Registration for REACH required for Non-EU Down Stream Manufacturer?

Harsh

Involved In Discussions
#1
Hello Everyone,

REACH seems way more complex when it comes to its applicability. I am working in a lab device manufacturing firm & the products manufactured by our company are Centrifuges, Vortex Mixers, Stirrers, etc. I was wondering that as we are a Non-EU manufacturer & also a downstream user (According to my understanding "Downstream Users" can only be the Manufacturers/Importers located in EU/EEA but we do provide OEM services to some of the companies located in EU that is why I have included this term. Please clarify if there is any misinterpretation happening here.) with products not intended to release any substances under the normal intended use condition is it mandatory for us to register for REACH?

Yes, I do understand that we need to coordinate with our suppliers if there is any SVHC available in the component or material that we are procuring from them but it is not clear to me about the registration requirement is applicable to us or not. Because according to my research & understanding I get to know that if the substances are intended to be released with the primary intended use then only there is a need for registration.

Also one more thing that the definition of Downstream Users given below is appropriate or not?
Downstream users are European manufacturers who do not manufacture & sell the chemical substances in EU but use them in the manufacturing/assembly process like for example: assemble the product with the use of adhesive right? But what about the Non-EU manufacturer in the same case?

Please Advise.

Thanks in advance.
 
Last edited:
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Enghabashy

Quite Involved in Discussions
#2
*I see you should refer to the EU importer ; he is responsible as representing or register this issue in ECHA agency , you are down stream user , you are out of EU & should provide all chemical information including CAS no ; REACH directive No & if it's under SVHC or not applicable , the information should include MSDS for components according European regulation;
*The registration or the waiver is the responsibility of EU manufacture or EU importer ; he is responsible to submit the file ;
*some of chemical components are not undergo REACH regulation ; i.e. : CO2 , O2, N2 gases are nature components of Air; it's not included
*you can correspond ECHA help disk also for more clarification ; I made it earlier from over 10 years ; they are cooperative to produce advice :

https://echa.europa.eu/contact
 

inspector625

Involved In Discussions
#3
I have a similar issue. We manufacture fasteners out of stainless steel that has a 24 % weight of nickel present in the material grade. The fasteners are not routinely touched. We are in Canada but sell our fasteners to the UK. Up until 2021 we were a manufacturer but now I believe we are considered an importer? Trying to read and understand the reach requirements and understand our role is daunting.
 
#5
Under the European Union's (EU) REACH regulation, non-EU manufacturers may be required to register their substances if they are:
  1. Imported into the EU in quantities of one metric ton or more per year.
  2. Used as intermediates in the production of other substances, and these intermediates are manufactured in quantities of one metric ton or more per year.
  3. Used in the production of articles in quantities of one metric ton or more per year, and the substance is intended to be released from the articles under normal or foreseeable conditions of use.
If you are a non-EU downstream manufacturer that falls into one of these categories, you may be required to register your substances with the European Chemicals Agency (ECHA). It is important to note that REACH applies to all chemical substances, regardless of whether they are imported or produced within the EU.
 

Harsh

Involved In Discussions
#6
Noted Sam, but the thing is we do not import the products in Europe but our retailers do. We are exporters so according to the guidelines it seems that the retailers are responsible for the registration.
 
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