食品衛生法施行規則 - 英語 - 日本法令外国語訳DBシステム

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Regulations for Enforcement of the Food Sanitation Act

Order of the Ministry of Health and Welfare No. 23 of July 13, 1948

The Regulations for Enforcement of the Food Sanitation Act is established as follows.

Chapter I Food, Additives, Apparatus and Containers and Packaging

Chapter II Labeling

Chapter III Plans for Monitoring and Guidance

Chapter IV Product Inspections

Chapter V Import Notification

Chapter VI Food Sanitation Inspection Facilities and Food Sanitation Inspectors

Chapter VII Registered Conformity Assessment Bodies

Chapter VIII Business

Chapter IX Miscellaneous Provisions

Supplementary Provisions

Chapter I Food, Additives, Apparatus and Containers and Packaging

Article 1Cases involving no risk to human health pursuant to the provisions of the proviso of Article 6, item (ii) of the Food Sanitation Act (Act No. 233 of 1947; hereinafter referred to as "the Act") are as follows:

(i)cases where substances, though toxic or harmful, are naturally contained in or attached to food or additives and are deemed to generally involve no risk to human health at such a dose or through treatment;

(ii)cases where it is inevitable to mix or add toxic or harmful substances in the process of producing food or additives and where it is found to generally involve no risk to human health.

Article 2An application for rescission under Article 7, paragraph (4) of the Act is to be filed by submitting a written application stating the matters listed in the following items to the Minister of Health, Labour and Welfare, attaching documents to prove that there is no longer any risk of food sanitation hazards resulting from the food or objects for which the application for rescission is filed:

(i)the address and name of the applicant (for a corporation, its name, the location of its main office, and the name of its representative);

(ii)the scope of the food or objects for which the application for rescission is filed;

(iii)the reason that there is no longer any risk of food sanitation hazards resulting from the food or objects pertaining to the prohibition and other matters that the Minister of Health, Labour and Welfare finds necessary.

Article 3(1)The grounds specified by Order of the Ministry of Health, Labour and Welfare under Article 8, 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."), 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 administrative guidance (meaning administrative guidance prescribed 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 under 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 listed in each item of Article 8, paragraph (1) of the Act accounts for approximately 5% or more of the total number of food or additives covered by those 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 pertaining to the specific foods, etc. by the government or local public entities of the country or region, the results of inspections with regard to the specific foods, etc. conducted by the government or local public entities of the country or region, and other food sanitation management pertaining to the specific foods, etc. of the country or region;

(iii)regarding specific foods, etc., food poisoning caused by the specific foods, etc. has occurred, or other health harm caused by or suspected to have been caused by the specific foods, etc. have occurred;

(iv)regarding specific foods, etc., a situation has occurred whereby the specific foods, etc. have been contaminated or are likely to be contaminated.

(2)The provisions of the preceding paragraph apply mutatis mutandis to the grounds specified by Order of the Ministry of Health, Labour and Welfare under Article 8, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.In this 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 the same item and items (ii) and (iv) of the same paragraph is deemed to be replaced with "specific toys," the term "regarding specific foods, etc." in item (iii) of the same paragraph is deemed to be replaced with "specific toys," and the term "food poisoning caused by the specific foods, etc. or other health harm caused by or suspected to have been caused by the specific foods, etc." in the same item is deemed to be replaced with "other health harm 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 under Article 8, paragraph (1) of the Act are as follows:

(i)the level of the risk that specific foods, etc. may harm human health;

(ii)the matters listed in each item of paragraph (1) of the preceding Article;

(iii)the probability that specific foods, etc. falling under food or additives listed in each item of Article 8, paragraph (1) of the Act may continue to be sold, or collected, produced, imported, processed, used, or cooked for the purpose of sale;

(iv)effects that measures other than the prohibition under Article 8, 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 Order of the Ministry of Health, Labour and Welfare under Article 8, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.In this 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 the same paragraph is deemed to be replaced with "toys."

Article 5(1)When the Minister of Health, Labour and Welfare intends to rescind the prohibition pertaining to specific foods, etc. under Article 8, paragraph (1) of the Act, based on an application from an interested person or as needed, pursuant to the provisions of paragraph (3) of the same Article, the Minister of Health, Labour and Welfare must consider the matters listed in each item of paragraph (1) of the preceding Article with regard to the specific foods, etc. pertaining to the rescission of the prohibition, when confirming that there is no risk of food sanitation hazards resulting from the specific foods, etc.

(2)The provisions of the preceding paragraph apply mutatis mutandis to the case where the prohibition under Article 8, paragraph (1) of the Act is rescinded pursuant to the provisions of paragraph (3) of the same Article as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.In this case, the term "specific foods, etc." in the preceding paragraph is deemed to be replaced with "specific toys."

Article 6(1)An application for rescission under Article 8, paragraph (3) of the Act is to be filed by submitting a written application stating the matters listed in the following items to the Minister of Health, Labour and Welfare, attaching documents to prove that there is no longer any risk of food sanitation hazards resulting from the food or additives for which the application for rescission is filed:

(i)the address and name of the applicant (for a corporation, its name, the location of its main office, and the name of its representative);

(ii)the scope of the food or objects for which the application for rescission is filed;

(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 rescission under Article 8, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.In this 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 under Article 9, paragraph (1) of the Act is to be buffaloes.

(2)The cases specified by Order of the Ministry of Health, Labour and Welfare under Article 9, paragraph (1) of the Act are as follows:

(i)the case where, with regard to livestock which are deemed to have had any diseases listed in the left-hand column of the Appended Table 5 of the Regulations for Enforcement of the Slaughterhouse Act (Order of the Ministry of Health and Welfare No. 44 of 1953) or are deemed to have had any disorders listed in the same column, the necessary measures, such as disposal, have been taken to prevent the parts listed respectively in the right-hand column of the same Table from being served for human consumption;

(ii)the case where, with regard to diseases or disorders listed in the left-hand column of the Appended Table 10 of the Regulations for Enforcement 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 listed in the right-hand column of the same Table have been taken, as a result of the inspections after evisceration under Article 33, paragraph (1), item (iii) of the same Order.

(3)The case where the Ministry officials find that the livestock pose no risk to human health and are edible pursuant to the provisions of the proviso of Article 9, paragraph (1) of the Act is when healthy livestock have been killed instantly due to an accidental disaster.

Article 8The products specified by Order of the Ministry of Health, Labour and Welfare under Article 9, paragraph (2) of the Act are processed meat products.

Article 9The matters specified by Order of the Ministry of Health, Labour and Welfare under Article 9, 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 prescribed in the preceding Article, the names and the types of the raw meat material or organs thereof;

(ii)the quantity and the weight;

(iii)the address and name of the consignor (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 position of the official 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 position of the official 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 or evisceration was carried out;

(c)for the meat or organs of livestock or poultry divided or chopped, the facility where those processes were carried out;

(d)for the products prescribed 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, prescribed in (a) through (d) of the preceding item was carried out in a sanitary manner based on equal or better criteria than those of Japan;

(viii)the date when 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 prescribed in the preceding Article, the production of those products.

Article 10When certificates set forth in Article 9, 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 prescribed 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 the same paragraph.

Article 11The countries specified by Order of the Ministry of Health, Labour and Welfare under the proviso of Article 9, paragraph (2) of the Act are the United States of America, Australia, and New Zealand.

Article 12Additives involving no risk to human health under Article 10 of the Act are as listed in the Appended Table 1.

Article 13The criteria specified by Order of the Ministry of Health, Labour and Welfare under Article 13, paragraph (2) of the Act (including as applied mutatis mutandis pursuant to Article 13, paragraph (4) or Article 14, paragraph (2) of the Act) are as follows:

(i)the following documents have been prepared for the comprehensive sanitation management and production process of the products:

(a)product descriptions stating the name, type, raw materials and other necessary matters of the products;

(b)documents concerning the processes of production or processing that state the performance and other necessary matters of machinery and tools used for production or processing;

(c)drawings of the facility showing the structures of facilities and equipment, movement routes of products, etc. and other necessary matters;

(ii)documents indicating the matters as prescribed as follows concerning the comprehensive sanitation management and production process of the products have been prepared:

(a)measures for the prevention of all food sanitation hazards that may occur to the products are to be specified by each substance that may cause the hazards and by each process where the hazards may occur, and in the case where substances pertaining to those measures do not contain substances that may cause any of the hazards listed in the right-hand column of the Appended Table 2 regarding food listed in the left-hand column of the same Table, the reasons are to be clarified;

(b)among the measures set forth in (a), measures that require sequential or frequent checking are to be specified in order to prevent food sanitation hazards pertaining to the products;

(c)methods for the checking set forth in (b) are to be specified;

(iii)documents indicating the methods of improvement measures to be taken when the checking set forth in (b) of the preceding item shows that the measures set forth in (b) of the same item have not been taken appropriately have been prepared;

(iv)documents indicating the methods concerning the sanitation management in facilities and equipment, sanitary education for employees, and other necessary matters, with regard to the sanitation management methods pertaining to the comprehensive sanitation management and production process of the products, have been prepared;

(v)documents indicating the test methods for the products, etc. and other methods for verifying that food sanitation hazards have been prevented appropriately, with regard to the comprehensive sanitation management and production process of the products, have been prepared;

(vi)documents indicating the methods for recording and the methods and period of time for retaining the records, with regard to the following matters, have been prepared:

(a)the matters concerning the checking set forth in item (ii), (b);

(b)the matters concerning the improvement measures set forth in item (iii);

(c)the matters concerning the sanitation management set forth in item (iv);

(d)the matters concerning the verification set forth in the preceding item;

(vii)with regard to the comprehensive sanitation management and production process of the products, a person has been placed who personally carries out the following duties (excluding the duties prescribed in the following item) or has another person previously appointed in accordance with the contents of the duties carry out the duties:

(a)monitoring that the measures and checking set forth in item (ii), (b) have been carried out appropriately and preparing the record thereof;

(b)carrying out maintenance of the machinery and tools used for checking set forth in item (ii), (b) (including calibration of measuring instruments) and preparing a record thereof;

(c)other necessary duties;

(viii)with regard to the verification set forth in item (v), a person has been put in place who personally carries out the following duties or has another person previously appointed in accordance with the contents of the duties carry out the duties:

(a)conducting tests on the products, etc.;

(b)carrying out maintenance of the machinery and tools (including calibration of measuring instruments) used for tests set forth in (a) and preparing a record thereof;

(c)other necessary duties.

Article 14(1)An application for approval under Article 13, paragraph (1) of the Act is to be filed by submitting a written application stating the following matters to the Minister of Health, Labour and Welfare:

(i)the address, name, and date of birth of the applicant (for a corporation, its name, the location of its main office, and the name of its representative);

(ii)types of products;

(iii)the name and location of the production or processing facility;

(iv)the outline of the comprehensive sanitation management and production process of the products.

(2)The written application set forth in the preceding paragraph must be attached with the following materials:

(i)the documents prescribed in items (i) through (vi) of the preceding Article;

(ii)the material concerning the effects of the measures set forth in item (ii), (b) of the preceding Article;

(iii)the material concerning the record prepared and retained with regard to the matters listed in item (vi), (d) of the preceding Article, based on the documents prescribed in the same item.

(3)A revenue stamp corresponding to the amount of the fee must be affixed to the written application set forth in paragraph (1).

Article 15(1)An application for approval for the change under Article 13, paragraph (4) of the Act is to be filed by submitting a written application stating the matters listed in the following items to the Minister of Health, Labour and Welfare:

(i)the matters listed in paragraph (1), items (i) through (iv) of the preceding Article;

(ii)the number and the date of the approval already obtained.

(2)The written application set forth in the preceding paragraph must be attached with the following materials:

(i)among the documents set forth in paragraph (2), item (i) of the preceding Article and the material set forth in item (ii) of the same paragraph, those pertaining to the matters that the applicant intends to change (for the documents set forth in item (i) of the same paragraph, difference between the original and changed descriptions is to be clearly presented);

(ii)the material set forth in paragraph (2), item (iii) of the preceding Article.

(3)A revenue stamp corresponding to the amount of the fee must be affixed to the written application set forth in paragraph (1).

Article 16(1)An application for approval for the renewal under Article 14, paragraph (1) of the Act is to be filed by submitting a written application stating the matters listed in each item of paragraph (1) of the preceding Article to the Minister of Health, Labour and Welfare.

(2)The written application set forth in the preceding paragraph must be attached with the following materials:

(i)the documents prescribed in Article 13, item (i) and items (iv) through (vi) (those with no changes are to be excluded and the difference between the original and changed descriptions pertaining to changed matters is to be clearly presented);

(ii)the documents prescribed in Article 13, items (ii) and (iii);

(iii)the material concerning the record prepared and retained with regard to the matters listed in Article 13, item (vi), (a), (b), and (d), based on the documents prescribed in the same item.

(3)A revenue stamp corresponding to the amount of the fee must be affixed to the written application set forth in paragraph (1).

Article 17(1)The grounds specified by Order of the Ministry of Health, Labour and Welfare under 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 apparatuses, etc."), 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 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 listed 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 those inspections;

(ii)the content of regulations and measures concerning food sanitation for specific apparatuses, etc. in a country or region where the specific apparatuses, etc. are produced, the inspection system and other systems for food sanitation management pertaining to the specific apparatuses, etc. by the government or local public entities of the country or region, the results of inspections with regard to the specific apparatuses, etc. by the government or local public entities of the country or region, and other food sanitation management pertaining to the specific apparatuses, etc. at the country or region;

(iii)regarding specific apparatuses, etc., health harm caused by or suspected to have been caused by the specific apparatuses, etc. have occurred;

(iv)regarding specific apparatuses, etc., a situation has occurred that contaminates or is likely to contaminate the specific apparatuses, 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 under Article 17, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.

Article 18(1)The matters specified by Order of the Ministry of Health, Labour and Welfare under Article 17, paragraph (1) of the Act are as follows:

(i)the level of the risk that specific apparatuses, etc. may harm human health;

(ii)the matters listed in each item of paragraph (1) of the preceding Article;

(iii)the probability that specific apparatuses, etc. falling under apparatus or containers and packaging listed in each item of Article 17, paragraph (1) of the Act may continue to be sold, produced or imported for the purpose of sale, or used in business;

(iv)effects that measures other than the prohibition under Article 17, 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 Order of Health, Labour and Welfare under Article 17, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.

