Document OJB12gkKo1Ld6dYQOLXo5B1de

'ECHA EUROPEAN CHEMICALS AGENCY The conditions of the restriction proposed by SEAC are: Perfluorooctanoic acid (PFOA, CAS 335-67-1, 1. Shall not be manufactured, used or EC 206-397-9) and its salts. placed on the market: Any substance (including salts and polymers) having a linear or branched perfluoroheptyl group with the formula (C7Fi5)C- as one of the structural elements5, 6 Any substance (including salts and polymers) having a linear or branched perfluorooctyl group with the formula C8Fi7as one of the structural elements2,3. The following substances are exempted from the above two paragraphs: C8Fi7-X, where X= F, Cl, Br. C8F17-C(=0)0-X' or C8F17-CF2-X' (where X'=any group, including salts). a) as substances; b) as constituents of other substances in concentrations equal to or greater than 25 ppb of PFOA or its salts or 1000 ppb for any single PFOA-related substance and 1000 ppb for the sum of all PFOArelated substances identified in column 1; c) as components of a mixture in concentrations equal to or greater than 25 ppb of PFOA or its salts or 1000 ppb for any single PFOA-related substance and 1000 ppb for the sum of all PFOArelated substances identified in column 1. 2. Articles or any parts thereof containing one of the substances identified in column 1 in concentrations equal to or greater than 25 ppb of PFOA or its salts or 1000 ppb of one or a combination of PFOA-related substances shall not be placed on the market. 3. Paragraphs 1 and 2 shall apply from (36 months after entry into force) with the exception of: a) latex printing inks, for which the transitional period is 5 years after entry into force; b) textiles for the protection of workers from risks to their health and safety, for which the transitional period is 6 years after entry into force; c) membranes intended for medical textiles, filtration in water In the case where a substance contains structural elements both inside and out of scope, then the substance is still within the scope. These substances are known as PFOA related substances. 7 US00007694 'EC HA EUROPEAN CHEMICALS AGENCY treatment, production processes, and effluent treatment for which the transitional period is 6 years after entry into force; d) non-implantable medical devices (except wheelchairs and dental treatment chairs) for which the transitional period is 15 years; e) pulsed plasma nano-coating produced using conditions that minimise emissions to the environment, for which the transitional period is 6 years after entry into force. 4. By way of derogation, paragraphs 1 and 2 shall not apply to Perfluorooctane sulfonic acid and its derivatives (PFOS) covered by the Regulation (EC) No 850/2004. 5. By way of derogation, paragraph 1 shall not apply to: a) the use of substances containing one or more constituents identified in column 1, as transported isolated intermediates where the conditions in Article 18(4) are met; b) the production, placing on the market and use of substances and mixtures containing one or more substances identified in column 1 for mixtures used in semiconductor photolithography processes and etching processes of compound semiconductors; c) the use of firefighting foams already placed on the market on [date of entry into force], even when subsequently mixed with foams placed on the market after [date of entry into force], for a transitional period of 20 years; d) placing on the market and use of firefighting foam concentrates containing PFOA or its salts or one or 8 US00007695 'EC HA EUROPEAN CHEMICALS AGENCY more PFOA-related substances identified in column 1, as constituents of other substances or components of a mixture in an individual concentration of less than or equal to 1000 ppb, for a transitional period of 20 years. 6. By way of derogation, paragraph 2 shall not apply to: a) the placing on the market of second hand articles for which an end-use in the European Union before the restriction becomes effective can be demonstrated; b) the placing on the market of articles produced from recycled articles; c) photographic coatings applied to films, papers or printing plates, nor to the manufacture, placing on the market and use of substances and mixtures needed to produce them; d) the placing on the market of spare parts, if the spare parts are already produced at the date of entry into force, and the date of production can be demonstrated; e) implantable medical devices as defined by Council Directive 93/42/EEC; f) the placing on the market of semiconductor manufacturing equipment for a period of 5 years after [date of entry into force]. 7. Fire fighting foams used for training should be used in such a way that emissions to the environment are minimised, and that effluents collected are safely disposed of. 9 US00007696 'EC HA EUROPEAN CHEMICALS AGENCY The following technical changes were introduced to the entry proposed by the Dossier Submitters to better reflect the scope of substances covered by the restriction, and to improve its readability: The general structure in column 1 was clarified, for example the reference to C7Fi5 as a structural element should have been to (C7Fi5)C-. It is clarified that the reference to PFOA also covers its salts and that PFOA-related substances cover polymers. The derogation for substances covered by the Perfluorooctane sulfonic acid (PFOS) and its derivatives entry in Regulation (EC) No 850/2004 on POPs is moved to column 2. It is clarified with a footnote that if a substance contains constituents both in and out of the scope, then it is considered to be in the scope. This could cover fluoropolymers which are out of scope unless they contain an impurity which is within scope above the relevant threshold. It could also cover a situation where a complex substance contains structural elements that were both in and outside of scope. In addition to PFNA (C8Fi7-C(=0)0H), the related substances C8Fi7-C(=0)0-X' should be exempted as these will not degrade to PFOA. The justifications for the changed concentration limits, the additional derogations and change in the transitional period are explained below in the Justification for the opinion of RAC and SEAC. 10 US00007697