Order for Enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.

Link to law: http://www.japaneselawtranslation.go.jp/law/detail_download/?ff=08&id=2017
Published: 2009

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Order for Enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.

(Class I Specified Chemical Substances)

Article 1 The Class I Specified Chemical Substances referred to in Article 2, paragraph (2) of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (hereinafter referred to as "Act") are the following chemical substances:

(i) polychlorinated biphenyls;

(ii) polychlorinated naphthalenes (limited to those containing three or more chlorine atoms);

(iii) hexachlorobenzene;

(iv) 1, 2, 3, 4, 10, 10-hexachloro-1, 4, 4a, 5, 8, 8a-hexahydro-exo-1, 4-end-5, 8-dimethanonaphthalene (also known as Aldrin; referred to as "Aldrin" in item (iii) of the table in Article 7);

(v) 1, 2, 3, 4, 10, 10-hexachloro-6, 7-epoxy-1, 4, 4a, 5, 6, 7, 8, 8a-octahydro-exo-1, 4-endo-5, 8-dimethano naphthalene (also known as Dieldrin; referred to as "Dieldrin" in item (iv) of the table in Article 7);

(vi) 1, 2, 3, 4, 10, 10-hexachloro-6, 7-epoxy-1, 4, 4a, 5, 6, 7, 8, 8a-octahydro-endo-1, 4-endo-5, 8-dimethano naphthalene (also known as Endrin);

(vii) 1, 1, 1-trichloro-2, 2-bis (4-chlorophenyl) ethane (also known as DDT; referred to as "DDT" in item (iii) of the table in Article 7);

(viii) 1, 2, 4, 5, 6, 7, 8, 8-octachloro-2, 3, 3a, 4, 7, 7a-hexahydro-4, 7-methano-1H-indene, 1, 4, 5, 6, 7, 8, 8-heptachloro-3a, 4, 7, 7a-tetrahydro-4, 7-methano-1H-indene and their analogous compounds (also known as Chlordane or Heptachlor; referred to as "Chlordanes" in item (v) of the table in Article 7);

(ix) bis (tributyltin) =oxide;

(x) N, N'-ditolyl-p-phenylenediamine, N-tolyl-N'-xylyl-p-phenylenediamine, or N, N'-dixylyl-p-phenylenediamine;

(xi) 2, 4, 6-tri-tert-butylphenol;

(xii) polychloro-2, 2-dimethyl-3-methylidenebicyclo [2. 2. 1] heptane (also known as Toxaphene);

(xiii) dodecachloropentacyclo [5. 3. 0. 0(2, 6). 0(3, 9). 0(4, 8)] decane (also known as Mirex; referred to as "Mirex" in item (ix) of the table in Article 7);

(xiv) 2, 2, 2-trichloro-1, 1-bis (4-chlorophenyl) ethanol (also known as Kelthane or Dicofol);

(xv) hexachlorobuta-1, 3-diene;

(xvi) 2-(2H-1, 2, 3-benzotriazol-2-yl)-4, 6-di-tert-butylphenol;

(xvii) perfluoro (octane-1-sulfonic acid) (also known as PFOS; hereinafter referred to as "PFOS") or its salts;

(xviii) perfluoro (octane-1-sulfonyl) =fluoride (also known as PFOSF);

(xix) pentachlorobenzene;

(xx) r-1, c-2, t-3, c-4, t-5, t-6-hexachlorocyclohexane (also known as alpha- hexachlorocyclohexane);

(xxi) r-1, t-2, c-3, t-4, c-5, t-6-hexachlorocyclohexane (also known as beta- hexachlorocyclohexane);

(xxii) r-1, c-2, t-3, c-4, c-5, t-6-hexachlorocyclohexane (also known as gamma- hexachlorocyclohexane);

(xxiii) decachloropentacyclo [5. 3. 0. 0(2, 6). 0(3, 9). 0(4, 8)] decan-5-one (also known as chlordecone);

(xxiv) hexabromobiphenyl;

(xxv) tetrabromo (phenoxybenzene) (also known as tetrabromodiphenyl ether; referred to as "tetrabromodiphenyl ether" in item (xii) of the table in Article 7);

(xxvi) pentabromo (phenoxybenzene) (also known as pentabromodiphenyl ether; referred to as "pentabromodiphenyl ether" in item (xiii) of the table in Article 7);

(xxvii) hexabromo (phenoxybenzene) (also known as hexabromodiphenyl ether);

(xxviii) heptabromo (phenoxybenzene) (also known as heptabromodiphenyl ether).

