CE Marking Wire and Cable — Necessity or Luxury?

When I set out to inves­ti­gate the need for CE Marks and HAR> marks on wire and cable prod­ucts, I would not have guessed that it would turn out to be as much of an odyssey as it did. For most prod­ucts, deter­min­ing the need for a CE Mark is rel­a­tive­ly straight­for­ward, but not for wire and cable prod­ucts! As equip­ment design­ers, engi­neers and tech­nol­o­gists, we rarely think much about wire and cable. We’re most­ly con­cerned with the insu­la­tion colours, num­ber of con­duc­tors, the gauge, and the volt­age rat­ing. Some­times we’re also con­cerned about the tem­per­a­ture rat­ing, the flex­i­bil­i­ty, or per­haps the shield­ing. The reg­u­la­to­ry approvals car­ried by the wire are often assumed, or not con­sid­ered at all. This com­mon prod­uct can bring a world of headaches if the require­ments are not ful­ly con­sid­ered.

Regulatory Requirements

North America

In North Amer­i­ca, the three main reg­u­la­to­ry orga­ni­za­tions for elec­tri­cal com­po­nent safe­ty cer­ti­fi­ca­tions are UL, CSA, and NOM. All three pub­lish stan­dards applic­a­ble to wire and cable, and the mark­ings and com­mon wire styles, like TEW, AWM, MTW, and SOW, are dri­ven by these stan­dards.

Europe — HAR Marking

What about Europe? The EU has a sep­a­rate sys­tem for iden­ti­fy­ing wire and cable, iden­ti­fied by the HAR Mark. Learn more about this mark.

Picture of the HAR Mark.
The HAR> Mark

The HAR mark, which stands for “Har­monised”, has been based on the appli­ca­tion of Har­monised Doc­u­ments (HD) pub­lished by CENELEC, includ­ing the HD 21.X and HD 22.X fam­i­lies, which was replaced by the EN 50525 series of stan­dards effec­tive 2014-01-17. But what is the basis for mark­ing, and is there a legal require­ment for man­u­fac­tur­ers to use marked wire? The HAR Mark is one of the ear­li­est com­mon marks in the EU, orig­i­nat­ing from an agree­ment signed in 1974. Man­u­fac­tur­ers who wish to use the HAR Mark are required to meet strin­gent qual­i­ty con­trol require­ments before being grant­ed the right to use the HAR mark. Wire and cable prod­ucts bear­ing the HAR mark are accept­ed by all of the sig­na­to­ry states to the HAR agree­ment. (Need to know more? Have a look at the EEPCA web site.) The HAR mark is not legal­ly required, but using prod­ucts bear­ing the HAR Mark may make a manufacturer’s life a bit eas­i­er when deal­ing with author­i­ties.

Europe — CE Marking

What about the CE Mark for wire and cable?  To answer that ques­tion, we need to look at the CE Mark­ing require­ments in more detail. In gen­er­al, CE Mark­ing Direc­tives are aimed at prod­ucts, not at com­po­nents, although there are some excep­tions. Wire and cable prod­ucts are one of those excep­tions that stand out. On its own, wire or cable has no defined use or appli­ca­tion, in that it must be built into some­thing to be use­ful. The com­pli­ance of the final prod­uct con­tain­ing the wire prod­ucts is deter­mined based on test­ing relat­ed to the fin­ished prod­uct, and the com­pli­ance of the wire used in the prod­uct is based on the spe­cif­ic appli­ca­tion and the wire product’s per­for­mance in that prod­uct. So why are wire and cable prod­ucts CE Marked on their own?

Determining the Right Directives

Most direc­tives require that prod­ucts with­in the scope have some defined func­tion, like the Machin­ery Directive’s def­i­n­i­tion of a machine:

…an assem­bly, fit­ted with or intend­ed to be fit­ted with a dri­ve sys­tem oth­er than direct­ly applied human or ani­mal effort, con­sist­ing of linked parts or com­po­nents, at least one of which moves, and which are joined togeth­er for a spe­cif­ic appli­ca­tion…”, [1]

or the EMC Direc­tive def­i­n­i­tion of “appa­ra­tus”:

…‘appa­ra­tus’ means any fin­ished appli­ance or com­bi­na­tion there­of made com­mer­cial­ly avail­able as a sin­gle func­tion­al unit, intend­ed for the end user and liable to gen­er­ate elec­tro­mag­net­ic dis­tur­bance, or the per­for­mance of which is liable to be affect­ed by such dis­tur­bance…” [2]

Clear­ly, these def­i­n­i­tions don’t include com­po­nents. So what direc­tives do apply to wire prod­ucts? The first direc­tive that comes to mind is the Low Volt­age Direc­tive. If we take a look at the def­i­n­i­tions in the Direc­tive [3] we find:

Arti­cle 1

For the pur­pos­es of this Direc­tive, ‘elec­tri­cal equip­ment’ means any equip­ment designed for use with a volt­age rat­ing of between 50 and 1 000 V for alter­nat­ing cur­rent and between 75 and 1 500 V for direct cur­rent, oth­er than the equip­ment and phe­nom­e­na list­ed in Annex II.

Once again, we have a pret­ty spe­cif­ic def­i­n­i­tion for the tar­get of the Direc­tive: “elec­tri­cal equip­ment”. Or do we? What, exact­ly, is “elec­tri­cal equip­ment”? The Direc­tive doesn’t define this term, but it does give us a list of exclu­sions in Annex II [3]:

Annex II

  • Equip­ment and Phe­nom­e­na out­side the Scope of this Direc­tive
  • Elec­tri­cal equip­ment for use in an explo­sive atmos­phere
  • Elec­tri­cal equip­ment for radi­ol­o­gy and med­ical pur­pos­es
  • Elec­tri­cal parts for goods and pas­sen­ger lifts
  • Elec­tric­i­ty meters
  • Plugs and sock­et out­lets for domes­tic use
  • Elec­tric fence con­trollers
  • Radio-elec­tri­cal inter­fer­ence
  • Spe­cialised elec­tri­cal equip­ment, for use on ships, air­craft or rail­ways, which com­plies with the safe­ty pro­vi­sions drawn up by inter­na­tion­al bod­ies in which the Mem­ber States par­tic­i­pate.