Article 19(1)When the Minister of Health, Labour and Welfare intends to rescind the prohibition pertaining to specific apparatuses, etc. under Article 17, paragraph (1) of the Act, based on an application from an interested person or as needed, pursuant to the provisions of Article 8, paragraph (3) of the Act as applied mutatis mutandis by replacing the terms under Article 17, paragraph (3) of the Act, the Minister of Health, Labour and Welfare must consider the matters listed in each item of paragraph (1) of the preceding Article with regard to the specific apparatuses, etc. pertaining to the rescission of the prohibition, when confirming that there is no risk of food sanitation hazards resulting from the specific apparatuses, etc.

(2)The provisions of the preceding paragraph apply mutatis mutandis to the case where the prohibition under Article 17 paragraph (1) of the Act, which is applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act, is rescinded pursuant to the provisions of Article 8, paragraph (3) of the Act, which is applied mutatis mutandis by replacing the terms under Article 17, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.

Article 20(1)An application for rescission under Article 8, paragraph (3) of the Act which is applied mutatis mutandis by replacing the terms pursuant to Article 17, paragraph (3) of the Act is to be filed by submitting a written application stating the matters listed in the following items to the Minister of Health, Labour and Welfare, attaching documents to prove 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 rescission is filed:

(i)the address and name of the applicant (for a corporation, its name, the location of its main office, and the name of its representative);

(ii)the scope of the apparatus or containers and packaging for which the application for rescission is filed;

(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 rescission under Article 8, paragraph (3) of the Act as applied mutatis mutandis by replacing the terms pursuant to Article 17, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act.

Chapter II Labeling

Article 21(1)The criteria for the labeling of food or additives specified in the Appended Table 3 which are served for the purpose of sale are as follows:

(i)the following matters are to be indicated on conspicuous parts of the containers and packaging (when the containers and packaging are wrapped for the purpose of retailing, the wrappings; the same applies in paragraphs (5) through (8) and paragraphs (16) and (19)), so that they can be read without opening the containers and packaging or wrappings;

(a)the name (for additives listed in the Appended Table 1 (excluding those listed in the Appended Table 4), only the names listed in the Appended Table 1);

(b)for food or additives whose quality may deteriorate rapidly when preserved by the specified methods, the date indicated with the letters meaning an expiration date (meaning a date showing the limit up to which the food or additives are deemed to have no hazardous risk through deterioration, rotting, or other quality degradation when preserved by the specified methods; the same applies hereinafter). For other food or additives, the date indicated with the letters meaning a freshness date (meaning a date showing the limit that the food or additives are deemed to fully maintain all expected qualities when preserved by the specified methods; the same applies hereinafter);

(c)the location of the production or processing facility (for imported goods, the location of the importer's business office; the same applies hereinafter), and the name of the producer or processor (for imported goods, the name of the importer; the same applies hereinafter) (for a corporation, its name; the same applies in paragraphs (8) and (10))

(d)for additive preparations, the ingredients thereof (excluding those used for flavoring food), and the percentage by weight of the respective ingredients (when the ingredients are vitamin A derivatives, their percentage by weight as vitamin A);

(e)for food containing additives (excluding those used for nutrient enrichment, processing aids (meaning substances which are added to food during the processing process and which are removed before the completion of the food, or which are changed by some of the raw materials of the food into ingredients such as those generally contained in the food without causing an evident increase in the total quantity of the ingredients, or ingredients whose quantity is so small as to have little impact on the food), and carry-over (meaning substances which are used in the process of producing or processing the raw materials of food but are not used in the process of producing or processing the food and whose quantity is not large enough to have an effect on the food); hereinafter the same applies in (e)) which are used as listed in the middle column of the Appended Table 5: the fact that the additives are contained and the labeling listed in the right-hand column of the same Table. For food containing other additives, the fact that the additives are contained;

(f)for processed food made from food listed in the Appended Table 6 (excluding milk) (including food made from the processed food and excluding those deemed to be nonantigenic and those listed in item 2 of the Appended Table 3), the fact that the food is contained as one of the raw materials. For processed food made from milk (including food made from the processed food and excluding those deemed to be nonantigenic and listed in item 2 of the Appended Table 3), the fact that milk is contained as one of the raw materials as specified by the Minister of Health, Labour and Welfare;

(g)for food containing additives derived from the food listed in the Appended Table 6 (hereinafter referred to as "specific raw materials") (excluding those deemed to be nonantigenic and flavoring agents; the same applies in (j)), the fact that the additives are contained and the fact that the additives contained in the food are derived from the specific raw materials;

(h)for food and additives for which the criteria for preservation methods (for food and additives for which the criteria for preservation methods have been established pursuant to the provisions of Article 11, paragraph (1) of the Act, the preservation methods that conform to the criteria) have been established and the criteria for methods for use have been established pursuant to the provisions of the same paragraph, the methods for use that conform to the criteria;

(i)for additives (excluding those prescribed in (j)), the letters “食品添加物(food additives)”;

(j)for additives derived from specific raw materials, the letters “食品添加物(food additives)” and the fact that the additives are derived from the specific raw materials;

(k)for preparations of tar a coal-tar color, the name of the effective color with the letters “製剤(preparations)”;

(l)for additives for which the standards established based on Article 11, paragraph (1) of the Act specify the amount for labeling purposes, their percentage by weight;

(m)for vitamin A derivatives used as additives, their percentage by weight as vitamin A

(n)for aspartame or preparations or food containing aspartame, the fact that the substance is an L-phenylalanine compound or that the product contains an L-phenylalanine compound;

(o)for types of mineral water (meaning carbonated drinks only made of water) whose carbon dioxide tension within the containers and packaging is less than 98kPa at 20 degrees centigrade and which are not sterilized or filtered (meaning to carry out such procedures as filtration to eliminate microbes which are derived from raw water, etc., exist in the food and may develop; the same applies hereinafter), the fact that they are not sterilized or filtered;

(p)for frozen fruit drinks (meaning frozen fruit juice extraction or frozen concentrated fruit juice extraction, excluding raw fruit juice), the letters “冷凍果実飲料(frozen fruit drink)”;

(q)for canned food, the names of the main raw materials;

(r)for processed meat, the types of poultry or livestock;

(s)for processed meat for which any of the following processes were carried out: chopping muscle and tissue short while keeping its original shape, infiltrating seasoning into the meat, attaching other meat pieces and pulling into shape, or other processes in which contamination caused by pathogens may expand inwardly, the fact that those processes have been carried out and that the entire meat product needs to be fully heated prior to human consumption;

(t)for food listed in item 4 of the Appended Table 3, the names of the raw meat materials (to be listed in the decreasing order of the amount blended; processed meat materials are to be indicated as is shown in (r), and fish meat materials are to be indicated clearly as fish meat);

(u)dried processed meat products (meaning processed meat products which are dried and sold as dried processed meat products; the same applies hereinafter), the fact that they are dried processed meat products;

(v)for unheated processed meat products (meaning processed meat products which are smoked or dried after salting and have not been sterilized by heating the center part at 63 degrees centigrade for 30 minutes or by any other equivalent or more effective methods; excluding dried processed meat products; the same applies hereinafter), the fact that they are unheated processed meat products and their pH and water activity;

(w)for specific heated processed meat products (meaning processed meat products which are sterilized by heating the center part at 63 degrees centigrade for 30 minutes or by any other equivalent or more effective methods; excluding dried processed meat products and unheated processed meat products; the same applies hereinafter), the fact that they are specific heated processed meat products and their water activity;

(x)for heated processed meat products (meaning processed meat products other than dried processed meat products, unheated processed meat products and specific heated processed meat products), the fact that they are heated processed meat products and whether they were sterilized by being heated after being packaged or were packaged after heat sterilization;

(y)for processed meat products, whale meat products, fish meat sausage, fish meat ham, or specially packaged fish paste which are packed and sealed in tight containers and packaging and are sterilized by heating the center part at 120 degrees centigrade for four minutes or by any other equivalent or more effective methods (excluding canned or bottled products), the methods for sterilization;

(z)for fish meat sausage, fish meat ham, or specially packaged fish paste whose pH is 4.6 or lower and whose water activity is 0.94 or lower (excluding canned or bottled products), the pH or water activity;

(aa)for produced or processed food (excluding carbonated drinks, processed meat products, whale meat products, fish paste products, boiled octopus and boiled crabs; hereinafter the same applies in this Article) which are frozen, whether they need to be heated or not prior to human consumption;

(bb)for frozen food which requires heating before consumption (meaning produced or processed food which is frozen and is deemed to require heating prior to human consumption; the same applies hereinafter), whether they were heated before freezing or not;

(cc)for cut or shelled fish and seafood (excluding raw oysters) which are frozen and raw oysters, whether they can be eaten raw or not;

(dd)for cut or shelled fresh fish and seafood (excluding raw oysters) (excluding those frozen), the fact they can be eaten raw;

(ee)for food listed in item 8 of the Appended Table 3, the fact that they have been irradiated;

(ff)for food listed in item 9 of the Appended Table 3 (excluding canned or bottled products), the fact that the food has been packed and sealed in tight containers and packaging and has been sterilized by autoclaving and heating;

(gg)for shell eggs (limited to those to be eaten raw), the fact that they can be eaten raw, that it is preferable to preserve them at ten degrees centigrade or lower, and that they need to be heat sterilized prior to human consumption after the freshness date;

(hh)for shell eggs (excluding those to be eaten raw), the fact that they cannot be eaten raw and that they need to be heat sterilized prior to human consumption;

(ii)for egg liquid (meaning the liquid part of shelled eggs; the same applies hereinafter) which are sterilized, the methods for sterilization;

(jj)for egg liquid other than sterilized egg liquid, the fact that it is not sterilized and that it needs to be heat sterilized prior to human consumption;

(kk)for raw oysters (limited to those to be eaten raw), the sea, lake or marsh waters where they were collected;

(ll)for boiled crabs, whether they need to be heated prior to human consumption or not;

(mm)for instant noodles which were processed with fat and oil, the fact they have been processed with fat and oil;

(nn)for farm products and processed food listed in item 12 of the Appended Table 3, the matters listed in 1 through 3 below according to the relevant classification set forth in 1 through 3 below:

1.farm products applying recombinant DNA technology (meaning farm products listed in the left-hand column of the Appended Table 7 which were produced by applying recombinant DNA technology (meaning technology to create recombinant DNA molecules by cutting and recombining DNA with enzymes and introducing them into live cells for breeding); the same applies hereinafter) or processed food made from farm products applying recombinant DNA technology (including food made from the processed food; the same applies in ii) for which Identity Preserved Handling (meaning a management system where farm products applying recombinant DNA technology and farm products not applying recombinant DNA technology (meaning farm products listed in the left-hand column of the Appended Table 7, excluding farm products applying recombinant DNA technology; the same applies hereinafter) are managed separately in each process for production, distribution, and processing with due care by a good manager and that fact is clearly certified with written documents; the same applies hereinafter) is confirmed to have been conducted:the matters listed in i or ii below according to the relevant classification set forth in i or ii below;

i.food of farm products:the fact that the food of farm products is food of farm products applying recombinant DNA technology;

ii.processed food:the names of the farm products listed in the left-hand column of the Appended Table 7 which are used as raw materials for the processed food, and the fact that the farm products are farm products applying recombinant DNA technology;

2.food of farm products in any process where the production, distribution, and processing of farm products applying recombinant DNA technology and farm products not applying recombinant DNA technology are not separated, or processed food made from those farm products (including food made from the processed food; the same applies in ii.): the matters listed in i or ii below according to the relevant classification set forth in i or ii below:

i.food of farm products:the fact that farm products applying recombinant DNA technology and farm products not applying recombinant DNA technology are not separated with regard to the food of farm products;

ii.processed food:the names of the farm products listed in the left-hand column of the Appended Table 7 which are used as raw materials for the processed food, and the fact that farm products applying recombinant DNA technology and farm products not applying recombinant DNA technology are not separated with regard to those farm products;

3.processed food made from farm products not applying recombinant DNA technology for which Identity Preserved Handling is confirmed to have been conducted (including food made from the processed food):the names of the farm products listed in the left-hand column of the Appended Table 7 which are used as raw materials for the processed food;

(oo)for food for specified health use (meaning food for which permission under Article 26, paragraph (1) of the Health Promotion Act (Act No. 103 of 2002) or approval under Article 29, paragraph (1) of the same Act (hereinafter referred to as "permission or approval" in (oo)) has been obtained to indicate to persons who consume the food for specified health purposes for their daily diet that they can expect to fulfill the health purposes by consuming the food; the same applies hereinafter), the fact that it is food for specified health use (for food which is required, upon the issuance of permission or approval, to show clearly under what conditions the expected specified health purposes can be met (hereinafter referred to as "conditional food for specified health use"), the fact that it is a conditional food for specified health use), the content of the labeling permitted or approved, the amount of nutrients, calories, the names of the raw materials, content weight, recommended consumption per day, consumption methods, notes for consumption, and the wording to recommend a well-balanced daily diet;

(pp)for food with nutrient function claims (meaning food which indicates the functions of the specified nutrients it contains to persons who consume the food to supplement the specified nutrients in their daily diet in accordance with the criteria specified by the Minister of Health, Labour and Welfare (excluding food for special dietary uses prescribed in Article 26, paragraph (5) of the Health Promotion Act and perishable food (excluding eggs)); the same applies hereinafter), the fact that it is food with nutrient function claims, the names and functions of the nutrients intended to be indicated as those conforming to the criteria specified by the Minister of Health, Labour and Welfare, the amount of nutrients, calories, recommended consumption per day, consumption methods, notes for consumption, the wording to recommend a well-balanced daily diet, and the fact that it has not undergone case-by-case reviews by the Minister of Health, Labour and Welfare;

(qq)for food for specified health use for which consumption criteria by gender and age (hereinafter referred to as "consumption criteria" in (qq)) with regard to nutrients that serve the objectives of healthcare are indicated for the purpose of maintaining and improving citizen's health, and for food with nutrient function claims for which consumption criteria are indicated with regard to nutrients whose functions are indicated, the rates of the respective nutrients contained in recommended consumption per day against the weighted average of criterial consumption calculated by using the population by gender and age (limited to six years old or older);

(rr)for food for specified health use or food with nutrient function claims which require special precautions with regard to the cooking or preserving methods, the precautions;

(ii)the matters listed in the preceding item are to be indicated in Japanese and in an accurate manner with wording which is easy to read and understand for persons who generally buy or use the food or additives;

(iii)for food with nutrient function claims, the following matters must not be indicated:

(a)the functions of nutrients other than those pertaining to the criteria specified by the Minister of Health, Labour and Welfare as prescribed in item (i), (pp);

(b)the fact that specified objectives of healthcare can be met;

(iv)for food other than food for specified health use and food with nutrient function claims (hereinafter referred to as "food with health claims"), indication of names liable to be confused with food with health claims or indications that nutrient functions or specified objectives of healthcare can be met must not be made;

(v)for food other than food of farm products not applying recombinant DNA technology for which Identity Preserved Handling is confirmed to have been conducted or processed food made from farm products not applying recombinant DNA technology for which Identity Preserved Handling is confirmed to have been conducted (including food made from the processed food), it must not be indicated that the food of farm products is food of farm products not applying recombinant DNA technology nor that the farm products listed in the left-hand column of the Appended Table 7 which are used as raw materials for the processed food are farm products not applying recombinant DNA technology.

