Indian CMSR (Chemicals Management and Safety Rules)
Table of Contents
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
(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
(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:
Secretary, Department of Chemicals and Petro-Chemicals
Member Secretary, National Disaster Management
Ex officio Member
Joint Secretary (Chemicals), Department of Chemicals and Petro-Chemicals
Ex officio Member
Joint Secretary (Explosives), Department for Promotion of
Industry and Internal Trade
Ex officio Member
Joint Secretary (HSM Division), Ministry of
Environment, Forest and Climate Change
Ex officio Member
Joint Secretary (Plant Protection), Department of
Agriculture, Cooperation and Farmers Welfare
Ex officio Member
Joint Secretary (FSSAI Division), Ministry of Health and
Ex officio Member
Joint Secretary (Trade Policy Division), Department of
Ex officio Member
Joint Secretary, Department of Pharmaceuticals
Ex officio Member
Joint Secretary, National Authority for Chemical
Ex officio Member
Drugs Controller General of India
Ex officio Member
Chairperson, Central Pollution Control Board
Ex officio Member
Chairman, Registration Committee under Insecticide Act,
Ex officio Member
CEO, Food Safety and Standards Authority of India
Ex officio Member
Principal secretary/ Secretary of Industries, from each State of India.
Ex officio Member
Persons having expertise in chemical management, coopted as and when the special need arises
Chief Controller of Chemicals, Chemical Regulatory
Division, National Chemical Authority
(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 Chemical Regulatory Division of the National Chemical Authority shall:
(a) Manage and coordinate the day to day functioning of the Division, including administrative tasks;
(b) Coordinate between the Scientific Committee, the Risk Assessment Committee and the Units of the Division; and
(c) Prepare a statement of revenue and expenditure, as well as implement the annual budget.
(3) Each of the following Units of the Division shall be headed by a Joint Chief Controller of Chemicals, assisted by three (3) Deputy Chief Controllers of Chemicals:
(a) Chemistry Unit;
(b) Toxicology Unit;
(c) Chemical Safety and Accidents Unit;
(d) Packaging and Labelling Unit;
(e) Techno-legal Unit;
(f) Priority Substance Unit;
(g) Information Technology Unit; and
(h) Socio-Economic Unit.
(4) A Director or Deputy Secretary level officer shall head the Administrative and Finance Unit of the Division and assisted by one Under Secretary.
(5) The Division shall, inter alia:
(a) Provide technical, scientific and administrative support to the Scientific Committee and Risk Assessment Committee;
(b) Administer procedures relating to Notification and Registration;
(c) Prepare and maintain a database of information;
(d) Disseminate information to the public;
(e) Ensure the enforcement of these Rules;
(f) Evaluate Notifications and Registrations, and make recommendations, in concurrence with the Scientific Committee and the Risk Assessment Committee, on the accuracy of the data submitted, and to identify Substances which require Registration, authorization under Restricted Use and prohibition from Use; and
(g) Ensure decisions taken on Substances are shared with the Notifier or Registrant.
5. Chemical Regulatory Division
Chapter III. Notification, Registration and Restrictions on Use
6. Placing in Indian Territory
(1) No person shall Place in Indian Territory any Substance, Mixture or Article unless they comply with these Rules.
(2) A Foreign entity who wishes to Place a Substance, Mixture or Article in Indian Territory may appoint an Authorised Representative, who shall be an Indian national or an entity registered in India with sufficient background in practical handling of Substances and with minimum average net worth of ten times the average value of Substances dealt by him during the last calendar/financial year. Such Authorised Representative shall be responsible to act on behalf of the foreign entity to ensure compliance with these Rules and shall be liable for the discharge of all obligations under these Rules.
7. Duty of Downstream Users
(1) A Downstream User shall not procure Substances, Mixtures, Intermediates or Articles in which Substances or Intermediates have not been Notified or Registered, as applicable, 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 in relation to such Use in accordance with Rule 12.
(1) 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 the commencement of the Initial Notification Period.
(2) All Manufacturers or Importers (or Authorised Representatives acting on behalf of foreign entities) shall Notify the Division of all Existing Substances that they have Placed in Indian Territory in quantities greater than 1 tonne per annum in accordance with Rule 9, within the Initial Notification Period.
(3) A Manufacturer or Importer (or Authorised Representative in the case of a Foreign Manufacturer) shall Notify the Division of any New Substance that they intend to Place in Indian Territory, after the expiry of the Initial Notification Period.
