Introduction
The Regulation (EC) No 1907/2006 of the European Parliament and of the Council of December 18, 2006 (EU-REGULATION) on the Registration,
Evaluation and Authorization of Chemicals (REACH) requires manufacturers and/or importers of chemicals and/or materials containing such
chemicals to pre-register and register those at the European Chemicals Agency/Helsinki (ECHA) within the deadlines and according to a procedure
prescribed in the EU-REGULATION.
© SASFORREACH Consortium GbR 2012
News
2024-08-13 / CS / CS dossier update completed
A Second set of nanoforms was included and the uses were updated. ECHA has accepted the dossier update; the completeness check has ensured
that all the necessary required elements have been provided. Details see updated Information Letter 2.
2024-08-10 / SAS / Silicon Dioxide / CLH classification - consultation closed
A position paper was submitted from ASASP and SASFORREACH to ECHA on August 8, 2024. Click here to visit the ASASP website
Registry of CLH intentions until outcome - ECHA (europa.eu) where you can download the policy paper.
2024-07-10 / SAS / SAS dossier update completed
ECHA has accepted the dossier update; the completeness check has ensured that all the necessary required elements have been provided.
2024-07-09 / SAS / Presentation from the ASASP Downstream Users Forum meeting
ASASP strategy on Silicon Dioxide ongoing CLH process
2024-06-17 / SAS / SAS dossier update rejected
ECHA has rejected the dossier update regarding the boundary composition of Set 2A. The lead registrant will review ECHA's comment from a scientific
and legal point of view and inform the co-registrants about the further development.
2024-06-10 / SAS / Silicon Dioxide CLH classification - consultation is open
Today the public consultation for Silicon Dioxide (EC / List no: 231-545-4 CAS no: 7631-86-9) (also called Synthetic Amorphous Silica (SAS)) has been
opened. The dossier has been submitted to ECHA by the Dutch National Institute for Public Health and the Environment (RIVM), proposing a
harmonised classification (CLH) for solid forms of Silicon Dioxide as STOT RE 1 by inhalation, (H372).
The public consultation on this proposal will run from June 10 until August 9, 2024. Click here to visit the ECHA website for more information: Registry
of CLH intentions until outcome - ECHA (europa.eu).
SAS is safe in all its applications and therefore ASASP (the Association of Synthetic Amorphous Silica Producers) and SASFORREACH do not agree
with the classification proposed by the Dutch competent authority. ASASP and SASFORREACH will contribute to the public consultation with robust
data and scientific arguments, validated by independent experts.
ASASP and SASFORREACH encourage SAS registrants and SAS downstream users to also send comments during the public consultation period.
2024-04-02 / SAS / New Information Letter 10 - Dossier update 2024
2023-11-14 / SAS / New Information Letter 9 - request for information on boundary compositions
2023-06-22 / SAS / Notification of a final decision on a compliance check under Regulation (EC) 1907/2006.
The Consortium is working on the dossier to submit the information needed to bring the registration of the Sets of Nanoforms ("synthetic amorphous
silica, nanostructured material_Set 1" and "synthetic amorphous silica, nanostructured material Set 2") into compliance with the information
requirements by the deadline of 2 April 2024.
We presume that co-registrants who are addressed by the final decision were also informed by ECHA directly on 22 June 2023. The Consortium is
currently updating the boundary composition in the light of ECHA´s decisions and will publish these information here on the webpage. In case that any
co-registrants find out later that their boundary compositions do not fit within the ranges defined in the joint submission, the data can be updated
accordingly, provided, however, that these registrants have provided a sufficient justification why their respective boundary composition should be
included in the respective set because the risk profile of their form is comparable to the risk profile of the set as defined by the Consortium. In this case,
the requesting company may be requested to provide the necessary data to expand the boundary composition at their own expense.
2023-06-21 / SAS / NAS / CS / AS1 / AS2 / Request for information regarding EU Sanctions
On June 21, 2023, the Consortium has requested information regarding the implementation of EU Sanctions to be provided by all co-
registrants of SAS, cf. below.
