Article 1The purpose of this Act is to establish a system for evaluating the properties of new chemical substances before their manufacture or import and to implement necessary regulations with respect to the manufacture, import, use, etc. of chemical substances, depending on their properties, etc., in order to prevent environmental pollution caused by chemical substances that pose a risk of harming human health or interfering with the inhabitation and/or growth of flora and fauna.

Article 2(1)The term "chemical substance" as used in this Act means a chemical compound obtained by causing chemical reactions to elements or compounds (excluding a radioactive substance and the following substances):

(2)The term "class I specified chemical substance" as used in this Act means a chemical substance that falls under either of the following items and is specified by Cabinet Order:

(3)The term "class II specified chemical substance" as used in this Act means a chemical substance that is specified by Cabinet Order and falls under either of the following items and is thought to pose a risk of causing damage to human health or damage to the inhabitation and/or growth of flora and fauna in the living environment due to a considerable amount of the chemical substance remaining in the environment over a substantially extensive area or because it is likely that such a situation will arise in the near future in view of its properties and manufacture, import, use, etc.:

(4)The term "monitoring chemical substance" as used in this Act means a chemical substance (excluding a new chemical substance) that falls under either of the following items and has been designated by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment:

(5)The term " priority assessment chemical substances" as used in this Act means chemical substances for which it is not clear whether they do not fall under any of the items of paragraph (3) from the perspective of currently available knowledge on the chemical substances, which are found to remain in the environment in considerable amounts or are expected to remain in such a situation in view of the knowledge and the state of manufacture, import, etc., and which are not found to be likely neither to harm human health nor to damage the inhabitation and/or growth of flora and fauna in the human living environment through environmental pollution by the chemical substance; they are therefore designated by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment as chemical substances that are found to require priority assessment of the likelihood of the chemical substances having the above risks through the collection of information on their properties and through the clarification of the status of their use, etc.

(6)The term "new chemical substance" as used in this Act means a chemical substance other than the chemical substances listed in the following items:

(7)The term "general chemical substance" as used in this Act means a chemical substance listed in the following (excluding priority assessment chemical substances, monitoring chemical substances, class I specified chemical substances, and class II specified chemical substances):

(8)The term "specified general chemical substance" as used in this Act means a chemical substance that falls within the category of a general chemical substance and that falls under any of the following items:

(9)When the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment has designated a chemical substance as a monitoring chemical substance or priority assessment chemical substance pursuant to the provisions of paragraphs (4) or (5), they should give public notice of its name without delay.

Article 3(1)A person who intends to manufacture or import a new chemical substance shall notify the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment, in advance, of the name of the relevant new chemical substance and other matters specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment; provided, however, that this does not apply to a case that falls under any of the following items:

(2)If the total quantity of a single new chemical substance calculated by a method specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment, as having an impact on the environment, based on the planned quantity to be manufactured and planned quantity to be imported to which the confirmation under the provisions of item (v) of the preceding paragraph pertains (including the planned quantity to be manufactured and planned quantity to be imported to which the confirmation under the provisions of paragraph (4) of Article 5 pertains) relating to the single new chemical substance exceeds the quantity specified by Cabinet Order, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment shall not issue the confirmation under the relevant item.

(3)In any of the cases listed in the following items, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should rescind the confirmation set forth in item (iv) of paragraph (1):

(4)In any of the cases listed in the following items, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should rescind the confirmation under item (v) of paragraph (1):

(5)In any of the cases listed in the following items, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should rescind confirmation under item (vi) of paragraph (1):

Article 4(1)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have received a notification under paragraph (1) of the preceding Article, they should make a determination as to which of the following items the new chemical substance falls under, within three months from the date of receipt of the notification, based on the available knowledge on the composition, properties, etc., of the new chemical substance to which the relevant notification pertains, and should notify the result thereof to the person who has given the notification:

(2)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have determined that a new chemical substance to which a notification under paragraph (1) of the preceding Article pertains falls under item (vi) of the preceding paragraph, they should promptly make a determination as to which one of items (i) through (v) of the relevant paragraph the new chemical substance falls under, based on the results of tests conducted on the new chemical substance, and should notify the result thereof to the person who has given the notification.

(3)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment find it necessary in order to make a determination under the preceding paragraph, they may request the person who has given the notification under paragraph (1) of the preceding Article to submit materials stating the results of tests prescribed in paragraph (7) relating to the properties of the new chemical substance to which the relevant notification pertains and any other documents specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment.

