India Releases Latest Draft Chemicals (Management and Safety) Rules

The India’s chemical regulation, Draft Chemicals (Management and Safety) Rules, 20xx, applies to all substances, substances in mixtures and intermediates that are manufactured, imported, placed or intended to be placed in Indian territory > 1 tonne per year. It requires manufacturers, importers or Authorized Representatives to notify new and existing substances and register substances that need registration. Restriction or prohibition of uses of certain substances may be required if they are evaluated and found posing unacceptable risks to human health and the environment. The rule will supersede two existing sets of rules – Manufacture, Storage and Import of Hazardous Chemical Rules, 1989, and the Chemical Accidents (Emergency Planning, Preparedness and Response) Rules, 1996. The draft rules also include provisions for labelling and handling of hazardous chemicals. It shall come into force on the date of their publication in the official gazette.

According to the draft rules:

Notification

• Notification will be required within 180 days from the date of enforcement of the regulations. This requirement applies to all existing substances imported or manufactured at a volume > 1 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 placed in Indian Territory.
• A safety data sheet (SDS) is expected as part of the Notification. India is proposing that the classification, labelling and SDS align with the United Nations 8^th Revised Edition of the Globally Harmonized System of Classification and Labelling of Chemical (UN GHS Rev. 8).

Registration

• Registration is required for all substances listed in Schedule VI that are or are intended to be manufactured, imported, and/or placed in India Territory > 1 tonne per year and within 18 months from the date of inclusion of the Substance in Schedule VI.
• Currently, 37 substances are listed under Schedule VI in the draft which require registration if in quantities > 1 tonne per year. The designated substances are vPvB substances, PBT substances, and carcinogenic substances, chemicals that are toxic for reproduction or of 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

• Substances listed in Schedule II are designated as Priority Substances. There are additional labelling 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, which will be subject to authorization and restriction after further assessment.

Foreign manufacturers may notify and register using an Authorized Representative (AR), which is similar to the Only Representative in EU REACH.

Also, the draft rules include provisions to minimise testing on animals, where reliable and relevant non-animal testing approaches has been adopted to protect human health and the environment. To avoid repeat testing on animals, the rules require that existing information be considered prior to conducting any new tests and that data submitted for the registration of substances in foreign jurisdictions be accepted by CRD. Any company registering a substance will be required to propose a testing strategy for approval by CRD prior to conducting any new animal tests.

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