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REACH PRE REGISTRATION GUIDANCE

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REACH PRE REGISTRATION GUIDANCE Powered By Docstoc
					R E A C H                 M a n g a n e s e                          C on s or t i u m




                                              REACH

      Pre-registration Guidance Document


                                             March 2008




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.




                                 Member Confidential/kh/0308/027/final
                                                                                                            Page | 2




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
Overview
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. Pre-
registration 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 pre-
  registration 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.                                   Page | 5

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 pre-
 registration 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 phase-
in 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)                                      Page | 6
              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.

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):
         – your user enters the name of the first constituent as if it were a mono-constituent      Page | 7
            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 read-
across:
        – 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
if you want to receive notifications about changes in the pre-SIEF in your internal mailbox       Page | 8

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).




Substance List

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 /                                            Substance      EINECS       CAS
                                           synonyms                                                 formula(2)    number(3)   number(4)
1    manganese                                                                                   Mn               231-105-1   7439-96-5
2    iron                                                                                        Fe               231-096-4   7439-89-6
3    silicon                                                                                     Si               231-130-8   7440-21-3
4    manganese oxide                                                                             MnO              215-695-8   1344-43-0
5    manganese dioxide (1)                                                                       MnO2             215-202-6   1313-13-9
                                                                                                                                           Page | 9
6    trimanganese tetraoxide                                                                     Mn3O4 Page | 9   215-266-5   1317-35-7
7    dimanganese trioxide                                                                        Mn2O3            215-264-4   1317-34-6
8    manganese carbonate, manganese (II) carbonate                                               CH2O3.Mn         209-942-9   598-62-9
9    manganese sulphate (1)                                                                      H2O4S.Mn         232-089-9   7785-87-7
10   manganese dinitrate                                                                         HNO3.1/2Mn       233-828-8   10377-66-9
11   manganese dichloride                                                                        Cl2Mn            231-869-6   7773-01-5
12   manganese bis(dihydrogen phosphate)                                                         H3O4P.1/2Mn      242-520-2   18718-07-5
13   manganese di(acetate)                                                                       C2H4O2.1/2Mn     211-334-3   638-38-0
14   manganese silicate                                                                          H2O3Si.Mn        231-848-1   7759-00-4
15   manganese sulphide                                                                          MnS              242-599-3   18820-29-6
16   zinc manganic oxide                                                                         ZnMn2O4             n/a          n/a
17   lithium manganese oxide                                                                     LiMn2O4             n/a      12057-17-9
18   lithium manganese phosphate                                                                 (Li,Mn) PO4         n/a          n/a
19   dicalcium silicate (5)                                                                      Ca.1/2H4O4Si     233-107-8   10034-77-2
20   slags, ferromanganese-manufg (6)                                                                    n/a      273-728-1   69012-28-8
21   slags, silicomanganese-manufg. (7)                                                                  n/a      273-733-9   69012-33-5
22   sinter ore                                                                                  MCS                 n/a          n/a
     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

				
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