Dear Co-Registrant of Synthetic Amorphous Silica (SAS) EC 231-545-4,
due to the EU sanctions against Russia and other countries the SASFORREACH Consortium ("Consortium") is required to verify whether a registrant is
a Designated Person as defined inter alia in Art. 2 Council Regulation (EU) No 269/2014, as last amended, or an affiliate of, or otherwise associated
person with, any such person.
Therefore, each co-registrant must
i.
confirm that the existing contract (name and UUID of each contract partner) with the SASFORREACH Consortium is still
applicable as signed, and
ii.
provide the requested data in the new form which is published on the webpage
https://www.reach-sas.org/how%20to%20register.htm (see Step 3)
Please note that without this information, the Consortium will not be able to carry out any communication & dossier updates going forward. Therefore,
the lead registrant will have to inform ECHA of any registrants who have not provided the requested information for verification on or prior to
August 30, 2023
ECHA will then take a decision on whether further communication with such co-registrants is permissible. Failure to provide the requested information
means in particular that the Consortium will no longer be able to provide economic resources (e.g. data sharing, dossier updates) to such co-
registrants. It should be stressed, however, that the Consortium has no powers to decide on any sanctions against such co-registrants like, e.g., a
suspension or revocation of a registration as such decisions are solely to be made by ECHA and/or the national competent authorities.
In this context, we would like to make you aware of a few other issues which have come up in our communication with co-registrants in connection with
the EU Sanctions review process. Please note that
1.
as stated in the questionnaire, where an only representative ("OR") is acting as an independent service provider, the requested
information needs to be provided in relation to both the OR and its client separately.
2.
all information provided by you will be treated confidentially, i.e., this information will only be available to (i) the Consortium manager, (ii) the
external service provider engaged by the Consortium for conducting the compliance checks electronically, and (iii) the legal advisors of the
Consortium, but not to any members of the Consortium or any co-registrants. This applies in particular in relation to any personal data which are
subject to protection under applicable data privacy laws. Please note that all of the aforementioned persons or entities are under confidentiality
obligations vis-à-vis the Consortium with regard to the information and data made available to them.
3.
Any kind of confirmation or compliance statements issued by a co-registrant, his parent company, OR or other third party on behalf of the co-
registrant will not be sufficient to comply with the diligence requirements imposed on the Consortium under the EU Sanctions regime and can
therefore not replace the information requested in the questionnaire.
4.
companies which are listed on a stock exchange mostly do not have any controlling shareholders. In this case, i.e., where the co-registrant or its
ultimate parent is a listed company, it is sufficient to provide a link to the webpage of the listed company which provides information on the
current shareholding structure of the listed company. In many jurisdictions such information must be provided under applicable securities laws.
5.
in light of the complexity of the review process and the amount of information which needs to be processed it is not possible to have individual
correspondence with a particular co-registrant. The requested information will be processed electronically and results will only be reviewed
manually in case the IT-based check indicates a concern.
6.
Co-registrants who already sent the form and were cleared do not need to send the form again; Only Representatives (OR) who have been
cleared must only provide the data regarding their client(s) which were not cleared yet.
2023-04-21 / SAS / Amended Draft Decision SAS
The Consortium will not comment the amended draft decision due to the fact that targeted registrants only at this stage in the process are invited to
comment on the suggested wording from the member state (Germany) and all other sections of the draft decision are closed for commenting.
2023-04-21 / SAS / NAS / CS / AS1 / AS2 / EU Sanctions - update
The Consortium will start in Q2/2023 with the check of each registrant (SAS will contact the registrants by email, REACH IT address):
•
registrants who fall under the sanctions will be reported to ECHA;
•
due to the high number of registrants no communication is possible during this process, in consequence incomplete forms = not verified
registrants will be reported to ECHA
•
OR changes which were not reported to the Consortium and has no legal contract with the Consortium will reported to ECHA
•
in expectation that some registrants will not respond and the dossier must be updated only verified registrants will be supported after a dossier
update to be fair to those registrants which respond in a correct way;
•
after a recalculation of the LoA cost no reimbursement is possible to unverified registrants
2023-03-28 / SAS / SAS / DECISION ON A COMPLIANCE CHECK OF A SET OF NANOFORMS
The SASFORREACH Consortium will soon publish new information about the draft decision here. Due to the EU sanctions regulations, no direct
communication with co-registrants is permitted for the time being as long as not all co-registrants have been cleared against EU sanction lists. The
Consortium therefore recommends that you check this website regularly for news in relation to all matters in connection with the joint registration
dossier of SAS.
