Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP

As far as I know the REACH regulation does apply to all medical devices and IVDs though the amounts in IVD are usually well under the limits established by the regulation.  When looking at compliance with REACH it is the finished device that should be the "unit" so amounts should be relatively small.  And yes, definitely the general purpose reagents and research use only products should be considered because sometimes those are provided in bulk.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Dec-2019 18:55
From: Anonymous Member
Subject: REACH /CLP

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP

This message was posted by a user wishing to remain anonymous

Thank you so much Richard!
Original Message:
Sent: 17-Dec-2019 03:48
From: Richard Vincins
Subject: REACH /CLP

As far as I know the REACH regulation does apply to all medical devices and IVDs though the amounts in IVD are usually well under the limits established by the regulation.  When looking at compliance with REACH it is the finished device that should be the "unit" so amounts should be relatively small.  And yes, definitely the general purpose reagents and research use only products should be considered because sometimes those are provided in bulk.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Dec-2019 18:55
From: Anonymous Member
Subject: REACH /CLP

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP

Hi folks.

I believe Richard is correct.  Any chemical substance (read as individual CAS number) is required to comply with EU REACH regulations as well as any IVD regulatory requirements.  So if you are shipping more than 1 metric ton of the CAS number into the EU in any particular year you are required to ensure that your chemical is listed under REACH, you have a current registration number for the chemical, your SDS documentation is updated and includes the REACH registration number once registration is complete, and if necessary you either must join a SEIF or you must register alone.  If there is a SEIF already created, and you still wish to do the registration on your own, you will need all necessary data and if you need to perform any specific animal studies for the purposes of REACH registration you will need to get approval of ECHA to run the studies.  This applies whether or not you join the SEIF but if there is a SEIF it might simply be possible to "buy into" the data already available from other sources of the chemical thereby saving time and money because you will pay only a portion of the costs for the data rather than the full costs of running the study or studies that might be necessary.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 17-Dec-2019 03:48
From: Richard Vincins
Subject: REACH /CLP

As far as I know the REACH regulation does apply to all medical devices and IVDs though the amounts in IVD are usually well under the limits established by the regulation.  When looking at compliance with REACH it is the finished device that should be the "unit" so amounts should be relatively small.  And yes, definitely the general purpose reagents and research use only products should be considered because sometimes those are provided in bulk.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Dec-2019 18:55
From: Anonymous Member
Subject: REACH /CLP

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP

This message was posted by a user wishing to remain anonymous

Thanks for this useful post. 
What confuses me is the below statement from ECHA website . Please refer to the second last statement and advise if IVDs like staining reagents and biopsy sample preparation reagents fall into this category.
Thanks for all this Help Richard & Victor !
Original Message:
Sent: 18-Dec-2019 08:51
From: Victor Mencarelli
Subject: REACH /CLP

Hi folks.

I believe Richard is correct.  Any chemical substance (read as individual CAS number) is required to comply with EU REACH regulations as well as any IVD regulatory requirements.  So if you are shipping more than 1 metric ton of the CAS number into the EU in any particular year you are required to ensure that your chemical is listed under REACH, you have a current registration number for the chemical, your SDS documentation is updated and includes the REACH registration number once registration is complete, and if necessary you either must join a SEIF or you must register alone.  If there is a SEIF already created, and you still wish to do the registration on your own, you will need all necessary data and if you need to perform any specific animal studies for the purposes of REACH registration you will need to get approval of ECHA to run the studies.  This applies whether or not you join the SEIF but if there is a SEIF it might simply be possible to "buy into" the data already available from other sources of the chemical thereby saving time and money because you will pay only a portion of the costs for the data rather than the full costs of running the study or studies that might be necessary.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 17-Dec-2019 03:48
From: Richard Vincins
Subject: REACH /CLP

As far as I know the REACH regulation does apply to all medical devices and IVDs though the amounts in IVD are usually well under the limits established by the regulation.  When looking at compliance with REACH it is the finished device that should be the "unit" so amounts should be relatively small.  And yes, definitely the general purpose reagents and research use only products should be considered because sometimes those are provided in bulk.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Dec-2019 18:55
From: Anonymous Member
Subject: REACH /CLP

