Page 179 - CW E-Magazine (20-5-2025)

Special Report

Navigating EU REACH and US TSCA compliance:

A guide for Indian chemical exporters

ver the past decade, Indian SHEEBA KAPOOR
chemical manufacturers have Senior Regulatory Specialist
Oexperienced a steady increase E-mail: sheebakapoor44@gmail.com
in demand from global markets, parti-
cularly from the European Union (EU)
and the United States (US). Along
with this growth, however, comes the
challenge of regulatory compliance.
Two major frameworks – REACH in
the EU and TSCA in the US – establish
the standards for registering, evaluat-
ing, and handling chemical substances.
These rules may seem technical and
sometimes confusing for exporters in company, not the regulator. That means gained more authority to review new
India but understanding them is not just you must show that your chemical is and existing substances and has taken a
essential for continued market access safe before placing it on the EU market. more proactive role in reviewing chemi-
but also empowers you to navigate the cal safety. For exporters, this means
global market with confi dence. From an Indian exporter’s perspec- more scrutiny and, in some cases, more
tive, REACH means two things: you paperwork before a product can be sold
must appoint an Only Representative in the US.
(OR) based in the EU and provide
detailed technical data for registration. For Indian exporters, the fi rst step
That data often includes physico-chemi- is to determine whether a chemical is
cal properties, toxicological studies, listed on the Toxic Substances Control
and environmental impact assessments. Act (TSCA) Inventory. If that’s the
These requirements can become costly case, you can move forward, although
if you’re not part of a consortium that you’ll still need to meet reporting
shares data. requirements. If not, you must submit
a Pre-Manufacture Notice (PMN) and
It’s also worth noting that REACH wait for EPA review. This process can
isn’t a one-time exercise. Substances take several months and may require
of Very High Concern (SVHCs) can be additional data, especially if the agency
REACH: A data-centric, pre-market added to the Candidate List at any time, believes the substance poses a risk.
obligation and certain chemicals may require
The EU’s REACH regulation authorization or be subject to restric- Compared to REACH, TSCA
came into eff ect in 2007 and has since tion. Keeping an eye on the evolving allows substances to enter commerce
become one of the most comprehensive regulatory landscape is part of the job. unless the EPA identifi es a concern.
chemical laws in the world. It requires That said, under the updated law, the
companies to register their substances TSCA: New chemicals and increas- agency has become more proactive,
before they are placed on the EU mar- ing scrutiny especially with chemicals used in high
ket. This applies to manufacturers and In the US, the Toxic Substances volumes or consumer products.
importers dealing with one tonne or Control Act (TSCA) governs the manu-
more of a chemical per year. facture, import, and use of chemicals. Diff erences Between TSCA &
The law was signifi cantly revised in REACH
A critical feature of REACH is that 2016 under the Lautenberg Chemical While REACH and TSCA aim to
it places the burden of proof on the Safety Act. Since then, the EPA has ensure the safe use of chemicals, they

Chemical Weekly May 20, 2025 179

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