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.


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.


Stay up-to-date

We use your email address exclusively for sending our newsletter. You have the right to revoke your consent at any time with effect for the future. For further information, please refer to our privacy policy.