increased complexity in ce relevant standards

Background 02

What is the presumption of conformity principle? 04

Publication process for references in the OJEU 06

Possible solutions 10

Questions and answers 12

References 15 | Author Michael Loerzer 16

INCREASED COMPLEXITY IN CE RELEVANT STANDARDS

HOW THE EU COMMISSION’S CHANGED PUBLICATION PRACTICE UNSETTLES MANUFACTURERS AND WHAT

SPECIFIC STEPS YOU SHOULD TAKE

CONTENTS

2WHITEPAPER // INCREASED COMPLEXITY IN CE RELEVANT STANDARDS

Four reference documents are significant here:

• The Blue Guide 2016 [1],

• The Standards Regulation (EU) 1025/2012 [2],

• The ECJ’s James Elliott judgment

• The CFI’s Global Garden judgment [5].

The three latter documents have had a huge influence on the way harmonized standards are published by the Com-mission, which presents challenges for the Commission itself and for the Eu-ropean standards organizations CEN, CENELEC and ETSI.

On July 12, 2018 a workshop on this topic was held in Brussels with the Commission, CEN and CENELEC. The Commission’s key statements can be summarized as follows:

1. Starting in 2008 the standards system was developed further based on the “New Approach” and organized in a more structured way. The reason for this is to safeguard the legitimization of standards created by the private sector and the related legal effects.

2. The ECJ’s James Elliott judgment gives the Commission more extensive responsibility related to the assessment and approval of harmonized standards for publication in the Official Journal of the EU.

3. Consequently, in accordance with Article 10 (5) of Reg-ulation (EU) 1025/2012, the Commission must assess whether a harmonized standard actually satisfies the essential requirements it covers in the context of the standardization request (mandate). Since the James El-liott judgment, the Commission has proceeded in a very formal manner.

4. In accordance with Art. 10 (6), the respective harmonized standard is not published in the EU Official Journal until it satisfies these requirements.

5. However, there have not yet been any detailed require-ments or regulations listing criteria for deciding which harmonized standards are to be published in the EU Offi-cial Journal. This is to be changed.

BACKGROUND

Even before the Radio Equipment Directive 2014/53/EU was published, it had become clear that there are obviously problems with the prompt provision of harmonized stand-ards in the Official Journal of the European Union. The reasons for the delay are neither transparent nor comprehensible for standards users.


6. But as the Commission does not have the expertise required to compare the original standardization re-quest with the standardization results, it commissioned an international business consulting company [6] that functions as a so-called “HAS (Harmonized Standards) Contractor”. This contractor selects HAS Consultants (who have replaced the New Approach Consultants) and charges them with assessing the standardization results in accordance with Art. 10 Section 5 of Regulation (EU) 1025/2012. They therefore ensure that the standardiza-tion results actually satisfy the essential requirements they cover, in connection with the harmonization legis-lation referenced. Once this compliance assessment has been successfully completed, the respective assessed standards are published in the EU Official Journal. How-ever, this process is more time-consuming than before, with the result that although many standards have been ratified and published, for much harmonization legisla-tion no new references have been published.

7. As a further consequence in connection with the Global Garden judgment, the Commission must explicitly assign the presumption of conformity to a harmonized standard, or, in the case of a subsequent objection, restrict the pre-sumption of conformity for the relevant sections of the standard, or explicitly withdraw the presumption of con-formity from a harmonized standard.

8. In addition, the Commission has been using a different publication practice since December 8, 2018. From that date, new harmonized standards or harmonized stand-ards with a restricted presumption of conformity, as well as harmonized standards from which the presumption of conformity has been withdrawn (because, for example, the transition phase has ended) are published in Official Journal L (Legislation) in a so-called implementing deci-sion.

9. What is more, in the case of some harmonization legisla-tion the previous overall lists of references to harmonized standards have been removed from EU websites (for ex-ample in the case of the Machine Directive).


