what to do when importing PPE (e.g. FFP2 masks) to the EU ?
remark : this article is valid for Personal Protective Equipment (PPE), such as protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc. The rules for medical devices (e.g. medical or surgical masks) are different and for those you should seek information from the relevant trade associations or authorities.
PPE made available on the EU (including EFTA/EEA) market must be in conformity with the applicable EU legislation. For PPE that is the Regulation (EU) 2016/425. Depending on the type of PPE and the intended purpose, also other legislation might be applicable (e.g. REACH is always applicable). This is still valid during the COVID-19 health crisis.
The COVID-19 crisis does not change the fact that PPE must be safe for the wearer, nor that the PPE must protect the wearer as claimed by the manufacturer. Even if some deviations of the conformity assessment procedures are made possible with the Commission Recommendation 2020/403, the essential health and safety requirements for PPE can under no condition be ignored. For more information on this specific aspect, see the page “exceptions to the conformity assessment rules for PPE”.
In the PPE Regulation, obligations for different economic operators are included (see chapter II of the Regulation) :
- The manufacturer is always responsible for the conformity assessment of the product. He has to follow the foreseen conformity assessment procedure, depending on the category of the PPE. For more info on the conformity assessment, see article “conformity assessment procedure for PPE”.
For the complete list of obligations of manufacturers, see article 8 of the PPE Regulation.
- The importer has several obligations (article 10 of the PPE Regulation).
First of all : importers shall only place compliant PPE on the market. To be able to do that, a minimal knowledge of the PPE legislation is necessary. This is more than knowing that there must be a CE mark on the product.
To be sure of that, importers shall, before placing the PPE on the market, check that the manufacturer, based outside the EU, has performed the correct conformity assessment procedure and fulfilled the obligations on marking and documents. The first thing to check is the availability and content of the Declaration of Conformity. It makes also sense to check that the information included in the Declaration of Conformity on the Notified Body responsible for the Type Examination (certification) and also the one for the production follow-up is correct. Asking for a copy of the certificate and the test reports is a way of doing this.
If an importer has reasons to believe the PPE is not in conformity with the EU legislation, he shall not place the product on the market.
Importers shall also indicate their name and address on the PPE (or at least on the packaging).
Importers must make sure that the required documents accompany the product (i.e. user instructions and Declaration of Conformity) and this in the necessary language(s).
For the complete list of obligations of importers, see article 10 of the PPE Regulation
- Also distributors of PPE have obligations described in the PPE Regulation. They have to check if the CE marking is on the product and that the required documents accompany the product in the necessary language(s).
For the complete list of obligations of distributors, see article 11 of the PPE Regulation
See also guidance document "How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used - also in the COVID-19 context" published by the EU Commission. Further information on the EU PPE Regulation is available on the PPE webpage of the EU Commission DG GROW.