(2)Notwithstanding the provisions of item (i) of the preceding paragraph, regarding shell eggs out of the food listed in item 10 of the Appended Table 3, the food listed in item 11, (c) of the same Table, and the food of farm products listed in item 12 of the same Table whose names are indicated on a nearby signboard or in other conspicuous places, the names thereof do not have to be indicated.

(3)Notwithstanding the provisions of paragraph (1), item (i), if the period between the date for production or processing and the freshness date exceeds three months, the month indicated with the letter meaning a freshness date may replace the date indicated with the letter meaning a freshness date.

(4)Notwithstanding the provisions of paragraph (1), item (i), for food listed in item 2 of the Appended Table 3, food packed in glass bottles (excluding glass bottles with paper caps) or polyethylene containers and packaging among those listed in item 3 of the same Table, food listed in item 11, (b) of the same Table (excluding food which has been canned, bottled, barreled, or jarred), food listed in (c) of the same item, food of farm products listed in item 12 of the same Table, and additives listed in item 14 of the same Table, the date indicated with the letters meaning an expiration date or a freshness date (hereinafter referred to as the "time limit") and the preservation methods do not have to be indicated (for food or additives for which the criteria for the preservation methods have been established pursuant to the provisions of Article 11, paragraph (1) of the Act, the time limit does not have to be indicated).

(5)Notwithstanding the provisions of paragraph (1), item (i), for food listed in item 6 of the Appended Table 3, the date indicated with the letters meaning import date is to be indicated in lieu of the time limit and preservation methods, on conspicuous parts of the containers and packaging or wrappings so that they can be read without opening the containers and packaging.

(6)Notwithstanding the provisions of paragraph (1), item (i), for food listed in item 8 of the Appended Table 3, the date indicated with the letters meaning irradiation date is to be indicated in lieu of the time limit and preservation methods (for food for which the criteria for preservation methods have been established pursuant to the provisions of Article 11, paragraph (1) of the Act, the time limit), on conspicuous parts of the containers and packaging or wrappings so that they can be read without opening the containers and packaging.

(7)Notwithstanding the provisions of paragraph (1), item (i), for shell eggs (limited to those to be eaten raw) among food listed in item 10 of the Appended Table 3, the time limit or preservation methods may be replaced with the date indicated with the letters meaning the date when the shell eggs were laid, the date when they were collected, the date when they were selected by weight and quality, or the date when they were packed, on conspicuous parts of the containers and packaging or wrappings so that they can be read without opening the containers and packaging.

(8)Notwithstanding the provisions of paragraph (1), item (i), for shell eggs among food listed in item 10 of the Appended Table 3, the location of the facility where the shell eggs were collected or where the shell eggs were selected by weight and quality and packed (for imported eggs, the location of the importer's business office) and the name of the person who collected the shell eggs or the person who selected the shell eggs by weight and quality and packed them (for imported eggs, the name of the importer) are to be indicated in lieu of the location of the production or processing facility and the name of the producer or processor, on conspicuous parts of the containers and packaging or wrappings so that they can be read without opening the containers and packaging.

(9)Notwithstanding the provisions of paragraph (1), item (i), labeling indicating that there is no need for refrigeration may be omitted;

(10)Notwithstanding the provisions of paragraph (1), item (i), for food listed in item 11, (c) of the Appended Table 3, food other than food of farm products listed in item 12 of the same Table, and additives, the location of the production facility and the name of the producer may be replaced by indicating the address and name of the producer and the marks unique to the production facility which the producer has notified to the Minister of Health, Labour and Welfare (limited to marks made in Arabic numerals, Roman letters, Hiragana, Katakana, or a combination thereof; hereinafter the same applies in this paragraph), or the address and name of the seller, the fact that the person is the seller, and the marks unique to the producer's production facility which the producer and the seller have notified to the Minister of Health, Labour and Welfare jointly. For food listed in item 11, (c) of the same Table and food of farm products listed in item 12 of the same Table, the location of the production or processing facility and the name of the producer or processor do not have to be indicated.

(11)Notwithstanding the provisions of paragraph (1), item (i), for additives which have a widely used name, labeling indicating that those additives are contained may be replaced with that name. For food containing additives used as those listed in the left- hand column of the Appended Table 8, the labeling may be replaced with the labeling listed in the respective right-hand column of the same Table. For food listed in item 11, (c) of the Appended Table 3 (limited to food containing additives other than additives used as those listed in the middle column of paragraph (8) of the Appended Table 5) and food of farm products listed in item 12 of the Appended Table 3, labeling indicating that those additives are contained may be omitted.

(12)Notwithstanding the provisions of paragraph (1), item (i), in cases listed in the following items, labeling listed in the respective items may be omitted:

(i)when labeling indicating that the additives are contained includes the letter "色(color)":food coloring or artificial coloring;

(ii)when labeling indicating that the additives are contained includes the letters "増粘(thickening)":thickening agent or thickener;

(iii)for food listed in item 11, (c) of the Appended Table 3, when it contains additives other than additives used as those listed in the middle column of paragraph (8) of the Appended Table 5:labeling listed in the right-hand column of the Appended Table 5 pertaining to those additives.

(13)Notwithstanding the provisions of paragraph (1), item (i), for processed food made from specific raw materials where it is easy to judge that specific raw materials are contained as raw materials from its name (hereinafter referred to as "specific processed food" in this paragraph), labeling indicating that the specific raw materials are contained as raw materials may be omitted. For processed food made from specific processed food (excluding those made from milk (meaning milk prescribed in Article 2, paragraph (1) of the Ministerial Order concerning the Ingredient Standards for Milk and Dairy Products (Order of the Ministry of Health and Welfare No. 52 of 1951)); the same applies hereinafter), labeling indicating that specific raw materials are contained as raw materials may be replaced by indicating that the specific processed food is contained as a raw material. For food containing additives derived from specific raw materials and which has labeling attached indicating that the specific raw materials or specific processed food made from the specific raw materials are contained as raw materials and where it is easy to judge that the specific raw materials are contained as raw materials from its name, labeling indicating that additives contained in the food are derived from those specific raw materials may be omitted. For additives derived from those specific raw materials where it is easy to judge that they are derived from specific raw materials from their name, labeling indicating that they are derived from the specific raw materials may be omitted.

(14)Notwithstanding the provisions of paragraph (1), item (i), labeling for the matters listed in paragraph (1), item (i), (nn), 1 through 3 may be omitted for food listed in the following items:

(i)processed food which does not use food of farm products listed in the left-hand column of the Appended Table 7 or processed food which uses the processed food as the main raw materials (meaning the top three raw materials accounting for the higher rates out of the total weight of raw materials and whose rate against the total weight is 5% or more; the same applies hereinafter);

(ii)processed food other than the processed food listed in the right-hand column of the Appended Table 7 as those in which recombinant DNA or the resultant protein remains even after processing procedures;

(iii)among the food of farm products listed in item 12 of the Appended Table 3, those for which the matters listed in paragraph (1), item (i), (nn), 1 through 3 are indicated on a signboard close to the food of farm products or in other conspicuous places;

(iv)among processed food listed in item 12 of the Appended Table 3, those falling under paragraph (1), item (i), (nn), 3 which are made from any of the farm products listed in the left-hand column of the Appended Table 7;

(v)food which is not sold directly to general consumers.

(15)When farm products applying recombinant DNA technology and farm products not applying recombinant DNA technology have been unintentionally mixed up to a certain degree in spite of conducting Identity Preserved Handling, and if the confirmation set forth in paragraph (1), item (i), (nn), 1 or 3 has been appropriately made, the provisions of paragraph (1), item (i) are applied, deeming that Identity Preserved Handling has been confirmed to have been conducted.

(16)Notwithstanding the provisions of paragraph (1), item (i), for food listed in item 11, (b) of the Appended Table 3 and processed food listed in item 12 of the same Table which are specified by the Minister of Health, Labour and Welfare as food with containers and packaging too small to have the matters listed in paragraph (1) clearly indicated, the labeling may be omitted.

(17)Notwithstanding the provisions of paragraph (1), item (i), labeling indicating the matters listed in the same item (excluding the matters listed in (a) and (c) of the same item) on containers and packaging may be replaced by indicating those matters in an invoice for food listed in the left-hand column of the Appended Table 9 when falling under cases listed in the respective right-hand column of the same Table.In this case, the mark which can identify the food is to be indicated on conspicuous parts of the containers and packaging so that they can be read without opening the containers and packaging, and the matters listed in (a) and (c) of the same item, the mark, and the name and address of the purchaser (for a corporation, its name and the location of its main office) must be indicated in the invoice.

(18)The provisions of paragraph (3) and paragraphs (9) through (12) apply mutatis mutandis to the case where the matters listed in paragraph (1), item (i) are indicated in an invoice pursuant to the provisions of the preceding paragraph.

(19)Notwithstanding the provisions of paragraph (1), item (i), labeling indicating that the objectives of the healthcare pertaining to food with health claims can be expected and labeling indicating the functions of the nutrients on containers and packaging may be replaced by indicating them in the attached documents.

Chapter III Plans for Monitoring and Guidance

Article 22(1)A prefectural governor, mayor of a city establishing health centers, or head of a special ward (hereinafter referred to as "prefectural governor, etc.") must submit prefectural plans for the monitoring of and guidance on food sanitation for each fiscal year to the Minister of Health, Labour and Welfare prior to the start of the fiscal year.

(2)A prefectural governor, etc., when intending to change the prefectural plans for the monitoring of and guidance on food sanitation, must submit the new plans to the Minister of Health, Labour and Welfare prior to implementation.

Article 23(1)A prefectural governor, etc. must publicize the outline of the performance results of prefectural plans for the monitoring of and guidance on food sanitation for every fiscal year by June 30 of the following fiscal year, compile the full text of the results and publicize it promptly.

(2)In addition to what is provided for in the preceding paragraph, a prefectural governor, etc. must prepare an outline of the performance results of the prefectural plans for the monitoring of and guidance on food sanitation for the summer, the year-end, or other necessary periods, and publicize it promptly.

(3)When publicizing an outline of the performance results pursuant to the provisions of the preceding two paragraphs, a prefectural governor, etc. must endeavor to use appropriate methods such as bulletins or the official written reports of the prefecture, city establishing health centers, or special ward or the internet to disseminate the content widely to the residents.

Chapter IV Product Inspections

Article 24An application for inspections under Article 25, paragraph (1) of the Act is to be filed by submitting a written application stating the following matters by products comprising each 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 address 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 thereof.

Article 25The collection of test samples under 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 from products comprising each lot, and the amount to be collected is to be the minimum amount necessary for the inspections.

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

Article 27The matters specified by Order of the Ministry of Health, Labour and Welfare under 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 main 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)concrete reasons to order a person to receive inspections.

Article 28(1)An application for inspections under Article 26, paragraph (1) of the Act is to be filed by submitting a written application stating the following matters by products comprising each lot:

(i)the name and address of the applicant (for a corporation, its name, the location of its main 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 set forth in the preceding paragraph must have a transcript of a written inspection order under Article 5, paragraph (1) of the Order attached; provided, however, that this does not apply to the case where an application for inspections has already been filed for the same order and a transcript of a written inspection order has already been submitted.

Article 29(1)An application for inspections under 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 main 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 main office);

(iv)the name and location of the production or processing facility;

(v)the date of the arrival of the products at a port;

(vi)the location of the product inventory;

(vii)the quantity for the application.

(2)The written application set forth in the preceding paragraph must have a transcript of a written inspection order (when the Minister of Health, Labour and Welfare has issued a notice of inspection using an electronic data processing system pursuant to the provisions of Article 34, paragraph (1), a transcript of the printout of the content of the order) attached.

Article 30The provisions of the preceding Article apply mutatis mutandis to an application for inspections under Article 26, paragraph (3) of the Act. In this case, the term "matters" in paragraph (1) of the same Article is deemed to be replaced with "matters (for an application for inspections of food other than processed food, excluding the matters listed in item (iii))", and the term "location" in item (iv) of the same 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 31The 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 under 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 prescribed in Article 27 of the Act (including as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act; the same applies in paragraph (7), paragraph (8), and the following Article) (such a person is referred to as an "importer" in 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 listed in item (xii)) and submit it to the head of a quarantine station listed in the right-hand column of the Appended Table 11 for the places listed in the respective left-hand column of the same Table from seven days prior to the planned arrival date of the cargoes (when an accident concerning the cargoes is suspected, after the carrying in), except in cases where the person intends to import food listed in the Appended Table 10; provided, however, that when submitting a written import notification prior to the carrying in and when there has been an accident concerning the cargoes, a written notification stating the outline of the accident must be submitted to the head of the quarantine station promptly after the carrying in:

(i)the name and address (for a corporation, its name and the location of its main 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 usage, and when the cargoes have any marks and numbers, 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 human consumption and is used as an additive, limited to those for which standards or criteria have been established pursuant to the provisions of Article 11, paragraph (1) of the Act), the name of the additives;

(iv)when the cargoes are processed food, the raw materials thereof and production or processing methods;

(v)when the cargoes are food of farm products or processed food listed in item 12 of the Appended Table 3 (excluding those listed in Article 21, paragraph (14), item (i) or item (ii)), the matters listed in paragraph (1), item (i), (nn), 1 through 3 of the same Article according to the relevant classification set forth in (nn), 1 through 3 of the same item;

(vi)when the cargoes are additives, or preparations containing the additives (excluding those used for flavoring and those generally served for human consumption which are used as additives), the ingredients thereof;

(vii)when the cargoes are apparatus, containers and packaging, or toys, the materials thereof;

(viii)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 main office);

(ix)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;

(x)the name or flight number of the ship or airplane loaded with the cargoes;

(xi)the name and location of the warehouse where the cargoes have been stored and the date of carrying in;

(xii)whether there have been any accidents concerning the cargoes and the outline of the accidents if any.

