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REGULATION & COMPLIANCE
Why India needs ICMSR
Shisher Kumra of Global Product Compliance outlines the need for India ’ s new chemical regulation and examines its potential impact
Regulations like EU REACH have set high benchmarks for chemical management , with a focus on protecting human health and the environment . These regulations cover all chemicals , emphasising safety in terms of acute and chronic effects , and they implement a precautionary principle where producers have the primary responsibility to demonstrate safety . Their principles require harmonised hazard classification , stringent compliance mechanisms , and a clear regulatory process of evaluation , restriction and authorisation .
Gaps in the framework
India ’ s current regulatory landscape is fragmented , with various acts and rules covering only a fraction of the chemicals in use . It currently has two main regulations governing the management of chemicals .
The Manufacture , Storage & Import of Hazardous Chemicals Rules ( 1989 ) mandates safety reporting for industrial facilities handling such chemicals , requires emergency plans for chemical accidents , and establishes information requirements and control systems for the import of hazardous chemicals .
The Chemical Accidents ( Emergency Planning , Preparedness & Response ) Rules ( 1996 ) provide the legal basis for crisis groups to prepare and respond to chemical accidents . They also establish a crisis alert system to improve communication between authorities and the public .
In addition , certain chemicals fall under the jurisdiction of the Bureau of Indian Standards ( BIS ), which was established as the national standards body in 2016 . The act setting up the BIS empowers the government to require
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Figure 1 - Timeline of ICMSR implementation
certification of goods or articles related to industries , processes , systems or services deemed essential for public interest , human , animal and plant health , environmental safety , prevention of unfair trade practices and national security .
This patchwork approach has left a significant portion of hazardous chemicals unregulated , posing ongoing risks to human health and the environment . For example , a large percentage of known carcinogenic , mutagenic and reprotoxic chemicals , as well as those with specific target organ toxicity , are not adequately regulated under India ’ s current laws .
Trade , health & environment
With approximately 60 % of India ' s chemical exports going to markets with stringent chemical regulations and a similar percentage of imports originating from these markets , the lack of equivalent regulatory measures puts India at a distinct disadvantage .
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The trade deficit in value terms underscores the urgency for India to adopt standards that align with these global practices to ensure competitiveness and access to these critical markets .
India ’ s alignment with these regulatory measures would not only facilitate access to international markets but also attract foreign investment by signalling a commitment to high standards of chemical safety and management .
In addition , exposure to chemicals can lead to a wide range of health effects , from acute poisoning and irritation to chronic effects such as cancer , reproductive toxicity and organ damage . The environmental consequences are equally serious , with issues such as persistence , bioaccumulation and toxicity to aquatic life posing significant risks .
Despite existing regulations covering approximately 2,000 substances , a vast number of substances of
MAY / JUN 2024 SPECCHEMONLINE . COM
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