Request a Demo
Japan mandates chemical suppliers to fulfill GHS-related obligations under multiple laws and regulations, among which the Industrial Safety and Health Law (ISHL) is the overarching legislation for implementing GHS in workplaces. The 2014 amendments to ISHL and the subsequent amendments to its Enforcement Order will impact the current labeling rules on 2 aspects:
1. Scope of substances subject to mandatory labelling
Before the amendments, more substances are subject to mandatory SDS delivery than are subject to labelling. Now all the substances subject to SDS delivery, which remain the same after the amendments, are subject to labelling. Details are shown in the following table:
Legal Basis | Labelling | SDS |
Industrial Safety and Health Law (ISHL) | Article 57-1: (paraphrase) A person who is to transfer or supply chemical substances specified in Article 17 or Article 18 of the Cabinet Order should properly label the containers/packages in accordance with Japan GHS standard. | Article 57-2: (paraphrase) A person who is to transfer or supply chemical substances specified in Article 17 or Article 18-2 of the Cabinet Order should deliver SDSs prepared in accordance with Japan GHS standard. |
Order for Enforcement of ISHL (“Cabinet Order”) | Article 17: Referring to substances listed in Appended Table 3(i) (7 substances + specified mixtures)
Article 18 (or 18-1): · Before amendment: Specifying 100 substances plus mixtures containing substances listed in sub-item 1~7 of item (1), Appended Table 3 (100 substances + specified mixtures) · After amendment: Referring to substances listed in Appended Table 9 (certain elements and their compounds are limited to the powder forms) (633 substances + specified mixtures) | Article 17: Referring to substances listed in Appended Table 3(i) (7 substances + specified mixtures)
Article 18-2: Referring to substances listed in Appended Table 9 (633 substances + specified mixtures) |
2. Information must be shown on labels
Article 57(1) of ISHL used to require information on the substance name, ingredients, effects on human body and precautions concerning storage or handling. Listing of all ingredients is no longer required in accordance with Cabinet Order No.82 of 2014 amending ISHL.
Transitional measures and implementation guidance
The changes introduced above will enter into force on June 1, 2016. For related products which are being circulated on the Japanese market before that date, they are not subject to the new labelling rules until June 1, 2017 as stipulated Cabinet Order No.250 of 2015 amending the Order for Enforcement of ISHL.
Japan Chemical Industry Association (JCIA) has published Guidance for Label Preparation Based on the Revised Industrial Safety and Health Law to help industry stakeholders better understand the changes and provide technical guidance for labelling. While the guidance only concerns ISHL, the users should take other GHS-related laws and regulations into consideration such as the PRTR Law, Poisonous and Deleterious Substances Control Law and Fire Service Law. These laws have different applicable scopes but all refer to the same standards on the criteria for classification, labeling and SDS preparation, namely:
If a substance is not subject to mandatory labeling or SDS but can be classified in accordance with JIS Z 7252, it’s recommended that stakeholders make their utmost efforts to prepare the label and SDS in accordance with JIS Z 7253 based on the classification results.
