December 10, 2021

Insight 5: Household biocides and hand sanitizers - how to walk the line between consumer expectations and regulatory demands

Hand and household hygiene have taken on new significance since COVID-19 came into our lives. At the start of the pandemic, some organizations entered the biocides market for the first time to meet the urgent need for these products. Meanwhile, many established players were keen to convey virucidal properties in their product claims.

Today, it’s clear that the world needs to learn to live with COVID-19 for the longer term, and that these products will continue to be in high demand. TSG Consulting has invested in extensive research to ascertain what consumers want from hand and household hygiene products. With these insights, we can help manufacturers establish product claims and characteristics that satisfy consumers while maintaining regulatory compliance.

The study encompassed six countries: the US, UK, Canada, France, Spain and Germany. We asked respondents about hygiene products purchased in response to COVID-19 and elicited their thoughts on factors such as efficacy, claims and labeling.

Key findings, and interpretation from our biocides regulations experts, are summarized in separate whitepapers for hand and household hygiene products.

Hand hygiene whitepaper

Overall, 67% of survey respondents said they had purchased antibacterial handwash or sanitizer for personal use because of COVID-19. This was consistently the most popular category across all six countries. However, leveraging opportunities in this space involves navigating complicated regulatory requirements, especially when looking to achieve international rollout.

Global regulatory frameworks share the overarching goal of ensuring hand hygiene products are safe and effective, but classifications and requirements can vary considerably. The situation is particularly complex in the European Union (EU) where a handwash or hand-rub may be categorized as a cosmetic, a biocidal product or even a medicinal product depending on its formulation, purpose, primary function, presentation, and claims.

A cosmetic, biocidal or medical product?

In the EU, if a hand hygiene product’s antimicrobial effects are secondary to the primary function of cleaning the hands, the Cosmetic Products Regulation (CPR) can apply. However, if the product is positioned as an agent to kill germs or disinfect hands, it falls under the EU Biocidal Products Regulation (BPR) as a biocidal product. The picture is similar in Great Britain (GB), albeit under the UK Cosmetics Regulation and GB BPR.

CPR requirements are more straightforward than those of the BPR. However, it’s important to balance the relative ease of this regulatory path with the need to maximize consumer appeal. Our research showed that ‘effectively killing germs/bacteria’ was the most important claim related to products purchased in response to COVID-19 in all six countries. Overall, 77% of respondents placed importance on this.

Ultimately, it is permissible for a cosmetic product to contain antibacterial ingredients and potentially make a biocidal claim, provided that the claim is secondary to the cosmetic function of the product and is supported by efficacy data. However, since this walks a fine line between the CPR and BPR, it’s important to proceed with caution.

Read the full whitepaper Aligning hand hygiene products with regulatory frameworks in the age of COVID-19 for more information on compliance, harmonization and labeling as well as regulatory insights for the US and Canada.

Household surface biocides whitepaper

Almost half (47%) of our research respondents said they had purchased products such as antibacterial wipes and multi-surface sprays in response to the pandemic. Overall, our findings indicate that consumers in all six markets are looking for ‘products that work’ while offering good value. However, this consistency of consumer expectation is not reflected in global regulatory requirements.

When it comes to household biocidal products, regulatory considerations encompass everything from formulation to efficacy claims, intended use and labeling. It’s a complex area with great variations between, and even within, international markets:

  • US: antimicrobials for controlling microorganisms which are infectious to humans are considered ‘public health antimicrobials’ when intended for use on inanimate objects. Such products must be registered with the Environmental Protection Agency (EPA) and in any state where they are distributed. They are evaluated in terms of chemistry, toxicology, efficacy performance and usage, according to guidelines established under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
  • Canada: disinfectant products for use on surfaces are regulated as drugs under Health Canada’s Food and Drugs Act because they decrease the chance of transmitting disease. The Natural and Non-prescription Health Products Directorate (NNHPD) reviews ingredients, uses and claims of these products before they can be marketed.
  • EU: antibacterial surface disinfectants fall under the BPR in the EU. However, while approval criteria are set out at an EU level, product authorization is generally granted at the national level. Despite ongoing efforts at harmonization and mutual recognition procedures, some Member States may have specific requirements for their own national market.

Our Head of Biocides & Cosmetics Amy Burrows says manufacturers need to strike a balance between what consumers want and the regulatory requirements of different markets:

“Our aim is to help manufacturers develop compliant products which hold consumer appeal. Regulatory requirements vary around the world, but the desire for ‘products that work’ is universal. COVID-19 is still a big part of our lives, and it’s important that consumers can make informed decisions about the products they choose.”

Access the full whitepaper Household biocides: Striking a balance between claims and regulations in the COVID-19 world for more regulatory insights surrounding household hygiene products.

If you have any questions about your own product’s regulatory strategy, do get in touch at info@tsgconsulting.com

Stay tuned for next week’s insights!

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