CE marking, harmonized EN standards, & EN 60204-1:2018

The main electrical safety standard for machinery, EN 60204-1, was revised by CENELEC and published on September 14, 2018.

The currently harmonized version, EN 60204-1:2006+A1:2009, is still the officially recognized version. What does this mean? As a primer, I suggest reading an article we published about the role of harmonized standards and your CE marking projects two years ago.

EN 60204-1:2006+A1:2009 is, for now, the recognized version but eventually we will see the new standard on the official list published in the Official Journal of the EU.

Upon review of the new standard I noticed there are differences in some requirements as compared to the superseded versions. That is of course to be expected. However, what I found particularly interesting is the total revision and expounded Annex ZZ in the new version of the standard. See immediately below Annex ZZ from EN 60204-1:2006+A1:2009.

Annex ZZ from EN 60204-1:2006+A1:2009 references the specific Annex I EHSR’s (Essential Health and Safety Requirements) from the Machinery Directive 2006/42/EC. These are the only requirements in the Machinery Directive that can be evaluated against EN 60204-1.

This means, for instance, that the EHSR 1.2.4.1 can be satisfied by applying EN 60204-1 to the machine.

1.2.4.1 is listed in Annex ZZ of EN 60204-1. Therefore, compliance with that standard confers the presumption of conformity (this is explained in F2’s August 2016 article) to the machine for that EHSR, and all EHSR’s that are linked to EN 60204-1. For every 2006/42/EC, Annex I EHSR there must be a corresponding evaluation of the equipment, for that risk, against a harmonized standard or relevant clause from a harmonized standard. As an example, EN 61010-1 is a very comprehensive electrical safety standard that is harmonized to the Low Voltage Directive 2014/35/EU. Except for the sole 2006/42/EC Annex I EHSR 1.5.1 Electricity Supply, it cannot be used to validate compliance of machinery to any other 2006/42/EC EHSR. (Please see this article from 2016 for an understanding of the relationship between the Machinery Directive 2006/42/EC and the Low Voltage Directive 2014/35/EU).

Let’s look at another example. See Annex ZB from another very common harmonized Machinery Directive EN standard, EN ISO 13857:2008 – Safety of machinery – Safety distances to prevent hazard zones being reached by upper and lower limbs 

Annex ZB from EN ISO 13857 lists three 2006/42/EC Annex I EHSR’s: 1.1.2, 1.3.7, & 1.4.1. Notice that none of these are listed in Annex ZZ of EN 60204-1. These EHSR’s are pasted below directly from the Machinery Directive.

2006/42/EC, Annex I, 1.1.2

2006/42/EC, Annex I, 1.3.7

2006/42/EC, Annex I, 1.4.1

Why is this important? A machine must be evaluated to EN ISO 12100:2010 in order to establish the applicable EHSR’s from 2006/42/EC, Annex I. There are many EHSR’s on that list and all of them may not be applicable to a particular machine. EN ISO 12100:2010 and the manufacturer’s risk assessment will tell a manufacturer exactly which of the EHSR’s are applicable.

But, you are not done at that step. The next step is to identify which harmonized EN standards can be used to evaluate the equipment to a particular EHSR or (as in the case of EN 60204-1) set of EHSR’s. For example, application of EN ISO 12100:2010 and the performance of a risk assessment may uncover a risk due to a moving transmission part. The manufacturer may then install a fixed guard over the part in order to protect operators and maintenance crews. This is referenced in clause 6.3.3.1.

Notice that EN ISO 12100:2010, 6.3.3.1 refers directly to ISO 13857. And EN ISO 13857 refers directly to 2006/42/EC, Annex I, 1.3.7. & 1.4.1.

Bringing this article back around to the new standard, EN 60204-1:2018, we refer to Annex ZZA, below.

