Asia Regulatory Update Cassandra Taylor
R&D Regulatory Supervisor,
Nexreg Compliance Inc.
Regulatory International
Influences
As we move toward the end of 2020, it seems like an appropriate
time to reflect on the shifts we have all made over
the past year. Working from home has become the norm
for many of us, and there have been some conspicuous changes in
the global regulatory sector. We have observed a surge of new products
coming to market to help fight COVID-19 such as cleaners,
disinfectants and hand sanitizers. These types of product already
tend to be highly regulated and the increase in market demand has
caused regulators to look more closely at many of them. We are
also seeing an increase in recalls for certain products, such as hand
sanitizers containing toxic methanol.
On the other hand, COVID-19 has effectively tied up resources
and slowed down several government actions. In many countries,
this has reduced the amount of new legislation being brought forward.
While we have seen a bit of a lull in North American regulatory
activity, several Asian regulatory bodies have continued to forge
ahead with new initiatives. This column will discuss some of the key
regulatory updates we have recently seen around Asia this year.
Philippines mandates GHS labeling; reinstates
licensing requirements for certain household products
In August 2020, FDA Circular No. 2025-025 was published on
the Philippines Food & Drug Administration (FDA) website. The
Circular implements Guidelines of Administrative Order No.
2019-0019, Reinstatement of Licensing as Importers, Exporters, Manufacturers,
Wholesalers, Distributors, Retailers,
or Re-Packers of Those Engaged in
Certain Household/Urban Hazardous
Substances, & from the Requirement
of Prior Registration and/or Notification
of Said Products. This finalized
a guideline on licensing, registration
and labeling requirements for household/urban hazardous
substance products (HUHS).
The new guideline, which will take effect in August 2023, incorporates
the Globally Harmonized System of Classification & Labeling of
Chemicals (GHS) into the regulatory requirements for HUHS. This
means that consumer products sold in the Philippines will soon
need to be classified and labeled according to GHS.
In addition to implementing GHS requirements, the Circular
establishes guidelines to register and authorize HUHS products,
updates the categorization of HUHS products, establishes licensing
and inspection guidelines and aims to ensure compliance of
HUHS establishments with FDA regulatory standards.
Exporters have expressed concern about the reinstatement of
licensing and registration requirements for HUHS because it will
make doing business in the Philippines more expensive. Under the
Circular, HUHS organizations must secure a License to Operate
(LTO) before engaging in the manufacture, importation, exportation,
sale and distribution of HUHS products.
HUHS establishments must also obtain a Certificate of Product
Registration (CPR) for their products, with only FDA-licensed
HUHS establishments permitted to apply for a CPR. The newlyapproved
Circular covers importers, exporters, manufacturers, toll
manufacturers, wholesalers, distributors, retailers and re-packers of
certain HUHS products who must comply with FDA licensing and
registration requirements to be allowed to handle these goods.
India proposes new version of “India REACH” Draft
In March of this year, India released the fourth version of the
Draft Chemicals (Management & Safety) Rules, also known as “India
REACH.” India REACH includes provisions for labeling and handling
of hazardous chemicals, as well as notification and registration
requirements for specified chemicals. The Rules are meant to
come into force on the date of their official publication, which was
unknown at SPRAY’s press time.
Substances listed in Schedule
VI of the Draft Rules have
registration requirements when
they are manufactured, imported
and/or placed in Indian Territory
in quantities greater than
one tonne per year. Registration
will need to take place within 1.5 years of the date of listing on
Schedule VI, which currently contains 37 substances. A technical
dossier must be submitted as part of the registration and a chemical
safety assessment is required for quantities above 10 metric
tonnes per year. A joint registration may be submitted, but this is
not a requirement.
Priority substances are listed in Schedule II of the Draft Rules.
Importers must notify the Chemicals Regulatory Division at least
15 days prior to importing priority substances. Chapter V of the
draft rules outlines additional labeling and packaging requirements
for Schedule II substances. There are currently 750 Schedule
II priority substances and this list is expected to grow.
Foreign entities wishing to notify and register products in India
will need to do so through an Authorized Representative. Much like
the Only Representative in Europe, the Authorized Representative
acts “on behalf of the foreign Manufacturer to ensure compliance
with these Rules and shall be liable for the discharge of all obligations
under these Rules.”
South Korea consults on updates to GHS classification list
In September, South Korea’s National Institute of Environmental
Research (NIER) published NIER Notice No. 2020-408 for consultation,
which announced a draft amendment of the Korean Regulations
on classification and labeling of chemical substances. The
proposed amendment would update classification and labeling
information for 11 previously published toxic substances and one
restricted substance. Forty-five additional substances are set to be
December 2020 SPRAY 19