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mike350  
#1 Posted : 08 June 2011 15:53:16(UTC)
Rank: Forum user
mike350

Please bear with me on this its a little convoluted. I've been asked by a client to look at a process machine that has recently been moved between factories. It has no O&M or Technical manual and no CE marking except on the incorporated valves and pumps etc. It's almost certainly been designed and built in house with no reference to any European Directive and used in an R&D environment. To all intents and purposes it is a simple machine for producing a liquid product and is a stand alone platform made up of a series of parts including a mixer, mixing vessel, two gravity fed powder hoppers and pipe work which works on a circulating system with the mixture ending up back in the mixer before being pumped out for disposal. Only the mixer and the mixing vessel could conceivably be moved and used in any other machine or line. It's currently idle while I try to get to the bottom of what is required and the question is can each element be assessed and a declaration of conformity or certificate of incorporation be issued or do I need to find someone to assess each section produce the necessary paperwork and CE mark it retrospectively. Or since it's not commercially available and is an in house build can it continued to be used as is. Any help or advice would be appreciated
Ron Hunter  
#2 Posted : 08 June 2011 16:08:56(UTC)
Rank: Super forum user
Ron Hunter

Asit's not commercially available and is an in-house build then yes, it can continued to be used as is - provided it meets essential safety requirements!
bleve  
#3 Posted : 08 June 2011 16:40:08(UTC)
Rank: Super forum user
bleve

If now intended for production purposes, it cannot be used, unless in conformity to the requirements of the machinery directive. The directive clearly states that equipment when put into service for own use is defacto placing the equipment on the market. I would refer you and Ron to the following from Article 2 of Directive 2006/42: Placing on the market’ means making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge; ‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In addition and depending on the physical properties of the powders, then DSEAR and ATEX (1994/9) conformity will also apply.
Ron Hunter  
#4 Posted : 08 June 2011 16:54:42(UTC)
Rank: Super forum user
Ron Hunter

My assumption is that the 'move between factories' was within the same organisation, and I think that can be excluded from 'placing on the market' - but it still has to be safe!
bleve  
#5 Posted : 08 June 2011 17:16:10(UTC)
Rank: Super forum user
bleve

If the equipment was first put into use any time after 1 Jan 1993, then it should have been provided with a demonstration of conformity & CE mark. Irrespective of it being moved from one site to another within the same organisation, the equipment should conform. Placing on the market is clearly defined as putting into service for one's own use. At some point this equipment had been placed onto the market even for own use. The key point here is the date of first putting it into use, if pre 1993 then PUWER will apply, post 1993, its the machinery directive & Puwer.
paul.skyrme  
#6 Posted : 08 June 2011 22:08:46(UTC)
Rank: Super forum user
paul.skyrme

bleve, is once again correct in this matter. This is the situation. If you are going to insist on CE for compliance with PUWER98 then you have no option other than to reverse engineer & CE mark the machine. PUWER98 compliance is most important, IMHO, however, the various new approach directives will apply, and, putting into service for ones own use is deemed as placing on the market in the eyes of the directives.
Ron Hunter  
#7 Posted : 08 June 2011 23:00:59(UTC)
Rank: Super forum user
Ron Hunter

"Placing on the market" continues to cause confusion I fear. The concensus of learned and respected body opinion leans towards the act of 'marketing' (free or for payment) to a third party, an act not applicable to (as I interpret) the actions in the initial post (in-house, one plant to another. It is this same interpretative scope that permits use and demonstration at trade fairs, exhibitions and the like. I emphasise again though, the equipment must be essentially safe, but it need not be CE marked and a technical file is not required. A quick Google of definition of the term quickly demonstrates some degree of differing interpretation, however I think I'll stick with the conscensus.
Ron Hunter  
#8 Posted : 08 June 2011 23:14:28(UTC)
Rank: Super forum user
Ron Hunter

Just to be crystal clear, I refer fellow posters to the EU Blue-Guide: http://ec.europa.eu/ente...guide/guidepublic_en.pdf and to the respective definitions of "placing on the market" and "putting into service" (sections 2.3.1 and 2.3.2 of the Guide)
bleve  
#9 Posted : 09 June 2011 01:25:14(UTC)
Rank: Super forum user
bleve

Confusion is on your part Ron. Mike, I suggest you ask the HSE for their opinion. I think I will rely on my own experience, training and credentials in this matter
bleve  
#10 Posted : 09 June 2011 02:07:19(UTC)
Rank: Super forum user
bleve

Ron, how do you explain the following from the Puwer ACOP? paragraph 203 of the PUWER98 Approved Code of Practice (relating to Regulation 10): These (Article 100a) Directives also apply to equipment made and put into service in-house. It is a common feature of these Directives that compliance is claimed by the manufacturer affixing a mark — ‘CE Marking’ - to the Equipment."
bleve  
#11 Posted : 09 June 2011 02:21:41(UTC)
Rank: Super forum user
bleve

