Objectives and Scope Of Indian REACH Compliance (Click Here)
The Objectives and Scope of Indian REACH as below:
- The objective of REACH Compliance is to ensure a high level of protection to human health and the
environment
through better and earlier identification of intrinsic properties of Substance, Mixture.
- CMSR applies to all Substances, Substances in Mixtures, and Intermediates that are Manufactured, Imported,
Placed, or intended to be placed in India.
- Chemicals (Management and Safety) Rules provide for safety procedures for the Manufacture, storage,
handling,
and Import of Priority Substances and preparedness and management of Chemical Accidents related to Priority
Substances, as identified under these Rules.
- India REACH regulation shall be applicable on Indian Importers, Indian Manufacturers, and Foreign entity
of
Priority Substance, Mixture, Intermediates, and Articles.
- REACH Rules provide for Notification, Registration, and Restrictions, or prohibitions, as well as
labelling
and packaging requirements related to the Use of Substances, Substances in Mixtures, Substances in Articles,
and
Intermediates Placed or intended to be placed in Indian Territory.
Function of National Chemical Authority:
- Evaluation of all Notifications and Registrations.
- Identify Substances that require Registration, authorization under Restricted Use, and prohibition from
Use.
- Evaluation of risks associated with the Use of Substances, Mixtures, Intermediates, and Articles, taking
into
account their impact on the human, plant, and animal health, as well as the environment.
- Ensure the enforcement of these Rules.
REACH COMPLIANCE REQUIREMENT
No Substance, Mixture, or Article shall be placed in Indian Territory by any person unless these regulations
are followed.
A foreign entity that desires to place a substance, mixture, or article in Indian Territory may designate an
Authorized Indian Representative in India to represent them and ensure that all requirements and registrations
are followed. The AIR must be a resident of India or a company established in India.
Aleph INDIA is the best choice for a foreign entity, manufacturer, importer, offers the best REACH regulatory
compliance services. Our conformity assessment vertical will meet all of your certification requirements, with
full assurance of comprehensive registration and hassle-free procedures.
(A) NOTIFICATION
Under Chemical Management and Safety Rules, “India REACH” All Manufacturer or Importer or AIR of all existing
and new substances that they have placed or intend to place in India in quantities greater than 1 tonne per
annum shall notify the division. The Initial Notification Period will begin on the date that is one year from
the date of coming into force of these Rules.
Registered Manufacturers and importers shall also notify the Division if they have registered a substance under
any other Indian Act, Rule, or Regulation currently in effect. Registration, Chemical Safety Assessment and
Evaluation, and Restriction are not required for such substances.
Process of REACH Notification (Click Here)
- Documentation: All manufacturers, importer, AIR of priority and hazardous substance must
prepare
all
relevant document and safety data sheet required for notification of such substance.
- Notification of substance: All existing and new substances that a manufacturer, importer, or
AIR
has
placed or intends to place in India in quantities higher than 1 tonne per annum must be notified to the
division. Notifiers must submit a safety data sheet as well as a notification fee to the division.
- Preliminary check: Upon receipt of a Notification, The authority will then perform a
preliminary
check to ensure that the Notification is complete and the required fee has been paid. The Division may
require
the Notifier to submit additional information if the Notification is incomplete.
- Acceptance of Notification: Once all relevant information for a Notification has been submitted
to
the satisfaction of the Chemistry Unit, The Notification shall be accepted and the Substance is included
in
the Register of Notified Substances.
- Grant of Notification certificate: A notification number will be provided to the Notifier, and
a
REACH Notification certificate in the prescribed form will be granted to the Notifier.
Annual update:
All notified substances notifiers must update the information regarding the actual quantities of substances
placed in the previous calendar year and any changes or additions to the information submitted at the time of
Notification submitted annually within 60 days after the end of each calendar year.
Fee: Both Notification and annual reporting are subject to an authority fee. Fees for Notification are
listed in Schedule XIX.
Information For Notification:
A Notification must include information regarding the Notifier, the Substance's identity, its Uses, the
Substance's quantity, current classification, and any other information specified in Schedule V. A Safety Data
Sheet is also needed to submit by Notifiers.
(B) REGISTRATION
All Manufacturers, Importers, and Authorized Representatives who have placed or intend to place a priority
substance in quantities greater than 1 tonne per annum in Indian Territory must register the substance within
one and a half years of its inclusion in Schedule II of Chemical Management and Safety Rules. If the chemical
is
used in quantities less than 1 tonne per year, registration may be necessary. A Technical Dossier, as
prescribed
in Schedule VII, must be submitted for registration.