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP

This message was posted by a user wishing to remain anonymous

Hi Victor 

Can you please check the site https://echa.europa.eu/support/registration/your-registration-obligations/does-my-substance-need-to-be-registered

• Non-isolated intermediates: intermediates that during the synthesis are not intentionally removed from the equipment in which the synthesis takes place (except for sampling).
• Substances used for product and process orientated research and development (PPORD): these substances are exempt from registration for five years (extensions possible), if you notify your PPORD activities to ECHA.
• Substances used in food or feeding stuffs (including uses as additives or flavourings).
• Substances (active substances or excipients) used in medicinal products for human or veterinary use.
• Active substances used in biocidal products or plant protection products. These are regarded as already registered.

Many thanks for all your inputs!
Original Message:
Sent: 18-Dec-2019 08:51
From: Victor Mencarelli
Subject: REACH /CLP

Hi folks.

I believe Richard is correct.  Any chemical substance (read as individual CAS number) is required to comply with EU REACH regulations as well as any IVD regulatory requirements.  So if you are shipping more than 1 metric ton of the CAS number into the EU in any particular year you are required to ensure that your chemical is listed under REACH, you have a current registration number for the chemical, your SDS documentation is updated and includes the REACH registration number once registration is complete, and if necessary you either must join a SEIF or you must register alone.  If there is a SEIF already created, and you still wish to do the registration on your own, you will need all necessary data and if you need to perform any specific animal studies for the purposes of REACH registration you will need to get approval of ECHA to run the studies.  This applies whether or not you join the SEIF but if there is a SEIF it might simply be possible to "buy into" the data already available from other sources of the chemical thereby saving time and money because you will pay only a portion of the costs for the data rather than the full costs of running the study or studies that might be necessary.​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 17-Dec-2019 03:48
From: Richard Vincins
Subject: REACH /CLP

As far as I know the REACH regulation does apply to all medical devices and IVDs though the amounts in IVD are usually well under the limits established by the regulation.  When looking at compliance with REACH it is the finished device that should be the "unit" so amounts should be relatively small.  And yes, definitely the general purpose reagents and research use only products should be considered because sometimes those are provided in bulk.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Dec-2019 18:55
From: Anonymous Member
Subject: REACH /CLP

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP

I'm confused by your questions because they seem to mix US regulatory terms and EU regulatory terms.

REACH/CLP are EU terms.

However, "list" is a US term in the sense of registration and list. When you have the devices listed, what is the list?

"General purpose reagent" is also a US term that shows up in the Part 809. The IVDD uses the term "product for general laboratory use. It states that, "Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination".

I could not find the term "research under use" in either US or EU. In the US Part 807 has RUO and IUO. In the IVDD the term is "device for performance evaluation".

Can you clarify? I infer you are asking about an IVD manufactured in the US and shipped into the EU.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 14-Dec-2019 18:55
From: Anonymous Member
Subject: REACH /CLP

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP

This message was posted by a user wishing to remain anonymous

Yes I am asking about IVDs/reagents shipped from US to EU.

Sorry i mixed up the terminologies :)
Original Message:
Sent: 18-Dec-2019 19:08
From: Dan O'Leary
Subject: REACH /CLP

I'm confused by your questions because they seem to mix US regulatory terms and EU regulatory terms.

REACH/CLP are EU terms.

However, "list" is a US term in the sense of registration and list. When you have the devices listed, what is the list?

"General purpose reagent" is also a US term that shows up in the Part 809. The IVDD uses the term "product for general laboratory use. It states that, "Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination".

I could not find the term "research under use" in either US or EU. In the US Part 807 has RUO and IUO. In the IVDD the term is "device for performance evaluation".

Can you clarify? I infer you are asking about an IVD manufactured in the US and shipped into the EU.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 14-Dec-2019 18:55
From: Anonymous Member
Subject: REACH /CLP

This message was posted by a user wishing to remain anonymous

Hi ,
Can someone please confirm if my below understanding is correct?
If the reagents are listed as  IVDs there is no need to comply with REACH /CLP
But if these fall under the category of general purpose reagents or Research under use one needs to be REACH/CLP compliant.

Thanks,
SP