2023-02-15 / SAS / NAS / CS / AS1 / AS2 / Compliance with REACH and EU sanctions against Russia
The SASFORREACH Consortium needs to implement certain administrative procedures to ensure compliance with the EU sanctions against Russia
and other countries. In the context of the REACH regulation the Consortium is obliged to investigate each co-registrant before selling a Letter of Access
or filing an update to the joint registration dossier. Co-registrants are expected to cooperate in this process by providing requested information in a
timely manner. This will lead to substantial additional administrative work which results in additional administrative costs and may also cause delays for
updates of the dossier.
The Consortium will continue to inform co-registrants about the status of each change in the registration process of the covered substances by
SASFORREACH.
2022-12-20 / SAS / Recalculation LoA cost
The SASFORREACH Consortium had originally planned to do the recalculation after the finalization of the substance evaluation. However, before this
work was finished the eMCA announced their intension to provide a classification and labelling proposal and ECHA started a dossier evaluation in
parallel. As both of these procedures are extremely labor-intensive and various new studies and expert statements are required to comply with the new
information requirements, the Consortium decided to postpone the re-calculation to include these new workstreams as well. The Consortium is
confident that after these procedures have been completed, SAS will get in more calm waters and the required workload to counter the actions of the
authorities will be substantially reduced. A recalculation will be prepared at such time.
2022-11-28 / SAS / Cost Sharing Memorandum
In an effort to provide maximum transparency on cost sharing issues, the Consortium has asked its legal advisors to prepare a document which
addresses certain issues in relation to the cost sharing formula applied by the Consortium. Copies of this memorandum may be obtained upon request
from the manager of the Consortium at sasforreach@sasforreach.eu.
2022-11-17 / SAS / Lead Dossier update / Action required from registrants
On November 17, 2022 all registrants of SAS EC 231-545-4 received an email via their REACH IT contact with information about the update of the
dossier which requires action from the joint submission members, for details see also INFORMATION LETTER 8.
2022-11-04 / SAS / Lead dossier update on new boundary composition of bulk (non-nano) synthetic amorphous silica (SAS)
On October 18, 2022 the lead registrant Evonik submitted on behalf of the joint submission an update of the joint registration. The update introduced
the NEW boundary composition for a BULK form of SAS. This submission now establishes the registration of both forms BULK and NANO and thus all
registrants must check if their SAS registration is referring to either NANO, BULK or both SAS forms. In case of NANO, the registrants need to up-date
the individual company information and refer to the boundary composition of the NANO form(s). If a registrant defines its SAS as BULK, also the link to
the new established BULK boundary composition is needed and the registration must link to the established BULK submission. In both cases actions
from all registrants is needed unless the registrants has already linked its dossier to the NANO form. Please be aware that any registration dossier
without individual opt-out data before the submission dated October 18th, 2022 only is only linked to the NANO form, even you have not done your
required NANO form update.
No additional costs would be incurred for the time being if existing registrants chose either the BULK or the NANO form, but also no reimbursement will
be granted if registrants chose the BULK. Registrants of the BULK form may need to contribute to the costs of the dossier generation and additional
studies which are done on BULK SAS to fulfill their registration obligations. This information will be available once the process is completed and
registrants have communicated their intention to register one or more specific set(s) of the NANO form, the BULK form, or both to the Consortium.
According to Annex VI of the REACH Regulation, a "nanoform" is a form of a natural or manufactured substance containing particles, in an unbound
state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external
dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or
more external dimensions below 1 nm. The concepts and terms used for nanoform in this guidance follow the concepts and terms used in the
European Commission's recommendation on definition of nanomaterial as outlined and explained in the Joint Research Centre (JRC) Report 'An
overview of concepts and terms used in the European Commission's definition of nanomaterial' (Please see Appendix for nanoforms applicable to the
Guidance on Registration and Substance Identification. Version 2.0 - January 2022).
2022-10-10 / SAS / Dossier update
The registration update which had been filed in May 2022 was deemed incomplete by ECHA.