(4) All New Substances have to be Notified at least 60 days prior to the date on which they are Placed in Indian Territory in quantities more than 1 tonne per annum. Any person intending to Place an Existing Substance in quantities greater than 1 tonne per annum in Indian Territory after the Initial Notification Period shall also Notify the Division in the same manner.
(5) The fees for Notification shall be as per Schedule XIX.
(6) All Manufacturers and Importers who have registered a Substance under any other Indian Act, Rule or Regulation currently in force, shall also Notify the Division in accordance with Rule 8 except sub-rule 12 and 13. Such Substances are exempted from Registration, Chemical Safety Assessment and Evaluation and Restriction and Rules 10, 13 and 16 will not apply in such cases.
(7) All Manufacturers and Importers who have Notified a Substance under this Rule shall update the information submitted annually, no later than 60 days after the end of each calendar year. Such update shall mandatorily be accompanied with fees as set out in Schedule XIX, if applicable and include information regarding the actual quantities of Substances Placed in Indian Territory in the previous calendar year. Additionally, any changes or additions to the information submitted at the time of Notification must be updated.
(8) Upon receipt of a Notification, the Chemistry Unit of the Division shall conduct a preliminary check to ensure that the Notification is complete, and the prescribed fee has been paid. If the Notification is incomplete, the Division may require the Notifier to submit additional information. The Notifier must comply with such request within a maximum period of 30 days.
(9) In case the Notifier is unable to furnish such information within 30 days, he may apply to the Division for an extension of a maximum of 30 days. The Division may, if it deems fit, grant such an extension.
(10) If the Notification passes such preliminary check, the Techno-Legal Unit shall take a decision on an application for confidentiality, if any.
(11) Once all required information regarding a Notification has been submitted to the satisfaction of the Chemistry Unit, the Notification shall be deemed accepted and the Substance shall be entered into the Register of Notified Substances. A notification number shall be assigned to the Notifier for such Substance and notification certificate in the form set out in Schedule XVIII shall be granted to the Notifier.
(12) Upon Notification of a Substance, the Priority Substance Unit shall check with the Division and Notifier for availability of data regarding the Substance to find out whether it falls within the definition of Priority Substance. All data submitted by the Notifier to any foreign regulator in other jurisdictions for the purpose of registration of the same Substance shall be acceptable to the extent possible. The Priority Substance Unit shall evaluate all Notified Substances, in concurrence with the Scientific Committee and the Risk Assessment Committee, and identify Substances that fall within the definition of Priority Substance. Scientific Weight of Evidence data, if made available by the Notifier, shall also be taken into account before making final determination about any Substance. Based on such evaluation, or based on non-availability of data, the Priority Substance Unit may recommend to the the Steering Committee for addition to or deletion from Schedule II.
(13) The Steering Committee shall hold public consultations within 90 days of receipt of recommendations, prior to forwarding such recommendations to the Central Government.
9. Information for Notification
(1) A Notification by a Manufacturer or Importer or Authorised Representative shall include information relating to the Notifier, identity of the Substance, its Uses, the quantity of the Substance that is or will be Placed in Indian Territory, current classification and such other information as set out in Schedule V.
(2) All Notifiers are also required to submit a Safety Data Sheet as required under Rule 12.
(1) 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.
(2) A requirement for Registration of Substances that are placed in Indian Territory in quantities lower than 1 tonne per annum, may also be published in Schedule II, based on the recommendations of the Scientific Committee and the Division.
(3) If Substances set out in Schedule II are present in Articles such that:
(a) Such Substances are intended to be or likely to be released from the Article under normal or foreseeable conditions of use, and
(b) Such Substance is present in the Article in quantities totalling over 1 tonne per producer or importer per year; then
the Manufacturer or Importer of such Article shall be required to Register such Substance in accordance with these Rules.
(4) Registration shall be done by submitting a Technical Dossier, as set out in Schedule VII.
(5) Upon the receipt of a Registration, the Toxicology Unit shall conduct a preliminary check to ensure that the Registration is complete, and that the prescribed fees have been paid. If the Registration is incomplete, the Division may require the Registrant to submit additional information for completing the Dossier within 60 days. For Substances already registered with any foreign regulator in other jurisdictions, the data submitted on the same Substance to that regulator for the purpose of registration shall be acceptable to the extent possible.
(6) The Techno-legal Unit shall take a decision on any applications regarding confidentiality.
