Article 1Cases in which there is no risk of harming human health under the provisions of the proviso to Article 6, item (ii) of the Food Sanitation Act (Act No. 233 of 1947; referred to below as "the Act") are as follows:

Article 2An application for cancellation under the provisions of Article 7, paragraph (4) of the Act is to be made by submitting a written application stating the following items, with documents proving that there is no longer a risk of food sanitation hazards resulting from the food or objects for which the application for the cancellation is made attached, to the Minister of Health, Labour and Welfare:

Article 2-2(1)A person who seeks to give a notification under the provisions of Article 8, paragraph (1) of the Act is to give the notification by submitting a written notification to a prefectural governor, mayor of a city with public health centers, or mayor of a special ward (referred to below 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 about the person who has suffered damage to their health due to refusal to provide the information or other circumstances, statement of the matters in items (iv) through (vii) is not required.

(2)The notification referred to in Article 8, paragraph (1) of the Act may be given 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:

(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 "specified foods, etc." in that item, and items (ii) and (iv) of that paragraph is deemed to be replaced with "specified toys", the term "for specified foods, etc." in item (iii) of that paragraph is deemed to be replaced with "for specified toys", and the term "food poisoning or other health damages caused or suspected to have been caused by the specified foods, etc." in that item is deemed to be replaced with "food poisoning or other health damages caused by or suspected to have been caused by the specified toys".

Article 4(1)The matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9, paragraph (1) of the Act are as follows:

(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 "specified foods, etc." in item (i), item (iii) and item (iv) of the preceding paragraph is deemed to be replaced with "specified toys", and the term "food or additives" in item (iii) of that paragraph is deemed to be replaced with "toys".

Article 5(1)When confirming that there is no risk of food sanitation hazards resulting from the specified foods, etc. occurring in canceling the prohibition under the provisions of Article 9, paragraph (1) of the Act for specified foods, etc., based on the provisions of Article 9, paragraph (3), an application from a person that has an interest, or as required, the Minister of Health, Labour and Welfare must take into account the matters stated in each item of paragraph (1) of the preceding Article for the specified foods, etc., related to the prohibition intended to be canceled.

(2)The provisions of the preceding paragraph apply mutatis mutandis to the case in which the prohibition under the provisions of Article 9, paragraph (1) of the Act is to be canceled based on 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 "specified foods, etc." in the preceding paragraph is deemed to be replaced with "specified toys".

Article 6(1)An application for cancellation under the provisions of Article 9, paragraph (3) of the Act is to be made by submitting a written application stating the matters in the following items to the Minister of Health, Labour and Welfare, with documents proving that there is no longer a risk of food sanitation hazards resulting from the food or additives for which application for the cancellation is made occurring:

(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 prescribed in Article 10, paragraph (1) of the Act are water buffaloes.

(2)The cases specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 10, paragraph (1) of the Act are as follows:

(3)The case in which the employees find that the livestock has no risk of harming human health and are suitable for eating or drinking pursuant to the provisions of the proviso to Article 10, paragraph (1) of the Act is when healthy livestock have instantly died due to an unforeseen disaster.

Article 8The 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:

Article 9The matters specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 10, paragraph (2) of the Act are as follows:

Article 10When the certificate referred to in 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 copy of the certificate 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 certificate referred to in that paragraph.

Article 11The countries specified by Order of the Ministry of Health, Labour and Welfare 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 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 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 prescribed in Article 11, paragraph (2) of the Act are as follows:

Article 12Additives that have no risk of harming human health pursuant to the provisions of Article 12 of the Act are as referred to in the Appended Table 1.

Article 13through Article 16 Deleted

Article 17(1)The grounds specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 17, paragraph (1) of the Act are as follows:

(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 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 prescribed in Article 17, paragraph (1) of the Act are as follows:

(2)The provisions of the preceding paragraph apply mutatis mutandis to the matters specified by Order of the Ministry of Health, Labour and Welfare 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 confirming that there is no risk of food sanitation hazards resulting from the specified apparatus, etc. in canceling the prohibition under the provisions of Article 17, paragraph (1) of the Act for the specified apparatus, etc., based on 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 application from a person that has an interest, or as required, the Minister of Health, Labour and Welfare must take into account the matters stated in the items of paragraph (1) of the preceding Article concerning the specified apparatus, etc., related to the prohibition to be canceled.