It is interesting to note that the author(s) of the new standard were very specific in outlining the particular 2006/42/EC Annex I EHSR’s that are covered by this standard. A very helpful addition is direct reference to the particular clauses in Annex ZZA from EN 60204-1 to satisfy these EHSR’s. This is because entire standards are not required in order to prove compliance. To illustrate this, we refer to, The ‘Blue Guide’ on the implementation of EU product rules 2016, section 4.1.2.2, para 9:

The author(s) of EN 60204-1:2018 even made sure to exclude parts of specific EHSR’s. See below 2006/42/EC, Annex I, 1.7.4.2. with ‘u’ highlighted.

A point was made to specifically eliminate the airborne noise requirements in the instructions from EN 60204-1:2018. There are other EN standards that refer to making noise measurements and recording them in the instructions as pertains machinery, but that will have to wait for another article.

Summarizing all the above, i.e., “what does this mean?”

It means that for every applicable Machinery Directive 2006/42/EC, Annex I EHSR there must be a corresponding harmonized EN standard, or a clause from a harmonized EN standard, that is directly linked to that EHSR. Therefore, every EHSR that is identified as applicable to the machinery must be evaluated against a particular harmonized EN standard. This will, typically, lead to a number of EN standards being listed in the Technical File of the machinery, per 2006/42/EC, Annex V11 (A.) (1.) (a) (5th indent):

Your machinery does not benefit from the presumption of conformity without that.

Note that the requirement in Annex VII, (A.), (1.), (a.), (5th indent) is a different requirement than 2006/42/EC, Annex II (1.), (A.) (7.), (8.):

And, next, see Article 7 (2.) from the Machinery Directive:

 

The common practice is to indicate the main standards used on the declaration of conformity. Backing that up, in the Technical File, should be a chart against Annex I of the Machinery Directive. That chart should indicate every applicable Annex I EHSR, cross-referenced with the harmonized EN standard (or clause from the standard) to show it was evaluated. And, usually, in Annex ZZ of the standard you will find a list of Annex I EHSR’s that are linked to the particular standard. In this way it all fits together.

Want some help to understand the requirements of CE marking and your EU project? F2 Labs helps manufacturers across the globe every day with small and large products. We have experts who quickly determine what is applicable to the equipment, legally and technically.

We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

F2 Labs is here to help.

Posted in CE marking, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC | Tagged , , , , | Leave a comment

Machinery Directive 2006/42/EC, Article 1 (b) interchangeable equipment

As usual, I opened the RAPEX Weekly Report that delivers to my inbox every Friday morning.

Scrolling through, I reviewed three cases involving saw blades. These are interesting because they were stopped for violating the Machinery Directive 2006/42/EC. Normally when we consider the Machinery Directive, we think of products that have linked parts under other-than-human (meaning electric, pneumatic, or hydraulic) power.

Below are the three saw blades that were stopped:

Model 61H199 – Link.

Model 61h197 – Link.

Model 61H196 – Link.

All three were found to violate the Machinery Directive 2006/42/EC and fail to comply with these harmonized Machinery Directive EN standards:

(Side note: F2 published an article about how to read/understand the above chart, here).

Although these saw blades are not ‘machines’ in the classic sense, they were stopped because they were classified as ‘interchangeable equipment’, which puts them in the scope, fully, of the Machinery Directive 2006/42/EC.

See the scope of the Machinery Directive in Article 1 – in particular, item (b):

Next, see the definition of ‘interchangeable equipment’ in Article 2 (b) of the Machinery Directive 2006/42/EC

However, the European Commission also published the Guide to application of the Machinery Directive 2006/42/EC, Edition 2.1, in 2017 (read it here). This document clearly explains every line of the Machinery Directive in plain text so that a layman can understand. We refer to it constantly at F2 Labs in order to help our customers. Section 41 is dedicated to interchangeable equipment. Paragraph 7 of Section 41 states:

So, we see that saw blades are not considered interchangeable equipment. The authorities noted, however, that there is a picture of an angle grinder on the packaging, included below.