(4)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have made a determination pursuant to the provisions of paragraphs (1) or (2), if they determine that the new chemical substance to which the notification under paragraph (1) of the preceding Article pertains falls under any of items (ii) to (iv) of paragraph (1) and also falls under any of the items of paragraph (8) of Article 2 (hereinafter referred to as a "specified new chemical substance"), they should notify the result thereof to the person who has given the notification; provided, however, that this does not apply to a specified new chemical substance that has been designated pursuant to the provisions of paragraph (5) of Article 2.

(5)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have given notice to the effect that the new chemical substance to which notification under paragraph (1) of the preceding Article pertains falls under any of items (ii) through (v) of paragraph (1), pursuant to the provisions of paragraphs (1) or (2), they should give a public notice of the name of the relevant new chemical substance, in accordance with Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment; provided, however, that this does not apply to a new chemical substance that has been designated pursuant to the provisions of paragraph (5) of Article 2.

(6)When the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have given notice pursuant to the provisions of paragraph (4), they should give public notice of the result of the determination under paragraph (4) upon giving public notice pursuant to the provisions of the preceding paragraph.

(7)The items to be tested and any other technical matters necessary for making a determination under paragraphs (1), (2), and (4) of this Article are to be specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment.

(8)In determining the order under the preceding paragraph, efforts are to be made to consider fully the international trends regarding the establishment of items to be tested relating to the evaluation of the safety of chemical substances, and other trends regarding the technical standards relating to the evaluation of the safety of chemical substances.

Article 5(1)A person who intends to give a notification under paragraph (1) of Article 3 and for whom the planned quantity to be manufactured or planned quantity to be imported of the new chemical substance to which the notification pertains during one fiscal year will be not more than the quantity specified by Cabinet Order set forth in item (i) of paragraph (4), when giving the notification, may make a request to the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment, to make a determination as to whether or not the relevant new chemical substance falls under either of the following items in the case where it falls under item (vi) of paragraph (1) of the preceding Article:

(2)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have received a request under the preceding paragraph, if they find that the new chemical substance to which the relevant request pertains falls under item (vi) of the relevant paragraph at the time of making a determination under item (i) of the preceding Article, they should, notwithstanding the provisions of the relevant paragraph, make a determination as to which of the following items the relevant new chemical substance falls under, in lieu of a determination to the effect that it falls under item (vi) of paragraph (1) of the preceding Article, based on already available knowledge on the composition, properties, etc., of the new chemical substance to which the relevant request pertains, within three months from the date of receipt of a notification under item (i) of Article 3, and should notify the result thereof to the person who has made the request under the preceding paragraph; in this case, the provisions of paragraph (2) of the relevant Article do not apply:

(3)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have determined that the new chemical substance to which a request under paragraph (1) pertains falls under item (iii) of the preceding paragraph, they should promptly make a determination as to which one of items (i) or (ii) of the relevant paragraph the relevant new chemical substance falls under, based on the results of tests conducted on the relevant new chemical substance, and should notify the result thereof to the person who has made the request.

(4)A person who has received notice to the effect that the new chemical substance to which a request made under the provisions of paragraph (2) or the preceding paragraph pertains falls under item (i) of paragraph (2) may make a request in advance, each fiscal year, to the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment and receive a confirmation to the effect that the manufacture or import of the new chemical substance to which the relevant notice pertains falls under the following items, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment:

(5)If the total quantity of a single new chemical substance calculated by a method specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment, as having an impact on the environment, based on the planned quantity to be manufactured and planned quantity to be imported to which the confirmation under the provisions of the preceding paragraph pertains (including the planned quantity to be manufactured and planned quantity to be imported to which the confirmation under the provisions of item (v) of paragraph (1) of Article 3 pertains) relating to a single new chemical substance exceeds the quantity specified by Cabinet Order, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should not issue the confirmation under the preceding paragraph.

(6)In any of the cases listed in the following items, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should rescind the confirmation set forth in paragraph (4):

(7)A person who has received notice to the effect that the new chemical substance to which their request pertains to falls under item (i) of paragraph (2), pursuant to the provisions of paragraph (2) or paragraph (3), when the person finds it necessary, may make a request to the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment to make a determination under the following paragraph with regard to the new chemical substance to which the relevant notice pertains, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment.

(8)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have given notice to the effect that the new chemical substance to which a request under paragraph (1) pertains falls under item (ii) of paragraph (2), pursuant to the provisions of paragraph (2) or paragraph (3), if they have not issued a confirmation to the effect that the manufacture or import of the new chemical substance to which a request under paragraph (4) pertains falls under the items of the relevant paragraph, where they have rescinded the confirmation under the relevant paragraph, or where they have received a request under the preceding paragraph, they should promptly make a determination as to which one of items (i) through (v) of paragraph (1) of Article 4 the relevant new chemical substance falls under, based on the results of tests conducted on the relevant new chemical substance, and should notify the result thereof to the person who has made the request under paragraph (1) with regard to the new chemical substance.

