Document QX2qGwyB3D2JEdkr0xOVv1QrL

3M Company Hermeslaan 7 B-1831 Diegem, Belgium Tel. +32 (2) 722 46 47 Ref. Ares(2016)1692687 - 11/04/2016 D.1 - REACH DG for Internal Market, Industry, Entrepreneurship and SMEs European Commission B-1049 Brussels April 8th, 2016 Subject: Reliable Analytical Measurement for Proposed Annex XV restriction on Perfluorooctanoic Acid (PFOA), its Salts and Related Substances Dear With the proposed Annex XV restriction on Perfluorooctanoic Acid (PFOA) 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 ensure compliance and respond concisely in these situations, 3M wishes to express its support for an adequate implementation time period consistent with the Committee for Socio-economic Analysis (SEAC) proposal of 36 months. 3M previously commented to SEAC regarding the implementation time frame (SEAC draft opinion comment ref. 244). 3M and others have previously commented on the importance of fluoromaterials in a wide variety of specialized industrial, commercial, and consumer applications. The focus of these comments is the realistic time frame to implement the proposed 25 ppb standard, a level that as you know is orders of magnitude lower than any other Restriction under REACH. The development of reliable methods for quantitative analysis of perfluorinated compounds (PFCs), including PFOA, has evolved over the last 20 years with great improvement in the quality of the data via the implementation of validated methods for specific matrices. Such validated methods are available today, ensuring the data quality when quantifying PFCs in specific matrices such as fish and blood, and environmental matrices such as water. This was not always the case and for many years the quality and reproducibility of this data was a concern. Studies have consistently shown that a useful method for one matrix does not always constitute a good method for a different one, due to interferences as a result of inadequate sample extraction and clean up. 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 1 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 study* 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) analyzed 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 fulfill the requirements of the recently published ECHA guideline on analytical methods**. 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 this validated methodology public. 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 SEAC position that 36 months is an appropriate minimum amount of time for implementation of the Proposed Annex XV restriction. 3M is willing to meet to further describe these points. Our team member @mmm.com) will contact your office to explore the possibility of scheduling a meeting and answer any question you or your services might have. Sincerely, 3M REACH Coordination Center 2