(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 as applied mutatis mutandis pursuant to Article 68, paragraph (1) of the Act, is canceled based on 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.

Article 20(1)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 is to be made by submitting a written application stating the matters stated in the following items to the Minister of Health, Labour and Welfare, by attaching a document proving that there is no longer a risk of food sanitation hazards resulting from the apparatus or containers and packages for which the application for the cancellation is made from occurring:

(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.

Article 21The wide-area cooperation council referred to in Article 21-3, paragraph (1) of the Act is to have for each jurisdictional district of a Regional Bureau of Health and Welfare, the Regional Bureau of Health and Welfare, and the prefectural government, the cities with public health centers and special wards, within the jurisdictional district of the Regional Bureau of Health and Welfare, as its members.

Articles 22 and 23Deleted

Article 24An application for inspection referred to in Article 25, paragraph (1) of the Act is to be made by submitting a written application stating the following matters for each product constituting a lot:

Article 25The 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; referred to below 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 inspections.

Article 26The labeling specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 25, paragraph (1) of the Act is to be made by sealing the container and package of the product with certificate of passing prepared by using Form No. 1.

Article 27The matters specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 5, paragraph (1) of the Order are as follows:

Article 28(1)An application for inspections referred to in Article 26, paragraph (1) of the Act is to be made by submitting a written application stating the following matters for each product constituting a lot:

(2)The written application referred to in the preceding paragraph must have a copy of a written inspection order referred to in Article 5, paragraph (1) of the Order attached; provided, however, that this does not apply if an application for inspection has already been made for the same order and a copy of a written inspection order has been submitted.

Article 29(1)An application for inspections referred to in Article 26, paragraph (2) of the Act is to be made by submitting a written application stating the following matters:

(2)The written application referred to in the preceding paragraph must have a copy of a written inspection order attached (when the Minister of Health, Labour and Welfare issues 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 printed out).

Article 30The provisions of the preceding Article apply mutatis mutandis to an application for the inspections referred to in 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 an inspection of food other than processed food, excluding the matters stated in item (iii))", and the term "location" in item (iv) of that paragraph is deemed to be replaced with "location (for an application for an inspection of food other than processed food, the place of production of the food)".

Article 31The payment of the fee for undergoing inspections conducted by the Minister of Health, Labour and Welfare is to be made by affixing a revenue stamp for the amount specified by the Minister which is referred to in Article 25, paragraph (2) of the Act, or for the amount equivalent to the amount specified by the Minister which is referred to in Article 26, paragraph (6) of the Act, to a written application referred to 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).

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 before the carrying-in of cargoes to the warehouse (referred to as "carrying-in" below in this paragraph), excluding the matters stated in item (xiv)) and submit the notification to the head of a quarantine station stated in the right-hand column of the Appended Table 11 for the places stated in the respective left-hand column of that Table on and after seven days before the planned arrival date of the cargoes (when an accident concerning the cargoes is suspected to have occurred, after the carrying-in), excluding the cases in which the food stated in the Appended Table 10 is sought to be imported; provided, however, that when a written import notification has been submitted before 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:

(2)When there is any change to the matters stated in items (x) through (xiii) of the preceding paragraph (for the matters stated in item (x), limited to the port of unloading and the arrival date), an importer must immediately submit a written notification to that effect to the head of the quarantine station referred to in that paragraph.

(3)Despite conducting identity preserved handling (meaning the handling defined in Article 2, paragraph (1), item (xix) of the Food Labeling Standards; the same applies below in this paragraph), there has been a certain amount of unintentional mixing of genetically modified agricultural products (meaning those defined in item (xv) of that paragraph) or non-genetically modified agricultural products (meaning those defined in item (xvi) of that paragraph), if the confirmation under 1-1 or 3 in the right-hand column of the row for processed foods stated in the right-hand column of Appended Table 17 and the middle-hand column of Appended Table 18 in the Table for 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 for Article 18, paragraph (2) has been appropriately made, the provisions of paragraph (1) are applied by deeming that identity preserved handling has been conducted has been confirmed.

