- Joint submission & Dossier Content
- Joint submission: Dossier & Costs
- SIEF, Consortium & Dossier
- Sameness & Impurities
- Uses & Chemical Safety Report (CSR)
- Payment & VAT
- Classification and Labelling Inventory
- Data sharing for non EU regulations
- Fee for additional administrative work
When was the lead dossier filed? When was the last update?
The lead dossier was first filed on January 26, 2009 by the then acting lead registrant for the carbon black joint submission, Evonik Degussa GmbH. It was confirmed to be technically complete by ECHA on May 6, 2009.
On March 15, 2018, ECHA accepted an update of the lead dossier. The Carbon Black REACH Consortium “Consortium”) including the current lead registrant (Orion Engineered Carbons GmbH) had decided to update the lead dossier due to the upgrade of the IUCLID tool from IUCLID 5 to IUCLID 6 and the REACH-IT associated upgrades as well as due to the listing of carbon black on the Community Rolling Action Plan (“CoRAP”) for evaluation in 2019 by the French Competent Authority (French Agency for Food, Environmental and Occupational Health & Safety, Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail “ANSES”).
What data are specifically included in the lead dossier? Which data are covered by the letter of access?
The lead dossier is a full package available for each of the four tonnage bands. The letter of access (“LoA”) grants a right to refer to all data contained in the technical part of the lead dossier.
Buyers will be provided with
- an LoA to the technical dossier
- an electronic token for becoming a member of the joint submission via IUCLID
and - only for tonnages >=10 t/a -
- an electronic copy of the chemical safety report (CSR) in pdf format.
This means that after filling out the specific company-related parts (e.g. address, contact, production/import volume, etc.) you can submit your member dossier, based on the lead dossier.
Does the LoA include access to the data? Will buyers of a LoA be provided with access to full study reports or summaries of the studies, for example in order to cover uses not covered by the chemical safety report?
The LoA grants a right to refer to the data but not does not grant access to the data itself. You will have no access to the full study reports and the LoA is not supplemented by study summaries. However, the robust study summaries of the studies in the dossier are available via the ECHA webpage. Furthermore, the CSR contains summaries of the key studies in the IUCLID 6 dossier and the list of uses is, to the best knowledge of the members of the Consortium, exhaustive.
What supplementary data do we have to provide on our own for completion of our member dossier?
Depending on the tonnage band, e.g. for a >1,000 t/a registration:
- General information: identity of manufacturer/importer of the substance
- General information: Identity of the substance (composition, purity, constituents…), analytical information (analytical methods and spectral data)
- Information on the manufacture, use and exposure: technological process (methods), estimated quantities, sites, form in the supply chain, identified uses and exposure scenarios, uses advised against, waste from production and use.
Please see for more details Art. 10 REACH and check the ECHA website for the current version of ECHA´s Guidance on registration and ECHA´s Guidance on data-sharing.
Who is responsible for determining whether my substance is carbon black as defined in the lead dossier?
Every registrant is solely responsible for self-identifying his substance as CAS# 1333-86-4 or EINECS 215-609-9, i.e., the substance defined in the lead dossier which has been submitted by the lead registrant and Registrants shall also provide any additional information required under REACH with regard to his respective substance and uses, if any, at his own cost. The Consortium will not be liable for any costs or damages caused by the failure of the registrant to properly identify his substance. If you are in doubt regarding the exact composition of the carbon black you are importing, please refer to your supplier for more information.
Is the lead dossier currently subject to a dossier compliance check/dossier evalua-tion or substance evaluation? Will the results be included in updates of the lead dossier?
ECHA opened a dossier evaluation for carbon black in January 2015. After a period of silence on this matter, on March 12, 2018, the lead registrant received a letter from ECHA announcing that ECHA terminated the compliance check procedure. ECHA explained that its decision is predicated on recent decisions issued by ECHA’s Board of Appeal that have resulted in the annulment of several of ECHA’s decisions addressed to registrants of nanomaterials. In light thereof, ECHA terminated the compliance check procedure related to the draft decision. ECHA, however, reserved its right to reopen further compliance checks on the present dossier at a later stage.
Carbon black is listed on the Community Rolling Action Plan (CoRAP) for evaluation in 2019 by the French Competent Authority (French Agency for Food, Environmental and Occupational Health & Safety, Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail “ANSES”).
It is possible that additional tests will be requested as a result of the substance evaluation process. The results of any tests mandated through the substance evaluation process will be included in the technical part of the dossier as a robust study summary and any costs resulting from such additional information requirements will need to be shared by all co-registrants of carbon black pursuant to the cost sharing provisions in the REACH Regulation and in the Implementing Regulation 2016/09.
Do I have to register chemically surface treated substances?
Please refer to ECHA guidance on this issue, in particular Source: ECHA
Does the CB4REACH Consortium offer a reimbursement for purchasers of a letter of access if more letters of access are sold than anticipated?
Yes, the cost calculation scheme makes allocations for reimbursements in accordance with REACH and the Implementing Regulation 2016/09 (“IR”).
Is access to the dossier and the CSR available separately?
An electronic copy of the CSR in pdf format is provided to buyers of LoA for tonnage bands above 10 t/a.
No CSR is included and provided for registrants of the tonnage band 1-10 t/a.
Access to the dossier is available separately if the buyer of an LoA intends to submit its own CSR separately.
Will the jointly submitted lead dossier enable buyers of a LoA to successfully register carbon black?
