Pre-registration and support to industry
Contents
1. 16 Available Information on ECHA E C H A We bs Ite 1 European Chemicals Agency Pre registration e Pre registration web pages and material Leaflets on Pre registration REACH REACH for exporters to EU Questions and answers Practical Steps for Pre registration e Guidance Documents Registration chapters 1 7 and 2 2 Data Sharing chapters 3 8 and 3 9 Section 4 Identification and Naming of Substances in REACH Available Information on n ECHA website 2 REACH IT e Leaflets How to Submit Data to ECHA e Training Material Overview Key Concepts Sign up and User Management Pre Registration Manuals Data Submission Manual 6 Submission of bulk pre registrations European Chemicals Agency IUCLID 5 e Pre registration plugin installation manual user guide Presentation video tutorials 1 and 2 e XML format Toolkit with examples e IUCLID 5 website End User Manual Installation Manuals Training material Formats Video Tutorials Pre registration Publications ECHA 2 page leaflet to raise your appetite to read more e Practical Steps guide tells you how it works e Will be published on ECHA web in 22 EU languages GECHA EB RECHA exp ache surup en http echa europa au Esirekister i k ytt m si kemikaalit N in jatkat liiketoimintaa Practical steps for REACH vaatimusten mukaisesti REACH pre registration Kemi2. L A enzija Ewropea tal Kimika Europees Chemicali nagentschap Europejska Agencja ds Substancji Chemicznych Ag ncia Europeia dos Produtos Quimicos Eur pska agent ra pre chemick l tky Evropska agencija za kemikalije European Chemicals Agency 2007 images by European Commission Follow the news on our home page 30 Info REACH Guidance RECHA European Chemicals Agency A REACH Navigator Authorisation Microsoft Internet Explorer FI Finnish e DrawingPad E File Edit View Favorites Tools Help Q EN a JO search She Favortes O A E jw gt LJ as Address http reach jrc it ER E A C H Guidance l Registration Evaluation Authorisation and restriction of CHemicals Site map Glossary Contact Feedback Form Search English en v About Reach Guidance Documents Formats Legislation Other Documents MAVIGATOR What can you find on this website MAVIGATOR This website assists industry and authorities to understand their obligations under REACH and provides What are my obligations under guidance on how to fulfil them It contains 5 main elements REACH Obtain a list of your obligations by answering guestions about the chemicals you handle About REACH gives an overview of the processes foreseen by REACH its scope and the main obligations of the actors Enter the Navigator involved in REACH Navigator is an IT tool to help industry determine its obligations under REACH Guidance document
3. first come first serve basis Not legally binding no additional obligations Can post information to the other participants in a separate text box on the pre SIEF webpage e g on further communication tools to be used 23 What Happens after BRECHA Pre registration European Chemicals Agency Pre List of pre SIEF SIEF registration pre registered ECHA industry substances website platform e Industry needs to agree on SIEF formation and share data and costs within the SIEF 24 What is a SIEF ECHA e Obligatory platform to share data among potential registrants of the same phase in substances and data holders avoid unnecessary testing agree on classification and labelling Suitable platform to organise the mandatory joint submission of data Potential registrants within a pre SIEF must discuss whether their substances are the same or not e f agreement on the sameness SIEF is born Article 29 25 SIEF Formation Key Issues ECHA e Industry must assess the sameness see guidance on substance identity No confirmation by ECHA e SIEF participants are free to organize themselves as they see fit Consortium is one possible form of co operation Co operation and collective approaches highly encouraged 26 SIEF Formation Key Issues ECHA e In many cases EINECS SIEF but substances within one EINECS number may after detailed examination turn out to b
