 (1) When the Minister of Health, Labour and Welfare is to confirm that there is no risk of food sanitation hazards resulting from the specific foods, etc. in canceling the prohibition for specific foods, etc., provided for in Article 9, paragraph (1) of the Act, based on an application from a person that has an interest or as necessary, pursuant to the provisions of paragraph (3) of that Article, the Minister must take into account the matters set forth in each item of paragraph (1) of the preceding Article with regard to the specific foods, etc., for the cancellation of the prohibition. (2) The provisions of the preceding paragraph apply mutatis mutandis to the case in which the prohibition under Article 9, paragraph (1) of the Act is canceled pursuant to the provisions of paragraph (3) of that Article as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act. In such a case, the term "specific foods, etc." in the preceding paragraph is deemed to be replaced with "specific toys".

Article 6 (1) An application for cancellation under the provisions of Article 9, paragraph (3) of the Act is to be filed by submitting a written application stating the matters set forth in the following items to the Minister of Health, Labour and Welfare, attaching documents proving that there is no longer any risk of food sanitation hazards resulting from the food or additives for which application for the cancellation is filed: (i) the address and name of the applicant (for a corporation, its name, the location of its principal office, and the name of its representative); (ii) the scope of the food or additives for which the application for cancellation is filed; and (iii) other matters that the Minister of Health, Labour and Welfare finds necessary. (2) The provisions of the preceding paragraph apply mutatis mutandis to an application for cancellation under the provisions of Article 9, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act. In such a case, the term "food or additives" in the preceding paragraph is deemed to be replaced with "toys".

Article 7 (1) The livestock specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 10, paragraph (1) of the Act are buffaloes. (2) The cases specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 10, paragraph (1) of the Act are as follows: (i) if, with regard to livestock that have been found to have any diseases set forth in the left-hand column of the Appended Table 5 of the Enforcement Regulation of the Slaughterhouse Act (Order of the Ministry of Health and Welfare No. 44 of 1953) or any of the disorders set forth in that column, the necessary measures, such as disposal, have been taken to prevent the parts set forth respectively in the right-hand column of that Table from being served for consumption; (ii) if, with regard to diseases or disorders referred to in the left-hand column of the Appended Table 10 of the Enforcement Regulation of the Poultry Slaughtering Business Control and Poultry Meat Inspection Act (Order of the Ministry of Health and Welfare No. 40 of 1990), measures such as disposal of the parts set forth in the right-hand column of that Table have been taken, as a result of the inspections after evisceration referred to in Article 33, paragraph (1), item (iii) of that Order. (3) The case in which the relevant employees find that the livestock pose no risk to human health and are edible pursuant to the provisions of the proviso to Article 10, paragraph (1) of the Act is when healthy livestock have died instantly due to an unforeseen disaster.

Article 8 The products specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 10, paragraph (2) of the Act are as follows: (i) processed meat products; (ii) milk (meaning milk provided for in Article 2, paragraph (1) of the Ministerial Order on Milk and Milk Products Concerning Compositional Standards, etc. (Order of the Ministry of Health and Welfare No. 52 of 1951); the same applies in the following Article, items (i), (ix), and (x)) and milk products (meaning milk products provided for in Article 2, paragraph (13) of the same Order excluding butter oil, cheese (limited to processed cheese), ice cream, formulated milk powder, formulated milk liquid, lactic acid bacteria beverage, and milk beverage; the same applies in the following Article, items (ix) and (x)).

Article 9 The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 10, paragraph (2) of the Act are as follows: (i) for the meat or organs of livestock or poultry, the types of livestock or poultry, and for the products provided for in the preceding Article, the names and the types of the meat, milk, or organs for raw material; (ii) the quantity and weight; (iii) the address and name of the shipper (for a corporation, its name and location); (iv) the address and name of the consignee (for a corporation, its name and location); (v) for the meat or organs of livestock or poultry (excluding those divided or chopped), the following matters concerning the name, etc. of the organization which conducted the inspections: (a) for livestock, the name of the organization which conducted the slaughtering inspections (meaning a biopsy before slaughtering and inspections before and after dressing; the same applies hereinafter), or the name and government position of the employee who conducted the slaughtering inspections; (b) for poultry, the name of the organization which conducted the poultry inspections (meaning a biopsy and inspections after plucking and evisceration; the same applies hereinafter), or the name and government position of the employee who conducted the poultry inspections; (vi) the name and location of facilities where the following processes such as slaughtering were carried out: (a) for the meat or organs of livestock (excluding those divided or chopped), the slaughterhouse where the slaughtering or dressing was carried out; (b) for the meat or organs of poultry (excluding those divided or chopped), the poultry slaughterhouse where the slaughtering, plucking, and evisceration was carried out; (c) for the meat or organs of livestock or poultry divided or chopped, the facility where the processes were carried out; (d) for the products provided for in the preceding Article, the production facility where the products were produced; (vii) the fact that processing or production, such as the slaughtering, dressing, plucking, evisceration, dividing, and chopping, provided for in (a) through (d) of the preceding item was carried out in a sanitary manner based on the criteria equal to or better than those of Japan; (viii) the date on which any of the following processes such as slaughtering were carried out: (a) for the meat or organs of livestock (excluding those divided or chopped), the slaughtering and slaughtering inspections; (b) for the meat or organs of poultry (excluding those divided or chopped), the slaughtering and poultry slaughtering inspections; (c) for the meat or organs of livestock or poultry divided or chopped, those processes; (d) for the products provided for in the preceding Article, the production of the relevant products. (ix) for milk or dairy products, the fact that production was carried out in a sanitary manner based on the criteria equal to those of Japan; (x) for milk or dairy products, the name of the governmental organization of the exporting country which issued the certificate provided for in Article 10, paragraph (2) of the Act or the name and government position of the employee who signed the certificate.

Article 10 When certificates set forth in Article 10, paragraph (2) of the Act are for the meat or organs of livestock or poultry whose slaughtering inspections or poultry slaughtering inspections have been conducted in a country other than the exporting country, a transcript of the certificates stating the matters provided for in the preceding Article which have been issued by a governmental organization of the country that conducted the slaughtering inspections or poultry slaughtering inspections must be attached to the certificates set forth in that paragraph.

Article 11 The countries specified by Order of the Ministry of Health, Labour and Welfare as referred to in the proviso to Article 10, paragraph (2) of the Act are the United States of America, Australia, and New Zealand.

Article 11-2 (1) Food or additives specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 11, paragraph (1) of the Act are the meat and organs of livestock and poultry. (2) Food or additives specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 11, paragraph (2) of the Act are oysters and pufferfish to be eaten raw. (3) The matters specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 11, paragraph (2) of the Act are as follows: (i) the name of the food to be imported (for pufferfish, including its scientific name); (ii) the quantity and the weight of food to be imported; (iii) the sea area from which foods to be imported were collected; (iv) the date when foods to be imported were collected; (v) the name and location of the facility that processed the foods to be imported; (vi) the address and name of the shipper (for a corporation, its name and location); (vii) the address and name of the consignee (for a corporation, its name and location); (viii) the fact that foods to be imported were handled in a sanitary manner based on the criteria equal to or better than those of Japan.

Article 12 Additives involving no risk to human health under the provisions of Article 12 of the Act are as set forth in the Appended Table 1.

Articles 13 through 16 Deleted

Article 17 (1) The grounds specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 17, paragraph (1) of the Act are as follows: (i) regarding specific apparatus or containers and packaging which are produced in a specific country or region, or which are produced by a specific person (hereinafter referred to as "specific apparatus, etc."), the results of inspections under the provisions of Article 26, paragraphs (1) through (3) of the Act or Article 28, paragraph (1) of the Act, or inspections conducted by a business person in accordance with administrative guidance provided by the State, prefectures, cities establishing health centers, or special wards show that the total number of objects falling under apparatus or containers and packaging set forth in each item of Article 17, paragraph (1) of the Act accounts for approximately 5% or more of the total number of apparatus or containers and packaging covered by the inspections; (ii) the content of regulations and measures concerning food sanitation for specific apparatus, etc., in a country or region where the specific apparatus, etc., is produced, the inspection system and other systems for food sanitation management related to the specific apparatus, etc., by the government of the country or region, or local public entities, etc., the results of inspections with regard to the specific apparatus, etc., by the government of the country or region, or local public entities, etc., and other status of food sanitation management related to the specific apparatus, etc., in the country or region; (iii) regarding specific apparatus, etc., the damage to health caused by or suspected to have been caused by the specific apparatus, etc., has occurred; (iv) regarding specific apparatus, etc., a situation that contaminates or is likely to contaminate the specific apparatus, etc. has occurred. (2) The provisions of the preceding paragraph apply mutatis mutandis to the grounds specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 17, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act.

Article 18 (1) The matters specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 17, paragraph (1) of the Act are as follows: (i) the level of the risk that specific apparatus, etc., may harm human health; (ii) the matters set forth in each item of paragraph (1) of the preceding Article; (iii) the possibility that specific apparatus, etc., falling under the apparatus or containers and packaging set forth in each item of Article 17, paragraph (1) of the Act may continue to be sold, or produced, or imported for the purpose of sale, or used in business; (iv) the effects that methods other than the prohibition provided for in Article 17, paragraph (1) of the Act are expected to have for preventing food sanitation hazards resulting from specific apparatus, etc. (2) The provisions of the preceding paragraph apply mutatis mutandis to the grounds specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 17, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act.

Article 19 (1) When the Minister of Health, Labour and Welfare is to confirm that there is no risk of food sanitation hazards resulting from the specific apparatus, etc. in canceling the prohibition related to specific apparatus, etc., provided for in Article 17, paragraph (1) of the Act, based on an application from a person that has an interest or as necessary, pursuant to the provisions of Article 9, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 17, paragraph (3) of the Act following the deemed replacement of terms, the Minister must take into account the matters set forth in each item of paragraph (1) of the preceding Article with regard to the specific apparatus, etc., related to the cancellation of the prohibition. (2) The provisions of the preceding paragraph apply mutatis mutandis to the case in which the prohibition under the provisions of Article 17 paragraph (1) of the Act which is applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act, is canceled pursuant to the provisions of Article 9, paragraph (3) of the Act which is applied mutatis mutandis pursuant to Article 17, paragraph (3) of the Act following the deemed replacement of terms as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act.