Model 61H199

Model 61h197

Model 61H196

So, the equipment is no longer excluded since it attributes a new function (chainsaw) to a different machine (angle grinder).

Even worse, this equipment is now in Annex IV of the Machinery Directive (included below).

And then see Paragraph 11 from Section 41 of the previously referenced guidelines:

Note this in particular, excerpted from the above:

“It should be noted that the assembly of interchangeable equipment with basic machinery may have the effect of creating a combination that belongs to one of the categories of machinery listed in Annex IV.”

OUTCOME: The use of the indicated blades therefore change an angle grinder into a chainsaw. Chainsaws are listed in Annex IV of the Machinery Directive. The above means that this manufacturer must not only conform with the Machinery Directive, but also follow a more stringent compliance process and probably involve a Notified Body.

We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

F2 Labs is here to help.

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The Machinery Directive 2006/42/EC and Notified Bodies

What is a Notified Body and what does it have to do with the Machinery Directive 2006/42/EC?

In most cases presented to us, absolutely nothing. I wanted to write this article because we are asked, from time to time, if we can offer a Notified Body certificate (more accurately called an EC type-examination certificate) for a machine.

A Notified Body is a company with a special status conferred upon it by an EU member nation, recognizing its technical competence in a specific aspect of compliance related to particular EU CE marking Directives, or a product category from a CE marking Directive.

A precise definition is offered in section 5.2.1. of the EU Blue Guide to Product Rules:

“Notified bodies are conformity assessment bodies which have been officially designated by their national authority to carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation when a third party is required. They are called ‘notified bodies’ under EU legislation.”

In the case of the Machinery Directive 2006/42/EC a Notified Body can only be involved for particular types of equipment. That equipment is listed in Annex IV:

ANNEX IV

Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must be applied

1. Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;
1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;
1.3 sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;
1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.
2. Hand-fed surface planing machinery for woodworking.
3. Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
4. Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
4.1. sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;
4.2. sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
5. Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.
6. Hand-fed tenoning machinery with several tool holders for woodworking.
7. Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
8. Portable chainsaws for woodworking.
9. Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
10. Injection or compression plastics-moulding machinery with manual loading or unloading.
11. Injection or compression rubber-moulding machinery with manual loading or unloading.
12. Machinery for underground working of the following types:
12.1. locomotives and brake-vans;
12.2. hydraulic-powered roof supports.
13. Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.
14. Removable mechanical transmission devices including their guards.
15. Guards for removable mechanical transmission devices.
16. Vehicle servicing lifts.
17. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres.
18. Portable cartridge-operated fixing and other impact machinery.
19. Protective devices designed to detect the presence of persons.
20. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11.
21. Logic units to ensure safety functions.
22. Roll-over protective structures (ROPS).
23. Falling-object protective structures (FOPS).

See that the descriptor under the title “Annex IV” refers to Article 12 (3) and (4). It is now worthwhile to explain Article 12 from the Machinery Directive. Article 12 lays out the conformity assessment procedures for machinery. This means, in English, “this is what you have to do to put a CE marking on your machine.”

First, I want to show Article 12 (2.):

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.

Article 12 (2) means that if your equipment is NOT indicated in the above Annex IV list then your only available procedure is to follow Annex VIII, which is below:

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.

There is no mention of Notified Body intervention.

Next, see Article 12 (3.):

3. Where the machinery is referred to in Annex IV and
manufactured in accordance with the harmonised standards
referred to in Article 7(2), and provided that those standards
cover all of the relevant essential health and safety requirements,
the manufacturer or his authorised representative shall
apply one of the following procedures:
(a) the procedure for assessment of conformity with internal
checks on the manufacture of machinery, provided for in
Annex VIII;
(b) the EC type-examination procedure provided for in
Annex IX, plus the internal checks on the manufacture of
machinery provided for in Annex VIII, point 3;
(c) the full quality assurance procedure provided for in
Annex X.

