CONSORTIUM MANAGEMENT

 

Reconsile REACH consortium

Manufacturers of Silanes and Siloxanes have joined efforts for their REACH compliance activities and have launched in July 2008 the Reconsile REACH Consortium. To prepare a consistent REACH registration dossier, the Secretariat of the Reconsile Consortium will be handled by ReachCentrum.

Substances Covered
The substances to be registered according to REACH prescriptions and covered in the Reconsile REACH Consortium are manufactured and/or imported by at least one Reconsile member. The substances to be registered by Reconsile can be found here. This overview is also mentionning the Reconsile registration intentions.

Uses covered(new section)
Reconsile intends to register several substances in early January 2010. The uses identified for these substances are described in the following document.

Risk management measures (new section)
Reconsile intends to register several substances in before dec 1st 2010 deadline. The risk management measures identified for the substances already assessed in the frame of  Chemical Safety assessments to date are described in the table below :
 
 Substance name  CAS number  Risk management measures
 Dichloro(dimethyl)silane  75-78-5  Summary
 Trimethoxysilane  2487-90-3  Summary
 Hexamethyldisilazan  999-97-3  Summary
Silane 7803-62-5 Summary
 
Membership
The Reconsile consortium includes a Steering Committee, a Technical Committee, several task forces (Classification and Labelling, Exposure Scenarios, and Health/Environment Projects) and the Consortium Secretariat managed by ReachCentrum. Reconsile is open to manufacturers/ importers/ non EU manufacturers (provided that they are represented by an Only Representative)  as defined in the REACH Regulation of the substance on its own, in preparations or in articles and that are subject to the registration requirements pursuant to the REACH Regulation, or Affiliates thereof.

Membership is open to any applicant fulfilling the membership criteria. Reconsile is specifically open to:

      • any EU manufacturer Silanes and Siloxanes
      • and non-EU companies manufacturing Silanes and Siloxanes, exporting them to the EU and having appointed an Only Representative, which are similar to one or several of the substances covered.

Downstream users and other data holders are invited to submit to the Consortium any relevant information that can support the Registration dossiers.

Reconsile and SIEF
Reconsile is a Consortium bringing together the interests of producers, importers and data holders of a large number (250+) of substances which each will have their own SIEF. Reconsile members have identified themselves in each SIEF as SIEF Formation Facilitators (SFF) and are proposing to be the respective Lead Registrants for the substances considered. ReachCentrum has agreed to coordinate SIEF activities on behalf of the SFFs.

ECHA has summarised key principles in the operation of SIEFs. Reconsile subscribes to these principles which include the formation of a consortium to provide practical help with SIEF data-sharing obligations and the preparation of registrations.

Reconsile has identified the need to communicate with more than one thousand Legal Entity Contact Points or distinct email addresses, based on pre-SIEF information downloaded from REACH-IT. In order to communicate efficiently with such a large number of contacts and to comply with REACH transparency requirements, all Legal Entities Contact Points will have received during April 2009 individual invitations to register on a dedicated and secured password-protected website: 

If you believe you should have received this invitation and that for any reason the invitation did not reach you, please contact the ReachCentrum secretariat.

Reconsile SIEF Communications Website
The website will provide the following information to Reconsile members as well as to all Legal Entity Contact Points which have pre-registered any of the silanes and siloxanes pre-registered by at least one Reconsile member:

  • Data which either a Reconsile member owns or has a right to reference
  • Substance Identification Profiles
  • Planned studies
  • Classification and labelling information
  • Cost of letters of access
  • End-uses covered by registration dossier

At the beginning not all information may be available. Registered members will have the option to subscribe to certain pages ensuring that they will be automatically notified by email when the relevant website sections are updated.

SIEF Members Status
On registration the users will be requested to mark their status preference for one of the following categories derived from Cefic guidance:

  1. Dormant (the SIEF member does not wish to be actively involved in all SIEF communications)
  2. Passive (the SIEF member is interested only in the final part of the joint registration and does not wish to become an active Reconsile member)
  3. Active (the SIEF member is interested in becoming an active Reconsile member; ReachCentrum will send to this member an information package allowing him to apply for Reconsile membership)

The Leading and Involved organisations which have the resources to become Active are brought together in Reconsile. The default status is Dormant. If the Legal Entity Contact Point wishes to be informed of SIEF activities by email or to apply for membership of the consortium, he should choose of the two other status categories, preferably before 30 April 2009.

Reconsile SIEF Communications Extranet Costs
Registration is free (the cost of this website will be integrated in the future letters of access); no commitments will be requested from the users who can change their preferred status at any time.

Reconsile SIEF Communications Extranet Registration Process
Acceptance of website registration will be conditional on matching the email addresses and the organisational affiliations as in REACH-IT. This implies that the website users will only have access to the data of the substances they have pre-registered.

Once the registration has been accepted, the website user (Legal Entity Contact Point) will be presented with a list of siloxanes and silane substances he or she has pre-registered. By selecting one of these substances by CAS Number, he will open a page which he can use to indicate whether he has data to share. On the same page, he will be able to enter data required to establish sameness with the substance made by Reconsile members.

