India has published a revised version of its draft Chemicals (Management and Safety) Rules.
Currently at the drafting stage, Chemicals (Management and Safety) Rules, 20xx, applies to all substances, substances in mixtures, and intermediates that are manufactured, imported, placed or intended to be made available in Indian at a quantity greater than one tonne per year. It also contains provisions relating to the labelling and handling of hazardous substances. When it is enforced, which is expected to be in 2022, it will supersede:
• Manufacture, Storage and Import of Hazardous Chemical Rules, 1989
• Chemical Accidents (Emergency Planning, Preparedness and Response) Rules, 1996
Provisions within the draft include:
• Notifications are required within 180 days of the date of enforcement of the regulations. Applies to all substances currently imported or manufactured at a volume greater than or equal to one tonne per year. The substance will be notified for certain uses and downstream users need to notify the Chemical Regulatory Division (CRD) if the intended use is not notified
• All new substances must be notified at least 90 days prior to the date they are made available in the Indian Territory
• A safety data sheet (SDS) must be part of the Notification. India is proposing that the classification, labelling and SDS align with the United Nations 8th Revised Edition of the Globally Harmonized System of Classification and Labelling of Chemical (UN GHS Rev. 8)
• All substances listed in Schedule VI that are or are intended to be manufactured, imported, and/or placed in the India Territory at a level greater than or equal to one tonne per year and within 18 months from the date of inclusion of the Substance in Schedule VI must be registered
• 37 substances are currently listed under Schedule VI in the draft, requiring registration if at quantities greater than or equal to one tonne per year. These are:
1. vPvB substances
2. PBT substances
3. Carcinogenic substances
4. Chemicals that are toxic for reproduction or have endocrine-disrupting properties
• A Chemical Safety Assessment Report is required for those in quantities over 10 tonnes per year
• Joint registration will be accepted but details have not yet been published
• Priority substances are listed Schedule II and they have additional labelling and packaging requirements noted in Chapter V of the draft
• 750 substances are currently listed as Priority in Schedule II, which will be subject to authorization and restriction after further assessment
Foreign manufacturers should be aware that, under the draft’s provision, they may notify and register using an Authorized Representative (AR) (similar to the Only Representative under the EU’s REACH regulations).
Indian is also keen to minimize testing on animals, where reliable and relevant non-animal testing approaches have been adopted to protect human health and the environment. The draft rules require existing information to be considered before new tests are conducted, with the requirement that data submitted for the registration of substances in foreign jurisdictions should be accepted by the CRD. Companies will be required to propose a testing strategy, to be approved by the CRD, before conducting new animal tests.
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