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Japan to Expand Scope of Mandatory Risk Assessment and GHS Labeling Requirements

On 24 Dec 2013, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced the proposed adjustments to the health and safety policy in chemical management.

In Japan the relevant health and safety policy is implemented by the Industrial Safety and Health Law (ISHL). The new proposal consists of two major amendments of the ISHL:

  1. Expanding the scope of substances subject to mandatory risk assessment obligation

  2. Expanding the scope of substances subject to mandatory GHS labeling obligation

More specifically, the number of substances mandated to fulfill full ISHL requirements (risk assessment, labeling and SDS) are proposed to increase from 100 to 640. At present, among the approximate 60,000 chemicals substances supervised by ISHL, 100 substances with serious health hazards are subject to full mandatory obligations including risk assessment, labeling and SDS. On top of which, 16 substances require risk assessment and SDS requirements only. In addition, 524 substances are subject to mandatory SDS obligation and “effort-obligation” in terms of risk assessment and labeling. According the ISHL provisions, effort-obligation refers to the highest degree of implementation of non-mandatory provisions for which violations or failure to implement do not incur penalties.

Figure below illustrates the proposed changes:

Figure was partly adopted from MHLW announcement. Content was translated by ChemLinked.

The amendments only influence the 640 priority chemical substances where requirements for the other substances under ISHL carry the effort-obligation duty only remained unchanged. It is noted that due to the large scope expansion, mixtures consisting of the expanded substances will need to incorporate more information in the label, and subsequently lead to a significant downsizing of the pictogram and front size

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