The Pressure Equipment Directive and machine builders

The Pressure Equipment Directive 97/23/EC was recast in 2014 and the new Pressure Equipment Directive 2014/68/EU replaced the old “PED” on July 19, 2016. This revision to the Pressure Equipment Directive was part of the New Legislative Framework and was part of the EU’s effort to coordinate the requirements of different Directives – for example, declarations of conformity now all have the same format. We notified our customers regarding the updated Directives for which we provide technical support and services.

Most of the recast Directives make no new technical requirements and the new PED makes no changes to the requirements or the classification tables in Annex II.

One thing that did change is the classification of the fluid group. The way these fluids are classified is now governed by Regulation (EC) No. 1272/2008. I say “now” because that became effective in June 2015 and did not wait for the new PED to take effect.

Although the PED applies to any pressure equipment or assembly with a maximum allowable pressure greater than .5 bar, there are generous exclusions. We will look at a couple of them in this post.

Wait, did I just write that the PED applies to anything with a pressure greater than .5 bar? That’s only 7 psi! Yes – .5 bar… and keep in mind that if your product is within the scope of the PED, and the pressures are above category I limits, then you MUST work with a Notified Body to claim conformity. All paths through the available conformity modules for equipment above category I pass through a Notified Body.

Do I have your attention now?

However, there are many circumstances where you can calculate or justify your way out of applying Annex I of the Pressure Equipment Directive to your product.

canstockphoto13675847

The CETOP Position Papers are a good starting point for hydraulic equipment used in assemblies and machines. The European Fluid Power Committee, or “CETOP,” published two position papers elaborating their position regarding the PED and the Machinery Directive 2006/42/EC.

The position papers demonstrate exclusions to the PED in favor of the Machinery Directive and clarify other inclusions of hydraulic and pneumatic equipment within the scope of the PED. These position papers were written with the PED 97/23/EC in hand so we will refer to that, although the references are shuffled in the new PED 2014/68/EU.

Most notable is the reference to Article 1 (3.6) of the PED 97/23/EC (Article 1 (2) (f) of PED 2014/68/EU) which excludes equipment from the scope of the PED if:

  1. It is within the scope of any of the following Directives: Machinery, Low Voltage, Lifts, Medical Devices, Gas Appliances, or ATEX.

AND –

  1. piping and connecting devices for liquids of group 2 when PS  ≤ 10 bar, or *DN ≤ 200, or when PS ≤ 5,000 bar

OR –

  1. piping and connecting devices for gas of group 2 when DN ≤ 32 or  PS*DN ≤ 1,000

*Note that in the PED, DN is outside thread diameter in millimeter and PS is pressure in bar.

Broadly, Article 1 (3.6) means that if the equipment is below “category 1” levels (which are indicated in Annex II of the Directive) and the equipment is within the scope of one of the other indicated Directives then the equipment is totally excluded from the Pressure Equipment Directive… the PED can be ignored in these cases.

See 2014/68/EU, Article 1 (2.) (f) – the equivalent to 97/23/EC, Article 1 (3.6) –

2014.68.eu.article1.2

2014.68.eu.article1.2.f

There are other exclusions to the PED within the Directive. We will address more next week in a new post.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Pressure Equipment Directive 2014/68/EU | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off on The Pressure Equipment Directive and machine builders

CE marking and the China Export mark

There are two commonly used markings on equipment that are very similar in appearance but mean different things.

The CE marking is a European compliance marking and indicates compliance to all applicable European CE marking Directives (like the Machinery Directive 2006/42/EC and the EMC Directive 2014/30/EU). This marking is placed on equipment by the manufacturer prior to placing in service in Europe. It does not refer specifically to export, instead it refers to the compliance of the equipment to applicable European laws.  The CE marking is specified for all CE marking Directives in the EU’s NLF framework regulation, 765/2008/EC, Annex II, and is below.

CE marking

Some Chinese products, manufactured in and exported from China, are designated with a similar marking. At first glance it looks identical, please see below.

Chinese mark
This appears to be a CE marking. It’s not. Some research into this matter has uncovered that not only is it not a CE marking but it is also not a “China Export” mark. There is no official “China Export” mark, It is fake, applied by unaccountable factories in China and is meant to put products on the market that have not had any type of safety evaluation, risk assessment, or testing. It is illegal.

