In March of this year, the European Commission, the executive body of the European Union, published its latest “Guide for the EMC Directive.”1 Updated to reflect the 2014 recast of the Directive, the Guide addresses various issues, not least what constitutes “inherently benign equipment” and “custom built evaluation kits.” This article reviews the content of the new Guide, highlighting key changes from the previous edition of the Guide published in 2010.
Background on the EMC Directive and the New Legislative Framework
The EMC Directive is a longstanding EU law subject to periodic revision. The most recent update occurred in 2014, when the Directive was recast to align it with the New Legislative Framework (NLF).
The NLF supersedes the New Approach to Technical Harmonization and Standards (“New Approach”) that had, from the mid-1980s onwards, provided for the setting of essential requirements in product legislation with more detailed rules regarding the application of these requirements to then be worked out and set in standards. The legislation would carry a presumption of conformity that could be invoked by product manufacturers when applicable, officially-referenced standards (harmonized standards) were followed in product design and manufacture. In other words, any product made to meet the requirements of applicable harmonized standards could be assumed to comply with the essential requirements of the law. When first published in 1989, the EMC Directive constituted a “New Approach Directive.”
The NLF retains many of the concepts in the New Approach, not least of which are the concepts of essential requirements, CE marking, harmonized standards and the presumption of conformity.
However, the NLF evolves the framework by stipulating that NLF laws apply to four different types of economic operator: manufacturers, the authorized representatives of manufacturers, importers and distributors.
With this in mind, the recast EMC Directive of 2014 has a dedicated chapter – Chapter 2 – that specifies the obligations falling upon economic operators. This was a key change to the earlier, 2004 version of the EMC Directive, and proposed by the European Commission in its role as the initiator of EU legislation.
About the EMC Directive Guidance
While the European Commission has the right of legislative initiative in the EU, it also prepares guidance to support the understanding and implementation of legislation. Such guidance is not legally binding, but nonetheless a source of interpretation and instruction for those affected by EU law. Most EU product legislation is supported by European Commission guidance and the EMC Directive is no different. In March 2018, the European Commission published the latest “Guide for the EMC Directive,” which supersedes the earlier version of the Guide from 2010.
As expected, the 2018 Guide differs to the 2010 version with the inclusion of a section on economic operator obligations. This makes sense given that the obligations were introduced to the EMC Directive for the first time with its 2014 recast. However, this is not the only new section of the Guide and sections from the 2010 version have been revised. An overview of the changes is presented in Table 1, and the rest of this article discusses each section of the Guide (excluding the disclaimer) in more detail.
Section of the Guide
|Disclaimer||Clarifies that the Guide is not legally binding and is no substitute for the law.||As 2010|
|Scope||Guidance divided between three subsections: general, defining the scope of apparatus, and defining the scope of fixed installations.||General guidance reduced while the information relating to “defining the scope of” apparatus/fixed installations is the same as in 2010. In addition, new guidance is introduced covering sections titled “geographic application,” “placing on the market/putting into service,” and “equipment and products.” A jammers case study is also a new subsection.|
|Essential Requirements||Presents an overview of mandatory requirements.||Also presents an overview of mandatory requirements.|
|Economic Operator Obligations||Not present.||Newly introduced section in light of the EMC Directive now having these obligations written into it.|
|Apparatus Conformity Assessment Procedure||Gives information including: the usual steps of an EMC assessment; information and documentation requirements; Declaration of Conformity and CE marking. More detailed guidance is provided for an EMC assessment where harmonized standards are not used or do not cover all protection requirements. Specific subsection on The concept of “holding at the disposal.”||Largely the same content, although new guidance is introduced pertaining to risk analyses and risk assessment (as this is new to the 2014 EMC Directive) while Declaration of Conformity and CE marking guidance is revised in light of a model Declaration coming into being and CE marking requirements now being found in Decision No 768/2008/EC. In addition, there is newly introduced guidance regarding “information on identification” and “information concerning the use of apparatus.” Specific subsection on The concept of “holding at the disposal” removed.|
|Fixed Installations||Guidance spans the relevant requirements and documentation needed for fixed installations, including the use of apparatus specifically for incorporation into a given fixed installation.||As 2010|
|Market Surveillance||Called “Enforcement of the EMC Directive.” Gives information on the duties of Member State authorities in checking for compliant apparatus with specific comment regarding the use of apparatus at trade fairs.||Very similar to 2010, only the comment regarding the use of apparatus at trade fairs is removed.|
|Notified Bodies||Guidance spans the role, selection, coordination and the treatment of complaints towards Notified Bodies.||Again similar to 2010, although new subsections are introduced regarding sub-contracting and information exchange.|
|Annexes||Similar to 2010, although there is now guidance relating to the application of the 2014 EMC Directive alongside the 2014 Low Voltage and Machinery Directives. A new subsection on Organizations and Committees is introduced that describes the EU Association of EMC Notified Bodies and the “EMC ADCO” of EU Member State Market Surveillance Authorities.|
Table 1: Similarities and differences between the 2010 and 2018 Guides
Section 1: Scope
The 2018 “General” subsection is a little different to what went before in that it characterizes the main objective of the EMC Directive as being to “guarantee the free movement of equipment and to create an acceptable electromagnetic environment whilst ensuring that equipment will function as intended in that environment.” The characterization of equipment “functioning as intended in that environment” is new and not something specified in the 2010 Guide; this Guide merely talked of an “acceptable electromagnetic environment” in the EU.