(Class II Specified Chemical Substances)

Article 2 The Class II Specified Chemical Substances referred to in Article 2, paragraph (3) of the Act are the following chemical substances:

(i) trichloroethylene;

(ii) tetrachloroethylene;

(iii) carbon tetrachloride;

(iv) triphenyltin=N, N-dimethyldithiocarbamate;

(v) triphenyltin=fluoride;

(vi) triphenyltin=acetate;

(vii) triphenyltin=chloride;

(viii) triphenyltin=hydroxide;

(ix) triphenyltin fatty acid salts (limited to those containing 9, 10 or 11 carbon atoms in the fatty acid);

(x) triphenyltin=chloroacetate;

(xi) tributyltin=methacrylate;

(xii) bis (tributyltin)=fumarate;

(xiii) tributyltin=fluoride;

(xiv) bis (tributyltin)=2, 3-dibromosuccinate;

(xv) tributyltin=acetate;

(xvi) tributyltin=laurate;

(xvii) bis (tributyltin)=phthalate;

(xviii) copolymer of alkyl=acrylate, methyl=methacrylate and tributyltin=methacrylate (limited to those containing 8 carbon atoms in the alkyl group of the alkyl=acrylate);

(xix) tributyltin=sulfamate;

(xx) bis (tributyltin)=maleate;

(xxi) tributyltin=chloride;

(xxii) mixture of tributyltin=cyclopentanecarboxylate and its analogous compounds (also known as tributyltin=naphthenate);

(xxiii) mixture of tributyltin=1, 2, 3, 4, 4a, 4b, 5, 6, 10, 10a-decahydro-7-isopropyl-1, 4a-dimethyl-1-phenanthrenecarboxylate and its analogous compounds (also known as tributyltin salt of rosin).

(Cases Not Requiring Notification of the Manufacture or Import of a New Chemical Substance)

Article 3 (1) The cases specified by Cabinet Order referred to in Article 3, paragraph (1), item (iv) of the Act are the following cases:

(i) when a person intends to manufacture or import a new chemical substance as the intermediate to another chemical substance, and has taken the necessary measures to prevent environmental pollution from the new chemical substance during the period until the new chemical substance is transformed into the other chemical substance;

(ii) when a person intends to manufacture or import a new chemical substance for use in such a way as to prevent any emission outside the facility or equipment, and has taken the necessary measures to prevent environmental pollution from the new chemical substance during the period until the new chemical substance is disposed of;

(iii) when a person intends to manufacture or import a new chemical substance for the purpose of export (limited to when the export is to a region that has been designated by Ordinance of the Ministry of Health, Labour and Welfare, Ordinance of the Ministry of Economy, Trade and Industry, and Ordinance of the Ministry of the Environment as a region where the necessary measures have been taken to prevent environmental pollution from the new chemical substance), and the person has taken the necessary measures to prevent environmental pollution from the new chemical substance during the period until the new chemical substance is exported.

(2) The quantity specified by Cabinet Order referred to in Article 3, paragraph (1), item (v) of the Act is 1 metric ton.

(Cases Subject to Exception to Evaluation, etc.)

Article 4 The quantity specified by Cabinet Order referred to in Article 5, paragraph (4), item (i) of the Act is 10 metric tons.