Article 20 (1) An application for cancellation under the provisions of Article 9, paragraph (3) of the Act which is applied mutatis mutandis pursuant to Article 17, paragraph (3) of the Act following the deemed replacement of terms is to be filed by submitting a written application stating the matters set forth in the following items to the Minister of Health, Labour and Welfare, attaching documents proving that there is no longer any risk of food sanitation hazards resulting from the apparatus or containers and packaging for which the application for the cancellation is filed: (i) the address and name of the applicant (for a corporation, its name, the location of its principal office, and the name of its representative); (ii) the scope of the apparatus or containers and packaging for which the application for cancellation is filed; and (iii) other matters that the Minister of Health, Labour and Welfare finds necessary. (2) The provisions of the preceding paragraph apply mutatis mutandis to an application for cancellation under the provisions of Article 9, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 17, paragraph (3) of the Act following the deemed replacement of terms as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act.

Chapter II Monitoring and Guidance

Article 21 The wide-area cooperation council referred to in Article 21-3, paragraph (1) of the Act is to consist of the Regional Bureau of Health and Welfare, the prefectural government within the jurisdictional district of the Regional Bureau of Health and Welfare, and the cities and special wards which establish health centers, established for each jurisdictional district of the Regional Bureaus of Health and Welfare.

Chapter III Deleted

Articles 22 and 23 Deleted

Chapter IV Product Inspections

Article 24 An application for inspection referred to in Article 25, paragraph (1) of the Act is to be filed by submitting a written application stating the following matters for each product constituting a lot: (i) the name and address of the applicant (for a corporation, its name, its location, and the name of its representative); (ii) the names of the products; (iii) the name and location of the production facility; (iv) the name of the food sanitation supervisor; (v) the date of production; (vi) the quantity for the application. (vii) the number of units by capacity of each packet; (viii) when inspections have been conducted by the producer, the results of the inspections.

Article 25 The collection of test samples under the provisions of Article 4, paragraph (3) of the Order for Enforcement of the Food Sanitation Act (Cabinet Order No. 229 of 1953; hereinafter referred to as "the Order") is to be made for each product constituting a lot, and the amount to be collected is to be the minimum amount necessary for the inspections.

Article 26 The labeling specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 25, paragraph (1) of the Act is to be conducted by sealing the containers and packaging of the products with certificates prepared according to Form No. 1.

Article 27 The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 5, paragraph (1) of the Order are as follows: (i) the name and address of the person who is to receive inspections (for a corporation, its name, the location of its principal office, and the name of its representative); (ii) the names of the products which are to receive inspections; (iii) the name and location of the production or processing facility; (iv) the period for the production or processing of the products which are to receive inspections; (v) specific reasons to order a person to receive inspections.

Article 28 (1) An application for inspections referred to in Article 26, paragraph (1) of the Act is to be filed by submitting a written application stating the following matters for each product constituting a lot: (i) the name and address of the applicant (for a corporation, its name, the location of its principal office, and the name of its representative); (ii) the names of the products; (iii) the name and location of the production or processing facility; (iv) the date of production or processing; (v) the quantity for the application. (2) The written application under the preceding paragraph must have a transcript of a written inspection order referred to in Article 5, paragraph (1) of the Order attached; provided, however, that this does not apply to the case in which an application for inspections has already been filed for the same order and a copy of a written inspection order has already been submitted.

Article 29 (1) An application for inspections referred to in Article 26, paragraph (2) of the Act is to be filed by submitting a written application stating the following matters: (i) the name and address of the applicant (for a corporation, its name and the location of its principal office); (ii) the names of the products; (iii) the name and address of the producer or processor (for a corporation, its name and the location of its principal office); (iv) the name and location of the production or processing facility; (v) the date of arrival of the products at the port; (vi) the location of the storage site; and (vii) the quantity for the application. (2) The written application under the preceding paragraph must have a copy of a written inspection order (when the Minister of Health, Labour and Welfare has issued a notice of inspection order using an electronic data processing system pursuant to the provisions of Article 34, paragraph (1), a document on which the content of the order is output) attached.

Article 30 The provisions of the preceding Article apply mutatis mutandis to an application for inspections under Article 26, paragraph (3) of the Act. In such a case, the term "matters" in paragraph (1) of that Article is deemed to be replaced with "matters (for an application for inspections of food other than processed food, excluding the matters set forth in item (iii))", and the term "location" in item (iv) of that paragraph is deemed to be replaced with "location (for an application for inspections of food other than processed food, the place of production of the food)".

Article 31 The payment of the fee for receiving inspections by the Minister of Health, Labour and Welfare is to be made by affixing a revenue stamp for the amount specified by the Minister of Health, Labour and Welfare under Article 25, paragraph (2) of the Act or Article 26, paragraph (6) of the Act to a written application set forth in Article 4, paragraph (2) or Article 6, paragraph (1) of the Order (including as applied mutatis mutandis pursuant to Article 7 of the Order).

Chapter V Import Notification

Article 32 (1) A person specified in Article 27 of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act; the same applies in paragraph (7), paragraph (8), and the following Article) (the person is referred to as an "importer" in item (xi), the following paragraph, and paragraphs (4) and (5)) must state the following matters in a written import notification (when submitting a written import notification prior to the carrying in of cargoes to the inventory location (hereinafter referred to as "carrying in" in this paragraph), excluding the matters set forth in item (xiv)) and submit the notification to the head of a quarantine station set forth in the right-hand column of the Appended Table 11 for the places set forth in the respective left-hand column of that Table on and after seven days prior to the planned arrival date of the cargoes (when an accident concerning the cargoes is suspected to have occurred, after the carrying in), except in cases where the person seeks to import food set forth in the Appended Table 10; provided, however, that when submitting a written import notification prior to the carrying in and an accident concerning the cargoes has occurred, a written notification stating the outline of the accident must be submitted to the head of the quarantine station immediately after the carrying in: (i) the name and address (for a corporation, its name and the location of its principal office); (ii) whether the cargoes are food, additives, apparatus, containers and packaging, or toys, the names of the articles, loaded quantity, loaded weight, type of packaging, and intended use, and when the cargoes have any marks and numbers affixed, the marks and numbers; (iii) when the cargoes are food containing additives which are used for purposes other than for flavoring (for food which is generally served for consumption and is used as an additive, limited to those for which criteria or standards have been established pursuant to the provisions of Article 13, paragraph (1) of the Act), the name of the additives; (iv) when the cargoes are processed food, its raw materials and production or processing methods; (v) when the cargoes are those set forth in the right-hand column of the Appended Table 17 of the Food Labeling Standards (Cabinet Office Order No. 10 of 2015) as those in which recombinant DNA or the resultant protein remains even after processing procedures are taken (including processed food for business use provided for in Article 2, paragraph (1), item (iii) of that Cabinet Office Order), the matters provided for respectively in 1-1 through 3 of the right-hand column in accordance with the cases provided for in 1-1 through 3 of the right-hand column of the row for processed food set forth in the right-hand column of Appended Table 17 and the middle column of Appended Table 18 in the table of Article 3, paragraph (2) of that Cabinet Office Order (excluding the case in which the labeling concerning genetic recombination of the raw material provided for in 5 of that column is not required pursuant to the provisions of the main clause of 5 of that column); (vi) when cargoes are target agricultural products provided for in Article 2, paragraph (1), item (xiv) of the Food Labeling Standards, matters provided for respectively in 1-1-(a) or (b) of the right-hand column in accordance with the cases provided for in 1-1-(a) or (b) of the right-hand column of the row of the target agricultural products in the table of Article 18, paragraph (2) of that Cabinet Office Order; (vii) when cargoes are additives, and the additives are preparations containing the additives (excluding those used for flavoring and those generally served for consumption which are used as additives), the ingredients; (viii) when cargoes are apparatus, containers and packaging, or toys, the materials; (ix) the name and address of the producer or processor of the cargoes (excluding food other than processed food) (for a corporation, its name and the location of its principal office); (x) the name and location of the production or processing facility of the cargoes (in the case of food other than processed food, the place of production), the loading port, loading date, unloading port, and arrival date of the cargoes; (xi) the name and address (for a corporation, its name and the location of its principal office) of the exporter (meaning a person who exports cargoes to the importer) of the cargoes (limited to foods other than processed foods; hereinafter the same applies in this item) and the name and address (for a corporation, its name and the location of its principal office) of the person who packages the cargoes (limited to when the cargoes are packaged); (xii) the name or flight number of the ship or aircraft loaded with the cargoes; (xiii) the name and location of the warehouse where the cargoes have been stored and the date of delivery; (xiv) whether there have been any accidents concerning the cargoes, and the outline of the accident, if any. (2) An importer must, when there have been any changes to the matters set forth in items (x) through (xiii) of the preceding paragraph (for the matters set forth in item (x), limited to the unloading port and the arrival date), immediately submit a written notification to that effect to the head of the quarantine station referred to in that paragraph. (3) When genetically modified agricultural products (meaning those provided for in the Food Labeling Standards Article 2, paragraph (1), item (xv); hereinafter the same applies in this paragraph) or non-genetically modified agricultural products (meaning those provided for in item (xvi) of that paragraph) have been unintentionally mixed into to a certain degree in spite of conducting identity preserved handling (meaning the handling provided for in item (xix) of that paragraph), if the confirmation under 1-1 or 3 in the right-hand column of the row of processed foods set forth in the right-hand column of Appended Table 17 and the middle-hand column of Appended Table 18 in the table of Article 3, paragraph (2) of that Order or in 1-1-(a) in the right-hand column of the row of target agricultural products in the table of Article 18, paragraph (2) has been appropriately made, the provisions of paragraph (1) are applied, deeming that identity preserved handling has been confirmed to have been conducted. (4) When an importer imports food, additives, apparatus, containers and packaging set forth in the middle column of the Appended Table 12 (hereinafter referred to as "food, etc." in this Article) and has submitted a written import notification stating the import plans for the same products as the food, etc. or equivalent products (hereinafter referred to as "the same food, etc.") for a period set forth in the right-hand column of that Table (the plans for the loaded weight, unloading port, and arrival date of the cargoes related to the import planned for that period; the same applies hereinafter), the submission, notwithstanding the provisions of the main clause of paragraph (1), may replace the submission of a written import notification under paragraph (1) with regard to the import of the same food, etc., planned for the period; provided, however, that this does not apply to the case in which the food, etc., related to the import falls under or is suspected to fall under any of the following items: (i) food or additives set forth in each item of Article 6 of the Act; (ii) food or additives provided for in Article 12 of the Act; (iii) food or additives which do not conform to the criteria established pursuant to the provisions of Article 13, paragraph (1) of the Act; (iv) food or additives which do not conform to the standards established pursuant to the provisions of Article 13, paragraph (1) of the Act; (v) food in which substances that are the ingredients of agricultural chemicals (meaning agricultural chemicals provided for in Article 2, paragraph (1) of the Agricultural Chemicals Regulation Act (Act No. 82 of 1948), the same applies hereinafter), substances that are used by being added, mixed, or infiltrated into feed (meaning feed provided for in Article 2, paragraph (2) of the Act on Safety Assurance and Quality Improvement of Feeds (Act No. 35 of 1953)) or are used by other methods for feeds for the purpose of providing them for usage specified by Order of the Ministry of Agriculture, Forestry and Fisheries based on Article 2, paragraph (3) of that Act, and pharmaceutical products that are provided for in Article 2, paragraph (1) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960) and that are to be used for animals (including substances chemically generated from the substances and excluding substances that are specified as clearly having no risk to human health pursuant to the provisions of Article 13, paragraph (3) of the Act) remain in a quantity exceeding the quantity specified as having no risk to human health pursuant to the provisions of Article 13, paragraph (3) of the Act (excluding cases where standards concerning the ingredients of food under Article 13, paragraph (1) of the Act have been established with regard to the residual limit of those substances in the food); (vi) apparatus or containers and packaging provided for in Article 16 of the Act; (vii) apparatus or containers and packaging which do not conform to the standards established pursuant to the provisions of Article 18, paragraph (1) of the Act; (5) In the case referred to in the preceding paragraph, an importer of food, etc., set forth in the middle column of paragraph (3) of the Appended Table 12 must submit a written import notification stating the import plans provided for in the preceding paragraph, by entering the past record of imports of the same food, etc., during the three years before the date of submission of the written import notification (the past record means the name of the importer related to the import carried out during that period (for a corporation, its name), the loaded weight, unloading port, and arrival date of the cargoes). (6) In the case referred to in the main clause of paragraph (4), the phrase "when submitting a written import notification prior to the carrying in" in the proviso to paragraph (1) is deemed to be replaced with "related to the import" and the term "the head of the quarantine station" is deemed to be replaced with "the head of a quarantine station set forth in the right-hand column of the Appended Table 11 for the places set forth in the respective left-hand column of that Table". (7) The Minister of Health, Labour and Welfare may have a person make a notification under the provisions of Article 27 of the Act using an electronic data processing system (meaning an electronic data processing system that connects a computer (including input-output devices; the same applies hereinafter) used by the Ministry of Health, Labour and Welfare and an input-output device used by a person who seeks to make a notification under the provisions of that Article via a telecommunications line; hereinafter the same applies in this Chapter). (8) With regard to the application of the provisions of paragraphs (1) and (2) to a person who seeks to make a notification under the provisions of Article 27 of the Act using an electronic data processing system, the phrase "state the following matters in a written import notification" is deemed to be replaced with "state the following matters," the phrase "when submitting a written import notification" is deemed to be replaced with "when the person records the matters in a file by inputting them through input-output devices set forth in paragraph (7) (limited to those used by a person who seeks to make the notification; hereinafter the same applies in this paragraph and the following paragraph)", the phrase "and submit the notification to the head of a quarantine station set forth in the right-hand column of the Appended Table 11 for the places set forth in the respective left-hand column of that Table" is deemed to be replaced with "in a file by inputting them through input-output devices", the phrase "when submitting a written import notification prior to the carrying in" in the proviso to paragraph (1) is deemed to be replaced with "when recording the matters in a file by inputting them through input-output devices", and the phrase "a written notification stating the outline of the accident must be submitted to the head of the quarantine station" is deemed to be replaced with "the outline of the accident must be recorded in a file by inputting it through an input-output device", and the phrase " immediately submit a notification to that effect to the head of the quarantine station set forth in the preceding paragraph" in paragraph (2) is deemed to be replaced with "record them in a file by inputting them through an input-output device". (9) The provisions of paragraphs (4) through (6) do not apply to a person provided for in the preceding paragraph.

