CMSR (Chemicals Management and Safety Rules)
Indian CMSR (Chemicals Management and Safety Rules)
Table of Contents
Draft Chemicals (Management and Safety) Rules, 20xx
Chapter I. Definitions, Objectives and Scope
2. Definitions
3. Objectives and scope
Chapter II. National Chemical Authority
Chapter III. Notification, Registration and Restrictions on Use
Chapter IV. Safety and Accident Preparedness
Chapter V. Labelling and Packaging
Chapter VI. Miscellaneous
Download the CMSR draft (English)
Draft Chemicals (Management and Safety) Rules, 20xx
In exercise of the powers conferred by Sections 3, 6 and 25 of the Environment (Protection) Act, 1986 (29 of 1986), and in supersession of the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 and the Chemical Accidents (Emergency Planning, Preparedness and Response) Rules, 1996, except things done or omitted to be done before such supersession, the Central Government hereby makes the following Rules relating to the management and safety of chemicals, namely:
1. Short Title and Commencement
(1) These Rules may be called the Chemicals (Management and Safety) Rules, 20xx.
(2) These Rules shall come into force on the date of their publication in the Official Gazette.
Chapter I. Definitions, Objectives and Scope
2. Definitions
(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.
3. Objectives and scope
(1) 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.
(2) These Rules also provide for safety procedures for the Manufacture, handling and Import of Hazardous Chemicals and preparedness and management of Chemical Accidents related to Hazardous Chemicals, as identified under these Rules. The objective of these Rules is to ensure a high level of protection to human health and the environment.
(3) These Rules apply to all Substances, Substances in Mixtures and Intermediates that are Manufactured, Imported, Placed or intended to be Placed in Indian Territory.
(4) These Rules do not apply to Substances in Articles except as otherwise set out in Rule 10 and Rule 12 hereinafter.
Chapter II. National Chemical Authority
4. Structure, duties and powers of National Chemical Authority
(1) The National Chemical Authority, consisting of the Steering Committee, the Scientific Committee, Risk Assessment Committee and the Chemical Regulatory Division is hereby set up in accordance with these Rules for the purpose of implementation of these Rules.
(2) The Steering Committee shall oversee technical and administrative matters arising out of these Rules, and carry out functions that may be assigned to it under these Rules including:
(a) Oversee the activities of the Division;
(b) Approve an annual budget for the functioning of the Division, prepare internal procedure for its day to day operations, and oversee the day to day operations of the Division; and
(c) Prepare and publish an annual report regarding the activities of the Division.
(3) The Steering Committee shall meet at least once every 90 days, and shall consist of the following:
(a)
Secretary, Department of Chemicals and Petro-Chemicals
Ex officio
Chairperson
(b)
Member Secretary, National Disaster Management
Authority
Ex officio Member
(c)
Joint Secretary (Chemicals), Department of Chemicals and Petro-Chemicals
Ex officio Member
(d)
Joint Secretary (Explosives), Department for Promotion of
Industry and Internal Trade
Ex officio Member
(e)
Joint Secretary (HSM Division), Ministry of
Environment, Forest and Climate Change
Ex officio Member
(f)
Joint Secretary (Plant Protection), Department of
Agriculture, Cooperation and Farmers Welfare
Ex officio Member
(g)
Joint Secretary (FSSAI Division), Ministry of Health and
Family Welfare
Ex officio Member
(h)
Joint Secretary (Trade Policy Division), Department of
Commerce
Ex officio Member
(i)
Joint Secretary, Department of Pharmaceuticals
Ex officio Member
(j)
Joint Secretary, National Authority for Chemical
Weapons Convention
Ex officio Member
(k)
Drugs Controller General of India
Ex officio Member
(l)
Chairperson, Central Pollution Control Board
Ex officio Member
(m)
Chairman, Registration Committee under Insecticide Act,
1968
Ex officio Member
(n)
CEO, Food Safety and Standards Authority of India
Ex officio Member
(o)
Principal secretary/ Secretary of Industries, from each State of India.
Ex officio Member
(p)
Persons having expertise in chemical management, coopted as and when the special need arises
Members
(q)
Chief Controller of Chemicals, Chemical Regulatory
Division, National Chemical Authority
Member Secretary
(4) The Scientific Committee shall be composed of the following members and shall carry out functions as set out in these Rules:
(a) A Chairperson, being the Joint Chief Controller of Chemicals (Chemistry Unit);
(b) One expert in chemistry or chemical regulations ;
(c) One toxicology expert ;
(d) One packaging and labeling expert, from the Indian Institute of Packaging, Ministry of Commerce and Industry;
(e) One environmental expert ;
(f) Two experts in socio-economic analysis, including for instance experts with background in Ecological Economics, Economic Sciences, Social Sciences, etc.;
(g) One expert each in analytical chemistry, environmental impact studies, packaging & labeling from industry associations with equivalent experience and
(h) Any senior staff member of the Chemistry Unit nominated by the Head as the Member Secretary;
(5) The Risk Assessment Committee shall be composed of the following members and shall carry out the functions set out in these Rules:
(a) A Chairperson, being the Joint Chief Controller of Chemicals (Toxicology Unit);
(b) One expert in chemistry or chemical regulations ;
(c) One medical toxicology expert ;
(d) One veterinary toxicology expert ;
(e) One phyto-toxicology expert ;
(f) One marine toxicology expert ;
(g) One environmental expert ;
(h) One expert each in environmental impact studies, medical toxicology, veterinary toxicology and environment toxicology nominated industry associations with equivalent experience; and
(i) Any senior staff member of the Toxicology unit nominated by the Head as the Member Secretary;
(6) All expert members of the Scientific Committee and the Risk Assessment Committee shall be part-time members and shall be nominated by the Steering Committee. Expert members shall have a minimum of 20 years of experience as scientists in the relevant areas in any institutes of Indian Council of Medical Research (ICMR), Council of Scientific & Industrial Research (CSIR), Indian Council of Agricultural Research (ICAR), National Institute of Pharmaceutical Education and Research (NIPER) or in any GLP certified lab. Serving or retired professors/ asst. professors with a minimum of 20 years of experience in the relevant areas in any Central University or any institute of national repute may also be nominated. All expert members shall be below 65 years of age on the date of nomination and shall, unless their seats become vacant earlier by resignation, death or otherwise, hold office for 3 years from the date of their appointment, and shall be eligible for re-appointment to either committee only once.
(7) No Person may serve as a member of the Scientific Committee and the Risk Assessment Committee simultaneously.
(8) All part-time expert members shall be paid sitting fees as per Schedule XIX and travel allowance from their place of residence at the same rate as applicable to a Director in Government of India.
(1) The Chemical Regulatory Division shall discharge the duties of secretariat of the National Chemical Authority and shall carry out all functions as required under these Rules. The Chief Controller of Chemicals, Joint Chief Controllers of Chemicals and Deputy Chief Controllers of Chemicals shall be of the rank of Joint Secretary, Director and Under Secretary to the Government of India respectively and shall be appointed by the Central Government on deputation basis from the officers of equivalent rank or a rank below in existing technical cadres of the government or statutory/ autonomous bodies, created for the purpose of dealing with chemicals and related matters. All these officers shall draw the same salary as in their parent organizations and also shall draw a deputation allowance of 25% of basic pay.
(2) The Chief Controller of Chemicals, being the Head of the
