The current crisis situation has resulted in huge demand for respiratory masks. Yet the task of importing such masks involves a complicated procedure. As a result, some products have entered the European market that do not deliver what they promise, as can be seen in the latest reports on the RAPEX list.
RAPEX stands for the European rapid alert system providing for dangerous and non-marketable products to be listed – often resulting in the relevant products having to be recalled.
In order to ensure that imports proceed smoothly, a few important points need to be considered. TMK Retail Service & Consulting GmbH emphasises that it is essential to distinguish between three different categories of masks:
Personal protective equipment, PPE (FFP class masks for protection against fine dust and other particles)
In order to be allowed to sell masks of the PPE category, a (type) test by a notified body is required, which then also confirms conformity with all relevant directives and regulations required for CE marking. The testing of masks of all FFP classes is carried out according to the European standard EN 149:2001 + A1: 2009.
Masks of class KN95, tested according to the Chinese standard GB 2626-2006, are roughly equivalent and are very likely to pass this test. However, they are still required to undergo the normal EU conformity procedure for FFP masks.
TMK can tell you how to arrange for such testing and what additional requirements your product must meet after a review of your documentation and artwork.
Simple medical products, Mouth and Nose Covers category 1 (surgical masks, non-sterile)
In contrast, simple non-sterile surgical masks only require testing according to EN 14683 followed by the CE conformity procedure in order to be marketable.
“Community masks” Mouth and Nose Covers (degree of efficiency not confirmed, considered to be textile products)
In contrast, community masks are only considered to be “items of clothing” or “garments” and must be tested and labelled accordingly - in this case, with the textile labelling according to the Textile Labelling Regulation. In addition, no protective effect may be promised for these.
Irrespective of the mask types, the following must always be observed: In order to ensure chemical safety, the REACh Regulation must be observed and complied with, for instance. Due to skin contact, special care is required when testing for polyaromatic hydrocarbons (PAHs).
Boris Berndt at TMK will be pleased to answer your questions; please phone +49/40/54090410-8 or send an e-mail message to email@example.com.