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
Schedule II currently includes 750 Substances, and it will be expanded as the Indian National Chemical Authority evaluates notified Substances and decides upon their inclusion in the Schedule.
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.