CHEMICAL MANAGEMENT AND SAFETY RULES [REACH |UK| KOREA| CHINA| EUROPE| INDIA| INDIA REACH]

INTRODUCTION

INDIA REACH, also known as the "Chemical (Management & Safety)" Rules, serves as the country's national chemical legislation. Recently, the Indian government has circulated a draft titled "Chemical (Management and Safety) Rules," commonly referred to as India-REACH (or ICMS Rules or CMS Rules). These proposed rules aim to replace the existing Manufacture, Storage and Import of Hazardous Chemicals (MSIHC) Rules 1989 and Chemical Accidents (Emergency Planning, Preparedness, and Response) (CAEPPR) Rules 1996. These regulations are formulated under the authority vested by Sections 3, 6, and 25 of the Environment (Protection) Act, 1986 (29 of 1986).

EXPECTED IMPLEMENTATION DURING 2021-22

INDIA REACH COMPILANCE

India REACH regulations will become applicable upon entering into force on the following dates:

• Indian Manufacturers

• Indian Importers

• Authorized Indian Representative-Indian representative appointed by overseas Manufacturers

Foreign manufacturers/companies can secure REACH Compliance Certificates by designating an Authorized Representative in India to advocate for their case and ensure adherence to regulations and registration requirements. Absolute Veritas stands out as the optimal choice for foreign manufacturers, offering top-tier regulatory compliance services. Our conformity assessment division caters to all your certification requirements, ensuring a seamless registration process with full assurance.

BASIC REQUIREMENTS

A. NOTIFICATION AND ANNUAL REPORTING

• Notification - All substances, both existing and newly introduced, classified as priority or hazardous, with quantities exceeding 1 tonne per year, must be reported to the authority. Additionally, compliance necessitates the provision of a safety data sheet (SDS) and other requisite information as per regulations. Upon successful submission, a notification number and certificate are issued.

• Annual Reporting- All substances that have been notified require annual updates to the information submitted. These updates must encompass details on the actual quantities of substances placed in the preceding calendar year, as well as any alterations or additions to the information provided during notification. This update must be completed no later than 60 days after the end of the reporting period. Both notification and annual reporting are subject to an authority fee.

B. REGISTRATION

Registration is mandatory for 750 substances listed in Schedule II, identified as priority substances, when utilized in quantities exceeding 1 tonne per year. Additional substances may be appended to the list following notification. Registration might also be necessary for substances utilized in quantities below 1 tonne per year. The registration deadline is set at 1.5 years from the date of inclusion of the substance in Schedule II.

To obtain REACH Certification in India, the submission process entails providing a technical dossier and chemical safety report (CSR), incorporating exposure scenarios (ES) akin to EU REACH standards. The requisite information aligns with Schedule VII specifications and necessitates test reports from either NABL (National Accreditation Board for Testing and Calibration Laboratories) or GLP Certified laboratories. To minimize redundancy, existing test data must be thoroughly evaluated before mandating new testing.

• Joint Registration: Additionally, Joint registration is available, allowing entities to collaborate with others handling the same substance and register it jointly. However, it's crucial to ensure that such joint registration fully complies with all obligations applicable to individual registrations under these Rules.

• Transported Intermediate Registration:Registration is necessary for all intermediates listed in Schedule II, regardless of their status as substances. For quantities below 1000 tpa, only physical and chemical properties need to be included in the Technical Dossier. However, for quantities exceeding 1000 tpa, both the Technical Dossier (containing information as per Schedule VII) and the chemical safety report are required.

The deadline for submitting intermediate registration is 1.5 years from the date of inclusion in Schedule II.

Following successful submission, a registration number and certificate are issued. Registration incurs tonnage-specific authority fees, which also cover updates. MSME companies (Micro, Small & Medium Enterprises) may benefit from discounted fees.

C. PRIORITY SUBSTANCES

• Hazard classifications such as CMR (Category 1 or 2) or STOT Cat 1 or 2 according to UN GHS Rev. 8

• Substances identified as PBT or vPvB as outlined in Schedule 1

• Any substance listed in Schedule II, currently encompassing 750 substances with additional additions anticipated during rule implementation.

Businesses dealing with priority substances must conduct a chemical safety assessment, including an exposure scenario for substances utilized up to 10 tonnes per year, and a chemical safety report for substances used in excess of 10 tonnes per year during the Notification/Registration process.