(2)An importer, when there have been any changes to the matters listed in item (ix) through item (xi) of the preceding paragraph (for the matters listed in item (ix), limited to the unloading port and the arrival date), must submit a notification to that effect immediately to the head of the quarantine station set forth in the preceding paragraph.

(3)When farm products applying recombinant DNA technology and farm products not applying recombinant DNA technology have been unintentionally mixed up to a certain degree, in spite of conducting Identity Preserved Handling, and if the confirmation set forth in Article 21, paragraph (1), item (i), (nn), 1 or 3 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 the food, additives, apparatus, containers and packaging listed in the middle column of the Appended Table 12 (hereinafter referred to as "food, etc." in this Article) and when the importer has submitted a written import notification stating the import plans for the same products as the food or equivalent products (hereinafter referred to as "the same food, etc.") for a period listed in the right-hand column of the same Table (such plans mean the loaded weight, unloading port, and arrival date of the cargoes pertaining to the import planned for the 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 where the food, etc. pertaining to the import falls under or is suspected of falling under any of the following items:

(i)food or additives listed in each item of Article 6 of the Act;

(ii)food or additives prescribed in Article 10 of the Act;

(iii)food or additives which do not conform to the criteria established pursuant to the provisions of Article 11, paragraph (1) of the Act;

(iv)food or additives which do not conform to the standards established pursuant to the provisions of Article 11, paragraph (1) of the Act;

(v)food in which substances that are the ingredients of agricultural chemicals (meaning agricultural chemicals prescribed in Article 1-2, paragraph (1) of the Agricultural Chemicals Control Act (Act No. 82 of 1948), the same applies hereinafter), substances that are used by being added, mixed or infiltrated into feed (meaning feed prescribed in Article 2, paragraph (2) of the Act on Safety Assurance and Quality Improvement of Feed (Act No. 35 of 1953)) or are used by other methods for feed for the purpose of providing it for usage specified by Order of the Ministry of Agriculture, Forestry and Fisheries based on Article 2, paragraph (3) of the same Act, and pharmaceutical products that are prescribed in Article 2, paragraph (1) of the Pharmaceutical Affairs Act (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 11, 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 11, paragraph (3) of the Act (excluding cases where standards concerning the ingredients of food under Article 11, 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 prescribed 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 set forth in the preceding paragraph, an importer of food, etc. listed in the middle column of paragraph (3) of the Appended Table 12 must submit a written import notification stating the import plans prescribed in the preceding paragraph, by stating the past record of imports of the same food, etc. during the three years before the date of submission of the written import notification (such past record means the name of the importer pertaining to the import which took place during that period (for a corporation, its name), the loaded weight, unloading port, and arrival date of the cargoes).

(6)In the case set forth in the main clause of paragraph (4), the term "when a written import notification has been submitted prior to the carrying in and there has been an accident concerning the cargoes" in the proviso of paragraph (1) is deemed to be replaced with "when there has been an accident concerning the cargoes pertaining to the import" and the term "the head of the quarantine station" is deemed to be replaced with "the head of a quarantine station listed in the right-hand column of the Appended Table 11 for the places listed in the respective left-hand column of the same Table."

(7)The Minister of Health, Labour and Welfare may have a person make a notification under Article 27 of the Act using an electronic data processing system (meaning an electronic data processing system connecting a computer (including input-output devices; the same applies hereinafter) used by the Ministry of Health, Labour and Welfare and input-output devices used by a person who intends to make a notification under the same Article through 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 intends to make a notification under Article 27 of the Act using an electronic data processing system, the term "state the following matters in a written import notification" is deemed to be replaced with "record the following matters," the term "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 intends to make the notification; hereinafter the same applies in this paragraph and the following paragraph)," the term "and submit it to the head of a quarantine station listed in the right-hand column of the Appended Table 11 for the places listed in the respective left-hand column of the same Table" is deemed to be replaced with "in a file by inputting them through input-output devices," the term "when submitting a written import notification prior to the carrying in" in the proviso of paragraph (1) is deemed to be replaced with "when recording the matters in a file by inputting them through input-output devices," and the term "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 input-output devices," and the term "submit a notification to that effect immediately 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 input-output devices."

(9)The provisions of paragraphs (4) through (6) do not apply to a person prescribed in the preceding paragraph.

Article 33(1)The input under paragraphs (1) and (2) of the preceding Article which is applied mutatis mutandis by replacing terms pursuant to paragraph (8) of the preceding Article must be entered through input-output devices of which a person has notified the Minister of Health, Labour and Welfare in advance.

(2)A person who intends to make a notification under Article 27 of the Act using an electronic data processing system is to make a notification set forth in the preceding paragraph by way of submitting a written notification stating the following matters to the Minister of Health, Labour and Welfare, with regard to the input-output devices the person intends to use:

(i)the name and address of the notifier (for a corporation, its name and the location of its main office);

(ii)a security code (limited to 12-character Arabic numerals or Roman letters or a combination thereof);

(iii)the places where the input-output devices are located, the names and model numbers of the equipment;

(iv)when a person other than the notifier manages the input-output devices, the name and address of the person (for a corporation, its name and the location of its main office).

(3)A person who has made a notification set forth in the preceding paragraph, when there are any changes to the matters listed in each item of the same paragraph or when the person has stopped using the notified input-output devices, must notify the Minister of Health, Labour and Welfare promptly.

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 Article 26, paragraph (2) or paragraph (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 pertaining to the notification, or issuing a notice of the results of the inspections under 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, when issuing a specific notice using an electronic data processing system pursuant to the provisions of the preceding paragraph, must input the content of the specific notice through the input-output devices set forth in Article 32, paragraph (7) (limited to those 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 and Food Sanitation Inspectors

Article 35(1)When a food sanitation inspector intends to remove food, additives, apparatus, containers and packaging, or toys listed in each item of Article 78 (hereinafter referred to as "food, etc.") pursuant to the provisions of Article 28, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 62, paragraphs (1) and (3) of the Act), the food sanitation inspector must issue a certificate for removal according to Form No. 2 to a person whose objects are removed.

(2)The identification to be carried by a food sanitation inspector when carrying out their duties is to conform to Form No. 3, and the emblem indicating that the person is a food sanitation inspector is to conform to Form No. 4.

(3)The Minister of Health, Labour and Welfare and a prefectural governor, etc., when entrusting the affairs concerning the examination to a registered conformity assessment body pursuant to the provisions of Article 28, paragraph (4) of the Act, must have an inspector of the registered conformity assessment body (meaning an inspector prescribed in Article 38, paragraph (1), item (ii)) conduct the examination at a level equal to or higher than the criteria listed in each item of Article 40.

Article 36The machinery and tools specified by Order of the Ministry of Health, Labour and Welfare under Article 8, paragraph (1) of the Order are 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 necessary machinery and tools.

Article 37The affairs concerning the inspections or examination under Article 8, paragraph (2) of the Order (hereinafter referred to as "inspections, etc." in this Article and the Appended Table 13) are to be managed as follows:

(i)confirming that inspections, etc. are conducted appropriately based on standard operation manuals prescribed in item (xi);

(ii)conducting internal checking of the management of the operation of inspections, etc. on a regular basis, based on documents set forth in item (xii);

(iii)conducting accuracy control (meaning maintaining the accuracy of inspections through such methods as ensuring the skill levels of persons engaged in inspections; the same applies hereinafter), based on documents set forth in item (xiii);

(iv)receiving external investigation of accuracy control (meaning investigation concerning accuracy control conducted by the State or other persons deemed to be appropriate; the same applies hereinafter) on a regular basis, based on documents set forth in item (xiv);

(v)recording the results of internal checking set forth in item (ii), accuracy control set forth in item (iii), and external investigation of accuracy control set forth in the preceding item (when improvement measures are required, including the content of the improvement measures);

(vi)taking improvement measures for the operation of inspections, etc. promptly in accordance with the records under the preceding item;

(vii)when there has been any deviation from the standard operation manuals prescribed in item (xi) and the documents prescribed in items (xii) and (xiii) upon inspections, etc., to assess the content of the deviation and take the necessary measures;

(viii)an employee who carries out the duties set forth in item (i) or the preceding two items must not conduct inspections, etc.;

(ix)an employee who carries out the duties set forth 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 set forth in item (i) or item (vi);

(x)making credibility ensuring duties independent from the operation of inspections, etc.;

(xi)preparing standard operation manuals as prescribed in the Appended Table 13;

(xii)preparing documents stating the methods for the internal checking of the management of the operation of inspections, etc.;

(xiii)preparing documents stating the methods for accuracy control;

(xiv)preparing documents stating the plans for receiving an external investigation of accuracy control on a regular basis;

(xv)preparing documents stating the training plans for employees who carry out credibility ensuring duties;

(xvi)preparing the following records and retaining them for three years from the day on which the records are prepared:

(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 62, paragraph (1) of the Act; the same applies in (b)) (for a corporation, its name and the location of its main 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)inspection items ;

(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)records under item (v);

(j)records based on the standard operation manuals set forth in item (xi);

(k)records concerning the training set forth in the preceding item.

Chapter VII Registered Conformity Assessment Bodies

Article 38(1)A person who intends to apply for registration under Article 31 of the Act must submit a written application according to Form No. 5 to the Minister of Health, Labour and Welfare, by attaching the following documents:

(i)the articles of incorporation or certificates of an act of endowment and registered matters;

(ii)the resume of a person who has the knowledge and experience that meet the conditions listed in column 3 of the Appended Table of the Act (hereinafter referred to as an "inspector");

(iii)documents to clarify the organization of departments prescribed in Article 33, paragraph (1), item (ii), (a) of the Act (hereinafter referred to as "departments conducting product inspections") and specialized departments prescribed in (c) of the same item (hereinafter referred to as "departments ensuring credibility");

(iv)a standard operation manual prescribed in Article 40, item (viii) and documents prescribed in items (ix) through (xii) of the same Article as documents prescribed in Article 33, paragraph (1), item (ii), (b) of the Act;

(v)documents stating the following matters:

(a)whether the corporation falls under any item of Article 32 of the Act;

(b)the type of product inspections to be conducted among those listed in column 1 of the Appended Table of the Act;

(c)the number and performance of the machinery, tools, and other equipment listed in column 2 of the Appended Table of the Act, whether the machinery, etc. are owned or leased, the place where the machinery, etc. are located, and the type of product inspections for which the machinery, etc. 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 prescribed in Article 40, item (i), and the name of the responsible person for the inspection category prescribed in item (ii) of the same Article and the type of product inspections that the person supervises;

(f)the name of the department ensuring credibility, and the name of the responsible person for the department ensuring credibility prescribed 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), (a) through (c) of the Act;

(i)for a stock company, the name and address of a shareholder who holds shares in excess of five percent of the total number of issued shares or a person who has contributed in excess of 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 prescribed in Article 575, paragraph (1) of the Companies Act (Act No. 86 of 2005)), the personnel in charge of its business), whether they have authority of representation, 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 set forth in the preceding paragraph.

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

(i)documents listed in paragraph (1), items (i) through (iii) of the preceding Article;

(ii)documents stating the matters listed in paragraph (1), item (v), (a), and (c) through (k) of the preceding Article;

(iii)material concerning the actual performance of product inspections.

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

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

(i)persons who carry out the following duties must be placed in departments conducting product inspections (hereinafter referred to as "persons responsible 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);

(c)other necessary duties;

(ii)at departments conducting product inspections, persons who carry out the following duties for product inspections based on standard operation manuals prescribed in item (viii) (hereinafter referred to as "persons responsible for inspection categories") must be placed for each category of physicochemical inspections, bacteriological inspections, and inspections using animals:

(a)when there has been any deviation from standard operation manuals prescribed in item (viii) and documents prescribed in item (ix) 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 prescribed 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 must be placed in departments ensuring credibility (hereinafter referred to as "persons responsible 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 control based on documents set forth in item (x), and when there has been any deviation from the documents, assessing the content of the deviation and taking necessary measures;

(c)conducting affairs for receiving an external investigation of accuracy control on a regular basis, based on documents set forth in item (xi);

(d)reporting the results of internal checking set forth in (a), accuracy control set forth in (b), and external investigation of accuracy control set forth in (c) (when improvement measures are required, including the content of the improvement measures) to persons responsible for departments conducting product inspections in writing and entering the record into the books set forth in Article 44 of the Act (hereinafter referred to as the "books");

(e)carrying out other necessary duties;

(iv)a department ensuring credibility must be independent from departments conducting inspections;

(v)persons responsible for departments conducting product inspections and persons responsible for departments ensuring credibility are to be officers of a registered conformity assessment body;

(vi)persons responsible for departments conducting product inspections and persons responsible for inspection categories must not hold the position of inspector concurrently;

(vii)persons responsible for departments ensuring credibility and persons appointed pursuant to the provisions of item (iii) must not hold the position of persons responsible for departments conducting product inspections, persons responsible for inspection categories and inspectors concurrently;

(viii)standard operation manuals have been prepared as prescribed in the Appended Table 13.In this case, the term "Methods for keeping records" in the same Table is deemed to be replaced with "Methods for entering, into the book, the records," the term "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 control have been prepared;

(xi)documents stating plans for receiving external investigations of accuracy control on a regular basis have been prepared;

(xii)documents stating training plans for persons responsible for departments ensuring credibility and persons appointed pursuant to the provisions of item (iii) have been prepared.

Article 41(1)A person who intends to notify the establishment, abolition, or changes of the locations of their office pursuant to the provisions of Article 36, paragraph (1) of the Act must submit a written notification according to Form No. 7 to the Minister of Health, Labour and Welfare.

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

Article 42(1)When a registered conformity assessment body intends to obtain approval 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 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 established in operational rules set forth in Article 37, paragraph (2) of the Act are as follows:

(i)types of product inspections and matters concerning the methods for the implementation and management of the operation of product inspections;

(ii)matters concerning the hours for conducting product inspections and holidays;

(iii)matters concerning the maximum number of applications for product inspections that may be received;

(iv)matters concerning places for conducting product inspections;

(v)the fee for each inspection item of product inspections and matters concerning methods for storage;

(vi)matters concerning the appointment and dismissal of persons responsible for departments conducting product inspections, persons responsible for inspection categories, inspectors, and persons responsible for departments ensuring credibility;

(vii)matters concerning the allocation of persons responsible for departments conducting product inspections, persons responsible for inspection categories, and inspectors;

(viii)matters concerning the retention of written applications for product inspections and other documents concerning product inspections;

(ix)matters concerning the keeping of financial statements, etc. (meaning financial statements, etc. prescribed 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.;

(x)in addition to what are listed in the preceding items, matters necessary for the operation of product inspections.

