FRANCESCA FASANO
Head of BU Chemical, ChemSafe, Colleretto Giacosa, Italy

Abstract

In 2020 due to the spread of COVID-19, the market experienced a sudden request of products for hand washing, and subsequently of surface disinfectant products. Several companies had to manage how to improve their generic disinfectants to products effective against enveloped viruses such as COVID-19. An overview on what happened in the disinfectant market in 2020 and what is happening during 2021 is presented.

INTRODUCTION
In March 2020 following the spread of COVID-19 one of the first actions carried out at EU level to prevent and reduce virus transmission was the enhancement of hygiene practices.
At the time, the use of disinfectant products for every day cleaning was limited to generic disinfectant products claiming efficacy against bacteria and yeast. Most of the disinfectant products available fulfilled the efficacy basic requirement foreseen in the ECHA efficacy guidance (1).

The absence of disinfectant with specific claim on the market was not a lack, for the needs of daily householding the general disinfectant where more than enough. In addition, there was quite no knowledge about the efficacy performance of the products.
Last year, suddenly the possibility to claim efficacy against virus became crucial. Therefore, on one hand there was a rush to test the products already present on the market to check their effectiveness against viruses. On the other hand, a great effort in formulating products that were effective against the virus in the shortest possible time.
In this context the authorities were of great help: they set up in each country the art 55 derogations for biocidal products containing authorized active substances and the actions taken for the transitional period (2, 3).

HOW TO ASSESS DISINFECTANT EFFICACY?
The ECHA efficacy guidance report which are the reference test to perform. For disinfection products the reference tests are the EN norms.
The EN norms used to test viruses foresee a tiered approach test that allow to test different group of viruses (4).

Virucidal activity: test the product against Poliovirus; Adenovirus; Murine Norovirus Limited spectrum virucidal activity: test the product against Adenovirus; Murine Norovirus Virucidal activity against enveloped viruses: test the product against Vaccinia virus

The virucidal test is a particularly challenging test to pass because viruses are more resistant than yeast and bacteria.

The key structural distinction between viruses is between viruses that have lipid-bilayer membranes and those that lack them, “enveloped” and “non-enveloped”, respectively. These differences reflect different mechanisms of cell entry and different pathways of assembly and maturation. Enveloped viruses enter by membrane fusion, either from an internal compartment following an endocytic step, or at the cell surface. Non-enveloped viruses require some form of membrane “perforation” (5).

The three European virucidal activity levels take into account that enveloped viruses contain lipids and have lipophilic properties. These viruses are sensitive to disinfectants that contain active substances that disrupt their lipid bilayer envelope. In contrast, nonenveloped viruses are usually hydrophilic and less susceptible to disinfectants (6).

The EN norms were developed according to the aims of the BPR to limit biocide use to what is necessary and there is no need to use more potent products, products at higher concentrations and longer contact times which are required to kill virus target organism.

This tiered virucidal activity where firstly applied for hand hygiene product, but it has been considered applicable also to the food industry, hospitals surfaces and veterinary hygiene etc where control of a specific pathogen is the purpose of using a disinfectant.

From the BPR point of view, information about this topic may be found in the Technical Agreements for Biocides on efficacy (7) in which is indicated that the Vaccinia virus is considered enough to claim efficacy against enveloped virus for products used for hand disinfection and animal skin disinfection (8).

For PT2 and 4 the claim against enveloped viruses is not accepted, it is necessary to claim efficacy against both enveloped and non-enveloped viruses.

At the time being no specific information is reported in the ECHA guidance II B+C (1) although, mention to the tiered approach for virucidal activity allows some scope for argument. This topic is under discussion at the BPR CA meeting and ECHA BPC EFF WG. The recent history of Covid-19 pandemic demonstrates the need for products effective against enveloped viruses. Changes may be introduced in a revised guidance, of which an update on the effectiveness of disinfectants is expected to be published next year.

WHAT ABOUT THE MARKET?
Beside the regulatory framework, from the marketing point of view what happened in 2020 and what is happening in 2021?
In February-March 2020 in Italy a huge increase in the request of hand disinfectants was experienced, with a growth of the market of more than + 100%. Later, in May-June, due to the phase-two opening, a big increase of the request of surface disinfectant and cleaning products was experienced (9).

Disinfectant and disinfection became the keyword of the shopping cart of consumers, companies, public administrations, hospitals, public businesses. The effect was observed because of different factors:
During lockdown there was an increasing demand of disinfection products because of the initial procurement fearing that the system would not be able to guarantee production and of an increase in the use of disinfectant. During phase two and phase three increased demand to support cleaning procedure for the reopening of commercial establishments and the subsequent reopening of schools and offices.
Data coming from a market research of Assocasa in collaboration with Nielsen report a growth of the Italian market more than 17% in June 2020 (10).

