1 Classification and Labelling notifications under the CLP regulation: How to be prepared? How to notify? C&L inventory creation CEFIC - REACH Implementation Workshop VI Brussells - November 2009 Sandrine Lefèvre-Brévart ECHA, Scientific IT tools Unit
2 Content 1- Legal obligations to notify 2- Who shall notify? When? 3- Information to be notified 4- Identified challenges of C&L notifications 5- The IT-tools to submit your C&L notifications 6- How to be prepared? 7- How the C&L notifications data will be used: the C&L inventory! 8- Conclusions
3 1- Legal obligations Title V (chapter 2) to CLP regulation: Obligation for Industry to notify ECHA (article 40-41) Obligation for ECHA to establish & maintain a C&L Inventory (article 42)
4 Which substances you shall notify? Substance subject to registration under REACH Also non-classified substances! If you register under REACH your substance before 3 January 2010 and the registration dossier contains the CLP information, you fulfil your C&L notification obligation, and no notification is required. Substances classified as hazardous under CLP No tonnage threshold! Substances classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I to CLP or in Directive 1999/45/EC which results in the classification of the mixture as hazardous AND PLACED ON THE MARKET!
5 2- Who shall notify? Notification must be performed by: Manufacturer, Importer, or Group of manufacturers/importers who places a hazardous substance on the market (on its own or in a hazardous mixture), who places on the market a substance subject to registration under REACH Note: downstream users, distributors and producers or importers of articles do not need to notify!
6 When to notify? General rule: Within one month from placing on the market Substances on the market on 1 December 2010 have to be notified by 3 January 2011 (EoB) (First working day after 1 January)
7 Practical examples Shall I notify, if: I am manufacturing/importing 100 kg/year of a hazardous substance: Yes, if my substance is placed on the market I am manufacturing/importing 500 kg/year of a nonhazardous substance: No! I am manufacturing a substance subject to REACH registration, I benefit from the transitional period and intend to register in 2013: Yes, if my substance is placed on the market. I have to notify my substance even if this substance is not hazardous!
8 Practical examples Shall I notify, if: I am manufacturing a substance subject to REACH registration, I have already submitted before 3 January 2010 a registration dossier containing C&L according to DSD and CLP criteria: No. I am fine! I am manufacturing a substance subject to REACH registration, I have already submitted before 3 January 2010 a registration dossier containing C&L according to DSD criteria only: From 1 December 2010, I shall update my registration dossier without undue delay, as I have to classify according to CLP from that date. (REACH Article 22) The same applies to the former NONS.
9 Practical examples Shall I notify, if: I am manufacturing a substance in October 2010 which I leave in stock for a while before I place it on the market in February 2011: Yes. I must notify it within 1 month after placing it on the market in I am manufacturing a substance which I supply to a distributor in June 2010 who leaves it in stock at first before he places it on the market in 2011: No for me and no for the distributor!
10 and what if you do not notify? You may be subject to enforcement! Remember that the classification and labelling you present in the Safety Data Sheet of your substance has to be consistent with the information you submit in your C&L notification. The Safety Data Sheets may be inspected by the relevant enforcement authorities in the Member States.
11 3- Information to be notified Article 40: Identity and contact details of the notifier Identity of the substance(s) Classification of the substance(s) according to CLP The reason for no classification SCLs or M-factors and justification Label elements (hazard pictograms, signal words, hazard statements and any supplemental hazard statements) about 200 IUCLID fields for one notification!
12 When updating your notification? Article 40(2): Submit an update of your notification when : new information available on your substance that has an impact on the C&L, more details available / changes on your substance composition, change in contact details, agreement with a classification and labelling already in the public C&L inventory, specification/update of the group of Manufacturers / Importers, following ECHA request, following an harmonisation procedure
13 Special case of substance registered under REACH If you have already submitted a registration dossier under REACH and if you want to update the C&L information, you shall update your registration dossier (REACH-article 22).
14 4- Identified challenges of C&L notifications Deadline : 3 January 2011! Huge number of C&L notifications to be submitted Amount of data requested per notification Quality of data on substance ID is of highest importance (to identify same substance for C&L agreement) Various profiles of notifiers with different needs: The well-organised corporate-industry having structured central data-base containing all their C&L The SME with few C&L to notify And all the ones not even aware of the need to notify!
