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View Full Version : REACH (Registration, Evaluation & Authorisation of CHemical): The new EU Legislation


Jonazzz
30th November 2007, 10:14 AM
Dear all,

As 1/07/2007 the new REACH legislation kicked in, and since a few months I 've been involved in this project in my company, I 've got a practical question.

The main goal of REACH is to make sure, that D.U.'s only use Registered substances.
At this moment a substance is identified by its CAS#, meaning if I access an open database, and input the CAS#, I can see the propertuies of this substance.
The ELINCS database already contains some over 4.300 registered substances, which are regarded as registered under REACH.
If you have a registration nr. from your substance supplier you can cross check it with this database.

In the process we 're almost ready to screen our supplybase (+ 200.000 articles, + 4.000 substances,...) and we will ask them CAS# and Registration# for each substance.

The problem is, that at this moment a CAS# can't be linked to a Registration#.

The Question :"Does anyone have a clue, if EChA will publish the "Candidate List", or even "Annex XIV" based on CAS# or Registration#??"

I don't want to second guess when building the IT-tool.

All replies are more than welcome.

:thanks:

Kales Veggie
30th November 2007, 10:58 AM
Jonazz,

I am confused. As far as I know, a substance/chemical can not be registered at this time. The ECHA office (in Helsinki) that will handle registration is not occupied yet.

Anne Johnson
30th November 2007, 06:53 PM
I have just found this whole REACh regulation difficult to understand. I understand the that at some point substances will need to be registered. But how do you identify what if required to be registered and what is not. At this point, I am sure we do not supply any type of substance, but we do supply articles, which may be made from raw substances.

Does anyone have a simplified version of the regulation?

Jonazzz
1st December 2007, 10:27 AM
I don't think that anyone got a simplified document for this legislation.

If you are mainly a produced of articles, than the only thing you should be aware of is the Annex XIV. Making sure that your articles don't contain more than 0,1% of an SVHC (which will be on the Annex XIV list).
If your article does contain more than 0,1% of a certain SVHC you have an information obliagtion towards your downstream users (read customers).
You need to infirm them about this substance. If necesarry your customer might ask some more questions about the substance in this article...

If you want some more explanation, feel free to post it here.

I just started the thread so that the discussion could more open.

Jonazzz
3rd December 2007, 06:47 AM
When looking for "simplified" documents, I've found 2.

The first is from Orgalime (Electric Industry), the second from AIG (Automotive).

I've attached both of them, you can also find them on the official websites, in some cases you might have to register, but this registration is for free.

The only advice I can give to these documents is, please don't take the flowcharts for gruanted.
In both cases, they 're merely a way of roughly finding your way in 850 pages of legislation.

Just for those of you who want to kick in, this might be ok.

If any questions, please post, I would like to have this Forum as a medium for all types of "practical" Q&A's.

Manix
4th December 2007, 07:24 AM
OK, Let's try and get some clarity. We are a tier 1 supplying OEMs (Automotive and Industrial). We supply (by definition given in the AIG document) "Articles". These articles do not release chemicals during normal use. Of course they have a varying chemical content, but this will be communicated by the channels stipulated in ELV, namely IMDS. We also have obligations to inform industrial OEMs under the RoHS directive.

I have been grappling with this for a few months, and this is the stages I find evolving when reviewing our obligations to European Legislation:

1. I read the bulk of the information and guidance when the legislation is first published and find myself saying "no we do not have an obligation".

2. I get inundated with leaflets and letters saying no matter what, you have an obligation under REACH. I find these sort of mail-outs annoying and frustrating, but they do force me to re-check the latest info. So I contact someone on a advisory basis. What do I hear, "Well you may have obligations as a downstream user"!!!! What obligations, I don't want to have to attend a seminar in the midlands to find out what I originally knew. The guidance notes you have attached are the best I have seen, and I will get more from them than any free seminar on the subject!

3. Finally I have some sense. These documents have provided some clarity, but I was hesitant to take it as Gospel given that the AIG document was a draft. I have attached the released version of this post.

