Industrial Safety and Health Act

A person that transfers or provides explosives, pyrophorus, flammables, or any other substance that could put a worker in danger and are specified by Cabinet Order; that transfers or provides benzene, preparations containing benzene, or other substances that could cause a worker's health to be impaired and are specified by Cabinet Order; or the substances referred to in paragraph (1) of the preceding Article, with putting them into a container or a package, must label the container or the package (or label the container, if the substances are put o a container and also packaged before being transferred or provided) with the following things, pursuant to Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply to containers or packages that are intended primarily for use by general consumers:

the following particulars:

the name of the substance;

its effects on the human body;

precautions concerning storage or handling;

particulars specified by Order of the Ministry of Health, Labour and Welfare, beyond what is set forth in (a) through (c).

the markings meant to draw the attention of workers handling those substances that are specified by the Minister of Health, Labour and Welfare.

A person that transfers or provides the substances specified by Cabinet Order that are referred to in the preceding paragraph, or the substances referred to in paragraph (1) of the preceding Article, in a manner other than that which is prescribed in the preceding paragraph must deliver a document giving the particulars referred to in each item of that paragraph to the person to which the substances are transferred or provided, pursuant to Order of the Ministry of Health, Labour and Welfare.

A person that transfers or provides a substance specified by Cabinet Order that could put a worker in danger or cause impairments of worker's health, or the substances referred to in the provisions of paragraph (1) of Article 56 (hereinafter in this Article and paragraph (1) of the following Article referred to as the "substance subject to notice") (such a person is referred to as a "transferor or provider of a substance subject to notice" in the following paragraph, paragraphs (3) and (9), and paragraph (1) of Article 100), must notify the person to which the substance subject to notice is to be transferred or provided of the following particulars (excluding the particulars prescribed in paragraph (2) of the preceding Article for a person prescribed in the provisions of that paragraph) through the delivery of a document or by any other means that is specified by Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply to the transfer or provision of a substance subject to notice intended primarily for ordinary use by general consumers:

the name of the substance;

the ingredients and their amounts;

the physical and chemical properties;

its effects on the human body;

precautions concerning storage or handling;

emergency measures to be taken if such incident as a spill occurs;

in addition to the matters set forth in each of the preceding items, those specified by Order of the Ministry of Health, Labour and Welfare.

If it becomes necessary for a transferor or provider of a substance subject to notice to change something about which it has provided notice pursuant to the provisions of the preceding paragraph, the person must endeavor to promptly notify the other parties to which it has transferred or provided the relevant substance of all the things referred to in the items of that paragraph after the change, through the delivery of a document or by any other means specified by Order of the Ministry of Health, Labour and Welfare.

If the information on an ingredient referred to in item (ii) of paragraph (1) concerning a substance subject to notice (limited to an ingredient that is a chemical substance specified by Order of the Ministry of Health, Labour and Welfare in consideration of the degree of the risk of danger or health impairment to workers) is information on a product that is managed as a secret or other information useful for business activities that is not publicly known, a transferor or provider of a substance subject to notice may, after clearly indicating that fact in advance to the person to which the substance subject to notice is to be transferred or provided, determine a chemical name in which part of the characters representing the structure or constituent elements of the ingredient in the chemical name of that ingredient has been omitted or replaced, or the particulars specified by Order of the Ministry of Health, Labour and Welfare (hereinafter referred to as an "alternative chemical name, etc."), and give notice of it in lieu of the notice under the provisions of the preceding two paragraphs.

A person that has given notice of an alternative chemical name, etc. pursuant to the provisions of the preceding paragraph (referred to as a "person notifying an alternative chemical name, etc." in the following paragraph and paragraph (4) of Article 103) must, pursuant to Order of the Ministry of Health, Labour and Welfare, record the ingredients of the substance subject to notice to which that notice pertains, the alternative chemical name, etc. that it has notified, and other particulars specified by Order of the Ministry of Health, Labour and Welfare.

If health impairments have occurred or are likely to occur due to a substance subject to notice, and it is necessary for diagnosis or treatment by a physician or any other act specified by Order of the Ministry of Health, Labour and Welfare, a person notifying an alternative chemical name, etc. must, at the request of that physician, disclose the information on the ingredients of that substance subject to notice to that physician, pursuant to Order of the Ministry of Health, Labour and Welfare.

When transferring or providing a substance subject to notice, a person that has been notified of an alternative chemical name, etc. for an ingredient of that substance subject to notice pursuant to the provisions of paragraph (3) may, after clearly indicating in advance to the person to which the substance subject to notice is to be transferred or provided that it has been notified of an alternative chemical name, etc. for the ingredient of that substance subject to notice, give notice of the alternative chemical name, etc. in lieu of the notice under the provisions of paragraph (1) or (2). The same applies to a person that has been notified of an alternative chemical name, etc. pursuant to the provisions of this paragraph.

Beyond what is provided for in the preceding six paragraphs, Order of the Ministry of Health, Labour and Welfare provides for the necessary particulars in connection with notices as referred to in paragraphs (1) and (2).

The Minister of Health, Labour and Welfare is to release the necessary guidelines to ensure the appropriate and effective implementation of notices of alternative chemical names, etc. under paragraphs (3) and (6).

The Minister of Health, Labour and Welfare may provide the necessary guidance to a transferor or provider of a substance subject to notice in accordance with the guidelines referred to in the preceding paragraph.

Pursuant to Order of the Ministry of Health, Labour and Welfare, an employer must assess the things such as the potential for danger or harm from the substances specified by Cabinet Order pursuant to paragraph (1) of Article 57 and from substances subject to notice.