4. 2008 30 000 m on line m bulk 20 000 10 000 REALES 10 After 3 months of pre registratioff ECHA European Chemicals Agency 9 126 Legal entities have signed up from all 27 EU Member States EAA Germany 2196 UK 1596 Netherlands 1096 France 996 e 352 641 pre registrations received Germany 4096 UK 3996 Netherlands 4 9 Italy 4 0 110 664 substances pre registered 104 725 substances pre registered by one UK company on line pre registration remains important 26 000 pre registrations per week e bulk pre registration 10 rejections Tvpical mistakes BECHA when pre registering European Chemicals Agency Use of ambiguous chemical names or trade names or company codes Using molecular formula instead of chemical names Substance is listed in EINECS but pre registered with different chemical name Pre registering polymers Pre registering preparations CAS number and CA index name do not fit together Given name does not refer to the CA index name but to synonym Spelling mistakes typing errors languages 12 Main recommendations DEL Hi e Follow the Guidance on substance identification for naming your phase in substance Respect the preferred order for substance identifiers to use 1 EC number 2 CAS number and CAS name 3 IUPAC name Specify the chemical name carefully use the IUPAC name in English add all other available numerical identi
5. GECHA European Chemicals Agency Pre registration and support to Industry Doris Thiemann September 2008 Iceland BECHA European Chemicals Agency Pre registration state of play Basics of pre registration MECHA Pre registration is a duty under REACH for every potential registrant of phase in substances taking place between 1 June 1 December 2008 granting them extended deadlines for registration Which substances A ECHA Phase in Substances Mono constituent substances Multi constituent substances UVCB substances e EINECS e CAS and CAS name e Chemical name How to do in practise A ECHA e Potential registrants first need to sign up to REACH IT e Each legal entity must sign up and pre register separately an Only Representative must sign up and pre register separately for each non EU manufacturer represented Pre registration is free of charge e 2 ways to pre register on line pre registrations created one at a time using REACH IT bulk pre registration file prepared in a separate system such as IUCLID and submitted via REACH IT What data to submit A ECHA n Chemicals Agen Substance name EINECS or NLP or CAS Similar substances optional substances which can be used for QSAR grouping or read across Envisaged tonnage band registration deadline Contact person details optional Third party representative contact details optio
6. National RECHA Established in 27 EU Member States in 2007 In most cases operated by national REACH Authorities e Provide Advice to companies and other stakeholders on their REACH obligations Wide ranging information on the provisions of REACH e National helpdesks the first point of contact for enquiries List of national REACH helpdesks available on ECHA website http echa europa eu reach helpdesk nationalhelp contact en asp 35 ECHA Helpdesk a ECHA Support to registrants on REACH REACH IT and IUCLID 5 http echa europa eu about contact form en asp topic reach ECHA Helpdesk Contact ECHA My question is related to please select one of the following options Enquiry on REACH Advice to registrants on REACH obligations More gt IUcHB 5 IT tool to capture store and exchange data on chemical substances for REACH and other t rposes worldwide More gt MAC setances To REACH and other EA Communications Web portal to submit REACH registrations and share information on chemicals More gt C Enquiry on specific submission to ECHA Questions related to specific submissions e g ongoing registrations PPORD inquiries Art 26 invoices O General enquiry E g on translation matters request for information on ECHA C ECHA website Feedback on the website e g improvements needed Webmaster Enquiries on these topics should be sent via this webform Continue gt gt ECHA helpde
7. Proin tempor magna Suspendisse sagittis orci consectetuer aliquet tristique nunc risus euismod ipsum li PRESS AND EVENTS imperdiet sapien orci vel sem Suspendisse hendrerit ornare nunc Ut egestas mi vel dui Fusce pretium enim quis lorem Nunc nisl nulla bibendum nec tincidunt id euismod metus Sed quis sem in mi vestibulum tempus Vestibulum dictum tempus erat ABOUT ECHA PUBLICATIONS WORKING WITH US LINKS Launch in mid May 2008 e Up to date info in 22 languages about e Pre registration e PPORD Inquiry Registration e http echa europa eu reachit 20 GECHA European Chemicals Agency Data sharing and SIEF 21 What is a Pre SIEF ECHA After pre registration a substance pre SIEF webpage will be formed for each EINECS n CAS n other identity code All potential registrants will be able to see each others contact details contact details from data holders identified read across possibilities remarks about the substance It is possible to navigate to the pre SIEF webpages of the substances identified for read across to and from If you have concerns on confidentiality use a third party representative during pre registration 22 SIEF Formation Facilitator MECHA To initiate discussions after pre registration a SIEF formation facilitator can be identified on the pre SIEF webpage Only potential registrants can volunteer to become SIEF formation facilitator on a
