Surgical masks

How to recognize if a mask is surgical?

The packaging must show the reference standard, the type, and the company name of the manufacturer. This is a self-declaration by the manufacturer, under their own responsibility, that the product complies with the standard. If the manufacturer is outside the EU (e.g. China), they must sign a private agreement with a company based in Europe. In this agreement, they appoint the company as their European representative; the packaging must display the representative’s company name. In addition, the company name and address of the importer must be indicated, if different from the European representative. The European representative assumes responsibility within the EU, including Italy.

What are the most common cases of counterfeiting and how to protect yourself?

• Missing information on the manufacturer’s company name, the standard, and the type on the packaging. Missing indication of the full address of the European representative and importer. This can easily be checked on the packaging.
• Non-existent European representative. The company indicated as the European representative does not exist. In EU countries it is generally possible to check business registers to verify if a company exists. Alternatively, a quick check is to search the representative’s company name on Google; if nothing appears, it is advisable to request clarification. Same applies to the importer.
• Self-declaration that does not correspond to actual compliance with the standard. This is the hardest to detect: the only way is to have the masks tested in a laboratory. It is not free — it costs several thousand euros and takes several weeks for results. This is what the US administration did in May: after receiving China’s whitelist of certified producers, it collected samples from each factory and independently tested them. 65% were non-compliant. At the same time, some Italian masks with Italian self-certification were also found non-compliant.

Is a mask without registration with the Ministry of Health (no RDM code) non-compliant?
Registration of medical devices in the Ministry of Health database is allowed but not mandatory for products made outside the EU. The Ministry receives the registration but does not perform prior checks; the registration is not validated by the Ministry.

Is a mask without Farmadati (Minsan–Paraf) code non-compliant?
Registration in the Farmadati database is not mandatory; it helps pharmacies manage medical and non-medical devices and facilitates tax deductions for private buyers. Farmadati receives the registration but performs no prior checks; the registration is not validated.

FFP2 Masks

How to recognize whether a mask is FFP1, FFP2, or FFP3?

On the market there are CE-marked products and non-marked products.

CE-marked products — What are the most common cases of counterfeiting and how to protect yourself?
A premise is needed: a product can be CE-certified only by a notified body authorized for the specific standard. The certification is printed on the product and on the packaging and shows CE xxxx, where xxxx is the identification number of the notified body. Standard UNI EN 149:2001+A1:2009 is part of the family of regulations grouped under EU 2016/425. The list of the notified bodies for EU 2016/425 can be consulted online here.

To verify whether a notified body is authorized for UNI EN 149:2001+A1:2009, you must click on the organization’s link and check whether it is authorized for Equipment providing respiratory system protection. After verifying the body’s authorization, you must ensure that the certificate is not fake — meaning CE marking is not being printed without authorization. To do this, each notified body usually has an open database on its website to verify certificates.
You must therefore examine a copy of the CE certificate that the seller must hold and verify on the notified body’s website whether the certificate is legitimate. In rare cases, not all notified bodies have a public database: in this situation it is necessary to send the certificate to the notified body and wait for their confirmation.
FFP1, FFP2 and FFP3 without CE marking manufactured under DL18. In this case, they will not carry the CE mark, but they must have explicit validation from Inail.
If they have it, they can be sold as PPE (personal protective equipment).
Inail requires a self-declaration, meaning that a company may have declared itself compliant with 149:2001+A1:2009 and Inail may have approved based on that declaration of responsibility.

How to verify actual compliance — Verifying real compliance is not quick, but it is possible. The first step is to request the test reports underlying the self-declaration. If they are missing, it is obvious that the product is not compliant — there is no reason to hide them. If they exist, you must verify that they are: complete (according to the cited standard), successfully passed (according to the cited standard), actually referring to the declared product (under a quality system), not forged (verify with the issuing laboratory), issued by a laboratory authorized to issue them (to be verified with the higher authority and with the laws regulating this in the issuing country).

Although this sounds complicated, in practice it is rare to reach the end of the verification process, because problems usually emerge in the early steps. For example:

• The certification refers to a different standard, such as GB2626, which is not equivalent.
• The test reports contain nonsense, such as “passed valve test” for a mask that does not have a valve.
• The laboratory is Chinese and not authorized for EN 149:2001+A1:2009. Few Chinese laboratories are authorized; the list is available online on the CNAS (China National Accreditation Service for Conformity Assessment) website.

Even today, some FFP2 masks on the market — including on important platforms such as Amazon — are not compliant, including some approved by Inail based on self-certifications.

KN95 Masks

What are KN95 masks? Are KN95 masks FFP2?

KN95 masks are a type of mask regulated by a Chinese standard, GB2626-2006, which regulates 14 different types of masks, including KN95.
There is a lot of inaccurate information circulating about the GB2626-2006 standard and about KN95 masks, mostly arising from a 3M document from January 2020 which led those who read it superficially to believe that FFP2 and KN95 are equivalent.

Why are they not equivalent? For two reasons:

• For KN95 masks, filtration capacity against particles is not required: “N” literally stands for “Non particle filtration”. It would be more appropriate to compare them with KP95 masks, where “P” stands for “Particle filtration”.
• GB2626-2006 is a self-certification by the Chinese manufacturer. It is not subject to certification by a notified body that monitors production, as explained in the part relating to FFP2 masks.

