India has recently circulated Draft – Chemical (Management and Safety) Rules, 20xx, “India- REACH” (or ICMS Rules or CMS Rules) which will replace existing Manufacture, Storage and Import of Hazardous Chemicals (MSIHC) Rules 1989 and Chemical Accidents (Emergency Planning, Preparedness and Response) (CAEPPR) Rules 1996.
These rules are framed in exercise of the powers conferred by Sections 3, 6 and 25 of the Environment (Protection) Act, 1986 (29 of 1986).
India REACH regulatory requirements shall come into force on the date of their publication in the Official Gazette, expected during 2021.
Following actors are required to comply with India REACH regulation once it enters into force:
- Indian Manufacturers
- Indian Importers
- Authorised Representative/AR – located in India appointed by Foreign Manufacturers
Like EU REACH regulation, Non-Indian companies can appoint an Authorised Representative in India to prepare and submit their notifications and registrations to the Indian Authority. At REACHLaw we will be happy to provide you with Authorised Representative services.
A. Notification and Annual Reporting
Notification: All existing and new substance, priority and hazardous substances in quantities greater than 1 tonne per year needs to be notified to the authority. It also requires safety data sheet/SDS and other information listed in schedule V.
A notification number is issued along with notification certificate after successful submission.
Annual Reporting: All notified substances notifiers must update the information submitted annually. Such update shall include information regarding the actual quantities of substances placed in the previous calendar year and any change or addition in the information submitted at the time of notification no later than 30 days after end of each calendar year.
Authority fees applies to both Notification and Annual reporting.
It is required for 37 Substances listed in Schedule VI (sch VI) if used in quantities greater than 1 tonne per year. More substances will be added later on after notification. Registration may also be required for the substance in quantities lower than 1 tonne per year. Timeline to register is 1.5 years from the date of inclusion of the substance in sch VI.
Registration requires submission of technical dossier and chemical safety report (CSR) including exposure scenario (ES) similar to EU REACH. Information required is as per schedule VII and requires test reports from NABL (National Accreditation Board for Testing and Calibration Laboratories located near New Delhi) or GLP lab (certified by National GLP Compliance Monitoring Authority (NGCMA) established by the Department of Science & Technology (DST), Government of India located in New Delhi) in India.
Joint Registration: Also there is provision of Joint registration and any entity may come to an arrangement with other entities of the same substance and jointly register such substance, provided however that such joint registration shall be in compliance with all such obligations applicable to an individual registration under these Rules.
Transported Intermediate Registration: All intermediate which are also substances listed in Schedule VI requires registration. Quantities below 1000 tpa requires only physical and chemical properties in the Technical Dossier whereas quantities above 1000 tpa requires Technical Dossier (information as per Schedule VII) and the chemical safety report.
Timeline to submit intermediate registration is 1.5 years from date of inclusion in Schedule VI.
A registration number is issued along with registration certificate after successful submission. Tonnage specific authority fee apply for registration, including updates and discounted fee in case of a MSME company (Micro, Small & Medium Enterprise).
C. Priority Substances
It covers those substances which qualify as a) CMR (Category 1 or 2) or STOT Cat 1 or 2 as Hazard Classifications as per UN GHS Rev. 8, b) PBT, vPvB as set out in Schedule 1 and c) any substance listed in Schedule II (presently it covers 750 substances, more to be added during the course of implementation of these rules)).
Companies in business with priority substances are required to perform chemical safety assessment, an exposure scenarios for substances used up to 10 tonne per year and chemical safety report for substances used more than 10 tonnes per year at the time of Notification/Registration.
The information required for CSR is as per Schedule VIII (covers ES)
Import Control of Priority/ Hazardous Substance
An importer of Priority substances or Hazardous chemicals after completion of relevant Notification & Registration requirement needs to submit at least 30 days before Importation.
- Name and address of the person receiving the consignment in India
- Port of entry in India
- mode of transport from the exporting country to India
- name and the quantity of Priority Substances or Hazardous Chemicals being imported; and
- all relevant product safety information, including Safety Data Sheet.
If the Concerned Authority, Chief Inspector of Dock Safety appointed under the Dock Workers (Safety, Health and Welfare) Act, 1986 is of the opinion that the Substance should not be Imported on safety or on environmental considerations, such Imports may be stopped.
No authority fee is defined in draft regulation.
Labelling & Packaging: Priority substances and Mixtures containing more than 10% w/w of priority substance before being placed and used in India shall bear labels as per schedule XVII and in accordance with GHS v.8. The labels shall be in English and Hindi.
Safety Data Sheet (SDS): All notifiers of a Priority Substance or an Intermediate which is also a priority substance, Mixture containing more than 10% w/w of priority substance, Article above 0.1% w/w of priority substances requires SDS before placing & using substance in India. The information requirement is listed in Schedule IX, as per GHS v.8.
Evaluation and Restriction: All notified substances shall undergo evaluation process for inclusion in Schedule II – Priority Substances and for inclusion/deletion in Schedule X, XI or XII – Hazardous chemicals. If risks posed by the use of a Priority Substances are substantial, they may be restricted or prohibited. Once a Restriction on a Priority Substance has been notified, a request for authorisation for use of a Restricted Substance may be submitted to the Division. The Authorisation for use can be granted for 4 years, further may extend to maximum 4 years on re-application.
Authority fee shall apply for authorisation for use of a Restricted Substance.