An employer must endeavor to take the necessary measures to prevent the endangerment of workers and the impairment of workers' health, in addition to taking measures under the provisions of this Act or an order under this Act, based on the results of the investigations referred to in the preceding paragraph.

The Minister of Health, Labour and Welfare is to release the necessary guidelines in connection with the measures referred to in the preceding two paragraphs in order to ensure the appropriate and effective implementation thereof, beyond what is provided for in paragraphs (1) and (3) of Article 28.

The Minister of Health, Labour and Welfare may provide the necessary guidance and assistance to employers and associations thereof in accordance with the guidelines referred to in the preceding paragraph.

To prevent the impairment of workers' health by chemical substances, an employer that seeks to manufacture or import a chemical substance other than a chemical substance that is specified by Cabinet Order as an existing chemical substance (including a chemical substance whose name has been made public pursuant to the provisions of paragraph (3)) (such an other chemical substance is hereinafter in this Article referred to as a "new chemical substance"), must first undertake a assessment of the potential for harm as specified by Order of the Ministry of Health, Labour and Welfare (meaning an assessment of the influence of the new chemical substance on the health of workers hereinafter the same applies in this Article) and, pursuant to Order of the Ministry of Health, Labour and Welfare, file a notification of the name of the new chemical substance and the result of the assessment of the potential for harm and other particulars with the Minister of Health, Labour and Welfare; provided, however, that this does not apply if the situation falls under any of the following items or in a case provided by Cabinet Order:

pursuant to Order of the Ministry of Health, Labour and Welfare, the employer has received confirmation from the Minister of Health, Labour and Welfare in respect of the new chemical substance indicating that things such as the manufacturing or handling method that is being contemplated for the new chemical substance has been reviewed and it is not likely that the workers will be exposed to the new chemical substance;

pursuant to Order of the Ministry of Health, Labour and Welfare, the employer has received confirmation from the Minister of Health, Labour and Welfare in respect of the new chemical substance, indicating that, based on things such as findings that have already been made, the new chemical substance does not have the toxicity prescribed by Order of the Ministry of Health, Labour and Welfare;

the employer seeks to manufacture or import the new chemical substance for the sake of research or studies;

the new chemical substance would be imported primarily as a product for ordinary use by general consumers (this includes a product containing the new chemical substance), and in the case specified by Order of the Ministry of Health, Labour and Welfare.

An employer that has carried out a assessment of the potential for harm must promptly take the necessary measures based on the results of the investigation to prevent the impairment of workers' health by the relevant new chemical substance.

Having received a notification for a new chemical substance under the provisions of paragraph (1) (or having made a confirmation under the provisions of item (ii) of that paragraph), the Minister of Health, Labour and Welfare must make public the name of the new chemical substance pursuant to Order of the Ministry of Health, Labour and Welfare.

Having received a notification under the provisions of paragraph (1) and on finding, after hearing the opinions of persons with relevant knowledge and experience on the results of the toxicity assessment pursuant to Order of the Ministry of Health, Labour and Welfare, that it is necessary to do so in order to prevent the impairment of workers' health by the chemical substance to which the notification pertains, the Minister of Health, Labour and Welfare may issue a recommendation to the employer filing the notification to establish or streamline facilities or equipment, make available personal protective equipment, or take other measures.

A person with relevant knowledge and experience who has been asked for an opinion on the results of an assessment of potential for harm pursuant to the provisions of the preceding paragraph must not divulge any secret learned in connection with the results of the toxicity assessment; provided, however, that this does not apply if the person is compelled to disclose this information for the purpose of preventing the impairment of workers' health.

On finding that it is necessary to do so in order to prevent the impairment of workers' health by a chemical substance that could give workers cancer or cause workers to sustain any other significant impairment to health, the Minister of Health, Labour and Welfare may, pursuant to Order of the Ministry of Health, Labour and Welfare, instruct employers that manufacture, import or use this chemical substance or other employers prescribed by Order of the Ministry of Health, Labour and Welfare to carry out the toxicity assessments specified by Cabinet Order (meaning assessment of the influence of that chemical substance on the impairment of workers' health) and to report the results.

The Minister of Health, Labour and Welfare is to give any instructions as under the provisions of the preceding paragraph in conformity with the standards established by the Minister of Health, Labour and Welfare, in consideration of things such as the technical level of the toxicity assessment of the chemical substance, the preparedness of the institution carrying out the investigation, and the investigative abilities of the employer concerned, in a comprehensive manner.

Before issuing the instructions under the provisions of paragraph (1), the Minister of Health, Labour and Welfare must first hear the opinions of persons with relevant knowledge and experience, pursuant to Order of the Ministry of Health, Labour and Welfare.

An employer that has carried out a toxicity assessment under the provisions of paragraph (1) must promptly take the necessary measures based on the results of that investigation to prevent impairment of workers' health by the relevant chemical substance.

A person with relevant knowledge and experience who has been asked for an opinion on the instructions under the provisions of paragraph (1) pursuant to the provisions of paragraph (3) must not divulge any secret learned in connection with those instructions; provided, however, that this does not apply if the person is compelled to disclose this information for the purpose of preventing the impairment of workers' health.

In order to contribute to the adequate implementation of a toxicity assessment under the provisions of the preceding two Articles, the State is to endeavor to streamline facilities that implement toxicity assessments for chemical substances, ensure the provision of information and other necessary assistance, and endeavor to carry out toxicity assessments by itself.