At this point, it doesn’t look like wire prod­ucts are includ­ed in the direc­tive. No fur­ther def­i­n­i­tion of “elec­tri­cal equip­ment” is giv­en, and wire and cable are not specif­i­cal­ly exclud­ed in Annex II. Where do we go from here to bet­ter under­stand the def­i­n­i­tion of “elec­tri­cal equip­ment”?

The IEC pub­lish­es the Inter­na­tion­al Elec­trotech­ni­cal Vocab­u­lary (IEV), IEC 60050 [4], defin­ing hun­dreds of terms relat­ed to elec­tro-tech­ni­cal top­ics. This is the next log­i­cal step in try­ing to under­stand what is cov­ered. Def­i­n­i­tions in the IEV are num­bered as a means to cat­a­log the terms, and I’ve pro­vid­ed the def­i­n­i­tion num­bers for ref­er­ence. Unfor­tu­nate­ly, the IEV does not con­tain a def­i­n­i­tion for “elec­tri­cal equip­ment”, but it does define “equip­ment” [3, 151–11-25]:

equip­ment — sin­gle appa­ra­tus or set of devices or appa­ra­tus­es, or the set of main devices of an instal­la­tion, or all devices nec­es­sary to per­form a spe­cif­ic task

Note – Exam­ples of equip­ment are a pow­er trans­former, the equip­ment of a sub­sta­tion, mea­sur­ing equip­ment.

The def­i­n­i­tion uses the term “appa­ra­tus”, which con­tin­ues the lack of clar­i­ty. Is wire appa­ra­tus? Look­ing up the def­i­n­i­tion for “Appa­ra­tus” 151–11-22, the IEV gives us:

appa­ra­tus — device or assem­bly of devices which can be used as an inde­pen­dent unit for spe­cif­ic func­tions

Note – In Eng­lish, the term “appa­ra­tus” some­times implies use by skilled per­sons for pro­fes­sion­al pur­pos­es.

Wire clear­ly doesn’t meet the def­i­n­i­tion for appa­ra­tus, since it couldn’t be con­sid­ered and “inde­pen­dent unit for a spe­cif­ic func­tion”, so is wire a device? Now we have one more term to try to under­stand. The def­i­n­i­tion for “device” is found in the IEV at 151–11-20:

device — mate­r­i­al ele­ment or assem­bly of such ele­ments intend­ed to per­form a required func­tion

Note – A device may form part of a larg­er device.

Now we’re get­ting some­where. Wire could def­i­nite­ly be con­sid­ered to be a “mate­r­i­al ele­ment”, but we’re stuck again at the need to “per­form a required func­tion”. One more term might apply. Let’s look at “com­po­nents”. The def­i­n­i­tion for a “com­po­nent” is found at 151–11-21:

com­po­nent — con­stituent part of a device which can­not be phys­i­cal­ly divid­ed into small­er parts with­out los­ing its par­tic­u­lar func­tion

Now we’ve got it! Wire is clear­ly a com­po­nent, and this clear­ly makes sense when you con­sid­er the use we make of wire and cable prod­ucts. But how does this relate back to the legal def­i­n­i­tion of “elec­tri­cal equip­ment”? Since the IEV is not called out by the Direc­tive, we can’t lean on this def­i­n­i­tion alone to decide the applic­a­bil­i­ty of the CE Mark to these prod­ucts.

Low Voltage Directive Requirements

The EU Com­mis­sion pub­lish­es a Guide for most of the Direc­tives, and the Low Volt­age Direc­tive is no dif­fer­ent. There is lit­tle direct ref­er­ence to wire and cable prod­ucts, how­ev­er, [5, para. 8] does men­tion it in broad terms, “…the Direc­tive cov­ers con­sumer and cap­i­tal goods designed to oper­ate with­in those volt­age lim­its, includ­ing in par­tic­u­lar, …elec­tri­cal wiring, appli­ance cou­plers and cord sets…” [5, Annex II] pro­vides a pic­to­r­i­al list of prod­ucts, illus­trat­ing the cord set require­ment. With­in the volt­age lim­its set by the scope of the LVD, the require­ment for cord sets and oth­er “safe­ty crit­i­cal” sub-assem­blies that include wire or cable makes sense. A com­plet­ed cord set with an IEC 320 con­nec­tor on one end and a coun­try spe­cif­ic plug, like a a CEE plug cap, is a com­plete prod­uct with a defined end-use, and so fits the scope. This seems to answer the orig­i­nal ques­tion: “Do wire & cable prod­ucts, on their own, require a CE Mark?”, at least under the LVD. The next ques­tion must be: “Are there any oth­er CE Mark­ing Direc­tives that might apply?”

RoHS and WEEE Directives

We can exclude the EMC Direc­tive, since the def­i­n­i­tion of appa­ra­tus in that direc­tive is quite clear. What about RoHS [6], and WEEE [7]? Let’s look at RoHS and WEEE togeth­er, since these two Direc­tives are linked in appli­ca­tion. The 2011 RoHS direc­tive [8] includes some def­i­n­i­tions of what elec­tri­cal and elec­tron­ic equip­ment is, and includes two key def­i­n­i­tions for machine builders:

Arti­cle 3 

Def­i­n­i­tions

For the pur­pos­es of this Direc­tive, the fol­low­ing def­i­n­i­tions shall apply:

  1. elec­tri­cal and elec­tron­ic equip­ment’ or ‘EEE’ means equip­ment which is depen­dent on elec­tric cur­rents or elec­tro­mag­net­ic fields in order to work prop­er­ly and equip­ment for the gen­er­a­tion, trans­fer and mea­sure­ment of such cur­rents and fields and designed for use with a volt­age rat­ing not exceed­ing 1 000 volts for alter­nat­ing cur­rent and 1 500 volts for direct cur­rent; 
  2. for the pur­pos­es of point 1, ‘depen­dent ‘ means, with regard to EEE, need­ing elec­tric cur­rents or elec­tro­mag­net­ic fields to ful­fil at least one intend­ed func­tion; 
  3. large-scale sta­tion­ary indus­tri­al tools’ means a large-scale assem­bly of machines, equip­ment, and/or com­po­nents, func­tion­ing togeth­er for a spe­cif­ic appli­ca­tion, per­ma­nent­ly installed and de-installed by pro­fes­sion­als at a giv­en place, and used and main­tained by pro­fes­sion­als in an indus­tri­al man­u­fac­tur­ing facil­i­ty or research and devel­op­ment facil­i­ty; 
  4. large-scale fixed instal­la­tion’ means a large-scale com­bi­na­tion of sev­er­al types of appa­ra­tus and, where applic­a­ble, oth­er devices, which are assem­bled and installed by pro­fes­sion­als, intend­ed to be used per­ma­nent­ly in a pre-defined and ded­i­cat­ed loca­tion, and de-installed by pro­fes­sion­als; 
  5. cables’ means all cables with a rat­ed volt­age of less than 250 volts that serve as a con­nec­tion or an exten­sion to con­nect EEE to the elec­tri­cal out­let or to con­nect two or more EEE to each oth­er; [7]

The term “large-scale” is nev­er defined in the direc­tive. So what is “Large-scale” when it comes to machine tools? An expla­na­tion of the term is giv­en in two places, [9] and [11]. The over­all descrip­tions get a bit involved, but essen­tial­ly it comes down to prod­ucts that weigh 3 tons or more, or are at least 2.5 m x 2.5 m. Any­thing small­er than this is not con­sid­ered “large-scale” and is there­fore with­in the scope of the WEEE Direc­tive. Some exam­ples of “large-scale sta­tion­ary indus­tri­al tools” include [9]:

  • Machines for the indus­tri­al pro­duc­tion and pro­cess­ing of mate­ri­als and goods, such as
    • CNC lath­es;
    • Bridge-type milling and drilling machines;
    • Met­al form­ing press­es;
    • News­pa­per print­ing press­es;
  • Machines for the test­ing of work pieces, such as
    • Elec­tron beam, laser, bright light, and deep ultra vio­let defect detec­tion sys­tems;
    • Auto­mat­ed inte­grat­ed cir­cuit board and print­ed wiring board testers;
  • Cranes;
  • Oth­er machin­ery of sim­i­lar size, com­plex­i­ty and weight.

What then, is a “large-scale fixed instal­la­tion”? [9] can help us out here too. Some exam­ples are giv­en in the FAQ:

  • Pro­duc­tion and pro­cess­ing lines, includ­ing robots and machine tools (indus­tri­al, food, print media etc.);
  • Pas­sen­ger lifts;
  • Con­vey­or trans­port sys­tems;
  • Auto­mat­ed stor­age sys­tems;
  • Elec­tri­cal dis­tri­b­u­tion sys­tems such as gen­er­a­tors;
  • Rail­way sig­nalling infra­struc­ture;
  • Fixed installed cool­ing, air con­di­tion­ing, and refrig­er­at­ing sys­tems or heat­ing sys­tems designed exclu­sive­ly for non-res­i­den­tial use.

So, machine tools that weigh less than 3 tons, or are small­er than 2.5 x 2.5 m, are includ­ed in the scope of the RoHS direc­tives, but machines larg­er that this, or sys­tems that fit the descrip­tions of Large Scale Fixed Instal­la­tions are out. What about WEEE? The WEEE Direc­tive gives us some sim­i­lar def­i­n­i­tions in Arti­cle 3:

For the pur­pos­es of this Direc­tive, the fol­low­ing def­i­n­i­tions shall apply:

  1. large-scale sta­tion­ary indus­tri­al tools’ means a large size assem­bly of machines, equip­ment, and/or com­po­nents, func­tion­ing togeth­er for a spe­cif­ic appli­ca­tion, per­ma­nent­ly installed and de-installed by pro­fes­sion­als at a giv­en place, and used and main­tained by pro­fes­sion­als in an indus­tri­al man­u­fac­tur­ing facil­i­ty or research and devel­op­ment facil­i­ty;
  2. large-scale fixed instal­la­tion’ means a large-size com­bi­na­tion of sev­er­al types of appa­ra­tus and, where applic­a­ble, oth­er devices, which: 
  3. are assem­bled, installed and de-installed by pro­fes­sion­als; 
  4. are intend­ed to be used per­ma­nent­ly as part of a build­ing or a struc­ture at a pre-defined and ded­i­cat­ed loca­tion; and 
  5. can only be replaced by the same specif­i­cal­ly designed equip­ment; 

WEEE also pro­vides anoth­er list of prod­ucts to con­sid­er in [8, Annex­es I & II]. From the point of view of machine builders we need only look at Annex II, 6., which lists exclu­sions:

6. ELECTRICAL AND ELECTRONIC TOOLS (WITH THE EXCEPTION OF LARGE-SCALE STATIONARY INDUSTRIAL TOOLS)

  • Drills 
  • Saws 
  • Sewing machines 
  • Equip­ment for turn­ing, milling, sand­ing, grind­ing, saw­ing, cut­ting, shear­ing, drilling, mak­ing holes, punch­ing, fold­ing, bend­ing or sim­i­lar pro­cess­ing of wood, met­al and oth­er mate­ri­als 
  • Tools for riv­et­ing, nail­ing or screw­ing or remov­ing riv­ets, nails, screws or sim­i­lar uses 
  • Tools for weld­ing, sol­der­ing or sim­i­lar use 
  • Equip­ment for spray­ing, spread­ing, dis­pers­ing or oth­er treat­ment of liq­uid or gaseous sub­stances by oth­er means 
  • Tools for mow­ing or oth­er gar­den­ing activ­i­ties 

If we take the inter­pre­ta­tion of “large-scale” as [11], then it becomes clear that WEEE does not include most heavy machin­ery. Small­er equip­ment, i.e. not “large scale”, would be includ­ed. Seems clear enough, but how does this relate back to wire and cable?

In read­ing [9, Q5.2], we find that “Inter­nal wires are not cables. Inter­nal wiring in any EEE that is with­in the scope of RoHS 2 must sim­ply meet the mate­r­i­al restric­tions like all oth­er parts of the EEE; there is no indi­vid­ual CE mark­ing and DoC require­ment. If an EEE is sub­ject to a tran­si­tion peri­od or a scope exclu­sion, the same applies to the inter­nal wiring. The same prin­ci­ple applies to per­ma­nent­ly attached cables, e.g. most lamp cables.” [9, Q5.3] con­tin­ues this line of rea­son­ing in rela­tion to exter­nal cables, adding, “Exter­nal cables that form part of anoth­er EEE because they are sold togeth­er or marketed/shipped for use with an EEE, e.g. pow­er cords, must meet the mate­r­i­al restric­tions but do not need an indi­vid­ual CE mark­ing and Dec­la­ra­tion of Con­for­mi­ty if they are cov­ered by the DoC for the EEE and the EEE is CE marked.” The com­ment regard­ing the applic­a­bil­i­ty of the CE mark applies only to the RoHS Direc­tive require­ments.

Read­ing the def­i­n­i­tions is nev­er enough. The exclu­sions to the RoHS Direc­tive [11, Art. 2] include some impor­tant points:

4. This Direc­tive does not apply to:

c) equip­ment which is specif­i­cal­ly designed, and is to be installed, as part of anoth­er type of equip­ment that is exclud­ed or does not fall with­in the scope of this Direc­tive, which can ful­fil its func­tion only if it is part of that equip­ment, and which can be replaced only by the same specif­i­cal­ly designed equip­ment;
d) large-scale sta­tion­ary indus­tri­al tools;
e) large-scale fixed instal­la­tions;
j) equip­ment specif­i­cal­ly designed sole­ly for the pur­pos­es of research and devel­op­ment only made avail­able on a busi­ness-to-busi­ness basis.

So machin­ery that is not either a large-scale sta­tion­ary machine tool nor a large scale fixed instal­la­tion is with­in the scope of the RoHS and WEEE Direc­tives.

Summing Up

It looks like we have the full pic­ture now, so let’s recap. Wire and cable prod­ucts:

  • are includ­ed in the LVD, despite their usu­al clas­si­fi­ca­tion as com­po­nents, and there­fore require CE Mark­ing under this direc­tive
  • are exclud­ed from RoHS and WEEE when in com­po­nent form,
  • are includ­ed in RoHS and WEEE when used in small-scale machin­ery (i.e., not large-scale sta­tion­ary indus­tri­al tools or a large-scale fixed instal­la­tion), con­sumer prod­ucts, and med­ical devices that are not in-vit­ro or active implantable devices

So why are these prod­ucts CE marked when in com­po­nent form? The most obvi­ous answer seems to be that some wire and cable prod­ucts have been explic­it­ly iden­ti­fied in the Com­mis­sion Guid­ance on the Direc­tive [5, Annex II]. Fur­ther, these prod­ucts must always be incor­po­rat­ed into some oth­er prod­uct, many of which are includ­ed in the scopes of LVD, RoHS and WEEE. In the case of the LVD, wire and cable prod­ucts have a direct impact on the safe­ty per­for­mance of many safe­ty-crit­i­cal assem­bles, like cord sets, so per­for­mance of the wire and cable prod­uct is essen­tial to the safe­ty of the end prod­uct.  It’s worth not­ing here that “cables” are includ­ed in the exam­ples [5, Annex II], but “wire”, e.g., an indi­vid­ual insu­lat­ed con­duc­tor, is not men­tioned. This implies that wire does not need to be CE Marked as a com­po­nent.

Is there a manda­to­ry require­ment for the use of CE Marked or marked wire and cable prod­ucts? No. No more so that there is for any oth­er com­po­nent that may be select­ed for use in a CE Marked prod­uct. How­ev­er, it is always rec­om­mend­ed to use CE Marked com­po­nents when­ev­er they are avail­able, as this reduces the like­li­hood of prob­lems relat­ed to these prod­ucts caus­ing issues with the com­pli­ance of the final prod­uct.

Acknowledgements

I’d like to acknowl­edge the con­tri­bu­tions of the fol­low­ing peo­ple to this arti­cle, and offer my thanks for their assis­tance. Some of those list­ed are mem­bers of the IEEE Prod­uct Safe­ty Engi­neer­ing Soci­ety, as well as mem­bers of the EMC-PSTC list:

Mr. Jon Cot­man, Mr. Ted Eck­ert, Mr. John Gav­i­lanes, Mr. Richard Robin­son, Mr. Joshua Wise­man, Mr. John Woodgate.

References

[1] DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machin­ery, and amend­ing Direc­tive 95/16/EC. Brus­sels: Euro­pean Com­mis­sion. 2006.

[2] DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 Decem­ber 2004 on the approx­i­ma­tion of the laws of the Mem­ber States relat­ing to elec­tro­mag­net­ic com­pat­i­bil­i­ty and repeal­ing Direc­tive 89/336/EEC. Brus­sels: Euro­pean Com­mis­sion. 2004.

[3] DIRECTIVE 2006/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 Decem­ber 2006 on the har­mon­i­sa­tion of the laws of Mem­ber States relat­ing to elec­tri­cal equip­ment designed for use with­in cer­tain volt­age lim­its. Brus­sels: Euro­pean Com­mis­sion. 2006.

[4] Inter­na­tion­al Elec­trotech­ni­cal Com­mis­sion (IEC). “Elec­tro­pe­dia: The World’s Online Elec­trotech­ni­cal Vocab­u­lary,”  electropedia.org. [Online]. Avail­able: http://www.electropedia.org [Accessed: 2013-12-19].

[5] L. Mon­toya, Ed. Guide­lines on the Appli­ca­tion of Direc­tive 2006/95/EC (Elec­tri­cal Equip­ment Designed for Use With­in Cer­tain Volt­age Lim­its). August 2007 (Last Mod­i­fied: Jan­u­ary 2012). Avail­able: http://ec.europa.eu/DocsRoom/documents/8716/attachments/1/translations/en/renditions/native. [Accessed: 2015-08-24].

[6] DIRECTIVE 2002/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 Jan­u­ary 2003 on the restric­tion of the use of cer­tain haz­ardous sub­stances in elec­tri­cal and elec­tron­ic equip­ment. Brus­sels: Euro­pean Com­mis­sion. 2002.

[7] DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 on waste elec­tri­cal and elec­tron­ic equip­ment (WEEE). Brus­sels: Euro­pean Com­mis­sion. 2012.

[8] DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restric­tion of the use of cer­tain haz­ardous sub­stances in elec­tri­cal and elec­tron­ic equip­ment. Brus­sels: Euro­pean Com­mis­sion. 2011.

[9] RoHS 2 FAQ. Euro­pean Com­mis­sion, Direc­torate-Gen­er­al Envi­ron­ment. 2012. Avail­able: http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf. Accessed 2013-12-12.

[10] DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restric­tion of the use of cer­tain haz­ardous sub­stances in elec­tri­cal and elec­tron­ic equip­ment, 2011/65/EU. Euro­pean Com­mis­sion, Brus­sels. 2011.

[11] DRAFT Fre­quent­ly Asked Ques­tions on Direc­tive 2012/19/EU on Waste Elec­tri­cal and Elec­tron­ic Equip­ment (‘new WEEE Direc­tive’). Euro­pean Com­mis­sion, Direc­torate-Gen­er­al Envi­ron­ment. Unpub­lished.

IMAGES: Selec­tion of wire and cable prod­ucts, unknown source. HAR mark cour­tesy Ören Kablo.

Understanding European Declarations of Conformity or Incorporation

Updat­ed 2014-10-29

In order to under­stand the var­i­ous types of EU Dec­la­ra­tions, it’s impor­tant to first under­stand a bit about the sys­tem that uses them. Two sys­tems of prod­uct safe­ty eval­u­a­tion are in wide use glob­al­ly: Cer­ti­fi­ca­tion, and Mark­ing. Under­stand­ing the dif­fer­ences between these two sys­tems is impor­tant for any­one who gets involved with reg­u­la­to­ry com­pli­ance activ­i­ties. It’s also impor­tant to know that these Dec­la­ra­tions have no rela­tion­ship to the com­pli­ance dec­la­ra­tions often used in com­mer­cial sup­ply chains. Sup­ply chain dec­la­ra­tions are sim­ply used to make sure that ven­dors attest to the fact that they sup­plied what the cus­tomer ordered. This type of doc­u­ment has no rela­tion­ship to the EU Dec­la­ra­tions dis­cussed here.

Certification vs. Marking

The old­est exist­ing sys­tem for prod­uct safe­ty is the Cer­ti­fi­ca­tion sys­tem. This sys­tem was first intro­duced by William H. Mer­rill [1], [2] in the ear­ly days of Under­writ­ers Lab­o­ra­to­ries [3]. In this sys­tem, an objec­tive third par­ty orga­ni­za­tion reviews the design and con­struc­tion of a prod­uct against the require­ments of an estab­lished stan­dard. Test­ing is nor­mal­ly a part of the eval­u­a­tion process, requir­ing a per­son or orga­ni­za­tion to sub­mit a num­ber of sam­ples of the prod­uct. Some of the sam­ples will nor­mal­ly be destroyed in the test­ing process. Tests can include any aspect of the design relat­ed to safe­ty, which could include the eval­u­a­tion of tox­i­c­i­ty of fin­ish­es, flam­ma­bil­i­ty of plas­tics and oth­er mate­ri­als used in the prod­uct, water and dust tight­ness, volt­age with­stand, etc. The com­po­nents used in the prod­uct will also be assessed. Those that have been assessed before and are “list­ed” may be exempt from fur­ther eval­u­a­tion, unless they are used in a way that is dif­fer­ent from their intend­ed appli­ca­tion (i.e., at a high­er volt­age, a high­er or low­er tem­per­a­ture, etc.). Once the eval­u­a­tion is com­plete and the prod­uct has suc­cess­ful­ly com­plet­ed all the required tests, the cer­ti­fy­ing lab­o­ra­to­ry will issue the man­u­fac­tur­er a license to apply the laboratory’s mark to the prod­uct, and a cer­tifi­cate attest­ing to the product’s con­for­mi­ty with the require­ments is issued, thus the term “cer­ti­fi­ca­tion.” From this point for­ward, the con­struc­tion of the prod­uct is frozen. Any changes to the com­po­nents used or the con­struc­tion of the prod­uct must be reviewed and approved by the cer­ti­fi­er.