Article 33 (1) The input pursuant to the provisions of paragraphs (1) and (2) of the preceding Article which is applied pursuant to paragraph (8) of the preceding Article following the deemed replacement of terms must be made through an input-output device that has been notified to the Minister of Health, Labour and Welfare in advance. (2) A person who seeks to make a notification under the provisions of Article 27 of the Act using an electronic data processing system is to make a notification referred to in the provisions of the preceding paragraph by submitting a written notification stating the following matters to the Minister of Health, Labour and Welfare, with regard to the input-output device the person seeks to use: (i) the name and address of the notifier (for a corporation, its name and the location of its principal office); (ii) a security code (limited to one using twelve Arabic numerals or Roman letters, or their combination); (iii) the place where the input-output device is located, and the name and model number of the equipment; (iv) when a person other than the notifier manages the input-output device, the name and address of that person (for a corporation, its name and the location of its principal office). (3) A person who has made a notification referred to in the preceding paragraph must, when there are any changes to the matters set forth in each item of that paragraph or when the person has stopped using the input-output device that has been notified, promptly notify the Minister of Health, Labour and Welfare.

Article 34 (1) The Minister of Health, Labour and Welfare may use an electronic data processing system when issuing a notice of an inspection order under the provisions of Article 26, paragraph (2) or (3) of the Act to a person who has made a notification using an electronic data processing system pursuant to the provisions of Article 32, paragraph (7) with regard to food, additives, apparatus, or containers and packaging related to the notification, or issuing a notice of the results of the inspection under the provisions of Article 26, paragraph (4) of the Act (hereinafter referred to as a "specific notice" in this Article). (2) The Minister of Health, Labour and Welfare must, when issuing a specific notice using an electronic data processing system pursuant to the provisions of the preceding paragraph, input the content of the specific notice through the input-output device referred to in Article 32, paragraph (7) (limited to one used by the Ministry of Health, Labour and Welfare) and record them in a file. (3) The Minister of Health, Labour and Welfare must obtain the consent of the other party in advance for issuing a specific notice using an electronic data processing system.

Chapter VI Food Sanitation Inspection Facilities

Article 35 Deleted

Article 36 (1) The criteria specified by Order of the Ministry of Health, Labour and Welfare concerning the matters set forth in Article 8, paragraph (2), item (i) of the Order are as follows; provided, however, that if implementation of a part of the affairs concerning product inspections and examinations referred to in Article 29 of the Act are ensured even in emergency by being entrusted to food sanitation inspection facilities established by other prefectures, cities establishing health centers, or special wards, or to registered inspection bodies, this does not apply to equipment related to the part of the affairs: (i) to provide physicochemical inspection rooms, bacteriological inspection rooms, animal breeding rooms, office rooms, etc.; and (ii) to provide water purifying apparatuses, automatic ovens, deep freezers, electric furnaces, gas chromatographs, spectrophotometers, autoclaves, dry heat sterilizers, constant temperature incubators, anaerobic culture systems, constant temperature tanks, and other machinery and tools necessary for inspection or examination. (2) The criteria specified by Order of the Ministry of Health, Labour and Welfare related to matters set forth in Article 8, paragraph (2), item (ii) of the Order are to assign employees necessary for inspection or examination.

Article 37 The affairs concerning the inspection or examination under the provisions of Article 8, paragraph (3) of the Order (hereinafter referred to as "inspections, etc." in this Article and the Appended Table 13) are to be managed as follows: (i) to confirm that inspections, etc., are appropriately conducted based on the standard operation manual provided for in item (xi); (ii) to conduct internal checking of the management of the operation of inspections, etc., on a regular basis, based on documents set forth in item (xii); (iii) to conduct accuracy management (meaning maintaining the accuracy of inspections through the method of ensuring the skill levels of persons engaged in inspections or other methods; the same applies hereinafter), based on documents set forth in item (xiii); (iv) to receive external investigation of accuracy management (meaning investigation concerning accuracy management conducted by the State or other persons found to be appropriate; the same applies hereinafter) on a regular basis, based on documents set forth in item (xiv); (v) to record the results of internal checking referred to in item (ii), accuracy management referred to in item (iii), and external investigation of accuracy management referred to in the preceding item (when improvement measures are required, including the content of the improvement measures); (vi) to take improvement measures for the operation of inspections, etc., promptly in accordance with the records under the provisions of the preceding item; (vii) when any deviation from the standard operation manual provided for in item (xi) and the documents provided for in items (xii) and (xiii) has been found upon inspections, etc., to assess the content of the deviation and take the necessary measures; (viii) an employee who carries out the duties referred to in item (i) or the preceding two items must not conduct inspections, etc.; (ix) an employee who carries out the duties referred to in items (ii) through (v) (hereinafter referred to as "credibility ensuring duties" in this Article) must not conduct inspections, etc., nor carry out the duties referred to in item (i) or (vi); (x) to make credibility ensuring duties independent from the operation of inspections, etc.; (xi) to prepare standard operation manuals as prescribed in the Appended Table 13; (xii) to prepare documents stating the methods of the internal checking of the management of the operation of inspections, etc.; (xiii) to prepare documents stating the methods of accuracy management; (xiv) to prepare documents stating the plans for receiving an external investigation of accuracy management on a regular basis; (xv) to prepare documents stating the training plans for employees who carry out credibility ensuring duties; (xvi) to prepare the following records and preserve them for three years from the day of their preparation: (a) the name and address of a person who has applied for inspections set forth in Article 25, paragraph (1) of the Act or Article 26, paragraphs (1) through (3) of the Act (hereinafter referred to as "product inspections") or a person who has had their objects removed pursuant to the provisions of Article 28, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act; the same applies in (b)) (for a corporation, its name and the location of its principal office); (b) the date on which the application for product inspections was received, or the date on which the objects were removed pursuant to the provisions of Article 28, paragraph (1) of the Act; (c) the name of the products for which inspections, etc., were conducted; (d) the date on which inspections, etc., were conducted; (e) the items for inspections, etc.; (f) the quantity of the test samples for which inspections, etc., were conducted; (g) the name of the employee who conducted inspections, etc.; (h) the results of inspections, etc.; (i) the records pursuant to the provisions of item (v); (j) the records based on the standard operation manual set forth in item (xi); (k) the records concerning the training referred to in the preceding item.

