Act on the Regulation of Manufacture and Evaluation of Chemical Substances(Act No. 117 of 1973)
Last Version: Act No. 53 of 2017
TOC
History

  • June 17, 2019
    • Last Version: Act No. 53 of 2017
    • Translated Date: March 19, 2018
    • Dictionary Version: 12.0
  • March 3, 2011
    • Last Version: Act No. 39 of 2009
    • Translated Date: December 1, 2009
    • Dictionary Version: 4.0
  • March 31, 2009
    • Last Version: Act No. 33 of 2005
    • Translated Date: April 1, 2009
    • Dictionary Version: 2.0

Act on the Regulation of Manufacture and Evaluation of Chemical Substances
Act No. 117 of October 16, 1973
Contents
Chapter I General Provisions(Articles 1 and 2)
Chapter II Evaluation and Regulation Concerning New Chemical Substances(Articles 3 to 7)
Chapter III Measures Concerning General Chemical Substances(Articles 8 and 8-2)
Chapter IV Measures Concerning Priority Assessment Chemical Substances(Articles 9 to 12)
Chapter V Regulations Concerning Class I Specified Chemical Substances
Section 1 Measures Concerning the Monitoring Chemical Substances(Articles 13 to 16)
Section 2 Regulations Concerning Class I Specified Chemical Substances(Articles 17 to 34)
Chapter VI Regulations Concerning Class II Specified Chemical Substances(Articles 35 to 37)
Chapter VII Miscellaneous Provisions(Articles 38 to 56)
Chapter VIII Penal Provisions(Articles 57 to 63)
Supplementary Provisions
Chapter I General Provisions
(Purpose)
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.
(Definitions)
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):
(i)specified poisonous substances prescribed in paragraph (3) of Article 2 of the Poisonous and Deleterious Substances Control Act (Act No. 303 of 1950);
(ii)stimulants prescribed in paragraph (1) of Article 2 of the Stimulants Control Act (Act No. 252 of 1951) and stimulants' raw materials prescribed in paragraph (5) of the relevant Article;
(iii)narcotics prescribed in item (i) of Article 2 of the Narcotics and Psychotropics Control Act (Act No. 14 of 1953)
(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:
(i)a chemical substance that falls under (a) and (b);
(a)a chemical substance that is not likely to undergo a chemical transformation through natural processes and is bioaccumulative
(b)a chemical substance that falls under either of the following:
1.A chemical substance that poses a risk of harming human health if taken in continuously
2.A chemical substance that, if taken in continuously, poses a risk of interfering with the inhabitation and/or growth of predatory animals at higher trophic level (meaning animals that fall under the category of flora and fauna in the human living environment (meaning flora and fauna for which interference with their inhabitation and/or growth would pose a risk of interfering with the conservation of the living environment; the same applies hereinafter) for which chemical substances falling under (a) are most likely to bioaccumulate through the food chain; the same applies hereinafter)
(ii)in the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under (a) and (b) of the preceding item;
(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.:
(i)a chemical substance that falls under either (a) or (b);
(a)a chemical substance (excluding one that falls under item (i) of the preceding paragraph) that is likely to pose a risk of harming human health if taken in continuously
(b)in the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under (a) (limited to a chemical substance that is not likely to undergo a chemical transformation through natural processes).
(ii)any chemical substance that falls under either (a) or (b):
(a)A chemical substance (excluding one that falls under item (i) of the preceding paragraph) that is likely to pose a risk of interfering with the inhabitation and/or growth of flora and fauna in the living environment, if the flora and fauna continuously take in or are exposed to the relevant chemical substance
(b)In the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under (a) (limited to a chemical substance that is not likely to undergo a chemical transformation through natural processes).
(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:
(i)a chemical substance that falls under (a) of item (i) of paragraph (2), and where it is unclear whether or not (b) of the relevant item applies;
(ii)in the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under the preceding item.
(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:
(i)a chemical substance for which public notice has been given by 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 paragraph (5) of Article 4 (including cases where it is applied mutatis mutandis pursuant to paragraph (9) of Article 5 by replacing the terms, and the cases in which it is applied mutatis mutandis pursuant to paragraph (2) of Article 7);
(ii)a class I specified chemical substance;
(iii)a class II specified chemical substance;
(iv)a priority assessment chemical substance (including one for which the designation has been rescinded pursuant to the provisions of Article 11 [limited to the part pertaining to (d) of item (ii)]);
(v)a chemical substance (excluding any of those set forth in the preceding items) listed in the list of existing chemical substances prescribed in paragraph (1) of Article 2 of the Supplementary Provisions of this Act that has been made public by the Minister of International Trade and Industry pursuant to the provisions of paragraph (4) of the relevant Article;
(vi)a chemical substance (excluding any of those set forth in the preceding items) listed in the list prescribed in Article 4 of the Supplementary Provisions of this Act that is made public by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment.
(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):
(i)a chemical substance listed in items (i), (v) or (vi) of the preceding paragraph;
(ii)a chemical substance for which designation as a priority assessment chemical substance is rescinded pursuant to the provisions of Article 11 (limited to the part pertaining to (d) of item (ii));
(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:
(i)a chemical substance that falls under (a) and/or (b);
(a)A chemical substance that poses a risk of seriouslyharming human health if taken in continuously
(b)in the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under (a) (limited to a chemical substance that is not likely to undergo a chemical transformation through natural processes).
(ii)any chemical substance that falls under either (a) and/or (b).
(a)a chemical substance that is likely to pose a risk of seriously interfering with the inhabitation and/or growth of flora and fauna in the living environment, if the flora and fauna continuously take in or are exposed to the relevant chemical substance
(b)In the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under (a) (limited to a chemical substance that is not likely to undergo a chemical transformation through natural processes).
(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.
Chapter II Evaluation and Regulation Concerning New Chemical Substances
(Notification of Manufacture)
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:
(i)if a person intends to import from a person who has submitted a notification under paragraph (1) of Article 7 and has received notice to the effect that the new chemical substance to which the relevant notification pertains falls under any of items (ii) through (v) of paragraph (1) of the following Article in accordance with the provisions of paragraphs (1) or (2) of the relevant Article as applied mutatis mutandis pursuant to paragraph (2) of Article 7, the new chemical substance to which the relevant notification pertains;
(ii)if a person intends to manufacture or import a new substance for testing and research purposes;
(iii)if a person intends to manufacture or import a new chemical substance as a reagent (which means a chemical substance used for the detection or quantification of a substance by a chemical process, or for the experimental synthesis of a substance, or for the measurement of the physical characteristics of a substance; the same applies hereinafter);
(iv)if a person has received a confirmation from 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 the effect that the manufacture or import falls under a case specified by Cabinet Order as one where the new chemical substance does not pose a risk of causing environmental pollution in consideration of the intended method of handling the relevant new chemical substance and other matters, and the relevant new chemical substance will be manufactured or imported in accordance with the particulars for which the relevant confirmation has been received;
(v)if the planned quantity to be manufactured or planned quantity to be imported (in the case of a person who intends to manufacture and import the relevant new chemical substance, the sum of these quantities; the same applies in Article 5, paragraph (1) and paragraph (4), item (i) of the relevant new chemical substance in one fiscal year is not more than the quantity specified by Cabinet Order, and where a person has received a confirmation from the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment, 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, to the effect that, as determined by already available knowledge, etc., the relevant new chemical substance is not one that poses a risk in harming human health or causing damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution, and that person is to manufacture or import the relevant new chemical substance in a quantity of no more than that to which the relevant confirmation pertains during the relevant fiscal year;
(vi)if the new chemical substance is a polymer and if a person has received confirmation from 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 the effect that the new chemical substance does not pose a risk of harming human health or damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution; and the relevant new chemical substance is manufactured or imported.
