Machi­nes wit­hout CE mar­king – the admi­nis­tra­ti­ve prac­ti­ce in the case of for­mal non-conformity

As part of the amend­ment to the Ordi­nan­ce on Indus­tri­al Safe­ty and Health (Betr­SichV) (only in Ger­man) of 5 June 2021, the Sta­te Com­mit­tee for Occu­pa­tio­nal Safe­ty and Safe­ty Tech­no­lo­gy (LASI) (only in Ger­man) addres­sed, among other things, the ques­ti­on of how to pro­ceed with machi­nes in ope­ra­ti­on that are not for­mal­ly com­pli­ant, and published a posi­ti­on paper on this on 10 Sep­tem­ber 2021, which paved the way for offi­ci­al admi­nis­tra­ti­ve prac­ti­ce. The main ques­ti­on in this con­text is whe­ther the­se ope­ra­tors can be obli­ged under occu­pa­tio­nal health and safe­ty law or moni­to­ring aut­ho­ri­ty aspects to sub­se­quent­ly assess the safe­ty of the machi­ne and pro­vi­de it with a CE marking.

Basic infor­ma­ti­on

The CE mar­king, as an indi­ca­ti­on of the product’s con­for­mi­ty with the rele­vant legis­la­ti­on, ful­fills an important role in the sys­tem of tech­ni­cal har­mo­ni­sa­ti­on regu­la­ti­ons, con­for­mi­ty assess­ment and mar­ket sur­veil­lan­ce. In prin­ci­ple, the obli­ga­ti­on to make a machi­ne available on the mar­ket in con­for­mi­ty with the direc­ti­ve appli­es to its manu­fac­tu­rer, wher­eby in the scope of the Machi­nery Direc­ti­ve 2006/42/EC (PDF), the manu­fac­tu­rer in the legal sen­se is also the per­son who manu­fac­tures the machi­ne and ope­ra­tes it him- or hers­elf. In this sys­tem, it is the­r­e­fo­re the manufacturer’s pri­ma­ry duty to estab­lish the for­mal con­for­mi­ty of the machi­ne, for exam­p­le by affi­xing the CE mar­king, befo­re pla­cing it on the market.

Legal impli­ca­ti­ons of for­mal non-compliance for operators

In con­trast to the manufacturer’s obli­ga­ti­ons, howe­ver, the operator’s obli­ga­ti­ons do not gene­ral­ly begin until after a machi­ne has been pla­ced on the mar­ket (excep­ti­on: manufacturer-operator). Pur­su­ant to § 5(3) Betr­SichV, com­mer­cial ope­ra­tors may only use work equip­ment that com­pli­es with the appli­ca­ble legal regu­la­ti­ons on safe­ty and health pro­tec­tion. When asses­sing the safe­ty of work equip­ment, the ope­ra­tor must the­r­e­fo­re not rely on for­mal mar­kings such as the CE mark, but must assess the hazards of the work equip­ment, with or wit­hout a CE mar­king, detached from this for­mal mar­king as well as the sub­stan­ti­ve safe­ty of use and rule out iden­ti­fied risks of use. The ope­ra­tor must repeat and veri­fy this assess­ment at regu­lar inter­vals. It is not the same as the con­for­mi­ty assess­ment for a machi­ne, which the manu­fac­tu­rer is obli­ged to car­ry out befo­re pla­cing it on the mar­ket, pos­si­bly with the invol­vement of a noti­fied body.

In order to effec­tively enforce the occu­pa­tio­nal health and safe­ty regu­la­ti­ons, the occu­pa­tio­nal health and safe­ty aut­ho­ri­ties have a ran­ge of mea­su­res at their dis­po­sal that are aimed at veri­fy­ing the sub­stan­ti­ve safe­ty of use, such as reques­t­ing infor­ma­ti­on and docu­ments (e.g. the manufacturer’s EU decla­ra­ti­on of con­for­mi­ty or tech­ni­cal docu­men­ta­ti­on), up to and inclu­ding orde­ring a tem­po­ra­ry or per­ma­nent ban on use if any uncer­tain­ty is iden­ti­fied. Howe­ver, the­se mea­su­res do not rela­te to a for­mal­ly com­pli­ant mar­king of the machines.

Con­clu­si­on and prac­ti­cal tips

Accor­ding to the LASI posi­ti­on paper, ope­ra­tors of machi­nes who are not at the same time manu­fac­tu­r­ers of the machi­nes have no obli­ga­ti­on to sub­se­quent­ly assess the con­for­mi­ty and estab­lish the for­mal con­for­mi­ty of the machi­ne if a sub­stan­ti­ve safe­ty inspec­tion has taken place pri­or to com­mis­sio­ning. For ope­ra­tors who are also manu­fac­tu­r­ers, the­re is also no obli­ga­ti­on for a sub­se­quent CE mar­king; the only obli­ga­ti­on is in rela­ti­on to the time befo­re the machi­ne was pla­ced on the market.

For manu­fac­tu­r­ers, it may nevert­hel­ess be advi­sa­ble to sub­se­quent­ly estab­lish for­mal con­for­mi­ty, sin­ce machi­nes that are not pro­per­ly mark­ed come into the focus of the aut­ho­ri­ties much more quick­ly than machi­nes that are in for­mal com­pli­ance. Aut­ho­ri­ties then beco­me tempt­ed by the for­mal non-conformity to also check the sub­stan­ti­ve safe­ty of the machi­ne. Should it beco­me appa­rent in this con­text that a machi­ne is unsafe, the manu­fac­tu­rer may be requi­red from a pro­duct safe­ty point of view to reas­sess the machi­ne, pos­si­bly with the invol­vement of a noti­fied body, and to sub­se­quent­ly estab­lish sub­stan­ti­ve con­for­mi­ty befo­re fur­ther operation.


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