8. Regulation is the only authentic legal reference and that the information in this website does not constitute legal advice The European Chernicals Agency does not accept any liability with regard to the content of this Website El http ffecha europa euf o BED B Inter gt fi My Docu 31 BECHA European Chemicals Agency Info REACH Brochures Where can find further informati D REACH The new EU chemicals legislation Does REACH affect me Do you know what REACH means for your products and your company You should find out your duties under REACH if How can prepare Identify within your company who will be responsible for REACH compliance The best way is to consult the website of the European Chemicals Agency REACH THE NEW EUROPEAN CHEMICALS LEGISLATION Create an inventory of all substances or substances in preparations articles that you import distribute handle Check if the substances or uses in your inventory are exempted from one or all aspects of REACH http echa europa eu This website contains gt A Navigator tool which will assist you to find out your Identify for each substance in which roles you need to act REACH obligations and how to fulfil them under REACH gt Manufacturer lmporter you manufacture or import a substance on Its own or In a preparation of gt 1 tonne year gt Producer lmporter or Supplier of ar
9. e so different in terms of composition that data from one substance may not be relevant to describe the profile of the other substance several SIEFs may be formed different EINECS numbers may reflect the same substance one SIEF may be formed e Data sharing obligations must be respected it is not allowed to form 2 SIEFs for the same substance 27 SIEF Formation Key Issues ECHA Cost sharing see guidance on data sharing e Costs must only be shared for information that a registrant is reguired to submit at the time when a registrant is required to submit the information e Costs must be shared in a fair transparent and non discriminatory way e If SIEF participants cannot reach an agreement costs shall be shared equally 28 i CHA European Chemicals Agency Support to industry Info ECHA website RECHA European Chemicals Agency bs M N J a Evropska agentura pro chemick latky Det Europaeiske Kemikalieagentur Europ isches Amt f r chemische Stoffe Euroopa Kemikaalide Amet Eupurraik g Opyavicu c Xnpikdv l Ipoi vruv European Chemicals Agency Agencia Europea de Sustancias y Preparados Qu micos Euroopan kemikaalivirasto Agence europ enne des produits chimiques Agenzia europea delle sostanze chimiche TIRITAS COTAS d 9 Jh Europos chemini med iag agent ra Eiropas misko vielu a ent ra Vegyi Anyagokkal Foglalkoz Eur pai gyn ks g
10. ears here User information Company name on Provides an online homepage to each company to submit data to E C H A e Industry testing in April You have 15 unread mes e Life from 1 June 2008 http echa europa eu REACH IT from 1 June 2008 European Chemicals Agency Username Password IT Tools IUCLID 5 RECHA a i i U Cc i i D Sign up new user Password recovery English en E ES EUROPEAN commission Home IUCLID 5 Project Get IUCLID 5 Pre Registration News AboutUs Documentation Training Links Get Reference substances IUCLID format FAQ Service Desk Contact Get e Software for companies to store gt REACH data and prepare for gt Software Tools their registration Documentation Find anything you want to impro ral enhance your knowledge in man related to our project Read more Her you wl find al infomation z gt IUCLID 5 Launched in June E fessi Or http iuclid eu 2007 iink Pre registration page Do you want to get information f Internet What other people lea lt you will find a selection of useful Read more e Plug in e XML format specs Get Support section e User guide training material FAQs etc Get Reference substances References substances provide identification information e g IUF pn names structural information fo than 68 000 substances listed o Read more 34 Helpdesks