See below both markings side-by-side for comparison.

CEvChineseCE

The European Parliament made a statement regarding this in 2008 and it is linked here.

Keep in mind that if you are building products for export to the EU it is you who will be responsible for the product’s compliance. That includes sub-assemblies and components with a false CE marking. A constructional review involving EN 60204-1, EN 61010-1, etc. will uncover these issues… before you build your products for sale.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

 

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LED lighting and FCC requirements

Manufacturers of LED lighting sometimes assume that they are subject to FCC Part 18 requirements for lighting since LED’s are lights. Apparently this approach is so widespread that on June 17, 2016 the FCC posted clarification online that most LED lighting is in fact subject to FCC Part 15 requirements and not Part 18 requirements.

pic_1

LED lighting is designed so that it emits RF and is subject to FCC requirements, as stated. However, as detailed at the linked document, different LED products are subject to different FCC requirements. The FCC document states that lighting products for, “general illumination, traffic signaling, roadway lighting, manufacturing processes, agriculture, etc.,” are classified as unintentional radiators and must meet limits specified in section 15.107 and section 15.109 of Part 15.

The link for this FCC post is here and the link for the actual guidance available on the page is here.

We have linked the FCC Part 15 requirements – FCC Part 15.

Also linked are the FCC Part 18 requirements – FCC Part 18.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

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The EMC Directive and “Fixed Installations”

A common discussion point with manufacturers is the notion of the “fixed installation”. Probably mostly due to recital (36) in the beginning of the EMC Directive 2014/30/EU:

2014.30.eu.recital36

Fixed installations are clearly defined in Article 3 (1.) (3.) of the EMC Directive 2014/30/EU:

2014.30.eu.article.3.1.3

Article 19 of 2014/30/EU specifies what is and is not required for EMC compliance for fixed installations. Mainly we see that Annex I (1.) General requirements are not applicable and that the requirements from Annex I (2.) are, and they are much more lax: “good engineering practices”. This is in stark contrast to the requirements in Annex I (1.). Of course it would be easier to comply with Annex I (2.) instead of Annex I (1.).

That “easier” compliance method coupled with the definition of a fixed installation listed in Article 3 (1.) (3.) leads some to believe that their industrial machine can benefit from the fixed installation “good engineering” practices. Unfortunately, it can’t.

One would think that a big, industrial machine which ships in pieces and is installed by professionals, and bolted to the floor is, “fixed,” but that is not what it means. To understand what is, we look to the guidance documents published by the European Commission in support of the law.

This guidance document references the now-expired EMC Directive 2004/108/EC: as of today there is no official guidance document for 2014/30/EU.

See the examples given for what a fixed installation is, insofar as the EMC Directive is concerned, in section 1.3 (1.3.1) (para 5) of the EMC guidance document:

emcguidelines.section1.3.para5

This suggests that a fixed installation is not only “fixed” but also, very large. As a result, industrial machines which are bolted to the floor are not considered “fixed installations” in the EMC Directive and do not benefit from the exclusion. Entire structures are considered as “fixed installations” but the equipment installed in it is not. This makes sense when you consider that it would be very difficult to proclaim an entire facility as compliant to the EMC Directive 2014/30/EU because testing the entire facility as one unit would be impossible. The component assemblies (i.e., the machinery and systems in it) can be tested.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you. you.

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RoHS Directive 2011/65/EU – Equipment for Research and Development

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The understanding of many CE marking Directives is enhanced oftentimes by comparing a specific product to the recitals, articles, and annexes of the Directive and a detailed reading of the accompanying guidance document that is usually available to read alongside the law.

The Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU and the RoHS 2 FAQ is an example of this. RoHS excludes certain equipment from the scope of applicability in Article 2. We will look in particular, today, at the Article 2 (4) (j) exclusion – Research and Development Equipment made only available business to business.

See RoHS 2011/65/EU, Article 2 (4) (j) below –

06232016_rohs_pic1

06232016_rohs_pic2

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On its face it would appear that equipment as describe above is categorically excluded from the Directive. That would be good news if you are a manufacturer of a product like, for instance – an electron microscope marketed solely for professional use.

