ILMA Compoundings - September 2020 - 14
INDUSTRY RUNDOWN
International Insight
India REACH: Has Systematic Chemical
Management Arrived?
By James Eggenschwiler
The progression by major industrialized nations around
the globe toward systematic chemical management
continues. India, in particular, began its formal efforts in
2008. The road has been long and filled with disagreement and frustration, largely due to deep differences in
philosophy and priorities among its provincial governments. Recent efforts, however, are proving more successful. Formal implementation this year seems plausible.
FALSE STARTS
Even the current plan has seen its share of turbulence. As
recently as February, the National Coordination Committee (NCC) insisted that the third release then circulating
was the final version. In mid-March, it released the fourth
version. At present, this most recent iteration seems to have
sufficient momentum to endure the rigors of implementation adjustments without requiring a major rewrite.
The NCC, a creation of the Ministry of Environment,
Forest and Climate Change, appears to have a governmental
backing authority to accommodate the competing priorities
and practicalities that have undermined previous efforts. Even
with this fourth version, implementation details will be challenging. For instance, 750 chemical substances are currently
identified in the accompanying schedules as "priority" chemicals. These are substances that, due to their higher hazard or
risk profile, require a formal notification at least 15 days prior
to their importation. It is easy to imagine the complexity this
will pose from an infrastructure and enforcement perspective.
Designing an efficient process and training in adequate staff
to adequately and timely evaluate and determine import
eligibility will not be easy.
In addition, India is transitioning from a virtually
unregulated status in this area. Each step is likely to be filled
with the need to reconcile conflicting perspectives in both
philosophy and approach. Other jurisdictions experienced
this as well, such as South Korea, and found it necessary
to amend the regulations and the processes repeatedly for
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SEPTEMBER 2020
| COMPOUNDINGS | ILMA.ORG
several years. The NCC and the Ministry of Environment,
Forest and Climate Change are likely to experience the same.
OVERVIEW OF REQUIREMENTS
The NCC looked at numerous jurisdictions as potential
models for its plan. At one time, the Europe Union (EU)
and U.S. were viewed as strong prototypes. Overall, India
desired a specific inventory status system but preferred the
European-style progression of chemical management offered
by EU REACH. The NCC's plan is a combination of both,
with many similarities to K-REACH in South Korea.
As in Europe and South Korea, the NCC plan includes
registration by tonnage band in identical increments
(1-10 tons/year, 10-100 tons/year, 100-1,000 tons/year
and 1,000-plus tons/year). The plan also provides for the
availability and use of "only representatives" to enable
compliance by exporters and other nonresident persons or
entities. From there, novelties begin to appear.
The first difference is that there is no provision for "pre-registration." In Europe, the pre-registration process is limited in
availability to the initial phase of Europe's REACH implementation and compliance. In South Korea, there continues
to be opportunity for late pre-registration for a period of years
to allow commercial volumes to continue until the scheduled
registration deadline is reached. India's approach is unique, in
that it requires registration within 18 months of first entry
by the substance into the Indian market. Like Europe and
South Korea (and unlike the U.S.), the obligation to register
the substance is supply chain-specific. Consequently, each
manufacturer or importer (or foreign exporter taking on the
obligation) must register the substance.
Another unique feature is that the only chemicals requiring registration are those that are listed in Schedule VI of
the regulation. Those not included in the schedule are not
under the registration requirement. This is unlike Europe
and South Korea, as well as the U.S. While many anticipate
that Schedule VI will grow to be market comprehensive
(and the NCC considers it to be the formation of a chemical
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ILMA Compoundings - September 2020
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ILMA Compoundings - September 2020 - 1
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