Interestingly, the 2018 Guide introduces clarification absent from the 2010 Guide: that functional safety aspects based on electromagnetic disturbance are regulated under other EU legislation, notably the Machinery, Low Voltage and General Product Safety Directives.
1.2 Geographic Application
New commentary confirms that the EMC Directive applies in EEA-EFTA2 countries while Mutual Recognition Agreements and/or Agreements on Conformity Assessment and Acceptance between the EU and a cosignatory (e.g., Canada, Israel, etc.) may provide for mutual recognition of EMC conformity assessment procedures when such Agreements address EMC.
1.3 Placing on the Market/Putting into Service
The 2018 Guide gives advice on both terms, mainly by way of extraction from the European Commission “Blue Guide” to product regulation.3 Moreover, the 2018 Guide states that, legally, economic operator obligations only refer to equipment placed on the market – not equipment put into service.
This is helpful up to a point. For those manufacturers that first place electrical equipment on the EU market (by selling it to another business) before it then goes into service, it is clear that they are bound by relevant obligations. Uncertainty arises in instances where a business acts as both manufacturer and, subsequently, user of the equipment that it puts straight into service without any transfer of ownership.
1.4 Equipment and Products
This subsection includes entirely new guidance related to the Radio Equipment Directive (RED), namely that the RED covers most radio equipment and includes EMC essential requirements identical to those of the EMC Directive.
What is also worth reviewing is what is in and out of the scope of the RED. By and large, the RED applies to everything that was in the scope of its legislative predecessor, the R&TTE Directive,4 plus some more items. Newly in-scope products include:
- Pure radio sound and radio TV receive-only equipment; and
- Equipment operating below 9 kHz.
As such, radio determination equipment is now included within the scope of the RED. However, some equipment that was within the scope of the R&TTE Directive is not in scope of the RED, most notably pure wired telecom terminal equipment. The EMC Directive applies to this equipment now.
Subsection 1.4 also spans guidance on “inherently benign equipment” and “custom built evaluation kits.”
In the former case, it is worth contextualizing the origins of this phrase. This is Recital 12 of the 2014 EMC Directive, which states that the Directive “should not regulate equipment which is inherently benign in terms of electromagnetic compatibility.”
Recital 12 therefore provides opportunity for exclusions, something that the 2010 Guide identified and discussed with examples. Consistent with the 2010 Guide, the 2018 Guide advises that “inherent benevolence” is conditional upon electrical equipment being:
- Incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and telecommunications equipment and other equipment to operate as intended; and
- Able to operate without unacceptable degradation in the presence of electromagnetic disturbance normally present in its intended environment.
The 2018 Guide repeats the examples listed in the 2010 Guide (not reproduced here), but also adds the following:
- Corded headphones, loudspeakers without amplification, guitar inductive sensors without active electronic parts;
- Induction motors without electronic circuits;
- Electromagnetic relays without active electronic parts;
- Electromagnetic locks without active electronic parts; and
- Cathode ray tubes.
The 2018 Guide makes a new point too, which is that if a product under assessment is not among the listed examples and the EMC assessment establishes inherent benevolence, then the Directive shall not apply.
Regarding custom built evaluation kits, an interpretation of what constitutes such kits is offered for the first time. More specifically, the 2018 Guide outlines criteria for determining what is “custom built” and, subsequently, an “evaluation kit.” The guidance is as follows:
i. A kit that has been built on the basis of a specific request from a specific customer or from a group of customers involved in a joint research and development project as for all or certain characteristics of the evaluation kit; or
ii. A kit that has been built for the specific requirements of a specific customer or a group of customers involved in a joint research and development project as for all or certain characteristics of the evaluation kit.