(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):
(i)if the person who has received the confirmation under item (iv) of paragraph (1) receives the relevant confirmation by wrongful means;
(ii)if the person who has received the confirmation under item (iv) of paragraph (1) is found not to be manufacturing or importing the new chemical substance to which the relevant confirmation pertains in accordance with the particulars for which the relevant confirmation has been received;
(iii)beyond the cases set forth in the preceding items, if it is found that the new chemical substance to which the confirmation under item (iv) of paragraph (1) pertains poses a risk of causing environmental pollution.
(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):
(i)if the person who has received the confirmation under item (v) of paragraph (1) had received the relevant confirmation by wrongful means;
(ii)if the person who has received the confirmation under item (v) of paragraph (1) is found to be manufacturing or importing the new chemical substance to which the relevant confirmation pertains in excess of the quantity to which the relevant confirmation pertains;
(iii)beyond the cases set forth in the preceding items, if it is found that the new chemical substance to which the confirmation under item (v) of paragraph (1) poses a risk of harming human health or damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution.
(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):
(i)if the person who has received confirmation under item (vi) of paragraph (1) receives the confirmation by wrongful means;
(ii)if it is found that the new chemical substance pertaining to the confirmation set forth in item (vi) of paragraph (1) poses a risk of harming human health or damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution.
(Evaluation)
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:
(i)a chemical substance that falls under any of the items of paragraph (2) of Article 2;
(ii)a chemical substance that falls under (a) and does not fall under (b):
(a)a chemical substance that falls under any of the following:
1.A chemical substance that is suspected to fall under (a) of item (i) of paragraph (3) of Article 2 (including those that fall under (a) of the relevant item and limited to chemical substances that are not likely to undergo a chemical transformation through natural processes);
2.In the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under 1.
(b)a chemical substance that falls under any of the following:
1.A chemical substance that is likely to pose a risk of interfering with the inhabitation and/or growth of flora and fauna (limited to chemical substances that are not likely to undergo a chemical transformation through natural processes and excluding those that fall under item (i) of paragraph (2) of Article 2);
2.In the case of a chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under 1.
(iii)a chemical substance that does not fall under (a) of the preceding item and that falls under (b) in the relevant item;
(iv)a chemical substance that falls under both (a) and (b) of item (ii);
(v)a chemical substance that does not fall under item (i) or (a) or (b) of item (ii);
(vi)a substance where it is unclear as to whether or not it falls under items (i) to (iv).
(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.
(Exception on an Evaluation when the Planned Quantity to be Manufactured is Below a Certain Quantity)
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:
(i)a chemical substance that falls under (a) and (b);
(a)a chemical substance that is not likely to undergo a chemical transformation through natural processes and is not bioaccumulative;
(b)a chemical substance where it is unclear as to whether or not it falls under items (ii) through (iv) of paragraph (1) of the preceding Article;
(ii)in the case of a new chemical substance that is likely to undergo a chemical transformation through natural processes, one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under the preceding item.
(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:
(i)a substance that falls under any of the items of the preceding paragraph;
(ii)a substance that does not fall under any of the items of the preceding paragraph;
(iii)a chemical substance where it is unclear as to whether or not it falls under any of the items of the preceding paragraph.
(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:
(i)the planned quantity to be manufactured or planned quantity to be imported of the relevant new chemical substance during the fiscal year to which the request pertains is not more than the quantity specified by Cabinet Order;
(ii)determined by already available knowledge, etc., the new chemical substance is not one that poses a risk of harming human health or damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution.
(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):
(i)if the person who has received the confirmation under paragraph (4) has received the relevant confirmation by wrongful means;
(ii)if the person who has received the confirmation under paragraph (4) is found to be manufacturing or importing the new chemical substance to which the relevant confirmation pertains in excess of the quantity to which the relevant confirmation pertains;
(iii)beyond the cases set forth in the preceding items, if it is found that the new chemical substance to which the confirmation under paragraph (4) pertains poses a risk of harming human health or damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution.
(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."
(Restrictions on Manufacture)
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:
(i)if the manufacture or import of the new chemical substance to which the relevant notification pertains falls under any of the items of paragraph (1) of Article 3;
(ii)in the case where the person has received confirmation under the provisions of paragraph (4) of the preceding Article regarding the manufacture or import of the new chemical substance to which the relevant notification pertains (excluding cases where confirmation is rescinded pursuant to the provisions of paragraph (6) of the relevant Article), where the quantity of manufacture or import of the relevant new chemical substance shall be not more than the quantity to which relevant confirmation pertains.
(Evaluation of a New Chemical Substance Pertaining to a Manufacturer in a Foreign Country)
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."
Chapter III Measures for General Chemical Substances
(Notification of Quantity of Manufacture)
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:
(i)if a person manufactures or imports a general chemical substance for testing and research purposes;
(ii)with regard to a general chemical substance, if the quantity of manufacture or quantity of import of the general chemical substance by the person (in the case of a person who manufactures and imports the relevant general chemical substance, the sum of these quantities) is less than the quantity specified by Cabinet Order;
(iii)if a person manufactures or imports a chemical substance that is found not to fall under any of the items of paragraph (2) or the items of paragraph (3) of Article 2 and other chemical substances that are specified by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment as chemical substances for which it is not found necessary to conduct an assessment as prescribed in paragraph (5) of the relevant Article.
(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.
(Provision of Information)
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.
Chapter IV Measures for Priority Assessment Chemical Substances
(Notification of Quantity of Manufacture)
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:
(i)if a person manufactures or imports a priority assessment chemical substance for testing and research purposes;
(ii)with regard to a priority assessment chemical substance, when the manufactured quantity or import quantity of the priority assessment chemical substance pertaining to the person (in the case of a person who manufactures and imports the relevant priority assessment chemical substance, the sum of these quantities) is less than the quantity specified by Cabinet Order.
(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.
(Study of Hazardous Properties of Priority Assessment Chemical Substances)
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.