When Registrants are required to conduct tests for the purpose of Registration, they must follow the testing
methodology/ protocol and the tests must be performed in NABL accredited or GLP certified laboratories.
Process of Registration (Click Here to Know)
- Documentation: Applicant needs to prepare all relevant documents and a technical dossier as per
prescribed form before registration of substance. Applicant must get their substance tested in NABL
accredited
or GLP certified laboratories.
- Registration of substance: All priority substance notifiers must register the substance. For
registration of such substance, the notifier must submit a technical dossier as well as a registration fee
to
the chemical division unit.
- Preliminary check: Upon the receipt of registration the authority shall conduct a preliminary check
to ensure that the registration is complete and the prescribed fee has been paid. If the Registration is
incomplete, the Division may request that the Registrant submit additional information within 60 days in
order
to complete the Dossier.
- Grant of registration certificate: Once all required information for a Registration has been
submitted to the satisfaction of the Toxicology Unit, the Registration will be deemed accepted, and the
Registrant of such Substance will be assigned a registration number, as well as a registration certificate
in
the prescribed form.
Annual update:
All Manufacturers, Importers, and Authorized Representatives who have Registered a Substance must update the
Technical Dossier and other data submitted with the Registration (if any) to reflect any change or revision in
the information affects hazard and risk management.
Joint registration:
Any Manufacturer, Importer, or AIR who is required to register a substance may reach an agreement with other
Manufacturers, Importers, or Authorized Representatives of the same substance to jointly register the substance,
provided that such joint Registration complies with all of the obligations imposed on an individual registration
under Chemicals (Management and Safety) Rules.
Transported intermediate registration:
Registration is required for all intermediate substances
listed in Schedule II of Chemical (Management and Safety) Rules.
Safety datasheet:
All Notifiers of a Substance or Intermediate listed in Schedule II or a Hazardous
Chemical are required to keep an up-to-date Safety Data Sheet in the prescribed format and share it with the
Substance's Downstream User.
Chemical safety assessment:
Manufacturers or Importers or AIR who place Substances listed in Schedule
II in quantities greater than 10 tonnes per year in Indian Territory must conduct a Chemical Safety Assessment
and submit a Chemical Safety Report in the format prescribed in Schedule VIII at the time of Notification or
Registration.
Manufacturers or importers who place priority substances less than or equal to 10 tonnes
but more than 1 tonne per year in the Indian Territory must submit an Exposure Scenario at the time of
registration.
Evaluation and restriction:
The Priority Substance Unit of the division will review the available
data of substances to determine if they pose an unacceptable risk to human safety or the environment during
varied usage. If the Priority Substance Unit believes the risk posed by the use of the Registered Substance is
significant, it may recommend restricting or prohibiting the use of such a Substance.
(C) SAFETY AND ACCIDENT PREPAREDNESS
Know about Safty and Accident Preparedness (Click Here)
Transport of Hazardous Chemicals
When an Occupier or any other person intends to transport a Hazardous Chemical, he must ensure that the
vehicle
is properly labelled in line with the UN-GHS classification system's eighth revision, and that
technology-enabled tracking and communication systems are used.
If Hazardous Chemicals are being transported to another state, the Occupier or individual must notify the
State
Pollution Control Board of the state to which the Hazardous Chemicals are being transported.
Submission of Information relating to Industrial Activity and Site Safety Report
An Occupier who has control of an Industrial Activity in which a Hazardous Chemical is handled must provide
evidence to the Concerned Authority that he has identified the Chemical Accident hazards, taken adequate steps
to prevent Chemical Accidents, and limit their consequences in terms of impact on people and the environment,
and provided information, training, and equipment, including antidotes, to ensure the safety of those working
on
the site.
Safety Audit Reports
At least once every two years, the occupant of a Major Accident Hazard Installation involving quantities of
Hazardous Chemicals exceeding the threshold quantity in column 4 of Schedules XI or XII must conduct an
independent safety audit of the Industrial Activity by an accredited expert agency appointed by the Steering
Committee. Within 180 days of the effective date of these Rules, the Occupier must submit at least one Safety
Audit Report.
Import of Priority Substances or Hazardous Chemicals
An Importer of priority Substances or Hazardous Chemicals in India must submit the following information to
the
Concerned Authority at least 15 days prior to the Importation of such Substance, after completing the relevant
Registration and Notification requirements.
- The name and address of the person receiving the consignment in India.
- The port of entry in India.