15 5- IT tools to submit your notifications C&L notifications shall be submitted electronically via the REACH-IT portal on the ECHA website. => If not yet done, you need to create your company account in REACH-IT Dedicated area in the main REACH-IT menu:
16 5- IT tools to submit your notifications Different submission tools to answer all Industry potential needs related to notification submission: Creation of C&L using IUCLID 5 Online creation and submission of C&L for SME XML creation and Bulk submission for company with many notifications to submit Specification and management of group of Manufacturers/Importers
17 Notification Submission flexibility All submission means will be compliant with IUCLID 5.2 and CLP regulation All submission means will be compatible between each other (including update, submission by a group of MI etc )
18 C&L notification with IUCLID 5 The notification is created in IUCLID 5 Template = REACH C&L notification in IUCLID 5.1 Template = CLP notification in IUCLID 5.2 The IUCLID 5 notification is submitted via REACH-IT User guide on how to fill-in the IUCLID 5 notification will be available at the same time as the tool
19 On-line C&L notification Target user: SMEs No need to use IUCLID 5 The C&L notification is prepared directly in REACH-IT Pragmatic approach to ease the encoding of data in the notification: Reduce number of fields Use of default value if possible On-line help and guide along the wizard Compulsory fields Link with the C&L inventory (incl. Annex VI) to ease the encoding of C&L agree concept
20 On-line dossier - overview Screen 2: Select a dossier type Screen 3-3: Update a submitted dossier Screen 3-1: Create a new dossier Screen 3-2: Continue with an existing dossier For a substance listed in AVI Screen 4: Select the C&L notification type For a substance NOT listed in AVI Start from last saved Screen Screen 5: Identify the index number Screen 6: Select the substance type Legend: Optional Screen One-way Screen flow. You can not go back. Two-way Screen flow. You can go back to former Screen and modify it. Screen 7: Specify identity and composition of the monoconstituent Mono-constituent Screen 12: Specify optical information UVCB Screen 8: Specify the identity of the UVCB Screen 9: Specify the composition of the UVCB Multi-constituent Screen 10: Specify the composition of the multi-constituent Screen 11: Specify the identity of the multi-constituent Screen 15: REACH-IT displays the harmonised entry Add info Screen 16: Notify further information For a substance listed in AVI Agree with C&L displayed For a substance NOT listed in AVI Screen 13: REACH-IT checks if the substance exists in the inventory Agree with C&L displayed Propose new C&L Screen 14: Propose new C&L Screen 17: Specify the group of MI Screen 18: Specify contact details Screen 19: Validate the content of the notification Submit the notification - Submission number + Reference number - Submission report - Downloadable iuclid 5 substance dataset
21 On-line dossier
22 Bulk C&L notifications Objectives: - Allow to submit in one shot many notifications - Allow to dump the C&L from industry s centralised DB - Reduce the amount of submission Creation of a bulk submission in a xml file and then submission of this bulk via REACH-IT ECHA will provide an excel tool for data creation and subsequent transfer to XML The xml bulk submission can be used only under the following strict conditions: Each substance you notify must be identified by a CAS number, You can not specify more than one composition for each substance, You can not notify a substance which is not classified as Hazardous, You can not set an M factor (if not given already in Annex VI to CLP) You can not specify a different SCL than the one already given in Annex VI to CLP regulation
23 Group of Manufacturers/Importers "A group of manufacturers or importers can be one of the following: - a Corporate company with different LEs - several companies that have no specific links between each other - a SIEF - a Joint Submission that agree on a common C&L for the same substance. Objectives : Allow industry to create and manage group(s) of Manufacturers/Importers Allow industry to submit C&L notification(s) as a group of Manufacturers/Importers (ie 1 notification submitted on behalf of max 499 companies) Offer to the user an easy solution to update its group(s) of MI without having to submit an update of the C&L notification Reduce the amount of agreed submissions
24 Group of Manufacturers/Importers A group is composed of minimum 2 members. It is not compulsory for the members to have a REACH-IT account. The submitted C&L will be considered as agreed by the group. What the user CAN do in this module: create a new group of MI: Outside REACH-IT in an xml format to be uploaded in REACH-IT Inside REACH-IT ahead of the notification Inside REACH-IT during the C&L notification submission (bulk, I5.2, or online). delete a group of MI update an existing group of MI: add a new member remove a member (only if group contains more than 2 members) update the company details of the member(s) Have an overview of the C&L notified by a group All actions related to the update of the group will be recorded/updated in the C&L inventory.