We see that if your equipment is indicated in Annex IV then you have three options IF you used relevant harmonized standards to address the risks. The standards for the Machinery Directive are listed here: LINK. In that case (Article 12 (3.) (a)) you are able to follow the Annex VIII conformity assessment procedure, one of the three options, and not involve a Notified Body.

If, however, you did not use relevant EN standards to address the risks, then you must follow Article 12 (4):

4. Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonised standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonised standards do not cover all the relevant essential health and safety requirements or if no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures:
(a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;
(b) the full quality assurance procedure provided for in Annex X.

In the above case (Annex IV machine and either the manufacturer did not use harmonized standards or none were available) then the process is more complex, and requires technical intervention by a Notified Body.

Therefore, if your equipment is not indicated in the Annex IV list there is no way to involve a Notified Body for the Machinery Directive compliance of your equipment.

To put a period on this sentence, next, I direct the reader to the official European Commission list of Notified Bodies for the Machinery Directive, here.

Notice that in order to select a Notified Body you must first select the product category, and the product categories are arranged per the Annex IV list;

If your customer is mandating that your product comes with Notified Body approval under the Machinery Directive and your equipment is not listed in Annex IV, call us. We can help you. In every case that I have been involved in as relates to this issue we have helped the customer (and our customer’s customer) understand the obligations and put this issue to rest. It saves everybody time and money.

We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

F2 Labs is here to help.

 

Posted in CE marking, Consulting, Machinery Directive 2006/42/EC, Product Testing | Tagged , , , | Leave a comment

CE marking Ambiguity

Yesterday I posted an article pertaining to last week’s RAPEX report and the scope of the Low Voltage Directive 2014/35/EU. Today I reviewed this week’s ‘catch’ of non-conforming products and it is a very illustrative of the opaqueness, sometimes, of the laws.

As we demonstrated, the Low Voltage Directive 2014/35/EU is applicable to products that operate with an input voltage of 50 to 1,000 VAC or 75 to 1,500 VDC. However, the EU drags other products into the scope as well. On November 1, 2016 the EU published a guideline document for the Low Voltage Directive 2014/35/EU, here.

On page 73 of that document exists a chart, in Annex VII, to give a reference for people trying to understand if a product is in or out of the scope.

If we zoom in, we can see that travel plug adapters are considered within the scope of the Directive.

So, it was with great interest that I saw this product, stopped in customs this week:

Going in for an even closer look (at the link) I see that the product does carry a CE marking.

But, what is interesting, to me, is that the notification does not reference the CE marking or the Low Voltage Directive 2014/35/EU. It references non-compliance to a ‘national standard’ which, in layman’s terms, means that the product does not comply with whatever standard is required in the importing country…. not that it does not comply with the Low Voltage Directive 2014/35/EU and the applicable harmonized EN standard, EN 62368-1.

And notice the last bullet point from the scope of EN 62368-1, below.

accessories intended to be used with equipment within the scope of this part of IEC 62368

The travel adapter is within the scope of the Low Voltage Directive 2014/35/EU and is within the scope of EN 62368-1:2014… not, in our opinion, a national standard.

This is a very important, critical distinction. To highlight this point, I reference section 4.1.2. from the EU Blue Guide to Product Rules:

National standards and harmonised standards are different and it means a great deal for your compliance project.

It can mean the difference between having your product seized in an EU customs border checkpoint or making its way to some store shelf or shelves all over the EU.

Want some help to understand the nuances and ambiguity of CE marking and your EU project ? F2 Labs helps manufacturers across the globe every day with small and large products. We have experts who quickly determine what is applicable to the equipment, legally and technically.

We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

F2 Labs is here to help.

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The Low Voltage Directive 2014/35/EU, its scope, and products that operate from DC voltage.

“F2 Labs is not the EU police and I do not know any EU police.”

I say that very often to customers when I speak with them, particularly as it relates to the Low Voltage Directive 2014/35/Eu and its scope, vis-a-vis a product presented to us for evaluation to determine applicable EU CE marking Directives.