The data necessary for the Chemical Safety Report (CSR) aligns with the specifications outlined in Schedule VIII, which encompasses Exposure Scenarios (ES).

IMPORT CONTROL OF PRIORITY SUBSTANCE/HAZARDOUS CHEMICALS

After fulfilling the pertinent Notification and Registration obligations, an importer of Priority substances or Hazardous chemicals must submit the required documentation at least 15 days before the intended Importation.

• Details of the recipient's name and address in India

• Designation of the port of entry in India

• Method of transportation from the exporting country to India

• Identification and quantity of Priority Substances or Hazardous Chemicals being imported

• Comprehensive product safety information, including Safety Data Sheet

If the appointed Concerned Authority, the Chief Inspector of Dock Safety under the Dock Workers (Safety, Health, and Welfare) Act, 1986 deems that the importation of a substance poses safety or environmental risks, such imports may be halted.

The draft regulation does not specify any authority fee.

• Labeling & Packaging:Priority substances, Hazardous chemicals, and Mixtures containing over 10% w/w of priority substance or hazardous chemical, before their placement and use in India, must display labels conforming to Schedule XVII and in compliance with GHS v.8. These labels should be in both English and Hindi. Packaging requirements adhere to standard specifications.

• Safety Data Sheet (SDS):All notifiers of a Substance or an Intermediate listed in Schedule II, or a Hazardous Chemical, must keep and provide an updated Safety Data Sheet (SDS). Additionally, all importers or manufacturers of an Article containing a Substance or an Intermediate listed in Schedule II, above a concentration of 1.0% w/w, are required to maintain and submit an up-to-date SDS. The necessary information is outlined in Schedule IX, following GHS v.8 guidelines.

• Evaluation and Restriction:All registered substances will undergo an evaluation process to determine if they present an unacceptable risk to human safety or the environment during their various uses in India. Risk-based methodologies, encompassing hazard identification, hazard characterization, exposure assessment, and risk characterization (probability of known and potential adverse effects occurrence), will be employed for comprehensive risk assessment, to the best extent feasible.

If the risk associated with the use of the Registered Substance is significant, there may be a proposal to restrict or prohibit its use. Additionally, based on evaluation, recommendations may be made to add or remove entries from Schedules X, XI, or XII (Hazardous chemicals).

Following the notification of a restriction on a Priority Substance, individuals may request authorization for its use from the Division. Authorization for use can be initially granted for a period of 4 years and may be extended for up to an additional 4 years upon re-application.

An authority fee will be applicable for the authorization to use a Restricted Substance.

D. HAZARDOUS CHEMICALS

These procedures pertain to safety measures for the manufacturing, handling, and importation of Hazardous Chemicals, as well as the preparedness and management of Chemical Accidents associated with such Hazardous Chemicals, as identified within these Rules.

TRANSPORT OF HAZARDOUS CHEMICALS

During the transportation of hazardous chemicals, it is the responsibility of the occupier to ensure that the vehicle used for transport is correctly labeled and equipped with technology-enabled tracking and communication systems.

The transportation of Hazardous Chemicals must adhere to the regulations outlined in these rules, as well as those established by the Central Government under the Motor Vehicles Act, 1988, and the guidelines provided by the division as applicable. When transporting Hazardous Chemicals to another Indian State, the Occupier must notify the State Pollution Control Boards (SPCB) of the receiving State in advance.

INDUSTRIAL ACTIVITY NOTIFICATION AND SITE SAFETY REPORT

• Simplified Site Safety Report:All industrial sites not covered by standard site safety reports must furnish evidence demonstrating that the occupier has identified Chemical Accident hazards and implemented sufficient measures to prevent such accidents and mitigate their impact on individuals and the environment. This evidence should include providing personnel working on the site with necessary information, training, and equipment, including antidotes, to ensure their safety. The occupier is required to submit this evidence within 30 days of commencing the activity or within 30 days of the enactment of these Rules, whichever is later. Acknowledgment from the Concerned Authorities must be obtained within 60 days of submission, failure of which will result in the cessation of the activity.

• Standard Site Safety Report:Occupiers of Industrial Activities must notify when the quantity of Hazardous Chemicals listed in column 2 of Schedule XII equals or exceeds the threshold quantity specified in column 3 of Schedule XII. Similarly, for isolated storage, notification is required when the quantity of a Hazardous Chemical listed in column 2 of Schedule XI equals or exceeds the threshold quantity specified in column 3 of Schedule XI.
  Furthermore, no new Industrial Activity can be undertaken without prior approval from the Concerned Authorities. The occupier must submit a notification report in the format specified in Part I and a Site Safety Report in the format specified in Part II of Schedule XIV, at least 90 days before commencing the activity, or within a shorter period as agreed upon by the Concerned Authority. Transitional provisions also apply in this regard.

