Hello all,
I am working on REACH complaince for a manufacturer of articles (based on the ink and the pen example given on many sources I have researched). Does this still mean we have to pre-register? My biggest frustration is that no one has yet to be able to give me a 100% confident anwser that we do or do not need to register. I have completed all of the decision trees, and all of them have led me to believe we are not required...We manufacture enclosures, not substances??? Any help would be greatly appreciated!!!

Try the following link or your local trade association.

People with REACH questions may also consider seeking help from the European Chemicals Agency (ECHA) (http://echa.europa.eu/reach/helpdesk/echahelp_en.asp)

Hi! It's been a long time I replied on this forum!

REACh is applicable if you import substances or articles (with substances that are supposed to be released; yes, ink in pens) into the EU in volumes of more than 1 ton.
In REACh-terms you are the importer.

If you import in the EU, you have to pre-register the substance before december 1st (so you have only a few days left!)
You can also use a so-called third party representative, but in your case (again: only if you are an importer in the EU) I would advise you to sign up at https://reach-it.echa.europa.eu/ and pre-register the substance(s).

Above is REACh in very simplified words... Keep in mind that:
- you will be a member of a pre-SIEF
- the substance has to registered before 2010, 2013, 2018 depending on the volumes you're importing, what will mean expensive files.

But for now: if you produce a substance that you import in a volume more than 1 ton, pre-register before december 1st (deadline) After january 1st it's not allowed to buy non pre-registered substances in EU.

But: your customer in EU is also allowed to pre-register if you're not willing to pre-register and register. That could be the case if your turnover is lower than the costs for a registration file.

Keep in mind that REACh is a lot more.

You can get more guidance on http://echa.europa.eu/reach/faq_en.asp

Regards, Jeroen
Risk & Compliance manager, Dishman Netherlands

My perception is that, philosophically, the primary goal of REACH is to make it too complex and costly to utilize selected materials in Europe, so that they will disappear from trade and eventually from the environment. The mechanism for this course of action is the dynamic Substances of Very High Concern list, not the four thousand page master list of "ordinary" regulated materials.

As a medical device maker, certainly we can take a hint. My recommendation to our top management, which I think we'll adopt, is that we discontinue offering any products based on flexible vinyl plastics to REACH-jurisdiction customers, even if they want to buy them based on superior medical performance. The potential risk to us of legal/economic liability due to retrospective regulatory actions is too great. The recent example of addition of fourteen more SVHC substances with a retroactive effectivity date was illustrative in that regard.

That's interesting... Does your company have a substantial turnover in Europe?
I understand that you produce medical devices; are this articles of PVC with phtalates? I worked for Solvay Draka and we had discussions about this. In my opinion medical devices (in unused form) are not articles with substances that are supposed to be released, so (pre-) registering is not neccesary.

And by the way: your customer in EU can also the substance!

Jeroen
Dishman Netherlands

REACh is applicable if you import substances or articles (with substances that are supposed to be released; yes, ink in pens) (...)

Our understanding is that, if there is significant scientific evidence that a constituent ingredient of a polymer material can migrate or evolve from that material under some normal or abnormal set of circumstances, even if ideally that would not occur, then any such migration from future uses of that polymer is "intended" (i.e. predictable, therefore deliberate) and therefore that polymer material does fall within the "supposed to be released" definition.

Do you know of definitive information to the contrary?

If you import in the EU, you have to pre-register the substance before december 1st (so you have only a few days left!)

I note that the OP is in the US. Our understanding is that pre-registration for small US substance makers practically requires a business relationship with an "only representative", who is required to have expertise in the relevant environmental-risk chemistry. I haven't yet figured out where the marketplace is for "only representative" candidates with particular esoteric chemistry knowledge.

That's interesting... Does your company have a substantial turnover in Europe? (...) I understand that you produce medical devices; are this articles of PVC with phthalates?

Yes, and yes...DEHP and others.

In my opinion medical devices (in unused form) are not articles with substances that are supposed to be released, so (pre-) registering is not neccesary.

(My emphasis above.)

It's well known that significant amounts of medical plastics are incinerated in EU waste streams. Is it your perception that in order to achieve the goal of elimination of complex chlorine and bromine compounds from incinerator effluent, REACH eventually will make manufacturers responsible for downstream chemical evolutions of ingredients in their substances, akin to ROHS constraints on lead and cadmium?

And by the way: your customer in EU can also the substance!

Our large OEM customers rely on us to handle regulatory issues. Our smaller distributor customers could not individually afford such costs. In any case, allowing customers to register our substances would subject us to the potential risk profile, which is what is to be avoided.

Our understanding is that, if there is significant scientific evidence that a constituent ingredient of a polymer material can migrate or evolve from that material under some normal or abnormal set of circumstances, even if ideally that would not occur, then any such migration from future uses of that polymer is "intended" (i.e. predictable, therefore deliberate) and therefore that polymer material does fall within the "supposed to be released" definition.

Do you know of definitive information to the contrary?



I note that the OP is in the US. Our understanding is that pre-registration for small US substance makers practically requires a business relationship with an "only representative", who is required to have expertise in the relevant environmental-risk chemistry. I haven't yet figured out where the marketplace is for "only representative" candidates with particular esoteric chemistry knowledge.

You're right: in your case it's polymers we are talking about. Polymers are a very difficult subject in REACH. I'm sorry, I don't have definitive information about that.

Regarding an only representative: I don't think it's really neccessary. Keep in mind that there are no costs for pre-registration. If you pre-register your business is covered after january 1st.
Depending on your volumes you have to register with a file in 2010, 2013 or 2018. It wil mean that you have to work with your SIEF-collegues. Well, that can be an argument for using an OR: travelling to Europe.
After january 1sth you can always decide to become a sleeping SIEF member and stop the import in EU.

Jeroen