(9)The provisions of paragraph (7) and paragraph (8) of the preceding Article apply mutatis mutandis to a determination under paragraph (2), the provisions of paragraph (3), paragraph (7) and paragraph (8) of the relevant Article apply mutatis mutandis to a determination under paragraph (3), and the provisions of paragraphs (3) through (8) of the relevant Article apply mutatis mutandis to a determination under the preceding paragraph. In these cases, the phrase "paragraph (1) or paragraph (2)" in paragraphs (4) and (5) of the relevant Article is deemed to be replaced with "paragraph (8) of Article 5."

Article 6A person who has given a notification under paragraph (1) of Article 3 shall not manufacture or import the new chemical substance to which the notification pertains pursuant to the provisions of paragraphs (1) or (2) of Article 4 or paragraph (8) of the preceding Article until after the receipt of notice prescribed in the provisions of paragraph (5) of Article 4 (when it is applied mutatis mutandis pursuant to paragraph (9) of the preceding Article by replacing the terms) relating to the relevant new chemical substance; provided, however, that this does not apply to either of the following cases:

Article 7(1)A person who intends to manufacture in a foreign country a new chemical substance to be exported to Japan or a person who intends to export a new chemical substance to Japan,, in advance, may notify the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment of the name of the relevant new chemical substance and any other matters specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment.

(2)The provisions of Article 4 apply mutatis mutandis to the notification under the preceding paragraph.In this case, the term "within three months" in paragraph (1) of the relevant Article is deemed to be replaced with "within four months."

Article 8(1)A person who manufactures or imports general chemical substances shall in every fiscal year, pursuant to Order of the Ministry of Economy, Trade and Industry, notify the Minister of Economy, Trade and Industry of the quantity of manufacture, quantity of import or other matters specified by Order of the Ministry of Economy, Trade and Industry for each general chemical substance in the preceding fiscal year; provided, however, that this does not apply if the person falls under any of the following items:

(2)The provisions of the preceding paragraph (excluding item (iii)) apply mutatis mutandis to a person who manufactures or imports a new chemical substance pertaining to the notice prescribed in paragraph (5) of Article 4 (including when it is applied mutatis mutandis pursuant to paragraph (9) of Article 5 by replacing the terms) (this person is to be limited to a person who has received the relevant notification) and to a person who imports a new chemical substance pertaining to notification as prescribed in paragraph (5) of Article 4 as applied mutatis mutandis pursuant to paragraph (2) of the preceding Article from a person who has received the relevant notification.

Article 8-2(1)If a person who engages in the business of manufacturing a specified general chemical substance, a person who uses a specified general chemical substance as their business and any other person who handles a specified general chemical substance as their business (collectively referred to as a "business operator handling a specified general chemical substance" in Articles 39 and 42) transfers or provides a specified general chemical substance to another business operator, the person must endeavor to provide information to the other party to whom the person makes the transfer or provision with regard to the name of the specified general chemical substance and the fact that the substance to be transferred or provided is a specified general chemical substance.

(2)When a person who engages in the business of manufacturing a specified new chemical substance, a person who uses a specified new chemical substance as their business and any other person who handles a specified new chemical substance as their business (collectively referred to as a "business operator handling a specified new chemical substance" in Articles 39 and 42) transfers or provides a specified new chemical substance to another business operator, the person must endeavor to provide information to the other party to whom the person makes the transfer or provision with regard to the fact that the substance to be transferred or provided is a specified new chemical substance.

Article 9(1)A person who manufactures or imports a priority assessment chemical substance (excluding one that is designated as a class II specified chemical substance by falling under any of the items of paragraph (3) of Article 2; the same applies hereinafter in this Article, and in Articles 12 and 41) shall in every fiscal year, pursuant to Order of the Ministry of Economy, Trade and Industry, shall notify the Minister of Economy, Trade and Industry of the manufactured quantity, import quantity or other matters specified by Order of the Ministry of Economy, Trade and Industry for each priority assessment chemical substance in the preceding fiscal year; provided, however, that this does not apply if the person falls under any of the following items:

(2)The Minister of Economy, Trade and Industry shall in every fiscal year, make public the sum of the manufacture quantity and import quantity in the preceding paragraph pertaining to the notification set forth in the preceding paragraph; provided, however, that this does not apply when the sum of the manufactured quantity and import quantity of a priority assessment chemical substance is less than the quantity specified by Order of the Ministry of Economy, Trade and Industry.

