They are in demand more than ever: disinfectants. As a result of the worldwide spread of the new Coronavirus (SARS-CoV-2 responsible for the Coronavirus disease COVID-19), the demand for ethanol, the alcoholic basis of many disinfectants, has risen dramatically.
In Switzerland, as in many other countries, there are signs that disinfectants are in short supply. According to recent press reports (for example here and here), the Swiss Confederation is partly responsible for this shortage. Until and including the year 2018, Switzerland used to maintain an ethanol reserve of roughly 10,000 tons. According to experts, those quantities would have been enough to meet the high demand for disinfectants in times of crisis. However, due to the privatization of the former Swiss Alcohol Board, the Swiss Federal Office for National Economic Supply (FONES) eliminated these reserves.
Classification of alcohol-based disinfectants as biocides
Disinfectants are biocidal products and must comply with the relevant regulatory requirements. In order to overcome the looming shortage, some manufacturers and distributors of disinfectants have been asking themselves in recent days whether disinfectants intended for disinfecting hands (e.g. hand cleaners with 70-80% ethanol) could be marketed as cosmetic products, for which fewer regulations apply.
However, according to a communication from the Swiss Cosmetic and Detergent Association to its members, the Swiss Federal Office of Public Health (FOPH) clarified that also hand cleaners and other products for human hygiene containing 70-80% ethanol are considered biocidal products and not cosmetics. They are produced with the purpose of protecting public health through biocidal action (e.g. disinfecting), thus reducing the transmission of viruses and other diseases rather than cleaning and caring for the skin. This classification of the FOPH is also in line with the EU Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.).
General Permits for alcohol-based disinfectants
Normally, biocidal products may only be placed on the Swiss market if they have been authorized by the Swiss Notification Authority on a case-by-case basis (see Article 3 of the Swiss Ordinance on Biocidal Products (OBP). As an exception, biocidal products (i) that have been authorized in an EU or EFTA Member State under the simplified procedure specified in Article 26 of Regulation (EU) No. 528/2012, (ii) belonging to an authorized biocidal product family, or (iii) that have been released for purposes of research and development do not need an authorization but may be notified only. It makes no difference whether the products are sold or given away for free.
However, to counter the feared shortages of disinfectants, the Swiss Notification Authority issued two General Permits for the production and supply of disinfectants on 28 February 2020 and on 9 April 2020.
The first General Permit of 28 February 2020 concerns certain biocidal products for human hygiene (hand disinfection), certain disinfectants that are not intended for direct application to humans and animals (surface disinfection) and certain disinfectants for food and feed (surface disinfection).
The first General Permit aims at ensuring and facilitating pharmacies and drugstores the manufacturing of biocidal products that comply with the specifics of the General Permit. Accordingly, the concerned biocidal products may be manufactured, marketed and sold without going through an individual authorization procedure. This permits pharmacies and drugstores to provide such disinfectants without having to submit a prior application to the Notification Authority for Chemicals.
The second General Permit of 9 April 2020 applies to disinfectants that are not intended to be used for human hygiene but only for the disinfection of surfaces and contain active chlorine.
In addition, the Federal Office of Public Health (FOPH) has published a list of disinfectants that have already been approved in an individual procedure and that are effective against viruses with viral envelopes such as the new Coronavirus. Coronaviruses belong to the viruses with viral envelopes, i.e. they are protected by a lipid-rich layer. Since chemical substances can break down this outer layer, the viruses become vulnerable to attack by disinfectants and lose their infectious power.
Despite the issuance of the General Permit, which renders individual authorization procedures for disinfectants superfluous for a limited amount of time, other general principles of the applicable law, such as the principle of self-regulation remain applicable.
Furthermore, the Swiss Notification Authority reiterates that the General Permit is no carte blanche to simply put disinfectants containing ethanol on the Swiss market without having to observe the relevant rules for the handling of ethanol:
- The Biocidal Products Ordinance and the Swiss legislation on chemicals still apply to the disinfectants that benefit from the General Permits.
- Although the General Permit does not restrict the circle of possible marketers (i.e. is not restricted to pharmacies or drugstores), the general principles of chemicals law still apply. This means, for example, that anyone wishing to place disinfectants on the Swiss market on the basis of the General Permit must check within the framework of self-regulation whether the intended alcohol
- is suitable for the disinfection of healthy human skin, and
- whether impurities or specific ingredients require a different classification and labelling of the disinfectant.
- Records must be kept of the production of each batch.
- Disinfectants must not be filled into food containers.
- Composition of the disinfectants:
- If perfume is added, any influence on classification and labelling must be checked.
- The percentages for the content of alcohols stated in the General Permit are volume percentages (v/v) – however, formulations are also accepted which are within the limits of weight percentages (w/w) according to the FOPH.
- Products according to the so-called “WHO formulation” may also be marketed in Switzerland according to the General Permit without prior approval. For hand disinfection products in the private sector there is no need for the addition of hydrogen peroxide according to the FOPH.
- hazard pictograms must have an edge length of at least 16 mm; for small packages of less than 125 mL, the edge length may be reduced to 10 mm.
- The labels must be in at least the official language of the sales region in Switzerland. Labels with at least two official languages can be marketed throughout Switzerland.
- The person placing the product on the market in Switzerland must be listed on the label as the legally responsible person for public goods. Goods that are sold to commercial users only may also bear an EEA address.