Cassandra Taylor
Regulatory International
Influences
Regulatory Specialist,
Nexreg Compliance Inc. The impact of COVID-19
on the global regulatory landscape
The year 2020 has been an interesting one so
far, to say the least. Coronavirus disease 2019
(COVID-19), the infectious disease caused
by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2), has spread around the world, resulting
in a global pandemic. This has forced many of
us to reconsider the way we live, socialize and do
business. Back in March, Nexreg transitioned to a
completely virtual workforce to continue delivering
chemical regulatory services to our clients while staying
safe at home in these uncertain times.
The spring and summer months brought a
whirlwind of new activity to the hazardous chemicals
sector. Unsurprisingly, demand has slowed
in certain areas as the needs of the market shift.
Many countries and states implemented emergency
lockdown measures and mandated shutdowns for
businesses deemed non-essential.
For those chemical companies able to adapt, new
opportunities could be found by changing course
and entering different areas of the industry. We
saw and expect to continue seeing a surge of new
products, especially hand sanitizers and surface
disinfectants, as companies move swiftly to meet the demands of
the changing global market.
When handwashing is not possible, hand sanitizers are an
effective way to kill a broad range of microorganisms including
SARS-CoV-2. Similarly, disinfectants can be used to sanitize
high-traffic surfaces such as door handles, to mitigate the spread
of COVID-19. Disinfectants and sanitizers have antimicrobial
properties and are regulated in many countries under biocide or
drug regulations, which call for specific label elements and product
registration. Since the supplier obligations for these products can
differ from those of other hazardous chemicals, it is essential to
understand the regulatory requirements before selling them in any
country.
Labeling & registration requirements
Antimicrobial products are a new market for many companies and
navigating the compliance requirements can be challenging. This
section will provide a basic overview of the supplier obligations for
hand sanitizer and surface disinfectant products.
The U.S. Environmental Protection Agency (EPA) regulates
surface disinfectants under the Federal Insecticide, Fungicide & Rodenticide
Act (FIFRA). Disinfectants must be registered with EPA as
a pesticide and there are specific labeling requirements. Additionally,
in the State of California there are website disclosure requirements
enforceable under the California Right to Know Act (SB-258).
The U.S. Food & Drug Administration (FDA) regulates most
hand sanitizers as drugs under the Over the Counter (O-T-C) Drug
Regulations. Registration is required and a drug facts chart must
appear on the product label.
Health Canada regulates surface disinfectants as non-prescription
drugs under the Food & Drug Act. Product registration is
required and a Drug Identification Number (DIN) must be listed
on the label. A disinfectant drug application that supports the
general safety, efficacy and quality requirements outlined by Health
Canada must be submitted to obtain a DIN for a new product.
Health Canada regulates hand sanitizers containing 60–80%
ethanol or 60–75% Isopropanol as the active ingredient as Natural
Health Products (NHPs) under the Natural Health Products Regulations.
Non-alcohol sanitizers
with specific drug ingredients
such as benzalkonium chloride,
are regulated as drugs in
Canada under the Food & Drugs Act. In both cases, registration
is required and a Natural Product Number (NPN) or DIN must
be obtained for NHPs and drugs, respectively. A site licence (SL) is
also required to manufacture, package, label and/or import NHPs
in Canada.
The The European Chemicals Agency Agency (ECHA) regulates
surface disinfectants and hand sanitizers under the the Biocidal
Products Regulation (BPR, EU No. 528/2012). Biocidal products
must be authorized by ECHA before they can be placed on the
32 Spray September 2020
Photo: CC0 Public Domain