Indian CMSR (Chemicals Management and Safety Rules)

(1) In these Rules, unless the context otherwise requires
(a) “Act” means the Environment (Protection) Act, 1986 (29 of 1986) as amended from time to time;
(b) “Article” means any object whose function is determined by its shape, surface or design to a greater degree than its chemical composition;
(c) “Authorised Representative” means a natural or juristic person in India who is authorised by a foreign Manufacturer under Rule 6(2);
(d) “Chemical Accident” means an accident involving a sudden or unintended occurrence while handling any Hazardous Chemical, resulting in exposure (continuous, intermittent or repeated) to the Hazardous Chemical causing death or injury to any person or damage to any property, but does not include an accident by reason only of war or radioactivity; (e) ―Competent Person‖ means a person recognized by the Chief Controller to be a competent person, or a person who holds a certificate of competency for the job in respect of which competency is required from an institution recognized by the Chief Controller in this behalf;
(f) “Concerned Authority” means an authority specified in column 2 of Schedule III;
(g) “Division” means the Chemical Regulatory Division of the Petroleum and Explosives Safety Organisation, whose functions are set out under Rule 5;
(h) “Downstream User” means any natural or juristic person in India, other than a Manufacturer or an Importer, who Uses a Substance in the course of his industrial or professional activities;
Explanatory Note: Downstream User does not include end-use consumer.
(i) “Existing Industrial Activity” means an Industrial Activity which is not a New Industrial Activity;
(j) “Existing Substance” means a Substance or an Intermediate which is already being Manufactured, Imported, supplied or Used in India or has already been Placed in Indian Territory prior to the expiry of the Initial Notification Period;
(k) “Exposure Scenario” means the set of conditions, including operational conditions and risk management measures, that describe how a Substance is Manufactured or Used during its life-cycle, and how the Manufacturer or Importer controls, or recommends Downstream Users to control, exposures to humans and the environment. These exposure scenarios may cover one specific process or Use or several processes or Uses as appropriate;
(l) “Hazardous Chemicals” means
i. Any Substance which satisfies any of the criteria laid down in Part I of Schedule X or any Substance listed in Part II of Schedule X;
ii. Any Substance listed in column 2 of Schedule XI;
iii. Any Substance listed in column 2 of Schedule XII;
(m) “Intermediate” means a Substance that is Manufactured for, consumed in, or Used for, chemical processing in order to be transformed into another Substance;
(n) ―Import” with its grammatical variations and cognate expressions, means bringing a Substance into India from a place outside India;
(o) ―Importer” means any natural or juristic person who Imports a Substance;
(p) “Industrial Activity” means:
i. an operation or process carried out in an industrial installation referred to in Schedule XIII involving or likely to involve one or more Hazardous Chemical and includes on-site storage or on-site transport, which is associated with that operation or process, as the case may be; or
ii. isolated storage; or
iii. pipeline;
(q) “Industrial Pocket‖ means an industrial zone notified either by a State Government or the ‗Industrial Development Corporation‘ of a State Government;
(r) “Initial Notification Period” means the period prescribed under Rule 8(1);
(s) “Isolated Storage” means storage of a Hazardous Chemical, other than storage associated with an installation on the same site specified in Schedule XIII where that storage, including storage in a warehouse, involves at least the quantities of that chemical set out in column 3 of the Schedule XI;
(t) “Major Chemical Accident” means a Chemical Accident involving loss of life inside or outside an installation, ten or more injuries inside and/or one or more injuries outside, release of toxic chemicals, explosion, fire spillage of Hazardous Chemicals resulting in on-site or off-site emergencies or damage to equipment leading to stoppage of process or adverse effects on the environment;
(u) “Major Accident Hazard Installations” means sites where an Industrial Activity (including handling and Isolated Storage, and transport through carrier or pipeline) involving Hazardous Chemicals in quantities equal to, or in excess of, the threshold specified in column 3 of Schedules XI and XII respectively is carried out;
(v) “Manufacture” means production or extraction of a Substance;
(w) “Manufacturer” means any natural or juristic person who Manufactures a Substance;
(x) “Mixture” means a mixture or solution composed of two or more Substances;
(y) ―New Industrial Activity‖ means an Industrial Activity which commences after the date of coming into force of these Rules;
(z) “New Substance” means all Substances and Intermediates that are Placed in Indian Territory after the expiry of the Initial Notification Period, and are therefore not Existing Substances;