D. Hazardous Chemicals
This is for safety procedures for the Manufacturing, handling and Import of Hazardous Chemicals and preparedness and management of Chemical Accidents related to Hazardous Chemicals, as identified under these Rules.
Transport of Hazardous Chemicals
When transporting a hazardous chemical an occupier shall ensure that the vehicle used for transport is properly labelled, and that technology enabled tracking and communication systems are used.
The transport of Hazardous Chemicals shall be in accordance with the provisions of these rules and the rules made by the Central Government under the Motor Vehicles Act, 1988 and the guidelines issued by the Central Pollution Control Board (CPCB) from time to time in this regard. In case of transportation of Hazardous Chemicals to another Indian State, the Occupier shall give prior intimation the State Pollution Control Boards (SPCB) of the State to which such Hazardous Chemicals are being transported.
Industrial Activity and Site Safety Report
Simplified Site Safety Report: It is required by all industrial sites (not covered by standard site safety report) to provide evidence to demonstrate that occupier has identified Chemical Accident hazards, and taken adequate steps to prevent Chemical Accidents and to limit their consequences in terms of impact on persons and the environment, provides persons working on the site information, training and equipment including antidotes necessary to ensure their safety.
Standard Site Safety Report: It is required for an Industrial Activity in which there is involved a quantity of Hazardous Chemical as listed in column 2 of Schedule XII which is equal to or more than the threshold quantity specified in the entry for that Hazardous Chemical in column 3 of Schedule XII and isolated storage in which there is involved a quantity of a Hazardous Chemical listed in column 2 of Schedule XI which is equal to or more than the threshold quantity specified in the entry for that Hazardous Chemical in column 3 of Schedule XI.
An Occupier shall not undertake any New Industrial Activity unless he has been granted an approval from the Concerned Authority for undertaking such activity and has submitted a report for notification in the format set out in Part I and Site Safety Report in the format set out in Part II of Schedule XIV,, at least 90 days before commencing that activity.
Safety Audit Reports: It is required by Major Accident Hazard Installation involving quantities of Hazardous Chemicals exceeding the threshold quantity of column 4 of Schedules XI or XII.
The Occupier shall submit at least one Safety Audit Report by Accredited expert agency empanelled by the Steering Committee within 180 days from the date of coming into force of these Rules and thereafter atlest once every 2 years
Revision and Update (Industrial activity and Site safety Report): If occupier makes any modification to an Industrial Activity which could materially affect the particulars in the reports submitted as per Part I of Schedule IV, or the Site Safety Report or the Safety Audit Report, he shall make a fresh report taking into account these modifications and submit such revised report to the Concerned Authority, no later than 30 days from the making of these modifications.
Where the Occupier has made a both simplified and standard Site Safety Report and such Industrial Activity is continuing, the Occupier shall within 3 years of the date of the last such report, make a further report which shall have regard in particular to new technical knowledge which has affected the particulars in the previous report relating to safely and hazard assessment and shall submit the updated Site Safety Report to the Concerned Authority.
On Site Emergency Preparation Plan: All occupier of existing and new industrial activity shall prepare and submit the On site Emergency Plan as per Part III of Schedule XIV how Major Chemical Accidents will be dealt with on the Site of the Industrial Activity. .
Timeline to submit on site emergency preparation plan for Existing Industrial Activity is 90 days of coming into force of these Rules and for New Industrial Activity is 30 days of commencement of the activity.
Detailed Mock Drill Report of the On site Emergency Plan is also required at least once in every 180 days by occupier and submit a detailed report on such mock drill to the Concerned Authority within 7 days of such drill.
Notification of Chemical Accidents
Where a Chemical Accident (including a Major Chemical Accident for the purpose of this Rule) occurs on-site or off-site, the Occupier shall notify and submit a Chemical Accident report of the accident to the Concerned Authority, as applicable in the format set out in Schedule XVI. The Occupier shall also notify the Chemical Accidents Unit of the Division.
Timeline to notify is within 24 hours of the occurrence of the Chemical Accident and the Chemical Accident report is to be submitted within 72 hours of the accident.
The Occupier shall submit to the Concerned Authority a report of all steps taken or to be taken to prevent a repetition of the accident within 180 days from the date of the Chemical Accident
Information to be given to persons liable to be affected by a Major Chemical Accident
The Occupier shall take appropriate steps to inform persons outside the site either directly or through Concerned authority who are likely to be in an area which may be affected by a Major Chemical Accident about the nature of the Major Chemical Accident hazard and the safety measures and the Dos and Don’ts which should be adopted in the event of a Major Chemical Accident.
Timeline: The Occupier shall inform persons about an Industrial Activity, before such activity is commenced, except in the case of an Existing Industrial Activity, in which case the Occupier shall comply with the requirements within 90 days of coming into force of these Rules.
At REACHLaw we are happy to provide you with following services:
- INDIA REACH REGULATORY DEVELOPMENT MONITORING*
- INDIA REACH AUTHORISED REPRESENTATIVE
- INDIA REACH NOTIFICATION, ANNUAL REPORTING
- INDIA REACH REGISTRATION (INCL. INTERMEDIATES)
- PRIORITY & HAZARDOUS SUBSTANCE COMPLIANCE SERVICES
- GHS (V8) SDS & LABEL SERVICES*
- LEGAL, TECHNICAL & TESTING SERVICES
- CONSULTING, COMPLIANCE AUDITS*