Categories of Substances
refers to substances that are notified within the Initial Notification Period.
refers to substances that are not notified within the Initial Notification Period. All New Substances in quantities more than 1 tonne per year have to be notified at least 60 days prior to the date on which they are placed in Indian Territory.
- Any Substance which falls under Hazard Classifications of the 8th revision of the United Nations Globally Harmonized System (GHS) of Classification and Labelling of Chemicals:
a.Carcinogenicity and/or Germ Cell Mutagenicity and/or Reproductive Toxicity and categorised as Category 1 or 2, or
b.Specific Target Organ Toxicity (Repeated Exposure or Single Exposure) Category 1 or 2; or
- Any Substance which fulfils the criteria of Persistent, Bio-accumulative and Toxic or very Persistent or very Bio-accumulative, as set out in Schedule I; or
- Any Substance listed in Schedule II;
Around 4700 substances could be considered as Priority Substances based on the definition above. All Priority Substances are subject to Labelling and Packaging requirements (Rule 33 & 34). Import of Priority Substances are required to notify to the Authority 15 days before the date of import (Rule 27).
Based on availability of data of notified substances, the Priority substance unit will decide on inclusion or deletion of the substance from Schedule II.
Certain Priority Substances may be added in Schedule X and/or XI, and/or XII and need to comply with regulations regarding transport and accident prevention of hazardous substances (Rule 16(3)).
Restricted and Hazardous substances:
Based on the date received from registration and the Chemical Safety Report (CSR), chemicals will be further assessed and categorized into: Restricted or Prohibited Substances (listed in Schedule IV) and Hazardous Substances (Listed in Schedule X, XI and XII).
Once a Restriction on a Priority Substance has been notified, a request for authorization for use of a Restricted Substance may be submitted by a Manufacturer, Importer or Authorized Representative to the Division along with the fees as provided in Schedule XIX. The authorization Fee is 1 M INR (about 14000 USD).
Other specific requirements for Hazardous Substances and Installations:
- For transport of Hazardous Substances, it will require a tracking and communication system and labelling.
- Safety Audit is required for installation within 6 months, and it should be updated every 2 years.
- Site Safety Report including accident prevention, training, information on equipment and antidotes should be provided.
- Details for isolated storage and quantity thresholds is listed in Schedule XI and XIII.
- Onsite/offsite Emergency Preparedness Plan should be prepared within 3 months.
- Chemical accident should be notified within 24 hrs and report should be done within 72 hours.