Sameness – An Introduction
Working through a technical consultant: Peter Fisk Associates Ltd. Reconsile has prepared Substance Identification Profiles (SIPs) which will be used as reference documents to check sameness. The SIPs consist of a non-confidential section open to all registrants and confidential annexes giving company-specific details – these are only available to ReachCentrum and the consultant. Further details about the analytical information required for sameness checking are summarized here.

As the substance sameness check is the last step in converting the Pre-SIEF into the SIEF, all registrants to the Reconsile Extranet are kindly requested to read and execute the 'Sameness Checking Procedure' by checking the box next to the following statement:

'I confirm that the properties of my substance meet the description in the SIP'

Organisations which have been invited to complete the Sameness Checking Procedure but which fail to do so will no become members of the SIEF.

Sameness Checking Procedure

  1. On the Reconsile SIEF Communications Extranet the SIP's for at least the 2010 deadline (Phase 1) substances are available to candidate co-registrants of the relevant substances.
  2. The candidate co-registrant must check the SIP and compare the specifications of its substances with the SIP. It will conclude whether its specifications are in line with the SIP.
  3. In case the candidate co-registrant concludes that is own substance specifications are within the SIP, he must indicate in the Reconsile Extranet that its substance meets the specifications as described in the SIP by checking the appropriate tick box.
  4. Closing time for the SIP confirmation is 30 November 2009.

Communications between SIEF members
The website will provide to the users the ability to communicate with other SIEF members and to receive emails addressed by ReachCentrum or by SIEF Formation Facilitators.

Lead Registrant Agreement
REACH requires that SIEF members formally agree to a Lead Registrant. The website will present to each SIEF member the following options:

    • Accepting Reconsile’s proposal
    • Abstaining
    • Selecting an alternative Lead Registrant among the other SIEF member organisations

The Reconsile Lead Registrant Agreement process ended on 31 August 2009. The Lead Registrant Agreement process may continue on a substance by substance basis until the process is closed a reasonable time prior to the intended Registration of the substance. As long as the Agreement process is on-going, the acting Lead Registrant will either be the organisation proposed by Reconsile, or the organisation having obtained the majority of the votes expressed. SIEF members will be informed of the outcome of the polling process.

Inquiries and lifetime of the SIEF Communications website
Other inquiries to the SFFs should be made to ReachCentrum at the address provided below. Reconsile intends to maintain this website during the time of its existence or of completion of Phase 3 registrations. All data entered in this website will be archived electronically and will be available as evidence of compliance from the part of respective SIEF members to the prescriptions of REACH.
Please visit: Reconsile SIEF Communications Website

Substances handled by Reconsile and other substances belonging to the same categories
Most of the 250+ substances handled by Reconsile belong to the following categories:

  • monoalkoxysilanes
  • dialkoxysilanes
  • trialkoxysilanes
  • tetraalkoxysilanes
  • monochlorosilanes
  • dichlorosilanes
  • trichlorosilanes
  • tetrachlorosilane
  • linear siloxanes
  • cyclic siloxanes

  • Should a legal entity intend to register a substance belonging to one of these categories, but not handled by Reconsile, it may be in its interest to contact the Reconsile Consortium secretariat to exchange information leading to the avoidance of unnecessary testing.

    Disclaimer
    The Reconsile SIEF Communications website is owned by the individual members of the Reconsile consortium, whose scope covers Silane and Siloxanes. It is provided as a free (*) service to Legal Entity Contact Points (LECPs) who wish to verify whether their substances which have been pre-registered in REACH-IT are the same than those pre-registered by Reconsile members pursuant to the REACH regulation, and in the event that the substances are the same, are interested in receiving general information on the Reconsile consortium's work in preparing the substance registration dossiers. The initial object of the website is to support the formation of the respective SIEFs as required by the REACH legislation.

    The information submitted by the LECPs will be treated in confidence by ReachCentrum and its subcontractors except information which:

        • is available by downloading from REACH-IT, or
        • is or becomes part of the public domain, or
        • ReachCentrum can sufficiently demonstrate that it was known to it prior to the disclosure, or
        • rightfully received by ReachCentrum without restriction from a third party which lawfully acquired the information.

    The submission of information to this website does not imply tacitly or otherwise membership of the Reconsile consortium or automatic access to registration dossiers. These are subject to their own respective conditions in accordance with REACH regulation and ECHA guidance.

    This voluntary tool has been designed using the best knowledge currently available, and is to be relied upon at the user’s own risk. The tool is provided in good faith and no representations or warranties are made with regards to the completeness and no liability will be accepted for damages of any nature whatsoever resulting from the use or reliance on this tool.

    (*) The members of the Reconsile consortium retain the right of recovering the cost of developing and managing this website and of the sameness process by way of charging new Reconsile members for historical costs and of registration dossier access costs.


    Interesting links
    REACH silicones- CES - Centre Européen des Silicones / European Silicone Center (Cefic Sector Group)
    Cefic

     

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