ILMA Compoundings - May 2020 - 14

INDUSTRY RUNDOWN

International Insight
Korea K-REACH and K-BPR: New
Developments
By James Eggenschwiler
The general chemicals (industrial and consumer)
regulatory environment in 2020 opened with a flurry of
activity. Jan. 1 saw the launch of three important initiatives related to product market eligibility: (1) enforcement of required existing substance preregistrations
under K-REACH; (2) commencement of the initial tier of
existing substance registrations; and (3) the first wave
of registrations under the new K-BPR, the new South
Korean biocides law, regulation. Amid the organizational activity inherent with these new processes, there were
questions abound - and so must the answers.
K-REACH
Against the background of late pre-registrations being submitted, regulatory staff and "only representatives" have begun
the formation of consortia around each of the preregistered
existing substances. These substances consist of Korean
Chemical Inventory-listed substances other than those previously identified as Priority Existing Chemicals. In most cases,
elections of lead registrants are still underway. As in the case of
EU REACH, the consortia are groupings of registrants for a
particular substance. Members of a consortium are divided into
"active" and "inactive" status, with the active members having
input into various group decisions through voting rights.
The first decision currently in process for many of the
consortia is the election of the lead registrant from among the
active members. This party prepares the initial registration
dossier, which serves as the master dossier upon which all
other consortium member joint-registration dossiers are based.
In this process, the lead registrant sets the course for verifying
the substance identity and specifying the data necessary to
support the registration requirements of K-REACH. This
includes determination of the strategy for development or
acquisition of the data, the cost of which is to be shared
equally by each of the members of the consortium, regardless
of the active or inactive status of any member.
The lead registrant election process begins when one or
more active members express interest in the role to their

14

MAY 2020

| COMPOUNDINGS | ILMA.ORG

only representative. The presiding only representative for the
group conducts the nomination and election process and
posts the result.
Most lead registrants will seek to purchase existing data
from current owners of the data, instead of duplicating the
development of that data. As was the case with the previous
inspiration of Priority Existing Chemicals in South Korea,
the preferred source of this data will likely be lead registrants
for EU REACH registrations concerning the same substance. This strategy offers the potential for cost-reduction
by limiting data development to only those data points that
are not included in the purchased data. Please keep in mind
that the term "purchased data" means the purchase of access
to and use of the data from K-REACH registrations, and
not actual acquisition of the data for unfettered use.
Several consortia are still in the early stages of formation.
The first registration period concerns registration of any substance for 1,000-plus metric tons/year and for any annual
volume less than 1 metric ton/year of a substance that is a
carcinogen, mutagen or reproductive toxicant (CMR). This
registration period requires submittal of dossiers on or prior
to Dec. 31, 2021. Other consortia are also beginning to
form substances that are not CMRs and where the maximum intended registration for the substance is less than
1,000 metric tons/year.


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ILMA Compoundings - May 2020

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ILMA Compoundings - May 2020 - Cover1
ILMA Compoundings - May 2020 - Cover2
ILMA Compoundings - May 2020 - 1
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