To this end the Commission in Brussels gives the three European standardization organizations, CEN, CENELEC and ETSI, mandates to create harmonized standards under the respective har-monization legislation. The basis of the stand-ardization work is Regulation (EU) 1025/2012 – in short: the Standardization Regulation.

It is the responsibility of the manufacturer to per-form a risk assessment in order to determine and evaluate dangers associated with the products to be manufactured. If the manufacturer uses a harmonized standard to satisfy the essential re-quirements, it is still necessary to perform a risk assessment. A single test report from an inspec-tion body is not sufficient. The manufacturer must evaluate whether the harmonized standard cov-ers all essential requirements connected with the product. The background to this is that it cannot be assumed that the harmonized standard covers all requirements of the harmonization legislation for a particular product (or even all essential re-

quirements of the specific legislative act accord-ing to which it was developed) (Figure 1).

For manufacturers it is important to know wheth-er the relevant harmonized standards – which are published in OJEU (Official Journal of the Europe-an Union) – cover all or only parts of the necessary essential requirements. Manufacturers should analyze the relevant annexes of the various har-monized standards to identify which essential re-quirements are covered by those standards.

WHAT IS THE PRESUMPTION OFCONFORMITY PRINCIPLE?Harmonization legislation defines the essential requirements that need to to be sat-isfied (see 4.1.1. of the Blue Guide [1]). These essential requirements are legally bind-ing obligations. Here, manufacturers have the option of applying harmonized standards voluntarily, in order to prove that that the essential requirements are being satisfied. In accordance with Decision 768/2008/EC, the adjusted and newly created harmonization legislation (in the form of regulations or directives) contains an article regarding the presumption of conformity (see Reference Provision R8 in Decision 768/2008/EC):

Products which are in conformity with harmonized standards or parts thereof the references of which have been published in the Official Journal of the Eu-ropean Union shall be presumed to be in conformity with the requirements covered by those standards or parts thereof, set out in … [reference to the rele-vant part of the legislation].


Figure 1From the Blue Guide (2016/C 272/01Commission NoticeThe ‘Blue Guide’ on the implementation of EU products rules 2016)

ESR = Essential requirement

All essential requirements

(legally binding, laid down in the

legislation)

ESR 1 xxxxxxx

ESR 2 xxxxxxx

ESR 3 xxxxxxx

ESR 4 xxxxxxx

ESR 5 xxxxxxx

ESR 6 xxxxxxx

ESR 7 xxxxxxx

Requirements considered

to be essential (specified by the manufacturer)

ESR 1 xxxxxxx

ESR 3 xxxxxxx

ESR 7 xxxxxxx

Specifications to ensure conformity with the require-

ments that need to be satisfied (selected by the manufacturer)

Harmonized standard (EN) and reference

published in OJ

ESR 1 xxxxxxx +

ESR 3 xxxxxxx covered

Other specification or direct application

Presumption of

No presumption

Risk assessment or equivalent

(by a manufacturer)


In accordance with the Standardization Regulation, the Commission gives the respective standardization requests (mandates) to the three European standardization organizations, CEN, CENELEC and ETSI, so they can ex-press the essential requirements from the relevant harmonization legislation in specific technical terms.

They accept the standardization re-quest and create the relevant harmo-nized standards. The HAS Consultants evaluate whether the standardization results conform to the standardization request.

WHAT DO HAS CONSULTANTS DO?1. Compliance Assessment (80%)Assessing the standards created by the European standard-ization organizations (ESOs) in relation to the standardiza-tion request on which the standards are based can take up to five weeks.

The compliance assessment can include the following assessment activities:• Assessment of working drafts (optional)• Assessment of drafts at Enquiry stage• Assessment of final drafts at Formal Vote stage• Assessment of already agreed standards (in exceptional

cases)

The assessment result can have one of the following grades:

PUBLICATION PROCESS FORREFERENCES IN THE OFFICIAL JOURNALHarmonized standards and their listing in the EU Official Journal are evaluated accord-ing to a new process (Figure 2).

