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(www.echa.europa.eu). 8. Editor. Sekisui Alveo AG. 3 Mar 2020 propose a substance to be identified as an SVHC by preparing a dossier in accordance with the requirements set out in Annex XV to REACH. of the Annex XV SVHC dossier until the decision given by the European Commission on the application for authorisation. All supporting information must be Annex XV dossiers, the simplified procedure for the identification of SVHC should be considered in order to increase the efficiency of nomination12.

10 November 2014 1 COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFICATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS Substance name: Cadmium fluoride CAS number: 7790-79-6 EC number: 232-222-0 The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH 11 November 2019 1 COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS Substance name: 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone CAS number: 119313-12-1 EC number: 404-360-3 The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH ANNEX XV – IDENTIFICATION OF SVHC France_A15_SVHC_diarsenic_trioxide[1327-53-3] 6/9 2 MANUFACTURE AND USES • Used as decolorizing agent for glass and enamels. • Used as refining and oxidizing agent for manufacturing special glass and lead crystal formulations. • Was used in Europe as wood preservative (in industrial installations using vacuum or This annotated template provides instructions on how to structure and present information in the Annex XV SVHC report. The aim of this structure is to provide clarity and avoid duplication, without requiring any further information than laid down in the REACH Regulation.

64 Table 30: CP concentrations (pg/m3) in atmosphere of King George Island, Antarctica between January 2014 to December 2018 (Jiang et al., 2021) 64 The aim of this template is to provide support to the authorities involved in the development of Annex XV dossiers for the identification of substances of very high concern (SVHC) with regard to the structure and content of the Annex XV report.This support is complementary to the provisions of the legal text and the information already available in the Guidance for the preparation of an Annex ANNEX XV – IDENTIFICATION OF LEAD AS SVHC 10 (18) *Since lead is classified as Repr. 1A it is covered by entry 30 in Annex XVII of REACH (as of 2018-03-01).

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Reason of the submission of the Annex XV: CMR. Disclaimer: The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. 1907/2006 (‘the Annex XV dossier’) proposing to restrict the manufacture and placing on the market of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances on their own, and to restrict their use in the production of, and placing on the market in, other substances as a constituent, mixtures and articles or parts thereof. In order to There are two submission windows per year for the submission of Annex XV SVHC dossiers.

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The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. The comments were received during the public consultation of the Annex XV ANNEX XV APPENDIX – IDENTIFICATION OF DECHLORANE PLUS AS SVHC i Appendix 1 Detailed summaries of data cited in the main report Contents 1 Identity of the substance and physical Authorities should use this template when preparing an Annex XV SVHC report, proposing the identification of a substance: in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity (CMR) category 1A or 1B; as persistent, bioaccumulative and toxic (PBT) and/or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII to the An Annex XV SVHC dossier consists of two parts: a) The Annex XV SVHC report: This report should be attached to the technical dossier in IUCLID. The information provided in Part I of the report is used to make the hazard based assessment of the properties and to confirm whether the substance can be successfully identified as an SVHC. ANNEX XV – IDENTIFICATION OF UV-328 AS SVHC 2 (158) CONTENTS PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICL BORIC ACID ANNEX XV DOSSIER FOR THE IDENTIFICATION AS SVHC Annex XV dossier PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS SUBSTANCE OF VERY HIGH CONCERN (SVHC) Substance Name: Boric acid EC Number: 233-139-2 / 234-343-4 CAS Number: 10043-35-3 / 11113-50-1 Annex XV transitional reports of existing substance risk assessments and risk reduction strategies developed under Regulation (EEC) No 793/93, where the work was not finalised by 1 June 2008. Further information 3. Preparation of an Annex XV dossier for the identification of substances of very high concern (Article 57 of REACH) 3.1 Before starting to prepare a dossier Before initiating work on an Annex XV SVHC dossier, the Authority should check whether another Member State or the Agency is already preparing such a dossier on the same ANNEX XV – IDENTIFICATION OF LEAD BIS(TETRAFLUOROBORATE) AS SVHC 5 PART I JUSTIFICATION 1 Identity of the substance and physical and chemical properties 1.1 Name and other identifiers of the substance ANNEX XV – IDENTIFICATION OF SVHC France_A15_SVHC_cyclododecane[294-62-2] Annex XV Dossier Cyclododecane EC Number: 206-033-9 CAS Number: 294-62-2 PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR CAT 1 OR 2, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN It is proposed to identify the substance as a PBT according to Article 57 (d). Annex XV SVHC report published in the context of SVHC identification in accordance with REACH Article 57 – Lead The Swedish Chemicals Agency (KemI) published a document in September 2017 presenting its conclusions from a “Risk Management Option Analysis” (RMOA).