A printed circuit board with an integrated circuit and support components to produce a working circuit for evaluation and development.
– Destined for professionals (customers), to be used solely at research and development facilities
Research and development facilities meaning public or private research and development bodies.
– For research and development purposes
Evaluation kits to be used in testing for further development/improvement of the function of the equipment under research and development.”
A non-exhaustive list of examples of evaluation kits that do not benefit from the custom built evaluation kit exemption is given including “for users in general [in R&D departments].” Many types of evaluation kits are made in large numbers for “users in general.” Typically, such users are electronic design engineers who use the kits to design new products that will benefit from the kits’ integrated circuits. The “users in general” example is therefore noteworthy as it appears to exclude many or most of the evaluation kits on the EU market.
1.5 Defining to the Scope of Apparatus
Just like the 2010 Guide, the 2018 Guide also tackles the issue of “does CE plus CE equal CE?” when multiple products are combined into apparatus.5 As in 2010, the 2018 guidance states that, when combined, two or more CE marked finished products do not necessarily constitute a “compliant” system. The 2018 Guide also moves on from this to state that, if a finished product is excluded from the EMC Directive but in scope of another EU law like the RED, then the product shall comply with that law when it is placed on the market.
New content also arises regarding components/subassemblies, which is subsection 1.5.3. Here it is stated that components/subassemblies are within the scope of the EMC Directive if two criteria are satisfied, namely that the components/subassemblies are:
- Intended for incorporation into an apparatus by the end-user; and
- Liable to generate electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.
Section 2: Essential Requirements
The guidance is the same as in 2010.
Section 3: Obligations of Economic Operators
While this section is entirely new, it really does not say that much. In fact, there are two sentences that convey two pieces of information: look to the Blue Guide regarding the basic obligations of economic operators, and that Section 4 of the Guide outlines EMC-specific obligations.
Section 4: Conformity Assessment Procedure for Apparatus
Much of this is the same as was previously stated in the 2010 Guide, although there are some notable differences.
4.2 Risk Analyses and Risk Assessment
Subsection 4.2 of the 2018 Guide is entirely new. This reflects on the entry of a requirement for risk analysis in NLF legislation. The 2018 Guide states the following:
“The conformity assessment procedures for apparatus require the manufacturer to establish technical documentation. This documentation shall make it possible to assess the conformity of the apparatus to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). In EMCD [the EMC Directive] the concept of risk refers to risks in relation to the electromagnetic compatibility protection aims specified in Annex I “Essential Requirements” and not to safety. On basis of the knowledge of the relevant EMC phenomena for the apparatus and its intended operating environments the EMC assessment according to chapter 4.3 can be performed. This EMC assessment is considered to be an adequate analysis and assessment of the risk(s).”
4.3 EMC Assessment
This section remains broadly the same as it was in 2010, although some new text is introduced pertaining to EMC assessment in practice. This is to be performed following a “defined methodology” with the guidance stating that:
“Any conformity assessment procedure requires the manufacturer to start with an analysis of the specific risks of the product to address them in order to comply with the essential requirements because not all products present the same risks.
“Once the risks are identified and the manufacturer has determined the measures to address those risks in order to comply with the essential requirements he can choose to apply the harmonized standards applicable to his product or he can choose other technical specifications.”
There is also new information in subsection 4.3.2, Use of EMC harmonized standards. This is that conformity with harmonized standards listed in the Official Journal of the European Union under the EMC Directive give presumption of conformity with the corresponding essential requirements of the Directive.
Similarly, new and different guidance is introduced in subsection 18.104.22.168, Relevant harmonized standards. The new information is that, should a manufacturer choose to apply one or more harmonized standards, then there is a preferred order for selection. This is:
- Product-specific standards (if available); then
- Product family standards (if available); then
- Generic standards.
In addition, clarification is offered that, for any given product, it may be necessary to apply several harmonized standards to cover the Directive’s essential requirements. The 2018 Guide advises that the aspects that are generally required to be covered are:
- Radiated disturbances;
- Conducted disturbances at mains and telecommunication ports;
- Immunity to continuous radiated and conducted disturbances; and
- Immunity to transient phenomena.
4.4.2 Declaration of Conformity (DoC)
Unsurprisingly, new guidance exists here owing to the introduction of a DoC model structure. The model structure is reproduced in the 2018 Guide.
Furthermore, comment is made that “the DoC can take any form as long as the information prescribed in the model structure in Annex IV of the EMCD is included as a minimum.”