Chapter VII Registered Inspection Bodies

Article 38 (1) A person who seeks to apply for registration under Article 31 of the Act must submit a written application prepared according to Form No. 5 to the Minister of Health, Labour and Welfare, by attaching the following documents: (i) the articles of incorporation or articles of endowment, and certificate of registered information; (ii) the resume of a person who has the knowledge and experience that meet the conditions set forth in column 3 of the Appended Table of the Act (hereinafter referred to as an "inspector"); (iii) the documents that clarify the organization of departments provided for in Article 33, paragraph (1), item (ii), (a) of the Act (hereinafter referred to as "departments conducting product inspections") and specialized departments provided for in (c) of that item (hereinafter referred to as "departments ensuring credibility"); (iv) the standard operation manual provided for in Article 40, item (viii) and documents provided for in items (ix) through (xii) of that Article as documents provided for in Article 33, paragraph (1), item (ii), (b) of the Act; (v) the documents that state the following matters: (a) whether the corporation falls under any item of Article 32 of the Act; (b) the type of product inspection to be conducted among those set forth in column 1 of the Appended Table of the Act; (c) the number and performance of the machinery, tools, and other equipment set forth in column 2 of the Appended Table of the Act, whether they are owned or leased, the place where they are located, and the type of product inspections for which they are used; (d) the name of the inspector and the type of product inspections to be conducted; (e) the name of the department conducting product inspections, the name of the responsible person for the department conducting product inspections provided for in Article 40, item (i), and the name of the responsible person for the inspection category provided for in item (ii) of that Article and the type of product inspections that the person manages; (f) the name of the department ensuring credibility, and the name of the responsible person for the department ensuring credibility provided for in Article 40, item (iii); (g) when a person has already conducted an examination business concerning food sanitation, the outline of the business; (h) whether the person falls under any of Article 33, paragraph (1), item (iii), sub-items (a) through (c) of the Act; (i) for a stock company, the name and address of a shareholder who holds shares exceeding five percent of the total number of issued shares or a person who has made a contribution that exceeds five percent of the total contribution, and the number of shares held by the person or the value of the contribution made by the person; (j) the names and addresses of officers (for a membership company (meaning a membership company provided for in Article 575, paragraph (1) of the Companies Act (Act No. 86 of 2005)), a member that executes its business), whether they have the representative authority, and their brief biographical outlines (including whether they fall under officers or employees of a business person subject to inspections prescribed in Article 33, paragraph (1), item (iii) of the Act (including those who have been officers or employees of the business person subject to inspections in the past two years)); (k) when a person conducts a business other than an examination business concerning food sanitation, the type and outline of the business. (2) A revenue stamp for the amount of the fee must be affixed to a written application referred to in the preceding paragraph.

Article 39 (1) A person who seeks to apply for renewal of registration under Article 34, paragraph (1) of the Act must submit a written application prepared according to Form No. 6 to the Minister of Health, Labour and Welfare, by attaching the following documents: (i) the documents set forth in paragraph (1), items (i) through (iii) of the preceding Article; (ii) the documents stating the matters set forth in paragraph (1), item (v), sub-item (a), and sub-items (c) through (k) of the preceding Article; (iii) material concerning the actual results of product inspections. (2) A revenue stamp for the amount of the fee must be affixed to a written application referred to in the preceding paragraph.

Article 40 The criteria specified by Order of the Ministry of Health, Labour, and Welfare as referred to in Article 35, paragraph (2) of the Act are as follows: (i) persons who carry out the following duties are assigned to departments conducting product inspections (hereinafter referred to as "responsible persons for departments conducting product inspections"): (a) supervising the duties of departments conducting product inspections; (b) taking improvement measures promptly for those duties in accordance with documents with which a report was made pursuant to the provisions of item (iii), (d); and (c) carrying out other necessary duties; (ii) at departments conducting product inspections, persons who carry out the following duties for product inspections based on the standard operation manuals provided for in item (viii) (hereinafter referred to as "responsible persons for inspection categories") are assigned for each category of physicochemical inspections, bacteriological inspections, and inspections using animals: (a) when any deviation from standard operation manuals provided for in item (viii) or documents provided for in item (ix) has been found upon product inspections, assessing the content of the deviation and taking necessary measures; (b) confirming that product inspections are conducted appropriately based on standard operation manuals provided for in item (viii) and carrying out other necessary duties; (iii) persons who personally carry out the following duties or have other people previously appointed in accordance with the content of the duties carry out the duties are assigned to departments ensuring credibility (hereinafter referred to as "responsible persons for departments ensuring credibility"): (a) conducting internal checking of the management of the operation of product inspections on a regular basis, based on documents set forth in item (ix); (b) conducting accuracy management based on documents set forth in item (x), and when any deviation from the documents has occurred, assessing the content of the deviation and taking necessary measures; (c) conducting affairs for receiving an external investigation of accuracy management on a regular basis, based on documents set forth in item (xi); (d) reporting the results of internal checking referred to in (a), accuracy management referred to in (b), and external investigation of accuracy management referred to in (c) (when improvement measures are required, including the content of the improvement measures) to responsible persons for departments conducting product inspections in writing and entering the record into the books referred to in Article 44 of the Act (hereinafter referred to as the "books"); (e) carrying out other necessary duties; (iv) a department ensuring credibility is to be independent from departments conducting product inspections; (v) responsible persons for departments conducting product inspections and responsible persons for departments ensuring credibility are officers of a registered inspection body; (vi) responsible persons for departments conducting product inspections and responsible persons for inspection categories do not concurrently hold the position of inspector; (vii) responsible persons for departments ensuring credibility and persons appointed pursuant to the provisions of item (iii) do not concurrently hold the position of responsible persons for departments conducting product inspections, responsible persons for inspection categories, and inspectors; (viii) standard operation manuals have been prepared as provided for in the Appended Table 13. In such a case, in that Table, the term "Methods for keeping records" is deemed to be replaced with "Methods for entering into the book, the records," the phrase "Standard operation manual for the implementation of inspections" is deemed to be replaced with "Standard operation manual for the implementation of product inspections," and the term "inspections, etc." is deemed to be replaced with "product inspections"; (ix) documents stating the methods for internal checking of the management of the operation of product inspections have been prepared; (x) documents stating the methods for accuracy management have been prepared; (xi) documents stating the plans for receiving external investigations of accuracy management on a regular basis have been prepared; (xii) documents stating the training plans for responsible persons for departments ensuring credibility and persons appointed pursuant to the provisions of item (iii) have been prepared.

Article 41 (1) A person who seeks to make a notification of the establishment or abolition of their place of business, or changes of its location pursuant to the provisions of Article 36, paragraph (1) of the Act must submit a written notification prepared according to Form No. 7 to the Minister of Health, Labour and Welfare. (2) A person who seeks to make a notification of changes pursuant to the provisions of Article 36, paragraph (2) of the Act must submit a written notification prepared according to Form No. 8 to the Minister of Health, Labour and Welfare.

Article 42 (1) When a registered inspection body seeks to obtain authorization for rules concerning the operation of product inspections (hereinafter referred to as "operational rules") pursuant to the provisions of the first sentence of Article 37, paragraph (1) of the Act, it must submit a written notification prepared according to Form No. 9 to the Minister of Health, Labour and Welfare, by attaching the operational rules and materials concerning the calculation of the fee for product inspections. (2) The matters to be specified in operational rules referred to in Article 37, paragraph (2) of the Act are as follows: (i) the types of product inspections and matters concerning the methods for the implementation and management of the operation of product inspections; (ii) the matters concerning the hours for conducting product inspections and holidays; (iii) the matters concerning the maximum number of applications for product inspections that may be received; (iv) the matters concerning places for conducting product inspections; (v) the amount of fees for each inspection item of product inspections and matters concerning methods for storage; (vi) the matters concerning the appointment and dismissal of responsible persons for departments conducting product inspections, responsible persons for inspection categories, inspectors, and responsible persons for departments ensuring credibility; (vii) the matters concerning the assignment of responsible persons for departments conducting product inspections, responsible persons for inspection categories, and inspectors; (viii) the matters concerning the preservation of written applications for product inspections and other documents concerning product inspections; (ix) the matters concerning the keeping of financial statements, etc. (meaning financial statements, etc., provided for in Article 39, paragraph (1) of the Act; hereinafter the same applies in this Article) and the acceptance of requests for the inspection, etc., of financial statements, etc.; and (x) beyond what is set forth in the preceding items, matters necessary for the operation of product inspections. (3) When a registered inspection body seeks to obtain authorization for changes to the operational rules pursuant to the provisions of the second sentence of Article 37, paragraph (1) of the Act, it must submit a written application prepared according to Form No. 10 to the Minister of Health, Labour and Welfare. In such a case, when the changes involve changes to the amount of the fee for product inspections, materials concerning its calculation must be attached.

Article 43 When a registered inspection body seeks to obtain permission for the suspension of all or part of the operations or the discontinuation of the operations of product inspections pursuant to the provisions of Article 38 of the Act, it must submit a written application prepared according to Form No. 11 to the Minister of Health, Labour and Welfare.

Article 44 The means specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 39, paragraph (2), item (iii) of the Act are the means of indicating the matters recorded on the electronic or magnetic record on paper or on the screen of an input-output device.

