Machinery Safety 101

Understanding European Declarations of Conformity or Incorporation

Updated 2021-04-06

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 two sys­tems for con­form­ity assess­ment in use today are cer­ti­fic­a­tion and mark­ing. There are sig­ni­fic­ant dif­fer­ences between these sys­tems, so let’s have a look at each.

Certification

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

Test­ing is nor­mally a part of the eval­u­ation pro­cess. A num­ber of samples of the product must be sub­mit­ted for test­ing, com­monly 10 samples for smal­ler products, but this can vary widely depend­ing on the tests that must be com­pleted, fail­ures encountered, etc. 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. 

Component evaluation

The com­pon­ents used in the product will also be assessed. Those that have been assessed before by the com­pon­ent man­u­fac­turer and which 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 cer­ti­fic­a­tion 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.

Since the use of the mark is licensed by the cer­ti­fi­er, they own the mark and can dic­tate any terms for the use of the mark that they wish. The man­u­fac­turer does not “own” the certification.

Certification audits

The cer­ti­fy­ing labor­at­ory will start a series of reg­u­lar fact­ory audits, usu­ally on a quarterly basis, to make sure that the pro­duc­tion pro­cesses used by the man­u­fac­turer are con­sist­ent and cap­able of pro­du­cing the cer­ti­fied product. They will also audit some product samples to veri­fy that the product con­tin­ues to meet the con­struc­tion require­ments and that the product con­tin­ues to per­form sim­il­arly to the ori­gin­al test samples. These audits are 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 a fraud.

At this writ­ing, 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.

Transfer of liability

One last myth to bust with respect to cer­ti­fic­a­tion. Many man­u­fac­tur­ers believe that by cer­ti­fy­ing their product that they have some­how magic­ally trans­ferred their product liab­il­ity to the cer­ti­fy­ing body. This is simply not true. The man­u­fac­turer is always 100% respons­ible for the safety of the product. Cer­ti­fic­a­tion is evid­ence of due-dili­gence on the part of the man­u­fac­turer, how­ever, the cer­ti­fi­er­’s liab­il­ity is strictly lim­ited in the cer­ti­fic­a­tion agree­ments. Usu­ally the lim­it­a­tion is to the spe­cif­ic ser­vices provided, i.e., the test­ing and exam­in­a­tions, how­ever, even then there are “out clauses” that pro­tect the cer­ti­fy­ing body. Don’t fall into the trap of think­ing that you need­n’t worry about your pro­duct’s safety because you had it certified.

Marking

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 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 meets the rel­ev­ant product safety require­ments. As part of this, the EU did not want to add unne­ces­sary costs and red-tape 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. 

Product liability

As part of the pro­gram, the EU passed the Liab­il­ity Dir­ect­ive [16] in 1985. This legis­la­tion required that

  • man­u­fac­tur­ers only place products on the mar­ket that were safe
  • products would provide the “level of safety that a per­son is entitled to expect.”

The level of safety that a per­son is entitled to expect is set by the Essen­tial Health and Safety Require­ments (EHSRs) that are defined in the product or sec­tor dir­ect­ives. [16] has been amended over the years but remains in force. There is a Decision that sup­ports the applic­a­tion of the Liab­il­ity Dir­ect­ive [10], and a Reg­u­la­tion [11] allow­ing the European Com­mis­sion to adjust the way the Liab­il­ity Dir­ect­ive is applied without hav­ing to go back to the EU Par­lia­ment for amend­ing legis­la­tion. This allows for much quick­er cor­rec­tion of prob­lems that become appar­ent once the reg­u­la­tions are put into practice.

Directives

Under the CE Mark­ing sys­tem, 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

Stand­ards would be har­mon­ized under the vari­ous dir­ect­ives, and these doc­u­ments, with num­bers start­ing with “EN”, were giv­en spe­cial status. The 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 a pre­sump­tion of con­form­ity with the essen­tial require­ments of the dir­ect­ive [13]. You can find the lists of Har­mon­ized Stand­ards here.

If a man­u­fac­turer does not want to use har­mon­ized stand­ards, they can use oth­er stand­ards e.g., ANSI, CSA, etc. How­ever, they are then required to jus­ti­fy the use of the oth­er standard(s) by writ­ing an engin­eer­ing rationale explain­ing the choice and describ­ing how the selec­ted standard(s) show com­pli­ance with the rel­ev­ant EHSRs.

If there are NO stand­ards that apply, per­haps because the tech­no­logy is too new, or so innov­at­ive that it does not resemble any­thing that came before, it is pos­sible to CE Mark using no stand­ards at all. As you might expect, the level of engin­eer­ing explan­a­tion required to show com­pli­ance with the EHSRs is even great­er than what is required for either of the pre­vi­ous routes (har­mon­ized stand­ards or non-har­mon­ized standards.)

Conformity assessment

Con­form­ity assess­ment is done by apply­ing all of the require­ments of the stand­ards selec­ted for the product. If there is test­ing or oth­er veri­fic­a­tion and val­id­a­tion activ­it­ies done, all of these activ­it­ies must be documented. 

CE Marking

Once the man­u­fac­turer is sat­is­fied that all the applic­able EHSRs for all of the applic­able dir­ect­ives have been met and com­piled a Tech­nic­al File for the product, the CE Mark can be placed on the product. An EU Declar­a­tion can be issued and the product shipped.

Other kinds of marking systems

In Canada, the fed­er­al Min­istry of Innov­a­tion, Sci­ence and Eco­nom­ic Devel­op­ment, formerly called Industry Canada, uses man­u­fac­turer­’s self-declar­a­tion and mark­ing for products fall­ing with­in the scope of some of the ICES stand­ards (ICES-001 and ICES-003). 

In the USA, the FCC uses man­u­fac­turer self-declar­a­tion and mark­ing for some classes of products. The com­mon FCC Class B mark­ing seen on all kinds of products is an example.

EU 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:

Dir­ect­iveDeclar­a­tion of Con­form­ityDeclar­a­tion 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 the 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.

[16] COUNCIL DIRECTIVE of 25 July 1985 on the approx­im­a­tion of the laws, reg­u­la­tions and admin­is­trat­ive pro­vi­sions of the Mem­ber States con­cern­ing liab­il­ity for defect­ive products (85/374/EEC), OJ L 210, p. 29. [online]. Brus­sels: European Com­mis­sion, 1985. Avail­able: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31985L0374. [Accessed: 2021-04-06].

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.