Overview of Chemical Regulations in India

The Indian chemical industry ranks the third largest in Asia and seventh in the world by output. It is predicted that by 2025 the Indian chemical industry will reach a valuation of USD403 billion and the Indian specialty chemical market is expected to reach USD70 billion by 2020. However, as a result of the diverse spectrum of chemical manufacturing and consumption in India, formulating chemical legislation is not an easy task. There are about 15 Acts and 19 Rules that have been laid down for chemical management, these Acts and Rules can be classified into the following groups:

Import and export;
Manufacturing of chemicals;
Transportation of chemicals;
Consumers’ interest in using chemicals; and protection of human health and environment.

Various Acts and Laws in India

1. Chemical imports and exports	2. Manufacturing of chemicals
3. Transportation of chemicals	4. Consumers’ use of chemicals
5. Protecting the environment and public health	6. Petroleum Act
7. Factories Act	8. Drugs and Cosmetics Act
9. Prevention of Food Adulteration Act	10. Water(Prevention & Control of Pollution) Act
11. Air(Prevention & Control of Pollution Act)	12. Motor Vehicles Act
13. Public Liability Insurance Act	14. Environment (Protection) Act
15. Explosive Act

Rules Governing the Chemical Industry

1. Manufacture, Storage and Import of Hazardous Chemicals Rules	2. Hazardous Waste (Management, Handling and Trans-boundary)Rules
3. Ozone-depleting Substances (Regulation and Control) Rules	4. Batteries (Management and Handling Rules)
5. Draft Hazardous Substances (CLP) Rules	6. E-waste (Management and Handling) Rules

India has also signed numerous International Conventions/ Protocols relating to chemical management, such as Basel Convention on the Control of Transboundary Movement of Hazardous Wastes and their Disposal, Rotterdam Convention for Certain Hazardous Chemicals & Pesticides in International Trade, Stockholm Convention on Persistent Organic Pollutants (POPs), Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and Chemical Weapon Convention. There are currently no regulations in India like EU-REACH or US-TSCA. There is also no national chemical inventory or mechanisms to register chemicals. In India the most important chemical regulations are the Manufacture, Storage and Import of Hazardous Chemical (Amendment) Rules, 1989, 1994, 2000 and Ozone Depleting Substances(R&C) Rules (2000). In addition, India’s Ministry of Environment and Forests published a draft legislation of Hazardous Substances (Classification, Packaging and Labelling) Rules, 2011, which lays out the responsibilities and procedures for key parties dealing with hazardous substances. The chemical regulatory system in India is also faced with many challenges. Firstly, multiple regulations currently govern different chemicals in India. Secondly, there is no single central agency or ministry which ensures proper implementation of the existing regulations. Thirdly, there is no overarching regulation in place or comprehensive inventory of all the chemicals circulating in the supply chain, therefore manufacturers of chemicals are not required to provide or generate data on hazards or risks associated with chemicals throughout their lifecycle and movement through the supply chain.

Manufacture, Storage and Import of Hazardous Chemical (Amendment) Rules, 1989, 1994, 2000

This regulation was firstly issued by Ministry of Environment and Forest in 1989 and later amended in 1994 and 2000. This regulation regulated the detailed obligations regarding hazardous Chemicals. The definition for hazardous chemicals as stipulated by the regulation is:

Any chemical which satisfies any of the criteria laid down in Part I of Schedule I and is listed in Colum 2 of Part II of this schedule;
Any chemical listed in Column 2 of Schedule 2;
Any chemical listed in Column 2 of Schedule 3;

Hazardous chemicals are clearly defined within Manufacture, Storage and Import of Hazardous Chemical Rules, 1989, the obligations of user and importer of hazardous chemicals are also be clarified.

Obligations of user of hazardous chemicals:

Notify the concerned authorities when a major accident occurs.
Update the site notification following changes in the threshold quantity.
Provide safety reports.
Prepare on-site emergency plan.
Prepare off-site emergency plan.

Obligations of importer of hazardous chemicals:

Provide the information of hazardous chemicals including:
- The name and address of the person receiving the consignment in India;
- The port of entry in India;
- Mode of transport from the exporting country to India
- The quantity of chemical(s) being imported
- Complete product safety information.
Ensure that transport of hazardous chemicals is in accordance with the Central Motor Vehicles Rules, 1989.
Maintain the records of the hazardous chemicals.

There are a total of 12 schedules in the document of Manufacture, Storage and Import of Hazardous Chemical Rules, 1989, and the first three schedules provides the definitions for hazardous chemicals.

Schedule 1 to the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989

Schedule 1 consists of two parts and it gives the criteria and lists of toxic, flammable and explosive chemicals and there are a total of 684 named chemicals listed in Schedule 1.

Schedule 2 and Schedule 3 to the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989

Schedule 2 gives the chemicals that need isolated storage at other installations separate to the storage place for chemicals contained within schedule 4.