AISE, which is the International Association for Soaps, Detergents and Maintenance Products, in its report about market and economic data of 2020, reports a growth of 4.7% in the household care sector and a growth of 22.9% in the professional cleaning and hygiene sector (11).

The same sale trend observed in EU, was observed in USA in 2020 with an increased demand of hand disinfectant flowed by the increasing need of surface disinfectant.

In 2021 in USA there was a decline in sales. It seems that the effects of the vaccination campaign have led public opinion to consider the coronavirus emergency now over. The condition of general relief can also be seen in the sales of products that have been deemed essential in the last year. It starts to be relevant the issue of selling the product stocks.

At the time being in Italy there is a decline in sales, but there is not the problem of product surpluses. This is mainly due to two different factors: The first one is that even though there is a decline of sales, the consumption of disinfectant is higher than in 2019 meaning that consumer habits changed since the beginning of last year. In fact, consumers are more attentive to hygiene and cleanliness, they pay more attention to safety. In Italy companies size is often small or medium, so product lots are smaller than the ones produced by multinational.

From this short overview it’s clear that disinfectant sales may decrease in the future, the entity of this decrease does not depend strictly on the market, but it will depend mainly on the policies adopted in the future against the pandemic.

REFERENCE AND NOTES

1. ECHA, Guidance on biocides legislation, Guidance on the BPR: Volume II Parts B+C, Version 3.0 April 2018;
   https://echa.europa.eu/documents/10162/23036412/bpr_guidance_assessment_evaluation_part_vol_ii_part_bc_en.pdf/950efefa-f2bf-0b4a-a3fd-41c86daae468 (last checked on Jul 12th, 2021)
2. ECHA, COVID-19 information: https://echa.europa.eu/it/covid-19 (last checked on Jul 20th, 2021)
3. Regulation (EU) no 528/2012 of the European Parliament and of the council concerning the making available on the market and use of biocidal products, consolidated version, https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02012R0528-20210610
4. EN Norms; EN 14476, EN 16777 ; http://store.uni.com/catalogo/index.php/home/?josso_back_to=http://store.uni.com/josso-security-check.php&josso_cmd=login_optional&josso_partnerapp_host=store.uni.com https://echa.europa.eu/it/covid-19 (last checked on Jul 20th, 2021)
5. Laboratory of Structural Cell Biology, online. Available from: https://crystal.harvard.edu/viruses/ (last checked on July 19th, 2021)
6. Eggers Maren, Schwebke Ingeborg, Suchomel Miranda, Fotheringham Valerie, Gebel Jürgen, Meyer Bernhard, Morace Graziella, Roedger Hans Joachim, Roques Christine, Visa Pilar, Steinhauer Katrin. The European tiered approach for virucidal efficacy testing – rationale for rapidly selecting disinfectants against emerging and re-emerging viral diseases. Euro Surveill. 2021;26(3):pii=2000708. https://doi.org/10.2807/1560-7917.ES.2021.26.3.2000708 (last checked on Jul 19th, 2021)
7. Technical Agreeement on Biocide (TAB) Efficacy (EFF), Version 2.2 July 2020; https://webgate.ec.europa.eu/s-circabc/faces/jsp/extension/wai/navigation/container.jsp (last checked on Jul 20th, 2021)
8. ECHA webpage, Product types; https://echa.europa.eu/regulations/biocidal-products-regulation/product-types (last checked on Jul 20th, 2021)
9. Federchimica webpage: https://www.federchimica.it/webmagazine/dettaglio-news/2020/06/08/detergenza-covid-19-cosa-%C3%A8-cambiato (last checked on Jul 20th, 2021)
10. Sole24ore website: article Parola d’ordine disinfettare: i detergenti crescono oltre il 10% sostenuti dalla aperture “ June 15th 2020 https://www.ilsole24ore.com/art/parola-d-ordine-disinfettare-detergenti-crescono-oltre-10percento-sostenuti-aperture-ADZ4yWX (last checked on Jul 19th, 2021)
11. AISE website, market and economic data: https://www.aise.eu/our-industry/market-and-economic-data-2292.aspx (last checked on July 19th, 2021).

ABOUT THE AUTHOR

Francesca Fasano has a Degree in Industrial Chemistry, one in Chemistry, and a PhD in Analytical Chemistry. During her PhD she worked at the US EPA. Francesca participated in several university research projects. Since January 2011 she has worked at Chemsafe on Agro/Biocide projects. In 2015 Francesca became Head of Agro/biocide BU and in 2020 she became Head of Chemical BU.