(Rescission of Designation as a Priority Assessment Chemical Substance)
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:
(i)if the priority assessment chemical substance is designated as a class I specified chemical substance, a class II specified chemical substance (limited to cases when it falls under all of the items of paragraph (3) of Article 2) or a monitoring chemical substance;
(ii)if the priority assessment chemical substance falls under any of the following (a) through (d) based on the submission of materials set forth in paragraph (1) of the preceding Article, the report set forth in paragraph (2) of the relevant Article or on knowledge that has been otherwise obtained and the status of its manufacture, import, use, etc.:
(a)if the relevant priority assessment chemical substance is designated as a class II specified chemical substance falling under item (i) of paragraph (3) of Article 2, when it is found that the relevant priority assessment chemical substance is not likely to cause damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution;
(b)if the relevant priority assessment chemical substance is designated as a class II specified chemical substance falling under item (ii) of paragraph (3) of Article 2, when it is found that the relevant priority assessment chemical substance is not likely to cause damage to human health by causing environmental pollution
(c)when the relevant priority assessment chemical substance is designated as a class II specified chemical substance falling under any of the items of paragraph (3) of Article 2, if it is found that the relevant priority assessment chemical substance falls under an item other than the relevant item
(d)if it is found that the relevant priority assessment chemical substance is not likely to harm human health or damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution
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.
(Provision of Information)
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.
Chapter V Regulations Concerning Class I Specified Chemical Substances
Section 1 Measures Concerning Monitoring Chemical Substances
(Notification of the Manufactured Quantity)
Article 13(1)A person who has manufactured or imported any monitoring chemical substance, each fiscal year, must notify the Minister of Economy, Trade and Industry of the manufactured quantity or the import quantity in the preceding fiscal year and other matters specified by Order of the Ministry of Economy, Trade and Industry for each monitoring chemical substance, 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 the person has manufactured or imported a monitoring chemical substance for testing and research purposes.
(2)The Minister of Economy, Trade and Industry should make public, each fiscal year, the sum of the manufactured quantity and import quantity in the preceding fiscal year to which the notification under the preceding paragraph pertains for each monitoring chemical substance; provided, however, that this does not apply to the case where the sum of the manufactured quantity and import quantity for one monitoring chemical substance is less than the quantity specified by Order of the Ministry of Economy, Trade and Industry.
(Study on Hazardous Properties of Monitoring Chemical Substances)
Article 14(1)In the case where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment find sufficient reason to suspect that any single monitoring chemical substance falls under any of the items of paragraph (2) of Article 2, if they have found it necessary to make a determination as to whether or not the relevant monitoring chemical substance falls under any of the items of the relevant paragraph since the relevant monitoring chemical substance is expected to pose a risk of causing environmental pollution if the relevant monitoring chemical substance falls under any of the items of the relevant paragraph, in view of the state of its manufacture, import, use, etc., they may instruct 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 a person engaged in the business of manufacturing or importing of the relevant monitoring chemical substance (including a person who engaged in such business and who is specified by Order of the Ministry of Economy, Trade and Industry) to conduct a study of the hazardous properties 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 (meaning a study on the effects of the relevant chemical substance on human health or on the life and/or growth of predatory animals at higher trophic levels if taken in continuously; the same applies in paragraph (3)) and to report the results thereof.
(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 report under the preceding paragraph, they should make a determination as to whether or not the monitoring chemical substance to which the relevant report pertains falls under any one of the items of paragraph (2) of Article 2 and notify the result thereof to the person who has made the report.
(3)When the Minister of Economy, Trade and Industry finds it particularly necessary for ensuring that the expenses for the study of the hazardous properties to which the instruction under the provisions of paragraph (1) pertains are shared out fairly among the business operators concerned, the minister may establish standards concerning the method and proportions of the sharing of the expenses required for the relevant study of the hazardous properties.
(Rescinding the Designation of Monitoring Chemical Substance)
Article 15When the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment find that a monitoring chemical substance falls under either of the following items, they should rescind the designation and make it public to that effect without delay:
(i)if the relevant chemical substance is designated as a class I specified chemical substance;
(ii)if the relevant chemical substance is found not to fall under any of the items of paragraph (2) of Article 2, based on a report under paragraph (1) of the preceding Article or on knowledge that has been otherwise obtained.
(Provision of Information)
Article 16When a person who engages in the business of manufacturing a monitoring chemical substance, a person who uses a monitoring chemical substance as their business and any other person who handles a monitoring chemical substance as their business (hereinafter collectively referred to as a "business operator handling a monitoring chemical substance") transfers or provides a monitoring 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 to the effect that the name of the relevant monitoring chemical substance and the substance to be transferred or provided is a monitoring chemical substance.
Section 2 Regulations Concerning Class I Specified Chemical Substances
(Permission to Manufacture)
Article 17(1)A person who intends to operate a business of manufacturing a class I specified chemical substance shall obtain permission from the Minister of Economy, Trade and Industry for each class I specified chemical substance and for each place of business.
(2)A person who intends to obtain permission under the preceding paragraph shall submit a written application stating the following matters to the Minister of Economy, Trade and Industry:
(i)the name and domicile, and in the case of a corporation the name of the representative person;
(ii)the location of the place of business;
(iii)the name of the class I specified chemical substance;
(iv)the structure and capacity of the manufacturing equipment.
(3)If the Minister of Economy, Trade and Industry has granted permission under paragraph (1), the minister is to notify the Minister of the Environment to that effect without delay.
Article 18No person other than the one who has obtained permission under paragraph (1) of the preceding Article shall manufacture a class I specified chemical substance; provided, however, that this does not apply to the case if a person manufactures a class I specified chemical substance for testing and research purposes.
(Disqualification Clause)
Article 19Permission under paragraph (1) of Article 17 is not to be granted to a person who falls under any of the following items:
(i)a person who has been sentenced to a fine or severer punishment for violation of this Act or any order based on this Act where two years have yet to elapse since the day on which execution of the sentence has been completed or the sentence has become no longer applicable;
(ii)a person whose permission has been rescinded pursuant to the provisions of Article 33 and for whom two years have yet to elapse since the date of the rescission;
(iii)an adult ward;
(iv)a corporation where the officers who carry out its operations include persons who falls under any of the preceding three items.
(Standards for Permission)
Article 20The Minister of Economy, Trade and Industry shall not grant permission under paragraph (1) of Article 17, unless the minister finds that the application for permission under the relevant paragraph conforms to the following items:
(i)the granted permission does not result in the capacity to manufacture the relevant class I specified chemical substance in excess in light of the demand for the relevant class I specified chemical substance;
(ii)the manufacturing equipment shall conform to the technical standards 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;
(iii)the applicant shall have a sufficient fiscal basis and technical capacity to implement the business appropriately.
(Permission for Change)
Article 21(1)A person who has obtained permission under paragraph (1) of Article 17 (hereinafter referred to as a "permitted manufacturer") shall receive the permission of the Ministry of Economy, Trade and Industry if the person intends to make changes to the matters set forth in item (iv) of paragraph (2) of the relevant Article; provided, however, that this does not apply to the case when a person intends to make minor changes specified by Order of the Ministry of Economy, Trade and Industry.