There is new guidance too. This clarifies that, where apparatus is subject to more than one EU law that requires a DoC, then a single DoC shall be drawn up in respect of all relevant legislation. However, the single DoC can be “made up of a dossier containing all relevant individual EU Declarations of Conformity.”
4.5 CE Marking
New guidance is given here, largely to reference and show consistency with one of the Regulations that form part of the NLF. This is Regulation (EC) No 765/2008; Article 30 of the Regulation lays down general principles for CE marking form and size.
4.5.3 Information for Traceability
The 2018 Guide offers new advice, which, for manufacturers, is that they are required to give their name, registered trade name or registered trade mark, and the postal address at which they can be contacted.
For apparatus made outside the EU, importers shall also indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted. In addition:
- All contact details shall be in a language easily understood by end-users and market surveillance authorities; and
- Traceability information shall be affixed on the apparatus itself. Failing that, it may be included on its packaging or in a document accompanying the apparatus.
4.5.4 Information Concerning the Use of Apparatus
New advice is presented, which is that apparatus is to be accompanied by:
- Information on any specific precautions that must be taken when the apparatus is assembled, installed, maintained or used, in order to ensure that, when put into service, the apparatus is in conformity with the Directive’s essential requirements;
- A clear indication on restriction of use in residential areas (where appropriate also on the apparatus packaging) if the compliance with the Directive’s essential requirements is not ensured in residential areas.
There is also a statement on language. This reads that the accompanying information shall be “in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.” Instructions and information, as well as any labelling, is also to be clear, understandable and intelligible.
Section 5: Fixed Installations
There is no new guidance on fixed installations; it all carries over from the 2010 Guide.
Section 6: Market Surveillance of the EMCD
Although the section title has changed, there is less guidance in 2018 and what guidance does exist is repeated from 2010 while also directing the reader to the Blue Guide.
Section 7: Notified Bodies
Much of the guidance is the same as in 2010, although there are new subsections regarding subcontracting and information exchange.
The 2018 Guide clarifies that subcontracting does not entail the delegation of powers or responsibilities.
7.3 Information Exchange
The 2018 Guide explains that Notified Bodies are obliged under Article 34 and Annex III of the EMC Directive to provide specific information to certain organizations, notably other Notified Bodies plus notifying authorities. The Guide advises Notified Bodies to check with the Notified Body Coordination Group (EUANB) over what information they are expected to provide and how this is to be communicated.
Some new information is noteworthy. In particular, there is newly introduced content regarding guidance on using a harmonized standard. This includes the following paragraphs:
“The harmonized standard may contain additional requirements that are not relevant to the presumption of conformity against the EMCD, however, the harmonized standard is required to maintain an annex which provides information on correlation of its technical requirements with the essential requirements of the Directive.
“The requirements and limits of the harmonized standards are expected to be met when the equipment is tested to the specification in the standard. Based on the risk analysis and if the applied harmonized standard does not cover all the phenomena expected from the equipment, the manufacturer is required to address the residual risks not covered by the harmonized standards to ensure that all the phenomena are considered.
“The only secure way for the manufacturer is thus to apply, without any deviation, the standards referred to, relevant for its equipment, while making the EMC assessment.”
There is also a clarifying statement concerning practice, specifically in the case of manufacturers that decide not to perform tests since they can satisfy themselves by other means. It is said that explanations have to be added to the technical documentation, and that these explanations should demonstrate how essential requirements are met.
While not a major overhaul, the 2018 Guide brings some key changes to the advice that the European Commission had previously offered on the EMC Directive, including new interpretation in the case of custom built evaluation kits and components/subassemblies, more examples and greater contextualization (specifically with regards the NLF, but also dividing lines between the EMC Directive and the RED). This article has highlighted significant differences, quoting new guidance verbatim in certain instances to help orientate readers.
- European Economic Area and European Free Trade Association
- Obtainable from: http://ec.europa.eu/DocsRoom/documents/18027
- Radio and Telecommunications Terminal Equipment Directive
- Under the EMC Directive, “apparatus” is a finished appliance, or combination thereof, made available on the market as a single functional unit, intended for the end-user. The 2018 Guide adds that a finished appliance is “any device or unit that delivers a function and has its own enclosure.”
Dr. Alex Martin is Senior Regulatory Consultant at RINA (formerly Edif ERA). Alex provides advice and compliance support on various regulations affecting electro-technical products, from EMCD, LVD and RED through to environmental laws like RoHS, REACH and WEEE. Alex can be reached at firstname.lastname@example.org.