India has proposed the latest version of draft Rules, a notification, registration, and restriction approach. The draft Rules are to come into force on the date of their official publication, expected December 2020 or early 2021. 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 will establish 3 committees: a Steering Committee, a Scientific Committee, and a Risk Assessment Committee. The Steering Committee will oversee technical and administration matters regarding the Rules, approve budgets, and oversee the Division. The Scientific Committee and Risk Assessment Committee will be comprised of various experts (toxicology, environmental, packaging and labelling). A Chemical Regulatory Division (the Division) will also be established and have a similar role to the European Chemicals Agency (ECHA). The Division would be responsible for the evaluation of notification and registrations and provide recommendations to the Committees.
Notification
The initial notification would begin one year from the Rules coming into force and would conclude 180 days from the commencement. Notification is required for all existing substances imported or manufactured ≥ 1 metric ton/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 like the requirements specified in the pre-registration phase of South Korea’s 2019 amended Act on Registration, Evaluation, etc. of Chemicals (K-REACH).
A safety data sheet (SDS) is expected as part of the Notification. India is proposing that the classification, labelling, and SDS align with the UN Revision 8 GHS. The Division will review the notifications and may determine if the notified substance is deemed high priority and/or subject to registration.
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 ≥ 1 tonne/year and within 1.5 years from the date of inclusion of the Substance in Schedule VI.
Currently, 37 substances are listed under Schedule VI in the draft. A technical dossier is required as part of the registration. A chemical safety assessment is required for quantities > 10 metric tons/year.
The draft Rules include the option to submit a joint registration, but this is not a requirement.
Priority Substances
Substances listed in Schedule II are designated as Priority Substances. 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.
Foreign manufacturers will require an Authorized Representative to notify and register. A Notifier or Registrant may also request that proprietary business information be kept confidential; the Division will review claim for validity. There are fees associated with notification, registration, and confidentiality claims.
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