Article 10(1)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment find it necessary to conduct the assessment prescribed in paragraph (5) of Article 2 for a priority assessment chemical substance, they may request that a person who engages in the business of manufacturing or importing the relevant priority assessment chemical substance (including a person who used to engage in these businesses and is specified by Order of the Economy, Trade and Industry; the same applies in the following paragraph) submit materials in which the results of the tests that are prescribed in paragraph (7) of Article 4 on the properties of the relevant priority assessment chemical substance and that are specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment.

(2)With regard to a priority assessment chemical substance, if it is found that there are reasons to suspect that it falls under any of the items of paragraph (3) of Article 2 from the perspective of the results of tests set forth in the preceding paragraph and other already available knowledge on the relevant priority assessment chemical substance and if the relevant priority assessment chemical substance falls under any of the items of the relevant paragraph based on its properties and the status of its manufacture, import, use, etc., it is expected that the relevant priority assessment chemical substance is likely to harm human health or damage the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution; so in case the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment find it necessary to judge whether or not the relevant priority assessment chemical substance falls under any of the items of the relevant paragraph, they may instruct a person who engages in the manufacture or import of the relevant priority assessment chemical substance to conduct a study of hazardous properties as specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment (the study means a study of the effects of the relevant chemical substance on human health and its effects on the inhabitation and/or growth of flora and fauna in the living environment if continuously taken in; the same applies in paragraph (4)) and report the results.

(3)If the report set forth in the preceding paragraph is made, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should judge whether or not the priority assessment chemical substance pertaining to the relevant report falls under any of the items of paragraph (3) of Article 2 and notify the person who made the report of the results.

(4)If the Minister of Economy, Trade and Industry finds it particularly necessary to ensure that the expenses required for the tests pertaining to the request pursuant to the provisions of paragraph (1) or the study of hazardous properties pertaining to the instruction pursuant to the provisions of paragraph (2) are divided fairly among the business operators concerned, the minister may establish standards concerning the method and proportion for sharing the expenses required for the relevant tests or the relevant study of hazardous properties.

Article 11If a priority assessment chemical substance falls under any of the following items, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should rescind the designation and make the rescission public without delay:

Article 11-2If a chemical substance for which the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have rescinded the designation as a priority assessment chemical substance pursuant to the provisions of the preceding Article (limited to the part pertaining to (d) of item (ii)) falls within the category of specified general chemical substance, they should make this public together with the rescission pursuant to the provisions of the same Article.

Article 12If a person who engages in the business of manufacturing a priority assessment chemical substance, a person who uses a priority assessment chemical substance as their business and any other person who handles a priority assessment chemical substance as their business (hereinafter collectively referred to as a "business operator handling a priority assessment chemical substance") transfers or provides a priority assessment chemical substance to another business operator, the person must endeavor to provide information to the other party to whom the person makes the transfer or provision with regard to the name of the relevant priority assessment chemical substance and the fact that the substance to be transferred or provided is a priority assessment chemical substance.

Article 35(1)A person who manufactures or imports a class II specified chemical substance, or a person who imports a product that is specified by Cabinet Order and in which a class II specified chemical substance is used (hereinafter referred to as a "product using a class II specified chemical substance"), for each class II specified chemical substance or each product using a class II specified chemical substance, shall notify the Minister of Economy, Trade and Industry, each fiscal year, of the planned quantity to be manufactured or planned quantity to be imported of the relevant class II specified chemical substance or the planned quantity to be imported of the relevant product using a class II specified chemical substance, and other matters specified by Order of the Ministry of Economy, Trade and Industry, pursuant to the provisions of Order of the Ministry of Economy, Trade and Industry; provided, however, that this does not apply to the case where a person manufactures or imports a class II specified chemical substance or imports a product using a class II specified chemical substance for testing and research purposes.

(2)If a person who has given a notification under the provisions of the preceding paragraph has made changes to the matters to which the notification under the relevant paragraph pertains, the person shall notify the Minister of Economy, Trade and Industry to that effect without delay.

(3)A person who has given a notification under the provisions of paragraph (1) shall not manufacture or import in excess of the planned quantity to be manufactured or the planned quantity to be imported to which the relevant notification pertains (when approval has been granted for changes under the preceding paragraph, in accordance with the plan after the changes).

