REGULATIONS ON CLASSIFICATION AND LABELLING OF CHEMICALS
Notice No. 201445, Dec. 31, 2014
Amended by Notice No. 20154, Feb. 17, 2015
Notice No. 20166, Apr. 25, 2016
Notice No. 201615, Aug. 26, 2016
Notice No. 201622, Oct. 31, 2016
Notice No. 20171, Jan. 31, 2017
Notice No. 201712, Jul. 20, 2017
Notice No. 201746, Sep. 29, 2017
Notice No. 20185, Feb. 28, 2018
Notice No. 201821, May 23, 2018
Notice No. 201844, Nov. 5, 2018
Notice No. 201862, Dec. 20, 2018
CHAPTER I GENERAL PROVISIONS
The purpose of these Regulations is to prescribe detailed matters concerning the classification and labelling of chemical substances and other necessary matters pursuant to Articles 14 (1), 12 (1) 2, and 21 (1) of the Act on Registration and Evaluation of Chemical Substances (hereinafter referred to as the "Act on Registration and Evaluation of Chemical Substances") and Articles 10 (2) 2 (a), 10 (3), and 28 of the Enforcement Rule of the aforesaid Act; Article 16 (1) of the Chemical Substances Control Act; and Article 12 (4) of the Enforcement Rule of the aforesaid Act.
The terms used in these Regulations shall be defined as follows:
| 1. | The term "hazard class" means physical hazards, health hazards, or environmental hazards, in intrinsic nature, as specified in attached Table 7 under Article 10 (3) of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances and subparagraphs 2 through 4 of attached Table 3 under Article 12 (3) of the Enforcement Rule of the Chemical Substances Control Act; |
| 2. | The term "hazard category" means a subclass of a hazard class, which is categorized according to the classification criteria under Chapters II through IV of attached Table 1 of these Regulations; |
| 4. | The term "single packaging" means any packaging other than combination packaging; |
| 5. | The term "combination packaging" means packaging with at least one container or package placed inside another container or package; |
| 6. | The term "outer packaging" means the packaging on the outermost surface of combination packaging, which includes absorbing and cushioning materials used to contain and protect inner containers and packages; |
| 7. | The term "inner packaging" means the packaging that requires outer packaging for transportation; |
| 8. | The term "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)" means the globally harmonized system established by the United Nations (UN) for classifying and labelling chemical substances; |
| 9. | The term "United Nations (UN) number" means a number for identifying a substance, as allocated by the United Nations for international transportation and protection of hazardous and dangerous substances and products; |
| 10. | The term "mixture" means a compound or solution of at least two different substances, as defined in subparagraph 2 of Article 2 of the Act on Registration and Evaluation of Chemical Substances, and impurities or by-products that affect final classification shall be deemed components for the purposes of classification under these Regulations; |
| 11. | The term "pyrotechnic article" means an article containing at least one pyrotechnic substance or mixture; |
| 12. | The term "detonation" means supersonic pyrolysis that occurs with a shock wave derived from decomposing substances; |
| 13. | The term "substance (or mixture) used in a pyrotechnic article" means a substance or mixture designed to produce an effect by heat, light, sound, gas, or smoke as a result of a non-detonative, self-sustaining, exothermic chemical reaction; |
| 14. | The term "explosive article" means a product that contains at least one explosive substance or mixture; |
| 15. | The term "intentional explosive substance or explosive" means a substance, mixture, or article, manufactured with intent to produce a practical explosive or pyrotechnic effect; |
| 16. | The term "mass explosion" means an explosion that affects almost an entire quantity present virtually instantaneously; |
| 17. | The term "aerosol (aerosol dispenser)" means a non-refillable receptacle made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved (including where the gas contains a liquid, paste or powder) with a release device that allows the contents thereof to be ejected as solid or liquid particles in suspension in the gas or as a foam, paste or powder in a liquid or in a gas; |
| 18. | The term "deflagration" means combustion quickly propagating without producing any shock wave; |
| 19. | The term "readily combustible solid" means a powdered, granular, or pasty substance or mixture, which can be easily ignited by brief contact with an ignition source, or the flame of which spreads rapidly; |
| 20. | The term "dust" means solid particles of a substance or mixture suspended in a gas (usually air) formed generally by mechanical processes; |
| 21. | The term "mist" means liquid droplets of a substance or mixture suspended in a gas (usually air) formed generally by condensation of over-saturated vapors or by physical shearing of liquids; |
| 22. | The term "vapor" means the gaseous form of a substance or mixture, released from its liquid or solid state; |
| 23. | The term "weighting factor" means a value applicable to a seriously hazardous ingredient according to the criteria for classification of mixtures that cause skin corrosion or irritation (3.2); serious eye damage or irritation (3.3); or hazards to the aquatic environment (4.1); listed in attached Table 1 of these Regulations; |
