ENVIRONMENTAL SANITIZATION AT THE TIME OF COVID-19: HOW TO RESTART PRODUCTION ACTIVITIES IN COMPLIANCE WITH LAWS AND REGULATIONS

29/04/2020

The environmental sanitization sector is subject to specific national and European regulations. Recently, it has been affected by emergency measures specifically aimed at regulating the sanitization service to prevent the spread of Covid-19. These measures, if not clear and unambiguous, complicate the resumption of production activities in compliance with the current legal framework. In fact, the violation of the rules exposes both the users of the sanitization services and the sanitization companies to risks. The latter may be subject to criminal, administrative and unfair competition sanctions.

 

The Covid-19 Epidemic has brought the spotlight on sanitization services, which in the coming months may affect all (or almost) public and private places where daily life in the country takes place.
Nowadays, many companies are offering environmental sanitization, sanitation and disinfection services. Caution though. The current emergency context, where ministerial directives and scientific reports on how to deal with the Covid-19 are often equivocal, exposes the companies to the risk of legal sanctions. The sanitization sector is, indeed, subject to specific regulations that concern both the products used [1] and the companies themselves which must meet certain requirements [2].

The first problem that arises is to understand which are the correct sanitization practices for Covid-19 and which products should be used according to the required procedure. The terms sanitation, sanitization and disinfection, although often used undifferentiated, have different meanings. The sanitization activity concerns the complex of procedures and operations aimed at making certain environments healthy through the activity of cleaning and/or disinfection and/or disinfestation. Disinfection is the process through which most pathogenic microorganisms are eliminated on inanimate objects. Finally, cleaning or sanitation consists of removing of organic and inorganic material from objects and surfaces and is usually performed using water and detergents.

A first directive concerning the correct sanitization procedure for Covid-19 was given by the Ministry of Health with Circular No. 5443 of 22/2/2020 (hereinafter also “the Circular”), which distinguishes the sanitization of hospital environments and non-hospital environments.

The sanitization of hospital environments
The Circular considers hospital environments to be at high risk of Covid-19 infection and indicates the following sanitization procedure:
1) cleaning with detergents; followed by
2) application of disinfectants for hospital use (sodium hypochlorite (0.1% -0.5%), ethanol (62-71%) or hydrogen peroxide (0.5%) suggested).
The Circular, therefore, suggests some disinfectants but does not exclude the use of other substances, as long as they are as effective as those mentioned.

The sanitization of non-hospital environments
The Circular indicates the following procedure for non-hospital environments in which a case of Covid-19 has been ascertained [3]:
1) cleaning with water and common detergents.
2) decontamination with recommended substances such as 0.1% sodium hypochlorite and 70% ethanol after cleaning with a neutral detergent.
In this case, the Circular does not expressly impose sanitization by means of disinfectants (as in the case of hospital environments), using the more generic term “decontamination”.

It should be asked whether the different wording used by the Circular (as well as the express distinction between hospital and non-hospital environments) implies the indication of a different sanitization procedure: specifically, whether only for hospital environments this should be done by means of disinfectants. This is a crucial aspect for the service operator since the qualification of a product as a disinfectant requires several fulfilments. As clarified by the Ministry of Health (see Communication 6/4/2020), all products claiming a disinfectant action are classified as biocides and can be placed on the market only after obtaining a specific authorization from the Ministry of Health or the European Commission [4]. Biocidal products are, in fact, subject to a preventive control in order to assess their effectiveness and safety for the consumer and the environment. It should be specified: products claiming sanitizing and/or germ and bacteria removal activities, if they do not have the above authorization, are not to be considered as disinfectants, but as common detergents. As such, they can be placed on the market for free sale [5] (see Communication of the Ministry of Health 20/2/2019).

As a result, two interpretations of the Circular seem abstractly possible.
According to the first, more liberal, for the sanitization of Covid-19 of non-hospital environments it would not be necessary to use disinfectants (in the sense of products legally qualifiable as such), with the conclusion that unauthorized products could be used.
Nevertheless, taking into consideration some scientific reports issued by competent bodies, another more rigorous and prudent interpretation of the Circular seems possible. In particular, the Recommendation of the Higher Institute of Health of 29 March 2020 states that products with disinfectant properties must be used for the environmental sanitization of Covid-19. As a logical consequence, the term “decontamination” implies, however, the use of a quid pluris with respect to common detergents, and therefore of real disinfectants (as such, specifically authorized by the competent authorities).

