A new Pro­duct Safe­ty Regu­la­ti­on for Europe

Advan­cing at what is a furious pace by Euro­pean stan­dards, the Com­mis­si­on, Coun­cil and Par­lia­ment agreed on a com­pro­mi­se text for the new Gene­ral Pro­duct Safe­ty Regu­la­ti­on (GPSR) In just one and a half years; adopted on 21 Decem­ber, the legis­la­ti­on pas­sed the Euro­pean Par­lia­ment on 30 March 2023. The way is now clear towards a gene­ral reform of Euro­pean pro­duct safe­ty law. What this means for Euro­pean eco­no­mic ope­ra­tors, par­ti­cu­lar­ly pro­duct manu­fac­tu­r­ers, is explai­ned in the artic­le below.


The cur­rent legis­la­ti­ve pro­cess was kicked off by a Pro­po­sal for a Regu­la­ti­on (COM/2021/346 final), published by the Euro­pean Com­mis­si­on in June 2021, which is sla­ted to replace the cur­rent Pro­duct Safe­ty Direc­ti­ve (2001/95/EC). The sta­ted goal of this new Regu­la­ti­on was to update the sta­tu­to­ry frame­work for gene­ral pro­duct safe­ty in non-food con­su­mer pro­ducts, streng­then con­su­mer pro­tec­tion and revi­se the legal frame­work so as to adapt to the spe­ci­fic chal­lenges posed by new tech­no­lo­gies and busi­ness models, inclu­ding e‑commerce. On 21 Decem­ber 2022, the Euro­pean Coun­cil, the Euro­pean Par­lia­ment and the EU Com­mis­si­on agreed on a com­pro­mi­se text for a new Gene­ral Pro­duct Safe­ty Regu­la­ti­on (GPSR), which pas­sed its first rea­ding befo­re the Euro­pean Par­lia­ment on 30 March 2023. Assum­ing that the bill is adopted by the Coun­cil, which is high­ly likely, the way is now clear towards publi­ca­ti­on in the Offi­ci­al Jour­nal of the Euro­pean Uni­on, after which the new Regu­la­ti­on should enter into effect in the second quar­ter of 2023.

New Look

Once the Regu­la­ti­on enters into effect, it will take direct and imme­dia­te effect in all EU mem­ber sta­tes. This will ensu­re a maxi­mum degree of har­mo­niza­ti­on within the EU, as well as pro­vi­ding more legal cer­tain­ty for com­pa­nies, sin­ce it eli­mi­na­tes the need to trans­la­te the Regu­la­ti­on into natio­nal law, as well as the risk that the various count­ries will for­mu­la­te the new rules in dif­fe­rent ways. As was the case befo­re, howe­ver, the new Regu­la­ti­on will be sup­ple­men­ted by pro­vi­si­ons of natio­nal law impo­sing fines and pen­al­ties, which will be neces­sa­ry for enforce­ment of the new Regu­la­ti­on. In Ger­ma­ny, the­se pro­vi­si­ons will likely be con­tai­ned, as befo­re, in the Act on Making Pro­ducts Available on the Mar­ket (the Pro­duct Safe­ty Act).

New and Safe Products

First of all, it is good to hear that the com­pro­mi­se text defi­ni­tively aban­dons the defi­ni­ti­on of “safe pro­duct” which found in the initi­al pro­po­sal, under which manu­fac­tu­r­ers would have had to anti­ci­pa­te misu­se of their pro­ducts by users in the design and manu­fac­tu­re of their pro­ducts, as this would have led to an irre­con­cilable con­flict in terms of legal inter­pre­ta­ti­on. Under the pre­vai­ling prin­ci­ples of pro­duct safe­ty law, manu­fac­tu­r­ers are only respon­si­ble for safe­ty within cer­tain bounds; spe­ci­fi­cal­ly, the manufacturer’s respon­si­bi­li­ty is limi­t­ed to cases of inten­ded and reason­ab­ly fore­seeable use. But the com­pro­mi­se text iden­ti­fies not “inten­ded” but “nor­mal” use as the start­ing point for con­side­ra­ti­on in terms of pro­duct safe­ty law. If this word choice is retai­ned, we will likely not have long to wait befo­re the Com­mis­si­on issues gui­de­lines on the inter­pre­ta­ti­on of this term, and pos­si­bly others as well.

