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India - Regulation

The Regulatory Body would be established within Petroleum and Explosives Safety Organisation (PESO) as a separate Division - Chemical Regulatory Division  - and is referred in the rules as "Division"

Three Key Committees:

  • Steering Committee, oversee functioning of the Division, meet at least one each 90 days
  • Scientific Committee, to evaluate and approve “Substances to be Registered”
  • Risk Assessment Committee, to evaluate the “Priority Substances” and propose restriction of substances and related conditions.

The implementation of rules would be supported by 8 units of the division:

  1. Chemistry Unit;
  2. Toxicology Unit;
  3. Chemical Accidents Unit;
  4. Packaging and Labelling Unit;
  5. Techno-legal Unit;
  6. Priority Substance Unit;
  7. Information Technology Unit; and
  8. Socio-Economic Unit.

Indian Chemicals (Management & Safety) (ICMS) Rules covers the following critical compliance criteria: 

  • ICMS Rules applies to all substances, substances in mixtures and Intermediates that are manufactured, imported, placed, or intended to be placed in the Indian territory.
  • All existing substances shall be notified if they are placed in the Indian territory in quantities greater than one tonne per annum.
  • Indian manufacturers, importers and Authorised Representative (AR) acting on behalf of a foreign manufacturer shall notify the Division any new substance that they intend to place into the Indian teritorry, after the expiry of initial notification period.
  • All New substances have to be notified at least 90 days prior to the date on which they are placed on the Indian territory.
  • The initial Notification period shall commence on the date that is one year from the date of coming into force of these Rules. The initial notification Period shall terminate on the date which is 180 days from the date of commencement of the Initial Notification Period.

Further, based upon the classification of notified substance registration requirements are decided:

  • 750 substances are included in Schedule II, designated as “Priority Substances “and another 37 substances in the Schedule VI, designated as “Substances to be Registered”.
  • Schedule VI would be updated from time to time based upon the evaluation of notified substances.
  • Registration requirements are applicable for all tonnage bands within 18 months after the substance is included in Schedule VI.

India proposes that classification, labeling, and SDS align with the United Nations Eighth Revised Edition (Rev 8) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

A Foreign manufacturer who wishes to place a Substance, Mixture or Article in Indian Territory may appoint an Authorized Representative to ensure compliance with these Rules and this Authorized Representative shall be liable for the discharge of all obligations under these Rules on behalf of Foreign manufacturer.

This Authorized Representative shall be an Indian national or an entity registered in India.

  • Downstream users shall ensure that substances and mixtures are notified and registered “in accordance with these Rules.”
  • In addition, downstream users are obligated to review uses that are part of the notified and/or registered substances. If their use is not included, then downstream user shall notify the use to the Division and shall submit a Safety Data Sheet in relation to such Use.

Notifier or Registrant may request that trade secrets, proprietary business information and other intellectual property related data and information shared by the Notifier or the Registrant be kept confidential and not be disseminated publicly. A request of confidnetiality may not be submitted for the Classification of Substances and endpoint summaries submitted during Notification or Registration. 

A request of confidentiality shall be accompanied by fees and a statement of reason identifying what information is to be kept confidential and the reason why such information should be kept confidential. 

Confidentiality request shall be submitted to the Division and which shall make the final determination of whether such request of confidentiality may be granted.

 

India proposes that classification, labeling, and SDS align with the United Nations Eighth Revised Edition (Rev 8) of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Following information shall be submitted to the Division for Notification of Substances. This information must be based on test reports from NABL accredited labs or GLP labs or any other Published Authentic study reports.

  • Name of Notifier
  • Chemical Identifiers including IN number and composition details
  • Chemical Structural details
  • Spectral data
  • Hazard classification of substance
  • Chemical Uses
  • Name of known Downstream Users
  • Tonnage band within which the chemical is placed in Indian territory
  • Annual quantity per annum
  • Maximum storage capacity/Maximum quantity stored

  • Transport vehicle carrying the hazardous chemical shall be properly labelling and enabled with Tracking & Communication system
  • On site safety Report – Chemical accident hazards should be identified, and adequate steps should be taken to prevent or limit chemical accidents. Site information, training equipment and antidotes shall be provided to the employees
  • Safety Report Audits - Safety audit shall be carried out at least every 2 years and safety audit report shall be submitted within within 6 months from the date of implementation of ICMR
  • On site/off site emergency plan - Emergency plan shall be prepared and submitted within 90 days from the date of implementation of ICMR. Mock drill of emergency plan shall be carried out at least once in every 6 months and its report shall be submitted within 7 days of the drill.
  • Notification of accidents – Chemical accidents shall be notified to the authority within 24 hrs of the accident and its report shall be submitted within 72 hrs.

  • Notification

All manufacturers or importers (or authorised pepresentatives acting on behalf of foreign entities) shall notify National Chemical Authority of all existing Substances that they have Placed in Indian Territory in quantities greater than 1 tonne per year. The notification is scheduled to start one year from the date of the enforcement of the rules, and end 180 days after their commencement. After this period, any substance not notified will be considered a new substance.

  • Registration

All manufacturers, importers and authorised representatives (in the case of Foreign Manufacturers) that have placed or are intending to place in Indian Territory a substance listed in Schedule II in quantities greater than 1 tonne per annum must register such substance within one and half years from the date of inclusion of the substance in Schedule II.

  • Evaluation and Restriction

The Priority Substance Unit of the authority shall evaluate the available data to assess if a registered substance poses an unacceptable risk to human safety or the environment during various uses in India. If the risk is not acceptable, it may propose to restrict the use of such substance or prohibit such substance.

The list of restricted/prohibited substances is listed in Schedule VI. Currently only one substance, phosgene, is restricted.

Priority substance is defined as:

  • Any Substance which falls under any of the following Hazard Classifications of the eighth revision of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS Rev. 8): a. Carcinogenicity and/or Germ Cell Mutagenicity and/or Reproductive Toxicity and categorised as Category 1 or 2, or b. Specific Target Organ Toxicity (Repeated Exposure or Single Exposure) Category 1 or 2; or
  • Any Substance which fulfils the criteria of Persistent, Bio-accumulative and Toxic or very Persistent or very Bio-accumulative, as set out in Schedule I of these Rules; or
  • Any Substance listed in Schedule II.

  • A Manufacturer, Importer or Downstream User shall ensure that all Priority Substances, Hazardous Chemicals and Mixtures containing more than 10% (w/w) of any Priority Substance or Hazardous Chemicals comply with labelling and packging requirements.
  • A Manufacturer, Importer or Downstream User shall ensure that all product identifiers, hazard statements and pictograms, signal words, and precautionary statements used in the labels of Priority Substances that they Place in Indian Territory shall be in accordance with the eighth revision of the United Nations Global Harmonised System of Classification (UN GHS).

  • Identification of compliance requirements under various guidelines including all data requirements.
     
  • Data gap analysis and pre-assessment support
     
  • Technical documentation support
     
  • Pre and post submission support and technical liaison with authorities.

India’s Chemicals (Management and Safety) Rules (ICMSR) also referred to as ‘India REACH’ will come into force on the date of their publication in the Official Gazette, expected mid-2021, and will regulate all substances, substances in mixtures, and intermediates that are manufactured, imported or placed on the market in the Indian territory at quantities greater than 1 tonne per year. Indian Draft Chemicals (Management and Safety) Rules has gone through several amendments and the latest draft amendment was published in Aug 2020. These 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 and introduce REACH-like registration requirements to certain priority substances. The rules are also known as "India REACH”.

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