(7) Once all required information regarding a Registration has been submitted to the satisfaction of the Toxicology Unit, the Registration shall be deemed accepted, a registration number shall be assigned to the Registrant of such Substance and a registration certificate in the form set out in Schedule XVIII shall also be granted to the Registrant.
(8) All Manufacturers, Importers or Authorised Representatives who have Registered a Substance shall update the Technical Dossier and other data submitted with the Registration (if any) to reflect any change or revision in the information submitted that affects hazard and risk management, not later than 60 days after the Manufacturer, Importer or Authorised Representatives has become aware of such change or revision.
(9) The fees for Registration shall be as per Schedule XIX.
(10) Any Manufacturer, Importer or Authorised Representative who has a duty to Register a Substance, may come to an arrangement with other Manufacturers, Importers or Authorised Representatives of the Same Substance and jointly Register such Substance:
Provided however that such joint Registration shall be in compliance with all such obligations applicable to an individual Registration under these Rules.
(1) Manufacturers, Importers or Authorised Representatives that transport or store or will transport or store Intermediates within the territory of India shall comply with Notification and Registration requirements as set out in this Rule. Intermediates produced in-situ which are not isolated but consumed in the same process are exempted from Notification and Registration.
(2) All Intermediates, which are also Substances included in Schedule II, and are stored in a facility (either for consumption in-situ or otherwise) shall be Registered in accordance with Rule 10 of these Rules.
(3) Transported Intermediates that are Substances included in Schedule II, shall be Registered as under:
(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 Dossier, and
(b) 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 and the Chemical Safety Report.
(4) Intermediates not included in Schedule II, are required to be Notified, but are exempted from Registration requirements under these Rules.
12. Safety Data Sheet
(1) All Notifiers of a Substance or an Intermediate listed in Schedule II or a Hazardous Chemical are required to maintain and submit an up-to-date Safety Data Sheet in the format set out in Schedule IX and share such Safety Data Sheet with the Downstream User of the Substance.
(2) All importers or manufacturers of an Article, where a Substance or an Intermediate listed in Schedule II is present in such Article above a concentration of 1.0 % weight by weight (w/w), shall maintain and submit an up-to-date Safety Data Sheet in the format set out in Schedule IX and share such Safety Data Sheet with the User of the Article.
(3) Any Registrant who is required under Rule 13 to carry out a Chemical Safety Assessment for a Substance included in Schedule II shall ensure that the information in the Safety Data Sheet is consistent with the information in the Chemical Safety Report.
(4) All Downstream Users of a Substance shall recommend additions to the Safety Data Sheet, if any, on the basis of their Use of the Substance.
(5) All Notifiers and Downstream Users shall update the Safety Data Sheet when new information on hazards or which may affect risk management becomes available.
13. Chemical Safety Assessment
(1) Manufacturers or Importers (or Authorised Representatives in the case of foreign Manufacturers) that Place Substances listed in Schedule II in Indian Territory in quantities greater than 10 tonnes per annum shall perform a Chemical Safety Assessment and submit a Chemical Safety Report in the format prescribed in Schedule VIII at the time of Notification or Registration.
(2) Manufacturers or Importers (or Authorised Representatives in the case of foreign Manufacturers) that Place Substances listed in Schedule II in Indian Territory in quantities less than or equal to 10 tonnes but more than 1 tonne per annum shall submit an Exposure Scenario at the time of Registration.
14. Information Dissemination
(1) The interactive digital platform set up by the Division for the operation of these Rules shall include, subject to Rule 17, an information portal to disseminate, inter alia, the following information to the general public:
(a) information relating to Notified and Registered Substances, their Uses and classification;
(b) Information relating to deadlines;
(c) Standard operating procedures and technical guidance on Notification, Registration, Chemical Safety Assessment, and Evaluation; and
(d) Templates for providing information for Notification and Registration.
(2) The Portal shall also, subject to Rule 17:
(a) contain Notices and other communication from the Division to Notifiers and Registrants, subject to the confidentiality obligations in Rule 17; and
(b) Have provisions for e-filing of appeals.
15. Dossier Evaluation
(1) The Chemistry and Toxicology Units of the Division shall evaluate the Technical Dossier within one year of its submission.
(2) If the Chemistry and Toxicology Units find that the Technical Dossier has incomplete information, they shall require the Registrant to furnish the same, including any additional test data within 120 days of being informed.
