© SASFORREACH Consortium GbR 2012 Imprint Frequently Asked Questions on REACH by Industry Synthetic amorphous Silica and Silicates (Silica/Calcium Silicate CS/Sodium Aluminium Silicate NAS) 1. Joint submission & Dossier Content General questions The Consortium can not and will not act as a consultant for any third party. Thus, please, contact your national helpdesk for general questions beside the registration of SAS. Contact data are available on the ECHA webpage. 1.1 What is the basis of the joint submission proposal from the SASFORREACH Consortium? 1.2 What data are specifically included in the Lead Dossier? 1.3 Does the LoA include access to the data or is it supplemented by summaries of the studies in order to cover uses not covered by the chemical safety report? 1.4 Do I have to register chemically surface treated substances? 1.5 Is Silica classified? 1.6 Does one LoA for SAS includes all SAS products from the various production processes listed in the SIEF Information Letter 1? 1.7 In December 2018 the European Commission amended some Annexes of the REACH regulation to include specific requirements for nanoforms of substances. These changes came into effect on January 1, 2020. Where can I find official information on it? 1.8 What is the current status of the substance evaluation of SAS? 2. Joint submission: Dossier & Costs 2.1 What would be the final cost of the Letter of Access for SAS? 2.2 Are the dossier and the CSR separately available? 2.3 On which basis was the LoA price calculated? How are the costs shared between the registrants? 2.4 When the entire package (Dossier & CSR) is not necessary, can reference right to individual studies be purchased? 2.5 Is the LoA granted per legal entity or per company? 2.6 Does the SASFORREACH Consortium GbR offer a rebate for purchasers of a letter of access if more LoAs are sold than anticipated? 2.7 If a company buys a LoA for, e.g., a 100-1000 t/a dossier and subsequently increases its tonnage band to > 1000 t/a, would it have to pay the difference? 3. SIEF, Consortium & Dossier 3.1 Given that the Lead Dossier for SAS has already been filed with ECHA, is it possible that a different dossier is jointly submitted? In other words, are two joint submissions acceptable for the same substance? 3.2 Does the submitted Silica dossier specifically include nanoforms and/or non-nanoforms of Synthetic Amorphous Silica (SAS)? 3.3 What do you need to do if you want to register a non-nanoform of SAS? 3.4 If you want to register a non-nanoform of SAS 3.5 What should I do if my registered substance is a non nano form / bulk form? 3.6 Will be the bulk form of SAS be part of the joint registration dossier? 3.7 Does the Consortium plan to reimburse registrants of SAS as a bulk form? 4. VAT / Payment 4.1 VAT 4.2 Payments 4.3 International Payments 5. Are Read-Across Data available? In light of recent developments in the regulatory environment the Consortium has decided that it will no longer offer Letters of Access for read-across purposes. In this context, it should be noted that unlike for data sharing for the same substance, there is no statutory obligation to share data for read-across purposes to another substance. Any requests for obtaining data for read-across purposes should be addressed to the respective data owner. The manager of the Consortium will identify the respective data owner upon request. Requests identifying the studies and/or data for which read-across access is requested may be addressed to: sasforreach@sasforreach.eu 6. Miscellaneous 6.1 Contact for questions about SAS, cosmetic products & nano labeling 6.2 Do you also cover the substance AMORPHOUS SILICA, CAS 112945-52-5, EC 601-216-3? 6.3 Does the SASFORREACH Consortium GbR also sell Letters of Access for registrations or other regulatory purposes outside the EU? 6.4 Brexit / Regulations outside the European Union 6.5 Fee for additional administrative work 6.6 OR Change Version 2.5 Release 7 Published on 1st March 2014 1.1 What is the basis of the joint submission proposal from the SAS For REACH Consortium? The letter of access agreement ("LoA") offered by the SASFORREACH Consortium GbR (the "Consortium") will enable any co-registrant of Synthetic Amorphous Silica ("SAS") to refer to the data in the joint registration dossier submitted to the European Chemicals Agency ("ECHA") by the lead registrant Evonik Operations GmbH ("Lead Dossier"). The Consortium will update the information contained in the Lead Dossier as and when required. If a potential co- registrant decides to purchase a LoA from the Consortium, it will be allowed to refer to both the corresponding Lead Dossier and the appurtenant chemical safety report (CSR) for SAS in their respective form, as