(Cases Not Requiring Notification of the Manufacture or Import of a General Chemical Substance)

Article 5 The quantity specified by Cabinet Order referred to in Article 8, paragraph (1), item (ii) of the Act (including when applied mutatis mutandis pursuant to paragraph (2) of said Article) is 1 metric ton.

(Cases Not Requiring Notification of the Manufacture or Import of a Priority Assessment Chemical Substance)

Article 6 The quantity specified by Cabinet Order referred to in Article 9, paragraph (1), item (ii) of the Act is 1 metric ton.

(Products Whose Import Is Prohibited If a Class I Specified Chemical Substance Is Used)

Article 7 The products specified by Cabinet Order referred to in Article 24, paragraph (1) of the Act are those listed in the right-hand column of the following table for the relevant Class I Specified Chemical Substance listed in the left-hand column of the table (excluding products designated by the Minister of Economy, Trade and Industry as being difficult to substitute with equivalent products produced in Japan and whose import is especially necessary in view of their usage).

|Class I Specified Chemical Substances|Products|

|(i) Polychlorinated biphenyls|(i) Lubricating, cutting, and hydraulic oils|

||(ii) Adhesives (excluding those of animal and botanical origin), putty, and filling materials for closing or sealing|

||(iii) Paints (excluding water-based paints), printing inks, and carbonless copying paper|

||(iv) Heating or cooling devices with a liquid heating medium|

||(v) Oil-filled transformers and paper condensers, and oil-filled condensers and organic-coated condensers|

||(vi) Air conditioners, television receivers, and microwave ovens|

|(ii) Polychlorinated naphthalenes (limited to those containing three or more chlorine atoms)|(i) Lubricating and cutting oils|

||(ii) Wood antiseptics, insecticides, and fungicides|

||(iii) Paints (limited to those for antiseptic, insecticidal, and fungicidal use)|

|(iii) Aldrin and DDT|(i) Wood antiseptics, insecticides, and fungicides|

||(ii) Paints (limited to those for antiseptic, insecticidal, and fungicidal use)|

|(iv) Dieldrin|(i) Wood antiseptics, insecticides, and fungicides|

||(ii) Paints (limited to those for antiseptic, insecticidal, and fungicidal use)|

||(iii) Wool (excluding greased wool)|

|(v) Chlordanes|(i) Wood antiseptics and insecticides|

||(ii) Wood adhesives|

||(iii) Paints (limited to those for antiseptic and insecticidal use)|

||(iv) Wood treated with antiseptics and insecticides|

||(v) Plywood treated with antiseptics and insecticides|

|(vi) Bis(tributyltin)=oxide|(i) Antiseptics and fungicides|

||(ii) Paints (limited to those used to prevent shellfishes, algae, and other living organisms in the water from adhering to surfaces) and printing inks|

||(iii) Fishnets|

|(vii) N, N'-Ditolyl-p-phenylenediamine, N-tolyl-N'-xylyl-p-phenylenediamine, or N, N'-dixylyl-p-phenylenediamine|(i) Rubber antioxidants|

||(ii) Styrene-butadiene rubber|

|(viii) 2, 4, 6-Tri-tert-butylphenol|(i) Antioxidants and other prepared additives (limited to those for lubricating and fuel oils)|

||(ii) Lubricating oils|

|(ix) Mirex|Wood insecticides|

|(x) 2-(2H-1, 2, 3-benzotriazol-2-yl)-4, 6-Di-tert-butylphenol|(i) Decorative laminate|

||(ii) Adhesives (excluding those of animal and botanical origin), putty, and filling materials for closing or sealing|

||(iii) Paints and printing ink|

||(iv) Helmets|

||(v) Radiator grills and other auto parts (excluding those made of metals)|

||(vi) Lighting covers|

||(vii) Lenses for protective spectacles and frames for spectacles|

||(viii) Deodorants|

||(ix) Waxes|

||(x) Surf-boards|

||(xi) Inked ribbons|

||(xii) Photographic paper|

||(xiii) Buttons|

||(xiv) Tubes, bathtubs, and other plastic products (limited to molded products)|

