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Article 57-4Assessment of the potential for harm from Chemical Substances

第五十七条の四(化学物質の有害性の調査)

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:

化学物質による労働者の健康障害を防止するため、既存の化学物質として政令で定める化学物質(第三項の規定によりその名称が公表された化学物質を含む。)以外の化学物質(以下この条において「新規化学物質」という。)を製造し、又は輸入しようとする事業者は、あらかじめ、厚生労働省令で定めるところにより、厚生労働大臣の定める基準に従つて有害性の調査(当該新規化学物質が労働者の健康に与える影響についての調査をいう。以下この条において同じ。)を行い、当該新規化学物質の名称、有害性の調査の結果その他の事項を厚生労働大臣に届け出なければならない。ただし、次の各号のいずれかに該当するときその他政令で定める場合は、この限りでない。

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;

当該新規化学物質に関し、厚生労働省令で定めるところにより、当該新規化学物質について予定されている製造又は取扱いの方法等からみて労働者が当該新規化学物質にさらされるおそれがない旨の厚生労働大臣の確認を受けたとき。

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;

当該新規化学物質に関し、厚生労働省令で定めるところにより、既に得られている知見等に基づき厚生労働省令で定める有害性がない旨の厚生労働大臣の確認を受けたとき。

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

当該新規化学物質を試験研究のため製造し、又は輸入しようとするとき。

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.

当該新規化学物質が主として一般消費者の生活の用に供される製品(当該新規化学物質を含有する製品を含む。)として輸入される場合で、厚生労働省令で定めるとき。

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.

有害性の調査を行つた事業者は、その結果に基づいて、当該新規化学物質による労働者の健康障害を防止するため必要な措置を速やかに講じなければならない。

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.

厚生労働大臣は、第一項の規定による届出があつた場合(同項第二号の規定による確認をした場合を含む。)には、厚生労働省令で定めるところにより、当該新規化学物質の名称を公表するものとする。

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.

厚生労働大臣は、第一項の規定による届出があつた場合には、厚生労働省令で定めるところにより、有害性の調査の結果について学識経験者の意見を聴き、当該届出に係る化学物質による労働者の健康障害を防止するため必要があると認めるときは、届出をした事業者に対し、施設又は設備の設置又は整備、保護具の備付けその他の措置を講ずべきことを勧告することができる。

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.

前項の規定により有害性の調査の結果について意見を求められた学識経験者は、当該有害性の調査の結果に関して知り得た秘密を漏らしてはならない。ただし、労働者の健康障害を防止するためやむを得ないときは、この限りでない。

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