R E A C H
M a n g a n e s e
C o n s o r t i u m
REACH Pre-registration Guidance Document
The pre-registration process is in the final stages of development by ECHA and it should be a simple, internet-based procedure. Important for potential registrants is to prepare all necessary information in readiness, including substance information, IUCLID5 user identification and access codes for the REACH-IT system. This guidance is intended to increase the awareness of the reader in order that pre-registration can be completed effectively and accurately to allow the Member can move to the next mandatory stage of REACH registration – the SIEF process
The REACH Manganese Consortium, the Consortium Manager and the International Manganese Institute do not accept any liability whatsoever with regard to the content, accuracy or use of information contained in this guidance. All users are reminded that the legal text of the REACH Regulation (as amended) is the only authentic legal reference and that the information in this guidance document does not constitute any legal advice.
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Table of Contents
Overview ........................................................................................... 3 What information is needed? ................................................................ 4 How to prepare for pre-registration. ..................................................... 4 What not to do. .................................................................................. 5 On-line and off-line pre-registration. ..................................................... 5 What if I import / manufacture for the first time after December 2008? .... 5 What happens immediately after pre-registration? ................................. 6 Step-by-step pre-registering on-line using REACH-IT. .............................. 6 Substance List .................................................................................... 8
The benefits of pre-registration are twofold: 1) Allowing companies to continue, from 1 December 2008, their manufacturing and/or importing activities involving phase-in substances, thus avoiding disruption in the supply chain. Page | 3 2) Enables a company time to organise the gathering and selection of available data, the sharing of existing data and the collective agreement for generation of missing information. The pre-registration process is in the final stages of development by ECHA/REACH-IT. Preregistration should be a simple, computer-based procedure; the key for EU organisations is to prepare all necessary information in readiness, including user identification and access codes for the REACH-IT system. If you have not already done so, go to the IT section of the ECHA website at http://ecbwbiu5.jrc.it/index.php?fuseaction=home.menuNOTSignedUp&type=public and click ‘sign up’ at the bottom of the text. Complete the data entry and you will receive an activation key that will allow you to access / download the IUCLID5 REACH software.
Pre-registration can only be performed by an EU-based legal entity (Importer, Manufacturer or Only Representative) or other data holders such as downstream users. Pre-registration is for potential registrants who wish to take advantage of the registration phase-in periods of up to 2018 (tonnage related). Pre-registration can only be performed between 1 June 2008 and 30 November 2008, inclusive. Pre-registration is free-of-charge. A potential registrant is not obliged to submit a full registration for each substance that it has pre-registered. If you do not pre-register and do not register, from 1 December 2008 you will be in contravention to the Regulation and subject to enforcement action by Member States. It you are based outside the EU, you should ensure that your EU importers or Only Representative aims to pre-register before 1 December 2008. Each potential registrant shall join the SIEF for each substance that it pre-registers
Importantly, the REACH provisions on data sharing and joint submission will apply to those potential registrants pre-registering the same substance. A vital first step to establish “sameness” is preregistration under the correct identity code/s. It is therefore strongly recommended that you verify the EINECS/CAS-entry related to each of your substances for pre-registration.
What information is needed?
Pre-registration takes place when you, as the potential registrant, submit electronically to ECHA the required substance information. For each substance, this includes the following four requirements: Page | 4 1. The name of the substance i.e. the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature or other international chemical name other name (e.g. chemical name) European Inventory of Existing Commercial Chemical Substances (EINECS) number (if available and appropriate) Chemical Abstract Service (CAS) name and CAS number (if available) other identity code (if available)
2. The legal name and legal address of the pre-registrant and the full name of its principal contact person (and third party representative if this option is elected for SIEF anonymity) 3. The tonnage band and envisaged registration deadline. 4. The name(s) of other substance(s) for which the available information is relevant for performing adaptations to the testing requirements, i.e. use of results from (Q)SAR models and read-across approach. Optionally, the pre-registrant can indicate whether he is willing to act as "facilitator" in the SIEF (i.e. act as a principal coordinator and initiator of communications). This role does not have any legal definition and is not the same as the Lead Registrant which does have legal status.
How to prepare for pre-registration.
1. List all the substances that you import/manufacture/represent. 2. Determine the EU annual tonnage of each substance (the tonnage that you manufacture in the EU and/or import into the EU, regardless of the final destination of the substance). 3. If you have plans to manufacture/import different substances in the future or to significantly change the tonnage that you handle, include this in your pre-registration plans. 4. Plan to pre-register all your substances, even if in doubt. 5. Determine those that are existing substances (note: it is unlikely in the metals business that you handle 'new' substances, but record the process of verifying this) and note the EINECS/CAS numbers. See http://ecb.jrc.it/esis/index.php?PGM=ein 6. Ignore impurities at this stage as impurities do not need to be pre-registered. 7. Nominate a suitable qualified employee/s to act as the principal contact for ECHA. Ensure that passwords and activation codes are securely stored, but available to a nominated second person. 8. Allocate resources to the pre-registration process, these resources should be available during the pre-registration period (June to Nov 2008), with appropriate back-up resource. 9. If you have a relatively small number of substances to pre-register (<20, say) these can be uploaded into the IUCLID system on-line during the pre-registration period. A larger number of pre-registrations can be prepared off-line and uploaded from 1 June. See box below. 10. For resource planning, allow 20-40 minutes on-line time to pre-register each substance.