(4)In the case of a situation when it is necessary to restrict the manufacture or import of a class II specified chemical substance or the import of a product using a class II specified chemical substance in order to prevent damage to human health or to the inhabitation and/or growth of flora and fauna in the human living environment through environmental pollution attributable to the relevant Class II Chemical Substance, in light of the state of the manufacture, import, use, etc. of the relevant class II specified chemical substance or product using a class II specified chemical substance as well as the effects, etc. of the implementation of measures under the provisions of the following Article and Article 37 taken in relation to the relevant class II specified chemical substance, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment are to make an acknowledgement to that effect, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment.

(5)When the acknowledgment under the preceding paragraph has been made, the Minister of Economy, Trade and Industry may order the person who has given a notification under the provisions of paragraph (1) to change the planned quantity to be manufactured or the planned quantity to be imported to which the relevant notification pertains (if a notification of change under the provisions of paragraph (2) has been given, the quantity after the change).In this case, the provisions of paragraph (3) apply mutatis mutandis.

(6)A person who has given a notification under the provisions of paragraph (1), each fiscal year, shall notify the Minister of Economy, Trade and Industry of the quantity of manufacture or the quantity of import in the preceding fiscal year and other matters specified by Order of the Ministry of Economy, Trade and Industry, for each class II specified chemical substance or each product using a class II specified chemical substance, pursuant to the provisions of Order of the Ministry of Economy, Trade and Industry.

(7)The provisions of paragraph (2) of Article 24 apply mutatis mutandis to the Cabinet Order set forth in paragraph (1).

Article 36(1)For each class II specified chemical substance, the competent ministers should publish technical guidelines on the measures to be taken by persons who operate the business of manufacturing the relevant class II specified chemical substance, persons who use the relevant class II specified chemical substance or products that are specified by Cabinet Order in which the relevant class II specified chemical substance is used (hereinafter collectively referred to as a "class II specified chemical substance, etc.") as their businesses, and any other persons who handle the relevant class II specified chemical substance, etc. as their businesses (hereinafter referred to as a "business operator handling a class II specified chemical substance, etc.") in order to prevent environmental pollution attributable to the class II specified chemical substance they handle.

(2)If the competent ministers have published technical guidelines pursuant to the provisions of the preceding paragraph, if they find it necessary, they may make necessary recommendations to a business operator handling a class II specified chemical substance, etc. pertaining to the relevant class II specified chemical substance with regard to the measures that should be taken for preventing environmental pollution attributable to the relevant class II specified chemical substance, by taking the relevant technical guidelines into consideration.

Article 37(1)For each class II specified chemical substance, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment is to determine the labeling information with respect to measures, etc., for preventing environmental pollution attributable to the relevant class II specified chemical substances, to be indicated on containers, packaging, or invoices for the class II specified chemical substance, etc. and give a public notice thereon.

(2)When a business operator handling a class II specified chemical substance, etc. transfers or provides a class II specified chemical substance, etc., the business operator shall, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment, implement labeling in accordance with the public notice given pursuant to the provisions of the preceding paragraph.

(3)If any business operator handling a class II specified chemical substance, etc. has violated the provisions of the preceding paragraph, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment may recommend the relevant business operator handling a class II specified chemical substance, etc. to implement labeling in accordance with the public notice given pursuant to the provisions of paragraph (1).

Article 38(1)When the competent ministers find a sufficient reason to suspect that a chemical substance other than a class I specified chemical substance falls under any of the items of paragraph (2) of Article 2, they may, to the extent necessary for preventing the spread of environmental pollution attributable to the relevant chemical substance, make any necessary recommendation concerning a restriction on the manufacture, import, use, etc. of the relevant chemical substance to a person operating the business of manufacturing or importing the relevant chemical substance or to a person using the relevant chemical substance as their business.

(2)If the competent ministers find a sufficient reason to suspect that a chemical substance other than a class II specified chemical substance falls under the requirements set forth in paragraph (3) of Article 2, they may, to the extent necessary for preventing the spread of environmental pollution attributable to the relevant chemical substance, make necessary recommendation concerning a restriction on the manufacture or import of the relevant chemical substance or an improvement in the method of use of the relevant chemical substance to a person operating the business of manufacturing or importing the relevant chemical substance or to a person using the relevant chemical substance as their business.

Article 39When the competent ministers find it particularly necessary for preventing environmental pollution attributable to a priority assessment chemical substance, a monitoring chemical substance, a class II specified chemical substance, a specified general chemical substance or specified new chemical substance they may provide a business operator handling the priority assessment chemical substance pertaining to the priority assessment chemical substance, a business operator handling a monitoring chemical substance, etc. pertaining to the monitoring chemical substance, a business operator handling class II specified chemical substance, etc. pertaining to the class II specified chemical substance, a business operator handling a specified general chemical substance pertaining to the specified general chemical substance or a business operator handling a specified new chemical substance pertaining to the specified new chemical substance with the necessary guidance and advice concerning the method of handling the each respective chemical substance.

