ABOUT INDIA REACH (CMSR)
Regulation Title: Draft Chemicals (Management and Safety) Rules, 20xx
Scope: The scope of the CMSR (India REACH) covers Notification, Registration and Restriction, or prohibition of use of Substances, Substance in Mixtures, and Substances in Articles and Intermediates placed in Indian Territory in quantities above one tonne per year.
Description: India released the fifth draft of the Chemical (Management and Safety) Rules (CMSR) on Aug. 24th, 2020. This overarching chemical law is expected to be finalized this year and will regulate Substances, Substances in Mixture, Substance in Articles, and Intermediates that are manufactured, imported, or placed in the Indian Territory. It will require notification for all chemicals and registration for 750 priority chemicals within 18 months. All actors in supply-chain are required to comply with the CMSR. Non-Indian enterprises can appoint an Autorized Representative (AR) with a legal entity in India, which will comply with the CMSR on their behalf.
The objective of the CMSR 20XX is to ensure a high level or protection to human health and the environment. The Rules also provide for procedures for the Manufacturer, handling and import of Hazardous Chemicals and preparedness and management of Chemical Accidents related to Hazardous Chemicals. The development of the chemical management law in India is summarized in the table below:
Table1: The Development of CMSR
Exemption: The following are exempted from the CMSR:
- Radioactive Substances.
- Substances under customs supervision, not being placed in Indian Territory.
- Substances stored in customs free zones with aim of re-exporting.
- Wastes, as defined in Hazardous Waste Management Rules 2016.
- Substances used for the purposes of defense.
- Substances used as food or feeding stuff for human beings or animals, including human or animal nutrition.
- Substances set out in Schedule IV.
Who will be affected by India REACH / CMSR?
The upcoming CMSR will affect both upstream and downstream actors within the chemical industry.
Duty of Downstream Users
All manufacturers or importers placing chemical substances in quantity greater that 1 tonne per year on Indian territory are obliged to notify the Division. The notification should be done within the Initial Notification Period (See the notification).
Non-Indian manufactures can appoint Authorized Representatives (acting on behalf of foreign entities) to notify substances.
In case the substance is listed in Schedule II and in quantities greater than 1 tonne per year, then registration is required.
Who can notify/register substance:
- Indian Manufacturer
- Indian Importer
- Authorized representative (on behalf of non-Indian enterprises)
Authorized Representative means a natural or juristic person in India who is authorized by a foreign Manufacturer under Rule 6(2).
Regulatory bodies
The competent authority of CMSR is Indian National Chemical Authority (INCA). Under INCA, there are 3 key committees: Steering Committee, Scientific Committee and Risk Assessment Committee.
The Chemical Regulation Division include following units:
- Chemistry Unit
- Toxicology Unit
- Chemical Accidents Unit
- Packaging and Labelling unit
- Techno-legal Unit
- Priority Substance Unit
- Information Technology Unit
- Socio-Economic Unit
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