ECHA requested an update of the endpoint study records of Sections 5.1.2 Hydrolysis and 5.4.1 Adsorption/desorption for the line item "boundary
composition synthetic amorphous silicon dioxide, nanostructured material_Set 1".
ECHA also requested an update of the endpoint study records of Sections 5.1.2 Hydrolysis, 5.4.1 Adsorption/desorption and 5.2.1 Biodegradation in
water for the line item "boundary composition synthetic amorphous silicon dioxide, nanostructured material_surface treated_Set 2".
All of the above deficiencies identified by ECHA were subsequently corrected and on September 29, 2022, ECHA confirmed the completeness of the
dossier update.
2022-10-09 / SAS / Feedback to ECHA on the DRAFT Decision
On October 4, 2022 the lead registrant Evonik submitted on behalf of all recipients of the Draft Decisions (20 June 2022) further clarifications on the
statements made within the commenting phase on Set 1 and Set 2 by Evonik demanded by ECHA dated Sept. 5th, 2022, to several registrants of Set 1
and Set 2.
2022-08-23 / SAS / Licensing opportunity for studies owned by the SASFORREACH Consortium
The SASFORREACH Consortium has in recent years conducted various studies in support of the registration of SAS. These studies were financed by
the SASFORREACH Consortium; 50% of the costs of these studies have been included in the cost sharing mechanism for REACH purposes. These
studies may also be useful for purposes (including, but not limited to, regulatory purposes) other than REACH in the EU and in other jurisdictions
worldwide (e.g., in Korea, Turkey, etc.). The Consortium has therefore decided to offer all registrants of SAS the opportunity to acquire a worldwide,
perpetual, transferable license (not: co-ownership) to all or part of these studies against payment of a total of 50% of the cost of these studies. This
license is for any use other than EU-REACH (which will remain with the Consortium). A list of the studies and the consideration for each of these is
available from the manager of the Consortium at sasforreach@sasforreach.eu. In case more than one licensee is interested, the 50% cost share will be
shared equally among all co-licensees. Therefore, information on the license fee to be paid by each licensee will only be available in October 2022 at
the earliest. Various members of the SASFORREACH Consortium have already indicated an interest in acquiring a license to various studies. Co-
Registrants are also given the opportunity to express their interest in obtaining a license, expressions of interest must be received by the manager of
the Consortium at sasforreach@sasforreach.eu by September 30, 2022 at the latest.
2022-08-11 / SAS / LoA COST UPDATE 12 years rule - 2022
The SASFORREACH Consortium is currently recalculating the LoA costs to comply with the "12-year rule" in Art. 25 para. 3 REACH. The result of this
recalculation is expected in Q4 2022.
The SAS dossier was submitted to ECHA for the first time on 22.01.2009. As a consequence hereof, new registrants of SAS after 22.01.2021 only have
to pay for those studies that have not yet exceeded the 12-year limit, except for all administrative costs, which are still to be paid by each registrant in
full on a pro rata basis. This means that:
•
Registrants who bought a LoA on or before 22.01.2021 have to bear the costs of all studies which were originally contained in the joint
registration from 2009 as well as those added during subsequent up-dates.
•
Registrants who bought a LoA after 22.01.2021 will receive a cost report and a partial refund after the recalculation of the LoA costs has been
completed.
The recalculation based on the outcome of the ongoing dossier evaluation process is still not finalized due to the pending decision; the Consortium
expects the decision to be issued by ECHA later this year.
2021-09-02 / SAS / Substance Evaluation for Synthetic Amorphous Silica concluded
On August 26, 2021 the European Chemicals Agency (ECHA) published on its website the substance evaluation conclusion and evaluation report by
the evaluating member state The Netherlands. With this report the procedure that started in 2012 is finally completed. REACH foresees several
potential follow up measures, of which the Netherlands proposed the following:
•
Harmonised Classification and Labelling
•
Other EU-wide measures
The Dutch competent authority intends to propose a harmonized classification as STOT RE 1 for either all SAS production routes or for pyrogenic SAS
only (this is currently unclear due to inconsistencies in the conclusion) and to potentially follow this up with an Occupational Exposure Limit proposal.