Figure 2From presentation

by Committee of Standards Users in DIN, Electrical

Engineering Sector Group,

Kevin Behnisch,DK

Compliant

Partial compliance

Lack of compliance

The reference can be published in the OJEU without restriction.

The reference can be published in the OJEU only with a note/footnote. The note/footnote is assumed in the assessment report.

Publication in the OJEU is probably not possible unless the document is reworked.

Essential requirements

EC decision on standardisation

request

Acceptance and execution of

standardisation request

Assessment by EY & HAS Consultants

EC decision on listing

Listing in OJEU

Presumption of conformity


2. Kommunikation (20%)

The HAS consultants communicate with the technical com-mittees of the European standardization organizations and provide input for the creation of standards in order to sup-port conformity with the standardization request on which those standards are based.

For the technical committees within CENELEC, for example, this ultimately means the following:• Direct adoption of international IEC standards as Euro-

pean standards means more coordination work. (at CEN: adoption of ISO standards)

• Interaction with HAS Consultants is required.• Creation of new elements, for example • Annex ZZ • Risk assessment • Justification of undated references• European amendments to IEC standards

(or ISO standards)

Previously, harmonized standards were published in Section C of the EU Official Journal, so that they would confer a pre-sumption of conformity. Since December 2018, the Commis-sion has used a different publication procedure. Since then, references to harmonized standards have been published as implementing decisions in section L of the EU Official Jour-nal. This was confirmed to us directly by the EU Commission (Figure 3).

Mail dated 5th March, 2019:

Dear Mr Loerzer,Indeed publication of standards is now done via a Commission Decision published in L series of the OJ, therefore providing legal value. I am not specifically aware of standard on accessibility, but there have been other publications of standards in the OJEU L series already.

Kind regards,Luca DEL COLOMBODesk Officer for the Low Voltage Directive

European CommissionDG for Internal Market, Industry, Entrepre-neurship and SMEsUnit C.3 – Advanced Engineering and Manu-facturing Systems

BREY 10/165B-1049 Brussels/Belgium

Dear Mr Colombo,I have a general question:I have received a information from a EMC/RED consultant …“Note that publication/citation of harmonised standards in Europe from now on (12/2018) will take place in the L section of the OJ, effectively allowing them the status of EU -law. A first standard on Accessibility of (governmental) Websites has already been published.” Is that true?

Best regards, Dipl.-Ing. (FH) Michael LoerzerRegulatory Affairs Specialist Managing DirectorGLOBALNORM

Figure 3Excerpt from an email exchange with the EU Commission


The first implementing decision following this new procedure was published on December 21, 2018 in connection with Directive (EU) 2016/2012. This directive does not provide for CE marking, but it does refer to harmonized standards. On March 19, 2019, it was followed by Implementing Decision (EU) 2019/436 on the Machine Directive with CE relevance. In the meantime additional im-plementing decisions have been published (Fig-ure 4).

These implementing decisions have no particu-lar addressees. In this author’s view, the inten-tion of this new publication of references in the form of an implementing decision was that deci-sions regarding the references listed here with the respective assigned type of presumption of conformity (full or restricted), or the deletion of the harmonized standards are legally binding for standards users – meaning for manufacturers but also for market surveillance authorities in the member states. This does not imply that the harmonized standards themselves have full legal effects (like legislation) and therefore have to be freely available, for example.

Taking the example of the Machine Directive, we find the following information on the EU website [8]:

What effect do the implementing decisions have and what might the Commission’s statement on the legal implications mean? It is first helpful to take a closer look at the definition of an implementing decision [9]:

EU legislation is divided into primary and secondary legislation. The treaties (primary legislation) are the basis for EU action and are also known as TFEU (Treaty on the Functioning of the European Union). The secondary legislation is adopted in the form of directives, regulations and decisions. In ac-cordance with 288 TFEU, European Union decisions are legally binding in all their parts.