Article 40(1)Conditions may be attached to any permission, and the conditions attached may be changed.

(2)The conditions under the preceding paragraph are limited to the minimum required for ensuring the secure implementation of the matters to which the permission pertains, and shall not impose undue obligations on the person who obtains the permission.

Article 41(1)When a person operating the business of manufacturing or importing any priority assessment chemical substance, any monitoring chemical substance, any class II specified chemical substance or any general chemical substance (hereinafter referred to as a "substance to be reported") has conducted tests for the items to be tested prescribed in paragraph (7) of Article 4 or for the studies of hazardous properties prescribed in paragraph (2) of Article 10 or paragraph (1) of Article 14 (including those cases in which knowledge equivalent to that which would be obtained from the relevant tests [limited to knowledge that is not publicly known] has been obtained) with regard to the substance to reported that the person has manufactured or imported and if the person has obtained, as a result thereof, knowledge specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment that indicates that that the substance to be reported possesses the following properties, the person shall report to the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment to that effect and provide the details of the relevant knowledge, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment; provided, however, that this does not apply to cases when the relevant person has obtained the relevant knowledge as a result of a study of hazardous properties to which an instruction under the provisions of paragraph (2) of Article 10 or paragraph (1) of Article 14 pertains and is reporting the details of the relevant knowledge pursuant to these provisions:

(2)The provisions of the main clause of the preceding paragraph apply mutatis mutandis to a person who engages in the business of manufacturing or importing a new chemical substance pertaining to the confirmation set forth in items (v) or (vi) of paragraph (1) of Article 3 or paragraph (5) of Article 5 (limited to a person who obtains the relevant confirmation), a person who engages in the business of manufacturing or importing a new chemical substance pertaining to the notification prescribed in paragraph (5) of Article 4 (including cases where it is applied mutatis mutandis pursuant to paragraph (9) of Article 5 by replacing the terms) (limited to a person who obtains the relevant confirmation) and a person who imports a new chemical substance pertaining to the notification prescribed in paragraph (4) of Article 4 as applied mutatis mutandis pursuant to paragraph (2) of Article 7 from another person who obtains the relevant notification.

(3)When a person who engages in the business of manufacturing or importing a priority assessment chemical substance, a monitoring chemical substance or a class II specified chemical substance has knowledge of the composition, properties, etc. of the priority assessment chemical substance, the monitoring chemical substance or the class II specified chemical substance that the person has manufactured or imported as specified by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment (the knowledge is limited to that which is not publicly known, and excluding that which is to be reported pursuant to the provisions of paragraph (2) of Article 10, paragraph (1) of Article 14 or paragraph (1) of this Article), the person must endeavor to report to that effect and the details of the relevant knowledge to the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment, pursuant to the provisions by Order of the Ministry of Health, Labour and Welfare, Order of the Ministry of Economy, Trade and Industry, and Order of the Ministry of the Environment.

(4)If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have found, based on a report under paragraph (1) (including in cases as applied mutatis mutandis pursuant to paragraph (2)) or the preceding paragraph or knowledge that has been otherwise obtained, that any substance to be reported or any new chemical substance pertaining to the report set forth in paragraph (1) as applied mutatis mutandis pursuant to paragraph (2) falls under any of the items of paragraph (2), any of the items of paragraph (3), any of the items of paragraph (4) of Article 2, or is no longer clearly found to fall under none of the items of paragraph (3) of the relevant Article, they are to take any other necessary measures without delay.

Article 42The competent ministers may request that a business operator handling a priority assessment chemical substance, a business operator handling a monitoring chemical substance, a business operator handling a class II specified chemical substance, etc., a business operator handling a specified general chemical substance or a business operator handling a specified new chemical substance report the status of their handling of a priority assessment chemical substance, a monitoring chemical substance, a class II chemical substance, etc., a specified general chemical substance or a specified new chemical substance.

Article 43(1)The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment, to the extent necessary for enforcing this Act, may have a person who has received a confirmation under items (iv) through (vi) of paragraph (1) of Article 3 or under paragraph (4) of Article 5 make a report concerning their operations.

(2)The Minister of Economy, Trade and Industry or the competent minister, to the extent necessary for enforcing this Act, may have, respectively, a permitted manufacturer, a permitted importer, a business operator handling class I specified chemical substance, etc. or a person who has given a notification under the provisions of paragraph (1) of Article 35 make a report concerning their operations.

(3)The competent ministers, to the extent necessary for enforcing this Act, may have a person prescribed in Article 34 or Article 38 make a report concerning their operations.