(2)If a permitted manufacturer has made changes to the matters set forth in item (i) or (ii) of paragraph (2) of Article 17 or has made minor changes specified by Order of the Ministry of Economy, Trade and Industry as set forth in the proviso to the preceding paragraph, the manufacturer shall notify the Minister of Economy, Trade and Industry to that effect without delay.
(3)The provisions of the preceding Article apply mutatis mutandis to the permission under paragraph (1).
(4)The provisions of paragraph (3) of Article 17 apply mutatis mutandis to the permission under paragraph (1) and the notification under paragraph (2).
(Permission to Import)
Article 22(1)A person who intends to import a class I specified chemical substance shall obtain permission from the Minister of Economy, Trade and Industry; provided, however, that this does not apply to the case when a person intends to import a class I specified chemical substance for testing and research purposes.
(2)A person who intends to obtain permission under the preceding paragraph shall submit a written application stating the following matters to the Minister of Economy, Trade and Industry:
(i)the name and domicile, and in the case of a corporation the name of the representative person;
(ii)the name of the class I specified chemical substance;
(iii)the import quantity;
(3)the provisions of paragraph (3) of Article 17 apply mutatis mutandis to the permission under paragraph (1).
(Standards for Permission)
Article 23(1)When the Minister of Economy, Trade and Industry has received an application for permission under paragraph (1) of the preceding Article, the minister should not grant permission under the relevant paragraph unless the minister finds that the import of the class I specified chemical substance to which the relevant application pertains is necessary for meeting the demand for the relevant class I specified chemical substance.
(2)The provisions of Article 19 apply mutatis mutandis to the permission under paragraph (1) of the preceding Article.
(Restrictions on Import of Products)
Article 24(1)A person shall not import any product that is specified by Cabinet Order and in which a class I specified chemical substance is used (hereinafter referred to as a "product using a class I specified chemical substance").
(2)The Cabinet Order under the preceding paragraph should established for each class I specified chemical substance by giving consideration to such matters as the circumstances of the use of the relevant class I specified chemical substance overseas.
(Restrictions on Use)
Article 25A person shall not use a class I specified chemical substance for any usages other than those specified by Cabinet Order for each class I specified chemical substance as being compliant with the following requirements; provided, however, that this does not apply to the case when a person uses a class I specified chemical substance for testing and research purposes:
(i)it is difficult to substitute the relevant chemical substance with any other substance with regard to the relevant usage;
(ii)it shall not be likely to pose a risk of harming human health or damage to the inhabitation and/or growth of flora and fauna in the living environment by causing environmental pollution attributable to the relevant class I specified chemical substance that is used for in the relevant usage.
(Notification of Use)
Article 26(1)A person who intends to use a class I specified chemical substance as their business shall notify the competent minister of the following matters, in advance, for each place of business; provided, however, that this does not apply to the case when a person intends to use a class I specified chemical substance as their business for testing and research purposes:
(i)the name and domicile, and in the case of a corporation the name of the representative person;
(ii)the location of the place of business;
(iii)the name of the class I specified chemical substance and the usage.
(2)If a person who has given a notification under the preceding paragraph (hereinafter referred to as a "notifying user") has made any changes to the matters under the items of the preceding paragraph, the person shall notify the competent minister to that effect without delay.
(3)The provisions of paragraph (3) of Article 17 apply mutatis mutandis to the notification under the preceding two paragraphs.
(Succession)
Article 27(1)If a permitted manufacturer, a person who has obtained permission under paragraph (1) of Article 22 (hereinafter referred to as a "permitted importer"), or a notifying user has become subject to inheritance or a merger, the heir (when there are two or more heirs and an heir who should succeed to the business is selected by unanimous consent of all heirs, such person who has been selected) or the corporation surviving the merger or the corporation incorporated by the merger is to succeed to the status of the permitted manufacturer, the permitted importer, or the notifying user.
(2)A person who has succeeded to the status of permitted manufacturer, permitted importer, or notifying user pursuant to the provisions of the preceding paragraph shall notify the Minister of Economy, Trade and Industry, in the case of a person who has succeeded to the status of permitted manufacturer or a permitted importer, and notify the competent minister, in the case of a person who has succeeded to the status of a notifying user, to that effect without delay together with a document proving such fact.
(3)The provisions of paragraph (3) of Article 17 apply mutatis mutandis to the notification under the preceding paragraph.In this case, the term "Minister of Economy, Trade and Industry" in paragraph (3) of the relevant Article is deemed to be replaced with "Minister of Economy, Trade and Industry or the competent minister."
(Obligation of Conformity to Standards)
Article 28(1)A permitted manufacturer shall maintain its manufacturing equipment in such a manner as to conform to the technical standards 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 under item (ii) of Article 20.
(2)When a permitted manufacturer, a person who uses a class I specified chemical substance or any product that is specified by Cabinet Order and in which a class I specified chemical substance is used (hereinafter collectively referred to as a "class I specified chemical substance, etc.") as their business or any other person who handles a class I specified chemical substance, etc. as their business (hereinafter referred to as a "business operator handling a class I specified chemical substance, etc.") handles a class I specified chemical substance, etc., the business operator shall follow the technical standards specified by order of the competent ministry.
(Labeling)
Article 29(1)For each class I 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 the environmental pollution attributable to the relevant class I specified chemical substances, to be indicated on containers, packaging, or invoices for the class I specified chemical substance, etc. and give a public notice thereon.
(2)When a business operator handling a class I chemical substance, etc. transfers or provides a class I specified chemical substance, etc., the business operator shall implement labeling, 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, in accordance with the public notice given pursuant to the provisions of the preceding paragraph.
(Order for Improvement)
Article 30(1)When the Minister of Economy, Trade and Industry finds that the manufacturing equipment of a permitted manufacturer does not conform to the technical standards 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 under item (ii) of Article 20, the minister may order the relevant permitted manufacturer to repair or remodel the manufacturing equipment or to take other necessary measures.
(2)When the competent minister finds that a business operator handling a class I chemical substance, etc. fails to use a class I specified chemical substance, etc. in accordance with the technical standards specified by order of the competent ministry under paragraph (2) of Article 28, the minister may order the relevant business operator handling the class I chemical substance, etc. to take the necessary measures for improving the method of handling the class I specified chemical substance, etc.
(3)If any business operator handling a class I chemical substance, etc. violates the provisions of paragraph (2) of the preceding Article, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment may order the relevant corporation handling the class I chemical substance, etc. to implement labeling in accordance with the public notice given pursuant to the provisions of paragraph (1) of the relevant Article.
(Books)
Article 31(1)A permitted manufacturer shall keep books and enter therein the items specified by Order of the Ministry of Economy, Trade and Industry with respect to the manufacture of the class I specified chemical substance.
(2)The books under the preceding paragraph shall be archived in accordance with the provisions by Order of the Ministry of Economy, Trade and Industry.
