FFp2 Masks - Let's do some clarity!
Over 97 of the applications submitted to Inail for thela
validation, according to the safety requirements, of
masks, goggles, half-mask visors, gloves e
shoes, had been rejected during the first phase. In
just over a month, from the start of the procedurei
validation, at the central offices of Inail in Rome areo
1,700 cases were examined, of these only 62
they have successfully passed the tests. In this listing
there is a company in our group which has obtained lok’ok
by the technical-scientific committee of the Instituteo
central: it is the Fin Group Safety Division of Cividate Al
Piano, which also got the month of June
a further validation. It seems important, aa
a few months after the beginning of the emergencyza
COVID 19, especially for work activities, in which
users must be equipped with the devices
suitable individual protective type maskso
FFP2 or FFP3, take stock of the situation. Indeedi
during the initial phase of the pandemic the market is
been invaded by hundreds of companies that have
improvised distributors, offering products that
they have also printed misleading CE marks. ButMa
to try to shed some light on thesei
articles, which by their nature of protection thata
of the respiratory tract, are considered thirda
category, i.e. with the highest standards,
let's take stock of the situation, starting from
before the emergency. On the market there wereno
masks mostly imported from non-EU countries,),
but that they followed all the procedures that each
importer must normally do, that is
submit them to certification by an Accredited Body that
authorized to print his own code
identifier next to the CE marking, a code
this one of four digits, for example CE 1234, where i
numbers represent the identity card of the entitye
who checks them annually. This procedure
on average it takes at least four months.
With the Covid emergency, faced with the need fori
have these products immediately available in
large quantities, importers had to search
mainly on the Chinese market, new suppliers
with products not yet certified according to i
European regulations on PPE. For this reason the
law decree number 18 of last March 17 has
delegated to validation, for devices of
individual protection FFP2, FFP3 masks3)
Inail, while at the Istituto Superiore di Sanità forer
surgical ones such as medical devices. Therefore
at INAIL must be subjected to validatione
masks without the CE mark. Caution
however, that the CE marking without the codes
identification of the Entity authorized as abovera
specified, constitute a markinga
fraudulent, and it is a deceptive method of doing
believe those who buy them that they are in order. To this
this is reported by numerous inspectors of
Notified Bodies, which are in circulation thousands of
false certifications, often of entities that with the
masks have nothing to do therefore
it is essential to check when purchasing
first of all if the CE marked products have i
requirements listed above, and in the case of masks
without this marking that the supplier to whom you are
addresses has obtained validation from Inail, listo
which can be consulted directly on the website www.inail.it.
We asked an expert, who provided us with the
regulatory references to draw up our investigation
what do you think of the situation of chaos that has arisen
to create, it is Stefano Galimberti in charge
of the PPE certification sector of one of the major bodies
Europeans: Certainly import and distribute thesei
products cannot be entrusted to improvisation..
They are in fact individual protective devices
which must ensure the safety of workers, forr
risks that can have huge consequences
serious For this reason it is essential to contact
specialized companies that are able to offer
also a product that can be used in
safety. In fact from some checks we are
doing, it appears that some products passed off as
FFP2 don't even reach performance
provided for class FFP 1 which is the minimum
required by the reference standard EN 149..