(3) In case the Registrant is unable to furnish such information within the prescribed period, he may apply to the Division for an extension of a maximum of 90 days. The Division may, if it deems fit, grant such extension.
(4) If the Registrant is unable to supply the required information within the deadline, the Registration of the Substance shall be suspended. If the Registration of the Substance remains suspended, the Registrant shall not Place the Substance in Indian Territory.
(5) Upon submission of the pending information to the satisfaction of Division, the suspension under sub-rule (4) shall be withdrawn.
16. Evaluation and Restriction
(1) The Priority Substance Unit of the Division shall evaluate the available data to assess if the Registered Substance poses an unacceptable risk to human safety or the environment during various uses in India. Risk-based approaches including hazard identification, hazard characterization, exposure assessment, and risk characterization (probability of occurrence of known and potential adverse effects) shall be adopted for such overall risk assessment to the extent possible.
(2) If the Priority Substance Unit is of the opinion that the risk posed by the use of the Registered Substance is substantial, it may propose to Restrict the use of such Substance or Prohibit such Substance. Such proposal shall be submitted to the Risk Assessment Committee for its concurrence based on socio-economic impact assessment and availability of suitable alternatives. The Priority Substance Unit may, based on its evaluation, also recommend to the Risk Assessment Committee that an entry be added to or deleted from Schedules X, XI or XII.
(3) Upon carrying out changes, if any, suggested by the Risk Assessment Committee, a Substance may be recommended for Restrictions or Prohibition to the Steering Committee. The Steering Committee shall hold public consultations within 90 days of receipt of the recommendations, prior to forwarding such recommendations to the Central Government.
(4) Once a Restriction on a Priority Substance has been notified, a request for authorization for use of a Restricted Substance may be submitted by a Manufacturer, Importer or Authorized Representative to the Division along with the fees as provided in Schedule XIX. Such request shall be analysed by the Priority Substance Unit, to determine if such Restricted Substance is essential for the operation of an industrial process or for Scientific Research and Development and a recommendation on such authorization shall be submitted to the Risk Assessment Committee. With the concurrence of the Risk Assessment Committee, such authorization may be granted.
(5) The Division may grant permission for authorised Use of Substances restricted under sub-rule (4) for an initial period of no more than 4 years. The Division may further extend such permission for a maximum additional period of 4 years on re-application by the Registrant.
(6) These Rules are without prejudice to any restrictions, prohibitions or regulations on the use of any Substances provided under any other enactment, for the time being in force.
(1) A 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.
(2) Foreign Manufacturers of any Substance, Intermediate, Mixture or Article may submit a request for confidentiality through their Authorised Representatives.
(3) A request for confidentiality should be accompanied by fees as provided in Schedule XIX and a statement of reasons clearly identifying:
(a) what information is to be kept confidential; and
(b) the reasons why such information should be kept confidential.
(4) The request for confidentiality will be submitted to the Division and it shall make the final determination of whether such request for confidentiality may be granted. The Division may require the Notifier or the Registrant to furnish documents or information to determine the validity of the request for confidentiality if it deems appropriate.
(5) The information or data with respect to which the request for confidentiality has been filed will be kept confidential and not disseminated publicly until such time as the Techno-legal Unit makes a final decision on the validity of such request.
(6) If a request for confidentiality has been granted with respect to certain information, then the Members of the Division, Scientific Committee, Risk Assessment Committee and the Steering Committee who have access to such information shall keep such information confidential even after the expiry of their term.
(7) A request for confidentiality may not be submitted for the classification of Substances and ‗endpoint‘ summaries submitted during Notification or Registration.
(8) Where for the purpose of evaluating Notifications and Registrations, the Division discloses that information to some other person, such person shall not use or disclose such information.
18. Methods of Testing
(1) When tests are required to be carried out by Registrants for the purpose of Registration, the Registrants shall comply with the testing methodology/ protocol laid down in the Organization for Economic Co-operation and Development (OECD) guidelines for the testing of Chemicals. If the guidelines provide different options for any test, any of the options may be adopted with concurrence of the Risk Assessment Committee. The tests must be carried out in NABL accredited or GLP certified laboratories.
(2) To avoid repeated testing, the existing test data must be considered prior to requiring a new testing. All efforts should be made to derive the required data using alternative methods recommended by OECD. The Registrant must propose a testing strategy and get it approved by the Division before conducting any new test. Tests on vertebrate animals shall be undertaken only as a last resort.