The exclusion is not available for electron microscopes or other equipment similarly described. This is uncovered by reading the RoHS 2 FAQ guidance document, published alongside the Directive on the European Commission page for the Environment.

Section 4 of the FAQ reveals detailed guidance, see below.

06232016_rohs_pic4

06232016_rohs_pic5

06232016_rohs_pic6

We note the reference to “custom built solely for very specific R&D applications.” This means that the exclusion is not available to equipment built for sale to whoever can use it. A good rule of thumb would be that if you are offering this for sale on your website to whoever wants it, you probably cannot benefit from Article 2 (4) (j).  The equipment meant to benefit from this exclusion is equipment designed and assembled for one specific task and then, at the conclusion of the activity, disassembled or mothballed.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.u.

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The RoHS Directive 2011/65/EU, RoHS markings, and the CE marking

The RoHS Directive 2011/65/EU, or ‘RoHS2’ as it is sometimes called, is a CE marking Directive and is a European law. The various RoHS markings seen on different pieces of equipment, while not illegal and possibly informative, have no legal meaning or standing.

rohs_image_1

What does that mean?

The RoHS Directive is a CE marking Directive. This means that equipment within its scope must carry a CE marking if it is offered for sale or placed on the market in the EU.  The CE marking is applied by the manufacturer (or Authorized Representative, if mandated) on the product. All CE marking Directives either indicate the parameters for the marking or direct the reader to Annex II of Regulation no. 765/2008/EC.

annexii

Regulation no. 765/2008/EC is one of three documents that outline the EU’s New Legislative Framework of 2008. The purpose of which was, “To improve the Internal Market for goods and strengthen the conditions for placing a wide range of products on the EU Market,…”.

All CE marking Directives also require that the product has a unique, traceable declaration of conformity. The declaration of conformity is mandated in Article 5 of Decision no. 768/2008/EC and detailed in each of the CE marking Directives. (768/2008/EC is one of the three documents that make up the New Legislative Framework). The declaration of conformity is a piece of paper that indicates information about the manufacturer and product, lists all of the applicable CE marking Directives, harmonized EN standards applied to prove conformity, and a statement that the product is in compliance and that the manufacturer (or Authorized Representative) takes responsibility for the compliance.

The RoHS Directive 2011/65/EU lists the declaration of conformity requirements in Annex VI.

annexvi

The RoHS markings seen on many products are not mentioned or referenced anywhere, in any of the New Legislative Framework documents, or in the RoHS Directive itself. Below are some samples collected from a google search:

rohs2_image

rohs_image_3

rohs_image_4

These markings are not illegal, but please note they hold no legal relevance.

The only legal marking, as pertains to RoHS and all CE marking Directives, is the CE marking. The CE marking on your product indicates that your product complies with all applicable CE marking Directives. That means your product must comply with any Directive that includes your product within its scope – and the relevant Directives must be indicated on the declaration of conformity for the product.

Your signature on the document is your legal claim that it does, and you may be pressed to prove this in a court in the EU, if challenged.

Before I end this article I want to point out that there is another “RoHS” which has its own markings: The Chinese RoHS. Chinese RoHS is concerned with the same six materials (four heavy metals and two flame retardants):

  • Lead
  • Mercury
  • Cadmium
  • Hexavalent Chromium
  • PolybrominatedBiphenyls
  • PolybrominatedDiphenyls Ethers

The markings are similar as well, but not quite the same. The markings with numbers in the middle indicate the number of years until the restricted material leaks out of the product. This is not addressed in RoHS 2011/65/EU. See below the Chinese makings:

Chinese_RoHS1

 

 

 

 

Chinese_RoHS3

Chinese_Rohs2

However, please note that Chinese RoHS is not equivalent to European RoHS compliance to 2011/65/EU.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

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Machinery Directive 2006/42/EC Article 1 (2) (k)

 

Previously we discussed some of the legal questions about compliance to either the Machinery Directive 2006/42/EC or the Low Voltage Directive 2014/35/EU.

This one question has led to many discussions at F2. Usually it starts with, “well, does a cooling fan on a computer mean that a computer is a machine?” And it’s all down hill from there. We have an overview of the Machinery Directive for review on our site. Sometimes though it is helpful to read straight from the Directive itself. Let’s take a closer look.