11. fiers if regarded necessary add synonyms and or chemical names in other languages Fill in your company s and contact person s details 13 Questions DEL H i European Chemicals Agency Regarding REACH IT e Unintentional creation of reaction mass e How can deactivate e How can modify e How can delete Pre registration Q amp A a ECHA Q1 What happens if do not pre register my phase in substance A1 You need to register your substance immediately or lower manufacturing or importing it to quantities lower than 1 tonne year Q2 What happens after pre registration period A2 ECHA will publish list of pre registered substances Downstream users shall inform ECHA if their substance is not listed Article Companies will on the basis of pre SIEFs create SIEFs industry responsibility out of scope of ECHA Companies will share data and prepare registration dossiers to be submitted to ECHA Pre registration web RECHA European Chemicals Agency Site map How to find us About website European Chemicals Agency Lega Notice Contact SEARCH HOME What you need to know PRE REGISTRATION What to know ar at When you start prepanng for REACH you should first know what roles your company may have in relation to its substances The following roles are relevant for pre registration Manufactafer importer of substantas ProduceNimponer of articles Only represe
12. kaalien v valmistaja maahantuoja tal ayoa ui esineiden maa 1 joulukuuta 2008 i ate Data Submission web RECHA European Chemicals Agency HOME PRE REGISTRATION REACH IT REACH Lorem ipsum dolor sit amet consectetuer adipiscing elit Pellentesgue rutrum nisi id tempus egestas tellus arcu dapibus erat suscipit iaculis nisi turpis vitae velit Aenean vel Nam quis quam Maecenas euismod lobortis nulla Cras a nulla Donec lacus quam placerat a rhoncus non euismod eget eros Donec pellentesque augue eget laoreet moll augue odio dapibus purus quis adipiscing nunc turpis tincidunt elit Proin tempor magna Suspendisse sagittis orci consectetuer aliquet tristique nunc risus euismod ipsum imperdiet sapien orci vel sem Suspendisse hendrerit ornare nunc Ut egestas mi vel dui Fusce pretium enim quis lorem Nunc nisl nulla bibendum nec tincidunt id euismod Registration metus Sed quis sem in mi vestibulum tempus Vestibulum dictum tempus erat REACH IT Portal Notificatio Enquiry PPOR POR Lorem ipsum dolor sit amet consectetuer adipiscing elit Pellentesque rutrum nisi id tempus egestas tellus arcu dapibus erat suscipit iaculis nisi turpis vitae velit Aenean vel CLASSIFICATION Nam quis quam Maecenas euismod lobortis nulla Cras a nulla Donec lacus quam placerat a rhoncus non euismod eget eros Donec pellentesque augue eget laoreet moll augue odio dapibus purus quis adipiscing nunc turpis tincidunt elit
13. nal Remarks about the substance optional REACH IT went live on 31 May 2008 at 21 15 e with company sign up and on line pre registration e the first company was signed up after 15 minutes e 1286 pre registrations were submitted on 01 June on 04 June Norway Iceland and Liechtenstein were added to the system on 22 July the bulk pre registration functionality became available e up to 500 substances pre registered with one file limited to substances with EC numbers e file must be compliant with the XML format published on the IUCLID website Stat si CS 08 September 2008 A ECHA e Number of pre registrations 246 794 e Number without EC number 5931 e Mono constituent substances 997 e Mono constituent by CAS 3529 e Multi constituent 1405 European Chemicals Agency A total 9126 15 9 2008 les signed u Germany Legal ent 101 LOZ uepeMg mmm egg uleds HE 6 BIMBAOIS CZ eluBwoy m 9 ebnuod m 933 puejod ma 29 AENJON F 826 spueueuleN FET United Kingdom 1347 LO O S C D gt O 0 GZ eine 609 Ae pu GL9 puejal G pueja 6 MebunH m gg 9999319 F DD ZEB DUST aN yg puelul4 8c eluo sy CJ yIieuuag ELL ougndeu u2ezo ma le snud 9 F LG euebing mr esy wnibjeg 241 Elisny ma 2 2000 1600 1200 800 0 Pre registrations per week DEL Hi 111641 1 SC 1 40 000 total 352 641 15 9
14. ntact detalls can be found on the ECHA website What is REACH repackaging spraying painting Carry out first preparatory actions for example establish a dialogue through the supply chain compile information on uses and use conditions according to your role Identify and plan for future responsibilities you will have keeping in mind the different timelines linked to the three tonnage levels 21 tonne gt 100 tonnes gt 1000 tonnes TIAVIGATOR What are my obligations under REACH Obtain a list of four obligations by answering questions about the chemicals you handle De Enter the Navigator NI ET LO LL HN European Communities 2007 Reproduction is authorised provided the source is acknowledged Printed in Italy Printed on recyded paper European Commission REACH is a new European Community Regulation onchemicalsand their safe use It deals with the Registration Evaluation Authorisation and Restriction of Chemical substances The new Regulation entered into force on 1 June 2007 European A ECHA Commission European Chemicals Agency 32 P IT Tools REACH IT RECHA European Chemicals Agency e IT portal for data submission to ECHA Contact Help Legal notice ZA MECHA Roser M connected as janedoe on behalf of The Chemical Company Inc Preferences Home Company Message of the day app