(1) Any person aggrieved by a decision of the Division may prefer an appeal to the Steering Committee.
(2) An appeal may only be filed in writing within 90 days of being notified of the decision of the Division. The appeal must set out the grounds.
(3) The Steering Committee must decide the appeal within 60 days from the date on which the appeal is filed.
(4) The fee for filing an appeal is as per Schedule XIX.
Chapter IV. Safety and Accident Preparedness
20. Duties of Authorities
The Concerned Authority shall, subject to other provisions of these rules, perform the duties specified in column 3 of Schedule III of these Rules.
21. Transport of Hazardous Chemicals
(1) When an Occupier or any person wishes to transport a Hazardous Chemical, he shall ensure that the vehicle used for transport is properly labelled in accordance with the eighth revision of the UN-GHS of classification, and that technology enabled tracking and communication systems as prescribed by the Division are used.
(2) The transport of Hazardous Chemicals shall be in accordance with the provisions of these rules and the rules made by the Central Government under the Motor Vehicles Act, 1988 and the guidelines issued by the Division from time to time in this regard. (3) In case of transportation of Hazardous Chemicals to another State, the Occupier or the person shall give prior intimation to the State Pollution Control Board of the State to which such Hazardous Chemicals are being transported. (4) In case of transit of Hazardous Chemicals through a State other than the States of origin and destination, the Occupier or the person shall give prior intimation to the concerned State Pollution Control Board of the States of transit.
22. Submission of Information relating to Industrial Activity and Site Safety Report
(1) An Occupier who has control of an Industrial Activity in which a Hazardous Chemical is handled and such Industrial Activity is not covered by sub-rule (2) below or Rule 24, shall provide evidence to the Concerned Authority to show that he has
(a) identified the Chemical Accident hazards; and
(b) taken adequate steps to (i) prevent Chemical Accidents and to limit their consequences in terms of impact on persons and the environment; and (ii) provide persons working on the site information, training and equipment including antidotes necessary to ensure their safety. This evidence shall be provided within 30 days of commencement of the activity or within 30 days of coming into force of these Rules, whichever is later. The occupier shall obtain the acknowledgement from the Concerned Authority within 60 days of submission, failing which he shall not continue the activity.
(2) The following Industrial Activities will have to be notified by the Occupier and approved in accordance with this rule
(a) an Industrial Activity in which there is involved a quantity of Hazardous Chemical as listed in column 2 of Schedule XII which is equal to or more than the threshold quantity specified in the entry for that Hazardous Chemical in column 3 of Schedule XII;
(b) isolated storage in which there is involved a quantity of a Hazardous Chemical listed in column 2 of Schedule XI which is equal to or more than the threshold quantity specified in the entry for that Hazardous Chemical in column 3 of Schedule XI.
(3) An Occupier shall not undertake any New Industrial Activity unless he has been granted an approval from the Concerned Authority for undertaking such activity and has submitted a report for notification in the format set out in Part I and Site Safety Report in the format set out in Part II of Schedule XIV, at least 90 days before commencing that activity or before such shorter time as the Concerned Authority may agree.
(4) The Concerned Authority shall,
(a) within 90 days from the date of receipt of the report, approve the report submitted or on consideration of the report if Concerned Authority is of the opinion that there is or has been a contravention of the provisions of the Act or the Rules, issue an improvement notice to the Occupier; and
(b) forward copies of all such reports and approvals, as well as any improvement notices to the Division, immediately.
(5) The Chemical Safety and Accidents Unit of the Division shall, from time to time, coordinate and ensure that all reports, approvals and improvement notices submitted to the Concerned Authorities under these Rules are shared with the Division.
(6) The Division may provide recommendations to the Concerned Authority in relation to any report, approval or improvement notice after reviewing the report forwarded to it.
23. Transitional Provisions
(a) at the date of coming into force of these Rules, an Occupier is in control of an Existing Industrial Activity which is required to be Notified and approved under Rule 22(2); or
(b) within 90 days after the date of coming into force of these Rules, an Occupier commences any New Industrial Activity which is required to be Notified and approved under Rule 22(2),
he may continue or commence such Industrial Activity:
Provided that he submits to the Concerned Authority, a report for notification as per Part I and a Site Safety Report as per Part II of Schedule XIV, within 120 days of the date of coming into force of these Rules.
