REACH
CERTIFICATION

Your Next Regulatory Challenge
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Introduction

Chemical substances are being used more these days in industrial operations, as well as things we use in our daily lives, such as cleaning products and paints, as well as articles like clothing, furniture, and electrical appliances. There are several substances on the market that are hazardous to human health and the environment, yet the government has no information about these chemicals.

To get details information about these chemicals and the risks they pose to human health, the Indian government recently circulated a draught of CMS rule, which is similar to the European Union's REACH legislation. The CMS rule's basic regulatory premise is same as other REACH laws i.e. no data, no market.

Under the rule, all Existing and new chemical substances manufactured, imported, or used in India must be notified, registered by manufacturers, importers, or authorized representatives. The goal of REACH compliance is to ensure a high degree of protection for human health and the environment by accurate and earlier identifying of inherent features of substances and mixtures.

The main reason for adopting and developing REACH in place of the existing Manufacture, Storage, and Import of Hazardous Chemicals Rule 1989 is that a large number of substances have been manufactured and placed on the Indian market, sometimes in extremely large quantities. There is insufficient information about the risks they pose to human health and the environment.

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What is Indian REACH?

The Indian government has recently circulated the Draft of Chemical (Management and Safety) Rules, also known as "India-REACH" (or ICMS Rules or CMS Rules), which will replace the existing Manufacture, Storage and Import of Hazardous Chemicals (MSIHC) Rules 1989 and Chemical Accidents (Emergency Planning, Preparedness, and Response) (CAEPPR) Rules 1996. The powers conferred by Sections 3, 6, and 25 of the Environment (Protection) Act, 1986 are used to frame these rules.

The Indian National Chemical Authority (INCA), similar to the European Chemicals Agency (ECHA), will be in charge of all actions related to notification and registration. REACH stand for Registration, Evaluation, Authorization, Restriction of chemical substances, Mixture, Intermediates.

INDIA REACH, also known as the "Chemical (Management & Safety) Rules", is the country's National Chemical law. The Chemicals (Management and Safety) Rules provide for Notification, Registration, and Restrictions or prohibition and labeling and packaging requirements related to Use of Substances, Mixtures, and Intermediates placed or intended to be placed in Indian Territory.

Types of reach

Every country has its own set of rules and regulations. Before releasing a product on the market, all manufacturers, importers, traders, and suppliers must meet the country's compliance and regulatory requirements. Same as other rules and regulation, every country has its own REACH law to regulate chemical substance regulatory requirements. Manufacture, importer, and AIR must all adhere to the REACH regulations of that specific country.

Same as EU REACH, some country has its own REACH compliance like:

  1. REACH (UK)
  2. REACH (KOREA)
  3. REACH (CHINA)
  4. REACH (EUROPE)
  5. INDIA (REACH)

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.
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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.

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(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)

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

  1. The name and address of the person receiving the consignment in India.
  2. The port of entry in India.
  3. The mode of transport used to convey goods from the exporting country to India
  4. The name and quantity of imported Priority Substances or Hazardous Chemicals
  5. 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:

  1. 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.
  2. 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.
  3. 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.

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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.

About us

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Visit Aleph India to know more about all types of certification. You may also reach Aleph INDIA toll-free helpline at 08048036869/+91-9990136656 for a quick response.

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