CMSR : India Chemicals Management and Safety Rules

India Chemicals Management and Safety Rules (CMSR or ICMSR) also known as India REACH, is a set of regulations designed to control and manage chemical production, import, handling, and transportation in India. Inspired by the EU REACH and the US Toxic Substances Control Act (TSCA), India REACH aims to provide a high level of protection for human health and the environment by regulating the use of chemicals. This article explores the key aspects of India REACH and its implications for various stakeholders.

Who Needs to Comply with India REACH or CMSR?

India REACH applies to different entities involved in the chemical industry. The following groups are required to comply with the regulations:

• Indian Manufacturers and Importers: Indian manufacturers and importers of chemical substances must adhere to the CMS Rules. They have the responsibility to ensure the safe production, handling, and usage of chemicals within India.
• Authorized Representative (AR): Foreign entities seeking to place their products in the Indian market should appoint an Authorized Representative (AR) located in India. The AR acts on behalf of the foreign manufacturers and ensures compliance with the CMSR.
• Notification and Registration Obligations: Substances in quantities above one tonne per annum (TPA) need to be notified, and only substances listed as "Priority Substances" in Schedule II of the CMSR require registration.

Regulatory Authority for India CMSR

The regulatory body responsible for overseeing and implementing the Indian Chemical Management System Regulations is the Central Chemicals Registration Authority (CCRA). The CCRA plays a vital role in enforcing compliance with the CMSR and promoting the safe management of chemicals in India. It collaborates with State Level Regulatory Authorities (SLRAs) to enforce the regulations at both the central and state levels. Regulatory body consists of various units that work together to ensure the safe and regulated use of chemicals and promote compliance with applicable chemical regulations and standards. These units include:

• Chemistry Unit
• Toxicology Unit
• Chemical Accidents Unit
• Packaging and Labelling Unit
• Techno-legal Unit
• Priority Substance Unit
• Information Technology Unit
• Socio-Economic Unit

The CCRA and SLRAs work together to monitor and regulate the registration, notification, and usage of chemicals. They also oversee inspections, enforcement actions, and penalties for non-compliance. Through their diligent efforts, they aim to protect public health, the environment, and workers' safety from potential risks associated with chemicals.

Categories of Substances in CMSR

India REACH categorizes substances to effectively regulate their use. The main categories include:

• New Substances: These are substances not notified within the Initial Notification Period and must be notified at least 60 days before being placed in Indian territory.
• Existing Substances: Also known as "phase-in substances," these are chemicals that were already on the market before the implementation of the regulations. Existing substances are subject to evaluation and registration requirements to ensure their safe use and minimize risks.
• Priority Substances: These substances fall under specific hazard classifications, such as carcinogenicity, mutagenicity, reproductive toxicity, or specific target organ toxicity. They require registration and may be subject to authorization and restriction measures.
• Restricted Substances: Chemicals listed in Schedule IV are categorized as restricted or prohibited substances. Manufacturers, importers, or authorized representatives may submit requests for authorization to use restricted substances, subject to specific conditions.
• Hazardous Substances: Hazardous substances encompass chemicals that pose risks to human health, safety, or the environment. They may include toxic, carcinogenic, mutagenic, flammable, corrosive, or environmentally hazardous substances. Hazardous substances are subject to regulations and controls to mitigate risks and ensure safe handling, storage, and disposal.

Main Obligations under CMSR aka India REACH:

India REACH imposes several obligations to ensure the safe management of chemicals:

• Notification: Importers and manufacturers of hazardous chemicals must notify the relevant authority about the substances they handle. The notification includes information on the nature, quantity, uses, and potential risks associated with the chemicals.
• Registration: Substances listed as Priority Substances in Schedule II require registration if their annual quantity exceeds one tonne. Registration ensures a comprehensive database of chemicals and allows for risk assessment and appropriate control measures.
• Safety Data Sheets (SDS): Importers and manufacturers must provide Safety Data Sheets for hazardous substances. SDS contains vital information about hazards, safe handling, storage, and emergency response measures.
• Labeling: Importers and manufacturers are obligated to label containers or packaging of hazardous chemicals with appropriate warning symbols, pictograms, and hazard information to ensure safe handling and use.
• Restrictions: Certain chemicals may be subject to restrictions or prohibitions due to their hazardous nature. Compliance with specific restrictions or prohibitions is necessary for importers and manufacturers.
• Testing and Assessment: Authorities may require importers or manufacturers to conduct testing or assessments to determine the hazards and risks associated with certain chemicals. This may involve toxicological, ecotoxicological, and environmental impact studies.
• Compliance with International Agreements: India may align its chemical regulations with international agreements such as the Rotterdam Convention and the Stockholm Convention. Compliance with these agreements may impose additional obligations for certain chemicals.
• Labeling and Packaging: Chemical manufacturers, importers, or downstream users must ensure that their products' labels contain the relevant product identifiers and hazard statements listed in Schedule XVII. The labels must comply with the United Nations Global Harmonized System of Classification (UN GHS) for proper placement in the Indian market.

Exemptions in India REACH & Definition of Substance in CMSR

Substance in CMSR is defined as 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. India REACH provides exemptions for certain substances. These exemptions include:

• Radioactive Substances.
• Substances under customs supervision not placed in Indian territory.
• Substances stored in customs-free zones with the aim of re-exporting.
• Wastes, as defined in Hazardous Waste Management Rules 2016.
• Substances used for defense purposes.
• Substances used as food or feeding stuff for human beings or animals.
• Substances listed in Schedule IV.

It is important to note that exemptions are granted based on specific criteria and should not compromise the overall objective of ensuring chemical safety. Authorities carefully evaluate exemption requests to ensure that adequate safeguards are in place to protect human health and the environment.

Enforcement and Penalties under CMSR or India REACH

India REACH incorporates a robust enforcement mechanism to ensure compliance with the regulations. The Central Chemicals Registration Authority (CCRA) and State Level Regulatory Authorities (SLRAs) are responsible for enforcing the provisions of the CMSR Rules. Non-compliance with the regulations may result in penalties and other enforcement actions.

The CMSR defines penalties for contraventions of the rules. Failure to notify or register a substance within the stipulated time, furnishing false information, procuring unnotified or unregistered substances, and non-compliant labeling or packaging of priority substances can all attract fines as set out in Schedule XIX. These fines may be applicable for each day of continuing contravention.

In case a violation is identified by the Concerned Authority, a notice will be served to the responsible party. The notice will outline the fines to be paid for each day of contravention and provide a timeframe, usually 45 days, to remedy the contravention. The notice will also specify the measures required to rectify the contravention.

To enforce compliance with the CMS Rules, inspections are conducted by the Concerned Authority or Competent Persons appointed by them. These inspections aim to ensure adherence to the regulations outlined in Chapter III and V of the CMSR. The Concerned Authority, identified in Schedule III, is responsible for enforcing specific provisions of Chapter IV and imposing fines for non-compliance.

Conclusion: India REACH, in the form of the Indian Chemical Management System Regulations (CMSR), presents a comprehensive framework for managing chemicals in India. By promoting safe handling, storage, and disposal of chemicals, the government aims to safeguard human health and the environment. Stakeholders, including manufacturers, importers, and authorized representatives, must understand and comply with the ICMSR's requirements to ensure responsible chemical management practices.

While the regulations are still in the early stages of implementation, they represent a significant step forward in enhancing chemical safety in India. The successful implementation and enforcement of India REACH will require cooperation between the government, industry stakeholders, and relevant authorities. By working together, companies can effectively mitigate risks associated with chemical substances and create a safer environment for all.