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Actionable Summary - Draft Indian Chemical and management Rules (CMSR) – India REACH

What is CMSR?

India released the fourth draft of the Chemical (Management and Safety) Rules (CMSR) on March 16, 2020. The CMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. The legal basis of the CMSR is section 3, 6, and 25 of Environmental Protection Act (1986) ; Further enactment of CMSR will result in suspension of two existing rules - Manufacture, Storage and Import of Hazardous Chemical Rules (1989) and Chemical Accidents (Emergency Planning, Preparedness and Response) Rules (1996). The CMSR is expected to come into force in 2020-2021. Indian manufacturers, importers and authorized representation (AR – acting on behalf of a foreign manufacturer) with an Indian legal entity, can comply with the CMSR..

How to Comply?

Notification

Notification is required for all substances that are in quantity above 1 TPA. Data Requirement for Notification: Submit Chemical information, Spectral data, Hazard Classification, Uses details, details of DU, Tonnage band, Storage capacity and SDS. A certificate of Notification along with Notification number will be issued once the notified substance is evaluated for its completeness by the Chemical Regulatory Division. Annual reporting is required for all Notified substances, to be submitted on 30th of Jan each year, and any change in tonnage band or other notified information will required to be promptly updated and may attract tonnage band change fee.  All New Chemical Substances must be notified at least 90 days prior to the date they are placed in Indian territory.

Registration

Only identified substances meeting criteria of “Substances To Be Registered” in Schedule VI of the CMSR and with the tonnage exceeding 1 TPA need to be registered. Currently, there are 37 Substances in Schedule VI and this list will be updated on regular basis. Registration should be carried out within 18 months after a substance is included in Schedule VI. Technical dossiers should be submitted while registering substance. For substance with a tonnage band more than 10 TPA, a Chemical Safety Assessment is also required to be submitted along with Technical dossier. Registration fee will depend on tonnage band and company size. Joint submission is a recommended option. The Intermediates with the tonnage band less than 1000 TPA should be registered with only the physical and chemical properties in the Technical Dossiers. Whereas Intermediates with the tonnage band above 1000 TPA should register with full information in the Technical Dossier along the Chemical Safety Report. Priority Substances in Article with the tonnage that exceeding 1 TPA will also need to register.

Annual Reporting

An annual report applies to all notified existing and new substances. The report should contain the quantity of substance place in India Territory in the previous calendar year and changes of information submitted at the time of notification. This should be done before the 30th of January of each calendar year.

Foreign Manufacturer and Authorized Representative

Foreign Manufacturers of substance, substance in mixture and priority substance in article should appoint an Authorized Representative that has an Indian legal entity to comply with the CMSR.

Actions for Manufacturers, Importers and Downstream Users

  • Set up a regulatory team 
  • Prepare an Inventory of substances being handled
  • Identify the quantity placed in India
  • Initiate communication with downstream users -
  • Update SDS in accordance with GHS Rev. 8
  • Stay updated on the CMSR
  • Internal training on the CMSR
  • Follow up on the Substance lists (Substances to be registered (Schedule VI), Priority Substance (Schedule II) and Hazardous Substance (Schedule X, XI, XII)) with us on www.gpcgateway.com  

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