Lets be very clear, an ACOP is stating that the requirements of the machinery directive is applicable to the manufacture or supply of in house equipment, the directive in its body of text makes no derogation to the requirement to provide technical file, declaration of conformity or ce mark. Would be interested to see your interpretation stand up before a court of law ;)
bob youel  
#12 Posted : 09 June 2011 08:52:25(UTC)
Rank: Super forum user
bob youel

Irrespective of CE marks or otherwise the kit must be safe & fit for purpose so an appropriately competent person should evaluate the kit and make that 'is it safe' decision. And this is where it can get complicated so unless a competent person is already in-house and can undertake this action U need to commission somebody who is and in most if not all situations that's an expensive action and the essential H&S parameters will need to be met ---- Also talk to your insurers as they should give U a good guide If pushed I would go with 'bleve' in this area
Ron Hunter  
#13 Posted : 09 June 2011 10:26:47(UTC)
Rank: Super forum user
Ron Hunter

We are of course discussing an area not (to the best of my knowledge) tested in a Court of Law (and perhaps unlikely it ever will be). My opinion (and it's only that) is that the matter of interpretation given by the same people who issued the Directives is the authorative one. I reiterate- if you want a definition of "putting into service", you have to look beyond PUWER and UK law. Every now and then, the UK makes interpretation errors in transposing Directives into Law and ACoP. Recent issues surrounding Control of Asbestos Regs being a current case in point. Good to have opportunity for open debate on this type of issue.
bleve  
#14 Posted : 09 June 2011 12:05:41(UTC)
Rank: Super forum user
bleve

Ron, I could not agree more, and as my final word, I would therefore refer you to the following: The 2nd Edition of the Guide to application of the Machinery Directive 2006/42/EC was endorsed by the EU Machinery Committee on 2 June 2010. http://ec.europa.eu/ente...rs/mechanical/machinery/ In particular: Page 60: § 80 A person manufacturing machinery for his own use A person who manufactures machinery for his own use is considered as a Manufacturer and must fulfil all the obligations set out in Article 5. In that case, the machinery is not placed on the market, since it is not made available by the manufacturer to another person but used by the manufacturer himself. However, such machinery must comply with the Machinery Directive before it is put into service – see §86: comments on Article 2 (k). Page 63: § 86 the definition of ‘putting into service’ The Machinery Directive applies to machinery when it is placed on the market and/or put into service. In the case of machinery manufactured by a person for his own use (that is not placed on the market), the Machinery Directive applies when the machinery or assembly of machinery is first put into service. In other words, such machinery must comply with ALL the provisions of the Directive before it is first used for its intended purpose in the EU. Note the stipulation of compliance with ALL the provisions. Finally, see requirements of Article 5: Article 5 Placing on the market and putting into service 1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall: (a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I; (b) ensure that the technical file referred to in Annex VII, part A is available; (c) provide, in particular, the necessary information, such as instructions; (d) carry out the appropriate procedures for assessing conformity in accordance with Article 12; (e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery; (f) affix the CE marking in accordance with Article 16. Now tell me that you disagree with the specific matter of interpretation given by the same people who issued the Machinery Directives.
Ron Hunter  
#15 Posted : 09 June 2011 15:26:02(UTC)
Rank: Super forum user
Ron Hunter

I concede to my learned colleague (bleve). I note in reading the (somewhat extensive!) footnotes that the Blue Guide I referred to mentions many relevant Directives (medical devices, low voltage, toys, construction products) - but not the Machinery Directive. As bleve correctly asserts, the Machinery Directive has its own explicit definition of "putting into Service". The Blue Guide is intended to guide in matters in interpretation where the Directive does not define this or other terms (and in that respect is a useful reference). Thank you all for a discussion which has expanded my understanding.
Jane Blunt  
#16 Posted : 09 June 2011 15:56:21(UTC)
Rank: Super forum user
Jane Blunt

Back to some practical advice. If it is a fairly simple machine, it should be possible for you to put together the necessary assessments and CE mark it yourself. The most useful webpage I know is this one: http://www.bis.gov.uk/po...ery-directive-2006-42-ec If you download the guide, http://www.bis.gov.uk/files/file52968.pdf you will find at Annex D a list of machinery that you cannot CE mark yourself. Provided your machine is not on this list, then the way is open to you to self certify. The essential health and safety requirements that it must meet are in Schedule 2 of this: http://www.legislation.g.../2008/1597/contents/made
bleve  
#17 Posted : 09 June 2011 16:15:38(UTC)
Rank: Super forum user
bleve

Ron a useful and interesting discussion. Jane, it may not be possible to self attest this equipment depending on the properties of the powder, method of charging the hoppers, extent and designation of hazardous area etc, it may well be the case that atex 1994/9 will apply.
Jane Blunt  
#18 Posted : 09 June 2011 18:34:10(UTC)
Rank: Super forum user
Jane Blunt

So let's ask Mike, what are the powders,liquid(s) and anything else that goes into this machine?
bleve  
#19 Posted : 09 June 2011 19:13:33(UTC)
Rank: Super forum user
bleve