amended from time to time (the "Documents"). As a result of the new information requirements for nanoforms, even though SAS will continue to be treated in a single registration, it will no longer be treated as a uniform substance for cost sharing purposes. Instead, each set of nanoforms as well as the bulk form of SAS, respectively, will be treated separately and, accordingly, will be subject to a different cost sharing mechanism. While there are certain studies and data which remain applicable to all sets of nanoforms (including, but not limited to, by way of a read-across to other sets of nanoforms), others may only be applicable to certain sets of nanoforms or to a single set of nanoforms. The pricing of a LoA is based on the tonnage bands provided in REACH and assumes that all information which is required for the registration of the respective set of nanoforms of amorphous, crystalline-free Silica as identified by the CAS and EC numbers for which the registration has been submitted is already included in the Documents. Currently, however, this assumption is - for the time being - only valid for the hydrophilic, untreated set of nanoforms since certain information and data for the other sets of nanoforms identified in the Lead Dossier, i.e., hydrophobic silica including surface-treated forms, is still missing and will be developed in due course. Any costs resulting from the development of missing data will likewise be included in the cost calculation for these sets of nanoforms. Furthermore, additional costs may be incurred should ECHA decide to separate either or both of the two sets of nanoforms identified in the Lead Dossier into additional, separate sets of nanoforms. Cf. also FAQ 1.2. Should ECHA require any further studies or additional information at any time as a result of a dossier or substance evaluation pursuant to Art. 41 et seq. REACH which lead to additional costs for the Consortium, the Consortium reserves the right to claim an adequate participation in such additional costs also from any registrant who has bought a LoA from the Consortium for the respective set of nanoforms in accordance with the principles on cost sharing set forth in REACH- Regulation, Commission Implementing Regulation (EU) 2016/9 and the guidance documents issued by ECHA. In any case, it is important to note that the Consortium did not and will not warrant the sufficiency, accuracy and/or completeness of the information in the Documents. Furthermore, any co-registrant will have to carefully review the information in the Documents to ensure that his synthetic amorphous silica is identical to the substance registered under the Lead Dossier, and provide any additional information required under REACH with regard to his respective substance and uses at his own cost, if such uses or information are not covered in the Documents. 1.2 What data are specifically included in the dossier? The LoA is a full package available for each of the four tonnage bands for the set of nanoforms identified as No. 1 (hydrophilic SAS). This package includes all available data and information for the registration of SAS (i.e., Lead Dossier; copy of the CSR). The data for the set of nanoforms identified as No. 2 (hydrophobic SAS) is likewise complete, however, based on a read-across approach. This means that after filling out the company-specific parts (e.g. address, contact, production/import volume, analytical data, etc.) you can file your dossier, based on the already approved Lead Dossier. In this context, it should be noted that there is no assurance that ECHA will accept the read-across justifications in the Lead Dossier for Set No. 2 (hydrophobic SAS), which may lead to additional costs, either for the conduct of new studies for this set of nanoforms, and/or for the amendment of the read-across justifications. For other sets of nanoforms which are currently still under development as well as for the bulk (i.e., non-nano) form of SAS, the package is still incomplete and will be supplemented from time to time as the definition and data collection process progresses. All associated costs which are eligible for cost sharing under REACH will be documented and included in the respective cost sharing formula. 1.3 Does the LoA include access to the data or is it supplemented by summaries of the studies in order to cover uses not covered by the chemical safety report? No, as a LoA buyer you have no access to the full study reports in the Lead Dossier and the LoA is not supplemented by study summaries. 1.4 Do I have to register chemically surface-treated substances? Surface treatment is one of the identifiers for nanoforms or set of similar nanoforms. Therefore, surface-treated substances have to be included in the registration dossiers as nanoforms or sets of nanoforms. 