India Draft Chemicals (Management & Safety) Rules, 20xx

Dr Pranav Tripathi​Deputy Director - Sustainability, Environment, and Regulatory Issues
Indian Chemical Council

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Contents➢

Objective of India Draft Chemicals (Management & Safety) Rules, 20xx➢

Content of the draft Rules➢

Chapter II: National Chemical Authority➢

Chapter III: Notification, Registration and Restriction on Use➢

Intermediates➢

Safety Data Sheet➢

Labelling Requirement➢

Exemption➢

Timeline➢

Summarize the ICMSR through flow diagram2

Objective of Draft Chemicals (Management &Safety) Rules, 20xx

What isCovered?

• Notification• Registration• Restrictions,• Labelling and Packaging requirement• Safety Procedures for the Manufacture, Handling and Import of Hazardous Chemicals
and preparedness and management of Chemical• Accidents related to Hazardous Chemicals
Health &Environment • Protection to human health and the environment

Rules areFramed for• All Substances• Substances in Mixtures• Intermediates that are Manufactured• Imported, Placed or Intended to be Placed in Indian Territory• Substances in Articles (Conditional)
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Content of the draft Rules
Chapter (6)Chapter I: Definitions, Objectives &ScopeChapter II: National Chemical
Authority
Chapter III: Notification,Registration, & Restrictions on Use
Chapter IV: Safety and Accident
Preparedness
Chapter V: Labelling and Packaging
Chapter VI: Miscellaneous

Schedules (19)
Schedule I: PBT and vPvB Assessment Criteria
Schedule II: List of Priority Substances to be registered (750 substances)
Schedule III: Concerned Authorities
Schedule IV: Substances exempt from Chapter III (Notification, Registration & Restriction onUse) and Chapter V (Labelling and Packaging)
Schedule V: Information to be provided for Notification
Schedule VI: Restricted or Prohibited Substances
Schedule VII: Content of Technical Dossier
Schedule VIII: Format for Chemical Safety Report
Schedule IX: Safety Data Sheet
Schedule X: Hazardous Chemicals (669 Substances)
Schedule XI: Isolated storages at Installations other than covered by Schedule XIII
Schedule XII: List of Hazardous Chemicals for application of Chapter IV (Safety & Accident
Preparedness (185 Substances or group of Substances)
Schedule XIII: Industrial installations
Schedule XIV: Information to be furnished by Occupier
Schedule XV: Details to be furnished in the Offsite Emergency Plan
Schedule XVI: Information to be furnished regarding Notification of Chemical Accident
Schedule XVII: Information in Labelling
Schedule XVIII: Format of Certificate
Schedule XIX: Fees and Fines Payable
4Chapter II: National Chemical Authority

National Chemical Authority

Steering
Committee

Chemistry
Unit

ScientificCommittee

Toxicology
Unit

Risk
Assessment
Committee

ChemicalAccident
Unit

Chemical
Regulatory
Division

Packaging& Labelling
Unit

TechnoLegal Unit

Priority
Substance
Unit

IT UnitSocioeconomicUnit

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Chapter III: Notification, Registration andRestriction on Use
6. Placing in Indian Territory
A Foreign entity who wishes to Place a Substance, Mixture or Article in Indian Territory
may appoint an Authorised Representative
7. Duty of Downstream Users(1) A Downstream User shall not procure Substances, Mixtures, Intermediates orArticles in which Substances or Intermediates have not been Notified or Registered, asapplicable, in accordance with these Rules.
(2) Every Downstream User whose Use of a Notified Substance is not included in its
Notification, shall notify the Division of such Use and submit a Safety Data Sheet inrelation to such Use in accordance with Rule 12.
6Notification TimelineInitial Notification Period (INP)
Entry into force