The Machinery Directive 2006/42/EC lists the scope of applicability in Article 1. See below.

MD_Article_1

And in Article 1 (2) it lists equipment which is excluded from its scope.

article-1-2-k

The reference to 73/23/EEC is a reference to the Low Voltage Directive that was law when the Machinery Directive was first published, back in 2006. By law, that reference is applicable to the currently valid Low Voltage Directive, which is the Low Voltage Directive 2014/35/EU.

OK, so what does this mean? It means that machinery, defined broadly in the Machinery Directive in Article 2 (a) as…

article-2-a

… but also falls into the categories set out in Article 1 (2) (k) can claim compliance to the Low Voltage Directive 2014/35/EU and not the Machinery Directive 2006/42/EC. This would be beneficial, immediately, because then the manufacturer would not need to add a European address on the EU declaration of conformity. It also means that a manufacturer will comply with Annex I from the Low Voltage Directive and not Annex I from the Machinery Directive, which is much longer and more detailed. It also means that less EN standards will be involved in the compliance process. In short, an evaluation to the Low Voltage Directive is preferable to an evaluation to the Machinery Directive.

Note, however, that you cannot just select the Low Voltage Directive if a product ‘could’ be used in the household or in an office. The product has to be specifically dedicated for the use(s) indicated in Article 1 (2) (k). To better understand this, we will review what the writers of the Machinery Directive clarified in the Guide to application of the Machinery Directive 2006/42/EC.

Section 63 of the Guide indicates basic interpretive guidance.

section-63

Then it goes into much greater detail regarding each of the previously referenced available exclusions. It is illuminating to read all of the sections but we will focus on section 64.

section-64

Notice that the product must be intended for domestic (household) use. Clearly this means that you cannot twist the exclusion to benefit a machine that could be used in the home. It must be intended for home use.

Additionally, please read the last paragraph. This makes it clear that the Market Surveillance Authorities have the option to review product brochures, your website, the manual, etc to glean the intended use for the product. In practical application this means that if your product is a commercial floor cleaner, marketed for commercial use – you cannot eliminate the Machinery Directive 2006/42/EC from your compliance path and claim it is a household product because it may be used in the home.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.u.

gears

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Machinery Directive or the Low Voltage Directive… which one?

The Machinery Directive and the Low Voltage Directive: how do I know which one?

The Machinery Directive 2006/42/EC and the Low Voltage Directive 2014/35/EU can both be applied to certain machines or equipment. The Machinery Directive excludes the Low Voltage Directive when it is applicable, but requires compliance with Annex I of the Low Voltage Directive. Confused? Lots of people are. Let’s take a closer look…

Below is Article 1 of the Machinery Directive.

MD.Article.1

The Low Voltage Directive 2014/35/EU applies to the following equipment:

LVD.Article1

Of course, there is broad room for overlap between these two Directives because most machinery operates at voltages within the scope of the Low Voltage Directive. The Machinery Directive addresses this specifically in Annex I, Essential Health and Safety Requirements (1.5.1.).

2006/42/EC, Annex I (1.5.1.) Electricity Supply:

MD.AnnexI.1.5.1

 

Regarding section 1.5.1. from the Machinery Directive, we note that 73/23/EEC refers to the Low Voltage Directive 73/23/EEC, before it was the Low Voltage Directive 2006/95/EC and before that became the current Low Voltage Directive 2014/35/EU. By law, 1.5.1. refers to the currently applicable Low Voltage Directive.

1.5.1. is saying that your equipment must comply with the technical (i.e., safety) requirements from Annex I of the Low Voltage Directive but in the same section it is telling you that your equipment is excluded from the Low Voltage Directive… the documentation and legal requirements: because the Machinery Directive is applicable.

Huh?

In plain English: The Machinery Directive is fully applicable and you will indicate it on the declaration of conformity. The Machinery Directive has also “rolled in” the safety requirements of the Low Voltage Directive (2006/42/EC, Annex I, 1.5.1.) while at the same time excluding the Low Voltage Directive – so you will not include any reference to the Low Voltage Directive on the declaration of conformity. In fact, it is incorrect to list the Machinery Directive AND the Low Voltage Directive on your declarations of conformity.