|(xi) PFOS or its salts|(i) Aircraft hydraulic oils|

||(ii) Oils used to spin thread|

||(iii) Etching agents used in metal machining|

||(iv) Etching agents used in the manufacture of semiconductors (excluding compound semiconductors that enable wireless devices that transmit/receive electrical waves of a frequency of 3 megahertz or more)|

||(v) Surface treatment agents and other prepared additives for plating use|

||(vi) Anti-reflection agent used in the manufacture of semiconductors|

||(vii) Abrasives|

||(viii) Fire extinguishers, fire-extinguishing agents for use in fire extinguishers use and fire extinguishing foam|

||(ix) Insecticides (limited to those used in the extermination of termites or ants.)|

||(x) Photographic paper|

|(xii) Tetrabromodiphenyl ether|(i) Paints|

||(ii) Adhesives|

|(xiii) Pentabromodiphenyl ether|(i) Paints|

||(ii) Adhesives|

(Possible Usages of Class I Specified Chemical Substances)

Article 8 For the Class I Specified Chemical Substances listed in left-hand column of the following table, the usages specified by Cabinet Order referred to in Article 25 of the Act are the usages listed in the right-hand column of the same table.

|Class I Specified Chemical Substances|Usage|

|PFOS or its salts|(i) Manufacture of etching agents (limited to those used in the manufacture of compound semiconductors that enable piezoelectric filters or wireless devices that transmit/receive electrical waves of a frequency of 3 megahertz or more.)|

||(ii) The manufacture of resist for semiconductor use|

||(iii) The manufacture of professional-use photographic film|

(Products in Which a Class I Specified Chemical Substance That Must Adhere to Technical Standards Are Used)

Article 9 For the Class I Specified Chemical Substances listed in the left-hand column of the following table, the products specified by Cabinet Order referred to in Article 28, paragraph (2) of the Act are the products listed in the right-hand column of the same table.

|Class I Specified Chemical Substances|Products|

|PFOS or its salts|(i) Etching agents (limited to those used in the manufacture of compound semiconductors that enable piezoelectric filters or wireless devices that transmit/receive electrical waves of a frequency of 3 megahertz or more.)|

||(ii) Resist for semiconductor use|

||(iii) Professional-use photographic film|

(Products for Which Notice Must Be Given with Regard to the Planned Quantity of Import, etc If a Class II Specified Chemical Substance Is Used)

Article 10 For the Class II Specified Chemical Substances listed in Article 2. items (xi) through (xxiii) (referred to as "tributyltin compounds" in item (iii) of the table set forth in following Article), the products specified by Cabinet Order referred to in Article 35, paragraph (1) of the Act are paints (limited to those used to prevent shellfish, algae, and other living organisms in the water from adhering to surfaces).

(Products in Which a Class II Specified Chemical Substance for Which Technical Guidelines Are Published Are Used)

Article 11 The products specified by Cabinet Order referred to in Article 38, paragraph (1) of the Act are the products listed in the right-hand column of the following table for the relevant Class II Specified Chemical Substance listed in the left-hand column of the same table.

|Class II Specified Chemical Substances|Products|

|(i) Trichloroethylene|(i) Adhesives (excluding those of animal and botanical origin)|

||(ii) Paints (excluding water-based paints)|

||(iii) Metalworking fluids|

||(iv) Cleaning agents|

|(ii) Tetrachloroethylene|(i) Vulcanized agents|

||(ii) Adhesives (excluding those of animal and botanical origin)|

||(iii) Paints (excluding water-based paints)|

||(iv) Cleaning agents|

||(v) Finishing agents for textiles|

|(iii) Tributyltin compounds|(i) Antiseptics and fungicides|

||(ii) Paints (limited to those used to prevent shellfish, algae, and other living organisms in the water from adhering to surfaces)|

(Fees)