(4)When an importer has imported food, additives, apparatus, containers and packages stated in the middle column of the Appended Table 12 (referred to as "food, etc." below in this Article) and has submitted a written import notification stating the import plan for the same product or equivalent product as the food, etc. (referred to below as "the same food, etc.") for the period stated in the right-hand column of that Table (meaning the plan for the weight loaded, the port of unloading, and the arrival date of the cargoes related to the import planned for that period; the same applies below), that submission may be substituted for the submission of a written import notification referred to in paragraph (1) for the import of the same food, etc., sought to be imported during that period, notwithstanding the provisions of the main clause of paragraph (1); provided, however, that this does not apply when the food, etc., related to the import falls under or is suspected to fall under any of the following items:

(5)In the case referred to in the preceding paragraph, an importer of food, etc. stated in the middle column of paragraph (3) of the Appended Table 12 must submit a written import notification stating the import plan provided for in the preceding paragraph by entering the import record of the same food, etc. for the three years before the date of submission of the written import notification (meaning the name of the importer related to the import made during that period (for a corporation, its name), the weight loaded, the port of unloading, and the 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 before the carrying-in" and the term "the head of the quarantine station" in the proviso to paragraph (1) are deemed to be replaced with "related to the import" and "the head of a quarantine station stated in the right-hand column of the Appended Table 11 for the places stated in the respective left-hand column of that Table", respectively.

(7)For a notification under the provisions of Article 27 of the Act, the Minister of Health, Labour and Welfare may have a person give the notification by using an electronic data processing system (meaning an electronic data processing system that connects a computer (including an input/output device; the same applies below) used by the Ministry and an input/output device used by the person who seeks to give a notification under the provisions of that Article via a telecommunications line; the same applies below in this Chapter).

(8)To apply the provisions of paragraphs (1) and (2) to a person who seeks to give a notification under the provisions of Article 27 of the Act using an electronic data processing system, the phrases "state the following matters in a written import notification", "when submitting a written import notification", " state the following matters... (when... excluding...)", and "and submit the notification to the head of a quarantine station stated in the right-hand column of the Appended Table 11 for the places stated in the respective left-hand column of that Table" in paragraph (1) are deemed to be replaced with "state the following matters", "when the person records the matters in a file by inputting them through an input/output device referred to in paragraph (7) (limited to the device used by a person who seeks to give the notification; the same applies below in this paragraph and the following paragraph)", "when... excluding...)", " must be recorded in a file by inputting them through an input/output device", respectively; the phrases "when a written import notification has been submitted" and "stating the outline of the accident must be submitted to the head of the quarantine station" in the proviso to paragraph (1) are deemed to be replaced with "when a written notification has been recorded in a file by inputting it through an input/output device" and "must be recorded in a file by inputting it through an input/output device", respectively; the phrase "must immediately submit a notification to that effect to the head of the quarantine station referred to 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 specified in the preceding paragraph.

Article 33(1)The input under 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 by using an input /output device that has been notified to the Minister of Health, Labour and Welfare in advance.

(2)The notification under the provisions of the preceding paragraph is to be given by a person who seeks to give a notification under the provisions of Article 27 of the Act using an electronic data processing system submitting a written notification stating the following matters to the Minister of Health, Labour and Welfare, for the input/output device the person seeks to use:

(3)When there are any changes to the matters stated in the item of that paragraph, or when the person who has given a notification referred to in the preceding paragraph has stopped using the input/output device that has been notified, the person must 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 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) concerning food, additives, apparatus, or containers and packages related to the notification, or a notice of the results of the inspection under the provisions of Article 26, paragraph (4) of the Act (referred to as a "specified notice" below in this Article).

(2)When issuing a specified notice using an electronic data processing system pursuant to the provisions of the preceding paragraph, the Minister of Health, Labour and Welfare must input the content of the specified notice through the input/output device referred to in Article 32, paragraph (7) (limited to a device used by the Ministry of Health, Labour and Welfare) and record the content in a file.

(3)The Minister of Health, Labour and Welfare must obtain the consent of the other party in advance, when issuing a specified notice using an electronic data processing system.