(3)The provisions of the preceding two paragraphs apply mutatis mutandis to a notifying user.In this case, the term "Order of the Ministry of Economy, Trade and Industry" in these provisions is deemed to be replaced with "order of the competent ministry."
(Notification of Abolition)
Article 32(1)When a permitted manufacturer or a notifying user has closed their business, the relevant person shall notify the Minister of Economy, Trade and Industry, in the case of a permitted manufacturer, and notify the competent minister, in the case of a notifying user, to that effect without delay.
(2)When a permitted manufacturer has closed their business, the relevant permission is to lose its effect.
(3)The provisions of paragraph (3) of Article 17 apply mutatis mutandis to the notification under paragraph (1).In this case, the term "Minister of Economy, Trade and Industry" in paragraph (3) of the relevant Article is deemed to be replaced with "Minister of Economy, Trade and Industry or the competent minister."
(Rescission of Permission)
Article 33(1)When a permitted manufacturer falls under any of the following items, the Minister of Economy, Trade and Industry may rescind the relevant permission or order the suspension of business for a specified period:
(i)if the permitted manufacturer has fallen under item (i), (iii) or (iv) of Article 19;
(ii)if the permitted manufacturer has made any changes to matters for which permission must be obtained pursuant to the provisions of paragraph (1) of Article 21 without obtaining that permission;
(iii)if the permitted manufacturer has violated an order under the provisions of paragraph (1) of Article 30;
(iv)if the permitted manufacturer has violated the conditions under paragraph (1) of Article 40.
(2)If a permitted importer has come to fall under item (i), (iii) or (iv) of Article 19 as applied mutatis mutandis pursuant to paragraph (2) of Article 23, the Minister of Economy, Trade and Industry may rescind the relevant permission, but only prior to the import of the class I specified chemical substance to which the permission pertains.
(3)The provisions of paragraph (3) of Article 17 apply mutatis mutandis to the rescission of permission under the preceding two paragraphs or an order to suspend business under paragraph (1).
(Order to Take Measures in Connection with Designation of Class I Specified Chemical Substances)
Article 34(1)If any chemical substance has been designated as a class I specified chemical substance, if the competent ministers find it particularly necessary for preventing the spread of environmental pollution attributable to the relevant chemical substance, they may, to the extent necessary, order persons who were operating the business of manufacturing or importing the relevant chemical substance or a product in which the relevant chemical substance is used at the time of the relevant designation to make efforts to recall the relevant chemical substance or the relevant product and to take any other measures necessary for preventing the spread of environmental pollution attributable to the relevant chemical substance.
(2)If any product has been designated as a product using a class I specified chemical substance, if the competent ministers find it particularly necessary for preventing the spread of environmental pollution attributable to the class I specified chemical substance being used in the relevant product, they may, to the extent necessary, order persons who were operating the business of importing the relevant product at the time of the relevant designation to make efforts to recall the relevant product which they imported and to take any other measures necessary for preventing the spread of environmental pollution attributable to the class I specified chemical substance being used in the relevant product.
(3)In any of the cases listed in the following items, if the competent ministers find it particularly necessary for preventing the spread of environmental pollution attributable to the class I specified chemical substance, they may, to the extent necessary, order the persons respectively specified in those items to make efforts to recall the class I specified chemical substance which they manufactured, imported or used or the product using a class I specified chemical substance which they imported and to take any other measures necessary for preventing the spread of environmental pollution attributable to the relevant class I specified chemical substance:
(i)if a class I specified chemical substance has been manufactured in violation of the provisions of Article 18:the person who has manufactured the relevant class I specified chemical substance;
(ii)if a class I specified chemical substance has been imported in violation of the provisions of paragraph (1) of Article 22:the person who has imported the relevant class I specified chemical substance;
(iii)if a product using a class I specified chemical substance has been imported in violation of the provisions of paragraph (1) of Article 24:the person who has imported the relevant product using a class I specified chemical substance;
(iv)if a class I specified chemical substance has been used in violation of the provisions of Article 25:the person who has used the relevant class I specified chemical substance.
Chapter VI Regulations Concerning Class II Specified Chemical Substances
(Notification of the Planned Quantity to Be Manufactured)
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).
(Publication of Technical Guidelines)
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.
(Labeling)
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).
Chapter VII Miscellaneous Provisions
(Recommendations)
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.
(Guidance and Advice)
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.
(Conditions for Permission)
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.
(Reporting of Hazardous Properties)
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:
(i)the substance reported is not likely to undergo a chemical transformation through natural processes;
(ii)the substance reported is bioaccumulative;
(iii)the substance reported poses a risk of impairing human health if taken in continuously;
(iv)the substance reported poses a risk of interfering with the inhabitation and/or growth of flora and fauna;
(v)in the case that the substance to be reported is likely to undergo a chemical transformation through natural processes, it is one where the chemical substance (including an element) generated by the chemical transformation through natural processes falls under any of the preceding items.
(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.
(Reporting on the Status of Handling)
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.
(Collection of Reports)
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.
(On-Site Inspections)
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.
(Orders to NITE)
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.
(Request for Review Regarding the Samples Taken by 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.
(Notification)
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.
(Requests)
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:
(i)an order prescribed in paragraph (1) of Article 30:the Minister of Economy, Trade and Industry;
(ii)an order prescribed in paragraph (2) of Article 30:the competent minister.
(Fees)
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.
(Special Provisions on Hearings)
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.
(Hearing of Opinion in Procedures of Request for Review)
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).
(Transitional Measures)
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.
(Competent Ministers)
Article 53(1)The competent ministers under this Act are as follows:
(i)with regard to a notification under the provisions of Article 26, paragraph (2) of Article 27, or paragraph (1) of Article 32, an order under the provisions of paragraph (2) of Article 30 (excluding an order given to a permitted manufacturer), the collection of reports under the provisions of paragraph (2) of Article 43, or the inspection, questioning, or taking of samples under the provisions of paragraph (2) of Article 44, the minister having jurisdiction over the business operated by the person giving such a notification or the person subject to such an order, the collection of reports or inspection, questioning, or taking of samples;
(ii)with regard to an order pursuant to the provisions of paragraph (2) of Article 30 (limited to an order given to a permitted manufacturer), the Minister of Economy, Trade and Industry;
(iii)with regard to an order under the provisions of Article 34, the publication of technical guidelines under the provisions of paragraph (1) of Article 36, a recommendation under the provisions of paragraph (2) of the relevant Article or Article 38, guidance and advice under the provisions of Article 39, the collection of reports under the provisions of Article 42 or paragraph (3) of Article 43, or the inspection, questioning or taking of samples under the provisions of paragraph (3) of Article 43, the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, the Minister of the Environment and the minister having jurisdiction over the business operated by the person subject to such an order, the publication of technical guidelines, recommendation, guidance and advice, collection of reports or inspection, questioning, or taking of samples.