The SASFORREACH consortium will evaluate the conclusion in the upcoming weeks in detail and - if applicable - will communicate relevant measures
via its website and/or via REACH-IT. Please make sure that your contact details in REACHT-IT are always up to date.
2021-04-13 / SAS / Information from the Lead Registrant about the recently performed dossier update was sent to all registrants via
their REACH IT contact details
2021-01-31 / SAS / Update on dossier update for SAS in relation to information on nanomaterials: On December 21, 2020, the Lead
registrant Evonik updated the joint registration dossier for SAS with the additional information on nanomaterials after ECHA has rejected two previous
updates because of format errors in the IUCLID dossier. ECHA confirmed the completeness of the latest update on December 22, 2020.
Action is required for the registrants of:
SAS (nano) = update needed (see email to all registrants from Dec 2019)
SAS non nano = opt out needed (see FAQ 3.5)
SAS Bulk form = opt out needed (see FAQ 3.5)
If any action is required the registrants will be always contacted directly via their REACH IT contact!
2020-09-21 / SAS / NAS / CS / AS1 / AS2 / BREXIT - OR CHANGE: any OR change must be notified to the Consortium because due to the legal
entity change a new contract must be signed with the new OR. The contract covers the OR change and includes a Letter of Access (LoA) for the new
OR; the agreement has to be signed by all parties, i.e., the old and the new OR and the Consortium; after payment of an administration fee the new
LoA will be issued. Please note that if the OR change is not documented properly the new OR has no valid Letter of Access from the SASFORREACH
Consortium with all consequences (no support, no right to refer to the studies in the joint submission, no legal documentation for checks by competent
authorities)!
2020-03-10 / SAS / Submission of data for lead dossier: The lead registrant submitted the updated lead dossier in due time. The dossier was in
compliance with the technical rules of ECHA and passed the technical completeness check. However, ECHA in addition added a second level of
surveillance to all nano dossiers, i.e., the so-called manual completeness check for which the rules were unknown at the time of submission.
Meanwhile ECHA provides additional information on their expectations through different channels which are, however, not easy to understand and
intensive work is required to meet these extended requests. ECHA has set the deadline to complete the update for May 16, 2020. Furthermore, ECHA
informed in a webinar that co-registrants may update their dossier at any time before the lead registrant has done so, however, they need to be aware
that the boundary composition of their update may interfere with the one presented by the lead registrant later on, if there has been no proper
communication from the co-registrants to the lead registrant via the consortium manager prior to any submission. In such a case the co-registrant has
either to correct its update or to file a full opt-out registration since, according to ECHA, partial opt-outs are legally not feasible for sets of nanoforms.
2020-02-24 / SAS / ECHA Webinar "Registering nanoforms: practical advice
We would like to draw your attention to the upcoming ECHA Webinar "Registering nanoforms: practical advice". The webinar will take place on 24th
February at 12:00 pm Northern Europe Time. All information as well as the registration form can be found on the ECHA homepage
The registration of nanoforms is mandatory since 1st January 2020. However, updating the registration dossiers with the new IUCLID version 6.4
turned out more complicated and many dossier updates were rejected by the technical or manual completeness check. Therefore, this webinar is a
welcome opportunity to directly address your specific problems to the ECHA experts.
2020-01-30 / SAS / Update on dossier update for SAS in relation to information on nanomaterials: On December 17, 2019, the Lead
Registrant Evonik updated the joint registration dossier for SAS with the additional information on nanomaterials which is required to be submitted by
January 1, 2020 („Nano Information“) pursuant to Commission Regulation (EU) 2018/1881. On January 17, 2020, ECHA informed the Lead Registrant
that the Nano Information submitted by the Lead Registrant for SAS did not pass a manual completeness check. ECHA has therefore invited the Lead
Registrant to discuss the way forward with regard to the submission of the Nano Information. The Consortium will inform Co-Registrants about the
outcome of the discussions with ECHA on Nano Information in due course.
In this context, it is important to note that even if the Nano Information provided in the joint registration dossier passes the completeness check, this
does not mean that ECHA may not require additional information (regardless of whether such information is Nano-Information or other information) in
connection with a compliance check pursuant to Art. 41 REACH or a substance evaluation pursuant to Art. 43 et seq. REACH.