• Safety Audit Reports:Major Accident Hazard Installations, which contain quantities of Hazardous Chemicals exceeding the threshold quantity specified in column 4 of Schedules XI or XII, are required to adhere to these regulations.
  The Occupier must furnish at least one Safety Audit Report conducted by an Accredited expert agency, as approved by the Steering Committee, within 180 days from the date of these Rules' enactment. Following this, such audits must occur at least once every 2 years thereafter.

• Revision and Update (Industrial activity and Site safety/Safety Audit Report):If the occupier implements any modifications to an Industrial Activity that could significantly impact the details provided in the reports submitted as per Part I of Schedule XIV, or the Site Safety Report, or the Safety Audit Report, they must prepare a fresh report considering these modifications. This revised report must be submitted to the Concerned Authority within 30 days of making the modifications.
  In cases where the occupier has prepared both simplified and standard Site Safety Reports, and the Industrial Activity is ongoing, they must, within 3 years of the date of the last such report, prepare a further report. This report should take into account any new technical knowledge that may have influenced the details in the previous report concerning safety and hazard assessment. The updated Site Safety Report must be submitted to the Concerned Authority.

• On Site Emergency Preparation Plan:An Occupier of a Major Hazard Installation must create and provide an updated On-site Emergency Plan to the Concerned Authority, outlining how Major Chemical Accidents will be managed on the Industrial Activities site, as specified in Part III of Schedule XIV. The Occupier is responsible for ensuring that the On-site Emergency Plan is revised in the event of any changes to the Industrial Activities.
  For Existing Industrial Activities, the deadline to submit the on-site emergency preparation plan is within 90 days of the enactment of these Rules. For New Industrial Activities, the plan must be submitted within 30 days of the commencement of the activity.

• Detailed Mock Drill Report of the On-site Emergency Plan:Additionally, the occupier must conduct mock drills at least once every 180 days and submit a comprehensive report on each drill to the Concerned Authority within 7 days of its completion.

• Off-site Emergency plan:To facilitate the preparation of the Off-site Emergency Plan, the Occupier must furnish the Concerned Authority with any information pertaining to the industrial activity under their control, as requested by the Concerned Authority. This information should encompass details regarding the nature, extent, and potential off-site impacts of potential Major Chemical Accidents.

NOTIFICATION OF CHEMICAL ACCIDENTS

In the event of a Chemical Accident, including a Major Chemical Accident as defined by this Rule, occurring either on-site or off-site, the Occupier must promptly notify the Concerned Authority and submit a Chemical Accident report in the format specified in Schedule XVI. Additionally, the Occupier must inform the Chemical Accidents Unit of the Division.

Notification must be made within 24 hours of the Chemical Accident occurring, and the submission of the Chemical Accident report should take place within 72 hours of the accident.

The Occupier must provide the Concerned Authority with a report detailing all actions taken or planned to prevent a recurrence of the accident within 180 days from the date of the Chemical Accident.

Information to be provided to individuals who may be impacted by a Major Chemical Accident.

The Occupier must ensure that individuals outside the site, either directly or through the Concerned Authority, are informed about the nature of the Major Chemical Accident hazard, safety measures, and the Dos and Don'ts to be followed in the event of such an accident.

The Occupier must notify individuals about an Industrial Activity before its commencement, with the exception of Existing Industrial Activities. For existing activities, the Occupier must comply with these requirements within 90 days of the enactment of these Rules. In conclusion, the expansion of mandatory certification for chemicals aims to ensure the quality, safety, and reliability of products in the market through robust certification regulations. In the future, we anticipate that more products will be subject to mandatory BIS ISI Registration and Certification. We are available to assist you and provide reliable information regarding Indian Chemical regulations for your products.

Conclusion

Understanding and achieving REACH compliance is crucial for businesses operating in the EU market. By staying informed and seeking expert guidance, companies can effectively manage their chemical substances and ensure the safety of their products. If you have further questions about REACH compliance or need assistance, feel free to reach out to Absolute Veritas!

For more details, please reach out to us via email at cs@absoluteveritas.com