Can virucidal/antiviral mouth-nose coverings and other masks be worn without hesitation?
In the trade, some protective masks and in particular mouth-nose coverings Face mask are offered, which contain virucidal substances, are coated with them or have textile layers that have been treated with virucidal substances. These virucidal substances can be silver ions, nano-silver, polihexanide (PHMB), so-called virus blockers or other substances that are used, for example, as disinfectants. These are designed to kill viruses, such as SARS-CoV-2, in the masks and in the inhaled air. In addition to the product safety requirements, virucidally equipped masks are also subject to biocide regulations, provided that the masks are not medical devices such as surgical masks.
The legal prerequisite for biocidal products to allow these substances to be used in the masks is that they are currently being or have been evaluated as biocidal active substances for the type of use “disinfectants without direct application to the skin” within the framework of the so-called existing active substance procedure and that the transitional regulations for biocidal products are met. Biocidal products evaluated and authorised for this use do not yet exist. If the active substance approval has already been granted, applications for approval must then be submitted for the continued marketability of the masks, and only in this procedure is the virucidal effect of the coverings concretely evaluated.
During the evaluation process, the use of the above-mentioned substances for the treatment of textiles is generally permitted from a biocidal law point of view, although efficacy and safety have not yet been officially tested. In some cases, the effect on the human body may be controversial or not sufficiently proven. In addition, it is already known from some of these substances that they can pose further health risks, e.g. by being carcinogenic or skin sensitizing. However, basic product safety requirements apply. According to this, such masks must both have the claimed protective effect and be safe, i.e. the substances contained must not pose any risks to human health. The manufacturer must ensure that this is the case.
Respirators, mouth-nose coverings, etc. have direct contact with the body and are also by definition in the air flow of the inhaled air. This body-hugging use must be given special consideration when using and evaluating virucidally equipped masks. It is therefore necessary to ask whether the active ingredient remains in the mask or whether it can be released from the mask by the air flow, sweat or saliva. There is a risk that it will be absorbed by the body, regardless of the type of mask and how the active ingredient is incorporated into the mask.
From BAuA’s point of view, it cannot therefore be ruled out that parts of a biocidal active substance may detach from a mask and enter the body. This can be done through the skin, the gastrointestinal tract as well as through the respiratory tract. A precise assessment of the risk is not possible on the part of BAuA at the present time. Nevertheless, an increased health risk can be assumed when using biocidal active substances in protective masks or mouth-nose coverings. It should also be noted that the contact time of the viruses in the inhaled air with the virucidal coating is likely to be too short to be efficient and effective.
Since the benefit of a virucidal/antiviral treatment of masks has not yet been proven, nor has their safety been officially verified, BAuA refrains from recommending the use of such masks.
Further information can be found in the FAQ “How are protective masks with or without biocidal equipment legally classified?”
FAQ-No.: PSA021Which goggles should be used in connection with SARS-CoV-2 in healthcare?
The recommendations can be found in TRBA 255
FAQ-No.: 0020Which respirators protect against SARS-CoV-2?
EN 149 Respiratory protective devices – Filtering half masks for protection against particles – Requirements, testing, marking; German version EN 149:2001+A1:2009 divides the particle-filtering half masks into the three device classes FFP1, FFP2 and FFP3. Masks from class FFP2 protect against CMR substances (substances that are carcinogenic, mutagenic, toxic to reproduction) and radioactive substances as well as airborne biological agents classified in risk group III. The Robert Koch Institute and the Working Committee on Biological Agents recommend that FFP2 masks or respiratory protection be worn preferentially when working with SARS-CoV-2.
An overview of the different types of masks and respiratory protection, their level of protection and areas of application can be found here.
Further information on respiratory protection is summarized in DGUV Regulation 112-190 “Use of respiratory protective devices”:
https://publikationen.dguv.de/widgets/pdf/download/article/1011
Masks that are marketable in the United States of America, Canada, Australia or Japan can also be regarded as marketable in Germany in accordance with Medical Supplies Ordinance – MedBVSV if they do not bear the CE marking, are not accompanied by proof of conformity or German operating instructions. If the marketability for one of the aforementioned countries is not available, it must be checked on a case-by-case basis, e.g. by a notified body, whether the masks meet the EU protection standards. The regulations of the MedBVSV currently apply until 25 November 2022.
Please note that plagiarism or counterfeit protective masks of reduced quality are still placed on the market!
Marking of masks from USA, Canada, Australia/New Zealand, Japan, China and Korea (PDF, 409 KB)
FAQ-No: PSA001Is there an overview of the use of mouth-nose coverings, medical face masks and respirators? How long can FFP2/FFP3 masks be worn without interruption? How long must the recovery period be after wearing?
In principle, but also against the background of an epidemic, the employer must review the defined measures of occupational infection protection. The basis for this is the updating of the risk assessment. In general, the TOP principle applies (technical protective measures take precedence over organizational ones, which in turn take precedence over personal protection measures). Accordingly, measures to reduce hazards at the workplace should only be taken in the last instance in the form of personal protective equipment (PPE). If, however, the risk assessment shows that employees must be provided with respiratory protection as personal protective equipment, e.g. in the form of FFP2/FFP3 masks, measures must be taken to avoid overuse of the wearer.
The strain of wearing FFP masks is caused by breathing resistance during inhalation and exhalation, which leads to increased breathing work and stress on breathing and the cardiovascular system. When assessing the load and the resulting stress, other factors must be taken into account: the severity of the work, climatic conditions, other protective equipment, spatial conditions, nature, duration and frequency of the work task and personal factors.
In order to reduce possible stress, breaks or recovery periods should be provided during which no mask is worn. The recovery period does not exclude other activities with light physical work. Irrespective of this, the break regulations according to the Working Hours Act (ArbZG) must be observed.
With occupational medical support, a graduated procedure for measuring the wearing time is always recommended on the basis of a risk assessment. Specifications for a fixed gestation time limit are not recommended, and instead reference is made to specifications for specific activities and the required risk assessment.