2020-01-15 / SAS / Dossier update SAS-nano / additional cost: The lead registrant has updated the SAS dossier for the first time in December
2019 to include the information requirements of Commission Regulation (EU) 2018/1881 of 3 December 2018 amending regulation (EC) 1907/2006
(REACH) Annexes I, III, VI, VII, VIII, IX, X, XI, XII to address nanoforms of SAS.
Co-Registrants have received the joint CSR and an i6z-file including Section 1.2 with all relevant information regarding boundary compositions. Please
check your REACH-IT account to which this information was sent by e-mail. Additional updates to include further sets of nanoforms into the boundary
composition are planned for 2020 and 2021. All information on nanoforms received from co-registrants is currently being evaluated by the trustee of the
SASFORREACH Consortium GbR to ensure compliance with applicable antitrust law and will be integrated into the SAS dossier in due course.
The updated guidance for registering substances in nanoform has been published by ECHA on December 3, 2019, however, it is currently still unclear
what additional information requirements will ultimately result from the REACH Annex amendments. Therefore, the Consortium is currently not in a
position to make any estimations on the additional costs to be shared among co-registrants of SAS resulting from such update(s).
Please bear in mind that the update of the nanoform-related information in the SAS dossier has only just begun and that this work also has to be
combined and coordinated with the ongoing substance evaluation process. Please note that the costs incurred by the SASFORREACH Consortium
GbR for both processes will be included in the recalculation of the LoA costs.
2019-07-15 / SAS / Dossier update SAS: The lead registrant Evonik Degussa GmbH has updated the SAS dossier as required by the Board of
Appeal decision. This update does not include the requirements of Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation
(EC) No 1907/2006 (REACH) Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances. Therefore, also the substance identity
profile remains unchanged. The SASFORREACH Consortium GbR has however, included assessment entities and boundary compositions for bulk
(non-nano) silicon dioxide, non-surface treated, and for SAS silanized. The latter includes all materials used in (eco-) toxicological and physico-
chemical studies that have been used for this update. For the time being this specific assessment entity for surface treated silicon dioxide does NOT
exclude other surface treatments because this will only be covered by Regulation (EU) 2018/1881 which applies from January 2020.
The update is also not complete regarding the requested study because final data and reporting from the toxicological institute are not available yet.
The lead registrant has communicated this to ECHA as well as to the evaluating member state. A second update including all study data will be made
by October 31, 2019. Both ECHA and the evaluating member state have confirmed not to take any enforcement actions until then.
For co-registrants no specific actions arise from this update of the joint part of the registration. The lead registrant will inform you directly via your
REACH-IT contact regarding the next steps. Please keep in mind, however, to keep your company specific part up to date.
2019-01-08 / SAS / Dossier update SAS: The SASFORREACH Consortium GbR is in the process of preparing two updates of the SAS dossier as
required by (i) the Board of Appeal decision (which will be implemented by July 2019) and (ii) by the Commission Regulation (EU) 2018/1881 of 3
December 2018 amending Regulation (EC) No 1907/2006 (REACH) Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances
[so called new REACH Annexes] (which will be implemented by January 2020). After finalization of the update the members of the joint submission will
be informed via the consortium webpage or by e-mail. In the meantime, should your substance meet the substance identification profile ("SIP") criteria
as described on the webpage / in the SIEF Information letter, please follow the short guidance for new registrations. Changes in the SIP and/or the
registration procedure, if any, will be published after finalization of the evaluation process.
Furthermore, please note that neither particle size (i.e., neither the size of the aggregates nor the size of the constituent particles) nor any BET values
are currently part of the SIP and, therefore, currently are not used for inclusion or exclusion from the dossier. ECHA is currently working with several
stakeholders to develop guidance documents related to the REACH annexes requirements on nanoforms of substances. As soon as these updates are
available, the SASFORREACH Consortium GbR will start implementing those requirements and contact co-registrants where necessary and relevant.