1.5 Is Silica classified? SAS - as currently registered by the Lead registrant and described in the SIEF Information letters - has an amorphous structure. It is important to distinguish between the synthetic amorphous and crystalline forms of silica which are different in their inhalation toxicity behaviour. Based on the data in the Lead Dossier the synthetic amorphous form is non-hazardous and, therefore, does not trigger any CLP classification. Please see also FAQ 1.9 on potential future classification of SAS. However, please also note that the RAC has proposed a classification of HMDZ1 -surface-treated SAS which will enter into force with the 18th Amendment to the CLP Regulation (ATP). 1 HMDZ = Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica (CAS 68909-20-6). 1.6 Does one LoA for SAS includes all SAS products from various processes listed in the SIEF Information Letter 1? Yes, after the payment for the LoA for SAS it is possible to register all silicas covered by the registration of the Lead Registrant and described in the Silica (SAS) - SIEF Information Letter 1: ...... Substance For this registration, the definition of SAS covers products from various processes: 1. Silica, amorphous, pyrogenic, crystalline-free (CAS#:7631-86-9, 112945-52-5), 2. Silica gel and precipitated silica, crystalline-free (CAS#: 7631-86-9, 112926-00-8), 3. Colloidal Silica (CAS#: 7631-86-9, 112926-00-8) ...... The cost of the LoA depends on the tonnage band in total off all SAS types! 1.7 In December 2018 the European Commission amended some Annexes of the REACH regulation to include specific requirements for nanoforms of substances. These changes came into effect on January 1, 2020. Where can I find official information on it? The European Commission has dedicated a website to nanomaterials and more specific to nano-materials in REACH and CLP. Please refer to https://ec.europa.eu/environment/chemicals/nanotech/reach-clp/index_en.htm to find the official text of Commission Regulation (EU) 2018/1881 to modify REACH Annexes I, III and VI-XII, introducing nano-specific clarifications and new provisions in the chemical safety assessment (Annex I), registration information requirements (Annex III and VI-XI) and downstream user obligations (Annex XII). ECHA also has its own website on nanomaterials. There you will find, inter alia, information about the definition of nano-forms as contained in Annex VI REACH, the recommendation of the European Commission and related guidance documents and several other links explaining nanomaterials in the EU regulations REACH and CLP. Finally, a guidance document entitled "Appendix on recommendations for nanomaterials applicable to the Guidance on Registration and Guidance on Substance ID" is available on ECHA´s website on on-going guidance consultations. Please note that all links are subject to change and will not be updated by the Consortium. If you experience any problems, please contact the respective owners of the webpages. 1.8 What is the current status of the substance evaluation of SAS? SAS is currently undergoing a substance evaluation under REACH. The substance evaluation conclusion issued by the evaluating competent member state authority in the Netherlands dated 9 July 2021 concludes that there are sufficient grounds to draft a proposal for harmonized classification and labeling (CLH) for the endpoint repeated dose toxicity via inhalation. It also suggests a subsequent Regulatory Management Option Analysis (RMOA) in which additional actions are assessed, such as the derivation of an Occupational Exposure Limit (OEL). 2.1 What would be the final cost of a Letter of Access for SAS? There is no "final" cost of a LoA. Under REACH, registrants need to constantly update their registration dossiers as new information regarding a substance becomes available. Furthermore, ECHA may ask for additional information on a substance to be provided. Therefore, this is an ongoing, continuous process. This means that there is also no limit to the cost sharing obligations of registrants of a substance both in terms of time and in terms of costs. However, the Consortium has documented all costs of the registration of SAS under REACH and seeks to complete a recalculation of the LoA cost once all additional information which is to be provided as a result of the entry into force of the new nano-related information requirements is available. In any case, the LoA cost (Dossier & CSR) is dependent on (i) tonnage band, and (ii) the set(s) of nanoforms for which the registration is submitted. 2.2 Are the dossier and the CSR separately available? No, the dossier and CSR are not available separately 2.3 On which basis was the LoA price calculated? How are the costs shared between the registrants? The LoA prices for the respective tonnage bands were calculated based on the actual costs incurred by the Consortium and its members for the relevant studies and projects. The data ownership and cost sharing processes were developed pursuant to the ECHA Guidance Document on Data Sharing. 2.4 When the entire package (Dossier & CSR) is not necessary, can reference right to individual studies be purchased? Yes, by payment of a compensation which is determined in a fair, transparent and non-discriminatory way. 2.5 Is the LoA granted per legal entity or per company? The LoA is granted per company, including affiliates. Individual tokens will be provided as per the definition of an affiliate, which means any undertaking 1. in which a company holds, directly or indirectly, at least 50% of the shares or voting rights, or 2. which is a party to a profit and loss absorption agreement with a company (either upstream or downstream), or 3. which is otherwise controlled by a company, or 4. which controls a Member directly or indirectly, or 5. which is controlled directly or indirectly by an undertaking which is a direct or indirect controlling shareholder of the company, and 6. which is either a manufacturer of the Substance or (vii) an importer of the Substance in the EU1. 1This means that a production facility owned directly or indirectly by a company or a parent of a company outside the EU (e.g., in China or India) that exports synthetic amorphous Silica to the EU is an Affiliate. Furthermore, this definition also includes sister companies of companies. Individual tokens will be provided per Legal Entity. 2.6 Does the SASFORREACH Consortium GbR offer a rebate for purchasers of a letter of access if more LoAs are sold than anticipated? 1. It is impossible to predict exactly how many LoAs will actually be sold for each tonnage band and each set of nanoforms. 2. In re-calculating the price of the LoA in connection with the substance evaluation of SAS conducted by ECHA, the Consortium has made certain assumptions regarding the likely number of purchasers to be expected for each tonnage band and the costs required to comply with the additional information requirements resulting from the substance evaluation. These assumptions are supported by the evidence available to date. 3. Of course, the Consortium will act in accordance with REACH REGULATION (EC) No 1907/2006 and with applicable antitrust law at all times. 4. Please note that if as a result of a substance and/or dossier evaluation under REACH additional studies need to be prepared, the costs for such studies as well as the administrative costs attributable to such studies (which are not included in the calculation of the LoA price) will have to be shared among all registrants of SAS in the tonnage bands for which such additional studies on a fair, transparent and non-discriminatory basis. 2.7 If a company buys a LoA for, e.g., a 100-1000 t/a dossier and subsequently increases its tonnage band to > 1000 t/a, would it have to pay the difference? Yes, in this case the difference would have to be paid. 3.1 Given that the Lead Dossier for SAS has already been filed with ECHA, is it possible that a different dossier is jointly submitted? In other words, are two joint submissions acceptable for the same substance? The "OSOR" principle (one substance, one registration) prevents a second registration for the same substance, see ECHA homepage (http://echa.europa.eu). However, it is always possible to declare a partial or full opt-out from the joint registration, e.g. for bulk SAS. 3.2 Does the submitted Silica dossier specifically include nanoforms and/or non-nanoforms of Synthetic Amorphous Silica (SAS)? The registration dossier for SAS covers both, nanoform(s) and non-nanoform(s) of SAS. SAS is a "nano-structured material" according to ISO TC 229 (Draft CS 27687, draft TS800004-5), consisting of aggregates and agglomerates. The consortium does not cover any non-nanoform of SAS at the moment. The Consortium has requested information regarding all forms in 2019 but received only very limited feedback from co-registrants. Therefore, the consortium is currently not in the position to give detailed information regarding the bulk form, but it was s decided in 2021 to prepare a REACH dossier update also covering the non-nanoforms of SAS. The Substance Identity Profile (SIP) of the non-nanoform form is published on the webpage (see webpage http://www.reach- sas.org/silica.htm). It is planned perform a SIEF survey again in the beginning of 2022 addressing all co-registrants to collect further information on the Bulk and nanoforms of SAS. After the feedback has been compiled the REACH dossier update for the non-nanoform of SAS is planned for Q3 of 2022. 