1 Year60 Days

180 Days
End of INPAll Existing Substances

New Substances

Notification (for New Substances)✓A Manufacturer or Importer or Authorized Representative shall Notify the Division of any
New Substance that they intend to Place in Indian Territory, after the expiry of the Initial
Notification Period, at least 60 days prior to the date on which they are Placed in Indian
Territory in quantities more than 1 tonne per annum.
✓Also for Existing Substance in quantities greater than 1 tonne per annum in Indian Territory
after the INP, they shall be Notified to the Division in the same manner
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Data Requirements for Notification

1. Detailed information of theNotifier
2. Substance identification
information
3. Impurities
4. Unknown Substances Details
5. Substance structural informationand spectra
6. Hazard classification
7. Usage
8. Downstream user
9. Tonnage
10. Maximum storage capacity
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Post Submission of Information for Notification➢ Notification shall be deemed accepted➢ Substance will be entered in the Register ofNotified Substances➢ A Notification Number will be issued to theNotifier for each substance➢ A Notification Certificate shall be issued to theNotifier➢ Priority Substance unit shall check if thesubstance falls under the Priority Substance9➢ Substances listed in Schedule II (750 Substances) in quantities >1
tonne per annum; to be done within one and a half year of inclusionof substance in Schedule II➢ Even for Substances in quantity less than 1 tonne per annum,
Registration may be required on recommendation of Steering
Committee and the Division➢ In case of Substances in Articles, intended for release, if the quantityof substances set out in Schedule II, present in the Article exceeds 1
tonne per annum, it requires Registration➢ Technical Dossier needs to be submitted as per Schedule VII forRegistration
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Post Submission of Information for Registration➢ Preliminary Check by Toxicology➢ Deemed acceptance of the Registration➢ Assigning of the Registration Number➢ Issuance of Certificate of Registration➢ Additional time of 60 days for incomplete
applications➢ Data Submitted to other Regulators in othercountries will be accepted to the extent possible.

➢ Joint Registration of a Substance is permitted
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Information to be submitted as part ofTechnical Dossier for Registration
1.
2.
3.
4.
5.

Registrant Detailed
Chemical identifiers
Chemical Structural Details
Identified Chemical UsesClassification and Labelling
Information
6. Robust Study Summaries
7. Main Use Categories
8. Specification for Industrial andprofessional use
9. Significant route(s) ofexposure
10. Environmental Exposure
11. Pattern of exposure
12Dossier Evaluation
Evaluation

By Chemistry & Toxicology Unit within
one year of its submission

Incomplete
information

Within 120 days of being intimation

Further extension

Maximum extension for 90 days

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Intermediates➢All intermediates transported/stored within India: Notification + Registration➢

In situ intermediates, consumed in the same process: No Notification & Registration➢

All Intermediates, which are also Substances included in Schedule II, and are stored in a facility(either for consumption in-situ or otherwise): Registration➢

Transported Intermediates that are Substances included in Schedule II, shall be Registered asunder:
a. registration of Intermediates transported or to be transported in quantities up to 1000
tonne per annum shall only contain details regarding the physical and chemical properties
in the Technical Dossierb. registration of Intermediates transported or to be transported in quantities greater than
1000 tonne per annum shall contain all information as required in the Technical Dossier andthe Chemical Safety Report
Intermediates not included in Schedule II, are required to be Notified, but are exempted fromRegistration➢14

Safety Data Sheet
All Substances or Intermediates listedin Schedule II or Hazardous chemicals
Article, where a substance orintermediate listed in Schedule II ispresent in such Article >1.0% (w/w)

Downstream
usershallrecommend that their uses areincluded in the Safety Data Sheet

Updating of Safety Data SheetWhenever new information ofhazard or anything that affect risk
management becomes available
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Labelling Requirement➢ All priority substances, hazardous chemicals, or mixtures containing>10% (w/w) of any Priority Substance, hazardous Chemicals to bearlabel as per Schedule XVII➢ All product identifiers, hazard statements and pictograms, signal words,
and precautionary statements used in the label of Priority substances

shall be in accordance with UN GHS (ver. 8)➢ The label shall be in English and Hindi
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Exemption
The following are exempted from the CMSR:➢Radioactive Substances.
➢Substances under customs supervision, not being placed in Indian Territory.
➢Substances stored in customs free zones with aim of re-exporting.
➢Wastes, as defined in Hazardous Waste Management Rules 2016.
➢Substances used for the purposes of defense.