2018-08-21 / SAS / Revision of LoA cost: The Consortium is currently still in the process of recalculating the LoA costs on the basis of the figures as
of July 31st, 2018. Once this process is completed, the Consortium will inform all joint submission members directly and publish the relevant
information for new registrants on its webpage http://www.reach-sas.org/. However, it is important to note that due to the ongoing substance evaluation
and significant upcoming changes in the REACH regulation which will be coming into force in 2020, a final recalculation of the LoA price can only be
prepared once the current substance evaluation process has been finalized and the impact of the new REACH provisions on the data to be provided in
the joint registration has been fully assessed and the additional information required has been generated. According to the information currently
available to the Consortium, this process will not be finalized before 2020 at the earliest. Therefore, it is likely that the final recalculation will only be
available in 2021 or later. For further details, please refer to the news item dated 2017-10-10 below.
Please also bear in mind that ECHA may also start another substance or dossier evaluation process at any time and that such new process may lead
to additional costs which need to be shared under REACH.
2017-10-10 / SAS / Revision of LoA cost: Due to (i) the currently ongoing substance evaluation process with regard to SAS and the costs of
complying with the additional information requirements resulting therefrom; (ii) the appeals filed against the final decision issued by ECHA as a result of
such evaluation, (iii) the new implementation regulation and the new version of the guidance on data sharing ("Guidance") the Consortium is the
process of reviewing the current cost sharing model applied in the calculation of the price for a letter of access for SAS (”LoA”).
This includes a recalculation of the LoA prices. Such recalculation may result in a different price for the LoA (i.e, either higher or lower). Such a
recalculation which needs to take into account a lot of different factors as provided in the Implementing Regulation and the Guidance (e.g., dossier
updates and administrative costs incurred since 2009), is a rather complex exercise which cannot be completed at short notice. Because the
Consortium need the total number of co-registrants the new LoA price calculation will be completed not before the REACH deadline May 2018.
Any change of the LoA cost / reimbursement / additional payments will be communicated on the webpage and if necessary directly with the co-
registrants.
The LoA cost published in the SIEF Information Letter 4 are still valid until recalculation!
2017-07-05 / SAS / Substance Evaluation SAS: The Board of Appeal (BoA) has issued decisions on two appeals for substance evaluation
decisions issued by ECHA on synthetic amorphous silica EC 231-545-4 (A-014-2015 and A-015-2015), published on https://echa.europa.eu)
2016-12-06 / SAS / Substance Evaluation SAS: The board of appeal closed the proceedings on the appeal
2016-10-12 / NAS / Dossier Evaluation NAS: The Board of Appeal (BoA) has issued decisions on appeals for four compliance check decisions
issued by ECHA on silicic acid, aluminium sodium salt (NAS) EC 215-475-1 (A-008-2015, published on https://echa.europa.eu).
2016-08-10 / SAS / Substance Evaluation SAS: In April, the interveners PISC (PETA International Science Consortium Ltd.) and ClientEarth/CIEL
(Center for International Environmental Law) lodged their observation on the appeals. The appellants made their observations on the interveners’
observations in May 2016. The written procedure has been closed in August. The hearing date was proposed by ECHA for October 2016.
2016-06-16 / NAS / Dossier Evaluation NAS: Four companies appealed their respective final decision on dossier evaluation in March 2015. The
executive director of ECHA partly rectified some decisions. In March 2016 the written proceedings were closed in all appeals and a joint oral hearing
took place in Helsinki in June 2016. The Board of Appeal has 90 working days from the date of the hearing for issuing a decision (i.e.,
September/October 2016).
2015-11-05 / SAS / Evaluation SAS: The Board of Appeal decided to extend the deadline for lodging the observations on the Defence to 15 January
2016.
2015-10-28 / SAS / Evaluation SAS: The appellants asked the Board of Appeal for a time extension to submit observations on the Defence.
2015-10-19 / SAS / Evaluation SAS: The Board of Appeal informed the appellants about the Defence submitted by the Agency on 21 September
2015. The Board of appeal invited the appellants to provide comments on the Defence until 19 November 2015.
2015-06-10 / SAS / Evaluation SAS: On June 10, 2015, the Lead Registrant Evonik and 20 other companies have filed a joint appeal against the
substance evaluation decision on SAS with the Board of Appeal of ECHA.
2015-03-11 / SAS / Evaluation SAS: ECHA sent the final decision on the substance evaluation to the Lead Registrant and all co-registrants via
REACH-IT. The Lead Registrant Evonik will inform the joint submission members directly via email about the next steps.
