SGS Helps Hand Sanitizer Manufacturers Understand Regulatory Changes in Response to COVID-19

SGS, the world’s leading provider of testing
and certification services, offers a range of solutions to help manufacturers
produce safe, effective, and compliant hand sanitizers.

After handwashing, using hand
sanitizers is one of the best ways to ensure
SARS-CoV-2, the virus that spreads
COVID-19, is rendered harmless. Most hand sanitizers are alcohol-based, often
using ethanol or isopropanol. To be effective they must be a minimum of 60%
alcohol by volume, although many commercial brands contain between 60% and 80%
alcohol by volume.

A basic hand sanitizer will also often contain glycerol (prevents dry
skin), hydrogen peroxide (inactivates contaminating bacterial spores) and distilled
water. In addition, commercially available hand sanitizers can also contain
antiseptics, such as chlorhexidine or quaternary ammonium derivatives, and
non-essential ingredients such as foaming agents, colorants and/or fragrances.

COVID-19 meant hand sanitizer supplies around the world were quickly
exhausted. In response, a variety of manufacturers, including distillers and
automotive industry suppliers, began manufacturing the product, although
regulations in some areas did not actually allow it. To address this, several
authorities eased their regulations.

In the US, either the Environmental Protection Agency (EPA) or the Food
and Drug Administration (FDA) regulate antimicrobial products:

  • EPA – antimicrobial products used on surfaces because
    they are identified as pesticides under the Federal Insecticide, Fungicide and
    Rodenticide Act (FIFRA). They require product-specific approval by way of
    a ‘registration’ of antimicrobial products and sources of active ingredients.
    Efficacy against public health pathogens must be demonstrated using specified
    EPA-approved studies
  • FDA – antimicrobial products used on humans or
    animals, regulated as over the counter (OTC) drugs under the Federal Food
    Drug and Cosmetics Act (FFDCA). The FDA typically determines whether the
    active ingredients used in OTC drugs are Generally Recognized as Safe and
    Effective (GRASE) through its monograph program. Under this, consumer
    antiseptic hand rub products can use ethyl alcohol, isopropyl alcohol or benzalkonium

The EPA already had a policy that allowed manufacturers to make claims
against emerging viral pathogens, provided the product met set efficacy tests. So,
although registrants and sellers on the EPA’s list cannot make specific claims
in relation to COVID-19, they can state they are on this list. Therefore, in
effect, they are demonstrating the EPA considers this product to be effective
against SARS-CoV-2 and COVID-19.

The EPA and FDA have both taken steps to help reduce the shortage in
hand sanitizers. For example, the EPA has eased the reporting requirements on
280 inactive disinfectant ingredients and the FDA has relaxed certain
restrictions. They have also announced that they will not enforce actions
against firms preparing alcohol-based hand sanitizers for consumer and public
health use until such a time that the emergency is lifted. In addition,
they will not take action against compounders, so long as they use ingredients
of United States Pharmacopoeia (USP) grade and utilize a formulation that is
consistent with WHO guidance.

Hand sanitizers are covered by Regulation (EU) 528/2012 – the Biocidal
Products Regulations (BPR) – the European Union (EU). Under Article 55 for the
BPR, Member States are allowed to set aside the standard BPR authorization requirements
in the event of a public health emergency. A national derogation can be
announced by a competent authority (CA) for a period of up to 180 days, which
may be extended. Several EU countries have adopted derogation. Stakeholders
should recognize that hand sanitizer products manufactured outside of the EU
are still subject to the requirements of the BPR.

During the COVID-19 pandemic regulatory authorities have relaxed certain
regulations to ensure a steady supply of hand sanitizers. As the situation
develops, it can be imagined these will develop further. It is therefore
important for manufacturers to ensure they are compliant with up to date
regulatory information.

SGS Hand Sanitizers and Disinfectant Services

Utilizing a global network of experts and laboratories, SGS provides a
comprehensive testing and registration service to help hand sanitizer
manufacturers ensure their products remain compliant with current market
regulations. Learn more about SGS Hand Sanitizers and
Disinfectants Services

For more information, please contact:

Hubert Brundu
Global Technical Manager
Cosmetics, Personal Care & Household



About SGS

SGS is the world’s leading
inspection, verification, testing and certification company. SGS is recognized
as the global benchmark for quality and integrity. With more than 89,000
employees, SGS operates a network of over 2,600 offices and laboratories around
the world.

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