| 24. | The term "multiplying factor" means a value applicable to highly toxic ingredients according to the criteria for classification of mixtures hazardous to the aquatic environment (4.1) in attached Table 1 of these Regulations; |
| 25. | Other terms used in these Regulations shall be defined by applying the GHS mutatis mutandis. |
| Article 3 (Scope of Application) |
These Regulations shall apply to the following matters:
| 1. | Detailed matters concerning the criteria for classification of hazard classes under Articles 14 (1) and 12 (1) 2 of the Act on Registration and Evaluation of Chemical Substances and Article 10 (2) 2 (a) and attached Table 7 under Article 10 (3) of the Enforcement Rule of the aforesaid Act; |
| 2. | Methods for reviewing hazards under Articles 18, 19, and 21 of the Act on Registration and Evaluation of Chemical Substances and Articles 23, 24, and 28 of the Enforcement Rule of the aforesaid Act and notice and public notification of the results of reviewing hazards; |
| Article 4 (Applicable Norms) |
The following norms shall apply to any matters not prescribed by these Regulations:
| 2. | The UN Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria. |
| Article 5 (General Principles for Classification and Labelling) |
| (1) | Detailed matters concerning the classification and labelling of chemical substances under Articles 14 (1) and 12 (1) 2 of the Act on Registration and Evaluation of Chemical Substances, and Article 10 (2) 2 (a) and attached Table 7 under Article 10 (3) of the Enforcement Rule of the aforesaid Act, shall be as specified in Chapter II of these Regulations. |
| (3) | The classification and labelling of chemical substances shall be based on currently available data. Therefore, it need not conduct any additional test for classification and labelling. |
| (4) | Notwithstanding paragraphs (1) and (2), if a hazardous chemical substance is listed in attached Table 4 of these Regulations for classification and labelling, the relevant classification and labelling may be used as they are: Provided, That, if the classification and labelling of a chemical substance are different from those specified in attached Table 4 of these Regulations, the evidence thereof shall be recorded and preserved. |
CHAPTER II CLASSIFICATION AND LABELLING
| Article 6 (Classification Criteria) |
| (1) | Detailed matters concerning the criteria for classification of hazard classes under attached Table 7 under Article 10 (3) of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances and attached Table 3 related to Article 12 (3) of the Enforcement Rule of the Chemical Substances Control Act shall be as specified in attached Table 1 of these Regulations: Provided, That the classification criteria in attached Table 1 of these Regulations shall not apply to any ingredient less concentrated than the concentration limit specified in either of the following subparagraphs, among ingredients of a chemical substance: |
| 1. | The general concentration limits specified in Chapter I-1 of attached Table 1 of these Regulations; |
| 2. | The concentration specified in Chapter II (Hazard Classes) of attached Table 1 of these Regulations or the concentration specified in the criteria for classification of mixture in Chapters III and IV (Hazard Classes) of the aforesaid Table. |
| (2) | If at least two concentration limits apply under the proviso of paragraph (1), the smallest value among them shall apply: Provided, That, if the classification and labelling of a chemical substance are changed as a consequence of applying a weighting factor or a multiplying factor, even at a concentration lower than the value, a different concentration limit shall apply. |
| Article 7 (Location of Labels) |
| 2. | The labels under subparagraph 1 shall be readable horizontally, when the container and package are placed normally. The location of label elements specified in attached Table 2 under Article 12 (2) of the Enforcement Rule, including the identity, pictograms, signal words, hazard and danger statements, precautionary statements, and information about the supplier, may be changed as necessary. |
| 1. | The name (or common name) and identification number (or Chemical Abstracts Service (CAS) number) of a hazardous chemical substance; |
| 2. | The product name or mixture name and the content of a hazardous chemical substance, if a mixture is a hazardous chemical substance. |
| (2) | When the hazard of acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitization, or specific target organ toxicity caused by a non-hazardous ingredient is described in the label of a mixture, which is a hazardous substance, the relevant chemical identity may be described in the label. |
| (3) | If it is impracticable to state the name of a hazardous substance under paragraph (1) or (2), the relevant CAS number may be described in lieu thereof. |
| (1) | The pictogram specified in subparagraph 6 (b) of attached Table 7 under Article 10 (3) of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances shall have a black symbol in white background and shall be enclosed by a red border with a conspicuous and sufficient width. The pictogram shall be in the shape of a rhombus set at a point. The same shall also apply to the labelling under Article 12 of the Enforcement Rule of the Chemical Substances Control Act. |
| (2) | The pictogram for each hazard class or category used in the labelling of a chemical substance shall be as specified in "Label Elements" in Chapters II through IV of attached Table 1 of these Regulations and attached Table 2 of these Regulations. |