24. Safety Audit Reports
(1) The Occupier of a Major Accident Hazard Installation involving quantities of Hazardous Chemicals exceeding the threshold quantity of column 4 of Schedules XI or XII shall carry out an independent safety audit of the Industrial Activity by an accredited expert agency empanelled by the Steering Committee, at least once every 2 years. The Occupier shall submit at least one Safety Audit Report within 180 days from the date of coming into force of these Rules.
(2) The Occupier shall send a copy of the auditor‘s report along with his comments to the Concerned Authority within 30 days after the completion of such audit. The Concerned Authority will forward a copy of such auditor‘s report to the Division.
(3) If an Occupier is conducting a safety audit during the period mentioned above for a Site under any other law for the time being in force, the requirement to conduct a safety audit shall be deemed to be fulfilled and the Occupier shall submit the Safety Audit Report of such audit to the Concerned Authority.
(4) The Concerned Authority may, if he deems fit, issue an improvement notice within 45 days of the submission of the Safety Audit Report submitted under this Rule.
(5) Steering Committee may direct safety audit of any industry, at random, or on receipt of any specific complaint.
25. Revision and updation of Reports submitted under Rules 22 and 24
(1) When an Occupier makes any modification to an Industrial Activity which could materially affect the particulars in the reports submitted as per Part I of Schedule XIV, or the Site Safety Report or the Safety Audit Report, he shall make a fresh report taking into account these modifications and submit such revised report to the Concerned Authority, no later than 30 days from the making of these modifications.
(2) Where the Occupier has made a Site Safety Report as provided in Part II of Schedule XIV in accordance with Rule 22 and sub-rule (1) of this Rule and such Industrial Activity is continuing, the Occupier shall within three years of the date of the last such report, make a further report which shall have regard in particular to new technical knowledge which has affected the particulars in the previous report relating to safely and hazard assessment and shall submit the updated Site Safety Report to the Concerned Authority.
(3) Where an Occupier has sent a Site Safety Report and the Safety Audit Report relating to an industrial activity to the Concerned Authority, such Authority may require the Occupier to provide additional information and the Occupier shall send such additional information within 90 days.
26. Forwarding of Safety Audit Report to the Division
A relevant Concerned Authority shall send a copy of every Safety Audit Report, submitted by an Occupier under Rule 24, to the Division promptly.
27. Import of Priority Substances or Hazardous Chemicals
(1) Upon completion of the relevant Registration and Notification requirements, an Importer of Substances listed in Schedule II or Hazardous Chemicals in India shall submit to the Concerned Authority, at least 15 days before Importation of such Substance in quantities greater than the lowest of 1 tonne, the quantity specified in column 3 of Schedule XII and column 3 of Schedule XI, information pertaining to-
(a) the name and address of the person receiving the consignment in India;
(b) the port of entry in India;
(c) mode of transport from the exporting country to India;
(d) name and the quantity of Priority Substances or Hazardous Chemicals being imported; and
(e) all relevant product safety information, including Safety Data Sheet.
(2) If the Concerned Authority is of an apprehension that the Substance being Imported is likely to cause a Major Chemical Accident, it may direct the Importer to take such safety measures as it may, deem appropriate.
(3) The Concerned Authority shall ensure that the Importer takes appropriate steps regarding safe handling of Priority Substances or Hazardous Chemicals while off-loading the consignment within the port premises.
(4) If the Concerned Authority, is of the opinion that the Substance should not be Imported on safety or on environmental considerations, the Concerned Authority may stop such Imports and inform the Chairman, Central Board of Indirect Taxes and Customs or a Competent Person under him to stop such import. The Concerned Authority shall in such a case provide relevant information relating to such stopped Imports to the Division.
(5) On successful compliance of sub-rules (1) to (3), an acknowledgement containing, inter alia, the name of Importer, name and Notification number (if applicable) of the Priority Substances or Hazardous Chemicals, quantity to be imported, name of the port, date of likely shipment, shall be immediately issued. The Chairman, Central Board of Indirect Taxes and Customs or the Competent Person under him shall not clear any consignment of Priority Substances or Hazardous Chemicals without this acknowledgment.
(6) All persons Importing Priority Substances or Hazardous Chemicals shall maintain records of the Priority Substances or Hazardous Chemicals Imported. The records so maintained shall be open for inspection by the Concerned Authority or any Competent Person. The Importer of the Priority Substances or Hazardous Chemicals of a person working on his behalf shall ensure that transport from port of entry to the ultimate destination is in accordance with the Rule 21.
