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.

You will find the RIP text summarized in the Annex.