India Updates Draft Chemicals (Management and Safety) Rules

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:

    • vPvB substances
    • PBT substances
    • Carcinogenic substances
    • 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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