Article 45 The electronic or magnetic means specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 39, paragraph (2), item (iv) of the Act are either of the means set forth in the following items specified by a registered inspection body: (i) the means of using an electronic data processing system that connects the computer used by a sender and the computer used by a receiver via a telecommunications line, by which information is sent via the telecommunications line and recorded in a file stored on the computer used by the receiver; or (ii) the means of delivering information recorded in a file prepared by a media in which certain information can be securely recorded on a magnetic disck or other equivalent means.

Article 46 (1) The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 44 of the Act are as follows: (i) the name and address of a person who has applied for product inspections (for a corporation, its name and the location of its principal office); (ii) the date on which the application for product inspections was received; (iii) the name of the products for which product inspections were conducted; (iv) the date on which product inspections were conducted; (v) the items for product inspection; (vi) the quantity of the test samples for which product inspections were conducted; (vii) the name of the inspector who conducted product inspections; (viii) the results of the product inspections; (ix) the records required to be entered into the books pursuant to the provisions of Article 40, item (iii), (d); (x) the records required to be entered into the books by the standard operation manuals prepared pursuant to the provisions of Article 40, item (viii); and (xi) the records concerning the training referred to in Article 40, item (xii). (2) The books must be preserved for three years from the date of the final entry.

Article 47 The identification card which the employees are to carry pursuant to the provisions of Article 28, paragraph (2) of the Act as applied mutatis mutandis pursuant to Article 47, paragraph (2) of the Act is to be prepared according to Form No. 12.

Chapter VIII Business

Article 48 A person who is found to have an academic ability equivalent to or higher than a person who has graduated from a high school or secondary education school prescribed in the School Education Act (Act No. 26 of 1947) or a secondary school prescribed in the former Secondary School Order (Imperial Order No. 36 of 1943), as provided for in Article 48, paragraph (6), item (iv) of the Act is as follows: (i) a person who has completed the first year of a senior course or special course at a girls' high school under the former Secondary School Order, which requires, as an entrance requirement, graduation from a four-year course of a girls' high school under that Order, which requires, as an entrance requirement, completion of a primary course at a national elementary school under the former National Elementary School Order (Imperial Order No. 148 of 1941) (hereinafter referred to as a "national elementary school"); (ii) a person who has completed the first year of a special course at a vocational school under the former Secondary School Order, which requires, as an entrance requirement, graduation from a four-year course of a vocational school under that Order, which requires, as an entrance requirement, completion of a primary course at a national elementary school; (iii) a person who has completed a preparatory course at a normal school under the former Normal School Education Order (Imperial Order No. 109 of 1943); (iv) a person who has graduated from an affiliated secondary school or affiliated girls' high school under the former Normal School Education Order; (v) a person who has completed the third year of a regular course of a normal school under the former Normal School Education Order (Imperial Order No. 346 of 1897) prior to the amendment by that Order; (vi) a person who has graduated from a secondary school pursuant to the provisions of Article 2 or Article 5 of Order of the Ministry of Education No. 63 of 1943 (regulations concerning the entrance into and transfer to other schools of students, pupils, or graduates of schools in regions other than the mainland) or a person who is treated in the same manner as a person set forth in item (i); (vii) a person who has graduated from a regular course at a boys' school (excluding schools with two-year term of study) under the former Boys' School Order (Imperial Order No. 254 of 1939); (viii) a person who has passed examinations under the former Technical College Entrance Examination Regulations (Order of the Ministry of Education No. 22 of 1924) based on the former Technical College Order (Imperial Order No. 61 of 1903), and a person designated by the Minister of Education as having an academic ability equivalent to or higher than graduates of a secondary school or girls' high school with regard to entrance into a professional training college pursuant to the provisions of Article 11, paragraph (2) of the Regulations; (ix) a person who has passed examinations under the formal Vocational School Graduation Level Examination Regulations (Order of the Ministry of Education No. 30 of 1925); (x) a person who has passed examinations under the provisions of Article 7 of the former High School Examination Order (Imperial Order No. 15 of 1929); (xi) a person who has a school teacher's license set forth in the left-hand column of item (ii), item (iii), item (vi), or item (ix) of the Table for Article 1, paragraph (1) of the Act for Enforcement of the Education Personnel Certificate Act (Act No. 148 of 1949), or a person who has a qualification set forth in the left-hand column of item (ix), items (xviii) through (xx)-4, item (xxi), or item (xxiii) of the Table for Article 2, paragraph (1) of that Act; (xii) a person who is specified in Article 150 of the Enforcement Regulations of the School Education Act (Order of the Ministry of Education No. 11 of 1947); and (xiii) beyond what is set forth in the preceding items, a person certified by the Minister of Health, Labour and Welfare to have an academic ability equivalent to or higher than graduates of a high school, secondary education school, or secondary school with regard to qualifications as a food sanitation supervisor.

Article 49 (1) The notification under the provisions of Article 48, paragraph (8) of the Act is to be made by submitting a written notification stating the following matters: (i) the name and address of the notifier (for a corporation, its name, the location of its principal office, and the name of its representative); (ii) the type of food or additives provided for in Article 13 of the Order; (iii) the name and location of the facilities; (iv) the name, address, and date of birth of the food sanitation supervisor; (v) the title, type of job, and content of the duties of the food sanitation supervisor; and (vi) the date the food sanitation supervisor was assigned or changed. (2) A written notification set forth in the preceding paragraph must be attached with a resume of the food sanitation supervisor, documents proving that the food sanitation supervisor falls under one of the items of Article 48, paragraph (6) of the Act, and documents proving the relations with the business person.

Article 50 The criteria specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 14 of the Order (including as applied mutatis mutandis pursuant to Article 9, paragraph (2) of the Order) are as follows: (i) the training institute is to be a university under the School Education Act or an educational facility that has courses that are recognized to provide education equivalent to that at universities or graduate schools pursuant to the provisions of Article 104, paragraph (7), item (ii) of that Act; (ii) for each curriculum stated in the left-hand column of the Appended Table 14, one or more subjects set forth in the right-hand column of that Table are to be taken, and the total number of credits is to be 22 or more; (iii) subjects set forth in the preceding item and subjects set forth in the Appended Table 15 are to be taken, and the total number of credits is to be 40 or more; and (iv) classes are to be conducted, in principle, by using the machinery and tools set forth in column 2 of the Appended Table of the Act.

Article 51 A written application referred to in Article 15 of the Order (including as applied mutatis mutandis pursuant to Article 9, paragraph (2) of the Order) must be attached with documents stating the following matters: (i) the name and location of the training institution; (ii) the name and location of the establisher of the training institution, and the date of establishment; (iii) the name and address of the head of the training institution; (iv) the name and personal history of each teacher, the subjects they teach, and whether they are full-time teachers or have other jobs; (v) plans of subjects to be taken each school year, the number of credits, and whether they are compulsory subjects or optional subjects; (vi) student quotas; (vii) entrance qualifications and the time of entrance; (viii) term of study; (ix) a list of machinery and tools and a library index for teaching and training; (x) drawings and layout of the school site and school buildings; (xi) school regulations; and (xii) other matters for reference.

Article 52 (1) The registration of a training institution under Article 48, paragraph (6), item (iii) of the Act is to be made by entering the following matters into the register: (i) the date of registration and registration number; and (ii) the name and location of the registered training institution (meaning a registered training institution provided for in Article 16 of the Order; the same applies hereinafter), and the name of its head. (2) The provisions of the preceding paragraph apply mutatis mutandis to the registration of a training institution referred to in Article 9, paragraph (1), item (i) of the Order.

Article 53 The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 16 of the Order (including as applied mutatis mutandis pursuant to Article 9, paragraph (2) of the Order) are to be what are set forth in Article 51, items (i) through (iii), items (v) through (viii), item (ix) (limited to those related to machinery and tools set forth in column 2 of the Appended Table of the Act), item (x), and item (xi).

Article 54 The written application referred to in Article 19 of the Order (including as applied mutatis mutandis pursuant to Article 9, paragraph (2) of the Order) must be attached with documents stating the following matters: (i) the reasons for seeking to obtain revocation of the registration; (ii) the planned date to obtain revocation of the registration; and (iii) when there are students that are attending school, measures to be taken for them.

Article 55 The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 20, item (ii) of the Order (including as applied mutatis mutandis pursuant to Article 9, paragraph (2) of the Order) are those set forth in Article 51, item (i).

Article 56 (1) The courses of training sessions referred to in Article 48, paragraph (6), item (iv) of the Act must satisfy all of the following requirements: (i) the subjects set forth in column1 of the Appended Table 16 and the subjects set forth in any of columns 2 through 7 of that Table are taught, and the number of hours is to be equal to or more than the the number of hours set forth in that Table; (ii) the lecturers are persons who teach subjects equivalent to those referred to in the preceding item at a university under the School Education Act, persons who are engaged in food sanitation administration or examination business concerning food sanitation at an entity of the State, prefecture, city establishing health centers, or special ward, or persons recognized as having knowledge and experience equal to the aforementioned persons; (iii) qualifications for taking training sessions are to be that a person has graduated from a high school or secondary education school under the School Education Act or a secondary school under the former Secondary School Order, or falls under those set forth in each item of Article 48, and has been engaged in sanitation management of production or processing of food or additives for two years or more at a production or processing business that is required to have food sanitation supervisors pursuant to the provisions of Article 48, paragraph (1) of the Act; and (iv) examinations are to be conducted for participants at the end of training sessions. (2) Notwithstanding the provisions of item (i) of the preceding paragraph, persons set forth in the following items may be exempted from taking subjects prescribed in the respective item: (i) a person who has studied subjects equivalent to or higher than those set forth in column 1 of the Appended Table 16 at a university under the School Education Act, a university under the former University Order (Imperial Order No. 388 of 1918), or a professional training college under the former Professional Training College Order: those subjects; and (ii) a person who has completed registered training sessions: for a person who has completed subjects set forth in column 1 of the Appended Table 16 and subjects set forth in column 2 or 3 of that Table, practical training on bacteriology set forth respectively in column 3 or column 2 of that Table.

