ILMA Compoundings August 2018 - 15

Substances greater than or equal to 1,000 t/y and carcinogen, mutagen or reproductive toxicant (CMR) substances
greater than or equal to 1 t/y: Dec. 31, 2021;
n Substances 100-1,000 t/y: Dec. 31, 2024; and
n Substances 1-100 t/y: Dec. 31, 2030.
Exempted from the substances required to be registered
are those substances categorically out of scope (i.e., pharmaceuticals, cosmetics, pesticides, medical devices, fertilizer
and others), where the substances are regulated under a
different structure.
Registration of existing chemicals is a "joint registration"
process. This includes a "Lead Registrant," whose role
is to prepare and submit the master registration ("Lead
Registration Dossier") and develop new or acquire existing
(from qualified sources) data to satisfy all the registration
requirements. This structure and process has already been
developed to support the current registration of the initial
510 designated existing substances required to be registered
by June 30, 2018.
With this current joint registration structure, the government has approved acquisition of data from European
REACH Lead Registrants through Letters of Access (LoAs).
This practice had occasional difficulties during the recent
registration process (the 510 designated substances) but
seemed to work well overall. This provides a reasonable and
proven foundation to support the larger data needs associated with more comprehensive registration of all existing
substances.
n

New chemicals
Among the changes provided by the amended K-REACH
is new relaxation of the registration burden for less than
100 kilograms per year for new substances. So far, including
at present, the manufacture or import of any amount of a
new substance not listed on the national inventory requires
registration. Beginning Jan. 1, 2019, only a notification will
be required for quantities less than 100 kg per year, with
registration required for any amount at or above 100 kg in
a given calendar year. This notification will likely require
more data than the pre-notification mentioned above for
existing chemicals, and it will also likely require government
approval based on evaluation of the data submitted. However, submittal of human or environmental health risk data
is not likely to be required, except perhaps in circumstances
where the new substance is known or believed to be a CMR.

Annual reporting
Along with the broad scope of changes introduced by the
amended K-REACH, the annual reporting responsibility is
dropped altogether for new chemicals and existing chemicals
alike. Other chemical management requirements have essentially replaced the need for these reports and have caused
them to be seen as redundant.
Product notification
Concurrent with the original enactment of K-REACH, the
Korean Legislature also replaced the former Toxic Chemical
Control Act (TCCA) with the CCA, which was incorporated into the K-REACH framework. The CCA places
responsibilities on manufacturers, importers and distributors
of products that contain designated hazardous substances.
Those responsibilities include product notification and
use-related licensing and permit requirements. This product-level regulatory approach is novel to K-REACH among
other similar national inventory-based chemical management systems.
The amended K-REACH retains this product-level
approach but expands the scope of the designated substances
that trigger notification and use responsibilities. This larger
menu of substances is expanded to the category of "priority
control substances," which increases the regulatory scope
of reasons for control. The product notification is generally
triggered by a product containing more than 1 ton per year
of a priority control substance at content greater than 0.1
percent. CCA compliance will be discussed in more detail in
a future article.
Ongoing chemical management and controls
There has been continual development since 2015 in
ongoing chemical management under K-REACH. These
measures are already too numerous and complex to discuss
here, and additional changes are on the way. Although no
references to "annexes" or other European REACH labels
have been used so far, the concepts continue to be developed
with great similarity, including the continual review and
evaluation of chemicals whose risk profile is perceived as less
tolerable and for which the Korean government, spurred by
the consuming public, desires lower-risk replacements.
Eggenschwiler, an ILMA consultant, is an international
trade attorney and director of global trade for the Redstone Group LLC. He can be reached at 614-923-7472 or
jeggenschwiler@redstonegrp.com.

15



ILMA Compoundings August 2018

Table of Contents for the Digital Edition of ILMA Compoundings August 2018

LETTER FROM THE PRESIDENT
LETTER FROM THE CEO
INSIDE ILMA
WHAT’S COMING UP
INDUSTRY RUNDOWN
IN GOOD HEALTH
STAYING SAFE
BUSINESS HUB
WASHINGTON LANDSCAPE
IN NETWORK
ILMA Compoundings August 2018 - Cover1
ILMA Compoundings August 2018 - Cover2
ILMA Compoundings August 2018 - 1
ILMA Compoundings August 2018 - 2
ILMA Compoundings August 2018 - LETTER FROM THE PRESIDENT
ILMA Compoundings August 2018 - 4
ILMA Compoundings August 2018 - LETTER FROM THE CEO
ILMA Compoundings August 2018 - INSIDE ILMA
ILMA Compoundings August 2018 - 7
ILMA Compoundings August 2018 - 8
ILMA Compoundings August 2018 - 9
ILMA Compoundings August 2018 - 10
ILMA Compoundings August 2018 - WHAT’S COMING UP
ILMA Compoundings August 2018 - INDUSTRY RUNDOWN
ILMA Compoundings August 2018 - 13
ILMA Compoundings August 2018 - 14
ILMA Compoundings August 2018 - 15
ILMA Compoundings August 2018 - 16
ILMA Compoundings August 2018 - 17
ILMA Compoundings August 2018 - IN GOOD HEALTH
ILMA Compoundings August 2018 - 19
ILMA Compoundings August 2018 - 20
ILMA Compoundings August 2018 - 21
ILMA Compoundings August 2018 - 22
ILMA Compoundings August 2018 - 23
ILMA Compoundings August 2018 - 24
ILMA Compoundings August 2018 - 25
ILMA Compoundings August 2018 - STAYING SAFE
ILMA Compoundings August 2018 - 27
ILMA Compoundings August 2018 - 28
ILMA Compoundings August 2018 - 29
ILMA Compoundings August 2018 - BUSINESS HUB
ILMA Compoundings August 2018 - 31
ILMA Compoundings August 2018 - 32
ILMA Compoundings August 2018 - 33
ILMA Compoundings August 2018 - WASHINGTON LANDSCAPE
ILMA Compoundings August 2018 - 35
ILMA Compoundings August 2018 - IN NETWORK
ILMA Compoundings August 2018 - 37
ILMA Compoundings August 2018 - 38
ILMA Compoundings August 2018 - 39
ILMA Compoundings August 2018 - 40
ILMA Compoundings August 2018 - Cover3
ILMA Compoundings August 2018 - Cover4
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