Article 35Deleted

Article 36(1)The criteria specified by Order of the Ministry of Health, Labour and Welfare concerning the matters stated in Article 8, paragraph (2), item (i) of the Order are as follows; provided, however, that if implementation of a part of the affairs on product inspections and examinations referred to in Article 29 of the Act are ensured even in emergencies by entrusting the implementation to food sanitation inspection facilities established by other prefectures or cities with public health centers, or special wards, or to registered conformity assessment bodies, this does not apply to equipment related to the part of the affairs:

(2)The criteria specified by Order of the Ministry of Health, Labour and Welfare related to matters stated in Article 8, paragraph (2), item (ii) of the Order are to be the assignment of employees necessary for inspection or examination.

Article 37The affairs concerning the inspection or examination under the provisions of Article 8, paragraph (3) of the Order (referred to as "inspections, etc." below in this Article and the Appended Table 13) are to be administered as follows:

Article 38(1)A person who seeks to make an application for the registration referred to in Article 31 of the Act must submit a written application prepared by using Form No. 5 to the Minister of Health, Labour and Welfare, by attaching the following documents:

(2)A revenue stamp for the amount of the fee must be affixed to the written application referred to in the preceding paragraph.

Article 39(1)A person who seeks to apply for renewal of registration referred to in Article 34, paragraph (1) of the Act must submit a written application prepared using Form No. 6 to the Minister of Health, Labour and Welfare, by attaching the following documents:

(2)A revenue stamp for the amount of the fee must be affixed to a written application referred to in the preceding paragraph.

Article 40The criteria specified by Order of the Ministry of Health, Labour, and Welfare referred to in Article 35, paragraph (2) of the Act are as follows:

Article 41(1)A person who intends to give a notification of the establishment or abolition of the place of business, or change of its location pursuant to the provisions of Article 36, paragraph (1) of the Act must submit a written notification prepared using Form No. 7 to the Minister of Health, Labour and Welfare.

(2)A person who intends to give a notification of change pursuant to the provisions of Article 36, paragraph (2) of the Act must submit a written notification prepared using Form No. 8 to the Minister of Health, Labour and Welfare.

Article 42(1)When a registered conformity assessment body seeks to obtain authorization for the rules concerning the operation of product inspections (referred to below 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 using 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 provided for in the operational rules referred to in Article 37, paragraph (2) of the Act are as follows:

(3)When a registered conformity assessment 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 using Form No. 10 to the Minister of Health, Labour and Welfare. In such a case, when the changes involve change of the amount of the fee for product inspections, materials concerning its calculation must be attached.

Article 43When a registered conformity assessment 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 using Form No. 11 to the Minister of Health, Labour and Welfare.

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

Article 45The electronic or magnetic means specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 39, paragraph (2), item (iv) of the Act are either of the following means that is specified by a registered conformity assessment body:

Article 46(1)The matters specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 44 of the Act are as follows:

(2)The books must be preserved for three years from the date of the final entry.

Article 47The 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 using Form No. 12.

Article 48A 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), provided for in Article 48, paragraph (6), item (iv) of the Act, is as follows:

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:

(2)A written notification referred to in the preceding paragraph must be attached with a resume of the food sanitation supervisor, a document proving that the food sanitation supervisor falls under one of the items of Article 48, paragraph (6) of the Act, and a document proving the relations with the business operator.

Article 50The criteria specified by Order of the Ministry of Health, Labour and Welfare 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:

Article 51A 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 a document stating the following matters:

Article 52(1)The registration of a training institution referred to in Article 48, paragraph (6), item (iii) of the Act is to be made by entering the following matters into the register:

(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 53The matters specified by Order of the Ministry of Health, Labour and Welfare 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 the matters stated in Article 51, items (i) through (iii), items (v) through (viii), item (ix) (limited to those related to machinery and tools stated in column 2 of the Appended Table of the Act), item (x), and item (xi).

