The corona crisis has led to a significant increase in global demand for face masks and the emergence of a large number of new manufacturers who have not certified their products but want to enter the European market as soon as possible.
The sale of protective masks requires proof of the relevant documentation of the masks – the technical properties, quality, documents, and product labeling of FFP2 and FFP3 masks must comply with the requirements of the European Union.
However, a large number of new providers have entered the market with certificates or product markings that are incomplete or even forged.
According to the law, masks must be inspected and approved by the relevant European Union body.
At present, more than thirty accredited laboratories in the European Union issue certificates of conformity for face masks in the European Union. FFP2 and FFP3 masks sold in Estonia must have a certificate of conformity, which proves both passing the assessment and compliance with the quality requirements.
The masks must also bear the CE marking required by the European Union, which can be used to identify the origin and manufacturer of the masks. This means that even products that meet the technical quality requirements and are certified may find it impossible to sell masks in the European Union due to insufficient product labeling.
Exceptions are possible
Due to the lack of personal protective equipment, it is possible to escape the documentation requirements if the masks are not sold to the general public but are used only by medical professionals or government agencies.
In this case, the masks must comply with the technical requirements, but the so-called simplified procedure applies when passing the conformity assessment. In this case, it is determined whether the masks meet the technical characteristics and safety requirements.
When granting an exemption, a letter of confirmation is required from both the supplier and the purchasing medical institution that the imported masks will be used by healthcare professionals and will not be sold to consumers.
However, there have also been a number of public procurements for masks sent to medical institutions, where the masks turn out to be far from meeting the required quality and do not provide the necessary safety for front-line workers.
Manufacturers who were involved in the production of personal protective equipment before the crisis are probably best equipped to ensure compliance with EU quality and documentation requirements. The production and delivery processes of experienced manufacturers are already in place and the right certificates have been obtained before the pandemic broke out. However, the industry that has operated so far is unable to keep pace with the explosive growth in global demand.
In any case, care must be taken when buying masks, as high demand has led to an increase in those who try to market protective equipment with insufficient documentation or, in the worst case, insufficient safety qualities.« Back to articles