We are not finished with addressing this issue. Our next post will focus on the Machinery Directive 2006/42/EC, Article 1 (2) (k) Low Voltage Directive exclusions. These exclusions are for products which technically meet the 2006/42/EC, Article 1 (1) scope requirements for inclusion in the Machinery Directive but can claim compliance to the Low Voltage Directive instead.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you. you.

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CE marking and the requirement for translations

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Your compliance requirements for export to the EU do not stop with putting the CE marking on your equipment. Depending upon the applicable CE marking Directives that are relevant to your equipment, you may be required to prepare or be able to prepare various translated documents.

 

There are different requirements for translations in the Directives and you are required to comply with the requirements in each of the Directives that are applicable to your equipment. Broadly, your electrical, electromechanical, and mechanical products with a CE marking require the following to be translated into the national language of the country in Europe to which you send your products:

  1. Declaration of conformity
  1. Operations and maintenance manuals
  • Machinery Directive 2006/42/EC – see 2006/42/EC, Annex I (1.7.4.)
  • Low Voltage Directive 2014/35/EU – see 2014/35/EU, Article 6 (7.)
  • EMC Directive 2014/30/EU – see 2014/30/EU, Article 7 (7.)
  • ATEX Directive 2014/34/EU – see 2014/34/EU, Article 6 (8.)
  • Radio Equipment Directive 2014/53/EU – see 2014/53/EU, Article 10 (8.)
  • Pressure Equipment Directive 2014/68/EU – see 2014/68/EU, Article 6 (7.)
  • Medical Devices Directive 93/42/EEC – see 93/42/EEC, Article 4 (4.)
  • RoHS Directive 2011/65/EU – no requirement

Additionally, upon the request of national authorities, you may be required to translate the technical file for your equipment. That request may include only the aspects of compliance related to the request or the entire technical file. This could mean that the technical reports require translation.

  1. Technical File
  • Machinery Directive 2006/42/EC – see Annex VII (A.): English is acceptable
  • Low Voltage Directive 2014/35/EU – see 2014/35/EU, Article 6 (9.)
  • EMC Directive 2014/30/EU – see 2014/30/EU, Article 7 (9.)
  • ATEX Directive 2014/34/EU – see 2014/34/EU, Article 6 (10.)
  • Radio Equipment Directive 2014/53/EU – see Article 10 (12.)
  • Pressure Equipment Directive 2014/68/EU – see 2014/68/EU, Article 6 (9.)
  • Medical Devices Directive 93/42/EEC – no translation requirement
  • RoHS Directive 2011/65/EU – see 2011/65/EU, Article 7 (j)

We commonly field questions regarding what needs to be translated and why. Since these requirements are listed in the different Directives, the requirements are different by Directive, and can be different based upon your role in the process, a more detailed analysis of the translation requirements follows.

Machinery Directive 2006/42/EC

Annex I, 1.7.1. Information and warnings on machinery

Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty by the Member State in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators. Annex I, 1.7.1.1. Information and information devices

The information needed to control machinery must be provided in a form that is unambiguous and easily understood. It must not be excessive to the extent of overloading the operator.

Visual display units or any other interactive means of communication between the operator and the machine must be easily understood and easy to use.

The European Commission provides information regarding what this actually means in the context of what you must do to comply. This is explained in the Guide to application of the Machinery Directive 2006/42/EC, § 245.

Relevant sections are copied below.

Section 245 Information and warnings on the machinery

The requirements set out in section 1.7.1 concern the form of information and warnings that are part of the machinery.

The first sentence of section 1.7.1 advises manufacturers to use readily understood symbols or pictograms for this purpose.

Well designed symbols or pictograms can be understood intuitively and avoid the need for the translation of written or verbal information. The second sentence of section 1.7.1 applies when information is provided in the form of written words or text on the machinery, on a monitor screen or in the form of oral text provided, for example, by means of voice synthesiser. In such cases the information and warnings must be provided in the official language or languages of the Member States in which the machinery is placed on the market and/or put into service. The user of machinery may also request the manufacturer to provide the information and warnings on the machinery or on monitor screens accompanied by versions in any other language or languages of the EU that are understood by the operators. This may be for various reasons, for example:

the persons who are to use the machinery do not understand the official language of the Member State concerned;

the machinery is to be used in a workplace that has a single working language other than the official language(s) of the Member State concerned; the machinery is to be used in one Member State and maintained by technicians from a different Member State;

remote diagnostics are to be carried out in a Member State different from the Member State where the machinery is to be used. Providing information or warnings on the machinery in EU languages other than the official language(s) of the Member State in which the machinery is placed on the market and/or put into service or in any other language(s) is a matter to be settled by contract between the manufacturer and the user when the machinery is ordered.