The reason I say that is because the scope of the Low Voltage Directive is excluded from products with an electrical input of 50 to 1,000 VAC or 75 to 1,500 VDC. Customers will often ask us for a CE marking quote for a product that charges from an AC/DC adapter or operate from an AC/DC adapter, directly.

In many cases (not all, but a lot) the customer assumes that since the product, let’s say a small toothpick dispenser, that operates from 12 VDC is excluded because of the above. However, the customer supplies a power supply with the product.

I tell the customer that I am not the police because I must relay information, regulatory information… compliance information… that he or she may not like. That information is that the product is still in the scope of the Low Voltage Directive.

There are a couple of reasons for this:

  1. The product is sent with the means to connect to AC mains power. The overall product is the toothpick dispenser and the power supply. That product has an AC mains connection.
  2. The power supply, assuming it has a valid CE marking, was likely tested to EN 62368-1 while a product like a toothpick dispenser would be under a different standard, EN 60335-1. Many times, a customer may assume that the CE marking from one product translates or attaches to another. In our opinion, that is not the case.

In this case our opinion would be that the overall product (toothpick dispenser and power supply) are actually one product made up of two sub-assemblies.  Probably that is the conclusion that an EU customs official will come to as well.

This brings me back to the reason I wrote this article today: this week’s EU RAPEX report, linked here.

I scrolled quickly through the list, published weekly, of products stopped in EU customs and now banned from the market.

First, I came to these gloves:

I am 100% sure that these gloves are not plugged in while the rider is riding the motorcycle. Therefore, the gloves must contain some type of battery… so the heating element itself is powered by DC power and the manufacturer of the glove may have considered the glove to be below the 75 VDC Low Voltage Directive threshhold. In our opinion this is an AC powered product and in the scope of the Low Voltage Directive. The EU customs officials agreed:

Next, I scrolled to this radio:

The radio is clearly “battery powered”. There is even a picture of a battery sitting on top of the radio on the box. But, the unit is supplied with an AC mains connection point, visible in the picture. This product is also in the scope of the Low Voltage Directive 2014/35/EU and as above, the EU customs officials are in agreement with that. See below:

Regarding the radio above, we note that the product would be subject to the Low Voltage Directive requirements even if rechargeable batteries were not a part of the system. That is because the Radio Equipment Directive 2014/53/EU makes the technical requirements of the Low Voltage Directive applicable if there is any wireless function, regardless of voltage.

That means that if your product has a radio in it and is powered by a tiny coin-cell battery then, legally, it must also comply with the safety requirements of the Low Voltage Directive 2014/35/EU. However, the safety compliance would be declared to the Radio Equipment Directive 2014/53/EU.

But that topic will have to wait for another article.

Want some help? F2 Labs helps manufacturers across the globe every day with small and large products. We have experts who quickly determine what is applicable to the equipment, legally and technically.

F2 Labs is here to help.

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, Consulting, Low Voltage Directive 2014/35/EU, Product Testing, Radio Equipment Directive 2014/53/EU | Leave a comment

Automatic Bar Controls, Inc. – Pizza Sauce Dispenser

F2 Labs and Automatic Bar Controls, Inc. have collaborated on many compliance projects over the years and so we are pretty familiar with some of their products.

It was very interesting to see some of the pizza sauce dispenser… which I personally have seen in pieces spread across a bench in our lab as we evaluated and tested it for safety… as the subject of a random youtuber’s video and the entertainment for his child.

And another –

I can only imagine how many hundreds of these machines are in Costco’s across the United States and I’m proud to say that F2 Labs assisted our customer, Automatic Bar Controls, Inc., in making it possible to meet the requirements so that they could supply all of these machines… and help us all get that gigantic slice of pizza when we visit Costco.

Want some help? F2 Labs helps manufacturers across the globe every day with small and large products. We have experts who quickly determine what is applicable to the equipment, legally and technically.