Article 54The 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 a document stating the following matters:

Article 55The matters specified by Order of the Ministry of Health, Labour and Welfare 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 stated 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:

(2)Notwithstanding the provisions of item (i) of the preceding paragraph, persons stated in the following items may be exempted from taking subjects prescribed in each of those items:

Article 57A person who seeks to make an application for registration pursuant to the provisions of Article 21 of the Order must submit a written application by attaching a copy of the resident record (for a corporation, articles of incorporation or articles of endowment, and certificate of registered information) and a document stating the following matters to the governor of the prefecture where the training sessions related to the registration are conducted:

Article 58The registration referred to in Article 21 of the Order is to be made by entering the following matters into the register:

Article 59The criteria specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 24, paragraph (2) of the Order are as follows:

Article 60The matters specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 25 of the Order are as follows:

Article 61When 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:

Article 62An 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; the same applies below in this Article) (when three months have not passed 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 63The provisions of Article 44 apply mutatis mutandis to the means specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 27, paragraph (2), item (iii) of the Order.

Article 64The provisions of Article 45 apply mutatis mutandis to the electronic or magnetic means specified by Order of the Ministry of Health, Labour and Welfare 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 referred to in Article 31 of the Order are as follows:

(2)The books referred to in Article 31 of the Order must be preserved for three years from the date of the final entry.

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

Article 66-2(1)The criteria specified by Order of the Ministry of Health, Labour, and Welfare 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 prescribed in the Appended Table 17.

(2)The criteria specified by Order of the Ministry of Health, Labour, and Welfare 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) for the matters stated in that paragraph are as prescribed in the Appended Table 18.

(3)A business operator must specify the necessary measures for public health based on 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, and abide by those measures:

(4)For a business operator stated in the following items, the provisions of the preceding paragraph are applied by the deemed replacement of the term "to prepare" in item (i) of the preceding paragraph with "to prepare as required" and the term "to record and preserve" in item (iii) of that paragraph with "to record and preserve as required".

(5)The provisions of the preceding paragraph (limited to the part on specifying the necessary measures for public health in accordance with the criteria referred to in the Appended Table 17, item (ix), (c)) do not apply to the persons stated in the following items among business operators:

Article 66-3The business operators specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 34-2, item (ii) of the Order are as follows:

Article 66-4The business operators specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 34-2, item (iv) of the Order are as follows:

Article 66-5(1)The criteria specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 52, paragraph (1), item (i) of the Act concerning the matters stated in that paragraph are as follows:

(2)The requirements specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 52, paragraph (1), item (ii) of the Act concerning the matters stated in that paragraph are as follows:

Article 66-6(1)A person who sells, or produces or imports for the purpose of selling apparatus, or containers and packages 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 packages under the provisions of Article 53, paragraph 1 of the Act as prescribed in the provisions of the following items:

(2)A person who sells, or produces or imports for the purpose of selling, raw materials of apparatus or containers and packages 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 as prescribed in the provisions of the following items:

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

Article 66-8The transaction methods specified by Order of the Ministry of Health, Labour, and Welfare referred to in Article 35, item (v) of the Order are as follows:

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

Article 66-10Foods specified by Order of the Ministry of Health, Labour and Welfare 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 soup products, 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 those foods, and vinegar.

Article 67A person who seeks to obtain an approval 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.

Article 67-2(1)A person who seeks to notify their succession to the status of a person who has obtained a business license under the provisions of Article 55, paragraph (1) of the Act (referred to below as a "licensed business operator") 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:

(2)The written notification referred to in the preceding paragraph must have documents proving the transfer of business attached.

Article 68(1)A person who intends to notify their succession to the status of a licensed business operator 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:

(2)The written notification referred to in the preceding paragraph must have the following documents attached:

Article 69(1)A person who intends to notify their succession to the status of a licensed business operator 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:

(2)The written notification referred to in the preceding paragraph must be attached with the certificate of the registered matters of the corporation surviving the merger or the corporation established by the merger.

Article 70(1)A person who intends to notify their succession to the status of a licensed business operator 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:

(2)The written notification referred to in the preceding paragraph must be attached with the certificate of registered information of the corporation that succeeded to the business through the split.

