Document eve9Y8g4N79X4Ba2z7m2ZRbBy

From: To: Subject: Date: Attachments: GROW D1 RE: PFOA vendredi 15 juillet 2016 15:53:02 image002.png image003.jpg Dear , Please accept our apologies for the delay in replying to your email of 13 May. In response to your question: PFOA has not been included in the candidate list (Annex XIV to Regulation (EC) 1907/2006) and no proposal has been made to this regard. However, Germany and Norway have submitted in December 2014 a proposal for a restriction on the manufacture, the placing on the market and use of PFOA, its salts and related substances. The Committees for Risk Assessment and Socio-Economic Analysis of the Chemicals Agency (ECHA) have delivered their opinion on this proposal in December 2015. The opinion is available on ECHA's website here: http://www.echa.europa.eu/documents/10162/13641/rest_pfoa_compiled_opinions_en.pdf It contains a proposal for a 15 year deferral period for the application of the restriction for nonimplantable medical devices. This should allow manufacturers of such products time for changing to alternatives. Please note that, since this is a restriction, there will be no possibility to obtain an authorisation for continued use after the deferral period has expired. The European Commission is currently preparing a draft Regulation for the restriction. We expect the draft to be discussed at REACH Committee meeting coming September or October. The Regulation could be published in the first half of 2017. The European Commission is also preparing a proposal to include PFOA in the annex to the socalled Stockholm Convention. Inclusion would have the effect of a global restriction rather than just in the EU alone. Please do not hesitate to contact us should you have any further question. Kind regards, REACH Unit Cordialement / Regards, REACH Unit European Commission DG Internal Market, Industry, Entrepreneurship and SMEs REACH Unit BREY B-1049 Brussels/Belgium +32 2 GROW-D1@ec.europa.eu Follow us on Facebook: Twitter: Our Websites: EU Growth @EU_Growth ec.europa.eu/growth ec.europa.eu/bienkowska Disclaimer EC: This message represents solely the views of its author and cannot in any circumstances be regarded as the official position of the Commission. It is intended solely for the person to whom it is addressed and may contain confidential information. If you have received this message in error, please notify me as soon as possible. From: Sent: Friday, May 13, 2016 2:49 PM To: COMM REP BRU Subject: PFOA Dear, @diasource.be] We are an in vitro diagnostic company located in Belgium, Louvain-La-Neuve, and we are concerned about the status of PFOA . We use PFOA in some of our products. I read that PFOA is considered as a substance of very high concern. Does this mean PFOA is already on the Authorization list or is it still on the candidate list? Can we apply to get authorization to still use PFOA? Can you please give me an update on the status? You can reply in Dutch or French if that's easier. Many thanks in advance for your help. Kind regards, ImmunoAssays S.A. Rue du Bosquet 2 - B-1348 Louvain-La-Neuve Tel: +32 10 Fax : +32 eMail : @diasource.be www.diasource.be P : Please consider the environment before printing this e-mail This email and any attached files are confidential and may be legally privileged. If you are not the addressee, any disclosure, reproduction, copying, distribution, or other dissemination or use of this communication is strictly prohibited. If you have received this transmission in error please notify the sender immediately and then delete this email.