F2 Labs is here to help.

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, Consulting, EMC Directive 2014/30/EU, FCC, General Product Safety Directive 2001/95/EC, IP Testing, Listing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Product Testing, RoHS Directive 2011/65/EU, UL 60335-1, UL 61010-1, UL 62368-1 | Tagged , | Leave a comment

REACH Regulation (EC) No 1907/2006 – Article 7, Annex VII, and practical considerations for manufacturers – the CRASH COURSE

One possible cause for an audible “gulp” coming from the reader of a specifications sheet is coming across a requirement to comply, vaguely, with the REACH Regulation (EC) 1907/2006.

Broadly, REACH is meant to ensure that products in Europe do not contain dangerous substances. The law is mainly focused at the manufacturers of large amounts of chemicals, but if you are a manufacturer who has been presented with this requirement, here is a crash course about three highly important items to get started. This blog article will focus on those items and is not complete (the law is over 500 pages, including the amendments).

The first item to consider is Article 6 (1), see below –

Article 6 (1) is stating that if you make a ‘substance’ and send it to Europe in quantities over one ton then they must be registered with the EU, following the REACH requirements.

The substance can be by itself (picture barrels of chemicals) or in an article. An ‘article’ is what you make, and makes up what you make. In other words: a screw holding something together in your product is an article. The ‘substances’ referred to are the substances called out in the REACH Regulation.

However, as pertains Article 6(1) and all of REACH: the responsibility to comply is with the entity in the EU. US manufacturers have no legal responsibilities under REACH.

The second item to consider is Article 7(1), see below:

Considering the guidance presented above regarding Article 6(1), we understand this to mean that your customers in the EU are responsible to submit a registration to the Agency if the products (articles) they buy from you contains substances that are restricted by REACH are either in quantities over one ton or expected to be released in the environment. The ‘Agency’ referred to is the European Chemicals Agency.

The requirements must be handled in Europe by the importer, but a US manufacturer  should assist them in complying with the law by determining if chemicals listed in REACH are inside the product.

The third item is Annex XVII – Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles.

Annex XVII lists substances that you cannot send in to Europe or can only send in after adhering to specific criteria. This brings me to the reason I decided to write this article, today. I received the weekly RAPEX report from the EU this morning.

I scrolled through it and came to this

Looking closely, we see the text –

 

 

Next, see the Reach regulation, Annex XVII (23) –

The Cadmium section goes on for four more pages, but see the second page –

This product contains 0.0676% in the plastic part of the lure, presumably that means the octopus eyeballs. The importer was forced to remove these items from the market and to warn customers of the risk.

These same restrictions apply to any equipment, it does not have to be a consumer good like a fishing lure.

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 Consulting, Product Testing, REACH, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , | Leave a comment

Partly completed machinery and the requirement for Assembly Instructions

Manufacturers who build parts of machines or incomplete machinery (for example: no controls) must be aware that their equipment must not carry a CE marking and must follow a separate compliance path in the Machinery Directive 2006/42/EC.

This is an important distinction because, in my opinion, it is more complicated (more documentation) to send a partly completed machine versus a fully functioning “machine” to the EU as pertains the MD 2006/42/EC compliance process.

For completed machinery, unless your equipment is under Annex IV, the process is very straightforward. See Article 12 –

This is the usual ‘self-certification‘ process: the manufacturer evaluates the equipment to Annex I usually with the aid of a competent 3rd party testing lab, uses applicable harmonized EN standards to evaluate and test, incorporates technical solutions, puts a CE marking on the equipment and… “off you go.”