(aa) “Notification” with its grammatical variations and cognate expressions, means a notification made under Rule 8;
(bb) “Notifier” means any person who has an obligation to notify under Rule 8;
(cc) ―Off-site Emergency‖ means an emergency that takes place in a Major Accident Hazard installation where the impact of such emergency extends beyond the premises of such installation;
(dd) “On-site Emergency” means an emergency that takes place in a Major Accident Hazard installation where the effects are confined to the premises involving only the people working inside the installation, and to deal with such eventualities is the responsibility of the occupier and is mandatory;
(ee) “Packaging” means one or more receptacles and any other components or materials necessary for the receptacles to perform containment and other safety functions with respect to Substances;
(ff) “Pipeline” means a pipe (together with any apparatus and works associated therewith) or system of pipes (together with any apparatus and work associated therewith) for the conveyance of a Hazardous Chemical other than a flammable gas as set out in column 2 of Part II of Schedule XII, where pipeline also includes inter-state pipelines;
(gg) ―Placing in Indian Territory” with its grammatical variations and cognate expressions, means supplying or making available a Substance or an Intermediate, whether in return for payment or free of charge, to a third party in the territory of India, and includes Manufacturing, packing, selling, offering for sale, or otherwise distributing, Substances or Intermediates. Import shall be deemed to be Placing in Indian Territory;
(hh) “Priority Substance” means
i.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
ii.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 iii. any Substance listed in Schedule II;
(ii) “Registrant” means a Notifier with an obligation to Register a Substance;
(jj) “Registration” with its grammatical variations and cognate expressions, means a registration made under Rule 10;
(kk) “Restriction” means a prohibition on, or conditions relating to, the Manufacture, Use or Placing in Indian Territory of a Substance;
(ll) “Risk Assessment Committee” means the committee constituted under Rule 4(4);
(mm) “Same Substance” means all Substances containing the same main constituent at a concentration of more than 80% (w/w) and not containing any other constituent listed in Schedule II at concentration of 10% (w/w) or more. Substances containing more than one main constituents with concentrations between 10% (w/w) and 80% (w/w) may be considered as Same Substance if they have the same composition. For Substances of Unknown or Variable Composition, Complex reaction products or Biological materials (UVCB) the sameness will be decided by the Division based on the information provided in 4a, 4b and 4c of Annexure V.
(nn) “Schedule” means a Schedule appended to these Rules;
(oo) “Scientific Research and Development” means any scientific experimentation, analysis or chemical research on, involving or Using a Substance, carried out under controlled conditions with no potential exposure towards workers and environment, provided that the volume of the Substance used is less than 100 kilogram per annum;
(pp) “Scientific Committee” means the committee constituted under Rule 4(3);
(qq) “Site” means any location where Hazardous Chemicals are Manufactured, processed, stored, handled, Used or disposed of and includes the whole of an area under the control of an Occupier and includes a pier, jetty or similar structure whether floating or not;
(rr) “Steering Committee” means the committee constituted under Rule 4(1) and with such composition as set out in Rule 4(2);
(ss) “Substance‖ means a chemical element and its compounds in their natural state or obtained by any Manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the Substance or changing its composition. Substance shall include Substances in Articles and Mixtures. Provided that, for the purposes of Chapter III of these Rules, the following shall not be included in the definition of Substance:
(i) Radioactive Substances;
(ii) Substances under customs supervision, not being placed in Indian Territory;
(iii)Substances stored in customs free zones with aim of re-exporting;
(iv) Wastes, as defined in Hazardous Waste Management Rules 2016;
(v) Substances used for the purposes of defence;
(vi) Substances used as food or feeding stuff for human beings or animals, including human or animal nutrition;
(vii) Substances set out in Schedule IV.
Explanatory Note: Where a Substance Used for a specific purpose is exempted, only such quantities of the Substances as are being Used for the said purpose, are exempted from the application of these Rules. Any Manufacturer, Importer or Downstream User Using any quantities of the same Substance for any other purpose will not be exempt from the application of these Rules.
(tt) “Technical Dossier” means a document providing such information as detailed in Schedule VII and to be submitted under Rule 10(1);
(uu) “Use” means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of Substance, Intermediate, Mixture and Article, or any other utilisation.
(2) Anything not hereby defined shall have such meaning as assigned to it under the Act.