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India released the fourth draft Chemicals (Management and Safety) Rules to select groups on March 16, 2020. This fourth draft is believed to be the final draft, despite assurances in February that the third draft was the final draft. The government is accepting comments until March 31, 2020. The draft Rules include significant revisions to the list of priority substances that are subject to importation notifications, and hazard communication obligations (i.e., safety data sheets, labeling, and packaging). In addition, the draft Rules include 37 substances that are subject to registration.
Background
India proposes in this latest version of draft Rules a notification, registration, and restriction approach. The draft Rules are meant to come into force on the date of their official publication. The “Rules apply to all Substances, Substances in Mixtures and Intermediates that are Manufactured, Imported, Placed or intended to be Placed in Indian Territory.” The draft Rules also include provisions for labeling and handling of hazardous chemicals.
India includes in the draft Rules the establishment of a Steering Committee that “shall oversee technical and administration matters arising out of these Rules, and carry out functions that may be assigned to it under these Rules.” The Steering Committee would meet at least every 90 days. A Scientific Committee and a Risk Assessment Committee would be developed, and a Chemical Regulatory Division (the Division) will be established and responsible for coordinating with the Committees and providing technical support to the committees. The Division, similar to the European Chemicals Agency (ECHA), would be responsible for the evaluation of notification and registrations and provide recommendations to the Committees.
The initial notification would commence one year from the Rules coming into force and would terminate 180 days from the commencement. Notification is required for all existing substances imported or manufactured at or above one metric ton per year. All new substances must be notified at least 90 days prior to the date they are placed in Indian Territory. Schedule V provides the details required for the Notification. The information is similar to the requirements specified in the pre-registration phase of South Korea’s 2019 amended Act on Registration, Evaluation, etc. of Chemicals (K-REACH) and includes a significant demonstration of substance identity, use, and hazard classification detail. A safety data sheet (SDS) is expected as part of the Notification. India proposes that classification, labeling, and SDS align with the United Nations Eighth Revised Edition (Rev 8) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Each Notification is associated with a fee and is reviewed by the Division. If during the review additional data are requested, the notifying entity must address the request within specified time frames. The current draft indicates 30 days with an allowance for an extension. The Division will determine if the notified substance is deemed high priority and/or subject to registration.
Registration is required for all substances listed in Schedule VI that are or are intended to be manufactured, imported, and/or placed in Indian Territory “in quantities greater than 1 tonne per annum … within one and half years from the date of inclusion of the Substance in Schedule VI.” The current Schedule VI in the draft Rules contains 37 substances. A technical dossier is required as part of the registration. A chemical safety assessment is required for quantities greater than 10 metric tons per annum. Each registration requires a fee, and the dossier is reviewed by units in the Division for technical completeness, including confirmation of payment of fees. Similar to ECHA’s process, if within the first check, the registration is incomplete, the Division may require a registrant to submit additional details. The units of the Division will evaluate all registrations within 90 days of submission. If incomplete, the registrant will be required to provide the information within 90 days with a possible extension of a maximum of 90 days. The draft Rules include the option to submit a joint registration, but this is not a requirement. Updates to technical dossiers are required within 30 days for “any change or revision in the information submitted.” There is a fee for updates to the registration.
Substances listed in Schedule II are designated as Priority Substances. Importers are required to notify the Concerned Authority at least 15 days before importation. There are additional labeling and packaging requirements noted for Schedule II substances in Chapter V of the draft Rules. There are currently 750 substances listed as Priority in Schedule II. It is expected that as notifications and evaluations continue, this list will grow.
India includes the option for foreign entities to notify and register using an Authorized Representative. Similar to the Only Representative function in other regions, the Authorized Representative acts “on behalf of the foreign Manufacturer to ensure compliance with these Rules and shall be liable for the discharge of all obligations under these Rules.”
Downstream users are expected to ensure that substances and mixtures are notified and registered “in accordance with these Rules.” In addition, downstream users are obligated to review uses that are part of the notified and/or registered substances. If their use is not included, the downstream user must submit the use and an SDS to the Division.
India addresses confidentiality and notes that “[a] Notifier or Registrant may request that trade secrets, proprietary business information and other intellectual property related data and information shared by the Notifier or the Registrant be kept confidential and not be disseminated publicly.” There are fees for confidentiality claims, and the Division will review claims for validity.
Commentary
India has been developing a comprehensive strategy for chemical regulation for some time now. The approach reflected in these draft Rules aligns with other countries’ approaches and uses fairly standard notification, registration, and evaluation measures. By incorporating elements from established governance frameworks including REACH in the EU and K-REACH in Korea, India is deploying a mechanism that is familiar to global chemical stakeholders. India’s framework deploys unique elements that are expected to generate confusion and some level of discord among manufacturers, importers, and downstream users. India’s notification program will allow impacted companies an opportunity to consider strategically how substances are introduced into India, as there are fees and distinctive data elements. Companies currently placing substances and mixtures on the market in India are urged to consider the implications of notification and registration requirements for any claim they may wish to assert as confidential. The draft Rules allow claims, but those claims must be reviewed to determine validity. In addition, downstream users are expected to be impacted as the draft Rules note that un-notified and un-registered substances are disallowed. Unsurprisingly, the draft includes provisions imposing penalties for noncompliance. India apparently intends to adopt Rev 8 GHS into hazard communication practices. If so, India would be the first country to adopt this edition. Companies will need to review all hazard communication elements to ensure alignment with the latest edition of GHS.