WHAT EXACTLY DO THE IMPLEMENTING DECISIONS MEAN?

Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from the Official Journal of the European Union by means of 'Com-mission implementing decisions'.

The references published under Directive 2006/42/EC on Machinery are found in the Commission communication published in OJ C 092 of 9 March 2018 and in the Commission Implementing Decision (EU) 2019/436 of 18 March 2019 (OJ L 75, 19 March 2019) listed below. They need to be read together, taking into account that the decision modifies some references pub-lished in the Communication.


This indicates that in the future there will be no overall lists for the relevant harmonization legislation. Instead, users must read in context the list formerly published in a notice in Official Journal Part C and the standards listed in the implementing decision.

Example: The Implementing Decision on the Machine Directive includes three annexes:

• I contains those harmonized standards that confer a complete presumption of conformity and have not yet been published in the EU Official Journal (see Notice 2018/C 092/01 in Official Journal C 92 from 09.03.2018).

• Annex II lists two harmonized standards with a restricted presumption of conformity.

• In addition, Annex III contains those harmo-nized standards that were deleted with effect from 19.03.2019 and therefore no longer confer a presumption of conformity.

In general it can be seen that for parts of much harmonization legislation it has been a long time since any updates on harmonized standards were published (Figure 4). Although the Com-mission is trying to reduce this backlog, there has not yet been any noticeable improvement.

In any case users should note the new publica-tion procedure with implementing decisions and either adjust their standards monitoring or hire specialized service providers for the task.

Figure 4Implementing decisions published in the Official Journal (as of 4.9.2019)

Harmonization legislation

Notices/decisions Official Journal date

89/868/EEC(personal protective equipment)

Implementing Decision (EU) 2019/1217

18/07/2019

93/42/EEC (medical devices)

2017/C 389/03 17/11/2017

98/79/EC (IVD)

2017/C 389/04 17/11/2017

2001/95/EC (GPSD)

2017/C 267/03 11/08/2017

2006/42/EC (machines)

2018/C 92/01

2018/C 92/01Implementing Decision (EU) 2019/436

09/03/2018 19/03/2019

1907/2006 (REACH)

2017/C 11/02 13/01/2017

2009/48/EC (toys)

2018/C 282/02


10/08/2018

23/07/2019

305/2011 (construction products regulation)

2018/C 92/06


09/03/2018

19/03/2019

2011/65/EU (RoHS)

2012/C 363/05 23/11/2012

2013/53/EU (personal watercraft)

2018/C 209/05


15/06/2018

05/06/2019

2014/30/EU (EMCD)

2018/C 246/01


13/07/2018

06/08/2019

2014/34/EU (ATEXD)

2018/C 371/01


12/10/2018

15/07/2019

2014/35/EU (LVD)

2018/C 326/02 14/09/2018

2014/53/EU (RED)

2018/C 326/04 14/09/2018


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POSSIBLE SOLUTIONS

We are happy to advise you, and together we’ll find the right solution for your company. Get in touch!

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Figure 5Screenshot of GLOBALnorm software: Overview of selected EC standards lists

In the detail view, users receive the information they need regarding the status of the harmonization legislation in question. Figure 6 shows an example from before the De-cision on the EMC Directive was published in the EU Official Journal. In the next update the status would then be updated (since 06.08.2019 this standard confers a presump-tion of conformity).» standards.globalnorm.de

STANDARDS MANAGEMENT SOFTWARE

Globalnorm GmbH’s GLOBALnorm standards management software focuses on an automated evaluation of the EU Official Journal and offers users comprehensive in-formation on the status of each standard as it relates to the harmonization legislation referenced (Figure 5).