(2)Order of the competent ministry under this Act is as follows:
(i)with regard to the keeping, entering, and the archiving of books under the provisions of paragraphs (1) and (2) of Article 31 as applied mutatis mutandis pursuant to paragraph (3) of the relevant Article, an order issued by the minister having jurisdiction over the business operated by a person using a class I specified chemical substance;
(ii)with regard to the technical standards under the provisions of paragraph (2) of Article 28 (excluding the technical standards pertaining to permitted manufacturers), an order issued by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, the Minister of the Environment and the minister having jurisdiction over the business operated by a business operator handling a class I specified chemical substance, etc.;
(iii)with regard to the technical standards under paragraph (2) of Article 28 (limited to the technical standards pertaining to permitted manufacturers), an order issued by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry and the Minister of the Environment.
(Delegation of Authority)
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.
(Relationship with Other Acts)
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:
(i)food prescribed in paragraph (1) of Article 4 of the Food Sanitation Act (Act No. 233 of 1947), additives prescribed in paragraph (2) of the Article, containers and packaging prescribed in paragraph (5) of the relevant Article, toys prescribed in paragraph (1) of Article 62 of the relevant Act, and detergents prescribed in paragraph (2) of the relevant Article;
(ii)agricultural chemicals prescribed in paragraph (1) of Article 1-2 of the Agricultural Chemicals Regulation Act (Act No. 82 of 1948);
(iii)ordinary fertilizers prescribed in paragraph (2) of Article 2 of the Fertilizers Regulation Act (Act No. 127 of 1950);
(iv)feeds prescribed in paragraph (2) of Article 2 of the Act on Safety Assurance and Quality Improvement of Feeds (Act No. 35 of 1953) and feed additives prescribed in paragraph (3) of the relevant Article;
(v)pharmaceuticals prescribed in paragraph (1) of Article 2 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices (Act No. 145 of 1960), quasi-drugs prescribed in paragraph (2) of the same Article, cosmetics prescribed in paragraph (3) of the same Article, medical devices prescribed in paragraph (4) of the same Article, and regenerative medicine products prescribed in paragraph (9) of the same Article.
(Hearing of Opinion of Councils)
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:
(i)when intending to plan out the establishment or revision of Cabinet Order under paragraph (2) of Article 2 (excluding the case of intending to plan out such establishment or revision based on a determination under paragraphs (1) or (2) of Article 4, paragraph (8) of Article 5, or paragraph (2) of Article 14), or when intending to plan out the establishment or revision of Cabinet Order under paragraph (3) of Article 2, paragraph (1) of Article 24, Article 25, paragraph (2) of Article 28, paragraph (1) of Article 35 or paragraph (1) of Article 36;
(ii)when intending to make a designation under paragraph (4) or (5) of Article 2 (excluding the case of intending to make such designation in accordance with the procedure as prescribed in the following paragraph);
(iii)when intending to make a determination under paragraph (1), (2) or (4) of Article 4, paragraph (2), (3) or (8) of Article 5, paragraph (3) of Article 10, or paragraph (2) of Article 14;
(iv)when intending to give an instruction under paragraph (2) of Article 10 or paragraph (1) of Article 14;
(v)when intending to make an acknowledgment under paragraph (4) of Article 35.
(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.
Chapter VIII Penal Provisions
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:
(i)a person who has operated the business of manufacturing a class I specified chemical substance without obtaining permission under paragraph (1) of Article 17;
(ii)a person who has violated the provisions of Article 18, paragraph (1) of Article 24, or Article 25;
(iii)a person who has imported a class I specified chemical substance in violation of the provisions of paragraph (1) of Article 22;
(iv)a person who has violated an order to suspend business under the provisions of paragraph (1) of Article 33;
(v)a person who has violated an order under the provisions of paragraph (3) of Article 34.
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:
(i)a person who has manufactured or imported a new chemical substance in violation of the provisions of paragraph (1) of Article 3;
(ii)a person who has violated the provisions of Article 6;
(iii)a person who has violated an instruction under the provisions of paragraph (2) of Article 10 or paragraph (1) of Article 14;
(iv)a person who has manufactured or imported a class II specified chemical substance or has imported a product using a class II specified chemical substance in violation of the provisions of paragraphs (1) or (3) of Article 35 (including cases where it is applied mutatis mutandis pursuant to paragraph (5) of the relevant Article).
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:
(i)a person who has made changes in the structure or capacity of manufacturing equipment in violation of the provisions of paragraph (1) of Article 21;
(ii)a person who has failed to give a notification or has given a false notification in violation of the provisions of paragraph (1) of Article 26;
(iii)a person who has violated an order under the provisions of Article 30 or paragraphs (1) or (2) of Article 34.
Article 60A person who falls under any of the following items is punished by a fine of not more than three hundred thousand yen:
(i)a person who has failed to keep books or make entries in them or has made false entries in them in violation of the provisions of paragraph (1) of Article 31 (when it is applied mutatis mutandis pursuant to paragraph (3) of the relevant Article), or has failed to preserve the books in violation of the provisions of paragraph (2) of the same Article (when it is applied mutatis mutandis pursuant to paragraph (3) of the relevant Article);
(ii)a person who has failed to give a notification under the provisions of paragraph (1) of Article 9, paragraph (1) of Article 13, paragraph (6) of Article 35 or has given a false notification;
(iii)a person who has failed to make a report under the provisions of Article 43 or has made a false report;
(iv)a person who has refused, obstructed, or evaded an inspection or the taking of samples under the provisions of paragraphs (1) through (3) of Article 44 or has refused to answer or has given a false answer to the questioning under these provisions.
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.
(i)Article 57:A fine of not more than one hundred million yen;
(ii)item (i), (ii) or (iv) of Article 58:A fine of not more than fifty million yen
(iii)Item (iii) of Article 58, Article 59, or the preceding Article:The fine prescribed 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:
(i)a person who has failed to give notification under the provisions of paragraph (1) of Article 8 (including in cases as applied mutatis mutandis pursuant to paragraph (2) of the relevant Article), paragraph (2) of Article 21, paragraph (2) of Article 26, paragraph (2) of Article 27, paragraph (1) of Article 32 or paragraph (2) of Article 35 or has given a false notification;
(ii)a person who has failed to make a report under the provisions of paragraph (1) of 41 (including cases where as applied mutatis mutandis pursuant to paragraph (2) of the relevant Article) or has submitted a false report.
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.
Supplementary Provisions[Extract]
(Effective Date)
Article 1This Act comes into effect as from the day on which six months have elapsed from the day of promulgation; provided, however, that the provisions of the following Article come into effect as from the day of promulgation.
(List of Existing Chemical Substances)
Article 2(1)The Minister of International Trade and Industry shall prepare a list (hereinafter referred to as the "list of existing chemical substances") of the names of chemical substances that were manufactured or imported as a business at the time of the promulgation of this Act (excluding those that were manufactured or imported for testing and research purposes and those that were manufactured or imported as reagents) and make a public notice of it within three months from the day of the promulgation of this Act.