In August 15 additional proposals to identify SVHC have been sent to ECHA . 7 ANNEX XV – IDENTIFICATION OF SVHC 10 Disodium tetraborate anhydrous REACH ref Annex, § Property Value Comment/reference VII, 7.1 Physical state at 20°C and 101.3 kPa White, crystalline, odourless solid VII, 7.2 Melting/freezing point 737°C Cordia JA et al.
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To achieve this target, the Commission and ECHA with the support of Member States Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name: Pyrene EC Number: 204-927-3 CAS Number: 129-00-0 Submitted by: FR-MSCA Date: 28 August 2018 REACH SVHC Risk vs. Annex XIV and Annex XVII. James Calder August 11, 2020 16:02. Follow. ANNEX XV – IDENTIFICATION OF BIS(2-(2-METHOXYETHOXY)ETHYL) ETHER AS SVHC 2 This document has been prepared according to template: TEM-0049.03 CONTENTS PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE ANNEX XV – IDENTIFICATION OF HEXAMETHYLENE DIACRYLATE AS SVHC Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name(s): Hexamethylene diacrylate EC Number(s): 235-921-9 CAS Number(s): 13048-33-4 Submitted by: Sweden Date: 2015-08-20 annex xv – identification of terphenyl, hydrogenated as svhc. annex xv – identification of terphenyl, hydrogenated as svhc. annex xv – identification of terphenyl, hydrogenated as svhc ANNEX XV REPORT.

Information on use, exposure, alternative and risks on Annex XV SVHC Substance name: Lead chromate molybdate sulfate red (C.I. Pigment Red 104) CAS number: 12656-85-8. EC number: 235-759-9 A: A substance may be identified as an SVHC when EU Member States or the European Chemicals Agency (ECHA) complete an Annex XV dossier to propose that a substance be identified. Once a substance has been identified as a SVHC, it is added to the Candidate List on the ECHA website. Currently the Candidate List contains 151 substances.
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This product complies with SVHC. stances of very high concern, SVHC) som identifierats i Reachförordningen. 34 European Chemicals Agency (2019), Annex XV Restriction Report, Proposal EU - REACH (1907/2006) - Submitted Annex XV Dossiers for Proposals for Substances of Very High Concern. This product complies with SVHC mm. Titel. 21 maj 2018 — så kallade särskilt farliga ämnen, SVHC-ämnen (SVHC=substances of very high concern).