For partly completed machinery the process is more complicated. See Article 13 –

This article will not detail every nuance of sending partly completed machinery to the EU but I want to stress three points:

  1. A CE marking is not allowed on the equipment until the integrator finishes the machine and makes it fully compliant.
  2. A declaration of incorporation instead of a declaration of conformity must be prepared. The most notable difference besides the title is that on a DoI the manufacturer must list every individual Annex I EHSR that is complied with. That is not done on a DoC.
  3. Assembly instructions must be prepared. That is kind of an innocuous term for what they really want because what they mean by “assembly instructions” includes any Annex I EHSR’s that are identified as applicable but not complied with because the equipment is not complete. In other words: the manufacturer must say to the integrator, “hey, we see this risk here and you have to address it when you complete the build.”

See the Guide to Application of the Machinery Directive 2006/42/EC, Edition 2.1, Section 390, para 3:

Are you bidding on or building a machine or partly completed machinery for the EU?

Want some help? F2 Labs helps manufacturers across the globe every day with these issues. We have experts who quickly determine what is applicable to the equipment, legally and technically.

F2 Labs is here to help.

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, Consulting, Machinery Directive 2006/42/EC, Product Testing | Tagged , , , , , , , , , | Leave a comment

CE marking Onsite Consulting and Training

F2 Labs is able to send a CE marking expert to your facility to provide overview training to your business – sales and engineering. We can quickly dig into the Directives that apply to your specific products and show your team exactly what is required and what your responsibilities are. Our approach is to show you the laws that you need to consider and real-world strategies for compliance. None of this is overly complicated but it can be intimidating at first. We will get you there.

Some questions we answer and discuss –

  • What Directives do we consider?
  • How do we know which standards?
  • How do I know if the testing I had done five years ago is still good enough?
  • What if I have ten really similar products?
  • Do I need a CE marking on my product to send it to a distributor for a trade show?
  • What if I am sending my system without controls?
  • Do I need an Authorized EU Representative? (teaser: in most cases, NO.)

 

Please contact your sales representative to discuss the training you may be interested in for your team. Each training presentation is uniquely tailored to your product and your business.

F2 Labs is here to help.

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, Consulting, EN 60601-1, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU | Tagged , , , , , | Leave a comment

Directive (EU) 2017/2102 and RoHS 2011/65/EU

The RoHS Directive 2011/65/EU was amended in November 2017 by Directive (EU) 2017/2102 with some administrative clarifications.

I found one item particularly interesting: Recital (2):

(2) Secondary market operations for EEE, which involve repair, replacement of spare parts, refurbishment and reuse, and retrofitting, should be facilitated to promote a circular economy in the Union. A high level of protection of human health and the environment should be ensured, including through the environmentally sound recovery and disposal of waste EEE. Any unnecessary administrative burden on market operators should be avoided. Directive 2011/65/EU allows EEE that fell outside the scope of the previous Directive 2002/95/EC of the European Parliament and of the Council (4), but which would not comply with Directive 2011/65/EU, to continue to be made available on the market until 22 July 2019. After that date, however, both the first placing on the market and secondary market operations of non-compliant EEE are prohibited. Such prohibition of secondary market operations is inconsistent with the general principles underlying Union measures for the approximation of laws relating to products and should therefore be removed.

I found it interesting because it shows the cooperative nature of many of the laws instituted in the EU. In summary – RoHS would have eventually required that “old” machinery be taken out of service because it was not compliant with the restriction levels. Since replacement parts would have to be sourced, probably from other retired machines, it would be impossible to bring in “RoHS compliant” replacement/spare parts for these machines. Meaning they would have to be retired.

The EU recognized that this was contrary to one of the purposes of RoHS 2011/65/EU and the WEEE Directive 2012/19/EU: keeping electrical equipment out of landfills.

Recital (2) allows machinery operators to continue to bring non-RoHS compliant spare parts in to the EU to keep legacy equipment operating… instead of forcing companies to dispose of the equipment.

F2 Labs can evaluate your equipment for RoHS compliance and we can compile the required EN 50581:2012 report to prove that your equipment conforms, allowing you to refer to RoHS 2011/65/EU on the EU declaration of conformity for your equipment.

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, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , | Leave a comment