Under the Indian CMSR, all Substances listed in Schedule II will require registration if placed on the Indian market in quantities greater than 1 tonne.
Additionally, Substances listed in Schedule II which are present in articles will also have to be registered when they fulfill the two following conditions:
- They are intended or likely to be released under normal or foreseeable conditions of use
- They are present in the Article in quantities greater than 1 tonne per producer or importer per year
Priority Substances, among which Schedule II Substances are chosen, include the following:
- Any substance falling under the following Hazard Classifications of the 8th Revision of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS):
- Carcinogenicity, Germ Cell Mutagenicity or Reproductive Toxicity, Categories 1 or 2
- Specific Target Organ Toxicity (Repeated Exposure or Single Exposure), Categories 1 or 2
- Any Substance which is considered to be Persistent, Bio-accumulative and Toxic (PBT) under the criteria set out in Schedule I
- Any Substance which is considered to be very Persistent and very Bio-accumulative (vPvB) under the criteria set out in Schedule I
- Any Substance listed in Schedule II
Information to be submitted for registration:
|Substance||1-10 TPA||Technical dossier|
|Above 10 TPA||Technical dossier and Chemical Safety Assessment|
|Chemical Safety Report (CSR) (Schedule VIII)|
|Intermediates||Below 1000 TPA||Only the physical and chemical properties in the Technical Dossiers|
|Above 1000 TPA||full Technical Dossier and Chemical Safety Report (CSR)|
|Tonnage band of Substance||MSME||Large|
|1 – 10 TPA||15,000 ₹||37,000 ₹|
|10 – 100 TPA||45,000 ₹||112,000 ₹|
|100 – 1000 TPA||120,000 ₹||300,000 ₹|
|> 1000 TPA||375,000 ₹||900,000 ₹|
- If the information in dossier is incomplete, the Division will grant 60 days for providing such information.
- Confidentiality of the dossier can be maintained on payment of fee (See Schedule XIX).
- Once all the information is submitted and accepted by the Toxicology Unit, a Registration number is assigned, and a Registration certificate (as given in schedule XVIII) will be granted to Registrant.
- Joint registration for the substance with other manufacturers is a recommended option.
- All the information submitted to any foreign regulator for registration of the same substance is also acceptable to Indian Regulatory to the possible extent.