25 Group of Manufacturers/Importers
26 C&L submission miles-stones Industry can already submit its C&L using IUCLID 5.1 (notification / registration) (but not fully in line with the CLP) New Notification Submission means will be available in 1st half of 2010 as soon as IUCLID 5.2 is released: IUCLID 5.2 (updated IUCLID according to CLP) bulk notification group of Manufacturers/Importers online C&L notification
27 6- How to be prepared? The submission tools are not yet available in REACH-IT, but you can already start preparing your notification!
28 6- How to be prepared? Make an inventory of the products you manufacture in the EU and import, Are those products substances or mixtures classified as hazardous? Are those substances exempted from CLP? Collect all information to properly identify your substances, Name the substances in line with the SID guidance, Are those substances listed in Part 3 of Annex VI to CLP? If your substance is not yet HARMONISED, gather all available and reliable information on the hazardous properties of the substances; Prepare a Chemical Safety Report with adequate and reliable information in the case where you want to specify a M-factor, or set a Specific Concentration Limit (article 10-CLP) Classify your substance by evaluating the available information against the classification criteria Create a group of MI if needed, etc
29 Where to find further information? ECHA web pages /classification_en.asp : Link to the CLP regulation Guidance on introduction to CLP, Application of CLP criteria Questions & Answers on CLP Further explanatory documents under development (IUM on how to create a C&L notification in IUCLID 5.2, Q&A on notifications, etc) CLP awareness campaign under preparation: ECHA s third Stakeholders Day on 7 December on CLP If you have questions: CLP / REACH helpdesk in your country ECHA Helpdesk your industry association can be a good source of information for sector-specific questions
30 Submission C&L treatment 7- How the C&L notifications data will be used: the C&L inventory! C&L Workflow Bulk (xml/xls) Iuclid 5 Annex VI CLH proposal Treatment out of REACH-IT Harmonised C&L Harmonisation C&L Inventory Inventory = C&L notifications + C&L from registrations + Annex VI of CLP
31 Overview of the public C&L inventory C&L Inventory = C&L notifications + C&L from registrations + Annex VI of CLP Filter Public C&L Inventory
32 Content of the C&L inventory What will it contain? The C&L entries of Annex VI to the CLP Regulation Information submitted by Industry according to Art 40(1): Notifier/registrant details including group of MI, Substance ID, C&L according to CLP Additional information inserted by ECHA Entry in Part 3 of Annex VI Joint entry between registrants of the same substance Agreed entry between notifiers / registrants Difference between other entries for the same substance Alternative name (if any) SEVESO categories
33 Content of the public C&L inventory A public version of the C&L inventory will be made available on ECHA s website. It will be the central source on information on classification and labelling for all users of chemicals According to Article 119(1) of REACH: Substance identifier IUPAC for dangerous substances EINECS if available C&L, incl. specific concentration limits (SCLs), M-factors and notes According to Article 42(3) of CLP: Entry in part 3 of Annex VI Joint entry between registrants of the same substance Agreed entry between notifiers or registrant
34 C&L inventory in a nutshell A repository of all C&L information submitted to ECHA (notifications, registrations) + Annex VI A database within the REACH-IT system A database fully accessible by ECHA and MSCA A database used as a background for the online submission of C&L notifications A database used for the dissemination of C&L => public C&L inventory end 2010
35 Conclusions Release of C&L functionalities in REACH-IT in 1st half of You can already start to prepare your C&L notification by manually compiling the required data, and creating your group of MI (if needed). Correct information on substance identity is crucial. We recommend you to start submitting your C&L notification to ECHA in Spring 2010 when all notification possibilities will be available in REACH-IT: If you need to notify only a few substances and you are not currently using IUCLID 5, the online notification via REACH-IT could be your preferred option. Bulk notification using the XML option may be more practical if you have to notify many chemical substances. If you register under REACH before 3 January 2010, include already the C&L according to CLP criteria in your dossier.
36 Thank you for your attention! These slides represent the work and opinions of the author and do not constitute official position of the European Chemicals Agency. This material has not been peer reviewed and is presented here with the permission of the author.
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