(2)Any person may, when finding it necessary to correct the list of existing chemical substances of which public notice has been given pursuant to the provisions of the preceding paragraph, propose to that effect to the Minister of International Trade and Industry, pursuant to the provisions of Order of the Ministry of International Trade and Industry, only within one month from the day of the publication of the list of existing chemical substances.
(3)When a proposal under the preceding paragraph has been made, if the Minister of International Trade and Industry finds grounds for the relevant proposal, the minister should add the name of the chemical substance to which the relevant proposal pertains to the list of existing chemical substances or delete it from the list of existing chemical substances, and should notify the person who has made the proposal to that effect.
(4)The Minister of International Trade and Industry should give public notice of the list of existing chemical substances that has undergone any additions or deletions under the provisions of the preceding paragraph by one month prior to the date of enforcement of this Act.
(Transitional Measures)
Article 3The provisions of paragraph (1) of Article 3 apply to a person who was, at the time of the enforcement of this Act, operating the business of manufacturing or importing any chemical substances other than the chemical substances listed in the list of existing chemical substances of which public notice has been given pursuant to the provisions of paragraph (4) of the preceding Article, by deeming the relevant person to be a person prescribed in paragraph (1) of Article 3.In this case, the term "in advance" as used in the relevant paragraph is deemed to be replaced with "within one month from the day of the enforcement of this Act."
Article 4Article 4 The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment should prepare a list in which the names of type II monitoring chemical substances as designated pursuant to the provisions of paragraph (5) of Article 2 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances, prior to their amendment pursuant to the provisions of Article 2 of the Act Partially Amending the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (Act No.39 of 2009; hereinafter referred to as the "Amendment Act" in this Article) and type III monitoring chemical substances as designated pursuant to the provisions of paragraph (6) of Article 2 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances prior to their amendment pursuant to the provisions of Article 2 of the Amendment Act, and should publish the list on the day of enforcement of the provisions listed in item (iii) of Article 1 of the Supplementary Provisions of the Amendment Act.
Supplementary Provisions[Act No.68 of July 25, 1975][Extract]
(1)This Act comes into effect as from the day specified by Cabinet Order within a period not more than one year from the day of promulgation.
Supplementary Provisions[Act No.57 of May 25, 1983][Extract]
(Effective Date)
Article 1This Act comes into effect as from the day specified by Cabinet Order within a period not more than three months from the day of promulgation; provided, however, that the provisions of Article 8 comes into effect as from the day specified by the Cabinet Order set forth in Article 1 of the Supplementary Provisions of the Act Partially Amending the Fertilizer Control Act (Act No. 40 of 1983).
Supplementary Provisions[Act No.44 of May 7, 1986]
(Effective Date)
(1)This Act comes into effect as from the day specified by Cabinet Order within a period not more than one year from the day of promulgation.
(Transitional Measures)
(2)Prior laws continue to govern the applicability of penal provisions to acts committed before the date of enforcement of this Act.
Supplementary Provisions[Act No.33 of June 19, 1990][Extract]
(Effective Date)
Article 1This Act comes into effect as from the day specified by Cabinet Order within a period not more than six months from the day of promulgation.
Supplementary Provisions[Act No.89 of November 12, 1993][Extract]
(Effective Date)
Article 1This Act comes into effect as from the day of enforcement of the Administrative Procedure Act (Act No. 88 of 1993).
(Transitional Measures Concerning Adverse Dispositions Following Appeal)
Article 2When an appeal or other request has been filed or made prior to the enforcement of this Act under the laws and regulations to a council or any other panel to require the implementation of procedures equivalent to the procedures to hold hearings or grant the opportunity for explanation and other procedures to hear statements of opinions prescribed in Article 13 of the Administrative Procedure Act, with regard to the procedures concerning adverse dispositions pertaining to the relevant appeal or other request, the provisions then in force remain applicable notwithstanding the provisions for the relevant Acts amended by this Act.
(Transitional Measures Concerning Penal Provisions)
Article 13Prior laws continue to govern the applicability of penal provisions to acts committed before the enforcement of this Act.
(Transitional Measures for the Arrangement of Provisions for Hearings)
Article 14Procedures for hearings (excluding those concerning adverse dispositions) implemented under Acts prior to the enforcement of this Act or incidental procedures are deemed to have been implemented under the relevant provisions of the respective Acts by this Act.
(Delegation to Cabinet Orders)
Article 15Beyond what is prescribed in Article 2 through the preceding Article of these Supplementary Provisions, the necessary transitional measures concerning the enforcement of this Act are specified by Cabinet Order.
Supplementary Provisions[Act No.151 of December 8, 1999][Extract]
(Effective Date)
Article 1This Act comes into effect as of April 1, 2000.
Article 4Prior laws continue to govern the applicability of penal provisions to acts committed before the enforcement of this Act.
Supplementary Provisions[Act No.160 of December 22, 1999][Extract]
(Effective Date)
Article 1This Act (excluding Articles 2 and 3) comes into effect from January 6, 2001.
Supplementary Provisions[Act No.96 of July 31, 2002][Extract]
(Effective Date)
Article 1This Act comes into effect as from the day specified by Cabinet Order within a period not more than three years from the day of promulgation; provided, however, that the provisions listed in the following items comes into effect as from the day specified in the relevant items respectively:
(ii)the provisions of paragraph (2) of Article 2, Article 5, Article 17, Article 27, and Articles 30 through 32 of the Supplementary Provisions:the day of promulgation
(Effects of Depositions)
Article 30Any dispositions, procedures or other acts conducted prior to the enforcement of this Act (or the respective provisions listed in the items of Article 1 of the Supplementary Provisions), pursuant to the provisions of the respective Acts prior to the amendment (including orders issued under them; hereinafter the same applies in this Article), if the respective amended Acts contain provisions corresponding to such provisions, are deemed to have been conducted under the relevant provisions of the respective amended Acts, except those otherwise provided for by the Supplementary Provisions.
(Transitional Measures Concerning Penal Provisions)
Article 31Prior laws continue to govern the applicability of penal provisions to acts committed prior to the enforcement of this Act (or the respective provisions listed in the items of Article 1 of the Supplementary Provisions) and acts committed after the enforcement of this Act but to which, pursuant to the Supplementary Provisions of this Act, are to continue to be governed by prior laws.
(Delegation to Cabinet Orders)
Article 32Beyond what is prescribed in these Supplementary Provisions, the necessary transitional measures concerning the enforcement of this Act are specified by Cabinet Order.
Supplementary Provisions[Act No.49 of May 28, 2003][Extract]
(Effective Date)
Article 1This Act comes into effect as from the day specified by Cabinet Order within a period not more than one year from the day of promulgation; provided, however, that the provisions of Article 3 of the Supplementary Provisions comes into effect as from the day specified by Cabinet Order within the period not more than nine months from the day of promulgation.