Figure 6Screenshot of GLOBALnorm software:Detail view of a harmonized standard


QUESTIONS AND ANSWERS

Are the standards lists that are to be found behind the following

link still being updated? Up to now we have used only

these standards lists.

https://ec.europa.eu/growth/ single-market/european-standards/

harmonised-standards/ electromagnetic-compatibility_en

We don’t yet have any official information regarding this question. We were simply informed in the context of the Machine Directive (see question 4) that there is to be a consolidated list for that directive. However, at the mo-ment these lists are no longer available in the harmoni-zation legislation for which implementing decisions exist. So users either have to compare the original lists (e.g. in the case of the EMC from Notice 2018/C 246/01, OJEU C 246 from 13.07.2018) with the respective implementing decisions manually and at their own risk, or use specially designed databases (e.g. GLOBALnorm software).

QUESTION 1

QUESTION 2

Why isn't the implementing decision to be found under

“Publications in the Official Journal” under the link above,

as it is, for example, in the case of the Toy Directive with the

current implementing decision.

https://ec.europa.eu/growth/ single-market/european-standards/

harmonised-standards/toys_en

That's because these specific Commission information pages are always slightly behind the Official Journal. So it can take some time before this implementing decision also appears on the Commission’s EMC Directive page. But it is certain that at that point the full standards list will also be removed from the EMC page.

QUESTION 3

Why do I not find this implementing decision when I

search for 2014/30/EU?

https://eur-lex.europa.eu

You can either search directly for the implementing deci-sion (to do that you need to select the document type of the legislative act – decision) or you can use the approach you mentioned and first search for the directive. When you then open the directive page, you’ll find “Document Information” on the left, and in that section you can “Select all docu-ments mentioning this document”. This will include the implementing decision. It’s not that easy to find if you don't have a legal background, so here are some instructions:


First WaySearch for the legislative act“Decision” (using the number), then open the link and click on “Document Information” in the menu.

Second WaySearch for the legislative act“Directive” (using the number), then open the link, click on “Document Infor-mation” in the menu and then open the link “Select all doc-uments mentioning this document”.


Could you please explain why EN 60204-1 suddenly stopped

being harmonized?

We need to split that question into EN 60204- 1:2006-06 and EN 60204-1:2018-09.

EN 60204-1:2006-06 has not been deleted and continues to confer a presumption of conform-ity. What do you need to do? See https://ec.eu-ropa.eu/growth/single-market/european-stand-ards/harmonised-standards/machinery_en:

“Since 1 December 2018 the references of har-monised standards are published in, and with-drawn from the Official Journal of the European Union by means of 'Commission implementing decisions'.

The references published under Directive 2006/42/EC on Machinery are found in the Com-mission communication published in OJ C 092 of 9 March 2018 and in the Commission Imple-menting Decision (EU) 2019/436 of 18 March 2019 (OJ L 75, 19 March 2019) listed below. They need to be read together, taking into account that the decision modifies some references published in the Communication.”

Then you would notice that the version from 2006-06 is listed in the EU Official Journal on March 9, 2018. Decision 2019/436 does not ref-erence that at all.

You are correct in saying that the new version from 2018-09 has not yet been published by the Commission in an implementing decision in the Official Journal. It therefore does not yet confer a presumption of conformity under the Machine Directive.

For your information, there follows an answer from the EU Commission from 19.07.2019 – you can see that things are not getting easier for the economic operators.

Dear Michael Loerzer,Apologies for the delayer reply.On the first question, the mention of EN ISO 12100:2010 in recital 14 is an editorial error that will be corrected in the forthcoming amendment. The standards withdrawn are only those set out in Annex III.

On the second question, the list of harmonized standards is referenced on our web page https://ec.europa.eu/growth/sectors/mechanical-engineering/machinery_en More specifically, the list is online https://ec.europa.eu/growth/single-market/european-standards/harmoni-sed-standards/machinery_en

Please note there are two different lists on the above-menti-oned web page: • the consolidated list delivered by the Commission com-

munication OJ C92 and• the most recent Commission Implementing Decision OJ

L75Since 1 December 2018 the references of harmonised standards are published in, and withdrawn from the Official Journal of the European Union by means of 'Commission implementing decisions'.