Article 12 The fees that a person listed in the left-hand column of the following table must pay pursuant to the provisions of Article 49 of the Act are as shown in the middle column of the same table (or as shown in the right-hand column of the table in the case of an electronic application (meaning an application filed using an electronic data processing system prescribed in paragraph (1) of Article 3 of the Act on the Use of Information and Communications Technologies for Administrative Procedures (Act No. 151 of 2002) pursuant to the provisions of the same paragraph; the same applies hereinafter)).

|Persons who must pay fees|Amount|Amount in the case of an electronic application|

|(i) Persons seeking to obtain permission under Article 17,paragraph (1) of the Act|220,600 yen|213,700 yen|

|(ii) Persons seeking to obtain permission under Article 21, paragraph (1) of the Act|121,700 yen|117,200 yen|

|(iii) Persons seeking to obtain permission under of Article 22, paragraph (1) of the Act|46,700 yen|39,900 yen|

(Advisory Councils, etc., Specified by Cabinet Order)

Article 13 The advisory councils, etc. pursuant to Article 56, paragraph (1) of the Act which are specified by Cabinet Order are those listed in the right-hand column of the following table for the relevant Minister listed in the left-hand column of the same table.

|Minister of Health, Labour and Welfare|Pharmaceutical Affairs and Food Sanitation Council|

|Minister of Economy, Trade and Industry|Chemical Substances Council|

|Minister of the Environment|Central Environment Council|

Supplementary Provisions

(Effective Date)

(1) This Cabinet Order comes into effect as of June 10, 1974; provided, however, that the provisions of Article 3 come into effect as of August 1, 1974.

(Repeal of the Cabinet Order to Specify Cases Not Requiring Notification of the Manufacture or Import of a New Chemical Substance set forth in Article 3, paragraph (1) of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.)

(2) The Cabinet Order to Specify Cases Not Requiring Notification of the Manufacture or Import of a New Chemical Substance set forth in Article 3, paragraph (1) of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Cabinet Order No. 102 of 1974) is hereby repealed.

(Temporary Measures Concerning Products in Which a Class I Specified Chemical Substance That Must Adhere to the Technical Standards Is Used)

(3) With regard to the application of the provisions of Article 9, until otherwise provided for by law, the phrase "(iii) professional-use photographic film" in the Table of the same Article is deemed to be replaced with "(iii) professional-use photographic film; (iv) fire extinguishers, fire extinguishing agents, and fire-extinguishing foam."

Supplementary Provisions [Cabinet Order No. 419 of September 19, 2003]

(Effective Date)

(1) This Cabinet Order comes into effect as of the date of enforcement of the Act Partially Revising the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (hereinafter referred to as "Revising Act") (April 1, 2004).

(Persons Subject to Transitional Measures Involving Confirmation)

(2) The persons specified by Cabinet Order referred to in Article 2 of the Supplementary Provisions of the Revising Act are those who manufacture or import a new chemical substance as the intermediate of medicine that is connected with the permission prescribed in paragraph (1) of Article 12 or paragraph (1) of Article 18 of the Pharmaceutical Affairs Act (Act No. 145 of 1960).

Supplementary Provisions [Cabinet Order No. 322 of October 31, 2007]

This Cabinet Order comes into effect as of November 10, 2007; provided, however, that the provisions for revising Article 3 come into effect as of May 1, 2008.

Supplementary Provisions [Cabinet Order No. 256 of October 30, 2009]

This Cabinet Order comes into effect as of April 1, 2010; provided, however, that the provisions listed in each of the following items come into effect as of the day specified in the relevant item:

(i) the provisions for revision adding as follows to the table in Article 3: May 1, 2010

(ii) the provisions for revision adding two Articles after Article 3 (limited to the part involving Article 3-3), the provisions for revising paragraph (3) of the Supplementary Provisions and the Provisions for Revision deleting paragraph (4) of the Supplementary Provisions: October 1, 2010

Supplementary Provisions [Cabinet Order No. 257 of October 30, 2009]

This Cabinet Order comes into effect as of April 1, 2011.