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.


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

*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.


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.


[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.


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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