The guidance document also provides information in §246 about the official languages of each Member State.

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Section 246 The official languages of the EU

There are 23 official EU languages, used in the following Member States:

Austria German Latvia Latvian

Belgium Dutch, French and German 

Bulgaria Bulgarian 

Cyprus English and Greek 

Czech Republic Czech 

Denmark Danish 

Estonia Estonian 

Finland Finnish and Swedish 

France French 

Germany German 

Greece Greek 

Hungary Hungarian 

Ireland English and Irish 

Italy Italian

Latvia − Latvian

Lithuania − Lithuanian

Luxembourg − French and German

Malta − English and Maltese

The Netherlands − Dutch

Poland − Polish

Portugal − Portuguese

Romania − Romanian

Slovakia − Slovak

Slovenia − Slovenian

Spain − Spanish

Sweden − Swedish

United Kingdom − English

Certain of the Member States with two or more official languages (Belgium, Finland) accept the use of one language only in areas where only that language is spoken. Manufacturers are advised to check this with the national authorities concerned. Other Member States with two official languages (Cyprus, Malta and Ireland) accept the sole use of English. In the other countries where the Machinery Directive applies in virtue of the EEA, the MRA between Switzerland and the EU-Turkey Customs Union, the national provisions implementing the Machinery Directive require the use of the official language(s) of the country concerned:

Iceland Icelandic, Switzerland French, German and Italian, Liechtenstein German, Turkey Turkish, Norway Norwegian

The translation requirement extends to the instructions (operator and maintenance manual) as well and this is specified in 2006/42/EC, Annex I, 1.7.4. & 1.7.4.1.

Annex I, 1.7.4. Instructions

All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.

The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.

By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.

The instructions must be drafted in accordance with the principles set out below.

2006/42/EC, Annex I, 1.7.4.1. General principles for the drafting of instructions

(a) The instructions must be drafted in one or more official Community languages. The words ‘Original instructions’ must appear on the language version(s) verified by the manufacturer or his authorised representative.

(b) Where no ‘Original instructions’ exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question. The translations must bear the words ‘Translation of the original instructions’.

(c) The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.

(d) In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.

Upon completion of your CE marking compliance project you will need to write a declaration of conformity and compile a technical file. The requirements for the translation of the declaration of conformity are stated in 2006/42/EC, Annex II (1.) (A.) (para 1):

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I, section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

The requirements for this are described in 2006/42/EC, Annex VII, A. technical file for machinery (para 1):

This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.

Note in particular the last line, “The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.”

This makes it clear: unless you have special instructions from your customer (who must have a valid reason), you must translate the manual and other documents related to operation and maintenance into the official language of the country to which you send the equipment. This can extend to other documents: for instance if you incorporate a bought sub-assembly like a pump that must be serviced then maintenance instructions for it must also be translated. The technical file itself may remain in English since it is an official Community language.

New Legislative Framework (NLF) 2008 CE marking Directives

It is useful to understand the translation requirements specified by the Machinery Directive first because until April 20, 2016 they were the most strenuous. The Low Voltage Directive 2006/95/EC, the EMC Directive 2004/108/EC, and the R&TTE Directive 1999/5/EC specified translations into a Community language only – and that meant English was acceptable. However, with the recast of many CE marking Directives in 2014, followed by their 2016 enforcement dates, this is changed.

The EU’s 2008 New Legislative Framework brought in an alignment of definitions across many of the CE marking Directives and stricter, more clearly defined responsibilities for manufacturers, distributors, and importers. The NLF, as it is called, is based on three documents. The relevant document for US manufacturers exporting to Europe is Decision no. 768/2008/EC, within which the rules governing the responsibilities of manufacturers are listed in Chapter R2, Obligations of economic operators, Article R2, Obligations of manufacturers. See in particular no. 7 and no. 9 from Article R2 below.