- The mode of transport used to convey goods from the exporting country to India
- The name and quantity of imported Priority Substances or Hazardous Chemicals
- All pertinent product safety data, including the Safety Data Sheet.
If the Concerned Authority believes that the Substance being imported is likely to cause a Major Chemical
Accident, it may instruct the Importer to take whatever safety precautions it deems necessary.
If the Concerned Authority believes that the Substance should not be imported for reasons of safety or the
environment, the Concerned Authority may stop imports and notify the Chairman, CBITC, or a Competent Person
under him, to do so.
Preparation of On-site Emergency Plan by the Occupier
An occupier of a Major Hazard Installation must prepare and submit to the Concerned Authority an up-to-date
On-site Emergency Plan outlining how Major Chemical Accidents will be handled on the Industrial Activity's
Site,
as well as the name of the person responsible for on-site safety and the names of those authorized to act in
an
emergency. The Occupier is responsible for informing everyone on the premises who are affected by the plan
about
its provisions.
At least once every 180 days, the Occupier must conduct a mock drill of the On-site Emergency Plan and submit
a
detailed report to the Concerned Authority within seven days of the drill.
Preparation of Off-site Emergency Plan
The Occupier shall provide information relating to the industrial activity under his control to enable the
concerned authority to prepare the Off-site Emergency Plan.
The Concerned Authorities shall prepare and keep up-to-date an adequate Off-site Emergency Plan for each Major
Accident Hazard Installation, detailing how emergencies relating to a possible Major Chemical Accident on that
site will be handled.
Notification of Chemical Accidents
When a Chemical Accident occurs on-site or off-site, the Occupier must notify the Concerned Authority as well
as the chemical accident unit within 24 hours of the occurrence of the Chemical Accident and submit a Chemical
Accident report in the prescribed format within 72 hours of the accident.
The Concerned Authority that receives the report must conduct a full analysis of the Chemical Accident and
submit an Analysis Report within 30 days of receipt of notice to the Division. The Occupier must submit to the
Concerned Authority a report detailing all steps taken or to be taken to prevent a repeat of the accident
Within
180 days of the Chemical Accident.
Information to be given to persons liable to be affected by a Major Chemical Accident
The Occupier shall take reasonable steps to notify persons outside the site, either directly or through a
Concerned Authority, who are likely to be in an area that could be affected by a Major Chemical Accident,
about
the nature of the Major Chemical Accident hazard, as well as the safety measures and Dos and Don'ts that
should
be followed in the event of a Major Chemical Accident. The Occupier shall take steps to inform persons about
an
Industrial Activity before such activity is commenced.
(D) LABELLING AND PACKAGING
Know about Labelling and Packaging (Click Here)
Labelling Requirements
Before being placed in Indian Territory, a Manufacturer, Importer, or Downstream User must ensure that all
Priority Substances, Hazardous Chemicals, and Mixtures containing more than 10% (w/w) of any Priority
Substance
or Hazardous Chemicals bear labels as per Schedule XVII read with this Rule and are packaged in accordance
with
Rule 34.
A Manufacturer, Importer, or Downstream User must ensure that all product identifiers, hazard statements and
pictograms, signal words, and precautionary statements used in the labels of Priority Substances placed in
Indian Territory shall be in accordance with the eighth revision of the United Nations Global Harmonised
System
of Classification. The label will be written in both English and Hindi.
Packaging Requirements
A Manufacturer, Importer, or Downstream User shall ensure that packaging containing a Priority Substance,
Hazardous Chemical, or a mixture containing more than 10% (w/w) of these must meet the following requirements:
- The packaging and fastenings must be designed and constructed so that the contents cannot escape, except
in
cases where more specific safety devices may be required.
- The materials constituting the packaging and fastenings shall not be susceptible to damage by the
contents,
or liable to form hazardous compounds with the contents.
- The packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and
will safely meet the normal stresses and strains of handling.
How can we help you in getting REACH certification?
REACH, or the Chemical Management and Safety Rule, is the next regulatory challenge in India for all chemical
substance manufacturers, importers, and foreign entities. REACH notification and registration certificates are
required from the division by all manufacturers, importers, and AIRs of existing and new substances.
Aleph India's regulatory expert can assist you in complying with REACH CERTIFICATION in India and other
chemical notifications around the world. We offer REACH services as well as extensive regulatory support for
businesses. Please visit ALEPH INDIA REACH CERTIFICATION for more information.
ALEPH INDIA is the best choice for foreign manufacturer, offers the best regulatory compliance services. Our
conformity assessment vertical will meet all of your certification requirements, with full assurance of a
comprehensive registration and hassle-free procedures.
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