Schedule 3 gives the list of hazardous chemicals subject to rules 5 and rules 7 to 15. Both schedule 2 and schedule 3 list some hazardous chemicals with assigned threshold quantities. In circumstances where a site handles hazardous chemicals in excess of thresholds, the site will be regarded as major accident hazard (MAH) installations and the site should subject to reporting, safety audit and contingency plan requirements.

The current SDS requirements in India are given in the Schedule 9 of the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989, which contains 9 sections:

Section 1: Chemical Identity
Section 2: Physical and Chemical Data Section
Section 3: Fire and Explosion Hazard Data Section
Section 4: Reactivity Data Section
Section 5: Health Hazard Data Section
Section 6: Preventive Measures Section
Section 7: Emergency and First Aid Measure
Section 8: Additional Information/References
Section 9: Manufacturer/Supplier Data

Ozone Depleting Substance (R&C) Rules (2000)

The draft Ozone Depleting Substances (R&C) Rules (2000) was published under the notification of India’s Ministry of Environment and Forests. This draft gives the regulation of production and consumption of ozone depleting substances, the prohibition on export to or import from countries not specified in schedule VI. Ozone depleting substances are to be exported to or imported from countries specified in Schedule VI under a license. There are a total of 10 Schedules contained in the draft of Ozone Depleting Substances (R&C) Rules (2000). The draft document can be accessed here.

Hazardous Substances (Classification, Packaging and Labelling) Rules, 2011

Hazardous Substances (Classification, Packaging and Labelling) Rules, 2011 is a draft legislation published by India’s Ministry of Environment and Forests. The rules specify the regulations, responsibilities and procedures for key parties dealing with hazardous substances. The rules apply to “any substance or preparation, which by reason of its chemical or physic-chemical properties or handling, is liable to cause harm to humans, or other living creatures, plants, micro-organism, property or the environment”, and define 9 hazardous classes which are explosives, gases, flammable liquids, flammable solids, oxidizing substances, toxic and infectious substances, radioactive materials, corrosive substances and miscellaneous dangerous substances. In addition, the responsibilities of users and consigner have also been listed in the document.
India has not officially adopted the GHS system yet and instead uses a standard 16-section GHS compliant safety data sheets in English. And the new 16-section SDS requirements in the draft document of Hazardous Substances (Classification, Packaging and Labelling) Rules, 2011 can help companies prepare SDSs for Indian market. According to the document, the new 16-section SDS requirements are as follows:

Section 1: Identification
Section 2: Hazard identification
Section 3 : Composition/information on ingredients
Section 4: First-aid measures
Section 5: Fire-fighting measures
Section 6: Accidental release measures
Section 7: Handling and storage
Section 8: Exposure controls/personal protection
Section 9: Physical and chemical properties
Section 10: Stability and reactivity
Section 11: Toxicological information
Section 12: Ecological information
Section 13: Disposal considerations
Section 14: Transport information
Section 15: Regulatory information
Section 16: Other information

In addition to the most important chemical regulations in India, other rules related to chemical management in India are also worth mentioning, such as:

Regulation of Polychlorinated Biphenyls Order, 2016

The Regulation of Polychlorinated Biphenyls Order, 2016 was published by India’s Ministry of Environment and Forests and Climate Change, which has already come into force. The Ban on Polychlorinated Biphenyls (PCBs) shall be phased in gradually: firstly, manufacture and import of PCBs and import of PCB-containing equipment are banned with immediate effect. Secondly, the use of PCB-containing equipment shall be permitted for the certified lifetime or 31 December, 2025, whichever is earlier, provided that the equipment is maintained properly without possibility of leakage or release of PCBs to the environment. Thirdly, the use of PCBs in any form shall be completely prohibited by 31 December, 2025.

E-Waste Management Rules

The E-Waste Management Rules was amended by India’s Union Environment Minister in 2018, for the effective management of e-waste in India. Indian government has amended the e-waste management rules in order to facilitate and effectively implement the management of e-waste in India. And some of the features of E-Waste Management Rules are:

E-waste collection targets under the EPR have been revised and is applicable from October 1, 2017.
The phase-wise collection targets for e-waste in weight shall be 10% of the quantity of waste generation as indicated in the EPR Plan during 2017-2018, with a 10% increase every year until 2023.
After 2023, the target will be 70% of the quantity of waste generation as indicated in the EPR Plan.

India RoHS

Under the Reduction of Hazardous Substance (RoHS) provisions, the cost for sampling and testing shall be borne by the government for conducting the RoHs test. If the product does not comply with RoHS provisions, the cost of the test will be borne by the producers. India RoHS restricts the same six substances at the same maximum concentrations as in the EU but the scope of products is slightly different.

Cadmium-0.01% (100 ppm)
Lead-0.1% (1000 ppm)
Mercury-0.1% (1000 ppm)
Chromium (VI)-0.1% (1000 ppm)
Polybrominated Biphenyls (PBBs)-0.1% (1000 ppm)
Polybrominated Biphenyls (PBDEs)-0.1% (1000 ppm）

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