EU Pro­duct Safe­ty Regu­la­ti­on update

Find out here what manu­fac­tu­r­ers can expect.

The EU Coun­cil has par­ti­al­ly toned down the Commission’s pro­po­sal, but has also added fur­ther obligations. 

As ear­ly as June 2021, the EU Com­mis­si­on published its pro­po­sal to revi­se Pro­duct Safe­ty Direc­ti­ve 2001/95/EC. The Direc­ti­ve pur­sues the goal of updating the legal frame­work for the safe­ty of non-food pro­ducts for con­su­mers and adap­ting the legal frame­work to the spe­ci­fic chal­lenges of new tech­no­lo­gies and busi­ness models. Howe­ver, this desi­re for Europe-wide stan­dar­di­s­a­ti­on, irre­spec­ti­ve of any natio­nal pecu­lia­ri­ties, leads to dubio­us deve­lo­p­ments for pro­duct safe­ty law.

The Council’s draft did defu­se the Commission’s draft in some respects: 

For exam­p­le, the defi­ni­ti­on of “secu­re pro­duct” was modi­fied, which ori­gi­nal­ly sti­pu­la­ted that pro­ducts had to be desi­gned secu­re­ly even for the case of abu­si­ve user beha­vi­or. This defi­ni­ti­on has been dele­ted in line with the pre­vious under­stan­ding that to attain the safe­ty of its pro­duct, a manu­fac­tu­rer need “only” anti­ci­pa­te inten­ded use and reason­ab­ly fore­seeable use, not misu­se, and take this into account in design and con­s­truc­tion. This dele­ti­on is to be wel­co­med, as it could have led to a lia­bi­li­ty risk for com­pa­nies that could hard­ly be contained.

In addi­ti­on, the mini­mum maxi­mum penal­ty of four per­cent of annu­al tur­no­ver for inf­rin­ge­ments was also dele­ted by the Coun­cil, with the result that the level of sanc­tions remains at the dis­cre­ti­on of the mem­ber sta­te aut­ho­ri­ties and is sub­ject to the prin­ci­ple of proportionality.

In addi­ti­on, the fol­lo­wing chan­ges, which are worth not­ing from our point of view, made requi­re­ments more stringent:

New obli­ga­ti­ons of eco­no­mic ope­ra­tors in the event of accidents 

The obli­ga­ti­on to report an acci­dent cau­sed by a pro­duct has been given a new and wel­co­me thres­hold by the pro­po­sal of the EU Coun­cil. Now, the­re is an obli­ga­ti­on to noti­fy the mar­ket sur­veil­lan­ce aut­ho­ri­ties only if the­re are “inci­dents rela­ted to the use of a pro­duct that have resul­ted in the death of a per­son or serious, per­ma­nent or tem­po­ra­ry impair­ment of his or her health and safe­ty, inclu­ding inju­ries, other bodi­ly harm, dise­a­ses or chro­nic dama­ge to health.” The­re was no such limi­ta­ti­on in the Commission’s proposal.

The dead­line for sub­mit­ting a report has also been eased. The noti­fi­ca­ti­on requi­re­ment of two working days (!) from the date know­ledge has been obtai­ned, as envi­sa­ged in the EU Commission’s pro­po­sal com­ple­te­ly inde­pen­dent of any ongo­ing root cau­se ana­ly­ses, has now been sof­ten­ed to the effect that such noti­fi­ca­ti­on must be made “wit­hout undue delay”, i.e. wit­hout a spe­ci­fic time limit.

Howe­ver, the EU Commission’s pro­po­sal con­ta­ins a sepa­ra­te obli­ga­ti­on for ope­ra­tors of online mar­ket­places. They must imme­dia­te­ly report any acci­dent of which they beco­me awa­re that “results in a serious hazard or actu­al harm to the health or safe­ty of a con­su­mer cau­sed by a pro­duct offe­red in their mar­ket­place.” Thus, unli­ke the scope of Mar­ket Sur­veil­lan­ce Regu­la­ti­on (EU) 2019/1020, online trade will be equip­ped with its own moni­to­ring and noti­fi­ca­ti­on requi­re­ments with the aim of fur­ther cur­bing trade in non-compliant pro­ducts on the EU market.