Article 70-2(1)A person who intends to give 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:

(2)The provisions of the preceding four Articles apply mutatis mutandis to a person who intends to notify their succession to the status of a person who has given a notification under the provisions of Article 57, paragraph (1) of the Act (referred to below as a "notifying business operator") 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 such a case, the phrases "business pursuant to" and "a person who has obtained a business license under the provisions of Article 55, paragraph (1) of the Act (referred to below as a "licensed business operator")" in Article 67-2, paragraph (1) of the Act are deemed to be replaced with "business pursuant to... (including cases prescribed in Article 68, paragraph (3) of the Act; the same applies below)" and "a person who has given 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) (referred to below as "notifying business operator")", respectively; the phrase "the license number for the facility and the date on which the license was obtained" in item (iv) of that paragraph is deemed to be replaced with "the location of the facility related to the succession to the status (for business conducted in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)"; the term "licensed business operator" in Article 68, paragraph (1) is deemed to be replaced with "notifying business operator"; the phrase "the license number for the facility and the date on which the license was obtained" in item (iv) of that paragraph is deemed to be replaced with "the location of the facility related to the succession to the status (for business conducted in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)"; the term "licensed business operator" in paragraph (2), item (ii) of that Article is deemed to be replaced with "notifying business operator"; the term "licensed business person" in Article 69, paragraph (1) is deemed to be replaced with "notifying business operator"; the phrase "the license number for the facility and the date on which the license was obtained" in item (iv) of that paragraph is deemed to be replaced with "the location of the facility related to the succession to the status (for business conducted in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)"; the term "licensed business operator" in paragraph (1) of the preceding Article is deemed to be replaced with "notifying business operator"; the phrase "the license number for the facility and the date on which the license was obtained" in item (iv) of that paragraph is deemed to be replaced with "the location of the facility related to the succession to the status (for business conducted in an automobile, the registration number of the automobile) and its name, shop name, or trade name (with phonetic transcriptions in hiragana)".

Article 71When changes are made to the matters stated 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 stated 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) (each including as applied mutatis mutandis pursuant to paragraph (2) of the preceding Article), or the matters stated in paragraph (1), items (i) through (iv) of the preceding Article (for item (ii), limited to the automobile registration number and its name, shop name, or trade name), a licensed business operator or a notifying business operator must promptly notify the prefectural governor, etc. who has jurisdiction over the location of the facility of that fact.

Article 71-2When it becomes no longer possible to continue the business due to discontinuation of business, a licensed business operator or a notified business operator must submit a written notification stating the following matters to the prefectural governor, etc. who has jurisdiction over the location of the facility:

Article 72A 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 below) must be made in writing, by phone, or orally within 24 hours for the following matters:

Article 73(1)The number specified by Order of the Ministry of Health, Labour and Welfare 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 below) is 50.

(2)The cases specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 63, paragraph (3) of the Act are as follows:

Article 74The matters specified by Order of the Ministry of Health, Labour and Welfare referred to in Article 37, paragraph (2) of the Order are as follows:

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 stated in each of those items:

(2)A detailed report of the food poisoning case provided for in item (i) of the preceding paragraph is to state the following matters:

Article 76(1)The written reports under the provisions of Article 37, paragraph (4) of the Order are written reports specified in the following items in accordance with the category of food poisoning cases stated in each of those items:

(2)A written report on the investigation results of the food poisoning cases referred to in the items of the preceding paragraph is to be prepared using Form No. 15.

(3)A written report on the investigation results of the food poisoning cases referred to in the items of paragraph (1) must be submitted each month by the tenth of the following month, by attaching the case notification forms of food poisoning cases referred to in the items of paragraph (1) of the preceding Article which were accepted in that month.

(4)A detailed report on the investigation results of the food poisoning case referred to in paragraph (1), item (i) is to be prepared by entering the matters set forth in the items of paragraph (2) of the preceding Article.

(5)A detailed report on the investigation results of the food poisoning case referred to in paragraph (1), item (i) must be prepared and submitted immediately after receiving the detailed report of the food poisoning case referred to in paragraph (1), item (i) of the preceding Article, pursuant to the provisions of Article 37, paragraph (3) of the Order.

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

Article 78The toys provided for in Article 68, paragraph (1) of the Act are as follows:

Article 79The following authority of the Minister of Health, Labour and Welfare is delegated to a Director-General of a Regional Bureau of Health and Welfare, pursuant to the provisions of Article 80, paragraph (1) of the Act and Article 41, paragraph (1) of the Order: