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,”  elec​tro​pe​dia​.org. [Online]. Available: http://​www​.elec​tro​pe​dia​.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/​D​o​c​s​R​o​o​m​/​d​o​c​u​m​e​n​t​s​/​8​7​1​6​/​a​t​t​a​c​h​m​e​n​t​s​/​1​/​t​r​a​n​s​l​a​t​i​o​n​s​/​e​n​/​r​e​n​d​i​t​i​o​n​s​/​n​a​t​ive. [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/​e​n​v​i​r​o​n​m​e​n​t​/​w​a​s​t​e​/​r​o​h​s​_​e​e​e​/​p​d​f​/​f​a​q​.​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​.wiki​pe​dia​.org/​w​i​k​i​/​W​i​l​l​i​a​m​_​H​e​n​r​y​_​M​e​r​r​ill. Accessed: 2013-​11-​20.

[2]     “History,” Underwriters Laboratories [online]. Available: http://​ul​.com/​a​b​o​u​t​u​l​/​h​i​s​t​o​ry/. Accessed: 2013-​11-​20.

[3]     “UL (safety organ­iz­a­tion),” Wikipedia [online]. Available: http://​en​.wiki​pe​dia​.org/​w​i​k​i​/​U​n​d​e​r​w​r​i​t​e​r​s​_​L​a​b​o​r​a​t​o​r​ies. 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/​L​e​x​U​r​i​S​e​r​v​/​L​e​x​U​r​i​S​e​r​v​.​d​o​?​u​r​i​=​C​E​L​E​X​:​3​1​9​9​3​L​0​0​6​8​:​e​n​:​H​TML. Accessed: 2013-​11-​20.

[5]     “One mar­ket without bor­ders,” Ed. European Union: europa​.eu [online], 2013. Available: http://​europa​.eu/​p​o​l​/​s​i​n​gl/. Accessed: 2013-​11-​20.

[6]     “CE Marking,” ed: Enterprise and Industry Directorate, European Commission, [online]. Available: http://​ec​.europa​.eu/​g​r​o​w​t​h​/​s​i​n​g​l​e​-​m​a​r​k​e​t​/​c​e​-​m​a​r​k​i​ng/. 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/​l​e​g​a​l​-​c​o​n​t​e​n​t​/​E​N​/​A​L​L​/​?​u​r​i​=​C​E​L​E​X​:​3​2​0​0​8​D​0​768, 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/​l​e​g​a​l​-​c​o​n​t​e​n​t​/​E​N​/​T​X​T​/​?​q​i​d​=​1​4​1​4​5​9​8​7​0​1​7​9​8​&​a​m​p​;​u​r​i​=​C​E​L​E​X​:​3​2​0​0​8​R​0​765. 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/​L​e​x​U​r​i​S​e​r​v​/​L​e​x​U​r​i​S​e​r​v​.​d​o​?​u​r​i​=​O​J​:​L​:​2​0​0​6​:​1​5​7​:​0​0​2​4​:​0​0​8​6​:​E​N​:​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.

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!