The AIG document clearly shows that if you import from outside or produce within the EU articles that do not contain SVHC (substances of very high concern), then you need not take any action.

At the moment, from the activity we currently do for ELV and RoHS, I do not believe any of our articles contain SVHC. However, am I correct in assuming any of my suppliers, must notify us if they do introduce any of these SVHC? Do they need to register these or is that down to us? Should we cover our backs by stipulating some sort of REACH clause within our normal material breakdown and declaration procedures that are used to confirm compliance with ELV and RoHS requirements?!! :confused:

:mad:The guys who make this legislation need a kick up the proverbial to make it clear to everyone how these should be interpreted. Not only is information unclear, un inviting and confusing, but guidance is so often wishy washy and is nearly always followed by a "urm well it depends". :mad:

Jonazzz
4th December 2007, 08:41 AM
Manix,

In the first place, thank you for your reply.
I really hoped that somebody out there (in the EU) would post questions, and have the same confusion and inclarity as I have.

So, as you are a producer of articles, you should know what is in your articles. Where you are an automotive supplier, you can actually consult IMDS, to know "what is in".
Problem there is that, you don't know if these substances in your articles are registered. Meaning, that if a substance is not registered it can't be put on market, meaning, it might cause somebody up your supply chain to stop delivering, which could end-up in a "stop-of-your-production".
So you might want to screen your supply base, and asking them if they are willing to pre-register, and register the substances in your articles.

You might believe that your articles don't contain SVHC's, but I think nobody knows untill the "candidate list" is published (09/2008).
The industry will not be able to screen untill this list has been published.
But your correct when you say, that as an Article producer without SVHC in your articles you have got no further obligations.

Third point is, I think every industry that makes something, has chemicals, or process chemicals. Unfortunately these chemicals are under the scope of REACH.
If you 're an ISO 14001 certified company, you 'll have your substance inventory, but than you need to know if these substances/preparations are comming from in our outside the EU, second if they will be registered or not.
Mainly, you need to check if your use is covered, or that the supplier you 're purchasing the substance/preparations from, is willing to register your use.
If he doesn't you might end-up in a SIEF doing the work from your supplier.

The consultant, you spoke with, was wright.

Again, you 're wright on the fact that your suppliers need to inform you as a downstream user that their articles contain more than 0,1% of an SVHC.
By doing this, you can calculate what the amount of SVHC is in your product, and if the same "information" obligation is raised in your products.

To stipulate a REACH declaration would be good.
Because the 6 substances in RoHS will end-up in Annex XIV. If a supplier would declare he is RoHS compliant, you might want to have him check on all SVHC's as well.


It is my believe that a lot of industries underestimate the legislation, its possible impact, and they 're wasting precious time.

The chemical industry is prepared, you can check it on their webpages, but the TierI, TierII,...??

I can understand why you 're :mad:, I 've had a lot of headaches myself reading, re-reading, interpretating, discussing,...

Hoped this helped?

Manix
4th December 2007, 10:22 AM
Sorry Jonazz, I think I may have have left some information out. We do no manufacturing within the EU. We do some light assembly work, but I think we would be classed as an importer. However, I believe the implications will be the same.

Thanks for the response and I thank you for opening this thread for discussion here, it is invaluable. I invite anyone else who is experiencing the same headaches, wherever you are based (as this has an international affect) to share what you have learnt and any question's you may have.

I recommend that AIG document, it is a very useful guide, which has sufficient detail, yet does not confuse you with complex wording and constant references to external sources. Others producing guides for this kind of legislation should take note. Most are either so brief you get virtually nothing from them (usually trying to sell training or their seminars and conferences) or they are unbelievably complex!

Mr Niceguy
4th December 2007, 11:34 AM
Others producing guides for this kind of legislation should take note. Most are either so brief you get virtually nothing from them (usually trying to sell training or their seminars and conferences) or they are unbelievably complex!

Mannix,

Does any of this apply to the UK Helpdesk http://www.hse.gov.uk/reach/faq.htm ?

If they are in some way failing to give useful advice or links they would be interested in feedback.

The same applies to the competent authority helpdesks of the other EU member states.

Jonazzz
5th December 2007, 02:25 AM
Mr. Niceguy,

I took a brief look at the link you posted, and I think that giving this kind of general information is good.
If you would be new in the REACH theme, than its worthwhile taking the tour on your website, and read all the Q&A which are published.
They 're easier to read than the Q&A published by EChA.
The site itselfs looks very well structured, and is ok to read.

What I can't find is the same as the question which I posted here as a start of this thread.

If ELINCS substances are regarded as registered already under REACH, as well as biocides (in RIP 3.5 roles for DU under point 2.3), how will the Annex XIV be build? On CAS#, or EINECS#?
We need to screen our supplybase, and as we are in the "white-goods" industry we don't have a fancy system like IMDS (a shame, but as none of our collegues in the industry is interested in a "full" material declaration system we don't have a chance of getting it :(), meaning that we need to depend on "self-declarations" of our suppliers.
What will we ask? CAS#, EINECS#, Registration#, all of them??

Second question, why isn't the fact that all ELINCS# are regarded as registered stated in RIP 3.4 (guidance on pre-registration,...)??

As you 're Mr. Niceguy :cool:, you might want to post your answer here, as well as on your site?

:thanx:

Manix
5th December 2007, 08:54 AM
Mannix,

Does any of this apply to the UK Helpdesk http://www.hse.gov.uk/reach/faq.htm ?

If they are in some way failing to give useful advice or links they would be interested in feedback.

The same applies to the competent authority helpdesks of the other EU member states.

The HSE site is perhaps an exception, I have referred here and got some good guidance. There are small things though that bug me. For example the following section is of most interest to me as it is the most relevant question:

Q. What about articles under REACH?
The REACH Regulation applies in certain cases to articles. There is a specific REACH definition for articles that you should consider before deciding whether you produce or import articles. However, generally speaking an article is a finished product such as clothing, furniture, motor vehicle parts etc.

Substances contained in articles are to be registered if they are intended to be released and they are in those articles in quantities totalling over 1 tonne per year. For most articles it is unlikely a registration will be required as very few intentionally release substances.

In addition, if the articles contain Substances of Very High Concern (SVHCs) which are listed on the candidate list for authorisation, the producer or importer of the article has an obligation to notify these substances to the European Chemicals Agency (EChA), if the substance is present in those articles in quantities over 1 tonne per producer/importer per year and the concentration is above 0.1 % (w/w) in the article as produced or imported. On request, any supplier of an article also has the duty to communicate information on SVHCs in articles to users and consumers, to allow for safe use of the article.



Ok fairly comprehensive and basically tells me what I want to know. However, In addition, if the articles contain Substances of Very High Concern (SVHCs)

Are they still talking about substances that are intended to be released, or does this relate to any substance greater than 0.1%? It is not clear from this text.

Jonazzz
5th December 2007, 09:21 AM
It relates to all substances in articles that are SVHC's.

If you 've got an article with intended release, than the substance/preparation that is released falls under the same obligations as it was an individual substance or preparation (meaning registration).

Mr Niceguy
5th December 2007, 09:28 AM
As you 're Mr. Niceguy :cool:, you might want to post your answer here, as well as on your site?

:thanx:

Jonazzz,

I don't have the answers but all the national helpdesks should be set up to answer email queries. Some of them become FAQs on their websites. For example the Belgian helpdesk is at http://mineco.fgov.be/organization_market/reach/home_fr.htm. Have you tried addressing your question there ?

The same goes for Mannix and the UK site (which BTW I am not responsible for). Apologies if you have tried this. There is always the possibility that the helpdesks will be OK answering generic questions from trade associations and less so for more detailed questions. I do know the UK site has answered 1300 questions since opening about 6 months ago.

Anne Johnson
7th December 2007, 01:02 PM
Thanks Jonazz. I was thrown this one, and was really not having fun trying to decifer. I have not had a chance to look a the attachments but from the responses above I will make sure that I do.

It is nice to knwo that I am notthe only one feeling :mad: