RoHS 3 – (EU) 2015/863 – Some FAQ’s

Now that we have been under the ‘new’ EU RoHS for a few months I thought it would be a good time to write a brief article to cover some of the most commonly asked questions.

  • What changed? RoHS 2011/65/EU restricts six substances. (EU) 2015/863 adds four more substances to this list. The original six substances are four heavy metals (inluding lead, not just lead) and two flame retardants. (EU) 2015/863 is an amendment to 2011/65/EU which added restrictions on the use of four phthalates.
  • What are phthalates? Phthalates are also called ‘plasticizers’ These are chemicals used in plastics to make them more flexible.
  • Does everything have to be retested to prove compliance? Not necessarily. Parts that are made of metal, 100%, have no phthalates. Most manufacturers have known about this amendment since it was introduced, four years ago, so chances are your products need new docmentation but not new testing.
  • Since (EU)2015/863 is an amendment to the RoHS Directive 2011/65/EU then isn’t a claim of compliance to RoHS 2011/65/EU also a claim of compliance to (EU)2015/863? That can be a question that is subjective, based on a few other “ifs”. For example, if the document claims compliance to RoHS 2011/65/EU and lists only the original six substances then we would not accept this (F2 Labs performs many EN 50581:2012 reviews for our customers). However, if the document indicates compliance to RoHS 2011/65/EU, while not indicating the list of restricted substances, and it is signed & dated past July 22, 2019 – we would probably accept it.

There are a few nuances to RoHS and we can help you with this.

We can be contacted via this link. We can be reached by phone at
877-405-1580 and are here to help you.

F2 Labs is here to help.

Posted in CE marking, RoHS Directive 2011/65/EU | Tagged , , , | Leave a comment

Translations and CE marking

This is an often-asked question, “Do I need to translate the manual for the EU and what do I need to translate?”

The answer is everything that is needed top assemble, safely operate, maintain, and eventually dispose of the equipment must be translated.

The EU changed the requirements for translations with the 2008 New Legislative Framework  (also called the 2008 NLF or just NLF). Several new CE marking Directives resulted from this including the below, though not an exhaustive list:

With these new Directives came more precise definitions of some terms and an alignment of requirements between the Directives. Prior to the 2008 NLF it was common to see differing requirements for the same document from Directive to Directive. For example, the formats for the declarations of conformity differed from one Directive to the next. The EU attempted to change that with the NLF and in addition to streamlining, they also tightened-up definitions, including the definitions and responsibilities of three classes of economic operators:

  • Manufacturers
  • Importers
  • Distributors

This article focuses only on the translation requirements as concerns manufacturers. In plain English: if you are a manufacturer in the United States and you want to send a product to the EU then you will need to translate everything associated with it into the native language of every country you send it to.

Oftentimes I will break this down and document it for a customer who asks. Today I was asked again and decided to lift that information from the email and place it in a blog article here for future reference. In this case the customer has a product that is in the scope of the Radio Equipment Directive 2014/53/EU and asked how much material (instruction and operation manuals, maintenance manuals, quick start guides, etc.) needs to be translated.

Below is the response. Documented in the response is the requirement in the Radio Equipment Directive 2014/53/EU, the explanation of Article 10 (8) in the RED guide, and section 3.1.4. from EU Blue Guide to Product Rules, which is referenced in section 2.6 (j) from the RED guide.

See the RED 2014/53/EU, Article 10 (8.)  –

Article 10

Obligations of manufacturers

8. Manufacturers shall ensure that the radio equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Instructions shall include the information required to use radio equipment in accordance with its intended use. Such information shall include, where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible. The following information shall also be included in the case of radio equipment intentionally emitting radio waves:

(a) frequency band(s) in which the radio equipment operates;

(b) maximum radio-frequency power transmitted in the frequency band(s) in which the radio equipment operates.

Next see the RED guide (attached), section 2.6 (j) –

j) Instructions

Article 10.8 of the RED requires manufacturers to accompany the equipment by instructions and safety information in a language which could be easily understood by consumers and other end- users, as determined by the Member State concerned. Furthermore, they shall be clear, understandable and intelligible. The Blue Guide, in Chapter 3.1.4, provides more details on how the instructions and safety information need to be provided. These instructions shall also include information required to use the radio equipment in accordance with its intended use. In particular, this information shall include, where applicable, a description of accessories and components, including software:

(1) have an influence on the conformity of the radio equipment, and

(2) are intended to be installed or changed by the user without the control of the manufacturer.

Accessories example:

? If the radio equipment is delivered without an antenna, then the technical features of the antenna that may be used in conjunction with the radio equipment shall be provided to the user. The user is responsible to operate the radio equipment and the accessories as intended and according to the description provided by the manufacturer. These technical features of the accessories shall therefore be mentioned in the instruction manual in order to enable the user to operate the compliant radio equipment. This information could be the generic characteristics of a given antenna type or a reference to a specific antenna(s) available on the market.

Software example:

? If the radio equipment has software (such as firmware, PC controlling software) that can affect its compliance with the Directive and the manufacturer intends and offers the possibility to the user to freely change it or modify it, then the software should be named in the instruction manual so that it is possible for the user to put a compliant radio equipment into operation. The manufacturer can decide the format of the description of this software as long as it can be identified.

On the other hand, if the radio equipment has software that can affect its compliance with the Directive but the manufacturer does not intend to allow the possibility for the user to change it or modify it, then no information has to be provided in the instruction manual. This is often the case of “software updates over the air” where the new software is installed under the full control of the manufacturer with no access by the user. In these cases the manufacturer ensures the installation of new software for which compliance with the Directive has been already assessed and reflected in the Technical Documentation.

With the objective of supporting authorities on their market surveillance activities, Article 10.8 of the RED requires manufacturers to accompany radio equipment which intentionally emits radio waves with information on the frequency bands and maximum output power with which the equipment is able to operate in the EU.

Manufacturers have different alternatives to fulfil these requirements. For example, any of the following options could be added to the instructions:

? the nominal frequency and transmitted power (radiated and/or conducted) used by the radio equipment, as reflected in the Technical Documentation,

or

? for radio equipment using standardized technologies, e.g. GSM/3G/LTE, indication of the frequency band in the way they are commonly well known (such as GSM 900, 1800). Where different power levels are possible, the nominal maximum power would be stated.

Next see section 3.1.4 from the Blue Guide:

As a general rule, when placing a product on the market the manufacturer must take all measures necessary to ensure that the manufacturing process assures compliance of the products and in particular:

4.accompany the product with instructions and safety information as required by the applicable Union harmonisation legislation, in a language easily understood by consumers and other end-users, as determined by the Member State concerned. Unless otherwise specified in specific legislation, instructions and safety information need to be provided, whether the product is intended for consumers or other end-users. This should include all the necessary information for the safe use of the product, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product. Instructions for assembly or installation should include the inventory parts and special skills or tools. Instructions on operation should include information for restriction of use, need for personal protective equipment, maintenance and cleaning or repair. It is for the manufacturer to determine the relevant information which should be included in the instructions and safety information for a particular product. Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product. Furthermore, a tool designed and intended to be used by professionals only might also be used by non- professionals, the design and instructions accompanied must take this possibility into account;

Our guidance and advice, based on the above and other similar documentation for other CE marking Directives, is that the manufacturer must make a translation of everything.

We can be contacted via this link. We can be reached by phone at
877-405-1580 and are here to help you.

F2 Labs is here to help.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU | Tagged , | Leave a comment

CE marking FAQ

Frequently at F2 Labs we get very deep into various topics regarding CE marking and other compliance requirements. I can only imagine the sinking feeling that a manufacturer must feel when seeing this on a request for bid: CE marking required.

There is no reason to feel any apprehension. We help customers to comply with CE marking requirements every day. We also help customers understand that some requirements foisted upon the project by a buyer are not even legally required.

Below is a list of some very common questions asked all the time by our customers who are new to CE marking. This list was drafted to send out to our customers at the start of a project. I thought it could be useful as an article for our blog. We hope this is helpful, please see below.

CE marking Overview – Frequently Asked Questions

Summary:

  • Placing a CE marking on your equipment means that you are making a claim that your product complies with any EU CE Directive that applies to your equipment.
  • The manufacturer places the CE marking, it is not issued by a testing laboratory.
  • Self-certification means that you, as the manufacturer, can place the CE marking without having a test lab place the marking (as is case with North American safety compliance, i.e., “Listings”). In most cases this will require technical intervention by an accredited 3rd party laboratory, like F2 Labs.
  • Your product must be accompanied by an EU Declaration of Conformity, or in some cases, a Declaration of Incorporation for Partly Completed Machinery.
  • In all cases you are required to compile and maintain a Technical File at your facility for ten years after you ship the last product to the EU.
  • The Technical File must contain the proof that your equipment complies with the applicable Directives. In almost all cases that will require Technical Reports prepared by an accredited 3rd party lab.
  • Only the authorities in the EU have a right to see your Technical File. You are not obligated to deliver the technical file to your customer as a part of CE marking compliance.

The Directives:

  • The Machinery Directive (MD) 2006/42/EC, is applicable to machinery, broadly defined as anything with linked components that move under other-than-human power. Some lifting apparatus and attachments for machinery are also included as is lifting devices that rely on human power.
  • The EMC Directive 2014/30/EU is applicable to anything with active electronics.
  • The Medical Device Directive (MDD) 93/42/EEC is applicable to medical devices.
  • The Low Voltage Directive (LVD) 2014/35/EU is applicable to any product with an input voltage of 50 – 1,000 VAC or 75 – 1,500 DC.
  • The Radio Equipment Directive (RED) 2014/53/EU is applicable to all equipment with any wireless function. It also makes the technical requirements of the LVD automatically applicable, regardless of voltage.
  • The Pressure Equipment Directive (PED) 2014/68/EU is applicable to any product with a pressure of .5 bar and above but there are numerous exclusions.
  • The ATEX Directive 2014/34/EU is applicable to equipment that operates in a potentially explosive atmosphere. However, explosive risks generated in your machinery are covered by the Machinery Directive 2006/42/EC.
  • The Restriction of Hazardous Substances Directive (RoHS) 2011/65/EU is applicable to any device with any electric power or function. This means even a device with a piezo ignitor button.

F2 Labs is here to help.

Please call us at 877-405-1580.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, Pressure Equipment Directive 2014/68/EU, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Leave a comment

Sending equipment to the EU when compliance is not an obvious path

Manufacturers contact F2 Labs from around the world to ask for assistance with EU regulations. While F2 Labs primarily focuses on electro-mechanical devices, including medical devices, we have also assisted many people with an understanding of what is legally required.

An example of this could be a manufacturer of an aircraft sub-assembly that has an installed laser as a part of the sub-assembly. The device itself is used in a military / security application and is powered from the aircraft battery. The question to F2 Labs in this case is usually, “what is applicable?” Since in our experience the end-user in the EU oftentimes is not able to provide this information to the manufacturer (and it’s not their responsibility either), we try to help.

In this case the device is DC powered and is below the voltage levels of the LVD 2014/35/EU scope. The LVD is applicable as per Article 1, paragraph 2:

Next, we look at Annex II and see this:

Note that although the equipment can be excluded from the scope of the LVD it must be in the scope of some other safety requirement in order to really be “out of scope”. However, this equipment is excluded even before we get to Annex II… because it operates from an input voltage lower than the scope of the LVD (per Article 1, paragraph 2).

In other words: if it is technically in the scope of the LVD and is also aeronautical equipment it can only be excluded from the LVD if it falls under the aeronautical regulation. You cannot exclude your equipment from the LVD because it’s aeronautical and then also exclude it from the aeronautical regulation.

Now we look at the EMC Directive 2014/30/EU. See Article 2, Scope 1:

Next, see Article 2, (2.), (b):

OK, here is a wrinkle. The EMCD 2014/30/EU is not applicable to aeronautical products if they are in the scope of Regulation (EC) No. 216/2008. Immediately we see Article 2 (2.) in Regulation No. (EC) 216/2008:

So, it is excluded from this regulation because it has a military / security application. This means therefore it is not excluded from the EMCD 2014/30/EU (because only aeronautical equipment in the scope of Regulation No (EC) 216/2008 is excluded from the EMCD 2014/30/EU).

We advise compliance with the EMC Directive 2014/30/EU using whatever applicable harmonized EMC testing standards are relevant.

Interesting to note that the Low Voltage Directive 2014/35/EU is nuanced because although the subject equipment could not escape the Low Voltage Directive 2014/35/EU due to being in the scope of Regulation No (EC) 216/2008, it is still out of scope due to being below the minimum voltage limit.

And there is a laser. Overall assemblies are in the scope of the harmonized Low Voltage Directive standard for laser safety, EN 60825-1:

But this is not in the scope of the Low Voltage Directive, so now what?

Our advice is this:

  1. Comply with the EMC Directive 2014/30/EU
  2. Have the apparatus tested to an appropriate safety testing standard, probably EN 62368-1, and receive a compliant report.
  3. Have the apparatus testing to IEC/EN 60825-1 and receive a compliant report.
  4. Indicate that the equipment is compliant to the EMC Directive 2014/30/EU on the EU declaration of conformity and additionally indicate that it has been tested to appropriate European safety standards, including laser testing, by listing those standards and report numbers on the document, but do not claim compliance to the Low Voltage Directive 2014/30/EU.

We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

F2 Labs is here to help.

Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC | Tagged , , , | Leave a comment

Ronin Revolution Corporation earns EC type-examination Certification for Ronin Lift from Notified Body.

Ronin Revolution Corporation worked with F2 Labs to evaluate and test the
Ronin Lift for compliance with the relevant CE marking Directives required to sell their product in Europe. The Ronin Left is a personal ascender used to lift people for both recreation and tasks.

We advised the engineering staff at Ronin that the equipment, a lifting device for people, is in the scope of the equipment listed in Annex IV of the Machinery Directive 2006/42/EC. Particularly, Annex IV (17), see below.


Equipment that is indicated in Annex IV is the only category of machinery that requires Notified Body involvement, in the form of an EC type-examination certificate. This is required under the following conditions:

  1. The equipment is listed in Annex IV.
  2. All the risks are not addressed by harmonized standards.

See Article 12 (4.) (a) below:

The engineering staff at both F2 Labs and Ronin Revolution Corporation worked together, extensively, to resolve the detailed risk assessment generated for the Ronin Lift and then set about testing every facet of the equipment. No stone was left unturned in preparation of the EC-type Examination. F2 Labs next assembled a complete Technical File, per 2006/42/EC, Annex VII (A.) and made contact with a Notified Body in the EU to finish the process.

After many rounds of testing, evaluation, and numerous conference calls, we are pleased to announce that Ronin Revolution Corporation has earned the EC type-examination certificate for the Ronin Lift. Congratulations from your friends and colleagues at F2 Labs!

F2 Labs is here to help.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

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CE marking – Equipment is stopped in French customs, what now?

The sales department at F2 Labs fields phone calls from primarily US manufacturers. We have heard every scenario imaginable as pertains CE marking, from, “What is CE marking? We are about to disassemble and crate our machine and noticed that CE is required in the purchase agreement,” to, “We have been shipping to Europe for twenty years without a CE marking and have never had a problem.

Getting your product through customs can seem like a roll of the dice but it is really not that complicated. Here is what you need:

  1. CE compliant product with a CE marking.
  2. EU declaration of conformity in the language of whatever country you are sending the equipment to.
  3. A Technical File at your facility, prepared and stored securely, and ready to deliver to the authorities if your product is stopped.

Note that for item 3 above you must be able to hand over a Technical File to the authorities if asked. Never send it with the product or to your customer. The Technical File is your proprietary information about your device and is your proof that it is compliant and was in a compliant state when sent to the EU. No one has a right to view it outside of your company except the authorities. And if they want it, they will ask for it.

Let’s look at a hypothetical case.  One of our customers has a stopped shipment in French customs. The product is a machine and was a model in a series of very similar models in a product family. A series approach to compliance is very routine, particularly with electro-mechanical devices. In most cases we advise that if there is a series of nearly identical equipment then the appropriate route is to test the most complex and “worst-case” configuration, the customer can then use the resulting Technical Reports to justify the compliance of the other models in the series.

The customs authority will next make a request for the Technical File and may indicate, upon review, that our customer’s product cannot proceed because the model that we tested (and indicated in the resulting IEC/EN Technical Reports in the Technical File) is not the same model as the model indicated on the declaration of conformity for the unit that is stopped in customs.

In most cases our customer will contact us at this point and ask for assistance. That is advisable. We can and will help you. We will next make a review of the correspondence between our customer, the international shipper, and the customs official. This will result in the following guidance, almost always:

Machinery Directive 2006/42/EC, Article 12 –

Article 12

Procedures for assessing the conformity of machinery

  1. The manufacturer or his authorised representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.

  2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.

In almost all cases, the manufacturer will follow Article 12 (1), (2), & (3) (a).

Please see Annex VIII, as referenced in Article 12 (3) (a) and note in particular, Annex VIII (2).

ANNEX VIII

Assessment of conformity with internal checks on the manufacture of machinery

  1. This Annex describes the procedure by which the manufacturer or his authorised representative, who carries out the obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant requirements of this Directive.

  2. For each representative type of the series in question, the manufacturer or his authorised representative shall draw up the technical file referred to in Annex VII, part A.

  3. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the requirements of this Directive.

We also note the guidance and direction regarding this as presented in the Guide to Application of the Machinery Directive 2006/42/EC, Edition 2.1.

See section 395, para 2:

Section 2 of Annex VIII recalls the obligation of the manufacturer or his authorised representative to draw up a technical file according to Annex VII A 1 for each type of machinery – see §103: comments on Article 5 (1) (b). The technical file must identify the EHSRs applicable to the machinery and describe how they have been fulfilled. The term ‘representative type’ is equivalent to the terms ‘type’ or model – see §392: comments on Annex VII A 1.

Next, see the referenced section 392, para 3 pertaining to ‘representative type’ from the guide –

A technical file is required for each model or type of machinery. The terms ‘model’ or ‘type’ designate machinery with a given design, technical characteristics and application. A type of machinery may be produced in series or as a single unit. One type of machinery may have variants; however, to be considered as belonging to the same type, variants must have the same basic design, present similar hazards and require similar protective measures. The description of the machinery in the technical file must specify any variants of the model or type concerned.

The subject equipment referenced on the declaration of conformity is extremely similar in design, function, and use as the model that was evaluated and tested in our laboratory.

The guidance provided by the European Commission in the Guide to application of the Machinery Directive 2006/42/EC, and displayed above, is the methodology we use when advising US manufacturers in regards to this common situation.

I hope this helps.

The stopped shipment has been immediately released in every case that the above synopsis of the Machinery Directive requirements concerning series manufacture and compliance has been referenced to EU customs officials.

We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

F2 Labs is here to help.

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Building a machine for the EU? Here is some wiring guidance from one of our senior safety engineers.

We help manufacturers every day with the task of CE marking their equipment for shipment to the EU. Very often we are asked questions by our customer’s engineering staff and one of the most common questions pertains to wire colors. The main electrical safety standard for machinery is EN 60204-1 – Electrical equipment of machines – Part 1: General requirements. EN 60204-1 is a B-type Machinery Directive standard and tells machine makers what colors are required for different wires, in clause 13.

However, it can be difficult to interpret, sometimes, exactly what the authors of the standard mean. If you are questioning what it means… it’s not you, it’s the standard. We get asked all the time about this subject.

Yesterday one of our senior safety engineers provided a response to this question for me to forward to a customer. The email he wrote is below for future reference.

F2 Labs is here to help.

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 CE marking | Leave a comment

RoHS 2011/65/EU – New Restrictions July 2019

RoHS 2011/65/EU presently requires compliance for electrical and electronic equipment to these six substances indicated in Annex II:

We note that RoHS 2011/65/EU was amended by Commission Delegated Directive (EU) 2015/863 in March of 2015. The new restrictions are highlighted in yellow and indicated in the Annex of (EU) 2015/863 which revises Annex II of 2015/65/EU:

The date for the new restrictions to take place is July 22, 2019. However, we note that for some product categories there are delays to the enforcement of the new restrictions for two years. See paragraph 1 of the revised Annex II:

This means that the above indicated equipment can continue to meet the restriction levels for the original list of six restricted substances until July 22, 2021. Otherwise, you must comply by this July.

