IMPORTANT INFORMATION

EU MARKETING REPORT KN95 MASKS AS FFP2

On April 23, the Ministry of Industry, Commerce and Tourism issued a resolution in which it allowed the use and commercialization of KN95 masks due to the shortage of Personal Protective Equipment (PPE)[1] from that moment.

The Association of Individual Protective Equipment Companies (ASEPAL) warns that the extraordinary commercialization of PPE without CE marking ends on December 31, 2020. “As of January 1, 2021, the only legislation applicable to PPE will be the Regulation ( EU) 2016/425, and the commercialization of PPE without CE marking will be outside the law. Therefore, as of January 1, 2021, only PPE bearing the CE mark should be marketed and purchased ”.

Therefore, KN95 masks are no longer a product approved for marketing in the European Union and only masks of this type that have the European Conformity (CE) marking may be sold.

 

1. Differences between KN95 masks and FFP2 masks.

 

Filtering Facepiece Respirators (FFRs) are subject to various regulatory standards around the world. The performance standards are as follows:

  • For KN95 (China GB2626-2006); Y
  • For FFP2 (Europe EN 149: 2001 + A1: 2009 on respiratory protection devices).

 

The key technical requirements established by each standard to try to establish an equivalence between both masks are detailed below, published by the Ministry of Labor and Social Economy.

 

The requirements and test methods are similar, but not the same for KN95 and FFP2, so a KN95 mask may not meet the quality standards of an FFP2 mask. This does not exclude that, some KN95 have similar characteristics to FFP2 and are capable of being validated and homologated as FFP2.

 

 2. Certification process-CE marking.

 

As of January 1, 2021, KN95 masks are approved as an approved product, and therefore, as warned by the Organization of Consumers and Users (OCU) "KN95 self-filtering masks that are considered equivalent to FFP2 can only be marketed if they have the CE marking in order".

Regarding the CE marking process, the European Safety Federation (EFS) collects in its publication of January 18, 2021, how protective masks (FFP2) are category III PPE in accordance with Regulation (EU) 2016/425.

“This means that the conformity assessment includes a type examination by a Notified Body, leading to an 'EU type examination certificate', as well as production monitoring by a notified body (controls random or system audit). This results in the CE marking with the number of the notified body responsible for monitoring production together with the CE marking. The manufacturer is obliged to issue the EU Declaration of Conformity, which must accompany the PPE, together with the instructions for use. "

Consequently, according to Regulation (EU) 2016/425[2] An EU-type Exam is carried out, included in Annex V of the Regulation as Module B. It must be issued by a Notified Body (ON) from those listed in the NANDO database.     

The NANDO database (New Approach Notified and Designated Organizations) is an official information system of the EU in which the NO are collected and it includes the identification number of each notified body, as well as the tasks for the that has been notified, and are subject to regular updating.

To obtain the homologation of the FFP2 masks, favorable tests must be obtained with an ON, applying the test methods of the UNE EN 149: 2001 + A1: 2009 Standard, of this module B and also, be complemented with one of the following two:

  • conformity to type based on internal production control plus supervised product control at random intervals (module C2, annex VII of Regulation (EU) 2016/425).
  • conformity to type based on quality assurance of the production process (module D, annex VIII of Regulation (EU) 2016/425).

The choice of conformity with one or the other is the choice of the PPE manufacturer, although the module with the highest quality requirements is C2, since the ON carries out a supervised control of the manufactured product at intervals.

3. Marketing of KN95s in Europe.

Finally, as a conclusion, if you want to import and market a KN95 mask in the EU, they must be tested under the requirements and standards of European regulations (UNE EN 149: 2001 + A1: 2009) before being introduced in the European market, and if they comply with the standards, the ON will issue an EU Type Certificate and a C2 module certificate and they can be marketed in the EU as FFP2 masks.

In this case, the masks would have a double certification, KN95 in origin (China) and FFP2 at European level.

Below we attach the CE certificate:

[1] Provision 4651 of BOE no. 115 of 2020

[2] REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of March 9, 2016 - relative to personal protective equipment and repealing Council Directive 89/686 / EEC (boe.es)