28. Duties of Chemical Safety and Accidents Unit
(1) The Chemical Safety and Accidents Unit shall:
(a) Set up a functional control room at such place as it deems fit to coordinate information sharing and communication in response to Chemical Accidents;
(b) Set up an information networking system with state and district control rooms;
(c) Publish a list of Major Accident Hazards Installations;
(d) Publish a list of Major Chemical Accidents;
(e) Take measures to create awareness amongst the public with a view to prevent Chemical Accidents;
(f) Provide information on methods and techniques for containment, mitigation and clean-up of Hazardous Chemicals;
(g) Provide assistance for field monitoring of spills and any release in the environment, and providing guidance at the field level with emergency response mobile vans, protective equipment, trained personnel to deal with accidents involving Hazardous Chemical;
(h) Assist in predicting dispersion pattern of chemicals involved and creating awareness among public likely to be affected; and
(i) Compile and publish information on Chemical Accidents.
(2) The Chemical Accidents Unit shall coordinate with and provide technical support to:
(a) the National Executive Committee constituted under the Disaster Management Act, 2005 in dealing with all matters related to chemical disasters and in the management of Major Chemical Accidents;
(b) the State Executive Committee constituted under the Disaster Management Act, 2005 in the management of Chemical Accidents at the State or Union Territory level; and
(c) the District Disaster Management Authority constituted under the Disaster Management Act, 2005, in the management of Chemical Accidents at the district level.
29. Preparation of On-site Emergency Plan by the Occupier
(1) An Occupier of a Major Hazard Installation shall prepare and submit an up-to-date On-site Emergency Plan to the Concerned Authority detailing as per Part III of Schedule XIV how Major Chemical Accidents will be dealt with on the Site of the Industrial Activity. Such On-site Emergency Plan shall include the name of the person who is responsible for safety on-site and the names of those who are authorised to take action in case of an emergency. The Occupier shall ensure that every person on the site who is affected by the plan is informed of relevant provisions of the On-site Emergency Plan.
(2) The Occupier shall ensure that the On-site Emergency Plan is updated in case of any modification of the Industrial Activity. The persons concerned and mentioned in sub-rule (1) shall be informed regarding the updated On-site Emergency Plan.
(3) The Occupier shall prepare and submit the On-site Emergency Plan required under sub-rule (1),
(a) in case of an Existing Industrial Activity, within 90 days of coming into force of these Rules; and
(b) in the case of a New Industrial Activity, within 30 days of commencement of the activity.
(4) The Occupier shall ensure that a mock drill of the On-site Emergency Plan is conducted at least once in every 180 days and submit a detailed report on such mock drill to the Concerned Authority within 7 days of such drill.
30. Preparation of Off-site Emergency Plan
(1) For each Major Accident Hazard Installation, the Concerned Authorities shall prepare and keep up-to-date an adequate Off-site Emergency Plan, containing particulars specified in Schedule XV and detailing how emergencies relating to a possible Major Chemical Accident on that site will be dealt with. In preparing the Off-site Emergency Plan, the Concerned Authorities shall consult an Occupier, the District Collector and such other persons as it may deem necessary, and get it approved by the District Disaster Management Authority.
(2) For the purpose of enabling the Concerned authority to prepare the Off-site Emergency Plan, the Occupier shall provide the Concerned Authority with such information relating to the industrial activity under his control as the Concerned Authority may require, including the nature, extent and likely off-site effects of possible Major Chemical Accidents.
(3) The Concerned authority shall prepare an Off-site Emergency plan
(a) in the case of an Existing Industrial Activity, within 90 days of coming into force of these Rules; and
(b) in the case of a New Industrial Activity, within 90 days of commencement of the industrial activity.
(4) The Concerned Authority shall ensure that a mock drill of the Off-site Emergency Plan is conducted at least once in a calendar year.
31. Notification of Chemical Accidents
(1) Where a Chemical Accident (including a Major Chemical Accident for the purpose of this Rule) occurs on-site or off-site, the Occupier shall notify and submit a Chemical Accident report of the accident to the Concerned Authority, as applicable in the format set out in Schedule XVI. The Occupier shall also notify the Chemical Accidents Unit of the Division.
(2) This notification requirement is to be complied with within 24 hours of the occurrence of the Chemical Accident and the Chemical Accident report is to be submitted within 72 hours of the accident.
