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 mentioning the Reconsile registration intentions. 

The Reconsile consortium includes a Steering Committee, a Technical Committee, several task forces (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 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, Reconsile will use LINKinSIEF as communication platform from April 1, 2011 onwards. LINKinSIEF is a dedicated and secured password-protected website. All SIEF members will receive the invitation to sign-up.

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.

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.

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.

Cost

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.

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 by clicking on "Reconsile Analytical Characterization and Substance Identification profile".

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.

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.

Introduction

It is very important to remember that apart from the submission itself, the analytical characterization information is important in order to ensure:

• Valid sharing of studies from different companies, as far as reasonably practicable.
• Proof of pre-SIEF Consortium arrangements and for the SIEF itself, include non-Reconsile ‘joiners’.
• Development of a generic description of the substance that covers all suppliers non-confidentially.

From information already submitted it is known that almost all the Phase 1 substances are mono-constituent and of high purity. Therefore there will no need to compare commercial products on the basis of properties, e.g. physicochemical, but only on analytical chemistry.

Consortium needs

For consortium purposes, ReachCentrum proposes to term such a description as the Substance Identification Profile (SIP). The Consortium Agreement includes an Annex with a clear overview of the commercial products covered by the consortium that contains sufficient generic substance identification data to evaluate what is covered and what not.

This web-based questionnaire is designed to support a clear process to facilitate the sameness checking between consortium members and other potential Registrants in the SIEF who were not consortium members during the pre-SIEF phase.

The Substance Identification Profile is a pragmatic approach for the sameness check routine for the consortium which contains sufficient information to identify the substance that will be registered, and a verification routine if it is necessary to verify if an individual product indeed fulfils the substance identification profile.

By this method, the member of the consortium intends taking a leading role during the pre-SIEF and make sure that its consortium activities will be aligned with the SIEF afterwards.

Development of SIP

Peter Fisk Associates will review the analytical data submitted by each SIEF member contact point for the Phase 1, 2 and 3 substances, and draw up a generic non-confidential description of each substance that encompasses the specification of each member’s present product(s), in other words, an “industry-wide specification” for each substance. Major impurities may differ but this will probably not be an issue unless the impurities include substances of very high concern at >0.1%, or have other hazardous properties (e.g. sensitization) and are present in sufficient amounts to contribute to the classification and labelling of the product.

The SIP will contain:

• Name
• CAS Number
• EC number
• % range of major constituent, made to be wider than the minimum for flexibility
• A description of other constituents if any, as well as their respective concentrations range
• Listing of any impurities common to all suppliers
• Listing of possible sVHC impurities noting the importance of the 0.1% cut-off
• Listing of other impurities that may contribute to the classification and labelling of the substance
• Description of the general structural types of impurities so as to demonstrate that they are not significant. The specific impurities for each supplier will not be named in any shared report.

This sameness checking process preferably is identical to the sameness checking process needed for current and Reconsile Members to work on the same registration dossier, as well as to check if data can be used.

A supplier whose substance does not fit the SIP is not excluded – they could use the substance data for their material, with appropriate interpretation.

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.

1. Analytical characterisation to confirm substance identity (from the REACH guidance)

When a registration is required under REACH it shall include information on the identification of the substance as specified in item 2 of Annex VI (see table 1). This information shall be adequate to enable each substance to be identified sufficiently. A “mono-constituent” substance (one constituent > 80%) is completely identified by its chemical composition, the chemical identity and the content of each constituent in the substance (identification parameters). If it is not technically possible, or if it does not appear scientifically necessary, to give information on one or more of the substance identification parameters, the reasons shall be clearly stated.
The analytical characterisation should on this basis confirm the identity of the substance, by defining its chemical composition.

Table 1 : Substance identification parameters in REACH Annex VI item 2 :

The analytical characterisation should help to feed the section 2.3 of this REACH Annex VI.

2. To which extent should we characterise the substance? (from RIP 3.10)

• The analytical characterisation should help to determine the nature and the purity of well defined substances.
• Normally, impurities present in a concentration 1% should be specified. However, impurities that are relevant for the classification and/or for PBT assessment5 shall always be specified.
• Additives should be completely specified in a similar way to that described for well defined substances.
• As a general rule, the compositional information should be completed up to 100%.

3. What analytical  Information  should be developed and reported ? ?(from RIP 3.10)

• Sufficient spectral data are needed to confirm the structure given for a mono-constituent substance or to confirm that a reaction mixture is not a preparation.
• Spectroscopic methods see below.
• Chromatographic methods, such as Gas Chromatography (GC) or High-Performance Liquid Chromatography (HPLC) is needed to confirm the composition of the substance. An appropriate chromatogram will confirm the existence of impurities, additives and the constituents of a reaction mixture.
• If appropriate, also other valid constituent separation techniques may be used. Spectroscopic and analytical methods are subject to continuous change. Therefore, it is the responsibility of the registrant to present appropriate spectral and analytical data.
• REACH requires the registrant to describe the analytical methods and/or to provide the bibliographical references for the methods used for identification of the substance and, where appropriate, for the identification of impurities and additives. This information should be sufficient to allow the methods to be reproduced.

4. Suggestion agreed at the Reconsile level during REACH TF meeting of the 22 November 2007

I. Each member should characterise a substance sample which is representative of a commercial grade. This sample would contain a reasonable level of impurities which would be representative of this commercial grade. Should different grades / sources exist, the chemical composition of the substance would be documented in the registration dossier in such a way that the impurities ranges would include these other grades. Should some impurities impact the classification of the substance, different chemical compositions will be entered in IUCLID 5, and different classifications and labelling will be associated with these chemical compositions.

II. Based on REACH analytical requirements, suggestion is to go for :

    ?    NMR ( 29Si , 13C, 1H )
    ?    GC-MS
    ?    DSC/TGA IR spectra would not bring additional information to the NMR and GC-MS data and UV-Vis would most of the time not be needed for Si based materials. A simple expert statement would be enough.

III. GLP is not required for the analytical characterisation

IV. Impurities should be identified if  > or = to 1%??V. SVHC impurities should be identified if > or = 0.1%

It is the responsibility of each company to select the right testing methods and operating conditions to test their substances. The only information that would be shared at the Reconsile level (via PFA) is the purity of the substance, and if necessary impurities names and quantities.

1. Once a SIP is finalized by the Reconsile members, the SIP will be posted on LINKinSIEF.
   All pre-registrants will be automatically informed about the posting of a specific SIP and will be invited to complete the sameness survey.
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 its own substance specifications are within the SIP, he must indicate via LINKinSIEF that its substnace meets the specifications as described in the SIP by responding to the questions in an appropriate way.
4. Closing time for the SIP confirmation is defined per SIP survey.

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.

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

For the 2010 substance, 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.

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.

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.

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.

CES - Centre Européen des Silicones / European Silicone Center (Cefic Sector Group)
Cefic

[email protected]

6, avenue E van Nieuwenhuyse
1160 Brussels
Belgium