INTRODUCTION
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 obtain REACH Compliance Certificate by appointing 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.
BASIC REQUIREMENTS
A. NOTIFICATION AND ANNUAL REPORTING
B. REGISTRATION
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.
REACH Certification in India 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
Indian Chemical regulations for your products.