The Regu­la­ti­on also cla­ri­fies the defi­ni­ti­on of “pla­cing on the mar­ket” for online sel­ling. It sta­tes that a pro­duct is con­side­red to have been made available on the mar­ket if an offer for sale is tar­ge­ted to con­su­mers in the EU and can be accept­ed at any time, i.e. if the eco­no­mic ope­ra­tor directs its acti­vi­ties to one or more mem­ber sta­tes. This is the case e.g. if the offer is available in EU lan­guages or if pay­ment can be made in Euros. The­se cri­te­ria were first legal­ly defi­ned in the new Mar­ket Sur­veil­lan­ce Regu­la­ti­on (EU) 2019/1020, but have long sin­ce been imple­men­ted in pro­duct safe­ty law (cf. Blue Gui­de 2022, No. 2.4).

New “Old” Players

The Regu­la­ti­on also intro­du­ces the con­cept of “sub­stan­ti­al modi­fi­ca­ti­ons,” under which anyo­ne who makes such a modi­fi­ca­ti­on to a pro­duct qua­li­fies as the manu­fac­tu­rer of a new pro­duct and is the­r­e­fo­re sub­ject to all the duties of a manu­fac­tu­rer. Under the Regu­la­ti­on, a modi­fi­ca­ti­on is dee­med “sub­stan­ti­al” if it crea­tes a chan­ge which is not cover­ed by the initi­al risk assess­ment, if it crea­tes a new risk or if it magni­fies a known risk. This under­stan­ding of “sub­stan­ti­al modi­fi­ca­ti­ons” has been the pre­vai­ling view in Ger­ma­ny for many years now, based in no small part on an Inter­pre­ta­ti­on Paper issued in 2015 by Germany’s Fede­ral Minis­try of Labor and Social Affairs, which was draf­ted for the mecha­ni­cal and plant engi­nee­ring sec­tor. Howe­ver, the GPSR now pro­vi­des, as a cor­rec­ti­ve, that this only appli­es if the modi­fi­ca­ti­on was not made by con­su­mers them­sel­ves or at their behest, sin­ce con­su­mers them­sel­ves should in no case be trea­ted as manufacturers.

Also added to the list of tho­se with pro­duct safe­ty obli­ga­ti­ons are some new eco­no­mic ope­ra­tors, albeit ones which have beco­me very fami­li­ar sin­ce the Mar­ket Sur­veil­lan­ce Regu­la­ti­on took effect: name­ly, “ful­fill­ment ser­vice pro­vi­ders,” online mar­ket­places and online inter­faces. Moreo­ver, con­sis­tent with the pro­vi­si­ons of the Mar­ket Sur­veil­lan­ce Regu­la­ti­on, the new Regu­la­ti­on imple­ments a duty under which a pro­duct can only be pro­vi­ded on the mar­ket if a “respon­si­ble per­son” has been estab­lished in the EU.

Addi­tio­nal Requi­re­ments for Eco­no­mic Operators 

In view of the pro­gres­si­ve digi­tiza­ti­on and inter­con­nec­tion of pro­ducts in the Inter­net of Things (IOT), manu­fac­tu­r­ers under­go­ing con­for­mi­ty assess­ment pro­ce­du­res in the future will have to con­sider not only the phy­si­cal safe­ty of their pro­ducts but cyber­se­cu­ri­ty as well, and the resi­li­ence of their pro­ducts in the face of exter­nal and pos­si­bly mali­cious influen­ces. In the case of AI appli­ca­ti­ons, manu­fac­tu­r­ers will also need to keep in mind the evol­ving, lear­ning and pre­dic­ti­ve func­tion­a­li­ties of their pro­ducts. Whe­ther the new rules will include stan­dards which will crea­te legal cer­tain­ty for manu­fac­tu­r­ers in this regard is unclear, but curr­ent­ly unlikely.

In case of doubt, this duty may also app­ly to the “respon­si­ble per­son” for the pro­duct. Under the GPSR, the respon­si­ble per­son is now also requi­red to veri­fy the sub­stan­ti­ve con­for­mi­ty of the pro­ducts it sup­pli­es, as well as their labe­l­ing and accom­pany­ing docu­ments. The­se duties go far bey­ond the com­pa­ra­ble duties of aut­ho­ri­zed repre­sen­ta­ti­ves under the Mar­ket Sur­veil­lan­ce Regu­la­ti­on, which lar­ge­ly con­sist of pro­vi­ding an EU Decla­ra­ti­on of Con­for­mi­ty and coope­ra­ting with the mar­ket sur­veil­lan­ce authorities.


