ILMA Compoundings - June 2020 - 15

Environmental Protection Agency's (EPA's) newfound
ability to limit pre-manufacturing notification (PMN)
approval to specific uses (as provided under the Lautenberg
amendments and EPA's subsequent emphasized use of
consent orders and SNURs) as part of the PMN approval
process. It also resembles the requirement to include specific
uses as part of registrations under EU REACH, which are
also limiting on registrants until the dossier is appropriately
amended with the additionally desired use statement.

regular registrations are concerned. After approval and IECSC
listing, new uses will require the submittal of a new regular
registration for any use not included in the previous registration
dossier and approval process. This is somewhat analogous to
a significant new use notification, or SNUN, in the U.S., but
there is no clear method to tie the original data to the new use
dossier. Again, the new process appears to add time and cost
well beyond that incurred under the current Order No. 7.

ORDER NO. 12
Clearly, the recent introduction of Order No. 12 by the
Ministry of Ecology and Environment (MEE) represents a
heightened emphasis on evaluating potential risks associated
with new chemical substances - particularly those that enter
the market at volumes of 10 metric tons per year or above.
The new law, which takes effect on Jan. 1, 2021, divides new
substance registrations into two primary registration types:
"regular" registration and "simplified" registration.

Chemical substances manufactured in or imported into
China at 1 metric ton per year (but less than 10 metric tons
per year) can achieve market eligibility through simplified
registration. Details for this registration type are less clearly
defined at the present time. They will likely be similar to
current simplified registration requirements, with additional
environmental toxicity data and some added mammalian
toxicity data that will remain meaningfully reduced from
that required by regular registration.

Regular registration

Regular registration is required for any "new" (not IECSClisted) chemical substance manufactured in or imported into
China at a volume of 10 metric tons per year or more. It is
also required for any new chemical substance that is manufactured in or imported into China at a volume of 1 metric
ton or more per year, if the new substance is classified as
persistent, bioaccumulative and toxic.
This form of registration will also become the only path
to listing of a new substance onto the IECSC. Under
the current Order No. 7, IECSC listing can be achieved
through lower-volume registrations that are less expensive.
Current methods require meaningfully less data and shorter
review time. This change is particularly problematic for
polymer manufacturers. Currently, polymer manufacturers
can obtain listing of new chemicals used as monomers
through use of less expensive lower-tonnage registration of
the substance intended for IECSC listing. Once listed, the
registered substance can currently be used as a monomer in
a low-concern polymer that requires only a simplified registration (less data required and less expensive). Under Order
No. 12, a new chemical intended for use as a monomer
must undergo regular registration to achieve the required
IECSC listing. This will add the need for substantially
greater toxicity testing (mammalian and environmental) and
will involve greater evaluation.
With the advent of use limitations being applied to new
chemical registrations, a significant cost risk is added where

Simplified registration

Record notification

A new feature introduced by MEE Order No. 12 is the
expanded use of record notification, a current feature used
within MEP Order No. 7 with respect to R&D evaluation
of new chemicals. This involves a "light" version of a dossier
with more basic chemical and use data that does not require
pre-market approval. This method is limited for use with
new chemical substances with annual production or import
volumes of less than 1 metric ton per year and with polymers
with less than 2% of new chemical monomers or polymers
of low concern, or PLC. Since no pre-market approval is
required, market eligibility is automatically available upon
confirmation by the agency of completeness of the submittal.
The detailed regulations supporting MEE Order No. 12
are still in development. MEE has been reassigning staff
from other sub-agencies to assist with this process, which
has caused significant delays in the registration process
currently. Companies desiring to register a new chemical
substance in China for IECSC should act quickly to accomplish this with less data and lower cost. Others desiring
lower-volume market entry at significantly reduced cost
might find it worthwhile to wait until January.
Eggenschwiler, an ILMA consultant, is an international
trade attorney and principal, global trade and chemical
regulations services, for the Redstone Group, a Trinity
Consultants company. He can be reached at
614-923-7472 or jeggenschwiler@redstonegrp.com.

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ILMA Compoundings - June 2020

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

ILMA Compoundings - June 2020 - Cover1
ILMA Compoundings - June 2020 - Cover2
ILMA Compoundings - June 2020 - 1
ILMA Compoundings - June 2020 - 2
ILMA Compoundings - June 2020 - 3
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