3.3 What do you need to do if you want to register a non-nanoform of SAS? The SASFORREACH Consortium GbR covers only nano-structured SAS. If you or your client needs a registration of a non-nano SAS (EC 231-545-4), in consideration of the "one substance, one registration" rule, the Consortium proposes the following procedure for the time being: The SIP conditions must be fulfilled (see webpage http://www.reach-sas.org/silica.htm) You have to provide a full dossier containing all 13 chapters with an opt-out justification for each end-point (total opt out) The individual part of your dossier must contain the specific analytic details of your non-nanoform. Another option is to wait with the importation or manufacture of non-nano SAS until the members of the Consortium who are working on a registration dossier for the bulk form of SAS have finalized the registration dossier for the bulk form of SAS, and join the joint submission for SAS at such time. Please bear in mind, however, that joining the joint registration for SAS is subject to further contractual and payment obligations. Once a full registration dossier for the non-nanoform of SAS has been submitted, a full opt-out may no longer be required. Cf. also FAQ 3.4. 3.4 If you want to register a non-nanoform of SAS The SASFORREACH Consortium GbR covers only nano-structured SAS at the moment. If you or your client need a registration of a non-nano SAS (EC 231- 545-4), in consideration of the one substance one registration rule, the SASFORREACH Consortium GbR proposes the following procedure:  The SIP conditions for the non-nano form must be fulfilled (see webpage http://www.reach-sas.org/silica.htm). The work for the dossier update to cover the non-nanoform of SAS is ongoing, thus, for the time being, you will have to provide a full dossier containing all 13 chapters with an opt-out justification for each end-point (total opt out). REACH dossier update for the non-nanoform of SAS is planned for Q3 of 2022. The individual part of your dossier must contain the specific analytic details of your non-nanoform. 3.5 What should I do if my registered substance is a non nano form / bulk form? If you registered SAS as a bulk or non-nano substance, you cannot refer to the existing dossier any longer, because it covers only nanoforms of SAS. Thus, you have to opt out for each endpoint and prepare all required data for your tonnage band yourself. The Consortium does not have any data for any non-nanoform of  SAS and thus cannot support you in your individual update. Any reimbursement of the paid fee for the LoA SAS is not foreseen due to the fact that the dossier covered all forms of SAS until the amendment of the REACH regulation in 2020. Please contact ECHA or your national helpdesk for further questions. 3.6 Will be the bulk form of SAS be part of the joint registration dossier? As the bulk form is now part of the joint submission, the registrants of the bulk form need to share in a fair and transparent way the administrative costs for the joint registration dossier. As currently no data for the bulk form are known to the SASFORREACH consortium, no data sharing costs will be charged. However, this might change in the future when a registration for the bulk form will have been generated by registrants of the bulk form. Such data will include both newly generated data as well as data generated by way of read across to the nanoform. In any case, the Consortium will not generate any data for the bulk form itself, but it is entirely up to the registrants of the bulk form to generate such data themselves. The Consortium is willing to allow data sharing to certain data by way of read-across, subject to appropriate cost sharing arrangements. However, the responsibility for generating the read-across justifications of such data for the bulk form will be upon the registrants of the bulk form. 3.7 Does the Consortium plan to reimburse registrants of SAS as a bulk form? Existing co-registrants of the bulk form who have already bought a Letter of Access from the Consortium in the past are not entitled to a reimbursement as the current data on SAS are so far the only data available, and market access was actually obtained by these registrants on the basis of the existing data. Without these data, no market access would have been possible for them, irrespective of whether and to what extent the available data actually cover their respective products. This means that market access was actually obtained by these registrants by relying on incomplete/insufficient data (which is per se not an uncommon phenomenon under REACH). However, going forward, it is up to the registrants of the bulk form to procure their own data (including, where possible, by way of read across to the nanoform). 