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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:
Schedule II listed Substance: Here > 1T/yr
Schedule II substances in Articles > 1T/yr
Intended to be released under normal or foreseeable conditions of use
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 |
| Substance | 1-10 TPA | Technical dossier (Schedule VII) |
| > 10 TPA | TD and Chemical safety report (Schedule VIII) | |
| Intermediate | =< 1000 TPA | Physical/Chemical properties of TD |
| > 1000 TPA | TD 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.