Article 57 A person who seeks to file an application for registration pursuant to the provisions of Article 21 of the Order must submit a written application to the governor of the prefecture where the training sessions related to the registration are conducted, by attaching a copy of the resident record (for a corporation, articles of incorporation or articles of endowment, and certificate of registered information) and documents stating the following matters: (i) the name and address of the organizer of the training sessions (for a corporation, its name, the location of its principal office, and the name of its representative); (ii) whether a fact that falls under any item of Article 22 of the Order exists; (iii) for a corporation, the names, addresses, and brief biographical outlines of its officers; (iv) the name and location of the venue of the training sessions; (v) the name and location of the place where practical training is held; (vi) the periods and schedules of the training sessions; (vii) the planned number of participants; (viii) the training subjects and the number of hours; and (ix) the names and occupations of lecturers, the training subjects they teach, and the number of hours for each training subject.

Article 58 The registration under Article 21 of the Order is to be made by entering the following matters into the register: (i) the date of registration and registration number; (ii) the name and address of the organizer of the registered training sessions (for a corporation, its name, the location of its principal office, and the name of its representative); and (iii) the implementation period of the registered training sessions.

Article 59 The criteria specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 24, paragraph (2) of the Order are as follows: (i) to confirm that the participant meets the qualifications for taking the training sessions through their resume, documents proving their relations with the place of business they have worked for, and other documents; (ii) to issue a certificate for the completion of training to the person who has completed the courses of the training sessions; and (iii) to hold registered training sessions pursuant to the provisions of Article 56.

Article 60 The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 25 of the Order are as follows: (i) the name and address of the organizer of the registered training sessions (for a corporation, its name, the location of its principal office, and the name of its representative); and (ii) the implementation period of the registered training sessions.

Article 61 When an organizer of registered training sessions seeks to suspend or discontinue the operation of the registered training sessions pursuant to the provisions of Article 26 of the Order, they must notify the governor of the prefecture where the registered training sessions are conducted of the following matters: (i) the reasons for the suspension or discontinuation and the scheduled date; (ii) when seeking to suspend the operation, the scheduled period of suspension.

Article 62 An organizer of registered training sessions must prepare the financial statements, etc. for the previous business year (meaning the financial statements, etc., provided for in Article 27, paragraph (1) of the Order; hereinafter the same applies in this Article) (when three months have not elapsed since the end of the previous business year, they may be replaced with the financial statements, etc., for the business year before the previous business year), and must keep the financial statements, etc. at the place of business from the time of registration until they terminate the registered training sessions.

Article 63 The provisions of Article 44 apply mutatis mutandis to the means specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 27, paragraph (2), item (iii) of the Order.

Article 64 The provisions of Article 45 apply mutatis mutandis to the electronic or magnetic means specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 27, paragraph (2), item (iv) of the Order.

Article 65 (1) The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 31 of the Order are as follows: (i) the names and personal histories of the participants; (ii) the number of participants; and (iii) the names, dates of birth, and addresses of persons who have received certificates for the completion of training, and the names and locations of the place of business they work for. (2) The books set forth in Article 31 of the Order must be preserved for three years from the date of the final entry.

Article 66 The certificate which the employees are to carry pursuant to the provisions of Article 33, paragraph (2) of the Order is to be prepared according to Form No. 13.

Article 66-2 (1) The criteria specified by Order of the Ministry of Health, Labour, and Welfare as referred to in Article 51, paragraph (1), item (i) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraph (3) of the Act) are as set forth in the Appended Table 17. (2) The criteria specified by Order of the Ministry of Health, Labour, and Welfare as referred to in Article 51, paragraph (1), item (ii) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraph (3) of the Act) are as set forth in the Appended Table 18. (3) A business person must provide and observe the measures necessary for public health pursuant to the provisions of Article 51, paragraph (2) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraph (3) of the Act), in accordance with the criteria referred to in the preceding two paragraphs, and pursuant to the provisions of the following items: (i) to prepare plans for sanitation management of facilities and handling, etc. of food or additives (hereinafter referred to as "sanitation management plan") and thoroughly inform the persons who handle food or additives and the relevant persons of the sanitation management plan, in order to prevent food sanitation hazards; (ii) to take into consideration the facilities and equipment, the structure and materials of machinery and tools, and the processes of producing, processing, cooking, transporting, storing, or selling food, and prepare a procedure manual for taking appropriate measures necessary for public health in these processes (hereinafter referred to as "procedure manual") as necessary; (iii) to record and preserve the implementation status of sanitation management. The period for preserving the records is to be reasonably established by taking into account the period until the food or additives handled are used or consumed; and (iv) to verify the effectiveness of the sanitation management plan and the procedure manual, and review their content as necessary. (4) For a business person prescribed in the following items, the provisions of the relevant paragraph are applied by replacing the term "to prepare" in item (i) of the preceding paragraph with "to prepare as necessary" and the term "to record and preserve" in item (iii) of that paragraph with "to record and preserve as necessary". (i) a person who conducts business of importing food or additives; (ii) a person who conducts business that only stores or transports food or additives (excluding a person who is engaged in the business of freezing or refrigerating food); (iii) a person who conducts business that sells food or additives packed or wrapped in containers and packaging which are unlikely to cause food sanitation hazards resulting from rotting, deterioration, or other degradation of quality when preserved by a method other than freezing or refrigerating; and (iv) a person who conducts business of importing or selling apparatus, or containers and packaging. (5) The provisions of the preceding paragraph (limited to the part regarding the provision of the measures necessary for public health pursuant to Appended Table 17, item (ix), (c)) do not apply to those listed in the following items among the business persons: (i) A person licensed under Article 43, paragraph (1) of the Health Promotion Act (Act No. 103 of 2002) regarding food for specified health uses (meaning food for specified health uses specified in Article 2, paragraph (1), item (v) of the Cabinet Office Order on Permission to Make Representations About a Special Use Prescribed in the Health Promotion Act (Cabinet Office Order No. 57 of 2009)); the same applies below); and (ii) A notifier prescribed in Article 2, paragraph (1), item (x), (b) of the Food Labeling Standards.

Article 66-3 The business persons specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 34-2, item (ii) of the Order are as follows: (i) a person who is engaged in a restaurant business provided for in Article 35, item (i) of the Order (including a person who is engaged in a coffee shop business (meaning business that sets up coffee shops, salons, and other facilities and serves drinks other than alcoholic beverages or refreshments to customers) and an establisher or a manager of such facilities at a school, hospital, or any other facility provided for in Article 68, paragraph (3) of the Act); (ii) a person who conducts business that cooks food using a vending machine that has a cooking function provided for in Article 35, item (ii) of the Order and sells the cooked food; (iii) a person who conducts business of producing bread (limited to that consumed in a relatively short period of time) among the confectionery production business provided for in Article 35, item (xi) of the Order; (iv) a person who conducts side dish production business provided for in Article 35, item (xxv) of the Order; and (v) a person who conducts business that cooks food using a vending machine that has a cooking function and sells the cooked food (excluding a person who conducts business provided for in item (i) or (ii)).

Article 66-4 The business persons specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 34-2, item (iv) of the Order are as follows: (i) a person who conducts business that divides food into small portions, places the food in containers and packaging, or wraps it in containers and packaging and sells it; (ii) in addition to the business persons set forth in the preceding item, among persons who conduct business of producing, processing, storing, selling, or treating food, a business person who has a workplace where less than 50 persons are engaged in handling food (hereinafter referred to as "small-scale workplace" in this item); provided, however, that if the business person has a workplace where 50 or more persons are engaged in handling food (hereinafter referred to as "large-scale workplace" in this item), the criteria specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 51, paragraph (1), item (ii) of the Act concerning the measures appropriate for the characteristics of food to be handled provided for in that paragraph apply only to a small-scale workplace owned by the business person and do not apply to a large-scale workplace owned by the business person.

Article 66-5 (1) The criteria specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 52, paragraph (1), item (i) of the Act concerning the matters set forth in that paragraph are as follows: (i) to assign necessary personnel, specify the content of work, and maintain facilities and equipment, etc., so that apparatus or containers and packaging will be appropriately produced; (ii) to perform necessary management on the maintenance of cleanliness and health conditions of the personnel engaged in production of apparatus or containers and packaging (hereinafter referred to as "workers" in this Article and the following Article) and make the workers understand the work procedures and matters necessary for sanitation management and have them conduct work in accordance with those procedures and matters; (iii) to make the structure of facilities or work areas capable of preventing contamination by dust and dirt, etc., as necessary, taking into account of the manner in which apparatus or containers and packaging are used, and to maintain the facilities and areas in a clean condition; (iv) to perform the cleaning and maintenance inspection of the facilities and the disposal of waste appropriately in order to maintain a clean working environment; (v) to conduct education and training for persons who manage the production of apparatus or containers and packaging and the workers, and share information and measures necessary to prevent food sanitation hazards among the persons concerned; (vi) to prepare work procedures, specify matters necessary for sanitation management as well as record the results of the measures, and preserve the results so that they can be confirmed promptly as necessary; and (vii) keeping records of the purchase, use, and disposal of raw materials of apparatus or containers and packaging as well as of the production, storage, shipment, and disposal of apparatus or containers and packaging, and preserve the apparatus or containers and packaging by taking into account the period of time during which the apparatus is used or the period of time until the food or additives packed or wrapped in the containers or packaging are consumed. (2) The requirements specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 52, paragraph (1), item (ii) of the Act concerning the matters set forth in that paragraph are as follows: (i) to use raw materials that conform to the provisions of Article 18, paragraph (3) of the Act for raw materials of the materials prescribed in Article 1 of the Order (hereinafter referred to as "raw materials" in this Article and the following Article); (ii) to confirm that the designed product conforms to the provisions of Article 18, paragraph (3) of the Act and that the production process conforms to the standards or criteria prescribed in paragraph (1) of that Article for product design of apparatus or containers and packaging; (iii) to analyze the measures to prevent food sanitation hazards or risks of the hazards occurring as necessary and specify the factors that require management; (iv) with regard to the factors that require management referred to in the preceding item, to determine the level of production and management necessary for preventing food sanitation hazards (hereinafter referred to as the "management level") and the management methods, and appropriately manage the factors; (v) to confirm that raw materials and apparatus or containers and packaging meet the appropriate management level; (vi) for raw materials, apparatus or containers and packaging, or collected apparatus or containers and packaging that do not meet the appropriate management level, or other apparatus or containers and packaging that may cause food sanitation hazards, to specify the method of response in advance; (vii) for raw materials, apparatus or containers and packaging, or collected apparatus or containers and packaging that do not meet the appropriate management level, or other apparatus or containers and packaging that may cause food sanitation hazards, to respond in accordance with the method prescribed in the provisions of the preceding item; and (viii) to preserve raw materials used for production and parts of apparatus or containers and packaging produced as necessary.