Article 44(1)The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment, to the extent necessary for enforcing this Act, may have their officials enter the offices or any other places of business of a person who has received a confirmation under items (iv) through (vi) of paragraph (1) of Article 3 or paragraph (4) of Article 5, inspect the books, documents, and any other articles, ask questions of the relevant persons, or sample the smallest quantity of chemical substances necessary for testing.

(2)The Minister of Economy, Trade and Industry or the competent minister, to the extent necessary for enforcing this Act, may have their officials enter the offices or any other places of business of a permitted manufacturer, a permitted importer, a business operator handling a class I specified chemical substance, etc. or a person who has given a notification under the provisions of paragraph (1) of Article 35, inspect the books, documents, and any other articles, ask questions of the relevant persons, or sample the smallest quantity of chemical substances necessary for testing.

(3)The competent ministers, to the extent necessary for enforcing this Act, may have their officials enter the offices or any other places of business of a person prescribed in Article 34, inspect the books, documents and any other articles, ask questions of the relevant persons, or sample the smallest quantity of chemical substances necessary for testing.

(4)If an official enters a site pursuant to the provisions of the preceding three paragraphs, the official shall carry identification and present it to the relevant persons.

(5)If the Minister of Economy, Trade and Industry find it necessary, the minister may have the National Institute of Technology and Evaluation (hereinafter referred to as "NITE") conduct the on-site inspection, questioning, or taking of samples under the provisions of paragraphs (1) through (3).

(6)If the Minister of Economy, Trade and Industry has NITE conduct the on-site inspection, questioning, or taking of samples pursuant to the provisions of the preceding paragraph, the minister is to instruct NITE to conduct such on-site inspection, questioning or taking of samples by indicating the place of the relevant on-site inspection and any other necessary matters.

(7)If NITE has conducted the on-site inspection, questioning, or taking of samples prescribed in paragraph (5), in accordance with the instructions under the preceding paragraph, it shall report the results thereof to the Minister of Economy, Trade and Industry.

(8)If an official of NITE enters a site pursuant to the provisions of paragraph (5), the official shall carry identification and present it to the relevant persons.

(9)The authority for the on-site inspection, questioning, and taking of samples under the provisions of paragraphs (1) through (3) should not be construed as an authority granted for the purpose of criminal investigation.

Article 45If the Minister of Economy, Trade and Industry finds it necessary for securing the proper implementation of operations relating to the on-site inspection, questioning, or samples taken prescribed in paragraph (5) of the preceding Article, the minister may issue the necessary orders concerning the relevant operations to NITE.

Article 46Any person who is dissatisfied with the samples taken by NITE may file a request for review with the Minister of Economy, Trade and Industry.In this case, with regard to the application of the provisions of paragraphs (2) and (3) of Article 25 and Article 47 of the Administrative Complaint Review Act (Act No. 68 of 2014), the Minister of Economy, Trade and Industry is deemed to be the higher administrative agency of NITE.

Article 47If the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, or the Minister of the Environment obtains knowledge, etc. of the properties, etc. of a chemical substance based on this Act, in order to contribute to measures based on another Act concerning the relevant chemical substance, the minister is to notify the Ministers governing the offices responsible for the enforcement of the relevant other Act of the details of the relevant knowledge, etc. where needed.

Article 48If the Minister of the Environment finds it necessary to achieve the purpose of this Act, the minister may request the ministers listed in the following items to take the measures set forth respectively in those items:

Article 49A person who intends to obtain permission under paragraph (1) of Article 17, paragraph (1) of Article 21, or paragraph (1) of Article 22 shall pay a fee of the amount specified by Cabinet Order in consideration of the actual expenses.

Article 50(1)If the Minister of Economy, Trade and Industry intends to issue an order under the provisions of paragraph (1) of Article 33, the minister should hold a hearing, regardless of the category of the procedure for hearing statements of opinion under the provisions of paragraph (1) of Article 13 of the Administrative Procedure Act (Act No. 88, 1993).

(2)The proceedings on the date of a hearing to which a disposition under the provisions of Article 33 pertains dhould be held in public.

(3)The presiding official of a hearing under the preceding paragraph should, when an interested person to whom the relevant disposition pertains has requested to intervene in the hearing process pursuant to the provisions of paragraph (1) of Article 17 of the Administrative Procedure Act, permit the relevant person to do so.

Article 51(1)A determination on a request for review with respect to a disposition made pursuant to this Act or inaction thereof should be made after giving advance notice of a reasonable period to the requester of review and after the review officer provided in paragraph (2) of Article 11 of the Administrative Complaint Review Act has heard opinions in public, except when the request for review is dismissed pursuant to Article 24 of the same Act.