| (3) | If the pictogram chosen under paragraph (2) falls under any of the following subparagraphs, it shall comply with the following rules: |
| 1. | If the skull and crossbones are applied, no exclamation mark shall be used; |
| 2. | If the corrosive symbol is applied, no exclamation mark shall be used to indicate skin or eye irritation; |
| 3. | If the health hazard symbol is applied for respiratory sensitization, no exclamation mark shall be used to indicate skin sensitization or skin or eye irritation; |
| 4. | The "UN Recommendation on the Transport of Dangerous Goods, Model Regulations" shall apply to the order of priority of pictograms indicating a physical hazard. |
| Article 10 (Signal Words) |
| (1) | The following terms shall be used as signal words referred to in subparagraph 6 (c) of attached Table 7 under Article 10 (3) of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances: Provided, That if "danger" is used as a signal word, "warning" shall be omitted. The same shall also apply to labeling under Article 12 of the Enforcement Rule of the Chemical Substances Control Act: |
| 1. | Danger: The word shall be used to indicate severer hazardous categories; |
| 2. | Warning: The word shall be used to indicate less severe hazardous categories. |
| (2) | The signal words used for each hazard class or category in labelling chemical substances shall be as specified in the "Label Elements" in Chapters II through IV of attached Table 1 of these Regulations. |
| Article 11 (Hazard or Danger Statements) |
The hazard or danger statements (codes) used for each hazard class or category in labelling chemical substances under subparagraph 6 (d) of attached Table 7 under Article 10 (3) of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances, shall be as specified in the "Label Elements" in Chapters II through IV of attached Table 1 of these Regulations and subparagraph 1 of attached Table 3 of these Regulations. The same shall also apply to labeling under Article 12 of the Enforcement Rule of the Chemical Substances Control Act.
| Article 12 (Precautionary Statements) |
| (1) | The precautionary statements (codes) used for each hazard class or category in labelling chemical substances under subparagraph 6 (e) of attached Table 7 of Article 10 (3) of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances shall be as specified in the "Label Elements" in Chapters II through IV of attached Table 1 of these Regulations and subparagraph 2 of attached Table 3 of these Regulations. The same shall also apply to labeling under Article 12 of the Enforcement Rule of the Chemical Substances Control Act. |
| (2) | If at least seven precautionary statements are chosen under paragraph (1), not more than six statements therefrom may be indicated according to the level of severity of hazard. |
| (3) | If the precautionary statements chosen under paragraphs (1) and (2) overlap or are mutually similar, they may be inserted in combinations. |
| (4) | The precautionary statements in paragraphs (2) and (3) may be labelled in the form of codes. |
CHAPTER III LIST OF CLASSIFICATION AND LABELLING
| Article 13 (List of Classification and Labelling) |
| (1) | The classification of hazard of hazardous chemical substances necessary for the labelling under Articles 14 (1) and 12 (1) 2 of the Act on Registration and Evaluation of Chemical Substances, Articles 10 (2) 2 (a) and 10 (3) of the Enforcement Rule of the aforesaid Act, Article 16 of the Chemical Substances Control Act, Article 12 of the Enforcement Rule of the aforesaid Act, and these Regulations, label elements, including pictograms, and multiplying factors shall be as specified in the List of Classification and Labelling in attached Table 4 of these Regulations. |
| (2) | The President of the National Institute of Environmental Research shall establish and maintain a list of classification and labelling under paragraph (1) in the form of a database so that the general public can use it easily. |
ADDENDA
Article 1 (Enforcement Date)
These Regulations shall enter into force on January 1, 2015.
Article 2 (Repeal of Former Regulations)
The Regulations on the Criteria for Classification of Toxic Substances, etc. and Methods of Labelling thereof (Public Notice No. 2014-41 by the President of the National Institute of Environmental Research on Dec. 26, 2014) shall be repealed simultaneously when these Regulations enter into force.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2015-4, Feb. 17, 2015>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2016-6, Apr. 25, 2016>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2016-15, Aug. 26, 2016>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2016-22, Oct. 31, 2016>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2017-1, Jan. 31, 2017>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2017-12, Jul. 20, 2017>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2017-46, Sep. 29, 2017>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2018-5, Feb. 28, 2018>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2018-21, May 23, 2018>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2018-44, Nov. 5, 2018>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.
ADDENDUM <Public Notice of the National Institute of Environmental Research No. 2018-62, Dec. 20, 2018>
(Enforcement Date) These Regulations shall enter into force on the date of their public notice.