Article 66-6 (1) A person who sells, produces or imports for the purpose of selling, apparatus, or containers and packaging that use the raw materials of materials specified by Article 1 of the Order, must give an explanation to the counterparty of the sales of the apparatus or containers and packaging under the provisions of Article 53, paragraph 1 of the Act in accordance with the provisions of the following items: (i) to specify the apparatus or containers and packaging that are the subject of explanation and convey information for confirming that they fall under either of Article 53, paragraph (1), item (i) of the Act or item (ii) of that paragraph; (ii) to establish a suitable system for conveying the information provided for in the preceding item, and if there is any change to the information referred to in the preceding item, to promptly convey the information. (2) A person who sells, produces or imports for the purpose of selling, raw materials of apparatus or containers and packaging whose materials are provided for in Article 1 of the Order, must endeavor to give an explanation under the provisions of Article 53, paragraph 2 of the Act in accordance with the provisions of the following items: (i) to specify the raw materials that are subject of explanation and convey the information confirming that the apparatus or containers and packaging which are produced by using the raw materials fall under either of Article 53, paragraph (1), item (i) of the Act or item (ii) of that paragraph; (ii) to establish a suitable system for conveying the information provided for in the preceding item, and if there is any change to the information referred to in the preceding item, to promptly convey the information.

Article 66-7 The criteria specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 54 of the Act are as set forth in the Appended Table 19 for matters common to the businesses set forth in each item of Article 35 of the Order (excluding the businesses set forth in items (ii) and (vi) of that Article), the Appended Table 20 for matters related to each business set forth in the items of that Article, and the Appended Table 21 in addition to the criteria stated in the Appended Tables 19 and 20 for the criteria of facilities related to businesses that handle meat to be eaten raw or pufferfish that conform to the standards or criteria specified pursuant to the provisions of Article 13, paragraph (1) of the Act.

Article 66-8 The methods of trade specified by Order of the Ministry of Health, Labour, and Welfare as referred to in Article 35, item (v) of the Order are as follows: (i) an auction; (ii) transactions by bidding; and (iii) relative transactions.

Article 66-9 Foods specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 35, item (xiii) of the Order are milk products prescribed in Article 2, paragraph (13) of the Order on Milk and Milk Products Concerning Compositional Standards, etc. (excluding ice creams prescribed in paragraph (21) of that Article) and lactic acid bacteria beverages prescribed in paragraph (41) of that Article that contain less than 3.0% of non-fat milk solids.

Article 66-10 Foods specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 35, item (xxx) of the Order are brown rice, milled rice, wheat, buckwheat seed, green coffee beans, roasted coffee beans, tea, roasted barley, tea substitutes (limited to dried products), dried mushrooms, dried cereals, dried seeds, dried pulses, honey, dried sweet potato, peanuts (excluding fresh or boiled peanuts), dried seaweed, dried and fermented fish, dried bonito shavings, liquid sugar, processed sesame seeds, dried kudzu starch noodles, dried soups, dried spices, dried tapioca, dried herbs, dried breadcrumbs, salt, gelatin, cooking roux, toasted wheat gluten bread, granular or powdery food, food prepared by compressing and molding granular or powdery food, granular or powdery food in capsules, food prepared by mixing these foods, and vinegar.

Article 67 A person who seeks to obtain a license for business under the provisions of Article 55, paragraph (1) of the Act must submit a written application stating the following matters to the prefectural governor, etc., who has jurisdiction over the location of the facility. (i) the name (with phonetic transcriptions in hiragana), date of birth, and address of the applicant (for a corporation, its name (with phonetic transcriptions in hiragana), its location, and the name of its representative (with phonetic transcriptions in hiragana); (ii) the location of the facility (for businesses that cook food in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana); (iii) the type and form of the business to be applied for and information on the food or additives mainly handled; (iv) the name of the food sanitation supervisor or the food sanitation manager (with phonetic transcriptions in hiragana), and the type of qualification and the training sessions that the person attended; (v) drawings showing the structure and equipment of the facility (when using potable water other than water supplied by the water supply business provided for in Article 3, paragraph (2) of the Water Supply Act (Act No. 177 of 1957), the dedicated water-supply system provided for in paragraph (6) of the Article, and the small water-supply system provided for in paragraph (7) of the Article (hereinafter referred to as "potable water" in the Appended Tables 17 and 19), including copies of the documents certifying the results of the water quality inspections on the water to be used conducted by an agency of a local public entity provided for in Article 20, paragraph (3) of the Act or a person designated by the Minister of Land, Infrastructure, Transport and Tourism and the Minister of the Environment); (vi) type of measures for managing processes that are particularly important for preventing food sanitation hazards or measures in accordance with the characteristics of food handled (limited to the case in which the applicant seeks to continue to be licensed for business upon expiration of the validity period of the license for business set forth in each item of Article 35 of the Order; provided, however, that for a person who applies for a license for business set forth in item (xxvi) or (xxviii) of that Article, this includes the case of a new application); (vii) whether the person falls under any of the items of Article 55, paragraph (2) of the Act, and when the person falls under any of them, the content thereof.

Article 67-2 (1) A person who seeks to notify their succession to the status of a person who has obtained a license for business under the provisions of Article 55, paragraph (1) of the Act (hereinafter referred to as a "licensed business person") through the transfer of business pursuant to the provisions of Article 56, paragraph (2) of the Act must submit a written notification stating the following matters to the prefectural governor, etc., who has jurisdiction over the location of the facility: (i) the name (with phonetic transcriptions in hiragana), date of birth, and address of the notifier (for a corporation, its name (with phonetic transcriptions in hiragana), its location, and the name of its representative (with phonetic transcriptions in hiragana); (ii) the name of the person who has transferred the business (with phonetic trascriptions in hiragana) and the address of that person (for a corporation, its name (with phonetic trascriptions in hiragana), its location, and the name of its representative (with phonetic trascriptions in hiragana); (iii) the date of the transfer of business; and (iv) the license number for the facility and the date on which the license was obtained. (2) The written notification referred to in the preceding paragraph must have documents evidencing the transfer of business attached.

Article 68 (1) A person who seeks to notify their succession to the status of a licensed business person through an inheritance pursuant to the provisions of Article 56, paragraph (2) of the Act must submit a written notification stating the following matters to the prefectural governor, etc., who has jurisdiction over the location of the facility: (i) the name (with phonetic transcriptions in hiragana), date of birth, address, of the notifier and their relationship to the decedent; (ii) the name (with phonetic transcriptions in hiragana) and address of the decedent; (iii) the date of the start of the inheritance; (iv) the license number for the facility and the date on which the license was obtained. (2) The written notification set forth in the preceding paragraph must have the following documents attached: (i) a certified copy of the family register or a copy of the statutory inheritance information chart prescribed in Article 247, paragraph (1) of the Ordinance on Real Property Registration (Order of the Ministry of Justice No. 18 of 2005) that has been issued pursuant to the provisions of paragraph (5) of that Article; and (ii) for a person selected as the successor to the status of the licensed business person with the consent of all the heirs when there are two or more heirs, the written consent of all those heirs.

Article 69 (1) A person who seeks to notify their succession to the status of a licensed business person through a merger pursuant to the provisions of Article 56, paragraph (2) of the Act must submit a written notification stating the following matters to the prefectural governor, etc., who has jurisdiction over the location of the facility: (i) the name of the corporation succeeding to the status (with phonetic transcriptions in hiragana), its location, and the name of its representative (with phonetic transcriptions in hiragana); (ii) the name of the corporation extinguished by the merger (with phonetic transcriptions in hiragana), its location, and the name of its representative (with phonetic transcriptions in hiragana); (iii) the date of the merger; (iv) the license number for the facility and the date on which the license was obtained. (2) The written notification set forth in the preceding paragraph must be attached with certificates of the registered matters of the corporation surviving the merger or the corporation established by the merger.

Article 70 (1) A person who seeks to notify their succession to the status of a licensed business person through a split pursuant to the provisions of Article 56, paragraph (2) of the Act must submit a written notification stating the following matters to the prefectural governor, etc., who has jurisdiction over the location of the facility: (i) the name of the corporation succeeding to the status (with phonetic trascriptions in hiragana), its location, and the name of its representative (with phonetic trascriptions in hiragana); (ii) the name of the corporation prior to the split (with phonetic trascriptions in hiragana), its location, and the name of its representative (with phonetic trascriptions in hiragana); (iii) the date of the split; and (iv) the license number for the facility and the date on which the license was obtained. (2) The written notification set forth in the preceding paragraph must be attached with the certificate of registered information of the corporation which succeeded to the business through the split.