4.1 VAT The Consortium is established as a taxable entity in Germany with a German VAT-number (DE-xxxxx). Services provided by the Consortium to LoA purchasers normally qualify as business to business (B2B) supply of services. Invoices are issued by the Consortium's accounting firm CRB in the name and on behalf of the Consortium. If the purchaser's place of establishment is in Germany, the supply of services is taxable in Germany. The purchaser will receive an invoice with 19% VAT added to the net total amount. Since the purchaser is normally acting as a taxable entity itself, input VAT paid by the purchasercan be deducted (Vorsteuerabzug). If the purchaser's place of establishment is not in Germany but is within the EU, the supply of service is taxable at the purchaser's place of establishment. In this case, the VAT Identification Number of the purchaser is required to issue an invoice. The purchaser will receive a net invoice showing no VAT charge. The purchaser will account for VAT at the purchaser's establishment under the reverse charge mechanism. 4.2 Payments Payments of invoices can be made from any bank account to the escrow bank account of the Consortium. We kindly ask to transmit payments by regular bank transfer rather than by SEPA. If SEPA transfer is used, please add the additional expenses to your payment that are charged to the recipient. 4.3 International Payments Invoices will be issued only to our contract partner in the EU. Payments can be made by any entity worldwide (e.g., by a parent company or affiliate outside the EU). We kindly ask to ensure that 1. the full invoice amount is credited to the account of the Consortium without any deduction (e.g., handling fees, etc.), and 2. the payment contains a full reference to the contract the payment is made for (e.g.: "LoA SAS for X GmbH as OR for Y, Inc."). The access token and the LoA will only be provided once payment has been received in full. If payment is not made by the invoice recipient, an internal reimbursement might be required between purchaser and payer. Such reimbursement will not affect the Consortium and should be negotiated between purchaser and payer. Tax implications of any such arrangement should be considered. 6.1 Contact for questions about SAS, cosmetic products & nano labeling For questions about SAS, cosmetic products & nano labeling please contact the Association of Synthetic Amorphous Silica Producers (ASASP) via the webpage: http://www.asasp.eu/ 6.2 Do you also cover the substance AMORPHOUS SILICA, CAS 112945-52-5, EC 601-216-3? The substances covered by the Consortium are published on the webpage and described in the SIEF Information letters; other silica with different EC numbers are NOT covered and must be registered separately. 6.3 Does the Consortium also sell Letters of Access for registrations or other regulatory purposes outside the EU? No, the sole purpose of the Consortium is to enable registrants to comply with their registration obligations under EU law. The Consortium is therefore not in a position to provide any advice or assistance in this regard. Irrespective hereof, the data owners are currently evaluating possible solutions for the joint handling of mandatory data sharing in jurisdictions other than the EU. 6.4 Brexit / Regulations outside the European Union For registrations outside the European Union please contact the responsible lead registrant or national helpdesk for further support. The Consortium is exclusively dealing with the registration under EU REACH only. 6.5 Fee for additional administrative work The Consortium will invoice a lump sum fee of € 1,000 plus VAT, where applicable, for additional administrative work incurred in connection with the preparation of a new LoA agreement due to a change of the contract partner (e.g., OR change, merger, reorganization, etc.); no additional costs will be charged for the inclusion of additional affiliates in an existing LoA agreement and the issuance of the corresponding letter of access. 6.6 OR Change For a change of an OR, the Consortium has prepared an agreement which must be signed by all contracting parties (old OR, new OR, customer of OR, Consortium). The new OR must follow the guidance (see webpage 'How to register') and send the corresponding information (NDA/form) to the manager of the Consortium (sasforreach@sasforreach.eu). After the finalisation and payment of the handling fee, the new Letter of Access will be issued to the new OR. Please note that without this contract, the new OR has no right to refer to the joint registration / Lead Dossier!