ILMA Compoundings - October 2020 - 18

INDUSTRY RUNDOWN

International Insight
Spotlight on Turkey: KKDIK Registrations Begin
By James Eggenschwiler
As a meaningful part of its bid to become a European
Union (EU) member state, Turkey is moving quickly
with remaining implementation details of its version
of the EU REACH regulation, titled "KKDIK." With the
pre-registration deadline of Dec. 31 rapidly approaching, many U.S. firms and their global counterparts are
investing last-minute efforts to preserve their market
opportunities (real or potential).
As a condition for eligibility to become an EU member
state, Turkey has attempted to mirror, or at least harmonize,
its laws to fit within the EU's legal structure. KKDIK is the
nation's second attempt at a national chemical law and is
perhaps the most prominent example of Turkey's attempt to
mirror the EU.
PRE-REGISTRATIONS
Like the EU's REACH regulation, KKDIK created an
Only Representative (OR) structure that requires all compliance filings to be made and managed by this designated
representative. Unlike the EU law, KKDIK requires an OR
to be a Turkish national, with no provision to allow European ORs under the REACH regulation to extend their
activities to KKDIK compliance. Another notable difference is the requirement for all information and documents
to be in Turkish.
However, the base requirement of a "pre-registration"
is the starting point. While the pre-registration is not a
required step to registration, it establishes and preserves
market eligibility - enabling commercialization of substances in products that enter the market. The document
and the submittal process are simple - much like the
EU - but for the language requirement. The cost is also
relatively low.
REGISTRATIONS
The concept of "registrations" is the same as with EU
REACH, but the process differs in that all registrations
are due within the same three-year period. This feature of
KKDIK offers greater simplicity by avoiding the complexity
of sequential tonnage-based registration deadlines, but the

18

OCTOBER 2020

| COMPOUNDINGS | ILMA.ORG

simplicity likely carries a significant cost in availability of
OR resources.
Given that all registration dossiers must be submitted in
Turkish, and by a Turkish national OR, the resources available to complete the process are quite limited. The options
at present are few. EU entities are beginning to align with
firms in Turkey to expand the community of ORs, but there
remains relatively few resident firms in Turkey that meet the
requirements. Consequently, the alignment by European
(and a few U.S.) firms adds more registrant interface capacity without adding meaningful registration dossier build and
submittal capability.
This funnel-like market dynamic is not only precipitated
by an inadequate availability of people with the language
skills and technical background residing outside of Turkey.
The greater impediments are the government-required (and
provided) KKDIK and SDS training requirements and the
government-provided certification requirements that precede the licensing process. Of course, these must occur in
Turkey, and they require several months to complete (under
the best of circumstances).
The three-year registration period magnifies this resource
limitation. A few firms might emerge during the next
three years, but the prospects are greater for more foreign
registrant-facing firms to appear without a unique support
team inside the country.
DATA REQUIREMENTS
KKDIK has incorporated all the fundamental architecture
of the EU REACH regulation concerning data endpoints
that must be satisfied concerning human and environmental
toxicity. The corresponding data required to accompany
each registration dossier typically align with the EU registration counterpart. What remains an open question is whether
the same data utilized by EU REACH registrants will be
available and acceptable for a KKDIK registration dossier.
The data used in EU REACH registrations were typically
developed and owned by the Lead Registrant, and co-registrants (joint registrants) contributed to the development cost
based on ECHA (European Chemicals Agency) guidelines.


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ILMA Compoundings - October 2020

Table of Contents for the Digital Edition of ILMA Compoundings - October 2020

ILMA Compoundings - October 2020 - Cover1
ILMA Compoundings - October 2020 - Cover2
ILMA Compoundings - October 2020 - 1
ILMA Compoundings - October 2020 - 2
ILMA Compoundings - October 2020 - 3
ILMA Compoundings - October 2020 - 4
ILMA Compoundings - October 2020 - 5
ILMA Compoundings - October 2020 - 6
ILMA Compoundings - October 2020 - 7
ILMA Compoundings - October 2020 - 8
ILMA Compoundings - October 2020 - 9
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ILMA Compoundings - October 2020 - 11
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ILMA Compoundings - October 2020 - 17
ILMA Compoundings - October 2020 - 18
ILMA Compoundings - October 2020 - 19
ILMA Compoundings - October 2020 - 20
ILMA Compoundings - October 2020 - 21
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