As long as coronavirus is around, the market for mouth and nose protection will continue to grow worldwide. An increasing number of textile manufacturers are serving the “community masks” market segment and, of course, the masks that are used in the medical field as well. A critical look at the plethora of offerings gives the impression that claims of a product's “antiviral” properties are sometimes made very loosely. This is risky for several reasons:
- There is the threat of fines in countries with clear specifications on the use of antiviral advertising claims
- Item complaints
- Debacle on social media channels
- Damage to the product brand and company's reputation.
- Financial losses
We would like to use this situation as an opportunity to remind you of the regulatory stipulations and country-specific requirements for antimicrobial and antiviral treatment of textiles and polymers that offer secure protection against SARS CoV-2.
As a minimum requirement, the utilized additives must have an officially certified antiviral effect, as is the case with SANITIZED AG products, e.g., tested according to ISO 18184 or ISO 21702.
Tests on the final product are crucial
However, the certified antiviral property of the additive cannot be automatically transferred to the final product, i.e. the mouth and nose protection, the clothing, or the polymer surface. The antiviral effect of the treated textile or polymer product must undergo official testing.
To this day, there are regrettably no globally uniform guidelines for the labeling of treated items offer protection against SARS CoV-2. In Europe, the provisions from the BPR (Biocidal Products Regulation) are applicable if the treated item is a “treated article”, or the provisions on “medical devices” apply if the items in question are masks or safety gear for medical personnel. In the U.S., the EPA is responsible for treated goods, and the FDA is responsible for medical products.
SANITIZED's customers are currently making very heavy use of the in-house regulatory department's expertise. They value know-how that is always up to date.
We have summarized comprehensive information in three specific regulatory guides:
Consumers have a right to product safety
That is SANITIZED's perspective and stance. This is why only officially registered biocides and additives have always been in the portfolio of the pioneer for antimicrobial hygiene function.
Apart from the finished item's tested antiviral properties, the effect's resistance to washing plays an additional, important role in product safety. Tests on the final product and the corresponding label are important.
Is nano the right technology for mouth and nose protection?
Some community mask vendors promise protection against SARS CoV-2via nano silver. But there are currently no clear research findings that prove whether and to which extent the nano particles remain in the textile or can actually enter the body via the respiratory tract. “SANITIZED has deliberately decided not to use nano technologies, and we generally do not carry it in our product range,” explains Urs Stalder, CEO of SANITIZED AG. SANITIZED indeed relies on silver and its proven effect, such as in the product Sanitized® T 11-15. This additive and Sanitized® T 99-19, which uses a patented, silane-based technology, have been officially tested as antiviral. Both products can be used for synthetic fibers and polymer coatings in the fight against the spread of SARS CoV-2.
Various polymer products made by SANITIZED also have antiviral effects, which have been tested by independent laboratories according to ISO 21702:2019.
SANITIZED makes an appeal: Take the labeling obligation seriously
Even if the rush towards mouth and nose protection that guards against SARS CoV-2 will continue, manufacturers should fully meet their labeling obligation.
Wearing mouth and nose protection makes an important contribution to stemming the coronavirus pandemic. SANITIZED supports manufacturers of masks, textiles for medical personnel, and polymer surfaces for public spaces or hospitals by providing comprehensive advising, information, and secure products against the spread of the coronavirus. And it is all responsibly, reputably, and safely based on our 85 years of experience and expertise in the field of antimicrobial active ingredients.
Please contact us for further questions.
To the Regulatory Guides: