India has released the fifth draft of the Chemical (Management and Safety) Rules (CMSR). The regulation will replace two existing rules – Manufacture, Storage and Import of Hazardous Chemical Rules, 1989, and the Chemical Accidents (Emergency Planning, Preparedness and Response) Rules, 1996.
The CMSR will apply to all substances, substances in mixture, substance in articles and intermediates that are manufactured, imported, or placed in the Indian Territory exceeding 1 TPA. The CMSR is expected to come into force in early 2021. It requires manufacturers, importers or Authorized Representatives to notify new and existing substances and register substances that need registration.
Notification is required for all substances exceeding 1 TPA. 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. Chemical Regulatory Division will issue a certificate of Notification along with Notification Number once the notified substance is evaluated for its completeness. All New Chemical Substances have to be notified at least 60 days prior to the date they are placed in Indian territory.
Data Requirements for Notification
- Detailed information of the Notifier
- Substance identification information
- Substance structural information and spectra
- Hazard classification
- Downstream user
- Maximum storage capacity
Registration is required for identified substances that are listed in "Priority Substances Required to be Registered" in Schedule II of the CMSR and with the tonnage exceeding 1 TPA. Currently, there are 748 substances listed in Schedule II and the list will be updated. Registration should be carried out within 18 months after a substance is included in Schedule II.
Technical dossier is required for registration. For substance exceeding 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.
The Intermediates less than 1000 TPA should be registered with only the physical and chemical properties in the Technical Dossiers. Whereas Intermediates exceeding 1000 TPA should register with full information in the Technical Dossier along with the Chemical Safety Report (CSR). Priority Substances in Article with the tonnage exceeding 1 TPA will also need to register.
Annual report is required for both Notification and Registration. The report should contain the quantity of substance placed in India Territory in the previous calendar year and changes to the information submitted at the time of notification/registration. The annual report should be completed before the 29th Feb. / 1st Mar of each calendar year.
Definitions of Key Words in the Regulation
Substances that are notified within the Initial Notification Period
Substances that are not notified within the Initial Notification Period
Any person within Indian Territory other than the Manufacturer and importer using the substance placed in the Indian Market for professional activity or industrial use. End use consumer is not accounted as a Downstream user.
Priority substances refer to those meet the definition set out in the Article 2(hh), they include:
a. Substances with the following classifications (in accordance with UNGHS Rev. 8):
- Carcinogenic Category I or II; and/or
- Mutagenic Category I or II; and/or
- Toxic to Reproduction Category I or II;
Based upon the above there could be about 4200 substances categorised as priority substance.
b. Substances that are categorised as persistent, bio-accumulative, and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Schedule I of the Indian CMSR;
It's estimated that about 185 substances would qualify as priority substances based upon the PBT and vPvB definition.
c. Substances that are included in Schedule II – “Priority Substances Required to be Registered” (currently there are 750 substances);
All Priority Substances has labeling and packaging requirements. An import notification will be issued 15 days before the date of import. But only priority substances that are included in Schedule II would require Registration.
- CMSR Compliance Analysis, Consulting and Training
- AR Authorisation
- Priority Substance Notification
- Priority Substance Registration
- Annual Report Preparation and Submission
CIRS is to host a free webinar concerning the Chemical (Management & Safety) Rules on 2 December 2020 in Chinese/Japanese/English. If you would liker to know more about the CMSR, please click here to register.
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