Document QJ80DQjVgQ4gMBVj6mOyR9Og6
From: To: Cc: Subject: Date: Attachments:
RE: List of substances for PFOA amendment and test method
22 July 2020 14:38:00
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DearA medical device that complies with exemption Sc requirements can benefit from it until 4 July 2023. Derogation Se allows the use of PFOA to manufacture fluoropolymers used in the production of specific membranes but it does not allow to use PFOA to treat the membranes (if this is the meaning of your question). Concerning the analytical methods, we do not intend to work on standardisation but, as you are probably aware, the Forum is going to update the compendium of analytical methods for restrictions and this work will include also PFOA. If you refer to the public consultation on some exemptions for C 9 -C14 PFCAs and PFOA, the question on analytical methods related to the possibility to detect low level of impurities in PFAS materials.
-Regards
From:
euratex.eu>
Sent: Friday, July 10, 2020 S:0S PM
@ec.europa.eu>
ec.europa.eu>;
euratex.eu>
Subject: RE: List of substances for PFOA amendment and test method
Dea
Thanks again for your swift reply.
I have a few other questions of clarification:
As you know, certain medical equipment falls both in the scope of MDR and PPE Regulations; in this case particularly considering the widespread demand for medical equipment (with unpredictable future scenario), EURATEX would welcome a clarification that medical protective textiles falling under both Regulations would conform to the derogation specified in Sc) with expiration date 4/7/2023
EURATEX would also welcome a further clarification on derogation Se) that currently exempts manufacturing of PTFE and PVDF for the production of certain membranes to also apply tofinalproducts
Regarding test methods, we understand from our Members and collaborating testing labs that a harmonised test method is still not available, however work is currently being done in CEN with ongoing discussion on the scope of substances. Will the Commission recommend a test method for enforcement purposes considering that the amendment is already applicable and ECHA Forum is looking into further enforcement activities for this issue? In addition, I noticed that ECHA is consulting on PFAS analytical methods by 24 July. Will this facilitate harmonisation of a test method?
Thank you in advance and nice WE,
Sustainable Businesses
Buratex-LOGO-small
Rue Belliard 40 - Box 2 I BE 1040 Brussels I www euratexeu I D D
From: Sent: jeudi 2 juillet 2020 10:54
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Cc:
@euratex.eu>
Subject: RE: List of substances for PFOA amendment and test method
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Dea-
sende1.
There is a Q&A on ECHA website on this. It gives you the links to the Background
Document where you find an indicative list.
https://echa.europa.eu/support/qas-support/browse /
/qa/70Ox/yjew/scope/RFACH/Restrjctjons
Additionally, POPRC prepared a non-exhaustive list of substances included (attached).
Please notice that POPRC should review this list and that the entry in the POPs
Regulation is slightly different from the substance identification of the Stockholm
convention. This is because if there were s ubstances covered by the REACH restriction
and not covered by the Stockholm Convention, we have included them.
-Kind regards
From:
@euratex.eu>
Sent: Wednesday, July 1, 2020 3:08 PM
@ec.europa.eu>
@ec.europa.eu>;
@euratex.eu>
Subject: List of substances for PFOA amendment and test method
Hope you are well.
Lately, we are receiving a lot of questions and concerns from our Members regarding the test method (or lack thereof) and list of substances to test in textiles for PFOA presence.
Particularly, the testing labs are faced with ambiguity over the substances in scope; I understand that the PFHxA proposed restriction has a very useful indicative list of substances. Does the PFOA amendment have something similar?
This will be extremely important for the upcoming REF project which might investigate PFOA in textiles, among other things.
Kind regards,
I Sustainable Businesses
Buratex-LOGO-small
Rue Belliard 40 - Box 2 I BE 1040 Brussels I www euratexeu I D D