Understanding European Declarations of Conformity or Incorporation

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 currently 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 ensure 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 article.

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 previously 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.

Listing vs Marking
Listing vs Marking

The certifying laboratory will also institute a series of regular factory audits, usually on a quarterly basis, to ensure that the product that is being marked continues to conform the those that were originally tested. 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.

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 at https://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/.

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:

DirectiveDeclaration of ConformityDeclaration of Incorporation
MachineryXX
Low VoltageX
EMCX
PEDX

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 ISO/IEC 17050–1 (8) and ISO/IEC 17050–2 (9). These standards lay out the general requirements for the structure and content of 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.

“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” (11). 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”.

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 stationary. This is not a requirement, just good practice in my opinion.

I’ve seen many Declarations that also bear the CE Mark. 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 layed 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
  • must 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;” (12)
  • must carry a listing of the relevant directives
  • may include the manufacturer’s logo, but use of letterhead is unclear
  • must 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)
  • must include all of the relevant information as laid out in the Annexes to the relevant Directives.

References

(1) “William Henry Merrill,” Wikipedia. Available: https://en.wikipedia.org/wiki/William_Henry_Merrill. Accessed: 2013–11–20.

(2) “History,” Underwriters Laboratories. Available: https://www.ul.com/global/eng/pages/aboutul/history/. Accessed: 2013–11–20.

(3) “UL (safety organization),” Wikipedia. Available: https://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, 1993. Available: https://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, 2013. Available: https://europa.eu/pol/singl/. Accessed: 2013–11–20.

(6) “CE Marking,” ed: Enterprise and Industry Directorate, European Commission. Available: https://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/index_en.htm. 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) “The European Union in Slides,” ed. Luxembourg: European Commission, 2013.

(11) D. E. Powell, “Re: [PSES] Rejected Manufacturer Declarations,” D. Nix, Ed., personal email, 2013.

(12) “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: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:0086:EN:PDF. Accessed: 2013–11–20.

(13) G. Gremmen, “Re: [PSES] Rejected Manufacturer Declarations,” D. Nix, Ed., personal email, 2013.

Acknowledgments

This article came about because a client of mine had questions regarding European declarations. To verify and validate my opinion, 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, 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, Sam Yogasunthuram,

This article was originally published 2013–11–20 on the Machinery Safety 101 blog: https://machinerysafety101.com/2013/11/20/understanding-european-declarations-conformity-incorporation/

Author: Doug Nix

2 thoughts on “Understanding European Declarations of Conformity or Incorporation”

  1. Some things not perfectly true, from experience the UL audit frequency can be very much like a sampling plan strategy i.e. non compliance = more regular than quarterly and manufacturing quantity dependant. We in the UK used to be audited roughly monthly with special follow ups as required our north American colleagues actually had a resident UL inspector to such an extent he had a desk internet and telephone at our site.
    Mention of manufacturing site assessment and approval is missing.
    UL scheme is quite different from EU and is far more involved from a UL perspective. I think the clue is in the name i.e. Underwriters.
    CE mark so you carry out your test according to a CE marking standard and it passes but the item is never used as a stand alone part and can only be used in another device. The first part says you can legally mark with CE but the second part says you can not so what to do? simple mark the packing but not the device and advise of the compliance to the marking standard in the documentation. Apparently marking the item could be confused with its finished assembly being CE accredited when it may not be.
    I like your brief introduction to the EU-EEC. Being in the UK and fairly aged I have witnessed all sorts of insane conveniences that the UK have implemented trying to dilute EU requirements and also the EU. Examples chocolate versus chocolate flavour, sausages that are not (bizarrely due to lack of meat in the UK) and from the EU bananas that are too bent. You missed the EFTA part of the EU story but I guess it’s days are numbered.
    “The mark is intended to be placed on the product and should be reserved for that purpose.” I would be inclined to agree whole heartedly with this statement. Apart from definitions of what the mark should look like it should be reserved for identifying things that are CE and I suppose ultimately it is the manufacturers guarantee of compliance to all applicable directives.
    You mention UL listed but they also have classified and now certified classes.
    https://www.ul.com/global/eng/pages/

    Reply
    • Andrew,

      Great points, thank you. You are correct, I did skip over the details of the UL / CSA site approval process, as I was simply trying to clearly delineate the difference between a certification process and a self-declaratory marking process.

      Factory audit schedules are always based on “need”, as defined by the certifying body. If there have been non-conformance problems with marked product from a given facility, you can be sure that there will be additional audits, until such time as the certifier feels comfortable that the facility has control of the process.

      There are a number of permutations and combinations of certification and listing under the NRTL system, of which UL is a part, but an in-depth discussion of these variations wasn’t that relevant to the key point: EU Declarations.

      The “Underwriters” in the the name “Underwriters Laboratories” is part of the company’s history: The company was originally formed in 1894 by William H. Merrill (https://en.wikipedia.org/wiki/UL_(safety_organization) and https://en.wikipedia.org/wiki/William_Henry_Merrill), an electrical engineer working in the Chicago area, around the time of the World’s Columbian Exhibition in Chicago in 1893 (https://en.wikipedia.org/wiki/World's_Columbian_Exposition). He was hired by the insurance carriers covering the Fair to investigate fires in the Electrical Exhibition. UL was born from those early investigations, but is not owned or controlled by any insurer.

      You are correct also regarding EFTA. I chose to leave it out because it was a free trade agreement, similar in some ways to the US-Canada FTA. Not a political union, but rather a commerce-based agreement. The other stages I did discuss were the seminal political treaties leading to the formation of the EU as we know it today.

      With regard to marking of components, it’s important to understand that they may only be marked if the fall within the scope of a directive that requires CE marking. One of the examples that comes immediately to mind is the wire and cable products used everywhere. At this point, there is no EU Directive that includes wire and cable in its scope, including the Low Voltage Directive, so therefore there is no valid way to CE Mark wire or cable. There are harmonized requirements for these products (HD 21.X and HD22.X, which are being replaced by EN 50525 standards), but these documents are not currently listed as harmonized under any directive.)

      Reply

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