Manu­fac­tu­r­ers and importers ali­ke will also be facing stric­ter labe­l­ing requi­re­ments. In addi­ti­on to a mai­ling address, it will now be neces­sa­ry for pro­ducts to indi­ca­te an elec­tro­nic (e‑mail) address at which the manu­fac­tu­rer or importer can be cont­ac­ted. Moreo­ver, as part of their com­plaint manage­ment pro­ce­du­res, manu­fac­tu­r­ers will also be requi­red to allow con­su­mers to lodge com­plaints electronically.

All eco­no­mic ope­ra­tors will also be facing stric­ter requi­re­ments when it comes to noti­fy­ing and coope­ra­ting with mar­ket sur­veil­lan­ce aut­ho­ri­ties, which must be infor­med when­ever an unsafe pro­duct is found by means of the Euro­pean Commission’s Pro­duct Safe­ty Alert Busi­ness Gate­way tool, regard­less of the degree of risk. The­se exten­si­ve noti­fi­ca­ti­on requi­re­ments were alre­a­dy estab­lished in the “RAPEX Gui­de­lines” in accordance with Imple­men­ting Decis­i­on (EU) 2019/417, but will now app­ly to com­pa­nies in sta­tu­to­ry form. Evi­dent­ly, this prin­ci­ple does not app­ly in cases whe­re use of a pro­duct results in a (fatal) acci­dent, in which case the noti­fi­ca­ti­on requi­re­ment appli­es pri­ma­ri­ly to the manu­fac­tu­rer of the rele­vant pro­duct, and only  the rele­vant aut­ho­ri­ty of the mem­ber sta­te in who­se sove­reign ter­ri­to­ry the acci­dent occur­red is to be informed.

In addi­ti­on, all eco­no­mic ope­ra­tors wit­hout excep­ti­on must be in a posi­ti­on to ensu­re the safe­ty and con­for­mi­ty of the pro­ducts which they make available on the mar­ket through sui­ta­ble pro­ces­ses and to docu­ment the­se pro­ces­ses as well.

Enhan­ced Pro­tec­tion in Online Selling

The Regulation’s enhan­ced con­su­mer pro­tec­tions in the area of online sel­ling will be of par­ti­cu­lar rele­van­ce in prac­ti­ce. The GPSR requi­res manu­fac­tu­r­ers to pro­vi­de con­cre­te infor­ma­ti­on about pro­ducts which are sold online, con­sis­ting nor only of a pho­to­graph of the rele­vant pro­duct, but the name of the pro­duct and the manu­fac­tu­rer and all infor­ma­ti­on neces­sa­ry for safe use of the pro­duct. In addi­ti­on, online mar­ket­places will be requi­red to allow con­su­mers to cont­act them and the mar­ket sur­veil­lan­ce aut­ho­ri­ties direct­ly by elec­tro­nic means. Unli­ke the case within the scope of the Mar­ket Sur­veil­lan­ce Regu­la­ti­on, which requi­res them only to coope­ra­te with the mar­ket sur­veil­lan­ce aut­ho­ri­ties, online mar­ket­places will have sur­veil­lan­ce requi­re­ments of their own under the new Regu­la­ti­on, and will be requi­red to quick­ly remo­ve hazar­dous pro­ducts from the mar­ket­place or affix a sui­ta­ble warning. 

Stan­dar­di­zed Rules for Pro­duct Recalls

The new Regu­la­ti­on also intro­du­ces stan­dar­di­zed rules for the con­duct of con­su­mer recalls and crea­tes incen­ti­ves which make it more attrac­ti­ve for con­su­mers to take part in recall cam­paigns. In the future, recalls will have to be initia­ted by a noti­ce which is desi­gna­ted as such, and which must be draf­ted in the lan­guage of each of the mem­ber sta­tes in which the rele­vant pro­duct has been pla­ced on the mar­ket. Manu­fac­tu­r­ers will be requi­red to use all available chan­nels, inclu­ding social media, in order to noti­fy con­su­mers of the pro­duct recall. In doing so, they will not be allo­wed to use terms which make the pro­blem appear harm­less, such as “vol­un­t­a­ry,” pre­cau­tio­na­ry” or “in rare/specific situa­tions,” so as to avo­id mis­lea­ding con­su­mers about the urgen­cy of taking action. This logic is not new, and can alre­a­dy be found in Gui­de­lines issued by the EU Com­mis­si­on in 2021 on the effec­ti­ve design of pro­duct recalls.