The legal requirements for sanitization companies
In addition to products compliance, the companies offering a sanitization service must meet all legal requirements (see Law No 82 of 25 January 1994 and Ministerial Decree No 274 of 7 July 1997).
Specifically, Ministerial Decree No 274 of 7 July 1997 identifies the specific requirements of “economic-financial capacity” and “technical and organizational capacity” for the exercise of sanitization activities. The latter, in particular, must be possessed by the owner, a partner or a person responsible for the technical management of the company with the exclusion of an external consultant.
The requirements of good reputation (e.g. absence of criminal sanctions, preventive measures, labor and social security fines) are provided by Article 2 of Law no. 82 of 25 January 1994 and must be possessed by different persons, depending on the type of business.
Sanitization companies that do not meet the above requirements are subject to administrative sanctions. In this respect, the ANID (National Association of Disinfection Undertakings) has announced legal actions against non-compliant companies.

In conclusion, the company already qualified to carry out sanitization services gains a competitive advantage compared to those that only recently decided to operate in this sector. This advantage is the result of years of investments, work and fulfilments. The current epidemic context, although dominated by the need for rapid responses, cannot lead to the liberalization of a specifically regulated sector. In this regard, it is worth remembering that the need to ensure compliance with the rules and procedures – as well as to provide operators with the necessary tools for the correct execution of the Covid-19 sanitization – is aimed at protecting public health and the environment.
It is clear that sanitization activities, as required by current legislation (particularly with regard to hospital environments, but also in the case of private offices when there has been an established infection), constitute a specific obligation for the company, which is required to comply with a series of measures in order to protect its employees, collaborators and users. The violation of the obligations, in addition to being sanctioned in administrative and criminal proceedings, could expose the company to liability for damages in the event that the sanitization is not carried out or is carried out incorrectly, and further contagion occurs.
A precise and unambiguous use of legal terms is therefore advisable in order to promote company compliance and to discourage any predatory behavior in the sanitization sector. In this regard, it should be noted that misleading advertising relating to one’s own products/services or the qualities possessed by the entrepreneur could also constitute a competitive offence. In particular, unfair competition for appropriation of the merits of others (see Art. 2598 no. 2 of the Italian Civil Code) occurs when an entrepreneur, in forms of advertising or equivalent, attributes to his products merits and qualities not possessed by them but belonging to the products of a competitor, thus disturbing the free choice of consumers. Similarly, it constitutes an act of unfair competition to carry out activities in violation of public rules, a situation that could occur if the company proposes itself for sanitization services in violation of the rules governing this specific sector and indicated above. The violation of the competition rules could be claimed in several areas, including, for example, before the antitrust authorities (with regard to misleading communications), i.e. the civil courts, with the possibility of applying sanctions such as injunction, publication, compensation for damages.

[1] Among others, see the EU Regulation 528/2012 on Biocidal products and the Decree 392/98 on medical surgery devices.
[2] The requirements that sanitization companies must meet are provided by Law No 82 of 25 January 1994 and Ministerial Decree No 274 of 7 July 1997.
[3] In particular, the shared Protocol for the regulation of measures to combat and contain the spread of Covid-19 in the work environments, dated 14/3/2020, sets out a series of indications for the sanitization of offices and factories. In case of confirmed cases of Covid-19, the Protocol refers to the provisions of the Circular (see point 4. of the shared Protocol).
[4] Specifically, products containing an active substance already approved under EU Regulation 528/2012 are exclusively regulated by this Regulation and placed on the market as biocidal products. Products containing an active substance under review in accordance with EU Regulation 528/2012 may be placed on the Italian market pursuant to Decree 392/98 as medical surgery devices.
[5] Unlike disinfectants, detergents are composed of chemical substances that act physically or mechanically to remove organic or inorganic material from surfaces, exerting a cleaning action.

Simona Lavagnini, Camilla Macrì