Uni­form requi­re­ments for pro­duct recalls

Euro­pean legis­la­tors have set them­sel­ves the fur­ther goal of making par­ti­ci­pa­ti­on in recall mea­su­res more attrac­ti­ve for con­su­mers as well, and will be rely­ing on a stan­dar­di­sed approach in the future.

In our view, legis­la­tors fail to reco­g­ni­se here that best prac­ti­ce pro­ce­du­res for recalls have alre­a­dy been estab­lished for the respec­ti­ve pro­duct types. Howe­ver, stan­dar­di­sing hazard pre­ven­ti­on mea­su­res for each type of pro­duct and each type of risk is not likely to make mea­su­res more effec­ti­ve, but rather, in cases of doubt, to lead to over­kill and go far bey­ond what can also be requi­red under admi­nis­tra­ti­ve law in accordance with the prin­ci­ple of proportionality.

In addi­ti­on, manu­fac­tu­r­ers should be able to access stored cus­to­mer data in the event of a recall and also noti­fy con­su­mers via the­se chan­nels in the cour­se of a recall, also wit­hout undue delay. In addi­ti­on, manu­fac­tu­r­ers are requi­red to use other chan­nels to issue a war­ning or com­mu­ni­ca­te a recall – such as the company’s own web­site or social media. In addi­ti­on, manu­fac­tu­r­ers are to be pro­hi­bi­ted from using tri­via­li­sing terms such as “vol­un­t­a­ry”, “pre­cau­tio­na­ry”, or even “in rare/specific cases”, as the­se terms are likely to mis­lead con­su­mers about the urgen­cy of a mea­su­re. This logic is not new, but was alre­a­dy found in a 2021 EU Com­mis­si­on gui­de to effec­ti­ve recall design.

Fur­ther, manu­fac­tu­r­ers must offer affec­ted con­su­mers at least two effec­ti­ve, free, and time­ly reme­dies. The type of reme­dy this must be is also spe­ci­fied by Euro­pean legis­la­tors: repair, repla­ce­ment of the recal­led pro­duct, and/or reim­bur­se­ment of the value of the recal­led pro­duct. In this regard, the Regu­la­ti­on spe­ci­fies that the amount to be refun­ded should be at least equal to the pri­ce paid by the con­su­mer. Howe­ver, the­se requi­re­ments, which are inten­ded to crea­te an incen­ti­ve for con­su­mers to par­ti­ci­pa­te in a recall and con­tri­bu­te to its effec­ti­ve­ness, bla­tant­ly com­pe­te with natio­nal­ly appli­ca­ble war­ran­ty law and can­not be recon­ci­led with it, at least from the per­spec­ti­ve of Ger­man natio­nal legis­la­ti­on and legal rulings.

Con­clu­si­on

The EU Council’s Decem­ber 2022 pro­po­sal for the new EU Pro­duct Safe­ty Regu­la­ti­on soli­di­fies the direc­tion that new Euro­pean pro­duct safe­ty law is taking. It is now time for com­pa­nies to beco­me awa­re of the new requi­re­ments that are likely to come and to prepa­re accor­din­gly. In con­trast to the Pro­duct Safe­ty Direc­ti­ve (Direc­ti­ve 2001/95/EC), which is curr­ent­ly still in force and as such requi­red a trans­for­ma­ti­on act into natio­nal law, all eco­no­mic ope­ra­tors must app­ly the pro­vi­si­ons of the future Pro­duct Safe­ty Regu­la­ti­on direct­ly as appli­ca­ble law. A final ver­si­on adopted by the EU Par­lia­ment and again by the EU Coun­cil can pro­ba­b­ly be expec­ted as ear­ly as the second quar­ter of 2023 with an imple­men­ta­ti­on peri­od for eco­no­mic ope­ra­tors of 18 months.

In our view, the­re is curr­ent­ly still con­sidera­ble need for adjus­t­ment. We will report on fur­ther developments.

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