Disinfectants and hand 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...
September 2020 SPRAY 33
European market. Approval is required for the active substances in
the product; and companies must additionally ensure that either
their substance, or product suppliers, or themselves are included
in the Article 95 list. Article 951 of BPR is a list of relevant active
substances and suppliers; raw
materials used in biocidal products
are not normally permitted
to be obtained from suppliers
that are not present on the list.
Specific labeling and registration requirements vary depending
on the country of sale, so it is important to review the supplier
responsibilities before entering a new market.
Interim policies due to COVID-19
The regulatory climate has been constantly evolving over the past
several months, with an array of temporary legislative changes being
implemented around the world in response to COVID-19.
The primary goal of many such changes has been to get essential
products on the market quickly so that consumers and businesses
have the tools they need to help curb the spread of the virus.
The U.S. FDA released a temporary policy for the preparation
of certain hand sanitizer products during the COVID-19 pandemic.
The non-binding document states that FDA does not intend
to take action against firms that prepare alcohol-based hand
sanitizers for consumer use, and for use as health care personnel
hand rubs, for the duration of the public health emergency. For
the temporary policy to be valid, several criteria must be met:
1. Hand sanitizer must be prepared using the specified
ingredients without any additives to improve the smell or
taste;
2. It must be prepared under sanitary conditions;
3. It must be manufactured according to formulas consistent
with World Health Organization (WHO) recommendations2;
4. The product should be labeled according to the
recommendations in the temporary policy; firms are still
expected to register their facility and list their products in the
FDA Drug Registration & Listing System (DRLS).
The EPA is offering expedited FIFRA registrations for products
with active ingredients appearing on list N3: Disinfectants for Use
Against SARS-CoV-2.
Health Canada is currently expediting registration applications
for hand sanitizer and disinfectant products as well as SLs. Hard
surface disinfectants that were authorized and registered in the
U.S. and Mutual Recognition Agreement (MRA) and Pharmaceutical
Inspection Co-operation Scheme (PIC/S) countries are
temporarily authorized for import into Canada. Additionally, to
improve the supply of raw materials, the use of technical-grade
ethanol in hand sanitizer products has been temporarily authorized,
with some additional labeling requirements.
Health Canada further released interim policies to help facilitate
access and immediate import of household and workplace
cleaning products as well as hand and body soaps. Labels may be
in only one official language, and do not have to conform to all
the prescribed label requirements to be sold in Canada temporarily.
These interim policies will be in effect for three months after
all provinces and territories have ended their states of emergency
related to COVID-19.
Several European countries took advantage of article 55(1) of
the BPR, which allows national authorities to give time-limited
derogations from the standard product authorization requirements
in situations where there is a threat to public health. In
many European States, alcohol-based hand sanitizers with specified
formulations could be produced temporarily without completion
of a full registration. Additionally, exceptions to the Article
95 supplier requirements were enacted by certain countries to
counteract raw material shortages.
How label claims affect regulatory requirements
It is important to note that the claims made on the product
label, as well as the identity of non-active ingredients, can
impact the regulations that a product is subject to. Hand sanitizer
products that make aesthetic claims, such as “softens and
moisturizes skin” will frequently fall under cosmetic regulations,
depending on the jurisdiction. Cleaning products with
biocidal label claims such as “kills 99.9% of bacteria” might be
subject to different regulations than a general cleaning product
that does not make any such assertions. The applicable regulations
and interim policies will vary depending on the product
use, formula, label claims and country of sale, so you will want
to be sure to check the requirements for your unique circumstance.
It is imperative to ensure that the correct labeling and registration
steps are taken when selling hazardous products. Even
during these unusual circumstances, recalls can occur for products
that are deemed unsafe, which is a costly process that is
best to be avoided. As SPRAY goes to press, the temporary policies
mentioned in this article were in place. It is unclear where
the industry will go and how the regulations will change, but
one thing is for sure—consumers want products to keep themselves
and their homes safe from COVID-19. Workplaces have
new obligations to keep their employees safe as well, which in
turn will mean a higher demand for chemical products.
Nexreg will certainly be paying attention to how the market
evolves going forward. Spray
1https://echa.europa.eu/information-on-chemicals/active-substancesuppliers
2https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf
3https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-againstsars
cov-2-covid-19