Con­for­mi­ty assess­ment and CE mar­king of pro­ducts after pla­cing on the market?

A pre­sen­ta­ti­on based on the exam­p­le of exis­ting machines

The har­mo­ni­sa­ti­on regu­la­ti­ons con­tain clear spe­ci­fi­ca­ti­ons rela­ting to the order in which the con­for­mi­ty of a machi­ne must be ensu­red and the point in time by which it needs to have been label­led. The cir­cle of eco­no­mic ope­ra­tors under obli­ga­ti­on in this con­text has also been con­clu­si­ve­ly defi­ned. Thus the­re is no room left for the sub­se­quent label­ling of a machi­ne that is alre­a­dy in the field by its manu­fac­tu­rer, ope­ra­tor or distributor. 

Given the num­ber and diver­si­ty of pro­ducts rea­ching the Euro­pean mar­ket, in par­ti­cu­lar via Inter­net plat­forms and ful­film­ent cen­tres, it is under­stan­da­ble that dis­tri­bu­tors are asking them­sel­ves whe­ther it is pos­si­ble or inde­ed man­da­to­ry for them to label pro­ducts which reach them wit­hout a CE mar­king retroac­tively. That ques­ti­on is curr­ent­ly also the sub­ject of keen dis­cus­sion in respect of machi­nes from the point of view of manu­fac­tu­r­ers and ope­ra­tors. So our aim here is to pre­sent and explain the cur­rent legal posi­ti­on loo­king at the exam­p­le of machines. 

Accor­ding to the spe­ci­fi­ca­ti­ons of the Machi­nery Direc­ti­ve 2006/42/EC (MRL), it is the manu­fac­tu­rer who is respon­si­ble for the con­for­mi­ty of a machi­ne. As a mat­ter of basic prin­ci­ple, the­r­e­fo­re, the manu­fac­tu­rer is the one who has to make sure that his machi­ne meets the basic safe­ty and health pro­tec­tion requi­re­ments that app­ly to it. He has to car­ry out a con­for­mi­ty assess­ment pro­ce­du­re, draw up a risk ana­ly­sis in which the hazards posed by the machi­ne are con­clu­si­ve­ly iden­ti­fied and asses­sed, issue an EC con­for­mi­ty decla­ra­ti­on, and final­ly affix his machi­ne with the CE mar­king. The cir­cle of tho­se under obli­ga­ti­on here in sta­tu­to­ry terms is thus clo­se­ly defi­ned. The­se respon­si­bi­li­ties can only be real­lo­ca­ted if the manu­fac­tu­rer, having no place of busi­ness in the EU, enga­ges an aut­ho­ri­sed repre­sen­ta­ti­ve to take care of the­se tasks for him. 

From the point of view of time too, the MRL lays down con­cre­te requi­re­ments as to the order in which the con­for­mi­ty of a machi­ne must be estab­lished. Infor­ma­ti­on about this is pro­vi­ded on the one hand by the spe­ci­fi­ca­ti­ons lis­ted in Annex I of the MRL, accor­ding to which the manu­fac­tu­rer must first iden­ti­fy the basic requi­re­ments rela­ting to safe­ty and health pro­tec­tion that app­ly to the machi­ne by means of a risk assess­ment, and then design and build the machi­ne taking tho­se insights into account. Moreo­ver, Art. 5 of the MRL sta­tes that the manu­fac­tu­rer alre­a­dy has to have ful­fil­led all the obli­ga­ti­ons lis­ted the­re befo­re pla­cing the machi­ne on the mar­ket, which also includes the con­for­mi­ty assess­ment and the label­ling. The­re is thus no pro­vi­si­on for car­ry­ing out the­se steps at any later point in time, and the­re is no neces­si­ty for it eit­her as long as all the requi­re­ments are met. 

Moreo­ver, the aim of the Euro­pean legis­la­tors, that of ensu­ring the safe­ty and health of indi­vi­du­als, in par­ti­cu­lar workers and con­su­mers and espe­ci­al­ly in rela­ti­on to the risks they incur when deal­ing with machi­nes, must not be igno­red eit­her. Thin­king logi­cal­ly, it would not be pos­si­ble to achie­ve that aim if manu­fac­tu­r­ers were allo­wed to place their machi­nes on the mar­ket and test their sui­ta­bi­li­ty for it befo­re estab­li­shing their conformity. 

But what does this mean for dis­tri­bu­tors and ope­ra­tors who are in pos­ses­si­on of machi­nes which have not been labelled? 

Art. 7 of the MRL covers the rebut­ta­ble pre­sump­ti­on that a machi­ne which has been label­led with the CE mar­king and has a cor­rect and pro­per EC decla­ra­ti­on of con­for­mi­ty atta­ched to it com­pli­es with the pro­vi­si­ons of the Direc­ti­ve. Howe­ver, that does not neces­s­a­ri­ly mean that a machi­ne which has been pla­ced on the mar­ket wit­hout a CE mar­king does not com­ply or, inde­ed, that it is unsafe. 

It fol­lows that the ques­ti­on of what obli­ga­ti­ons are incum­bent on the ope­ra­tor of an unla­bel­led machi­ne can thus be ans­we­red pri­ma­ri­ly from the points of view of indus­tri­al and ope­ra­tio­nal safe­ty. Accor­ding to the requi­re­ments of the Indus­tri­al Safe­ty Regu­la­ti­on (Betr­SichV), a com­mer­cial ope­ra­tor is under obli­ga­ti­on to iden­ti­fy and assess hazards which could be posed by his machi­ne befo­re using it, and to do so regard­less of whe­ther the machi­ne car­ri­es a CE mar­king or not. If neces­sa­ry, he must deri­ve sui­ta­ble pro­tec­ti­ve mea­su­res from that assess­ment. For the ope­ra­tor, the use of working mate­ri­als is thus pri­ma­ri­ly a ques­ti­on of mate­ri­al safe­ty, not one of for­mal conformity. 

As par­ti­ci­pa­ting eco­no­mic ope­ra­tors, dis­tri­bu­tors make their con­tri­bu­ti­on to the ful­film­ent of the­se legis­la­ti­ve objec­ti­ves by pla­cing only safe pro­ducts on the mar­ket. They must not place pro­ducts on the mar­ket which they know or should know to be non-compliant, and they may for this reason be sub­ject to mar­ket sur­veil­lan­ce mea­su­res. In addi­ti­on to that, they also ren­der them­sel­ves vul­nerable under the law of com­pe­ti­ti­on if they sell machi­nes or other pro­ducts wit­hout a CE mar­king in spi­te of their being requi­red to be label­led by law. 


To sum up, it can be said that the­re is no pro­vi­si­on for the sub­se­quent label­ling of a machi­ne which is alre­a­dy in the field by its manu­fac­tu­rer, ope­ra­tor or distributor.


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