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.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.

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.

Get the Basics Right!

For more than 15 years I’ve been teaching people about risk assessment, machinery safety and CE Marking of machinery in private, onsite classes and through presentations at safety conferences. Things are about to change!

This fall, Compliance InSight Consulting will begin offering open-enrolment workshops in CE Marking, Risk Assessment Functional Safety, and Machinery Safety, all with a focus on industrial machinery. These courses will be hands-on events, with students engaged in workshop activities throughout eachTraining event event.

In the winter, these workshops will also migrate to our on-line education platform, so students in any location around the world can access our training programs.

This is an exciting step for CIC, and the workshops we have planned are engaging, dynamic and information packed.

Watch the blog, and subscribe to our mailing list to be the first to know when registration opens. Workshops will be limited size, first-come, first-served. We’ll announce dates and locations in early August!

New HSE advice on CE marking assemblies of machinery

This post was originally published on machinebuilding.net. Reprinted with permission.

By Jon Severn, machinebuilding.net

Guarded machinery in a plantA degree of confusion surrounds the question of CE marking assemblies of machinery under the Machinery Directive 2006/42/EC. To help clarify the situation, the HSE (Health and Safety Executive) has published a new page on its website entitledIn situ manufacture or assembly of work equipment and plant. This contains plenty of useful information for machine builders, system integrators, line builders and end users. Without wishing to repeat the contents in their entirety, the following highlights some of the more important points relating to assemblies of machinery and the addition of new machinery to existing assemblies.

What is an ‘assembly of machinery’?

As the HSE web page explains, an assembly of machines must be CE marked as a whole when individual machines are linked in order to perform a common function, when those machines are interconnected so that an individual machine (or element) affects the operation of others such that the whole needs to be risk-assessed, and when there is a common control system for the constituent units. On the other hand, if the connected machines function independently, this is not considered to be an assembly of machines for the purpose of CE marking to the Machinery Directive.

What about an entire plant?

The HSE says that a complete industrial plant comprising many individual machines, assemblies of machines and other equipment should be treated as separate sections, with any risks at the interfaces covered by installation instructions.

The responsible ‘manufacturer’

Assemblies of machines must be CE marked as a whole by the responsible ‘manufacturer’ – which might be the system integrator, line builder or end user, whether or not they have manufactured the constituent units. If the individual units are capable of operating independently then they should be CE marked and be accompanied by a Declaration of Conformity (DoC); if they are placed on the market as partly completed machinery (intended for incorporation within an assembly of machinery, for example), then they should not be CE marked but they should be accompanied by a Declaration of Incorporation (Dol) and assembly instructions.

Extent of responsibilities

According to the HSE, a ‘manufacturer’ who is creating an assembly of machines is not responsible for the design of the individual machines and partly completed machines, provided the ‘manufacturer’ has checked that the equipment came with a DoC or Dol and adequate instructions (covering installation, operation, maintenance, etc), is CE marked where appropriate, and is free from ‘obvious’ defects (the HSE gives the example of damaged or missing guards).

Adding new machinery to old assemblies

So far we have considered only new assemblies of machinery, but the HSE web page for In Situ Manufacture also addresses the question of assemblies comprising new and existing machinery – as might be the case when a line is being modified, upgraded or extended. Whether or not the whole assembly needs to be reassessed under the Machinery Directive will depend on ta number of factors, so the HSE directs readers to the European Commission’s official Guide to the Machinery Directive 2006/42/EC. However, the HSE’s new web page does state ‘where a new machine is added to an assembly you do not have to re-asses those other machines in the assembly which are not affected in any way.’ Having said that, bear in mind that employers have certain duties under the Provision and Use of Work Equipment Regulations (PUWER), which may have implications for older machinery whether or not it is being modified.

More information is available on the HSE website, in the EC’s official Guide to the Machinery Directive, and in various machinery safety guides and White Papers published by Procter Machine Guarding.

Thanks to Jonathan Severn at machinebuilding.net!

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