Reach annex viii. ANNEX XVII TO REACH – Conditions of restriction . REACH ANNEX VIII / STANDARD 8. 2. need help with reach or clp? call us: +44 870 8 200 310. 7 of REACH Annex VIII “in Annex VIII to CLP Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures 11 1. Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII, VIII and IX. Each entry shows a substance or a group of substances or a substance in a mixture, and the consequent restriction conditions. ‘Transient’ means normally intended for continuous use for less than 60 minutes. / information on the 8. Importers and downstream users placing on the market mixtures for consumer use, within the meaning of Section 2. Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 10 tonnes or more in accordance with Article 12(1)(c). Safety Data Sheets don’t change very often – this is an uncommon and important update. Activated sludge respiration inhibition testing ANNEX XVII TO REACH – Conditions of restriction . Follow the general information requirements for all registrants, including those that cover your substance identification, which are described in Annex VI to REACH. 1 table column 2 unnumbered paragraph 1: 08/01/2022: Modifies : 32006R1907: Replacement: annex VIII subsection 8. 6. Languages. However, paragraph 3 shall not apply to: (a) motor fuels which are covered by Directive 98/70/EC; (b) substances and mixtures for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation; M33 (c) natural gas placed on the market for use by consumers, provided that the concentration of benzene remains below 0,1 % 1. Each entry shows the substance or group of substances or the mixture, and the consequent restrictions conditions. Feb 15, 2021 · A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2. Annex VIII to the CLP Regulation, adopted in March 2017, defines the harmonised requirements for the ‘poison centre notifications’ (PCN), applicable as of 1 January 2021. They depend on the quantity of the substance that is manufactured or imported into the EU/EEA and are described in Annexes VI to X to REACH. 1. These substances are found in everyday products, and they have been linked to serious and often irreversible effects on health or the environment. 2 table column 2 Section 2. These reporting obligations address specific information requirements, outlined in revised annexes to the REACH regulation: characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI); chemical safety assessment (Annex I); registration information requirements (Annexes III and VII-XI); and 4. 4 of Par t A of this Annex, shall comply with this Annex from 1 Januar y 2020. Column 2 specifies the adaptation possibilities for the specific properties. Close menu. 7 %µµµµ 1 0 obj > endobj 2 0 obj > endobj 3 0 obj >/ExtGState >/XObject >/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595. reach; annex vii: standard information requirements for substances manufactured or imported in quantities of one tonne or more; current: 7. 6 table column 1 Text: 08/01/2022: Modifies : 32006R1907: Replacement: annex VIII subsection 8. DURATION OF USE 1. Posted by Dr. 1 table column 2 Text: 08/01/2022: Modifies : 32006R1907: Replacement: annex VII subsection 7. 1). Entry 51 . The European Commission has amended Annex II of REACH, concerning the compilation of Safety Data Sheets (SDSs). Different provisions apply to hazardous components considered of major concern and to other hazardous components and components not classified as hazardous. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use This Annex lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT substances), and very persistent and very bioaccumulative substances (vPvB substances) as well as the information that must be considered for the purpose of assessing the P, B, and T properties of a substance. 4 of Part A of this Annex, shall comply with this Annex from 1 January 2020. The standard information requirements are those which are required as a minimum to meet the registration obligations of REACH. 100% Free. Under REACH, a PBT/vPvB assessment is required for all substances for which a chemical safety assessment is carried out. annex vii Consolidated version of the REACH Regulation. ‘Long term’ means normally intended for continuous use for more than 30 […] Annex XIII to the REACH Regulation sets criteria for substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 10 tonnes or more in accordance with Article 12 (1) (c). Standard information required under REACH; 1 to < 10: Annex VII: 10 to <100: Annexes VII-VIII: 100 to < 1000: Annexes VII-IX: 1000 or more: Annexes VII-X (2) Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (OJ L 308, 4. Dec 30, 2015 · REACH Restricted Substance List 2023 (REACH Annex XVII) Currently there are 77 valid entries on REACH Annex XVII (updated 2023). Any other relevant physicochemical To register a substance in the 10 to 100 tonnage band, you need to provide information specified in Column 1 of REACH Annexes VII and VIII, comprising certain physicochemical data, toxicological and ecotoxicological information. 2018, p The long-term aquatic toxicity study on fish (Annex IX, Section 9. Entry 63 . Substances falling within one or more of the following points: (a) substances classified as any of the following in Part 3 of Annex VI to Regulation (EC) No 1272/2008: and of the Council on the Registration, Evaluation, Authorisation and Restr iction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanofor ms of substances (OJ L 308, 4. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 Guidance on Annex VIII to CLP Description: This document provides guidance on the provisions of Article 45 and Annex VIII to CLP. / TOXICOLOGICAL Under REACH, consumers have the right to know whether the products they buy contain harmful chemicals. However 5 these comparisons have certain restrictions with regard to their applicability. 1. Aug 8, 2019 · Classification rules CHAPTER I Definitions specific to classification rules 1. exemptions from the obligation to register in accordance with article 2(7)(a) annex v. 32 842. exemptions from the obligation to register in accordance with article 2(7)(b) annex vi. To register a substance in the 1 to 10 tonnage band, you need to provide information specified in Column 1 of REACH Annex VII, including certain physicochemical data, toxicological information and ecotoxicological information, except where the requirement does not apply to your substance. Please also refer to the Poison centre notifications Handbook for further support. or annex viii / standard 8. 12. annex iv. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available. GENERAL REQUIREMENTS. %PDF-1. : information on the physicochemical properties of the substance Safety data sheets shall also be required for the special cases listed in paragraph 1. Draft regulation Amendment of REACH Annex II (Safety Data Sheets); Draft regulation Amendment of Annex XVII REACH and its Appendices regarding CMRs, liquid substances or mixtures and testing methods; Annex VIII to the CLP Regulation has provisions on the information provided on the concentration of mixture components (substances or mixture in mixtures). Under dossier evaluation the Agency may assess these adaptations to the standard testing regime. 4. 1 – November 2012 . This information is submitted to the appointed bodies in the Member State and is used for emergency health response (the Poison Centres). Application. Shall not be placed on the market, or used, ANNEX XVII TO REACH – Conditions of restriction . criteria for substances registered in quantities between 1 and 10 tonnes. / toxicological information; 9. 3 of Annex I to Regulation (EC) No 1272/2008 for which there are labelling derogations. Entry 35 . 7. Entry 75 . 04] /Contents Jul 8, 2022 · 2022年上半年欧洲化学品管理局（ECHA）并未对欧盟REACH法规附件XVII限制物质清单作出正式修订，但ECHA分别于5月份和6月份提议在清单中新增甲醛释放量（点此回顾）和PVC制品中铅的限制条款（点此回… annex iii: criteria for substances registered in quantities between 1 and 10 tonnes Criteria for substances registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b): M3 In addition to the specific rules set out in column 2 of Annexes VII to X, a registrant may adapt the standard testing regime in accordance with the general rules set out in Section 1 of this Annex. Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annex VII. David Howes, Informed Consultant in Chemical Legislation and Chemistry. Dec 31, 2020 · In such a dossier, you should redact the information relating to Annex VII-XI, leaving only the Annex VI information and any attachments. 附属書xvii物質リスト翻訳版 2024年5月更新 ・本リストは附属書xvii修正版の物質リスト部分を抜粋して翻訳したものです。 • Title VI, Article 45 and Annex VIII (new) regarding poison centre notification • Title IV, Article 31 and Annex II, Section 1. 1 REACH Regulation Jan 28, 2021 · REACH Update. PART A. / ecotoxicological information; Oct 8, 2019 · 9. Substances which are classified as carcinogen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 1 or Appendix 2, respectively. Note: The Comply with UK REACH service will only accept dossiers compiled using IUCLID 6 and above. Harmonised information relating to emergency health response and preventative measures. Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles . 3 Further information on adsorption desorption depending on the results of the study required in Annex VIII IX Justification required to use Kow, dissolution rate or dispersion stability for waiving the study. Annex VI: Information requirements referred to in article 10 Annex VII/VIII/IX/X: Standard information requirements for substances manufactured or imported in quantities of one tonne or more / 10 tonnes or more / 100 tonnes or more / 1 000 tonnes or more Annex XI: General rules for adaptation of the standard testing regime set out in annexes Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 100 tonnes or more in accordance with Article 12(1)(d). Annex XIII to the REACH Regulation (as amended3 3 Commission Regulation (EU) No 253/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) as regards Annex XIII (OJ L 69/7, 16. Monitor substances in REACH with EcoMole Watchdog. Please note that entry 33, 39 and 42 have been deleted due to REACH updates and they are no longer valid. 9. ‘ANNEX VIII. annex vii: standard information requirements for substances manufactured or imported in quantities of one tonne or more Column 1 of this Annex establishes the standard information required for: (a) non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes; The table below is the Annex XVII to REACH and includes all the restrictions adopted in the framework of REACH and the previous legislation, Directive 76/769/EEC. The regulation aligns REACH Annex II with the 6th and 7th revisions of GHS, and brings in a number of modifications to SDSs. Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. In vitro gene mutation study in mammalian cells, if a negative result in Annex VII, Section 8. Conditions of restriction Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30: 1. 2018, p. Article 2(7)(b) of the Regulation (EC) No 1907/2006 (REACH) and its amendment by Regulation (EC) No 987/2008 of 8 October 2008 sets out criteria for exempting substances covered by Annex V from the registration, downstream user and evaluation ANNEX XVII TO REACH – Conditions of restriction . cs; de; en; Regulations. To assist consumers, REACH introduced the "consumer right to know" in Article 33. pdf Annex IX ข้อกำหนดเกี่ยวกับมาตรฐานข้อมูลสารเคมีที่ผลิตหรือนำเข้า ในปริมาณตั้งแต่ 100 ตัน หรือมากกว่า Apr 27, 2018 · • UFI submitted with all information (Annex VIII) • UFI only meaningful once submitted • The UFI is a link - code itself does not reveal any compositional information • UFI is unique per mixture composition but also flexible • Re-labelling require planning for approaching deadlines –can start now! With over 70 experts in the areas of regulatory compliance, chemistry and toxicology, UL is your source for the latest regulatory news, webinars, white papers and expert industry advice. response - Annex VIII to CLP Dear user of this Guidance, When reading this ECHA Guidance document, please be aware that the consulted competent authorities of EU/EEA Member States were unable to reach a consensus on the interpretation of duty holders underArticle 45 and the legal obligations stemming from Article (10). download full PDF document (02/05/2022) Additional information on the ECHA website Draft regulation Amendment of Annexes VII to XI to the REACH Regulation (EC) No 1907/2006; Draft regulation Amendment of the Annex XIV to REACH as regards phthalates; Draft implementing regulation Commission Regulation on applications for authorisation procedure for uses in legacy spare parts; For substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this Annex are required. Guidance for Annex V Version 1. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. Follow the specific hazard information requirements relevant for the different tonnage bands outlined in Annexes VII-X to REACH. 4 of Par t A of this Annex, shall comply with this Annex from 1 Januar y 2021. information requirements referred to in article 10. These concern the obligation to submit certain information on hazardous mixtures placed on the market, for emergency response reasons. 3. Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 1 000 tonnes or more in accordance with Article 12(1)(e). The following phthalates (or other CAS and EC numbers covering the substance): (a) Bis (2-ethylhexyl) phthalate (DEHP) CAS No 117-81-7 response - Annex VIII to CLP Dear user of this Guidance, When reading this ECHA Guidance document, please be aware that the consulted competent authorities of EU/EEA Member States were unable to reach a consensus on the interpretation of duty holders underArticle 45 and the legal obligations stemming from Article (10). Jun 7, 2023 · Avoiding obstacles with REACH Annexes VII-X. 1 ANNEX VII: RELEVANT INFORMATION ON 2 TRANSPORT CLASSIFICATIONS 3 Table VII-a provided in this annex contains additional information on transport 4 classifications in relation to CLP classifications that could be of added value. Jan 6, 2021 · Information companies placing hazardous mixtures on the UK market (such as manufacturers, importers, downstream users and distributors) should submit to the National Poisons Information Service. Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII and VIII. annex iii. Substances falling within one or more of the following points: (a) substances classified as any of the following in Part 3 of Annex VI to Regulation (EC) No 1272/2008: they can give advice to the citizens or medical personnel in the event of an emergency. [1] REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. 2011). 6) shall be considered if the substance is poorly water soluble. EC No 201-197-8 A new Annex VIII was added to the CLP Regulation in 2017, implementing harmonised information requirements for notifications under Article 45. EC No 231 -100-4 Jun 29, 2023 · Article 138(9) states that within 18 months of the end of the EU Exit transition period the Secretary of State shall review the testing requirements of Section 8. annex VII point 8. Impor ters and downstream users placing on the market mixtures for professional use, within the meaning of Section 2. 1,1,2,2-Tetrachloroethane CAS No 79-34-5 . ANNEX VIII: STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE. Lead CAS No 7439 -92-1 . 4 regarding emergency number • In Ireland: • Notifying mixtures applies only to hazardous mixtures within the scope of CLP Article 45 including biocides and plant protection products REACH_annex_VIII. annex vii / standard 7. and Annex VIII, Section 8. 8. PREFACE . / toxicological information reach; current: annex ii annex ii: requirements for the compilation of safety Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. In the EU, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations address the manufacturing and import of chemicals to ensure they are safe for human health and the environment. 0. gnbiqlwwejzgpsognglfdervowsbztmldyyijnpnulwrztaaoeh