(3)When a registered conformity assessment body intends to obtain approval 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 according to Form No. 10 to the Minister of Health, Labour and Welfare.In this case, when the changes are accompanied with changes to the amount of the fee for product inspections, materials concerning the calculation thereof must be attached.

Article 43When a registered conformity assessment body intends to obtain approval for the suspension, in whole or in part, of the operation of product inspections or the abolition of the operation of product inspections pursuant to the provisions of Article 38 of the Act, it must submit a written application according to 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 under Article 39, paragraph (2), item (iii) of the Act are to be the means of indicating the matters recorded on the electronic or magnetic records on paper or on the screen of an input-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 to be either of those listed in the following items specified by a registered conformity assessment body:

(i)means of using an electronic data processing system connecting the computer used by a sender and the computer used by a receiver through a telecommunications line, by which information is sent through the telecommunications line and recorded in a file stored on the computer used by the receiver;

(ii)means of delivering information recorded in a file which is prepared in the form of a magnetic disk or other equivalent means that may record or reliably store certain matters.

Article 46(1)The matters specified by Order of the Ministry of Health, Labour and Welfare under 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 main 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)product inspection items;

(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 product inspections;

(ix)records to be entered into the books pursuant to the provisions of Article 40, item (iii), (d);

(x)records to be entered into the books in standard operation manuals prepared pursuant to the provisions of Article 40, item (viii);

(xi)records concerning the training set forth in Article 40, item (xii).

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

Article 47The identification which the officials 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 conform to Form No. 12.

Chapter VIII Business

Article 48A person who is deemed to have an equal or greater academic ability than a person who has graduated from a high school or secondary education school under the School Education Act (Act No. 26 of 1947) or a secondary school under the former Secondary School Order (Imperial Order No. 36 of 1943) as prescribed in Article 48, paragraph (6), item (iv) of the Act is as follows:

(i)a person who has completed the first year of a higher 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 the same 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 the same 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 attached secondary school or attached 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 prior to the amendment by the same Order (Imperial Order No. 346 of 1897);

(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 way as a person listed in item (i);

(vii)a person who has graduated from a regular course at a boys' school (excluding schools of two-year courses) under the former Boys' School Order (Imperial Order No. 254 of 1939);

(viii)a person who has passed examinations under the former Vocational Training School Entrance Examination Regulations (Order of the Ministry of Education No. 22 of 1924) based on the former Vocational Training School Order (Imperial Order No. 61 of 1903), and a person designated by the Minister of Education as having an equal or greater academic ability than graduates of a secondary school or girls' high school with regard to entrance into a vocational training school pursuant to the provisions of Article 11, paragraph (2) of the same 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 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 listed 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 School Teacher's License Act (Act No. 148 of 1949), or a person who has a qualification listed 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 the same Act;

(xii)in addition to what are listed in the preceding items, a person deemed by the Minister of Health, Labour and Welfare to have an equal or greater academic ability 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 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 main office, and the name of its representative);

(ii)the type of food or additives prescribed 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;

(vi)the date for putting the food sanitation supervisor in place or changing the food sanitation supervisor.

(2)A written notification set forth in the preceding paragraph must be attached with a resume of the food sanitation supervisor, documents certifying that the food sanitation supervisor falls under any of the items of Article 48, paragraph (6) of the Act and documents certifying the relations with the business person.

Article 50The criteria specified by Order of the Ministry of Health, Labour and Welfare under 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 deemed to provide education equivalent to that at universities or graduate schools pursuant to the provisions of Article 68-2, paragraph (4), item (ii) of the same Act;

(ii)for each curriculum listed in the left-hand column of the Appended Table 14, one or more subjects listed in the right-hand column of the same Table are to be taken, and the total credits are to be 22 or more;

(iii)subjects listed in the preceding item and subjects listed in the Appended Table 15 are to be taken, and the total credits are to be 40 or more;

(iv)classes are to be conducted, in principle, by using the machinery and tools listed in column 2 of the Appended Table of the Act.

Article 51A written application set forth 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 institute;

(ii)the name and location of the founder of the training institute, and the date of foundation;

(iii)the name and address of the head of the training institute;

(iv)the name and personal history of the teachers, the subjects they specialize in, and whether they are full-time workers or have other jobs;

(v)plans for taking subjects in each year, the number of credits, and whether they are compulsory subjects or optional subjects;

(vi)student quotas;

(vii)entrance requirements and the season for entrance;

(viii)course terms;

(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;

(xii)other referential matters.

Article 52(1)Registration of a training institute under Article 48, paragraph (6), item (iii) of the Act is to be made by entering the following matters into the registry:

(i)the date of registration and registration number;

(ii)the name and location of the registered training institute (meaning a registered training institute prescribed 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 institute set forth in Article 9, paragraph (1), item (iv) of the Order.

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

Article 54A written application set forth 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 intending to receive rescission of the registration;

(ii)the planned date to receive rescission of the registration;

(iii)when there are students still in school, measures to be taken for them.

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

Article 56(1)Courses of training sessions set forth in Article 48, paragraph (6), item (iv) of the Act must conform to all the following requirements:

(i)subjects listed in 1 of the Appended Table 16 and subjects listed in any of 2 through 7 of the same Table are to be taught, and the number of hours is to be those listed in the same Table or more;

(ii)lecturers are to be persons who teach subjects equivalent to those set forth 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 any entity of the State, prefecture, city establishing health centers, or special ward, or persons deemed to have equal knowledge and experience as those mentioned above;

(iii)requirements 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 listed in each item of Article 48 and who has been engaged in sanitation management of the production or processing of food or additives for two years or more at production or processing businesses for which food sanitation supervisors are required pursuant to the provisions of Article 48, paragraph (1) of the Act;

(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 listed in the following items may be exempted from taking subjects prescribed in those respective items:

(i)a person who has studied subjects at levels equal to or higher than those listed in 1 of the Appended Table 16 at a university under the School Education Act, university under the former University Order (Imperial Order No. 388 of 1918), or vocational training school under the former Vocational Training School Order:those subjects;

(ii)a person who has completed registered training sessions:for a person who has completed subjects listed in 1 of the Appended Table 16 and subjects listed in 2 or 3 of the same Table, practical training on bacteriology listed respectively in 3 or 2 of the same Table.

Article 57A person who intends to apply for registration under Article 21 of the Order must submit a written application to the Minister of Health, Labour and Welfare, by attaching a transcript of the certificate of residence (for a corporation, articles of incorporation or certificates of an act of endowment and registered matters) 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 main office, and the name of its representative);

(ii)whether the person falls under any item of Article 22 of the Order;

(iii)for a corporation, the names, addresses, and brief biographical outlines of its officers;

(iv)the name and location of the site for 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 number of planned participants;

(viii)the training subjects and the number of hours;

(ix)the names and occupations of lecturers, the training subjects they specialize in, and the number of hours for each of the training subjects.

Article 58Registration under Article 21 of the Order is to be made by entering the following matters into the registry:

(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 main office, and the name of its representative);

(iii)the period of the registered training sessions.

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

(i)confirming that the participant meets the requirements for taking training sessions by checking their resume, the documents certifying their relations with the business entity they have worked for, and other necessary documents;

(ii)issuing a certificate for the completion of training to the person who has completed the courses of the training sessions;

(iii)holding registered training sessions as prescribed in Article 56.

Article 60The matters specified by Order of the Ministry of Health, Labour and Welfare under 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 main office, and the name of its representative);

(ii)the period of the registered training sessions.

Article 61When an organizer of registered training sessions intends to suspend or abolish the operation of the registered training sessions pursuant to the provisions of Article 26 of the Order, they must notify the Minister of Health, Labour and Welfare of the following matters:

(i)the reasons for the suspension or abolition and the planned date therefor;

(ii)when intending to suspend the operation, the planned period of time.

Article 62An organizer of registered training sessions must prepare the financial statements, etc. (meaning the financial statements, etc. prescribed in Article 27, paragraph (1) of the Order; hereinafter the same applies in this Article) for the previous business year (when three months have not yet elapsed after 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 them at the office from the time of registration up to the end of 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 under 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 under 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 under Article 31 of the Order are as follows:

(i)the names and personal histories of the participants;

(ii)the number of participants;

(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 business entities they work for.

(2)The books set forth in Article 31 of the Order must be retained for three years from the date of the final entry.

Article 66The identification which the officials are to carry pursuant to the provisions of Article 33, paragraph (2) of the Order is to conform to Form No. 13.

Article 67(1)A person who intends to obtain approval for business pursuant to the provisions of Article 52, paragraph (1) of the Act must submit a written application stating the following matters, with drawings showing the structures of business facilities, to the prefectural governor governing the location of their business office with regard to businesses requiring the approval of the prefectural governor (for designated cities set forth in Article 252-19, paragraph (1) of the Local Autonomy Act (Act No. 67 of 1947) and core cities set forth in Article 252-22, paragraph (1) of the same Act, the approval of the mayor of the designated city or core city; the same applies hereinafter), and to the city mayor or ward mayor governing the location of their business office with regard to businesses requiring the approval of the city mayor of a city establishing health centers or ward mayor of a special ward:

(i)the name, address, and date of birth of the applicant (for a corporation, its name, the location of its main office, and the name of its representative);

(ii)the location of the business office;

(iii)the name, shop name, or trade name of the business office;

(iv)the type of business;

(v)an outline of the business facilities;

(vi)whether the person falls under any of the items of Article 52, paragraph (2) of the Act, and when the person falls under any of them, the content thereof.

(2)When a person who has obtained approval for business under Article 52, paragraph (1) of the Act (referred to as an "approved business person" in the following Article through Article 71) intends to obtain approval for the same business continuously upon expiration of the valid period of the former approval, the person is to enter the following matters into a written application, notwithstanding the provisions of each item of the preceding paragraph:

(i)the matters listed in items (i), (ii), (iv), and (vi) of the preceding paragraph;

(ii)the number of approvals for business already obtained and the date the approvals were granted.

Article 68(1)A person who intends to notify their succession to the status of approved business person through an inheritance pursuant to the provisions of Article 53, paragraph (2) of the Act must submit a written notification stating the following matters to the prefectural governor governing the location of their business office with regard to businesses for which the approval of the prefectural governor has been obtained, and to the city mayor or ward mayor governing the location of their business office with regard to businesses for which the approval of the city mayor of a city establishing health centers or ward mayor of a special ward has been obtained:

(i)the name, address, and date of birth of the notifier and their relationship to the decedent;

(ii)the name and address of the decedent;

(iii)the date of the start of the inheritance;

(iv)the location of the business office;

(v)the type of business;

(vi)the number of approvals for business already obtained and the date the approvals were granted.

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

(i)a transcript of the family register;

(ii)for a person selected as the successor to the status of the approved 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 intends to notify their succession to the status of approved business person through a merger pursuant to the provisions of Article 53, paragraph (2) of the Act must submit a written notification stating the following matters to the prefectural governor governing the location of their business office with regard to businesses for which the approval of the prefectural governor has been obtained and to the city mayor or ward mayor governing the location of their business office with regard to businesses for which the approval of the city mayor of a city establishing health centers or ward mayor of a special ward has been obtained:

(i)the name of the notifier, the location of their main office, and the name of their representative;

(ii)the name of the corporation extinguished by the merger, the location of its main office, and the name of its representative;

(iii)the date of the merger;

(iv)the location of the business office;

(v)the type of business;

(vi)the number of approvals for business already obtained and the date the approvals were granted.

(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 intends to notify their succession to the status of approved business person through a split pursuant to the provisions of Article 53, paragraph (2) of the Act must submit a written notification stating the following matters to the prefectural governor governing the location of their business office with regard to businesses for which the approval of the prefectural governor has been obtained and to the city mayor or ward mayor governing the location of their business office with regard to businesses for which the approval of the city mayor of a city establishing health centers or ward mayor of a special ward has been obtained:

(i)the name of the notifier, the location of their main office, and the name of their representative;

(ii)the name of the corporation prior to the split, the location of its main office, and the name of its representative;

(iii)the date of the split;

(iv)the location of the business office;

(v)the type of business;

(vi)the number of approvals for business already obtained and the date the approvals were granted.

(2)The written notification set forth in the preceding paragraph must be attached with certificates of the registered matters of the corporation which succeeded to the business through the split.

Article 71When there are any changes to the matters set forth in Article 67, paragraph (1), item (i), item (iii), or item (v), Article 68, paragraph (1), item (i), Article 69, paragraph (1), item (i) or paragraph (1), item (i) of the preceding Article, an approved business person must make a notification promptly to the prefectural governor governing the location of their business office with regard to businesses for which the approval of the prefectural governor has been obtained and to the city mayor or ward mayor governing the location of their business office with regard to businesses for which the approval of the city mayor of a city establishing health centers or ward mayor of a special ward has been obtained.

Chapter IX Miscellaneous Provisions

Article 72A notification by a physician under Article 58, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 62, 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 person who has died (hereinafter referred to as a "patient, etc.");

(iii)the causes of the food poisoning (meaning poisoning caused by food, etc.; the same applies hereinafter);

(iv)the date and time the disease occurred;

(v)the date and time of the diagnosis or examination.

Article 73(1)The number of persons poisoned by food, etc. specified by Order of the Ministry of Health, Labour and Welfare under Article 58, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to Article 62, paragraph (1) of the Act; the same applies hereinafter) is to be 50.

(2)The cases specified by Order of the Ministry of Health, Labour and Welfare under Article 58, paragraph (3) of the Act are as follows:

(i)when a fatality 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 listed in the Appended Table 17;

(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 actual situation of the poisoning;

(vi)when it is difficult to take countermeasures pursuant to the provisions of Articles 54 through 56 of the Act (hereinafter referred to as "countermeasures") or to judge the appropriateness of the contents thereof in light of the actual situation of the poisoning.

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

(i)the location of the patients, etc. and the date of notification under Article 58, 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 identifying it as the cause;

(iv)the disease agents that caused or are suspected to have caused the poisoning and the reasons for identifying them as the cause;

(v)the business facilities that caused or are suspected to have caused the poisoning (hereinafter referred to as "facilities causing poisoning") and the reasons for identifying them as the cause;

(vi)in addition to what are listed in the preceding items, matters deemed important in carrying out investigations of the causes of the poisoning and taking countermeasures.

Article 75(1)Written reports under Article 37, paragraph (3) of the Order are to be written reports specified in the following items according to the classification of food poisoning cases listed in those respective items:

(i)food poisoning cases which prefectural governors, etc. have reported immediately to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 58, paragraph (3) of the Act:a report of the food poisoning case according to Form No. 14 and written details of the food poisoning case;

(ii)food poisoning cases other than those listed in the preceding item:a report of the food poisoning case according to Form No. 14.

(2)Written details of the food poisoning case prescribed 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 deaths;

(e)the number of patients;

(f)the food, etc. causing poisoning;

(g)the disease agents.

(ii)matters concerning the gathering 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 gender and age;

(b)the number of patients and the deceased by date and time;

(c)the ratio of patients and the deceased among those who have consumed the food, etc. causing poisoning;

(d)the time taken 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 their number by symptom;

(iv)the following matters concerning the food, etc. causing poisoning and its contamination routes:

(a)the process of identifying the food, etc. causing poisoning and the reasons for identifying it as the cause;

(b)the contamination routes of the food, etc. causing poisoning;

(v)matters concerning facilities causing poisoning:

(a)the situation of water supply and drainage and other sanitary conditions at facilities causing poisoning;

(b)the health conditions of workers at facilities causing poisoning;

(vi)matters concerning disease agents:

(a)the results of microbiological investigations, physicochemical investigations, or investigations using animals;

(b)the process of identifying the disease agents and the reasons for identifying them as the cause of the disease;

(vii)countermeasures and other measures taken by prefectural governors, etc.

Article 76(1)Written reports under Article 37, paragraph (4) of the Order are to be written reports specified in the following items according to the classification of food poisoning cases listed in those respective items:

(i)food poisoning cases which prefectural governors, etc. have reported immediately to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 58, paragraph (3) of the Act:a report on the investigation results of the food poisoning case and written details thereof;

(ii)food poisoning cases other than those listed in the preceding item:a report on the investigation results of the food poisoning case.

(2)A report on the investigation results of the food poisoning case set forth in each item of the preceding paragraph is to be prepared according to Form No. 15.

(3)A report on the investigation results of the food poisoning case set forth in each item of paragraph (1) must be submitted monthly by the 10th of the following month, by attaching all written reports of food poisoning cases set forth in each item of paragraph (1) of the preceding Article which were accepted in that month.

(4)Written details of the investigation results of the food poisoning case set forth in paragraph (1), item (i) are to be prepared by stating the matters listed in each item of paragraph (2) of the preceding Article.

(5)Written details of the investigation results of the food poisoning case set forth in paragraph (1), item (i) must be prepared and submitted immediately after receiving written details 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 77The number of persons poisoned by food, etc. specified by Order of the Ministry of Health, Labour and Welfare under Article 60 of the Act is to be 500.

Article 78The toys prescribed in Article 62, paragraph (1) of the Act are as follows:

(i)toys made of paper, wood, bamboo, rubber, leather, celluloid, synthetic resins, metals, or ceramics, which are used by infants mainly by putting them in their mouth;

(ii)ground cherries;

(iii)transfer pictures, origami, and building blocks;

(iv)the following toys made of rubber, synthetic resins, or metals:

Okiagari (daruma doll made so as to right itself when knocked over), masks, rattles, toy phones, toy animals, dolls, clay, toy vehicles (excluding those clockwork-driven and electrically-driven), balloons, blocks, balls, and toys for playing house.

Article 79(1)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 70, paragraph (1) of the Act and Article 41, paragraph (1) of the Order; provided, however, that this does not prevent the Minister of Health, Labour and Welfare from personally exercising the authority listed in item (vi) (limited to the authority pertaining to Article 18 of the Order (including as applied mutatis mutandis pursuant to Article 9, paragraph (2) of the Order)):

(i)the authority prescribed in Article 41 of the Act;

(ii)the authority prescribed in Article 42 of the Act;

(iii)the authority prescribed in Article 46, paragraph (2) of the Act;

(iv)the authority prescribed in Article 47, paragraph (1) of the Act;

(v)the authority prescribed in Article 48, paragraph (6), item (iii) of the Act;

(vi)the authority prescribed in Articles 15 through 19 of the Order (including as applied mutatis mutandis pursuant to Article 9, paragraph (2) of the Order);

(vii)the authority prescribed in Article 28 of the Order;

(viii)the authority prescribed in Article 29 of the Order;

(ix)the authority prescribed in Article 32 of the Order;

(x)the authority prescribed in Article 33 of the Order.

(2)The authority listed in items (v) and (vi) of the preceding paragraph is delegated to the head of the Regional Branch of Health and Welfare, pursuant to the provisions of Article 70, paragraph (2) of the Act and Article 41, paragraph (2) of the Order; provided, however, that this does not prevent the Director-Generals of the Regional Bureaus of Health and Welfare from personally exercising the authority.

Appended Table 1 (Re: Art. 12 and Art. 21)

1. Zinc Salts (limited to Zinc Gluconate and Zinc Sulfate)

2. Sodium Chlorite

3. Nitrous Oxide

4. Adipic Acid

5. Sodium Nitrite

6. L-Ascorbic Acid (Vitamin C)

7. L-Ascorbic Acid 2-Glucoside

8. L-Ascorbic Stearate (Vitamin C Stearate)

9. Sodium L-Ascorbate (Vitamin C Sodium)

10. L-Ascorbyl Palminate (Vitamin C Palminate)

11. Monosodium L-Aspartate

12. Aspartame (L-alpha-Aspartyl-L-Phenylalanine-Methyl Ester)

13. Acesulfame Potassium (Acesulfame K)

14. Acetaldehyde

15. Ethyl Acetoacetate

16. Acetophenone

17. Acetone

18. Anisaldehyde (p-Methoxybenzaldehyde)

19. Amylalcohol

20. alpha-Amylcinnamaldehyde (alpha-Amylcinnamic Aldehyde)

21. DL-Alanine

22. Sodium Sulfite (Disodium Sulfite)

23. L-Arginine L-Glutamate

24. Ammonium Alginate

25. Potassium Alginate

26. Calcium Alginate

27. Sodium Alginate

28. Propylene Glycol Alginate

29. Benzoic Acid

30. Sodium Benzoate

31. Methyl Anthranilate

32. Ammonia

33. Ionone

34. Ion Exchange Resin

35. Isoamylalcohol

36. Isoeugenol

37. Isoamyl Isovalerate

38. Ethyl Isovalerate

39. Isothiocyanate (excluding substances generally accepted as highly toxic)

40. Allyl Isothiocyanate (Volatile Oil of Mustard)

41. Isobutanol

42. Isopropanol

43. L-Isoleucine

44. Disodium 5' -Inosinate (Sodium 5' -Inosinate)

45. Imazalil

46. Indole and derivatives thereof

47. Disodium 5' -Uridilate (Sodium 5' -Uridilate)

48. gamma-Undecalactone (Undecalactone)

49. Ester Gum

50. Esters

51. Mixture of 2-Ethyl-3, 5-Dimethylpyrazine and 2-Ethyl-3, 6-Dimethylpyrazine

52. Ethylvanillin

53. 2-Ethyl-3-Methylpyrazine

54. Calcium Disodium Ethylenediaminetetraacetate (Calcium Disodium EDTA)

55. Disodium Ethylenediaminetetraacetate (Disodium EDTA)

56. Ethers

57. Erythorbic Acid (Isoascorbic Acid)

58. Sodium Erythorbate (Sodium Isoascorbate)

59. Ergocalciferol (Vitamin D2)

60. Ammonium Chloride

61. Potassium Chloride

62. Calcium Chloride

63. Ferric Chloride

64. Magnesium Chloride

65. Hydrochloric Acid

66. Eugenol

67. Octanal (Octyl Aldehyde, Caprylic Aldehyde)

68. Ethyl Octanoate (Ethyl Capryate)

69. o-Phenylphenol and Sodium o-Phenylphenate

70. Sodium Oleate

71. Hydrogen Peroxide

72. Benzoyl Peroxide

73. Sodium Caseinate

74. Ammonium Persulfate

75. Calcium Carboxymethylcellulose (Calcium Cellulose Glycolate)

76. Sodium Carboxymethylcellulose (Sodium Cellulose Glycolate)

77. beta-Carotene

78. Isoamyl Formate

79. Geranyl Formate

80. Citrinellyl Formate

81. Xylitol

82. Disodium 5' -Guanylate (Disodium Guanosine 5'-Monophosphate)

83. Citric Acid

84. Isopropyl Citrate

85. Potassium Dihydrogen Citrate, Tripotassium Citrate

86. Calcium Citrate

87. Sodium Ferrous Citrate

88. Ferric Citrate

89. Ferric Ammonium Citrate

90. Trisodium Citrate

91. Glycine

92. Glycerol (Glycerine)

93. Glycerol Esters of Fatty Acids

94. Calcium Glycerophosphate

95. Disodium Glycyrrhizinate

96. Glucono-delta-Lactone (Gluconolactone)

97. Gluconic Acid

98. Potassium Gluconate

99. Calcium Gluconate

100. Ferrous Gluconate (Iron (II) Di-D-Gluconate Dihydrate)

101. Sodium Gluconate

102. L-Glutamic Acid

103. Monopotassium L-Glutamate

104. Monocalcium Di- L-Glutamate

105. Monosodium L-Glutamate

106. Monomagnesium Di- L-Glutamate

107. Cinnamic Acid

108. Ethyl Cinnamate

109. Methyl Cinnamate

110. Ketone

111. Geraniol

112. High-Test Hypochlorite

113. Succinic Acid

114. Monosodium Succinate

115. Disodium Succinate

116. Cholecalciferol (Vitamin D3)

117. Sodium Chondroitin Sulfate

118. Isoamyl Acetate

119. Ethyl Acetate

120. Geranyl Acetate

121. Cyclohexyl Acetate

122. Citronellyl Acetate

123. Cinnamyl Acetate

124. Terpinyl Acetate

125. Sodium Acetate

126. Polyvinyl Acetate

127. Phenethyl Acetate (2-Phenethyl Acetate)

128. Butyl Acetate

129. Benzyl Acetate

130. l-Menthyl Acetate (p-Menthan-3-yl Acetate)

131. Linalyl Acetate

132. Saccharin

133. Sodium Saccharin (Soluble Saccharin)

134. Methyl Salicylate

135. Magnesium Oxide

136. Iron Sesquioxide (Anhydrous Ferric Oxide or Anhydrous iron (III) Oxide)

137. Hypochlorous acid water

138. Sodium Hypochlorite

139. Sodium Hydrosulfite

140. Allyl Cyclohexylpropionate

141. L-Cysteine Monohydrochloride

142. Disodium 5' -Cytidylate

143. Cytral

144. Cytronellal

145. Cytronellol

146. 1, 8-Cineole (Eucalyptol)

147. Diphenyl (Phenylbenzene)

148. Butylated Hydroxytoluene

149. Dibenzoyl Thiamine

150. Dibenzoyl Thiamine Hydrochloride

151. Fatty Acids

152. Aliphatic Higher Alcohols

153. Aliphatic Higher Aldehydes (excluding substances generally accepted as highly toxic)

154. Aliphatic Higher Hydrocarbons (excluding substances generally accepted as highly toxic)

155. Oxalic Acid

156. Potassium Bromate

157. DL-Tartaric Acid (2, 3-Dihydroxysuccinic Acid)

158. L- Tartaric Acid (2, 3-Dihydroxybutanedioic Acid)

159. Potassium DL-Bitartrate

160. Potassium L-Bitartrate

161. Disodium DL-Tartrate (Sodium dl-Tartrate)

162. Disodium L-Tartrate (Sodium Dextro-tartrate)

163. Potassium Nitrate

164. Sodium Nitrate

165. Food Red No. 2 (Amaranth) and Food Red No. 2 Aluminium Lake

166. Food Red No. 3 (Erythrosine) and Food Red No. 3 Aluminium Lake

167. Food Red No. 40 (Allura Red AC) and Food Red No. 40 Aluminium Lake

168. Food Red No. 102 (New Coccine)

169. Food Red No. 104 (Phloxine)

170. Food Red No. 105 (Rose Bengal)

171. Food Red No. 106 (Acid Red 52, C.I. 45100)

172. Food Yellow No. 4 (Tartrazine) and Food Yellow No. 4 Aluminium Lake

173. Food Yellow No. 5 (Sunset Yellow FCF) and Food Yellow No. 5 Aluminium Lake

174. Food Green No. 3 (Fast Green FCF) and Food Green No. 3 Aluminium Lake

175. Food Blue No. 1 (Brilliant Blue FCF) and Food Blue No. 1 Aluminium Lake

176. Food Blue No. 2 (Indigo Carmine) and Food Blue No. 2 Aluminium Lake

177. Sucrose Esters of Fatty Acids

178. Silicone Resin (Polydimethylsiloxane)

179. Cinnamyl Alcohol (Cinnamic Alcohol)

180. Cinnamaldehyde (Cinnamic Aldehyde)

181. Potassium Hydroxide (Potassium Hydrate)

182. Calcium Hydroxide (Slaked Lime)

183. Sodium Hydroxide (Sodium Hydrate)

184. Sucralose (4, 1' , 6' -Trichlorogalactosucrose)

185. Calcium Stearate

186. Magnesium Stearate

187. Calcium Stearoyl Lactylate (Calcium Stearoyl Lactate)

188. Sorbitan Esters of Fatty Acids

189. D-Sorbitol (Sorbit)

190. Sorbic Acid

191. Potassium Sorbate

192. Ammonium Carbonate

193. Potassium Carbonate, Anhydrous

194. Calcium Carbonate

195. Ammonium Bicarbonate (Ammonium Bicarbonate)

196. Sodium Bicarbonate (Sodium Acid Carbonate, Baking Soda or Sodium Bicarbonate)

197. Sodium Carbonate (crystal: Carbonate of Soda, anhydrous; Soda Ash)

198. Magnesium Carbonate

199. Tiabendazole

200. Thiamine Hydrochloride (Vitamin B1 Hydrochloride)

201. Thiamine Mononitrate (Vitamin B1 Mononitrate)

202. Thiamine Dicetylsulfate (Vitamin B1 Dicetylsulfate)

203. Thiamine Thiocyanate (Vitamin B1 Rodanate)

204. Thiamine Naphthalene-1, 5-Disulfonate (Thiamine Naphthalene-1, 5-Disulfonate or Vitamin B1-1, 5-Disulfonate)

205. Thiamine Dilaurylsulfate (Vitamin B1 Dilaurylsulfate)

206. Thioethers (excluding substances generally accepted as highly toxic)

207. Thiols (Thioalcohols) (excluding substances generally accepted as highly toxic)

208. L-Theanine

209. Decanal (Decyl Aldehyde)

210. Decanol (Decyl Alcohol)

211. Ethyl Decanoate (Ethyl Caprate)

212. Sodium Iron Chlorophyllin

213. 2, 3, 5,6-Tetramethylpyrazine

214. Sodium Dehydroacetate

215. Terpineol

216. Terpene Hydrocarbon

217. Sodium Carboxymetylstarch

218. Sodium Starch Phosphate

219. Copper Salts (limited to Copper Gluconate and Copric Sulfate)

220. Sodium Copper Chlorophyllin

221. Copper Chlorophyll

222. dl-alpha-Tocopherol

223. all-rac-alpha-Tocopheryl Acetate

224. d-alpha-Tocopheryl Acetate

225. DL-Tryptophan

226. L-Tryptophan

227. 2, 3, 5-Trimethylpyrazine

228. DL-Threonine (DL-Threonine)

229. L-Threonine

230. Natamycin (Pimaricin)

231. Sodium Methoxide (Sodium Methylate)

232. Nicotinic Acid (Niacin)

233. Nicotinamide (Niacinamide)

234. Sulfur Dioxide

235. Chlorine Dioxide

236. Silicon Dioxide

237. Carbon Dioxide

238. Titanium Dioxide

239. Lactic Acid

240. Calcium Lactate

241. Iron Lactate

242. Sodium Lactate

243. gamma-Nonalactone (4-Nonanolide)

244. Potassium Norbixin

245. Sodium Norbixin

246. Vanillin

247. Isobutyl p-Hydroxybenzoate

248. Isopropyl p-Hydroxybenzoate

249. Isopropyl p-Hydroxybenzoate

250. Butyl p-Hydroxybenzoate

251. Propyl p-Hydroxybenzoate

252. p-Methylacetophenone

253. L-Valine

254. Calcium Pantothenater

255. Sodium Pantothenate

256. Biotin

257. L-Histidine Monohydrochloride

258. Bisbentiamine

259. Vitamin A (Retinol)

260. Vitamin A Fatty Acid Ester

261. Hydroxycitronellal

262. Hydroxycitronellal Dimethyl Acetal

263. Hydroxypropyl Cellulose

264. Hydroxypropylmethyl Cellulose

265. Piperonal (Heliotropin)

266. Piperonyl Butoxide (Piperonyl Butoxide)

267. Glacial Acetic Acid

268. Pyridoxine Hydrochloride (Vitamin B6)

269. Potassium Pyrosulfite (Potassium Pentaoxodisulfate or Potassium Metabisulfite)

270. Disodium Pyrosulfite (Disodium Pentaoxadissulfite, Sodium Metabisulfite or Sodium Disulfite)

271. Potassium Pyrophosphate

272. Calcium Dihydrogen Pyrophosphate (Acid Calcium Pyrophosphate)

273. Disodium Dihydrogen Pyrophosphate (Acid Sodium Pyrophosphate)

274. Ferric Pyrophosphate

275. Sodium Pyrophosphate

276. L-Phenylalanine

277. Isoamyl Phenylacetate

278. Isobutyl Phenylacetate

279. Ethyl Phenylacetate

280. Phenol Ethers (excluding substances generally accepted as highly toxic)

281. Phenols (excluding substances generally accepted as highly toxic)

282. Ferrocyanides (limited to Potassium Ferrocyanide (Potassium Hexacyanoferrate (II)), Calcium Ferrocyanide (Calcium Hexacyanoferrate (II)) and Sodium Ferrocyanide (Sodium Hexacyanoferrate (II)))

283. Butanol

284. Butylated Hydroxyanisole

285. Fumaric Acid

286. Monosodium Fumarate (Sodium Fumarate)

287. Furfural and derivatives thereof (excluding substances generally accepted as highly toxic)

288. Propanol

289. Propionic Acid

290. Isoamyl Propionate

291. Ethyl Propionate

292. Calcium Propionate

293. Sodium Propionate

294. Benxyl Propionate

295. Propylene Glycol

296. Propylene Glycol Esters of Fatty Acids

297. Hexanoic Acid (Caproic Acid)

298. Allyl Hexanoate (Allyl Caproate)

299. Ethyl Hexanoate (Ethyl Caproate)

300. Ethyl Heptanoate (Ethyl Oenanthate)

301. l-Perillaldehyde

302. Benzyl Alcohol

303. Benzaldehyde

304. Aromatic Alcohols

305. Aromatic Aldehydes (excluding substances generally accepted as highly toxic)

306. Propyl Gallate

307. Sodium Polyacrylate

308. Polyisobutylene (Butyl Rubber)

309. Polyvinylpolypyrrolidone

310. Polybutene (Polybutylene)

311. Potassium Polyphosphate

312. Sodium Polyphosphate

313. d-Borneol

314. Maltol

315. D- Mannitol (D-Mannite)

316. Potassium Metaphosphate

317. Sodium Metaphosphate

318. DL-Methionine

319. L-Methionine

320. Methyl N-Methylanthranilate

321. 5-Methylquinoxaline

322. Methylcellulose

323. Methyl beta-Naphthyl Ketone

324. Methyl Hesperidin (Soluble Vitamin P)

325. dl-Menthol

326. l-Menthol

327. Morpholine Salts of Fatty Acids

328. Folic Acid

329. Butyric Acid

330. Isoamyl Butyrate

331. Ethyl Butyrate

332. Cyclohexyl Butyrate

333. Butyl Butyrate

334. Lactones (excluding substances generally accepted as highly toxic)

335. L-Lysine L-Aspartate

336. L-Lysine Monohydrochloride

337. L-Lysine L-Glutamate

338. Linalool

339. Calcium 5' -Ribonucleotide

340. Disodium 5' -Ribonucleotide (Sodium 5' -Ribo-nucleotide)

341. Riboflavin (Vitamin B2)

342. Riboflavin Tetrabutyrate (Vitamin B2 Tetrabutyrate)

343. Riboflavin 5' -Phosphate Sodium (Sodium Riboflavin Phosphate, Sodium Vitamin B2 Phosphate)

344. Sulfuric Acid

345. Aluminium Ammonium Sulfate (crystal: Ammonium Alum, exsiccated: Ammonium Alum, Exsiccated)

346. Aluminium Potassium Sulfate (crystal: Alum, Potassium Alum, exsiccated: Alum, Exsiccated)

347. Ammonium Sulfate

348. Calcium Sulfate

349. Ferrous Sulfate

350. Sodium Sulfate

351. Magnesium Sulfate

352. DL-Malic Acid (dl-Malic Acid)

353. Sodium DL-Malate (Sodium dl-Malate)

354. Phosphoric Acid

355. Tripotassium Phosphate (Tripotassium Monophosphate)

356. Tricalcium Phosphate (Calcium Phosphate Tribasic)

357. Trimagnesium Phosphate (Magnesium Phosphate, Tribasic)

358. Diammonium Hydrogen Phosphate (Diammonium Hydrogen Tetraoxophosphate)

359. Ammonium Dihydrogen Phosphate (Ammonium Dihydrogen Tetraoxophosphate)

360. Dipotassium Hydrogen Phosphate (Dipotassium Hydrogen Monophosphate)

361. Potassium Dihydrogen Phosphate (Monopotassium Dihydrogen Monophosphate)

362. Calcium Hydrogen Phosphate (Secondary Calcium Phosphate)

363. Calcium Dihydrogen Phosphate (Monocalcium Phosphate)

364. Disodium Hydrogen Phosphate (Disodium Hydrogen Monophosphate)

365. Sodium Dihydrogen Phosphate (Monosodium Dihydrogen Monophosphate)

366. Trisodium Phosphate (Trisodium Monophosphate)

Appended Table 2 (Re: Article 13)

Category of food	Substances which may cause food sanitation hazards
Carbonated drinks	1. Foreign contaminants
	2. Yersinia enterocolitica
	3. Staphylococcus aureus
	4. Campylobacter jejuni
	5. Campylobacter coli
	6. Clostridium genus
	7. Antimicrobial substances (limited to chemically synthesized compounds (meaning substances obtained by causing a chemical reaction other than a degradation reaction to elements or compounds by chemical means; the same applies hereinafter) contained in milk, etc. used as raw materials (meaning milk, etc. specified by Ministerial Order concerning the ingredient standards for milk and dairy products; hereinafter the same applies in this table) or in processed products thereof)
	8. Antibiotics
	9. Bactericides
	10. Salmonellae genus
	11. Heavy metals and compounds thereof (limited to heavy metals and compounds thereof for which standards have been established with regard to food ingredients pursuant to the provisions of Article 11, paragraph (1) of the Act and which are contained in raw materials; hereinafter the same applies in this table)
	12. Bacillus cereus
	13. Detergents
	14. Food additives (limited to food additives for which standards have been established with regard to usage pursuant to the provisions of Article 11, paragraph (1) of the Act and excluding bactericides; hereinafter the same applies in this table)
	15. Substances which are ingredients of anti-parasite medicine (including those chemically generated from such substances, excluding those specified as clearly having no risk to human health pursuant to the provisions of Article 11, paragraph (3) of the Act, and limited to those contained in raw materials; hereinafter the same applies in this table)
	16. Substances which are ingredients of agricultural chemicals (including those chemically generated from such substances, excluding those specified as clearly having no risk to human health pursuant to the provisions of Article 11, paragraph (3) of the Act, and limited to those contained in raw materials; hereinafter the same applies in this table)
	17. Enteropathogenic Escherichia coli
	18. Putrefactive microbe (bacteria)
	19. Listeria monocytogenes
Processed meat products	1. Aflatoxin (limited to aflatoxin contained in spices used as raw materials; hereinafter the same applies in this table)
	2. Foreign contaminants
	3. Staphylococcus aureus
	4. Campylobacter jejuni
	5. Campylobacter coli
	6. Clostridium genes
	7. Antimicrobial substances (limited to chemically synthesized compounds contained in milk, etc., meat, poultry eggs or fish and seafood used as raw materials or in processed products thereof; hereinafter the same applies in this table)
	8. Antibiotics
	9. Bactericides
	10. Salmonellae genus
	11. Bacillus cereus
	12. Detergents
	13. Trichina worm
	14. Vibrio parahaemolyticus (limited to vibrio parahaemolyticus contained in fish and seafood or whale meat used as raw materials or in processed products thereof)
	15. Food additives
	16. Substances which are ingredients of anti-parasite medicine
	17. Enteropathogenic Escherichia coli
	18. Putrefactive microbe (bacteria)
	19. Substances which are ingredients of hormones (including those chemically generated from such substances, excluding those specified as clearly having no risk to human health pursuant to the provisions of Article 11, paragraph (3) of the Act, and limited to those contained in raw materials; hereinafter the same applies in this table)
Fish jelly products	1. Anisaks
	2. Aflatoxin
	3. Foreign contaminants
	4. Staphylococcus aureus
	5. Clostridium genus
	6. Bactericides
	7. Salmonellae genus
	8. Pseudoterranova
	9. Bacillus cereus
	10. Detergents
	11. Diplogonoporous grandis
	12. Vibrio parahaemolyticus
	13. Foods additives
	14. Histamine (limited to histamine contained in fish and seafood used as raw materials or in processed products thereof; hereinafter the same applies in this table)
	15. Enteropathogenic Escherichia coli
	16. Putrefactive microbe (bacteria)
Retort pouch food	1. Aflatoxin
	2. Foreign contaminants
	3. Staphylococcus aureus
	4. Clostridium genus
	5. Diarrheal and paralytic shellfish poison (limited to diarrheal and paralytic shellfish poison contained in shellfish used as raw materials or in processed products thereof)
	6. Antimicrobial substances
	7. Antibiotics
	8. Bactericides
	9. Heavy metals and compounds thereof
	10. Bacillus cereus
	11. Detergents
	12. Food additives
	13. Substances which are ingredients of anti-parasite medicine
	14. Substances which are ingredients of agricultural chemicals
	15. Histamine
	16. Putrefactive microbes (bacteria)
	17. Substances which are ingredients of hormones

Appended Table 3 (Re: Article 21)

1. Margarine

2. Alcoholic liquor (meaning alcoholic liquor which contains 1% or more alcohol by volume (including drinking products in powder form which contain 1% or more alcohol by volume when dissolved))

3. Carbonated drinks

4. Processed meat products

5. Fish meat ham, fish meat sausage, whale meat bacon, and the like

6. Pulses which contain cyanide compounds

7. Frozen food (meaning produced or processed food (excluding carbonated drinks, processed meat products, whale meat products, fish jelly products, boiled octopus and boiled crabs) and cut or shelled fresh fish and seafood (excluding raw oysters) which are frozen and packed in containers and packaging.)

8. Irradiated food

9. Retort pouch food

10. Poultry eggs

11. Food packed in containers and packaging (excluding those listed in the preceding items) which are listed below:

(a) Processed meat, raw oysters, fresh noodles (including boiled noodles), instant noodles, ready-made lunches, prepared bread, daily dish, fish jelly products, moist confectioneries, cut or shelled fresh fish and seafood (excluding raw oysters) (excluding those frozen), and boiled crabs.

(b) Processed food other than those listed in (a)

12. Food of farm products listed in the left-hand column of the Appended Table 7, and processed food made from the food (including any food made from the processed food)

13. Food for special dietary use

14. Food additives

Appended Table 4 (Re: Article 21)

Isothocyanates

Indole and Derivatives thereof

Ethers

Esters

Ketones

Fatty Acids

Aliphatic Higher Alcohols

Aliphatic Higher Aldehydes

Aliphatic Higher Hydrocarbons

Thioeters

Thiols

Terpene Hydrocarbons

Phenol Ethers

Phenols

Furfural and Derivatives thereof

Aromatic Alcohols

Aromatic Aldehydes

Lactones

Appended Table 5 (Re: Article 21)

1	Sweetener	Sweetener, artificial sweetener, or synthetic sweeteners
2	Food color	Food coloring or artificial coloring
3	Preservative	Preservative or artificial preservative
4	Thickening agent, stabilizer, gelling agent or thickener	Thickening agent or thickener, where the substance is used mainly for thickening
		Stabilizer or thickener, where the substance is used mainly for stabilizing
		Gelling agent or thickener, where the substance is used mainly for gelling
5	Antioxidant	Antioxidant
6	Color fixative	Color fixative
7	Bleaching agent	Bleaching agent
8	Antimold agent	Antimold agent

Appended Table 6 (Re: Article 21)

Wheat

Buckwheat

Eggs

Milk

Peanuts

Appended Table 7 (Re: Article 21)

Farm products	Processed Food
Soybeans (including immature soybeans and bean sprout)	1. Tofu (soybean curd) and Aburaage (fried soybean curd)
	2. Kooridofu (frozen soybean curd), Okara (dried Tofu refuse) and Yuba (dried soybean milk membrane)
	3. Natto (fermented soybeans)
	4. Soybean milk
	5. Miso (fermented soybean paste)
	6. Soybean Nimame (cooked soybeans)
	7. Canned soybeans and bottled soybeans
	8. Kinako (roasted soybean flour)
	9. Roasted soybeans
	10. Food made mainly from ingredients listed in item 1 through item 9
	11. Food made mainly from soybean for cooking
	12. Food made mainly from soybean flour
	13. Food made mainly from soybean protein
	14. Food made mainly from immature soybean
	15. Food made mainly from soybean sprouts
Corn	1. Corn snack confectionery
	2. Corn starch
	3. Popcorn
	4. Frozen corn
	5. Canned corn and bottled corn
	6. Food made mainly from corn flour
	7. Food made mainly from corn grits (excluding corn flakes)
	8. Food made mainly from corn for cooking
	9. Food made mainly from ingredients listed in item 1 through item 5
Potato	1. Potato snack confectionery
	2. Dried potato
	3. Frozen potato
	4. Potato starch
	5. Food made mainly from potato for cooking
	6. Food made mainly from ingredients listed in item 1 through item 4
Rapeseed
Cottonseed
Alfalfa	Food made mainly from alfalfa
Sugar beet	Food made mainly from sugar beet for cooking

Appended Table 8 (Re: Article 21)

Yeast food	Yeast food
Gum base	Gum base
Kansui (Alkaline preparations for Chinese noodles)	Kansui
Enzyme	Enzyme
Glazing agent	Glazing agent
Flavoring agent	Flavoring agent or synthetic flavoring agent
Acidifier	Acidifier
Softener for chewing gum	Softener
Seasoning (excluding seasoning falling under sweeteners or acidifiers)	Seasoning (Amino acid), where the substance is composed exclusively of amino acids
	Seasoning (Amino acid, etc.), where the substance is composed mainly of amino acids (excluding the case where the substance is composed exclusively of amino acids)
	Seasoning (Nucleic acid), where the substance is composed exclusively of nucleic acids
	Seasoning (Nucleic acid, etc.), where the substance is composed mainly of nucleic acid (excluding the case where the substance is composed exclusively of nucleic acid)
	Seasoning (Organic acids), where the substance is composed exclusively of organic acids
	Seasoning (Organic acids, etc.), where the substance is composed mainly of organic acids (excluding the case where the substance is composed exclusively of organic acids)
	Seasoning (Inorganic salts), where the substance is composed exclusively of inorganic salts
	Seasoning (Inorganic salts, etc.), where the substance is composed mainly of inorganic salts (excluding the case where the substance is composed exclusively of inorganic salts)
Coagulant for Tofu (soybean curd)	Coagulant for Tofu or coagulant
Bittering agent	Bittering agent
Emulsifier	Emulsifier
Acidity regulator	Acidity regulator
Raising agent	Raising agent, baking powder, or baking soda

Appended Table 9 (Re: Article 21)

Raw fruit juice (limited to products contained in cans with a capacity of 200 liters or more)	When a delivery unit consisting of 10 cans or more is sold to a person licensed for a carbonated drink producing business as prescribed in Article 35, item (xix) of the Order for Enforcement of the Food Sanitation Act
Concentrated coffee solution (limited to products contained in cans with a capacity of 20 liters or more)	When a delivery unit consisting of 20 cans or more is sold to a person licensed for a carbonated drink producing business as prescribed in Article 35, item (xix) of the Order for Enforcement of the Food Sanitation Act
Raw fish meat Surimi (limited to products contained in containers and packaging with a capacity of 20 kilograms or more)	When a delivery unit consisting of 10 or more of the containers and packaging is sold to a person licensed for a fish jelly product producing business as prescribed in Article 35, item (xvi) of the Order for Enforcement of the Food Sanitation Act or for a daily dish producing business as prescribed in Article 35, item (xxxii) of the Order for Enforcement of the Food Sanitation Act

Appended Table 10 (Re: Article 32)

Raw salt

Copra

Fat or oil of animal origin or plant origin which is used in the production of edible fat and oil

Raw sugar

Crude alcohol

Molasses

Malt

Hops

Appended Table 11 (Re: Article 32)

Places for customs clearance	Names of quarantine stations
Hokkaido	Otaru
Aomori Prefecture, Iwate Prefecture, Miyagi Prefecture, Akita Prefecture, Yamagata Prefecture, and Fukushima Prefecture	Sendai
Chiba Prefecture (limited to Narita City; Taiei-machi, Katori-gun; Tako-machi, Katori-gun; and Shibayama-machi, Sanbu-gun)	Narita Airport
Ibaraki Prefecture, Tochigi Prefecture, Gunma Prefecture, Saitama Prefecture, Chiba Prefecture (excluding areas under the jurisdiction of the Narita Airport Quarantine Station), Metropolis of Tokyo, Kanagawa Prefecture (limited to Kawasaki City), Yamanashi Prefecture, and Nagano Prefecture	Tokyo
Kanagawa Prefecture (excluding areas under the jurisdiction of the Tokyo Quarantine Station)	Yokohama
Niigata Prefecture	Niigata
Shizuoka Prefecture, Gifu Prefecture, Aichi Prefecture, Mie Prefecture, and Wakayama Prefecture (limited to Singu City and Higashimuro-gun)	Nagoya
Toyama Prefecture, Ishikawa Prefecture, Fukui Prefecture, Shiga Prefecture, Kyoto Prefecture, Osaka Prefecture (excluding areas under the jurisdiction of the Kansai Airport Quarantine Station), Nara Prefecture, and Wakayama Prefecture (excluding areas under the jurisdiction of the Nagoya Quarantine Station)	Osaka
Osaka Prefecture (limited to the Kansai International Airport)	Kansai Airport
Hyogo Prefecture, Okayama Prefecture, Tokushima Prefecture, and Kagawa Prefecture	Kobe
Tottori Prefecture, Shimane Prefecture, Hiroshima Prefecture, Ehime Prefecture, and Kochi Prefecture	Hiroshima
Yamaguchi Prefecture, Fukuoka Prefecture, Saga Prefecture, Nagasaki Prefecture, Kumamoto Prefecture, Oita Prefecture, Miyazaki Prefecture, and Kagoshima Prefecture	Fukuoka
Okinawa Prefecture	Naha

Appended Table 12 (Re: Article 32)

1	Machines used for the production of foods	Three years from the date of the submission of an import notification
	Apparatus or containers and packaging made of aluminum
	Apparatus or containers and packaging made of stainless steel
	Apparatus or containers and packaging made of colorless glass
2	Alphanized rice	One year from the date of the submission of an import notification
	Ethyl alcohol
	Barley
	Canned food or bottled food (excluding processed meat products or wine)
	Original alcohol not bottled for retail sale (excluding original wine)
	Kaoliang
	Sesame
	Wheat
	Rice
	Safflower seeds
	Distilled alcohol
	Food (excluding processed meat products) which are packed and sealed in tight containers and packaging and are sterilized by autoclaving and heating (excluding canned food and bottled food)
	Vegetable protein
	Buckwheat
	Soybean
	Starch (excluding tapioca starch)
	Animal fat and oil (excluding fish and marine mammal fat and oil)
	Rapeseed
	Sunflower seeds
	Indian millet
	Rye
	Apparatus or containers and packaging made of materials other than aluminum, stainless steel, colorless glass, or synthetic resins
3	The following food, additives, apparatus, or containers and packaging which had been continuously imported before the submission of an import notification stating the import plans prescribed in Article 32, paragraph (4) and which had never fallen under any of the items of the same paragraph for three years prior to the submission of the notification	One year from the date of the submission of an import notification
	An (sweetened bean jam)
	Fruits and fruit peel temporarily stored
	Roasted coffee beans or ground roasted coffee beans
	Locusts boiled in water
	Fish roes (limited to dried roes)
	Fish Tsukudani (preservable food boiled down in soy sauce)
	Fish or marine mammal fat and oil
	Oatmeal
	Seaweeds
	Cacao beans (excluding roasted ones)
	Original wine
	Frozen food which requires heating prior to consumption
	Gymnema tea
	Raw fruit juice
	Flours of cereals, beans, or potatoes
	Cocoa products (excluding powdered carbonated drinks)
	Coffee extract
	Coffee beans (excluding roasted ones)
	Corn flakes
	Konnyaku (taro jelly)
	Salt
	Vegetable creaming powders
	Vegetable fat and oil
	Shortening
	Sake (rice wine)
	Tea
	Chocolate
	Sugar
	Tochu tea
	Nimame (cooked beans)

Appended Table 13 (Re: Article 37 and Article 40)

Type of standard operation manuals to be prepared	Matters to be entered
Standard operation manual for maintenance of machinery and tools	1. The names of the machinery and tools
	2. Methods for routine maintenance (including calibration of gauges)
	3. A plan for regular maintenance
	4. Measures to be taken if a breakdown occurs (including how to handle test samples if a breakdown occurs during testing)
	5. Methods for keeping records concerning maintenance of machinery and tools
	6. Dates for preparing and revising the standard operation manual
Standard operation manual for management of reagents, etc.	1. Methods for labeling the containers used for reagents, test solutions, culture media, reference standards, standard solutions, and standard microorganism strains (hereinafter referred to as "reagents, etc.")
	2. Notes concerning the management of reagents, etc.
	3. Methods for keeping records concerning the management of reagents, etc.
	4. Dates for preparing and revising the standard operation manual
Standard operation manual for animal husbandry management	1. Methods for managing animal rooms
	2. Notes when receiving animals
	3. Methods for animal husbandry
	4. Methods for observation of animal health conditions
	5. Methods for handling animals that have or are suspected to have diseases
	6. Methods for keeping records concerning animal husbandry
	7. Dates for preparing and revising the standard operation manual
Standard operation manual for handling of test samples	1. Notes when collecting, transporting, and receiving test samples
	2. Methods for managing test samples
	3. Methods for keeping records concerning the management of test samples
	4. Dates for preparing and revising the standard operation manual
Standard operation manual for the implementation of inspections	1. Items for inspections, etc.
	2. Name of the product
	3. Methods for conducting inspections, etc.
	4. Methods for selecting and preparing reagents
	5. Methods for handling standard microbe strains for bacteriological inspections
	6. Methods for preparing samples
	7. Methods for operating machinery and tools used for inspections, etc.
	8. Notes when conducting inspections, etc.
	9. Methods for processing data obtained by inspections, etc.
	10. Methods for keeping records concerning inspections, etc.
	11. Dates for preparing and revising the standard operation manual
Remarks 1. The standard operation manual for animal husbandry management is to be prepared only by a person who conducts inspections using animals.
2. The standard operation manual for the implementation of inspections is to be prepared for the respective items of inspections, etc.

Appended Table 14 (Re: Article 50)

Curriculum	Subjects
Chemistry	Analytical chemistry, Organic chemistry, Inorganic chemistry
Biological chemistry	Biological chemistry, Food chemistry, Physiology, Food analysis, Toxicology
Microbiology	Microbiology, Food microbiology, Food preservation, Food production
Public health	Public health, Food hygiene, Environmental hygiene, Health administration, Epidemiology

Appended Table 15 (Re: Article 50)

Fish chemistry, Livestock chemistry, Radiation chemistry, Dairy chemistry, Meat chemistry, Polymer chemistry, Biological organic chemistry, Analysis of environmental pollution substances, Enzyme chemistry, Physical and chemical study of food, Fishery physiology, Livestock physiology, Plant physiology, Environmental biology, Applied microbiology, Dairy microbiology, Pathology, Outline of medical science, Anatomy, Medical chemistry, Industrial medical science, Blood science, Serology, Genetics, Parasite science, Veterinary medicine, Nutritional chemistry, Health statistics, Nutritional science, Environmental health, Health supervision, Fishery production, Production of livestock products, Production of agricultural products, Production of brewery products and seasoning products, Production of dairy products, Production of distilled wine, Canned product engineering, Food engineering, Food preservation, Freezing and cold storage, Quality control, and other subjects related to food sanitation

Appended Table 16 (Re: Article 56)

	Classification	Subjects	Hours
1	General common subjects	1. Overview of public health	9
		2. Food Sanitation Act and related laws and regulations	18
		3. Standards and criteria for food and food additives, etc.	18
		4. Introduction to chemistry	18
		5. Introduction to bacteriology	18
		6. Toxicology	9
		7. Food poisoning basics	15
		8. Food science (including nutritional science)	18
		9. Sanitation management in facilities	9
2	Subjects related to dairy products	1. Standards and criteria for dairy products	12
		2. Practical training on bacteriology	18
		3. Inspection methods for dairy products	6
		4. Practical training on dairy product inspections	18
		5. Visits to facilities and on-site training	15
3	Subjects related to processed meat products	1. Standards and criteria for processed meat products	12
		2. Practical training on bacteriology	18
		3. Inspection methods for processed meat products	6
		4. Practical training on processed meat product inspections	18
		5. Visits to facilities and on-site training	15
4	Subjects related to fish meat ham and fish meat sausage	1. Related laws and regulations and standards and criteria concerning fish meat ham and fish meat sausage	15
		2. Practical training on bacteriology	18
		3. Inspection methods for fish meat ham and fish meat sausage	9
		4. Practical training on fish meat ham and fish meat sausage inspections	15
		5. Visits to facilities and on-site training	15
5	Subjects related to edible fat and oil	1. Overview of fat and oil chemistry	10
		2. Utilization criteria for food and food additives	14
		3. Duties of food sanitation supervisors	4
		4. Responsibilities of food sanitation supervisors	3
		5. Theory of and practical training on inspection methods for fat and oil	28
		6. Visits to facilities and on-site training	10
6	Subjects related to margarine and shortenings	1. Nutritional science and analytical methods	6
		2. Sanitation management in the production process	6
		3. Sanitation criteria in the production process	3
		4. Introduction to judgment method for food additives	6
		5. Practice on analytical methods	16
		6. Practical training on judgment method for food additives	15
		7. Visits to facilities and on-site training	21
7	Subjects related to food additives	1. Overview of analytical methods for food additives	9
		2. Introduction to judgment method for food additives	9
		3. Practical training on judgment method for food additives	24
		4. Visits to facilities and on-site training	15

Appended Table 17 (Re: Article 73)

1. Salmonella enteritidis

2. Clostridium botulinum

3. Enterohaemorrhagic Escherichia coli

4. Yersinia enterocolitica O8

5. Campylobacter jejuni/coli

6. Vibrio cholerae

7. Shigella

8. Typhoid bacillus

9. Paratyphoid A bacillus