(3) The Concerned Authority that receives a Chemical Accident report shall undertake a full analysis of the Chemical Accident and submit an Analysis Report within 30 days of the receipt of notice of the Chemical Accident to the Division.
(4) The Occupier shall submit to the Concerned Authority a report of all steps taken or to be taken to prevent a repetition of the accident within 180 days from the date of the Chemical Accident.
(5) The Chemical Accidents Unit shall in writing inform the occupier, of any lacunae which in its opinion needs to be rectified to avoid major accidents. The Chemical Accidents Unit of the Division shall compile information regarding all Chemical Accidents that take place in a calendar year and submit a copy of the information to the Steering Committee.
(6) The Occupier at every Major Accident Hazards Installations in the industrial pockets in a district shall aid, assist and facilitate functioning of the Concerned Authority and the Chemical Accidents Unit of the Division.
32. Information to be given to persons liable to be affected by a Major Chemical Accident
(1) The Occupier shall take appropriate steps to inform persons outside the site either directly or through Concerned authority who are likely to be in an area which may be affected by a Major Chemical Accident about-
(a) the nature of the Major Chemical Accident hazard; and
(b) the safety measures and the Dos and Don‘ts which should be adopted in the event of a Major Chemical Accident.
(2) The Occupier shall take the steps required under sub-rule (1) to inform persons about an Industrial Activity, before such activity is commenced, except in the case of an Existing Industrial Activity, in which case the Occupier shall comply with the requirements of sub-rule (1) within 90 days of coming into force of these Rules.
Chapter V. Labelling and Packaging
33. Labelling Requirements
(1) 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, that they Place in Indian Territory bear labels as per Schedule XVII read with this Rule and are packaged in accordance with Rule 34, before being Placed in the Indian Territory.
(2) 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.
(3) Manufacturers, Importers or Downstream Users shall ensure that statements that are inconsistent with the classification of that Priority Substance or Hazardous Chemical do not appear on the label or packaging of that substance.
(4) The Manufacturers, Importers and Downstream Users shall affix the labels firmly to one or more surfaces of the packaging containing the Priority Substance which shall be readable horizontally when the package is set down normally.
(5) The label elements in the Schedule XVII shall be clearly and indelibly marked. They shall stand out clearly from the background and be of such size and spacing as to be easily read.
(6) A label shall not be required when the label elements in the Schedule XVII are shown clearly on the packaging itself.
(7) The label shall be in English and Hindi.
34. Packaging Requirements
A Manufacturer, Importer or Downstream User shall ensure that packaging containing a Priority Substance or a Hazardous Chemical or a Mixture containing more than 10% (w/w) of these, satisfies the following requirements:
(a) the packaging shall be designed and constructed so that its contents cannot escape, except in cases where more specific safety devices may be required;
(b) the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;
(c) the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;
(d) packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping; and
(e) if supplied to the general public shall not have either a shape or design likely to mislead consumers.
Chapter VI. Miscellaneous
(1) Any contravention of these Rules, including specifically:
(a) Failure to Notify or Register a Substance or Intermediate within the stipulated time periods;
(b) Furnishing of false information at the time of Notification or Registration;
(c) Procuring Substances, Mixtures, Intermediates or Articles by Downstream Users which have not been Notified or Registered; or
(d) Labelling or packaging the Priority Substances in contravention to these Rules,
shall be subject to fines as set out in Schedule XIX for each day of continuing contravention.
(2) If the Concerned Authority is of the opinion that a person has contravened the provisions of Chapter IV of these Rules, then it shall serve on such Person an ―notice‖ requiring that person to pay fines as set out in Schedule XIX for each day of contravention and to remedy the contravention or, as the case may be, the matters occasioning it within such period as may be the matters occasioning it within 45 days.
(3) A ―notice‖ served under sub-rule (2) shall clearly specify the measures to be taken by the Occupier in remedying the said contraventions.
(1) The Concerned Authority shall, by itself or through Competent Persons, carry out inspections from time to time on the activities of Manufacturers, Importers, Authorised Representatives and Downstream Users in order to ensure compliance with Chapter III and V of these Rules and also impose and collect fines as per Rule 35.
(2) The Concerned Authority identified in Schedule III for each of the provisions of Chapter IV, shall also be responsible, either by itself or through Competent Persons, for the enforcement of the respective provision set out in Chapter IV and also impose and collect fines as per Rule 35.
These Rules shall be without prejudice to any other law or any other Registration or Notification requirement issued by the Central Government for the time being in force.