Personal protective equipment (ppe) and ce marking

dispositivi di protezione individuale

The use of a specific type of personal protective equipment (PPE) in a workplace is stated in several legislations, both Italian and European, which can also force workers to use it, if some risk factors cannot be avoided or reduced by prevention or common protection means.

Two regulatory references define all the activities related to PPE design, manufacture and placing on the market in Italy: the Regulation (EU) 2016/425 and the Italian legislative decree N°17 of February 19th, 2019. In the latter some aspects not detailed in the Regulation, such as sanctions and burdens for the economic operator, who does not respect law requirements, have been established.

The PPE definition reported in the Regulation specifies that it is an “equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety”.

A PPE manufacturer must necessarily carry out the applicable conformity assessment procedure, on the basis of the technical documentation drawn up, or have it carried out. Once the conformity is demonstrated, the manufacturer draws up the EU Declaration of Conformity and affixes the CE mark to the PPE (if the operation is not possible, the CE mark is affixed to the packaging or to the accompanying documents). When PPE belongs to category III (such as FFP2 and FFP3 type masks), it is necessary that a third-party entity, the Notified Body (NB), verifies the conformity of the PPE under study. If the result of the evaluation is positive, the NB will release an approval certificate and have its identification number affixed to the PPE next to the CE mark. The Regulation (EU) 2016/425 states that all PPEs must be CE marked before placing them on the European market.

However, the present pandemic, afflicting Europe and the entire world, drove the European Commission to publish the Recommendation (EU) 2020/403. This recommendation, intended to favour the matching of the offer in both the PPE and the medical devices (MDs) field, ask the NBs to give precedence to the evaluation of PPEs useful against the pandemic (such as FFP2 and FFP3 type masks), and to follow the recommendations given by the World Health Organization (WHO) in the evaluation of PPEs, whose conformity has been demonstrated by means of non harmonized technical standards (i.e. different from the standards approved by UE). According to these statements, some Nbs could release “ad hoc” certificates, lasting only until the end of the pandemic and with limitations in the use.

Morevoer, the Recommendation (EU) 2020/403 gives to the Member States the possibility to authorize the placing on the market of non CE marked PPEs, which however guarantee an adequate level in terms of health and safety. In this context, Italy has defined a “derogation procedure” for PPEs, that provides for an evaluation process performed by the Istituto Nazionale per la prevenzione contro gli infortuni sul lavoro (INAIL).

Placing on the market and making available on the market PPEs without the CE marking will be possible only until the end of the pandemic, but only if the PPEs got the authorization of the INAIL.

Written by: Daniele Scarpino