What not to do.
Do not pre-register trade names, brand names, product names. Do not pre-register ores and concentrates (as defined in REACH). Do not pre-register impurities. Do not leave pre-registration until the last moment, and Do not assume that others will pre-register on your behalf.
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On-line and off-line pre-registration.
ECHA will not check the correctness of your pre-registration entry so you are strongly encouraged to double-check before submission. If you make a mistake (e.g. pre-register with an incorrect EINECS n°) simply pre-register again with the correct EINECS and withdraw the incorrect pre-registration (or let the incorrect one lapse). If a substance has more than one EINECS number (a weakness of the former system) it is recommended to make a pre-registration under each EINECS number to keep your SIEF options open in finding the correct SIEF with all potential members present for the same substance. Another option is to add other EINECS numbers into the “similar substance” pre-registration box.
Pre-registration can be performed via the internet in two main ways: 1. by direct encoding of the information on the REACH-IT website (on-line pre-registration) 2. by submission of ‘single’ or a 'bulk' pre-registration prepared separately off-line in a specified computer file format and uploaded at the moment of the pre-registration (recommended for potential registrants of a large number substances). ECHA has released a downloadable XML format for option 2. The XML Format is intended for companies that need to register a large number of phase-in substances and prefer to develop their own tool for creating the XML files. It also offers a toolkit with examples to show how to carry out data submission. Download the Pre-Registration XML Format REACH-IT also provides a function to allow parent companies or head offices to submit preregistration for several legal entities belonging to the same company group (“Super User”) provided that all legal entities are informed by the parent company or head office and have access to the information submitted in the pre-registration. Note; even if this function is used, the pre-registration remains specific for each legal entity.
What if I import / manufacture for the first time after December 2008?
A first-time Manufacturer or Importer is one that manufactures or imports a substance in quantities of 1 tonne or more for the first time after 1 December 2008. To benefit from the phasein period, the first-time manufacturer/importer must pre-register: 1. at the latest 6 months after its manufacturing / import exceeds 1tpa, and 2. no later than 12 months before the relevant deadline for registration.
First-time Manufacturers or Importers will therefore have to submit their pre-registration before 30/11/2009, 31/05/2012 or 31/05/2017, whichever is relevant to their tonnage band.
What happens immediately after pre-registration?
After submission of the pre-registration, each potential registrant will receive: a submission number (used for contact with ECHA) a link to the submission report ( as a PDF file) a pre-registration number, and access to a pre-SIEF webpage for that specific substance After the first pre-registration of a substance, a dedicated webpage (the pre-SIEF) will automatically be created for that substance. On this webpage, which will only be accessible by the substance pre-registrants, details of other pre-registrants and data holders (after 1.1.2009) and registrants of substances regarded as registered will be made available. Page | 6
Step-by-step pre-registering on-line using REACH-IT.
The process as understood today typically takes 20 – 40 minutes to complete all steps • before pre-registration: - you must be signed up to REACH-IT - your user needs to be logged in - your user needs to have at hand all information on the substance/s to pre-register • selects “pre-register a phase-in substance” in the functional menu • A wizard then takes your user through a number of steps (implemented as different tabs) 0. declaration on “phase-in” status will be added (mandatory) 1. identification: mandatory 2. similar substances: optional 3. tonnage/date: mandatory 4. contact: optional 5. representative: optional 6. remarks: optional 7. validation: mandatory 1. identification: type in the name of the substance that you want to pre-register For a (mono-constituent) substance that has an EINECS n°: – your user specifies: • EINECS number or the EINECS name, or • the CAS number, or • the molecular formula. – REACH-IT then retrieves the substance from the EINECS inventory. – your user confirms / selects the substance he wants to pre-register from options given. –additional chemical names cannot be entered. 1. identification: For a (mono-constituent) substance that DOES NOT have an EINECS n°: – your user specifies: • CAS number and name(s), or the chemical name(s). – REACH-IT then checks • the EINECS inventory • all the previously pre-registered substances
– if REACH-IT finds a match, your user confirms whether or not (one of) the presented option(s) is the substance that you want to pre-register. – additional chemical names can be entered to assist substance identification. 1. Identification: For a multi-constituent substance (MCS): Page | 7 – your user enters the name of the first constituent as if it were a mono-constituent substance, – then he clicks “add more constituents” until he has entered all constituents (max.10) of the substance that you want to pre-register. 1. Identification: your user types in the name of the substance you want to pre-register – wild card symbol can be used, so there can be more than one match when retrieving a substance from the EINECS inventory. – EINECS number and CAS number have to be entered in the correct format. – check digit for CAS number is checked. Similar substances: type in the names of the substances suggested for QSAR, grouping or readacross: – using the same mechanism for identifying a substance as in “1. identification” – a large number of similar substances can be accommodated Tonnage: select the envisaged registration deadline and tonnage band from a pick list – tonnage band: 4 options • over 1000 tonnes/year • between 100 and 1000 tonnes/year • between 10 and 100 tonnes/year • between 1 and 10 tonnes/year – envisaged registration deadline: 3 options • 30/11/2010 • 31/05/2013 • 31/05/2018 Contact: type in or select your company contact person for this pre-registration – your user can type in the contact details of a new contact person, or – he can select a previously specified contact person. – a contact person does not automatically have access to the company pages in REACH-IT. If this is needed a user account needs to be created. ] Contact: 3 possible scenarios: – If your user specifies or selects a contact person within the company, his/her contact details will be made available in the pre-SIEF to others pre-registering this substance, unless a third party representative (TPR) is specified or selected. – If a company uses a TPR, the contact details of the TPR will be made available in the pre-SIEF to those pre-registering this same substance. – If no contact person is selected, and no TPR is specified, the company’s general contact details will be made available in the pre-SIEF.
