INDIA REACH is the country’s national chemical law which is referred to as the “Chemical (Management & Safety)” Rules. The Indian government has recently circulated Draft – Chemical (Management and Safety) Rules, “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).
EXPECTED IMPLEMENTATION DURING 2021-22
INDIA REACH COMPLIANCE
India REACH regulation shall be applicable once it enters into force on the following;
- Indian Manufacturers
- Indian Importers
- Authorized Indian Representative–Indian representative appointed by overseas Manufacturers
Foreign Manufacturers/companies can appoint an Authorized Representative in India to represent their case and comply with the regulations and registrations purposes. ALEPH INDIA is the best choice for Foreign Manufacturers, provides the best regulatory compliance services. Our conformity assessment vertical will fulfill all your certification needs with full assurance of a complete registration process and hustle free procedures.
A. NOTIFICATION AND ANNUAL REPORTING
It is required for 750 Substances listed in Schedule II (schedule II as a priority - substances) 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. The timeline to register is 1.5 years from the date of inclusion of the substance in schedule II.
Registration requires submission of the 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 Certified lab. To avoid repeated testing, the existing test data must be considered prior to requiring new testing.
- Joint Registration: Also, there is the 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 is also substances listed in Schedule II, requires registration. Quantities below 1000 tpa require only physical and chemical properties in the Technical Dossier, whereas quantities above 1000 tpa require Technical Dossier (information as per Schedule VII) and the chemical safety report.
The timeline to submit intermediate registration is 1.5 years from the date of inclusion in Schedule II.
A registration number is issued along with the registration certificate after successful submission. Tonnage-specific authority fees apply for registration, including updates and discounted fees in the case of an MSME company (Micro, Small & Medium Enterprise).
C. PRIORITY SUBSTANCES
- CMR (Category 1 or 2) or STOT Cat 1 or 2 as Hazard Classifications as per UN GHS Rev. 8,
- PBT, vPvB as set out in Schedule 1 and
- 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 scenario for substances used up to 10 tonnes per year, and a 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 SUBSTANCE/HAZARDOUS CHEMICALS
An importer of Priority substances or Hazardous chemicals after completion of relevant Notification & Registration requirements needs to submit at least 15 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 number 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 the draft regulation.
- Labeling & Packaging: Priority substances, Hazardous chemicals and Mixtures containing more than 10% w/w of priority substance or hazardous chemical 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. The packaging requirements are of standard nature.
- Safety Data Sheet (SDS): All Notifiers of a Substance or an Intermediate listed in Schedule II or a Hazardous Chemical are required to maintain and submit an updated SDS. Further, all importers or manufacturers of an Article, where a Substance or an Intermediate listed in Schedule II is present in such Article above a concentration of 1.0 % weight by weight (w/w), shall maintain and submit an up-to-date SDS. The information required is listed in Schedule IX, as per GHS v.8.
- Evaluation and Restriction: All registered substances shall undergo an evaluation process to ascertain if they pose an unacceptable risk to human safety or the environment during various uses in India. Risk-based approaches including hazard identification, hazard characterization, exposure assessment, and risk characterization (probability of occurrence of known and potential adverse effects) shall be adopted for such overall risk assessment to the extent possible.
If the risk posed by the use of the Registered Substance is substantial, it may propose to Restrict the use of such Substance or Prohibit such Substance, further based on evaluation, may also recommend for an entry be added to or deleted from Schedules X, XI or XII (Hazardous chemicals).
Once a Restriction on a Priority Substance has been notified, a request for authorization for the use of a Restricted Substance may be submitted to the Division. The Authorization for use can be granted for 4 years, further may extend to a maximum of 4 years on re-application.
Authority fee shall apply for authorization for the 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 labeled 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 division from time to time in this regard. In case of transportation of Hazardous Chemicals to another Indian State, the Occupier shall give prior intimation to the State Pollution Control Boards (SPCB) of the State to which such Hazardous Chemicals are being transported.
INDUSTRIAL ACTIVITY NOTIFICATION 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. This evidence shall be provided within 30 days of commencement of the activity or within 30 days of coming into force of these Rules, whichever is later. The occupier shall obtain the acknowledgment from the Concerned Authorities within 60 days of submission, failing which he shall not continue the activity.
- Standard Site Safety Report: It is required by an occupier of an Industrial Activity to notify 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 approval from the Concerned Authorities 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 or before such shorter time as the Concerned Authority may agree. Some transitional provisions also apply here.
- 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 at least once every 2 years.
- Revision and Update (Industrial activity and Site safety/Safety Audit 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 XIV, 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 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 safety and hazard assessment and shall submit the updated Site Safety Report to the Concerned Authority.
- On Site Emergency Preparation Plan: An Occupier of a Major Hazard Installation shall prepare and submit an up-to-date On-site Emergency Plan to the Concerned Authority detailing as per Part III of Schedule XIV how Major Chemical Accidents will be dealt with on the Site of the Industrial Activities. The Occupier shall ensure that the On-site Emergency Plan is updated in case of any modification of the Industrial Activities.
Timeline to submit on site emergency preparation plan for Existing Industrial Activity is within 90 days of coming into force of these Rules and for New Industrial Activity is within 30 days of commencement of the activity.
- Detailed Mock Drill Report of the On-site Emergency Plan: is also required at least once every 180 days by the occupier and submits a detailed report on such mock drill to the Concerned Authority within 7 days of such drill.
- Off-site Emergency plan: For the purpose of enabling the concerned authority to prepare the Off-site Emergency Plan, the Occupier shall provide the Concerned Authority with such information relating to the industrial activity under his control as the Concerned Authority may require, including the nature, extent, and likely off-site effects of possible Major Chemical Accidents.
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.
The 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.
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 last, I would like to conclude that the extension of the scope of mandatory certification for chemicals is in line, and the motive behind this is to ensure the quality, safety, and reliability of the products available on the market through strong expansions of the certification regulations. In the coming years, we can expect more and more products will come under mandatory BIS ISI Registration and Certification. We can assist you and provide you with reliable information about the regulations for your products.