2014-11-27 / SAS / Evaluation SAS: ECHA invited a representative of the Lead Registrant of synthetic amorphous Silicon dioxide and 2 experts
(toxicology, physico-chemistry) to the next Member State Committee meeting (MSC-39, 8-11 December). After receiving the final decision the
Consortium will inform the SIEF with a new SIEF INFORMATION LETTER.
2014-11-13 / SAS / Evaluation SAS: The Lead Registrant Evonik submitted the documents commenting ECHA´S and MSCA´s proposed
amendments to the Draft Evaluation Decision to the agency within the given deadline.
2014-10-10 / SAS / Evaluation SAS: ECHA informed the registrants about the receipt of proposals for amendments to the final Draft Decision from
member states and ECHA.
2014-10-09 / SAS / Evaluation SAS: MSC meeting with a representative of the Lead Registrant of synthetic amorphous Silicon dioxide and 2
experts (toxicology, physico-chemistry).
2014-09-04 / SAS / Evaluation SAS: Evaluation SAS: Dutch eMSCA forwarded final Draft Decision to ECHA.
2014-08-27 / SAS / Evaluation SAS: Conference call between representatives of the Lead Registrant EVONIK Industries and the SASFORREACH
Consortium GbR & the Dutch eMSCA.
2014-05-12 / SAS / Evaluation SAS: Meeting between representatives of the Lead Registrant EVONIK Industries and the SASFORREACH
Consortium GbR & the Dutch eMSCA.
2013-12 -17 / SAS / Evaluation SAS: LR Evonik shared data with the Dutch eMSCA requested during the last meeting (Reuzel study, morbidity
study, proposal of grouping grades, information on surface treated SAS).
2013-08-29 / SAS / Evaluation SAS: Meeting between representatives of the Lead Registrant EVONIK Industries and the SASFORREACH
Consortium GbR & the Dutch eMSCA. The draft decision of the CA and the comments from the LR were outlined and discussed. It was decided to
further exchange information and to continue the communication process in an effort to revise the draft decision.
2013-05-06 / SAS / Evaluation SAS: LR Evonik sent comments on the draft decision (DD) to the Dutch evaluating Member State competent authority
(eMSCA).
2013-04-29 / SAS / Evaluation SAS: The Lead Registrant Evonik discussed the DD and the comments during a conference call with interested co-
registrants.
2013-04-13 / SAS / Evaluation SAS: The Dutch evaluating Member State competent authority eMSCA prepared the draft decision (DD) on SAS and
informed the Lead Registrant Evonik and all co-registrants.
Imprint
Notice to all (potential) Co-Registrants of SAS and Silicates covered by the SASFORREACH
Consortium GbR
The SASFORREACH Consortium GbR ("Consortium") cannot assist with general questions regarding REACH (Dossier updates, nanoform-related
information, etc.); therefore please check the ECHA webpage / related guidance text etc. and inform yourself about your responsibility as a registrant
under REACH. If you have problems with the dossier preparation or general questions regarding, e.g., substance identification or the registration
process please contact ECHA or your national helpdesk.
EU-REGULATION.
The Consortium will answer questions on SAS/NAS/CS/AS1/AS2 only by referring to the webpage http://www.reach-sas.org/faq.htm, where all
relevant information for a joint submission is published. The Consortium will continue to communicate information which is relevant for the registration
of SAS (EC 231-545-4) and the silicates directly and/or via the webpage only.
The Consortium will of course continue to support each co-registrant in the LoA purchase process as necessary. Also, the Consortium confirms that
the lead registrant will act in full compliance with the REACH regulation and up-date the dossiers as required. This, however, will not release any co-
registrant from its obligation to up-date the company-specific information or any information in connection with opt-outs made by any co-registrant.
IMPORTANT: For communication with the joint submission members and the co-registrants, only the contact data from REACH -IT will be used,
thus it is important that the email address of each joint submission member is valid. It is in the responsibility of every joint submission member to
update his contact data in REACH-IT when necessary. The conclusion in the BoA decision are relevant for all registrants and thus it is the obligation
of each registrants to contribute/to comply to/with any future activities to up-date the dossier.