15. ntative Downstream user Distributer Data holder E REACH x I sinl If you are a manufactuf r or importer of Substances which ECHA CHEM you need to register Bk Ihe registration requirement appli importers of articles f substances are intentionally release Launch on 14 April 2008 CE EE D CLASSIFICATION Companies that are not established in he EU have no obff step guide from What to know to ABOUT ECHA not pre register and register However a non EU manufactura di N m z articles whose products are imported into the EU can appoin Registration PRESS amp EVENTS Only Representative well then carry out the REACH obligati 2 linked to the imported substances An only representative va PUBLICATIONS the event that the importer had already registered the substa 3 Is available in 22 EU languages WORKING WITH US Downstre am users api distributors who buy their substand release substances from EU suppliers or non EU suppliers STAKEHOLDERS Representative do not need to pre register and register Howe Y http echa europa eu pre registration suppliers they will be considered as importers under REACH LINKS register as importers If a downstream user or a third party is holding data on substances 7 nt J the intention of participating to exchange of information with the registrants The REACH IT portal has a separate functionality for these Data holders
16. s provides the Guidance Documents on REACH processes and methods to be used by industry and DOCUMENTS authorities Formats Technical Guidance Documents contains the key templates that industry and authorities can use in the context of REACH e g format REACH Legislation legal text Y for Chemical Safety Report format for Substance Evaluation Report formats for Annex XV dossiers Formats Legislation Other Documents contains different legislative texts related to EU chemicals policy in particular the REACH Regulation in all official languages of the EU Some parts of this website are still under construction especially Guidance Documents and will be regularly updated with new documents as soon as they become available Parts of this website are accessible in all languages of the European Community For the parts which are not translated the default language used is English If you need an overview of REACH we recommend that you start with about REACH If you are a manufacturer an importer or a user of chemicals and you are not familiar with REACH you can find out your obligations using the Navigator tool If you are a manufacturer an importer or a user of chemicals familiar with your role or obligations under REACH you can access the relevant guidance documents directly Disclaimer This website contains guidance on REACH explaining the REACH obligations and how to fulfil them However users are reminded that the text of the REACH
17. sk 36 Questions GECHA European Chemicals Agency NNN NS 4 A Ld 4 A A K IUCLID 5 htto ecbvvbiu5 jrc it REACH IT http echa europa eu reachit en asp 37
18. ticles you manufacture Import articles or place them on the market About REACH which gives an overview of the legislation Guidance documents IT tools for REACH FAQ Frequently asked Ouestions in English gt You manufacture or import chemical substances or mixtures of chemical substances preparations gt You produce or import articles for example construction materials electronic components toys or vehicles which contain substances Included In a list of substances of very high concern or which are released during thelr use Information for exporters to the European Union What should your company know Your industry association is a good source of Information for sector specific Issues and your supplier s can answer chemical specific questions gt Distributor including retailers you store and place on the market a substance on Its own or In a preparation You process chemicals or you formulate preparations for end use for example cleaning products paints or motor olls or you use these formulated products professlonally In this case you are a downstream user gt Downstream user you use a substance elther on Its own or In a preparation In the course of Industrial or professional activities for example formulation dilution The REACH helpdesk in your country provides advice about your responsibilities and roles Thelr co
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