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.

Author: Doug Nix

+DougNix is Managing Director and Principal Consultant at Compliance InSight Consulting, Inc. (http://www.complianceinsight.ca) in Kitchener, Ontario, and is Lead Author and Managing 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.

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