Article 70-2 (1) A person who seeks to make a notification under the provisions of Article 57, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3) of the Act; the same applies in the following paragraph) must submit a written notification stating the following matters to the prefectural governor, etc., who has jurisdiction over the location of the facility: (i) the name (with phonetic transcriptions in hiragana), date of birth, and address of the notifier (for a corporation, its name (with phonetic transcriptions in hiragana), its location, and the name of its representative (with phonetic transcriptions in hiragana); (ii) the location of the facility (for businesses that operate in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana); (iii) the business (including cases specified in Article 68, paragraph (3) of the Act; the same applies in Article 71-2) form and information on the food, additives, apparatus, or containers and packaging mainly handled; and (iv) the name of the food sanitation manager (with phonetic transcriptions in hiragana; provided, however, that this excludes business persons who produce apparatus or containers and packaging that use materials provided for in Article 1 of the Order). (2) The provisions of the preceding four articles apply mutatis mutandis to a person who seeks to notify their succession to the status of a person who has made a notification under the provisions of Article 57, paragraph (1) of the Act (hereinafter referred to as "notifying business person") pursuant to the provisions of Article 56, paragraph (2) of the Act, as applied mutatis mutandis pursuant to Article 57, paragraph (2) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3) of the Act) following the deemed replacement of terms. In this case, "business through" in Article 67-2, paragraph (1) of the Act is deemed to be replaced with "business through (including cases specified in Article 68, paragraph (3) of the Act; the same applies below)"; "a person who has obtained a license for business under the provisions of Article 55, paragraph (1) of the Act (hereinafter referred to as a "licensed business person")" with "a person who has made a notification under the provisions of Article 57, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraphs (1) and (3) of the Act) (hereinafter referred to as "notifying business person")"; "the license number for the facility and the date on which the license was obtained" in item (iv) of the same paragraph with "the location of the facility relating to the succession to the status (for businesses that operate in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)"; "licensed business person" in Article 68, paragraph (1) with "notifying business person"; "the license number for the facility and the date on which the license was obtained" in item (iv) of the same paragraph with "the location of the facility relating to the succession to the status (for businesses that operate in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)"; "licensed business person" in paragraph (2), item (ii) of the same Article with "notifying business person"; "licensed business person" in Article 69, paragraph (1) with "notifying business person"; "the license number for the facility and the date on which the license was obtained" in item (iv) of the same paragraph with "the location of the facility relating to the succession to the status (for businesses that operate in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)"; "licensed business person" in paragraph (1) of the same Article with "notifying business person"; and "the license number for the facility and the date on which the license was obtained" in item (iv) of the same paragraph with "the location of the facility relating to the succession to the status (for businesses that operate in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)".

Article 71 When there are any changes to the matters set forth in Article 67, items (i) through (vi) (for item (ii), limited to the automobile registration number and its name, shop name, or trade name, and for item (iii), excluding the type of business); the matters set forth in Article 67-2, paragraph (1), item (i) (excluding the date of birth), Article 68, paragraph (1), item (i) (excluding the date of birth), Article 69, paragraph (1), item (i), or Article 70, paragraph (1), item (i) (respectively including as applied mutatis mutandis pursuant to paragraph (2) of the preceding Article); or the matters set forth in items (i) through (iv) of the preceding Article, paragraph (1) (for item (ii), limited to the automobile registration number and its name, shop name, or trade name), a licensed business person or a notifying business person must promptly notify the prefectural governor, etc., who has jurisdiction over the location of the facility of that fact.

Article 71-2 A licensed business person or a notified business person must, when they are unable to continue the business due to discontinuation of business, submit a written notification stating the following matters to the prefectural governor, etc., who has jurisdiction over the location of the facility: (i) the name (with phonetic trascriptions in hiragana) and address of the notifier (for a corporation, its name (with phonetic trascriptions in hiragana), its location, and the name of its representative (with phonetic trascriptions in hiragana)); (ii) the address of the facility (when conducting business in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic trascriptions in hiragana); (iii) the date of discontinuation of business; and (iv) for a licensed business person, the license number of the facility and the date on which the license was obtained;

Chapter IX Miscellaneous Provisions

Article 72 A notification by a physician under the provisions of Article 63, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act; the same applies hereinafter) must be made in writing, by phone, or orally within 24 hours, with regard to the following matters: (i) the address and name of the physician; (ii) the location, name, and age of the poisoned patient, the person who is suspected to have been poisoned, or the deceased (hereinafter referred to as "patients, etc."); (iii) the causes of the food poisoning (meaning poisoning caused by food, additives, apparatus, containers and packaging, or toys set forth in each item of Article 78 (referred to as "food, etc." in the following Article and Article 74, paragraph (1), item (iii)); the same applies hereinafter); (iv) the date and time the disease occurred; and (v) the date and time of the diagnosis or postmortem examination.

Article 73 (1) The number of persons poisoned by food, etc., specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 63, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act; the same applies hereinafter) is 50. (2) The cases specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 63, paragraph (3) of the Act are as follows: (i) when a fatality or a severe illness has occurred due to the poisoning; (ii) when the poisoning has been caused or is suspected to have been caused by imported food, etc.; (iii) when the poisoning has been caused or is suspected to have been caused by any of the disease agents set forth in the Appended Table 22; (iv) when patients, etc., suffering from the poisoning are found in multiple prefectures; (v) when investigations of the causes of the poisoning are difficult in light of the status, etc., of the outbreak of the poisoning; and (vi) when it is difficult to render dispositions pursuant to the provisions of Articles 59 through 61 of the Act (hereinafter referred to as "dispositions") or to judge the appropriateness of the content of the dispositions in light of the status, etc., of the outbreak of the poisoning.

Article 74 The matters specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 37, paragraph (2) of the Order are as follows: (i) the location of the patients, etc., and the date of notification pursuant to the provisions of Article 63, paragraph (1) of the Act; (ii) the number of the patients, etc., and their symptoms; (iii) the food, etc., that caused or is suspected to have caused the poisoning (hereinafter referred to as the "food, etc., causing poisoning") and the reasons for specifying the food, etc., as the cause; (iv) the disease agents that caused or are suspected to have caused the poisoning and the reasons for specifying them as the cause; (v) the business facilities that caused or are suspected to have caused the poisoning (hereinafter referred to as "facilities causing food poisoning") and the reasons for specifying the facilities as the cause; and (vi) beyond what is set forth in the preceding items, matters found important in conducting investigations of the causes of the poisoning or rendering dispositions.

Article 75 (1) The written reports under the provisions of Article 37, paragraph (3) of the Order are those specified in the following items in accordance with the category of food poisoning cases set forth in the respective items: (i) food poisoning cases which prefectural governors, etc., have immediately reported to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 63, paragraph (3) of the Act: a case notification form of the food poisoning case prepared according to Form No. 14 and a detailed report of the food poisoning case; (ii) food poisoning cases other than those set forth in the preceding item: a case notification form of the food poisoning case prepared according to Form No. 14. (2) A detailed report of the food poisoning case provided for in item (i) of the preceding paragraph are to state the following matters: (i) the following matters concerning the outline of the occurrence of the food poisoning: (a) the date of occurrence; (b) the place of occurrence; (c) the number of persons who have consumed food, etc., causing poisoning; (d) the number of the deceased; (e) the number of patients; (f) the food, etc., causing poisoning; (g) the disease agents; (ii) matters concerning the understanding of information on the occurrence of the food poisoning; (iii) the following matters concerning the situation of the patients and the deceased: (a) the number of patients and the deceased by sex and age; (b) the number of patients and the deceased by date and time of occurrence of the food poisoning; (c) the proportion of the patients and the deceased among the persons who consumed the food, etc., causing poisoning; (d) the time it took for the disease to develop from the time the patients and the deceased consumed the food, etc., causing poisoning; (e) the symptoms of the patients and the deceased and the number of patients by symptom; (iv) the following matters concerning the food, etc., causing poisoning and its contamination route: (a) the process of specifying the food, etc., causing poisoning and the reasons for specifying the food, etc., as the cause; (b) the contamination route of the food, etc., causing poisoning; (v) matters concerning facilities causing food poisoning: (a) the situation of water supply and drainage and other sanitary conditions at facilities causing food poisoning; (b) the health conditions of employees at facilities causing food poisoning; (vi) matters concerning disease agents: (a) the results of microbiological examinations, physicochemical examinations, or examinations using animals; (b) the process of specifying the disease agents and the reasons for specifying the disease agents as the cause; (vii) the dispositions and other measures taken by prefectural governors, etc.

Article 76 (1) The written reports under the provisions of Article 37, paragraph (4) of the Order are to be written reports specified in the following items in accordance with the category of food poisoning cases set forth in the respective items: (i) food poisoning cases which prefectural governors, etc., have immediately reported to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 63, paragraph (3) of the Act: a written report on the investigation results of the food poisoning case and a detailed report on the investigation results of the food poisoning case; and (ii) food poisoning cases other than those set forth in the preceding item: a written report on the investigation results of the food poisoning case. (2) A written report on the investigation results of the food poisoning case referred to in each item of the preceding paragraph is to be prepared according to Form No. 15. (3) A written report on the investigation results of the food poisoning case referred to in each item of paragraph (1) must be submitted each month by the 10th of the following month, by attaching the case notification forms of food poisoning cases referred to in each item of paragraph (1) of the preceding Article that were accepted in that month. (4) A detailed report on the investigation results of the food poisoning case set forth in paragraph (1), item (i) is to be prepared by entering the matters set forth in each item of paragraph (2) of the preceding Article. (5) A detailed report on the investigation results of the food poisoning case set forth in paragraph (1), item (i) must be prepared and submitted immediately after receiving the detailed report of the food poisoning case set forth in paragraph (1), item (i) of the preceding Article, pursuant to the provisions of Article 37, paragraph (3) of the Order.

Article 77 The number of persons specified by Order of the Ministry of Health, Labour and Welfare as referred to in Article 65 of the Act is 500.

Article 78 The toys provided for in Article 68, paragraph (1) of the Act are as follows: (i) toys which are essentially intended for infants to bring into contact with their mouth; (ii) accessory toys (toys used as accessories by infants), transfer pictures, Okiagari (daruma doll made so as to right itself when knocked over), masks, origami, rattles, educational toys (limited to those that may come into contact with the mouth, excluding those set forth in this item), building blocks, toy phones, toy animals, dolls, clay, toy vehicles, balloons, blocks, balls, cooking utensils for playing house; and (iii) toys to be played with in combination with the toys referred to in the preceding item.

Article 79 The following authority of the Minister of Health, Labour and Welfare is delegated to the Director-Generals of the Regional Bureaus of Health and Welfare, pursuant to the provisions of Article 80, paragraph (1) of the Act and Article 41, paragraph (1) of the Order: (i) the authority provided for in Article 41 of the Act; (ii) the authority provided for in Article 42 of the Act; (iii) the authority provided for in Article 46, paragraph (2) of the Act; and (iv) the authority provided for in Article 47, paragraph (1) of the Act.