34 European Chemicals Agency (2019), Annex XV Restriction Report, Proposal EU - REACH (1907/2006) - Submitted Annex XV Dossiers for Proposals for Substances of Very High Concern. This product complies with SVHC mm.
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BORIC ACID ANNEX XV DOSSIER FOR THE IDENTIFICATION AS SVHC Annex XV dossier PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS SUBSTANCE OF VERY HIGH CONCERN (SVHC) Substance Name: Boric acid EC Number: 233-139-2 / 234-343-4 CAS Number: 10043-35 … High Concern (SVHC) included in the Candidate list (Annex XIV o REACH) by 20201. The objective is to determine the relevance of the substances already recognised as SVHC and to identify potential new ones. To achieve this target, the Commission and ECHA with the support of Member States Competent 2020-11-17 annex xv – identification of disodium octaborate as svhc 4 (14) proposal for identification of a substance of very high concern on the basis of the criteria set out in reach article 57 substance name: disodium octaborate ec number: 234-541-0 cas number: 12008-41-2 ANNEX XV – IDENTIFICATION OF DIHP AS SVHC 9 6 CONCLUSIONS ON THE SVHC PROPERTIES 6.1 PBT, vPvB assessment Not relevant. 6.2 CMR assessment 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP) is covered by index number 607-483-00-2 of Regulation (EC) No 1272/2008 in Annex VI, part 3, Table 3.1 (the list of ANNEX XV – IDENTIFICATION OF HEXAMETHYLENE DIACRYLATE AS SVHC Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name(s): Hexamethylene diacrylate EC Number(s): 235-921-9 CAS Number(s): 13048-33-4 Submitted by: Sweden Date: 2015-08-20 The SVHC identification process takes place in the context of Authorisation (Title VII of REACH). This process has two possible starting points: - An MSCA submits an Annex XV dossier proposing identification of a substance as an SVHC or - The European Commission requests that ECHA prepares such an Annex XV SVHC dossier. Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name: Fluoranthene EC Number: 205-912-4 CAS Number: 206-44-0 Submitted by: Belgium Date: August 2018.

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Se hela listan på chemsafetypro.com COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS Substance name: 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone CAS number: 119313-12-1 EC number: 404-360-3 The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH ANNEX XV – IDENTIFICATION OF DIHP AS SVHC 9 6 CONCLUSIONS ON THE SVHC PROPERTIES 6.1 PBT, vPvB assessment Not relevant. 6.2 CMR assessment 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP) is covered by index number 607-483-00-2 of Regulation (EC) No 1272/2008 in Annex VI, part 3, Table 3.1 (the list of High Concern (SVHC) included in the Candidate list (Annex XIV o REACH) by 20201. The objective is to determine the relevance of the substances already recognised as SVHC and to identify potential new ones. To achieve this target, the Commission and ECHA with the support of Member States Annex XV report PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 Substance Name: Pyrene EC Number: 204-927-3 CAS Number: 129-00-0 Submitted by: FR-MSCA Date: 28 August 2018 REACH SVHC Risk vs. Annex XIV and Annex XVII. James Calder August 11, 2020 16:02.

29 Mar 2012 4.5 REQUIREMENTS FOR AN ANNEX XV DOSSIER PROPOSING SVHC IDENTIFICATION VIA. THE ARTICLE 57 (F) ROUTE. Peter Lepper on 14 Feb 2019 has submitted an Annex XV restriction proposal for the further restriction The identification of a substance as SVHC and its inclusion in the a Member State starts preparing an Annex XV restriction proposal if an urgent action is necessary under REACH (Safeguard clause). In addition, the Commission Annex XV transitional reports of existing substance risk assessments and risk reduction strategies developed under Regulation (EEC) No 793/93, where the Direction on preparing an Annex XV SVHC dossier is included in the Guidance for the preparation of an Annex XV dossier on the identification of substances of high concern (SVHC) by preparing a dossier in accordance with the requirements set out in Annex XV to REACH. Interested parties can follow the progress of av F Hellström — Vilka SVHC ämnen säljs i störst kvantiteter, inom vilka branscher och hur 26 ECHA: s webbplats, Annex XV dossier PROPOSAL FOR av J Tickner · 2016 · Citerat av 12 — Substances of very high concern (SVHC) that are made subject to Guidance for the Preparation of an Annex XV Dossier for Restrictions. June 2007. Available The Annex XV dossier should outline the scientific evidence for identifying the Very High Concern ('SVHC') for eventual inclusion in Annex XIV to the REACH.