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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Author: Doug Nix

Doug Nix is Managing Director and Principal Consultant at Compliance InSight Consulting, Inc. (http://www.complianceinsight.ca) in Kitchener, Ontario, and is Lead Author and Senior Editor of the Machinery Safety 101 blog. Doug's work includes teaching machinery risk assessment techniques privately and through Conestoga College Institute of Technology and Advanced Learning in Kitchener, Ontario, as well as providing technical services and training programs to clients related to risk assessment, industrial machinery safety, safety-related control system integration and reliability, laser safety and regulatory conformity. For more see Doug's LinkedIn profile.