The references published under Directive 2006/42/EC on Machinery are found in the Commission communication published in OJ C 092 of 9 March 2018 and in the Com-mission Implementing Decision (EU) 2019/436 of 18 March 2019 (OJ L 75, 19 March 2019). They need to be read together, taking into account that the decision modifies some references published in the Communication.

Please note the last one will be amended to correct some editorial errors.In addition, with the next publication of standards under the Machinery Directive, DG GROW will publish consolidated list of all standards giving presumption of conformity.

Kind regards,Mikhail Simonov, PhDPolicy Officer, Machinery Directive

European Commission – DG GROWUnit C3 – Advanced Engineering and Manufacturing Systems

QUESTION 3


REFERENCES

[1] COMMISSION NOTICE “Blue Guide” on the implementation of EU products rules 2016, Notice 2016/C 272/01 (Official Journal C 272 from 26.7.2016, p. 1)

[2] Regulation (EU) No. 1025/2012 of the European Parliament and of the Council from 25 October 2012 on European standardization, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing the decision (Official Journal L316 from 14.11.2012, p. 12)

[3] OPINION OF ADVOCATE GENERAL MANUEL CAMPOS SANCHEZ-BORDONA of January 28, 2016 on Case C-613/14 James Elliott Construction Limited v Irish Asphalt Limited, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62014CC0613, last accessed on 04.09.2019

[4] http://ecostandard.org/wp-content/uploads/2018-06-11-The-use-of-standards-in-legislation-

and-policies-ECOS-discussion-paper.pdf, last accessed on 04.09.2019

[5] https://www.zvei.org/fileadmin/user_upload/Themen/Maerkte_Recht/Harmonisierte_ Rechtsvor-schriften_als_Erfolgsgarant_fuer_den_Binnenmarkt/Vermerk-EuGH_Rasenmaeher_ 2017-05-16.pdf, last accessed on 04.09.2019

[6] http://www.hastart.eu/, Ernst & Young, last accessed on 04.09.2019

[7] https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en, last accessed on 04.09.2019

[8] https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/machi-nery_en, last accessed on 04.09.2019

[9] https://europa.eu/european-union/law_de, last accessed on 04.09.2019


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LEGAL NOTICE

Picture credits Title: Zvonimir Atletic @shutterstock.comPrinted byPinguin Druck, Berlin2019-09-10

Dipl.-Ing. (FH) Michael Loerzer has been a regula-tory affairs specialist since 1999, advising compa-nies on all aspects of product compliance manage-ment. He is the managing director of Globalnorm GmbH, which provides IT solutions and services for supplying information about product compliance and standards.

Michael Loerzer studied com-munications engineering at Berlin University. After his studies he began working at the traditional Berlin-Kreuz-berg company Bosse Tele-fonbau GmbH in 1988, as a development and EMC test engineer. After that he was the general manager of an accred-ited testing laboratory and depu-ty director of the competent body in accordance with EMC Directive 89/336/EEC. In 2003 he initiated the founding of the Prod-uct Compliance Interest Group of the DIN Stand-

ardization Committee (ANP-TGP). He has been the elected chairman of the Interest Group since March 3, 2004. Since October 2009 he has been a member of the IEEE Product Safety Engineering Society (PSES). He has also been a member of the

Radio Equipment Directive Compliance Association (REDCA, www.redca.eu)

since 2017, as well as founder and chair of the Product Compliance

working group in the Netzwerk Compliance e.V. association (www.netzwerk-compliance.de).

He has written expert contri-butions and books on these

topics for numerous publish-ing houses and is a speaker for

a range of seminar and conference organizers. He lectures on standards

systems as part of the Business Engineer-ing program at Baden-Wuerttemberg Cooperative State University Stuttgart, Campus Horb.

AUTHOR MICHAEL LOERZER

OUR EVENT CALENDAR

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