  • 768/2008/EC, Chapter R2, Article R2 (7.)

Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and end-users, as determined by the Member State concerned.

  • 768/2008/EC, Chapter R2, Article R2 (9.)

Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.

The text from no.’s 7 & 9 of 768/2008/EC, Chapter R2, Article R2 is repeated in the following places in the below, recast Directives:

  • Low Voltage Directive (LVD) 2014/35/EU, Article 6 (7.) & (9.)
  • Electromagnetic Compatibility Directive (EMC) 2014/30/EU, Article 7 (7.) & (9.)
  • Equipment & Protective Systems for use in Potentially Explosive Atmospheres Directive (ATEX) 2014/34/EU

See Article 6 (8.) & (10.)

  • Radio Equipment Directive (RED) 2014/53/EU, Article 10 (8.) & (12.)
  • Pressure Equipment Directive (PED) 2014/68/EU, Article 6 (7.) & (9.)
  • Restriction of Hazardous Substances (RoHS) 2011/65/EU, Article 13 (2) only

This means that if your project is within the scope of any of the directly above CE marking Directives or the Machinery Directive 2006/42/EC then you will need to make translations of at least the operations and maintenance instructions as well as the declaration of conformity. Keep in mind that in many cases you will need to provide both the original documents in English and the translated documents with the word “Translated,” or “Translated from the original instructions,” printed on them. The words, “Original Instructions,” may need to be printed on the originally drafted instructions.

Medical Devices Directive 93/42/EEC

The Medical Devices Directive 93/42/EEC, aka the MDD, also makes requirements for translations of various documents. These are detailed below.

Article 4 Free movement, devices intended for special purposes (4.)

Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.

Upon review of Annex I (13) “Information supplied by the manufacturer,” we see it includes instructions and maintenance information, labels (including labels on detachable components), recycling information, and other information.

Article 11 Conformity assessment procedures (12.)

The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body.”

Article 11 (1-6) includes items dealing with the chosen conformity assessment procedure, including the declaration of conformity. This means that English may be acceptable but that the Notified Body involved in the process may request the information in the language of the member state in which the Notified Body is situated.

The ‘Blue Guide’ on the implementation of EU product rules 2016

The latest revision of the Blue Guide was published on the European Commission’s website on April 5, 2016. This document is made available for use by CE marking professionals, manufacturers, importers, distributors, and authorized representatives. In particular, the preface of the new document instructs that the revision was at least partly initiated by the changes brought on by the 2008 NLF.

Below are references to translation requirements required by the CE marking process. Please note that the Blue Guide is not a law like the Directives. Rather it is a reference document to be used as a guide.

Unabridged paragraphs of abridged sections of the Blue Guide are presented below for review.

4.4 EU Declaration of Conformity, para 7:

The EU declaration of conformity must be translated into the language or languages required by the Member State in which the product is placed or made available on the market. Union harmonisation legislation does not necessarily specify who has the obligation to translate. Logically, this should be the manufacturer or another economic operator making the product available. The EU declaration of conformity must be signed by the manufacturer or his authorised representative. If a translation of the EU declaration of conformity has been produced by another economic operator and is not signed by the manufacturer, a copy of the original EU declaration of conformity signed by the manufacturer must also be provided together with the translated version.

7.2 Controls by Market Surveillance Authorities, para 16, para 17:

In the case of a reasoned request it is sufficient for the manufacturer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, the request for translation of technical documentation should be limited to these parts of the documentation. If the market surveillance authority considers a translation necessary, it must clearly indicate the part of the documentation to be translated and allow reasonable time for this to take place. No further conditions may be imposed on the translation, such as a requirement of a translator accredited or recognised by the public authorities.

National authority might accept a language they understand and which is different from the national language(s). The language chosen could be a third language, if accepted by that authority.

Summary

It is clear that if you are sending equipment to Europe you will need to provide translations of some of the documentation for the product, unless you are shipping to Ireland or the UK. At a minimum you will need to translate the declaration of conformity and the operations and maintenance manuals. You may be required to translate some or all of the Technical File if there is ever a problem or question with your equipment.

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Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Pressure Equipment Directive 2014/68/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , , , , , , | Comments Off on CE marking and the requirement for translations