China has 9 different standards for masks:

1. GB 19083-2010 medical protective masks
2. YY 0469-2011 surgical masks
3. YY T0969-2013 disposable medical masks
4. GB 2626-2006 non-powered non-medical protective respirators (PFE >=95%)
5. GB 15979-2002 hygiene standard for single-use medical devices
6. T/CTCA 1-2019 PM2.5 protective respirators
7. T/CTCA 7-2019 ordinary protective respirators (PFE >= 80%)
8. GB/T 32610-2016 daily protective masks (national standard)
9. T/GDBX 025-2020 daily protective masks (additional standard for the Guangdong region, issued on 20 March 2020)

Some standards are recommended (in the sense that the manufacturer should comply with them but is not obliged to do so), others are mandatory (in the sense that the manufacturer must comply with them). GB2626-2006 is one of the mandatory standards and is the most similar, among Chinese standards, to 149:2001. However, while in Europe the mandatory standard 149:2001 for FFP2 masks is subject to certification by a notified body that monitors production, in China they are all self-certified by the manufacturer and there is no requirement for any external body to monitor production.

Alongside a certain quantity of KN95 masks illegally marked CE or FFP2, an equally significant quantity of masks marked KN95 that do not actually comply with the Chinese standard. From the point of view of European law, all these “KN95” masks are equivalent because Chinese regulations obviously do not apply on European soil. In reality these products, at least the majority of those we have been able to verify, not only do not have the characteristics needed to pass 149:2001, but are also well below the standard for GB2626-2006.

Urban legends about masks

Are the lighter test, deodorant test or confetti test reliable?

Deodorant-under-the-arm tests, confetti tests, lighter tests, mask origami… many things have been seen online. No test can replace laboratory testing, and much of what is found online is decidedly false.
Does the flame go out? It proves nothing. Does deodorant not pass through? Not enough. Do confetti stick to it? Not enough. Folding a mask on the sides to increase the seal? The effect is probably the opposite.
The effectiveness of a mask can only be measured in a laboratory according to the standards required by law.
COVID-19 has an average diameter of 0.1 microns, but it spreads through droplets — droplets we emit when breathing, talking, or coughing, and these are 3 to 10 times larger. Just as a fisherman who wants to stop sardines in his net needs the mesh to be tight enough to catch them while still letting water pass through, we need a mask made with a fabric tight enough to stop droplets, but that still allows the air we need to breathe to pass through.
The production standard is melt-blown, a synthetic polypropylene fabric to which an electrical charge is added. This electret, if properly manufactured, combines a tight but breathable structure with an electric charge that traps droplets. It is generally the middle layer of the layers that make up the most commonly available masks.

Do we need masks?

The scientific consensus circulating already in January, and which we published at the end of February, has not changed. Masks for the general population — meaning people who do not work in high-risk environments — are useful. They are useful for three things, in order of importance:

1. Avoiding self-infection
2. Encouraging social distancing
3. Reducing the risk of emitting the virus into the environment and of inhaling the airborne virus around us

The third point is the one on which the scientific debate has focused the most, and this in turn influenced political decisions which, regarding masks, were largely — and unfortunately for a long time — not the best ones. What follows is not a partisan political judgment, because in our country, as in other Western countries, no political side — neither government nor opposition — has been able to act as a proper guide in the months following the beginning of the pandemic.

• First critical decision: communicating that masks are not useful. Until early April, this was the position of Western Ministries of Health. It would have been better to say: masks are useful, they are currently not available, make them yourselves, and here is how.
• Second critical decision: the DPCM 17 of March 18, 2020 It required surgical masks and EU-standard respirators (FFP2) for all workers without first verifying availability, and in contrast with the public message of the time (that masks were unnecessary), which lasted until early April. In Italy, production of masks and respirators was non-existent at that time. The consequence was that Italy was flooded with imported Chinese masks, mostly made according to Chinese standards and therefore obviously non-compliant with European standards. As a result, they were seized in large quantities and left unused in customs warehouses across the country. It would have been better not to block them — the benefit would have been much greater than the risk.
• Third critical decision: giving Inail the responsibility of evaluating FFP2 masks without creating a control laboratory. Reaction times were incompatible with the emergency. It took about a month to evaluate a small number of masks, without laboratory tests, based solely on unverified self-certifications. It would have been better to establish a control laboratory to test as many masks as possible and publish the results.
• Fourth critical decision: from late March, expropriating imported masks. This caused a dramatic slowdown in the importation of masks. It would have been better not to do this — or, if absolutely necessary to supply healthcare workers and essential categories, to pay for the expropriated goods immediately, in order not to discourage importers. Instead, expropriations were paid two months later, severely delaying availability for ordinary people.
• Fifth critical decision: imposing a fixed price on surgical masks This was based on the assumption that Italian companies were ready to produce 660 million pieces. If you impose a price, you need to be like Apple: from tomorrow the product must be in stores, fully organized, with complete control of the supply chain. Instead, this measure further slowed imports — and for months masks were impossible to find because there were not even machines available to produce them in Italy or Europe. The two companies that Civil Protection had commissioned to produce 25 machines each had not yet finished receiving the components for the first machine. They “promised the iPhone in stores at a fixed price on April 26,” but by May 9 the welding line needed to fix the screen was still missing. It would have been better not to impose the price — the market would have adjusted itself shortly after, as indeed happened, without making masks unavailable for two months.
• Sixth correct decision: for those who do not work in high-risk environments, DIY masks are suitable. We published a scientifically based video on how to make your own mask. We did not spend several thousand euros to test these DIY masks in a laboratory, but we trust those who have done so authoritatively and with no personal interest. Protection results at 80%. If everyone always had 80% personal protection, it would be as if we reduced the R₀ index from 3 to 0.6 — a remarkable result, considering that during the first wave it took two and a half months to bring the R₀ from 3 to 0.6 in Lombardy. It is important to keep in mind that a well-made DIY mask is better than a poorly made community mask. Laboratory studies on the protective index of a very wide range of materials are available. Therefore, it is important to research properly before choosing this option.