Document zjek7k7ERGGm2zMq3p9eQjya

Ref. Ares(2016)6183701 - 28/10/2016 EUROPEAN COMMISSION INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP AND SMEs DIRECTORATE-GENERAL Consumer, Environmental and Health Technologies REACH Unit Brussels, 28/10/2016 Meeting (via teleconference) with 3M on PFOA, its salts and PFOA-related substances restriction 18 October 2016 Participation For 3M: , , , For DG GROW D.1: , For DG ENV B.2: Background 3M is developing an analytical method for the determination of PFOA and PFOA-related substances in fluoropolymers that could be used to demonstrate compliance with the forthcoming restriction on PFOA and PFOA-related substances. The conference call was organised by 3M with the aim to provide us an update on their work. 3M does not use PFOA and PFOA-related substances in their production but do have them as impurities. Additionally, some of the semi-finished articles that they use may also contain PFOA and PFOA-related substances. Summary of the meeting 3M informed us that they are still working in the development of an analytical method for the determination of PFOA and PFOA-related substances in fluoropolymers and they expect to have such work finalised in 12 to 18 months. 3M further added that the critical part of the method is the sample preparation, which can lead to false results (i.e. due to the mechanical energy necessary1 to prepare the sample, PFOA and/or PFOA-related substances can be either be created or destroyed). The lack of laboratories with the necessary expertise to make the sample preparation was also mentioned. 3M mentioned that they are not, at least for now, using reference sample materials and only internal laboratories are involved. It was mentioned that Plastics Europe intends to create a working group on analytical methods for the determination of PFOA and PFOA-related substances and 3M will make their method available to the group. 3M referred their intention to also use national laboratories and that they might appeal to COM to facilitate such access. 3M expects to have their method fully developed in 36 months, which will be challenging but doable. Finally, 3M informed us that they have recently contacted Member States Competent Authorities to provide them an update of their work. The information provided by 3M to MS is added as an Annex to this document. 1 In the sampling preparation, fluoropolymers need first to be mechanical crushed and only after can a solvent be used. 3M has been able to have a recovery of 80 to 90% of PFOA and PFOA-related substances. Annex - Information provided by 3M to Member States: We understand that the proposed Annex XV restriction on Perfluorooctanoic Acid (PFOA) will be discussed at the upcoming Art 133 Committee meeting on the 26 October. As you know, 3M is currently working on developing the improved analytical methodology to determine compliance with the proposed PFOA standard for fluoromaterials, used in a wide variety of specialized industrial, commercial, and consumer applications. Based on the information and data we analysed so far, we would like to express our support for the recent Commission proposal with regard to the 25 ppb threshold level and the 36 months implementation period. With the proposed PFOA restriction, technical challenges in determining compliance as well as the number of supply chain communications are expected to be significant. In order for industry to be able to consistently assure compliance and respond concisely in these situations, 3M wishes to express its further support for an adequate implementation time period consistent with the Commission proposal of 36 months. Although standardized analytical methods for very low detection limits of PFOA in selected matrices are available, the adaption and validation of these methods for the broad spectrum of substrates, compounds and articles which are subject to the Restriction proposal has not yet been accomplished. For example, CEN/TS 15968 is currently considered the "official" EC test method for determination of PFOS in articles. However, recent results in an interlaboratory study2 relevant to plastic articles for PFOS/PFOA, of which 13 of 53 laboratories used CEN/TS 15968, showed it performed poorly. Spiked samples containing 0.06% PFOS (24,000 times the 25 ppb subject proposal) analysed using the CEN/TS 15968 method reported a value from 0.0146% to 0.0909%, representing a recovery range of 24% to 152%. Laboratories using other methods had an even broader range from 0.00608% to 0.426%, a recovery range of 10% to 700%. This study illustrates the inherent difficulty in quantifying these types of substances in plastic materials and the need for improved methodologies and standardized methods. Note also that the results of this study were based on a threshold value which is orders of magnitude higher than the proposed PFOA restriction level. Even so, the method was unable to fulfil the requirements of the recently published ECHA guideline on analytical methods3. In recognition of these difficulties, 3M has already initiated development of improved analytical methodology to determine compliance with the proposed PFOA standard for fluoropolymers and related matrices. 3M's intention is to make the draft method publicly available in the coming weeks. The proposed very low (25 ppb) threshold for restriction, the current state of PFOA analytical methodology, and the availability of PFOA data for various materials in commerce; all need to be carefully considered in establishing a realistic transition timeframe. 3M strongly supports the Commission position that 36 months is an appropriate minimum amount of time for implementation of the Proposed Annex XV restriction. ____________ 2 http://www.iisnl.com/pdf/iis14P07revised.pdf 3 https://www.echa.europa.eu/documents/10162/13577/methodology analytical methods en.pdf