(2)At a hearing of opinions under the preceding paragraph, the requester of review and the interested person should be given an opportunity to produce evidence and state their opinions with regard to the case.

(3)The provisions of Article 31 of the Administrative Complaint Review Act do not apply to a request for review prescribed in paragraph (1), and the provisions of paragraphs (2) through (5) of the same Article apply mutatis mutandis to the hearing of opinions under paragraph (1).

Article 52When an order is established, revised, or abolished based on the provisions of this Act, required transitional measures (including transitional measures concerning penal provisions) may be specified by the relevant order to the extent found reasonably necessary in line with the establishment, revision or abolition thereof.

Article 53(1)The competent ministers under this Act are as follows:

(2)Order of the competent ministry under this Act is as follows:

Article 54The authority of the Minister of the Environment prescribed in this Act may be delegated to the Director Generals of the Regional Environment Offices, pursuant to Order of the Ministry of Environment.

Article 55The provisions of Article 3, paragraph (1) of Article 7, paragraph (1) of Article 8 (including in cases as applied mutatis mutandis pursuant to paragraph (2) of the same Article), Article 8-2, paragraph (1) of Article 9, paragraphs (1) and (2) of Article 10, Article 12, paragraph (1) of Article 13, paragraph (1) of Article 14, Article 16, paragraph (1) of Article 17, Article 18, paragraphs (1) of Article 22, Article 25, paragraph (1) of Article 26, paragraph (2) of Article 28, paragraph (1) of Article 29, paragraphs (1) and (3) of Article 34, paragraph (1) of Article 35, paragraph (1) of Article 36, paragraph (1) of Article 37, Article 38, Article 39, paragraphs (1) (including in cases as applied mutatis mutandis pursuant to paragraph (2) of Article 40) and (3) of Article 40 and Article 42 do not apply to the chemical substances which constitute the articles listed in the following items; the provisions of paragraph (1) of Article 24, paragraph (2) of Article 28, paragraph (1) of Article 29 and Article 34 do not apply to the products listed in the following items in which class I specified chemical substances are used; the provisions of paragraph (1) of Article 35, paragraph (1) of Article 36, paragraph (1) of Article 37, Article 39 and Article 42 do not apply to the articles listed in the following items in which class II specified chemical substances are used; and the provisions of Article 8-2, Article 12, Article 16, Article 25, paragraph (1) of Article 26, paragraph (2) of Article 28, paragraph (1) of Article 29, paragraph (3) of Article 34, paragraph (1) of Article 36, paragraph (1) of Article 37, Article 38, Article 39 and Article 42 do not apply to the use of chemical substances as raw materials for the articles listed in the following items, but the Acts set forth in the following items apply to them respectively:

Article 56(1)In the following cases, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment are to hear the opinions of the councils, etc., (organizations prescribed in Article 8 of the National Government Organization Act [Act No. 120 of 1948]; the same applies in the following paragraph) that are specified by Cabinet Order, in advance:

(2)When the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry and the Minister of the Environment judge pursuant to the provisions of paragraphs (1) or (2) of Article 4 or paragraph (8) of Article 5 that a new chemical substance subject to the notification set forth in paragraph (1) of Article 3 falls under any of items (ii) through (iv) of paragraph (1) of Article 4, they are to hear the opinions of the councils, etc., specified by the Cabinet Order set forth in the preceding paragraph without delay regarding whether or not it is necessary to provide the designation set forth in paragraph (5) of Article 2 to the relevant chemical substance.

Article 57A person who falls under any of the following items is punished by imprisonment for not more than three years or by a fine of not more than one million yen, or both:

Article 58A person who falls under any of the following items is punished by imprisonment for not more than one year or by a fine of not more than five hundred thousand yen, or both:

Article 59A person who falls under any of the following items is punished by imprisonment for not more than six months or by a fine of not more than five hundred thousand yen, or both:

Article 60A person who falls under any of the following items is punished by a fine of not more than three hundred thousand yen:

Article 61Where a representative, an agent, an employee or any other worker of a corporation or an individual commits a violation of any of the provisions set forth in the following items with regard to the business of the corporation or the individual, beyond the offender being subject to punishment, the corporation is subject to the fine referred to in the relevant items, and the offender is subject to the fined referred to in the relevant Article.

Article 62A person who falls under either of the following items is punished by a non-penal fine of not more than two hundred thousand yen:

Article 63In the case where an order under the provisions of Article 45 has been violated, an officer or officers of NITE who have committed the relevant act in violation is punished by a non-penal fine of not more than two hundred thousand yen.