The EU Reg. 2016/425 - published in the OJ on 31 March 2016 - concerns personal protective equipment (PPE). The new Regulation applies from April 21, 2018 and has a strong impact on companies in the optical sector that produce and/or import and distribute sunglasses (or related lenses and frames). Let's look at how this new Regulation came about and what are its new aspects.

Personal protective equipment has been regulated since the 80s by Dir 89/686/CEE, which belongs to the so-called New Approach Directives. This directive was then implemented in Italy with Legislative Decree 475/92.

At the end of the 2000s, with the aim of aligning all the New Approach Directives with the New Legislative Framework, the Community legislator revised the directive 89/868/EEC and issued the EU Reg 2016/425 in 2016.

The changes are relevant. First of all it is important to specify that the chosen legal instrument is a Regulation: it is therefore a directly applicable act that does not need implementation at a national level. In other words, what is written in the Regulation is already law today.

Undoubtedly, the Regulation has a stronger impact on economic operators. With the aim of making the whole supply chain responsible and increasing the post-marketing surveillance procedures, the Regulation provides for much more precise obligations not only for manufacturers but also for importers and distributors.

The manufacturer carries - as in all product-related directives - all the obligations relating to the full compliance of the product with the discipline, as well as the obligation to guarantee this compliance for the whole life of the product. The changes particularly concern the obligations of importers and distributors, which are very numerous in Italy.

Article 10 of the EU Reg. 2016/425 establishes that importers are required to carry out a series of checks on the correct application of the Regulation by the manufacturer. More precisely they must ascertain that the manufacturer has carried out an adequate conformity assessment procedure, ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the CE marking, that it is accompanied by the required documents and also that the manufacturer has met the requirements of Article 8, paragraphs 5 and 6.

An importer who has reason to believe that a PPE does not comply with the applicable essential health and safety requirements set out in Annex II, shall not place it on the market until it has been brought into conformity. Furthermore, if the PPE presents a risk, the importer must inform the manufacturer and the market surveillance authorities ". In addition, importers, such as manufacturers, ensure that the PPE is accompanied by the instructions and information referred to in point 1.4 of Annex II, and where they consider or have reason to believe that a PPE which they have placed on the market is not in conformity with this Regulation, they immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken”.

The distributor, in turn, when making PPE available on the market (Article 11), is required to verify that it bears the CE marking, that it is accompanied by the required documents, by instructions in a comprehensible language (depends on the country where it is marketed) and that the instructions or packaging bears the name of the manufacturer/ importer and a batch or serial number which allows identification.

In addition, any distributor who considers or has reason to believe that a PPE does not comply with the applicable essential health and safety requirements set out in Annex II, shall not make it available on the market until it has been brought into conformity. If the PPE presents a risk, the distributor must inform the manufacturer or importer and the market surveillance authorities.

As specified above, the contents of EU Reg. 2016/425 are directly applicable (and can not be modified by Member States). With the Italian law n. 163/2017 the government was delegated to issue the provisions that will allow the Italian legal system to move from Legislative Decree 475/92 to the Regulation, as well as to to lay down the related sanctions. It is nonetheless true that on April 21st the new discipline will become fully effective.