Fur­ther­mo­re, manu­fac­tu­r­ers will have to offer the affec­ted con­su­mers at least two effec­ti­ve, cost-free and time­ly reme­dies, such as repair, repla­ce­ment of the recal­led pro­duct or a refund for the value of the recal­led pro­duct. In the lat­ter case, the amount of the refund must be at least as high as the pri­ce which the con­su­mer paid. The­se rules are inten­ded to crea­te an incen­ti­ve for con­su­mers to take part in the recall cam­paign. But at the moment, the pro­po­sed rules con­flict bla­tant­ly with natio­nal war­ran­ty laws, and with exis­ting case law in Germany.

It remains to be seen whe­ther the stan­dar­diza­ti­on of mea­su­res for each pro­duct and each type of risk can effec­tively redu­ce the exis­ting risk in each indi­vi­du­al case while at the same time satis­fy­ing the prin­ci­ple of pro­por­tio­na­li­ty. Howe­ver, con­flicts appear to be inevitable. 

Hig­her Trans­pa­ren­cy and Inter­con­nec­tion

In addi­ti­on to updating and exten­ding the Safe­ty Gate Rapid Alert Sys­tem (RAPEX), which allows anyo­ne to free­ly view infor­ma­ti­on about hazar­dous pro­ducts curr­ent­ly in cir­cu­la­ti­on, the EU Com­mis­si­on is plan­ning to crea­te a “Tracea­bi­li­ty Regis­ter” in which manu­fac­tu­r­ers of pro­ducts which are typi­cal­ly asso­cia­ted with a serious pro­duct risk will be requi­red to store pro­duct data and infor­ma­ti­on about pro­duct com­pon­ents and the sup­p­ly chain. This data will be acces­si­ble to con­su­mers, e.g. through a data car­ri­er pla­ced on the pro­duct, but also to other eco­no­mic ope­ra­tors and mar­ket sur­veil­lan­ce aut­ho­ri­ties. While the Regu­la­ti­on does not requi­re manu­fac­tu­r­ers to crea­te a “digi­tal pro­duct pass­port” such as is pro­vi­ded in the new Eco-Design Regu­la­ti­on (as we repor­ted), this new regis­ter repres­ents a big step towards the EU’s goal of cen­tra­li­zing pro­duct infor­ma­ti­on. This is in addi­ti­on to the noti­fi­ca­ti­on and com­mu­ni­ca­ti­on sys­tem which has alre­a­dy been crea­ted within the scope of the Mar­ket Sur­veil­lan­ce Regu­la­ti­on for the struc­tu­red coll­ec­tion, pro­ces­sing and sto­rage of infor­ma­ti­on con­cer­ning mar­ket sur­veil­lan­ce, and which is con­nec­ted to RAPEX via interfaces.


With the agree­ment on a new Pro­duct Safe­ty Regu­la­ti­on, the new direc­tion in Euro­pean pro­duct safe­ty law is taking shape. When they take effect, the imple­men­ted mecha­nisms will great­ly enhan­ce con­su­mer pro­tec­tion and pro­du­ce a noti­ceable inten­si­fi­ca­ti­on in mar­ket sur­veil­lan­ce acti­vi­ties. With a rela­tively short 18-month tran­si­tio­nal peri­od, begin­ning when the legis­la­ti­on enters into effect in the 2nd quar­ter of 2023, the GPSR is expec­ted to come into force at the end of 2024. This lea­ves eco­no­mic ope­ra­tors rela­tively litt­le time in order to adapt their pro­ces­ses to con­form to the new rules. It also remains to be seen how quick­ly the mar­ket sur­veil­lan­ce aut­ho­ri­ties will act when it comes to stream­li­ning mecha­nisms in mar­ket sur­veil­lan­ce law. But one con­clu­si­on is ine­s­ca­pa­ble: the EU is serious about pro­duct safety!


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