➢Substances used as food or feeding stuff for human beings or animals,including human or animal nutrition.

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Timeline
Rules Enforced
0th Month (When??)Emergency Plan (Hazardous Substances) 3rd Month (Deadline)
Safety Audit (Hazardous Substances)
Initial Notification Starts
Initial Notification Closes

6th Month (Deadline)
13th Month (12 month after)
18th Month

Initially Listed: Registration
New Substances Notification
No New Substances to be Placed

18th Month18th Month onwards (90 days prior)
19th to 21st Month

Annual Report
1st Completeness: Registration

30th Jan Each Year
21st Month (within 90 days)

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Stakeholders
Notifiers / Registrants
Person Placing
substance in Indian
Territory
1.Manufacturer
2.Importer
3.Formulator
4.Packer
5.Seller
6.Distributor
Down Stream User

Authorized
Representative
Of Foreign
Manufacturer

National Chemical Authority
Chemical Regulatory Division

Units of the Division

Secretariat

Steering Committee

Scientific Committee

RiskAssessment
Committee

Enforcement / Concerned Authority(Schedule III ) or Competent Authority

1. Chemistry Unit.
2. Toxicology
3. Chemical Safety andAccident unit
4. Packaging & Labelling
Unit
5. Techno – Legal Unit
6. Priority SubstanceUnit
7. Information
Technology Unit
8. Socio – EconomicUnit
Public19

Process flow for Notification
Compile Details

Notifier
1.Manufacturer
2.Importer
3.Authorized
4.Representative

For Entity

1. Make a list of products
manufactured or imported(including transported andstored intermediates.)
2. Segregate into:a. Substanceb. Mixtures
c. UVCB`S
3. Identify Substances inmixtures.
4. Determine quantities for each
substance per annum.
5. Determine if exemption isapplicable

Entity details
1.Company – Name, Address, Phone, E-mail2.Appoint Authorized Person (AP)
3.Name, address, phone, E-MAIL of AP
4.Details of Foreign Manufacturer for imported goods
5.Location of Manufacture or Own use sites

Details of Substance
1.Main Component
2.Type of Substances (Mono, Multi or UVCB)
3.Composition & Impurity profile
4.Chemical structures
5.Spectral
6.Hazard classification
7.Chemical Uses
8.Top 3 DU`S
9.Actual quantities (TPA)
10.Storage details
11.Any data to be kept confidential

SubmitNotification and
Pay Fees foreach Substance

Receive
Notification
No and Certificate

Prepare SDS as per UN GHS (for substance or mixtures)20

Process flow for Registration
Registrant
1.Manufacturer
2.Importer
3.Authorised
Representative

1. Review the listof all notified
substance(>1TPM)
2. Determine
whether
individualsubstance isincluded inscheduled IIFor Entity

Compile Details
Entity Details :1.Registrant Details (done in notification)

Details of Substances (party done in the notification)
1.Chemical Identifiers
2.Chemical Structures
3.Identified Uses
4.Hazard Classification and Labeling
5.Robust Summaries
6.Main Use Categories
7.Specification for Industrial and professional Use
8.Significance Root of Exposure
9.Environmental Exposure
10.Pattern Exposure
For eachsubstance

SubmitNotification andPay Fees foreach Substance

Receive
Notification Noand Certificate

Prepare SDS as per UN GHS for substance or mixture> 10 TPA – Conduct Chemical Safety Assessment (CSA) andCompile Chemical Safety Report (CSR)< 10 TPA – Compile Exposure Scenarios2122