Yes Jane, and while we are at it lets ask him how he is going to verify against EN 60204-1 or how he will ensure electro magnetic emissions affecting other equipment or control systems will not be an issue or even if operating above 0.5 Bar(g) , what PED category the equipment falls under. This subject is not as straight forward as you present or perceive it to be. Yet again, safety bods not knowing what they do not know............
Jane Blunt  
#20 Posted : 10 June 2011 06:47:37(UTC)
Rank: Super forum user
Jane Blunt

Bleve, I would prefer to be positive and helpful, and take one question at a time. You do not know my level of experience in this area, you do not know how many things I have been instrumental in CE marking, so your approach towards me and your judgement of me is totally unjustified.
bleve  
#21 Posted : 10 June 2011 07:56:22(UTC)
Rank: Super forum user
bleve

Jane, Your first post did not contain any reference to the salient or relevant points (ATEX, PED LVD, EMC etc)that will make Mike's task difficult and IMO it was misleading.
bleve  
#22 Posted : 10 June 2011 08:04:54(UTC)
Rank: Super forum user
bleve

Mike, As my final post on this topic, My advice is to obtain professional help with this task, requiring approx (6-8 hours) work in total.
achrn  
#23 Posted : 10 June 2011 08:23:07(UTC)
Rank: Super forum user
achrn

Although the thread seems to be drawing to a close, I note that no-one has raised the observation that the previously referenced document http://ec.europa.eu/ente...guide/guidepublic_en.pdf states (sidebar alongside clause 2.3.1) "Products built for own use are, generally, not considered as being placed on the market." That seems fairly clear.
bleve  
#24 Posted : 10 June 2011 08:29:43(UTC)
Rank: Super forum user
bleve

achrn wrote:
Although the thread seems to be drawing to a close, I note that no-one has raised the observation that the previously referenced document http://ec.europa.eu/ente...guide/guidepublic_en.pdf states (sidebar alongside clause 2.3.1) "Products built for own use are, generally, not considered as being placed on the market." That seems fairly clear.
Yes it is very clear, except that the note in question does not relate to machinery!! See Ron's posts.
Jane Blunt  
#25 Posted : 10 June 2011 08:37:22(UTC)
Rank: Super forum user
Jane Blunt

Whether the item needs to be CE marked or not is secondary to the fact that it must meet the relevant safety requirements, otherwise it will not be fit and safe to use in the factory. We do not know enough about it to determine how many of the pieces of legislation are relevant, which is why we need Mike to give us more information. It is indeed possible that there is a show-stopper, which brings it within a requirement to use a Notified Body (i.e. a requirement that would preclude self-certification), but his original description suggests this is unlikely.
SteveL  
#26 Posted : 10 June 2011 08:57:54(UTC)
Rank: Super forum user
SteveL

one for the Löfstedt review?
achrn  
#27 Posted : 10 June 2011 11:01:50(UTC)
Rank: Super forum user
achrn

Bleve wrote:
Yes it is very clear, except that the note in question does not relate to machinery!!
Right, that's the step I missed in trying to follow it all. Thanks.
Ron Hunter  
#28 Posted : 10 June 2011 11:40:53(UTC)
Rank: Super forum user
Ron Hunter

Just noticed the "R&D" element in the original post, and (always keen to learn and seek clarity) wondered if the machine was considered to be an in-house 'prototype' (I'm mindful of the derogation for such machines at Trade Fairs, Exhibitions etc.) would the compliance requirements in the employer's premises not be relaxed to the same extent?
bleve  
#29 Posted : 10 June 2011 12:16:19(UTC)
Rank: Super forum user
bleve

Derogation for the purposes of R&D only apply for temporary (short term use) equipment.
Terry556  
#30 Posted : 10 June 2011 12:25:28(UTC)
Rank: Super forum user
Terry556

The machinery will still have to be inspected by a competant person, and the PUWER assessment will have to be done, along with the RA.
Ron Hunter  
#31 Posted : 10 June 2011 12:54:57(UTC)
Rank: Super forum user
Ron Hunter

In a previous (work) life, I recall prototype phases going on for years!
MaxPayne  
#32 Posted : 10 June 2011 13:24:42(UTC)
Rank: Super forum user
MaxPayne

Beware of the difference between the European CE mark and the Chinese Export CE marking. http://www.icomuk.co.uk/...ryID=3508&cCID=17103
mike350  
#33 Posted : 13 June 2011 16:33:36(UTC)
Rank: Forum user
mike350

Thanks to all who have responded to this post which appears to have provoked a lively debate. I have little information at this stage other than that I included in the original post, I know that the ingedients include starch, vegetable oil, water and some (unidentified) flavourings. I should know more later this week when I speak to the client again. The question was prompted after the client started to do the Risk Assessment and look at the installation and guarding, since the first question was, "is there a CE mark" the rest of the assessment was put on hold and I was asked for my input. Since I found the requirement confusing, I thought I post and see if I could get some other opinions from someone who knew more than me. If and when I get more useful information I'll post again if I think it'll be useful. Mike
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