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ICMSR: India’s Chemicals (Management And Safety) Rules. (DRAFT)

  • CMSR: Chemical Management and Safety Rules 

  • Released fifth draft of CMSR Aug 24th, 2020 (Here)

  • Indian manufacturers, importers, and authorized representatives
    (AR - acting on behalf of a foreign manufacturer) with an Indian legal entity can comply with the CMSR. 

  • These Rules shall come into force on the date of publication

Timeline of ICMSR (DRAFT)


Key Requirement (DRAFT)

  • Initial Notification 

    • Scope: All substances introduced in India > 1T/yr

  • Notification (After the expiry of Initial Notification Period)

    • Scope: > 1T/yr All NEW substances and Existing substances

    • All NEW substances >= 1T/yr and Existing substances > 1T/yr must be notified at least 60 days prior to import after Initial notification period termination

    • Notification No. shall be granted to the notifier 

Data required

Notifier’s details, Substances identifiers, Impurities, Substance structural details and Spectral data,

Hazardous classification, Uses details, Details of Downstream users, Tonnage band, Storage capacity, SDS


  • Registration

    • Scope: 

      • Intended to be released under normal or foreseeable conditions of use

      • Schedule II listed Substance: Here > 1T/yr

      • Schedule II substances in Articles  > 1T/yr

    • Registration Due date: 18 months after included in Schedule II (from publication date)

    • Required data: Registration No. shall be granted to registrant 

Category

Tonnage band

Requirement

Substance1-10 TPATechnical dossier (Schedule VII)
> 10 TPATD and Chemical safety report (Schedule VIII)
Intermediate=< 1000 TPAPhysical/Chemical properties of TD
> 1000 TPATD and CSR
    • Content of Technical dossier: (Here) Robust summaries and Exposure scenarios included 

      • Existing test data must be considered prior to requiring new test

      • New Tests must be approved by the Division for a test proposal and strategy 

      • New Tests must be carried out in GLP/NABL certified labs and shall comply OECD TG 


  • Annual report (update notification information annually)
    • Scope: All notified substances 

    • Required data:

      • Quantity of substance in the previous calendar year

      • Changes to the information submitted at the time of notification

    • Due date: before 29th Feb. / 1st Mar. of each calendar year


Q: When can we expect implementation of the ICMSR?

 - While the drafting process of the ICMSR is well advanced, some industry concerns have been put forward on the basis of the current draft. Additionally, a process of ministerial vetting must take place to ensure the proper fit of ICMSR with existing regulations. 

 - Once a final draft is produced, it must be submitted to the WTO and officially adopted by the Central Government (including a Gazette Notification).

 - Another key period is the establishment of the Indian National Chemicals Authority (INCA), which is the leading authority in implementing ICMSR. While the Rules do not contain a clear timeline for this, it will involve the setting up of the Authority, the setting up of the system for Notification and Registration, and the issuance of relevant guidance.









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