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.