(Transitional Measures Concerning Confirmation)
Article 2A person who is specified by Cabinet Order among persons who actually manufacture or import a new chemical substance at the enforcement of this Act by falling under the cases specified by Cabinet Order under the proviso to Article 3 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances prior to the amendment by this Act without making the notification set forth in the relevant Article may continue to manufacture or import the relevant new chemical substance without making the notification set forth in paragraph (1) of Article 3 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances after the amendment by this Act (hereinafter referred to as "new Act") for the period from the day of enforcement of this Act (hereinafter referred to as the "enforcement day") until a day when six months elapses, notwithstanding the provisions of paragraph (1) of Article 3 of the new Act.
(Preparatory Actions)
Article 3A person who intends to manufacture or import a new chemical substance may obtain confirmation from the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment in accordance with the provisions of item (v) of paragraph (1) of Article 3 of the new Act even prior to the enforcement day.In this case, a person who obtains the relevant confirmation is deemed to have obtained confirmation from the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment on the enforcement day, pursuant to the provisions of the relevant item.
(Transitional Measures Concerning Application of Penal Provisions)
Article 4Prior laws continue to govern the applicability of penal provisions to acts committed before the enforcement of this Act.
(Delegation to Cabinet Orders)
Article 5Beyond what is prescribed in these Supplementary Provisions, the necessary transitional measures concerning the enforcement of this Act is specified by Cabinet Order.
(Review)
Article 6When five years have elapsed since the enforcement of this Act, the government is to, while taking into account the status of enforcement of the New Act, review the provisions of the New Act and take any necessary measures based on the review when it finds it necessary.
Supplementary Provisions[Act No.55 of May 30, 2003][Extract]
(Effective Date)
Article 1This Act comes into effect as from the day specified by Cabinet Order within a period not more than three months from the day of promulgation; provided, however, that the provisions listed in the following items come into effect as from the day specified in the relevant items respectively:
(iii)the provisions of Article 2 (excluding the provisions for amendment listed in the following item), Article 6 (excluding the provisions for amendment listed in the following item), Article 8 (excluding the provisions for amendment listed in the following item) and Article 10 of this Act; the provisions of Articles 2 through 5, Article 8, Articles 16 through 18, Articles 21 through 26, Article 31, Article 33 and Article 35:the day specified by Cabinet Order within a period not more than nine months from the day of promulgation
Supplementary Provisions[Act No.33 of April 27 of 2005][Extract]
(Effective Date)
Article 1This Act comes into effect as of October 1, 2005.
(Transitional Measures)
Article 24When an order is established, revised or abolished based on the provisions of the respective Acts after their amendment by this Act, the order may provide necessary transitional measures (including transitional measures concerning penal provisions) to the extent that it is judged reasonably necessary for their establishment, revision or abolishment.
Supplementary Provisions[Act No.39 of May 20, 2009][Extract]
(Effective Date)
Article 1This Act comes into effect as from the day specified by Cabinet Order within a period not more than three years from the day of promulgation; provided, however, that the provisions listed in the following items comes into effect as from the day specified in the relevant items respectively:
(i)the provisions of paragraph (1) of the following Article and Article 5 of the Supplementary Provisions:the day of promulgation;
(iii)the provisions of Article 2 of this Act, Article 3 (excluding paragraph (3)) and Article 7 of the Supplementary Provisions:the day specified by Cabinet Order within a period not more than two years from the day of promulgation.
(Transitional Measures)
Article 2(1)The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment may hear the opinions of a council, etc. as specified by Cabinet Order under paragraph (1) of Article 41 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances after the revision pursuant to the provisions of Article 1 of this Act (hereinafter referred to as the "new Act" in this Article) in order to enact or amend the Cabinet Order set forth in paragraph (2) of Article 17 or paragraph (1) of Article 27 of the new Act, even prior to the enforcement of this Act.
(2)With regard to measures pursuant to the provisions of paragraph (4) of Article 31-2 of the new Act where the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment have found that a substance to be reported (meaning a substance to be reported as prescribed in paragraph (1) of Article 31-2 of the new Act) falls under any of the items of paragraph (6) of Article 2 of the new Act or is suspected to fall under item (i) of paragraph (3) of the relevant Article, they are to be taken by considering whether or not a considerable amount of the relevant substance to be reported are expected to remain in the environment.
Article 3(1)Prior laws continue to govern a report which is to be made by a person who is instructed pursuant to the provisions of paragraph (1) of Article 24 or paragraph (1) of Article 25-3 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances prior to their revision pursuant to the provisions of Article 2 of this Act (hereinafter referred to as the "former Act" in this Article) and who actually engages at the time of the enforcement of the provisions listed in item (iii) of Article 1 of the Supplementary Provisions in the business of manufacturing or importing a type II monitoring chemical substance as prescribed in paragraph (5) of Article 2 of the former Act (hereinafter referred to as a "type II monitoring chemical substance" in the following paragraph) or a type III monitoring chemical substance as prescribed in paragraph (6) of the relevant Article of the former Act (hereinafter referred to as a "type III monitoring chemical substance").
(2)Prior laws continue to govern a report which is to be made by a person who actually engages at the time of the enforcement of the provisions listed in item (iii) of Article 1 of the Supplementary Provisions in the business of manufacturing or importing a type II monitoring chemical substance or a type III monitoring chemical substance for which the knowledge prescribed in paragraphs (1) or (3) of Article 31-2 of the former Act is obtained with respect to a type II monitoring chemical substance or a type III monitoring chemical substance.
(3)The Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry, and the Minister of the Environment may hear the opinions of a council, etc. as specified by Cabinet Order under paragraph (1) of Article 56 of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances after their revision pursuant to the provisions of Article 2 of this Act (hereinafter referred to as the "new Act" in this Article) in order to provide a designation under paragraph (5) of Article 2 of the new Act, even prior to the day of enforcement of the provisions listed in item (iii) of Article 1 of the Supplementary Provisions.
(4)A type I monitoring chemical substance that is actually designated pursuant to the provisions of paragraph (4) of Article 2 of the former Act at the time of the enforcement of the provisions listed in item (iii) of Article 1 of the Supplementary Provisions is deemed to be a monitoring chemical substance as designated pursuant to the provisions of paragraph (4) of Article 2 of the new Act.
(Transitional Measures Concerning Penal Provisions)
Article 4Prior laws continue to govern the application of penal provisions to acts committed prior to the enforcement of this Act (or the respective provisions listed in the items of Article 1, item (iii) of the Supplementary Provisions) and acts committed after the enforcement of this Act, in case which is to continue to be governed by prior laws pursuant to the provisions of paragraphs (1) and (2) of the preceding Article.
(Delegation to Cabinet Order)
Article 5Beyond what is prescribed in these Supplementary Provisions, the necessary transitional measures concerning the enforcement of this Act (including transitional measures concerning the penal provisions) is specified by Cabinet Order.
(Review)
Article 6When five years have elapsed since the enforcement of this Act, the government is to, while taking into account the status of enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances, review the provisions of the New Act and take any necessary measures based on the review when it finds it necessary..