Understanding European Declarations of Conformity or Incorporation

Updated 2021-04-06

To understand the various types of EU Declarations, it’s important first to understand the system that uses them. Two product safety evaluation systems are widely used globally: Certification and Marking. Understanding the differences between these two systems is important for anyone 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 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 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. Several product samples must be submitted for testing, commonly ten samples for smaller products. However, 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 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 product’s construction must be reviewed and approved by the certifier.

Since the certifier licenses the mark, they own it and can dictate any terms for using the mark 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 ensure that the manufacturing processes 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. Even putting a mark on your product that might be confused with an existing certification mark can be 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 concerning certification. Many manufacturers believe that by certifying their product, 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 manufacturer’s part; 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, necessitating the harmonization of product safety requirements across all 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 a person is entitled to expect is set by the Essential Health and Safety Requirements (EHSRs) 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 correcting of problems that become apparent once the regulations are implemented.

Directives

Under the CE Marking system, manufacturers must determine what product safety laws, called Directives, are applied to their products and what technical standards are applied to them.

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 annually 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 must then justify using 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 NO standards 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 engineering explanation required to show compliance with the EHSRs is even greater than what is required for either of the previous routes (harmonized or non-harmonized standards.)

Conformity assessment

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

CE Marking

Once the manufacturer is satisfied that all the applicable EHSRs for all 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, some standards 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 permitted (Declaration of Conformity or Declaration of Incorporation) and the Declaration’s content. 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 reside above the Sector Directives like the Machinery, Low Voltage or EMC Directives. Under this regulation is a list of harmonized standards, including 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 1950s. 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 policies. 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, ensure 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 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. I would recommend strongly challenging the rejection through the appropriate channels if it did. [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 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. Still, in my opinion, other than attaching a drawing of the mark to the Declaration, I would not use it 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; a sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled per 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 website (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.

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