The cer­ti­fy­ing lab­o­ra­to­ry will also start a series of reg­u­lar fac­to­ry audits, usu­al­ly on a quar­ter­ly basis, to make sure that the prod­uct con­tin­ues to con­form to the per­for­mance of the orig­i­nal test sam­ples. This is done at the manufacturer’s expense. The fac­to­ry vis­its will con­tin­ue until pro­duc­tion of the prod­uct is dis­con­tin­ued, or the cer­ti­fi­ca­tion is end­ed for anoth­er rea­son. Appli­ca­tion of a cer­ti­fy­ing laboratory’s mark to a prod­uct with­out hav­ing passed through the cer­ti­fi­ca­tion process and obtained the license from the own­er of the mark is fraud. In fact, even putting a mark on your prod­uct that might be con­fused with an exist­ing cer­ti­fi­ca­tion mark can be fraud.

Cur­rent­ly, there are six­teen accred­it­ed prod­uct safe­ty cer­ti­fi­ca­tion bod­ies in Cana­da, and fif­teen Nation­al­ly Rec­og­nized Test­ing Lab­o­ra­to­ries (NRTL) in the USA. Many of the orga­ni­za­tions that are accred­it­ed in the US are also accred­it­ed in Cana­da.

Proportional drawing showing design of EU CE Mark graphic
CE Mark

The “mark­ing” process is a rel­a­tive­ly new sys­tem, intro­duced by the Euro­pean Union (EU) in the 1993 [4] as part of the intro­duc­tion of the EU CE Mark­ing sys­tem. The EU vision includ­ed the elim­i­na­tion of tech­ni­cal bar­ri­ers to trade by cre­at­ing a uni­fied mar­ket with­in the EU Mem­ber States. The “Sin­gle Com­mon Mar­ket” [5] was cre­at­ed in 1987, and this neces­si­tat­ed the har­mo­niza­tion of prod­uct safe­ty require­ments across all of the Mem­ber States. The CE Mark was intro­duced [6] as a sign that the prod­uct met the rel­e­vant prod­uct safe­ty require­ments. As part of this, the EU did not want to add unnec­es­sary cost for man­u­fac­tur­ers, so rather than imple­ment­ing a cer­ti­fi­ca­tion sys­tem like that used in North Amer­i­ca, it was decid­ed to use a “self-declara­to­ry” process [7] for every­thing except the most haz­ardous prod­ucts. Man­u­fac­tur­ers would be required to deter­mine what prod­uct safe­ty laws, called Direc­tives, applied to their prod­ucts, and fur­ther­more what tech­ni­cal stan­dards applied to their prod­ucts. Stan­dards were har­mo­nized under the var­i­ous direc­tives, and these doc­u­ments, with num­bers start­ing with “EN”, were giv­en spe­cial sta­tus. Use of har­mo­nized EN stan­dards in the design and man­u­fac­ture of a prod­uct con­fers a “pre­sump­tion of con­for­mi­ty” with the directive(s) under which the stan­dard is har­mo­nized. Not all EN stan­dards are har­mo­nized. A list of har­mo­nized stan­dards is pub­lished about once a year for each Direc­tive in the C ver­sion of the EU offi­cial jour­nal. Only those stan­dards, ref­er­enced by date, allow for pre­sump­tion of con­for­mi­ty with the essen­tial require­ments of the direc­tive [13]. You can find the lists of Har­mo­nized Stan­dards here.

Once the man­u­fac­tur­er is sat­is­fied that all the required mea­sures have been tak­en, and has com­piled a Tech­ni­cal File for the prod­uct, the CE Mark can be placed on the prod­uct, an EU Dec­la­ra­tion issued and the prod­uct shipped.

Declarations

Under the CE Mark­ing sys­tem, the manufacturer’s dec­la­ra­tion is a con­tract between the man­u­fac­tur­er of a prod­uct and the EU Mem­ber State(s) in which the prod­uct is sold. Depend­ing on the Direc­tives that apply to the prod­uct there are a few pos­si­ble vari­a­tions on what is required:

Direc­tive Dec­la­ra­tion of Con­for­mi­ty Dec­la­ra­tion of Incor­po­ra­tion
Machin­ery X X*
Low Volt­age X
EMC X
PED X**

*Under the Machin­ery Direc­tive, Par­tial­ly Com­plet­ed Machin­ery does not receive a CE Mark, although it is required to have a Dec­la­ra­tion of Incor­po­ra­tion.

**Under the Pres­sure Equip­ment Direc­tive, prod­ucts falling into the Sound Engi­neer­ing Prac­tice (SEP) clas­si­fi­ca­tion are not CE Marked under the PED.

There are unique cir­cum­stances under the indi­vid­ual direc­tives that are too detailed to go into here, but it is impor­tant to under­stand that there are vari­a­tions between Direc­tives.

As with almost any top­ic in the reg­u­la­to­ry field, there are stan­dards that apply to the struc­ture and con­tent of Dec­la­ra­tions. In this case EN ISO/IEC 17050–1 [8] and EN ISO/IEC 17050–2 [9]. These stan­dards lay out the gen­er­al require­ments for the struc­ture and con­tent of the manufacturer’s dec­la­ra­tions. In addi­tion, each Direc­tive has an Annex that describes the spe­cif­ic types of dec­la­ra­tions that are per­mit­ted (Dec­la­ra­tion of Con­for­mi­ty or Dec­la­ra­tion of Incor­po­ra­tion), and the con­tent of the Dec­la­ra­tion. If you are inter­est­ed in the ratio­nale for the use of these stan­dards, you must track back to Deci­sion 768/2008 [10] and Reg­u­la­tion 765/2008/EC [11]. The Deci­sion and the asso­ci­at­ed reg­u­la­tion set out the require­ments for accred­i­ta­tion and mar­ket sur­veil­lance in the EU Com­mon Mar­ket, and resides in at a lev­el above the Sec­tor Direc­tives like the Machin­ery, Low Volt­age or EMC Direc­tives. Under this reg­u­la­tion is a list of har­monised stan­dards, and that list includes the EN ISO/IEC 17050 stan­dards. Note that the linked doc­u­ment was cur­rent as of 2014-10-29 and may have been updat­ed since then.

EC Declaration…” or “EU Declaration…”?

The Euro­pean Union has gone through sev­er­al dif­fer­ent iden­ti­ties since it was orig­i­nal­ly formed in the 1950’s. The orig­i­nal six coun­tries came togeth­er in 1953 as the Euro­pean Steel and Coal Com­mu­ni­ty. In 1958, the Treaty of Rome cre­at­ed the Euro­pean Eco­nom­ic Com­mu­ni­ty (EEC), and then in 1993 the Maas­trict Treaty cre­at­ed the Euro­pean Union (EU) [10].  Upon the entry into force of the Maas­tricht Treaty in 1993, the EEC was renamed the Euro­pean Com­mu­ni­ty (EC) to reflect that it cov­ered a wider range of pol­i­cy. This was also when the three Euro­pean Com­mu­ni­ties, includ­ing the EC, were col­lec­tive­ly made to con­sti­tute the first of the three pil­lars of the Euro­pean Union (EU), which the treaty also found­ed. The EC exist­ed in this form until it was abol­ished by the 2009 Treaty of Lis­bon, which merged the EU’s for­mer pil­lars and pro­vid­ed that the EU would “replace and suc­ceed the Euro­pean Com­mu­ni­ty” [12]. So in all cas­es, dec­la­ra­tions should bear the title “EU Dec­la­ra­tion of…”, regard­less of what you find in the cur­rent edi­tions of the Direc­tives. This is a fine tech­ni­cal point, and should not result in your dec­la­ra­tion being reject­ed by cus­toms inspec­tors. If you want to get things right, make sure your doc­u­ments say “EU”.

NOTE (updat­ed 9-Dec-13) — Some author­i­ties in the EU dis­agree with this, based on the real­i­ty that the Nation­al Trans­po­si­tions of the Direc­tives (the Nation­al imple­men­ta­tions of the EU Direc­tives) still say “EC”, and until / if they are updat­ed the most cor­rect answer to this ques­tion is to fol­low the text of the Nation­al Trans­po­si­tions of the Direc­tives. In my opin­ion, this flies in the face of the intent to elim­i­nate tech­ni­cal bar­ri­ers to trade by har­mo­niz­ing the legal and tech­ni­cal require­ments, how­ev­er, it is a rel­a­tive­ly triv­ial tech­ni­cal point, and not one that should result in the rejec­tion of a Dec­la­ra­tion by the Author­i­ties. If it did, I would rec­om­mend strong­ly chal­leng­ing the rejec­tion through the appro­pri­ate chan­nels. [13], [15].

Use of Logos and the CE Mark on Declarations

There is noth­ing that I could find that pro­hibits or requires the use of cor­po­rate logos on Dec­la­ra­tions. My usu­al guid­ance to clients is to pub­lish their Dec­la­ra­tions on com­pa­ny let­ter­head, since the dec­la­ra­tion is a de-fac­to con­tract, and should there­fore be pub­lished on offi­cial sta­tionery. This is not a require­ment, just good prac­tice in my opin­ion.

I’ve seen many Dec­la­ra­tions that also bear the CE Mark. EN ISO/IEC 17050–1 sug­gests that marks placed on the prod­uct should be ref­er­enced by and trace­able to the Dec­la­ra­tion, and that the mark may be shown in an attach­ment if desired [8, A.1, 6)]. Show­ing the mark on the face of the dec­la­ra­tion is nei­ther required nor explic­it­ly pro­hib­it­ed, but in my opin­ion, oth­er than attach­ing a draw­ing of the mark to the Dec­la­ra­tion, I would not use it in this way. The mark is intend­ed to be placed on the prod­uct and should be reserved for that pur­pose.

Summary

Sum­ming up the dis­cus­sion, EU Dec­la­ra­tions:

  • should be based on EN ISO/IEC 17050–1 and sup­port­ed by doc­u­men­ta­tion (e.g., a Tech­ni­cal File) as laid out EN ISO/IEC 17050–2 and the rel­e­vant Annex­es to the applic­a­ble direc­tives.
  • should state “EU Dec­la­ra­tion of Con­for­mi­ty” or “EU Dec­la­ra­tion of Incor­po­ra­tion” as appro­pri­ate
  • shall include the rel­e­vant state­ments from the direc­tives (i.e., “a sen­tence express­ly declar­ing that the machin­ery ful­fils all the rel­e­vant pro­vi­sions of this Direc­tive and where appro­pri­ate, a sim­i­lar sen­tence declar­ing the con­for­mi­ty with oth­er Direc­tives and/or rel­e­vant pro­vi­sions with which the machin­ery com­plies. These ref­er­ences must be those of the texts pub­lished in the Offi­cial Jour­nal of the Euro­pean Union;” and “ a sen­tence declar­ing which essen­tial require­ments of this Direc­tive are applied and ful­filled and that the rel­e­vant tech­ni­cal doc­u­men­ta­tion is com­piled in accor­dance with part B of Annex VII, and, where appro­pri­ate, a sen­tence declar­ing the con­for­mi­ty of the part­ly com­plet­ed machin­ery with oth­er rel­e­vant Direc­tives. These ref­er­ences must be those of the texts pub­lished in the Offi­cial Jour­nal of the Euro­pean Union;” [14])
  • shall car­ry a list­ing of the rel­e­vant direc­tives
  • may include the manufacturer’s logo, but use of let­ter­head is unclear
  • shall include the manufacturer’s infor­ma­tion AND the EU Autho­rized Representative’s infor­ma­tion
  • should be includ­ed as a hard­copy with the ship­ping paper­work
  • should be includ­ed in the prod­uct doc­u­men­ta­tion
  • may be made avail­able on the com­pa­ny web site (many man­u­fac­tur­ers do this)
  • shall include all of the rel­e­vant infor­ma­tion as laid out in the Annex­es to the rel­e­vant Direc­tives.

References

[1]     “William Hen­ry Mer­rill,” Wikipedia [online]. Avail­able: http://en.wikipedia.org/wiki/William_Henry_Merrill. Accessed: 2013-11-20.

[2]     “His­to­ry,” Under­writ­ers Lab­o­ra­to­ries [online]. Avail­able: http://ul.com/aboutul/history/. Accessed: 2013-11-20.

[3]     “UL (safe­ty orga­ni­za­tion),” Wikipedia [online]. Avail­able: http://en.wikipedia.org/wiki/Underwriters_Laboratories. Accessed: 2013-11-20.

[4]     “Coun­cil Direc­tive 93/68/EEC of 22 July 1993”, Ed. Euro­pean Union: Eur-Lex [online], 1993. Avail­able: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:en:HTML. Accessed: 2013-11-20.

[5]     “One mar­ket with­out bor­ders,” Ed. Euro­pean Union: europa.eu [online], 2013. Avail­able: http://europa.eu/pol/singl/. Accessed: 2013-11-20.

[6]     “CE Mark­ing,” ed: Enter­prise and Indus­try Direc­torate, Euro­pean Com­mis­sion, [online]. Avail­able: http://ec.europa.eu/growth/single-market/ce-marking/. Accessed: 2013-11-20

[7]     Guide to the imple­men­ta­tion of direc­tives based on the New Approach and the Glob­al Approach. Lux­em­bourg: Office for Offi­cial Pub­li­ca­tions of the Euro­pean Com­mu­ni­ties, 2000.

[8]     “Con­for­mi­ty assess­ment — Supplier’s dec­la­ra­tion of con­for­mi­ty — Part 1: Gen­er­al require­ments,” ed. Gene­va: ISO Stan­dard 17050–1, 2004.

[9]     “Con­for­mi­ty assess­ment — Supplier’s dec­la­ra­tion of con­for­mi­ty — Part 2: Sup­port­ing doc­u­men­ta­tion,” ed. Gene­va: ISO Stan­dard 17050–2, 2004.

[10]   Deci­sion No 768/2008/EC of the Euro­pean Par­lia­ment and of the Coun­cil of 9 July 2008 on a com­mon frame­work for the mar­ket­ing of prod­ucts, and repeal­ing Coun­cil Deci­sion 93/465/EEC. Ed. Euro­pean Union: Eur-Lex [online], 2008. Avail­able: http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32008D0768, Accessed: 2018-10-29.

[11]     Reg­u­la­tion (EC) No 765/2008 of the Euro­pean Par­lia­ment and of the Coun­cil of 9 July 2008 set­ting out the require­ments for accred­i­ta­tion and mar­ket sur­veil­lance relat­ing to the mar­ket­ing of prod­ucts and repeal­ing Reg­u­la­tion (EEC) No 339/93 (Text with EEA rel­e­vance). Ed. Euro­pean Union: Eur-Lex [online], 2008. Avail­able: http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1414598701798&uri=CELEX:32008R0765. Accessed: 2018-10-29.

[12]     “The Euro­pean Union in Slides,” Ed. Lux­em­bourg: Euro­pean Com­mis­sion, 2013.

[13]     D. E. Pow­ell, “Re: [PSES] Reject­ed Man­u­fac­tur­er Dec­la­ra­tions,” D. Nix, Ed., per­son­al email, 2013.

[14]     “DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machin­ery, and amend­ing Direc­tive 95/16/EC (recast)”, ed. Euro­pean Union: Eur-Lex, 2006.Available: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:0086:EN:PDF. Accessed: 2013-11-20.

[15]   G. Grem­men, “Re: [PSES] Reject­ed Man­u­fac­tur­er Dec­la­ra­tions,” D. Nix, Ed., per­son­al email, 2013.

Acknowledgements

This arti­cle came about because a client of mine had some ques­tions regard­ing dec­la­ra­tions. I put the ques­tion to the mem­bers of the IEEE Prod­uct Safe­ty Soci­ety’s EMC-PSTC list, a group of over 650 expe­ri­enced prod­uct safe­ty pro­fes­sion­als, to ver­i­fy and val­i­date my opin­ion before i respond­ed to my client. I want to acknowl­edge con­tri­bu­tions to the dis­cus­sion by the fol­low­ing mem­bers of that list, in alpha­bet­i­cal order: Gert Grem­men, Bri­an Kunde, Chuck McDow­ell, Bri­an O’Connel, Dou­glas E. Pow­ell, Mark Schmidt, Joshua E. Wise­man, John Woodgate, and Sam Yoga­sun­thu­ram.

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Get the Basics Right!

For more than 15 years I’ve been teach­ing peo­ple about risk assess­ment, machin­ery safe­ty and CE Mark­ing of machin­ery in pri­vate, onsite class­es and through pre­sen­ta­tions at safe­ty con­fer­ences. Things are about to change!

This fall, Com­pli­ance InSight Con­sult­ing will begin offer­ing open-enrol­ment work­shops in CE Mark­ing, Risk Assess­ment Func­tion­al Safe­ty, and Machin­ery Safe­ty, all with a focus on indus­tri­al machin­ery. These cours­es will be hands-on events, with stu­dents engaged in work­shop activ­i­ties through­out eachTraining event event.

In the win­ter, these work­shops will also migrate to our on-line edu­ca­tion plat­form, so stu­dents in any loca­tion around the world can access our train­ing pro­grams.

This is an excit­ing step for CIC, and the work­shops we have planned are engag­ing, dynam­ic and infor­ma­tion packed.

Watch the blog, and sub­scribe to our mail­ing list to be the first to know when reg­is­tra­tion opens. Work­shops will be lim­it­ed size, first-come, first-served. We’ll announce dates and loca­tions in ear­ly August!