ILMA Compoundings May 2017 - 12

INDUSTRY RUNDOWN

International Insight
K-REACH Bringing Sweeping Changes
in June 2017
By James Eggenschwiler
Commonly called K-REACH, the South Korean Act on Registration and Evaluation of Chemical Substances became
effective Jan. 1, 2015. The new law was the product of a
strong disagreement between the South Korean Legislature and the relevant regulators, led by the Ministry
of Environment (MOE). At that time, MOE had drafted a
version of K-REACH regulations that were closely aligned
with European Registration, Evaluation, Authorization
and Restriction of Chemicals (REACH). The legislature
rejected this approach, intending a much stricter system
of controls and evaluations. The present form of K-REACH
embodies a variety of concepts that seem to borrow from
various jurisdictions.
CHANGE AS A CONSTANT
K-REACH is no stranger to change. Since its effective
date, K-REACH has undergone constant change. Some of
the changes have been visible, in the form of new regulatory provisions. The majority of the changes, however, have
occurred behind the scenes. Various data requirements,
exemption approval standards and dossier details have been
adjusted in the brief two-year period.
This past December and January, entire new substructures
were designed, separating some of the responsibilities of the
Korean Chemical Manufacturers Association (KCMA) and
assigning them to a newly added sub-agency, the Korean
Environmental Corporation (KECO). With this latter
development, a new information technology system and
substantially revised data requirements, review standards and
approval thresholds were created. Submittals already pending approval required reworking and a new review process.
NEWLY ANNOUNCED MAJOR REWRITE
In the midst of the infrastructure changes mentioned above,
on Dec. 28, MOE notified the World Health Organization of South Korea's new intention to dramatically alter
K-REACH, with an anticipated adoption as soon as

MAY 2017

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June 30, 2017, and an effective date of June 30, 2018. MOE
simultaneously provided a basic outline that included several
of the planned details. Following is a discussion of some of
the more salient of these details.
The annual reporting system will be abolished (Article
8 of K-REACH revised). Instead, a pre-registration system
will be adopted. No details concerning the pre-registration
system have yet been provided. However, since the new
amendments to K-REACH will not become effective until
June 2018, the annual report that is due June 30, 2017, will
still be required.
The rationale for this change is to avoid duplicate reporting.
The Chemicals Control Act (CCA), which was adopted concurrently with K-REACH and which became incorporated into
it, already requires similar reporting on chemical substances.
The establishment of a pre-registration system is
intended to streamline mandatory joint registration of
identical substances. Currently, joint registration is only
required for the registration of Priority Existing Chemicals.
The system for designation of Priority Existing Chemicals (PECs) in three batches for joint registration will be
deleted (Article 9 of K-REACH). Instead, the abovementioned pre-registration process will be required for
approximately 7,000 existing chemical substances that are
manufactured or imported at annual volumes greater than
or equal to one ton per year (Article 10 of K-REACH).
Pre-registration substances will be subject to deadlines based
on tonnage bands, much like the process followed under
European REACH. The list of substances requiring preregistration is currently being prepared.
This change poses significant uncertainty for those companies that are currently in the process of joint registrations
under the first batch of PEC substances whose registration
must be completed in June 2018. MOE has not yet clarified
what will happen with these proposed PEC registrations.
Although it might be implied, there is no confirmation that
the 510 PEC substances included in this first batch will be
among the 7,000 substances designated for pre-registration.
Many companies have already begun the PEC joint registration process - at considerable cost. Many others have not

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ILMA Compoundings May 2017

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