Representative: specify or select a third party representative (TPR) for the pre-registration – your user can type in the UUID (unique user identity) of his TPR. – REACH-IT then checks if this UUID is known to belong to a TPR. – if so, your user can confirm his TPR. Remarks: type in all additional information you want to make available in the pre-SIEF and choose Page | 8 if you want to receive notifications about changes in the pre-SIEF in your internal mailbox Validation: validation of all of the previously entered information – validation is the final step before submission. – your user can review all the information entered in the previous tabs. – if necessary, your user can navigate to different tabs to correct information. After submission: – your user will receive a submission number after validation. – your user will receive a message in his internal mailbox containing: • a link to the submission report (pdf format) and • the pre-registration number. – your user will have access to the pre-SIEF webpage (all users). – your user can view all his pre-registration/s by selecting “view pre-registrations” in the functional menu (all users).
The following table details the substance list for pre-registration as adapted from Annex 1 of the REACH Mn Consortium Agreement. In some cases the EINECS/CAS number is not available. The potential registrant should check that this substance is indeed a phase-in substance as defined in REACH before attempting a pre-registration. Phase-in substance: means a substance that meets at least one of the following criteria: (a) it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS); (b) it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this; (c) it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995 or on 1 May 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this.
Substance name / synonyms 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 manganese iron silicon manganese oxide manganese dioxide (1) trimanganese tetraoxide dimanganese trioxide manganese carbonate, manganese (II) carbonate manganese sulphate (1) manganese dinitrate manganese dichloride manganese bis(dihydrogen phosphate) manganese di(acetate) manganese silicate manganese sulphide zinc manganic oxide lithium manganese oxide lithium manganese phosphate dicalcium silicate (5) slags, ferromanganese-manufg (6) slags, silicomanganese-manufg. (7) sinter ore
Notes: (1) Classified: Annex 1 index# 025-001-00-3 (2) formula as listed in EINECS (3) EINECS (European INventory of Existing Commercial chemical Substances). (4) CAS (Chemical Abstracts Service) (5) in sinter ore? (6) By-product of the manufacture of ferromanganese alloy containing primarily oxides of aluminum, manganese and silicon. (7) By-product of the manufacture of silicomanganese alloy containing oxides of aluminum, calcium, magnesium, manganese and silicon (8) multi constituent substance/MCS of MnO, Mn3O4 and Mn2SiO4
Substance formula(2) Mn Fe Si MnO MnO2 Mn3O4 Page | 9 Mn2O3 CH2O3.Mn H2O4S.Mn HNO3.1/2Mn Cl2Mn H3O4P.1/2Mn C2H4O2.1/2Mn H2O3Si.Mn MnS ZnMn2O4 LiMn2O4 (Li,Mn) PO4 Ca.1/2H4O4Si n/a n/a MCS
EINECS number(3) 231-105-1 231-096-4 231-130-8 215-695-8 215-202-6 215-266-5 215-264-4 209-942-9 232-089-9 233-828-8 231-869-6 242-520-2 211-334-3 231-848-1 242-599-3 n/a n/a n/a 233-107-8 273-728-1 273-733-9 n/a
CAS number(4) 7439-96-5 7439-89-6 7440-21-3 1344-43-0 1313-13-9 1317-35-7 1317-34-6 598-62-9 7785-87-7 10377-66-9 7773-01-5 18718-07-5 638-38-0 7759-00-4 18820-29-6 n/a 12057-17-9 n/a 10034-77-2 69012-28-8 69012-33-5 n/a
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