We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

F2 Labs is here to help.

Posted in CE marking, Consulting, REACH, RoHS Directive 2011/65/EU | Tagged , , , , | Leave a comment

EN 62368-1:2014 will replace EN 60950-1 and EN 60065

EN 62368-1:2014 will replace two main EN standards on December 20, 2020. A year or two years ago this seemed a long way off. Now it is right around the corner.

To begin with, we want to take a look at the status of EN 62368-1:2014 on the list of official Low Voltage Directive 2014/35/EU harmonized standards published in the Official Journal of the EU, here. See below pertaining to EN 62368-1:2014:

We know from reading this article, published on August 29, 2016 on this blog, that the first date shown, 8.7.2016, is the date that EN 62368-1:2014 was published in the Official Journal of the EU and was acceptable to use to prove conformity to the Low Voltage Directive 2014/35/EU. The next block to the right shows the standards it will replace: EN 60065 and EN 60950-1. Immediately to the right of that block is the date that EN 62368-1 totally replaces the other two standards.

As of December 20, 2020 you will not be able to send products to the EU that are in the scope of the Low Voltage Directive 2014/35/EU or the Radio Equipment Directive 2014/53/EU unless they are tested to EN 62368-1:2014.

This means that if you are making products that were tested to EN 60950-1 or EN 60065 now is the time to investigate testing to EN 62368-1:2014. In the fall of 2020 our labs are going to be filled with projects undergoing UL/CSA/EN/IEC 62368-1 testing.

Beat the rush, contact us now.

F2 Labs is here to help.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

Posted in CE marking, Low Voltage Directive 2014/35/EU, Radio Equipment Directive 2014/53/EU | Tagged , , , , , , , , , | Leave a comment

Changes to the Machinery Directive 2006/42/EC

Some pretty drastic changes to the Machinery Directive 2006/42/EC were published on the European Commission’s Machinery Directive page on March 18, 2019.

Most noticeably, prior to March 18, all of the harmonized standards attached to the Machinery Directive and published in the Official Journal of the EU were displayed in order (A-type, then B-type, then C-type) running down the page.

Now, this is displayed:

The two links are important and the purpose of this article. The first link refers to Commission Implementing Decision (EU) 2019/436. I will refer to it as 2019/436 in this article. The second link refers to the currently accepted harmonized EN standards available to prove compliance to the Machinery Directive.

2019/436 does a few things that are most notable and we want to spread that information to our customers and interested parties as soon as possible. See below.

  1. EN ISO 12100:2010, the sole A-type Machinery Directive standard, dealing with risk assessment, is called out for elimination from the official list of harmonized standards. We do not know when this will happen or what will replace it. See below recital (14) –

2. 2009/436 has three annexes. These three annexes are lists of standards with the following criteria –

  • Annex I – harmonized EN standards added to the list of Machinery Directive standards.
  • Annex II – harmonized EN standards added to the list of Machinery Directive standards, but with a restriction.
  • Annex III – harmonized standards withdrawn from the Machinery Directive standards list. Note that this is not immediate. The dates for each standard’s removal is published next to the standard.

3. EN ISO 12100:2010 is not listed in any of the above three Annexes so while we expect it to be removed or replaced, that is not decided or scheduled yet.

4. EN 60335-1:2012+A11:2014+A13:2017 is published to the Machinery Directive list in Annex I (really, this just adds the A13 amendment) and will be required as of May 3, 2020. Interestingly, the A13 amendment is not yet published to the Low Voltage Directive 2014/35/EU list of standards. This means that if your product complies with EN 60335-1 and is in the scope of the Machinery Directive 2006/42/EC then you must consider the A13 amendment prior to May 3, 2020. Any products sent to the EU with a declaration of conformity indicating compliance to the Machinery Directive and En 60335-1 must, by May 3, 2020, indicate EN 60335-1:2012+A11:2014+A13:2017.

We will perform an intensive review of 2019/436 and will publish more information regarding these important changes.

We can be contacted via this link. We can be reached by phone at 877-405-1580 and are here to help you.

F2 Labs is here to help.

Posted in CE marking, Machinery Directive 2006/42/EC | Leave a comment