The LoA offered by the Carbon Black REACH Consortium ("Consortium") will enable any registrant to refer to the jointly submitted information which is currently contained in the technical part of the lead dossier submitted by the Lead registrant to ECHA.
If a registrant purchases a LoA from the Consortium, the registrant will be allowed to reference data currently contained in the technical part of the lead dossier and - for registrations >10t/a - the current CSR for carbon black which has been submitted by the lead registrant (together, the "Documents").
The pricing of the LoA is based on the tonnage bands provided in REACH. Please note that each registrant still has to bear its own registration fee which is charged separately by ECHA.
Do we have to pay additional compensation in case of updates to the lead dossier, for example during substance evaluation? Can the substance evaluation process trigger additional costs for LoA buyers?
The tonnage band for which a LoA is purchased must be calculated on the basis of the tonnage band applicable to the legal entity with the highest production and/or import volume, as calculated according to REACH.
The Consortium and the lead registrant will update the information contained in the lead dossier if necessary, for example due to changes in the regulatory framework or when requested by ECHA or other competent authorities, for example following a a substance evaluation process.
Should any update (e.g. further studies or additional information) trigger additional costs (including administration 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 an LoA from the Consortium in accordance with the principles on cost sharing set forth in the REACH-Regulation and the IR.
In any case, it is important to note that the Consortium will not warrant the sufficiency, accuracy and/or completeness of the information in the Documents as this is subject to change over time, taking into account additional information requirements imposed by ECHA or the European Commission.
Is the LoA granted per legal entity or per company?
As in many other REACH consortia, the LoA is currently granted per legal group, including affiliates. Individual tokens will be provided per legal entity.
Definition of an ‘Affiliate’:
Affiliate shall mean any undertaking (i) in which a company holds, directly or indirectly, at least 50% of the shares or voting rights, or (ii) which is a party to a profit and loss absorption agreement with a company (either upstream or downstream), or (iii) which is otherwise con-trolled by a company, or (iv) which controls a Member directly or indirectly, or (v) which is controlled directly or indirectly by an undertaking which is a direct or indirect controlling shareholder of the company, and (vi) which is either a manufacturer of the Substance or (vii) an importer of the Substance in the EU.
This 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 carbon black to the EU is an Affiliate. Furthermore, this definition also includes sister companies of companies. Individual tokens will be provided per Legal Entity.
If a company needs a co-registration also for its affiliates, on which basis must the tonnage band be calculated?
The tonnage band must be calculated on the basis of the tonnage band applicable to the legal entity with the highest production and/or import volume, as calculated according to REACH.
When the entire package (Lead Dossier & CSR) is not necessary, can the right to reference individual studies be purchased?
Yes, by payment of a fair, transparent and non-discriminatory contribution to the costs of the studies.
If a company buys the LoA for a 1-10 tpa dossier and increases its tonnage band to e.g. 100 t/a, would it have to pay the difference?
Yes, in this case the difference would have to be paid. If you bought an LoA before the recalculation of the LoA cost you have to pay the difference between the old and the new LoA cost.
LoA 1-10t paid: 20.000€
Update to 10-100t, new LoA cost: 59.000€
Difference to pay: 39.000€
Can other SIEF members join the joint submission later?
New SIEF members, such as new importers or manufacturers, can join the joint submission later. However, after the expiry of the last registration deadline, the Consortium does not expect a significant increase of members of the SIEF. However, the consequences of BREXIT may result in new members to the SIEF who may join the joint submission later.
Given that the SIEF is formed and that a carbon black registration lead dossier has already been filed with ECHA, is it possible that some SIEF members submit a different dossier jointly? In other words, are two joint submissions acceptable within a same SIEF?
No, ECHA accepts only one registration and one registration dossier due to the OSOR-principle (one substance, one registration; please refer to ECHA guidance for details on possi-ble separate registrations of intermediates); a (partial or complete) opt out and separate submission of information is still possible, however, even (full) opt-out registrants must become a member of the joint submission.
Does knoell Germany GmbH take the position as Lead Registrant for the SIEF?
No, knoell Germany GmbH is the Consortium manager; the current Lead registrant is Orion Engi-neered Carbons GmbH, a member of the Consortium.
To ensure the validity of a joint registration for carbon black, how do I establish the sameness of my product (substance identity information, compositional specification)?
The sameness criteria for carbon black have been published in the SIEF Information Letter 2 which is available here.
Are there any restrictions on the manufacturing process and/or the impurities (if applicable)?
The process is not restricted to the manufacturing processes described on the webpage of the Consortium (www.cb4reach.eu). The impurity levels have been posted in the SIEF In-formation Letter 2 (updated 2016) which is available here.
Does the submitted lead dossier specifically include nano-forms of carbon black?
Carbon black is a so-called “nano-structured material” (ISO TC 229, Draft TS 12921), i.e., consisting of primary particles formed in the carbon black production process that combine within milliseconds after formation in the reactor to aggregates and agglomerates. Therefore, a differentiation for carbon black between nano-material and bulk/conventional material has not been made in the lead dossier.
Does carbon black contain SVHC as per the candidate list?
Carbon black as registered in the lead dossier does not contain any of the currently listed SVHC above 0.1%.
Beyond the list of uses given on the CB4REACH website, which other uses are addressed in your CSR? This information is necessary to cover all exposure scenarios relevant to carbon black.
Carbon black is not classified as a hazardous material; therefore, no exposure scenario is necessary.
Should further information be required, the potential registrant should disclose his use to the consortium manager on a confidential basis for him to check whether such use is covered by the lead dossier or not.
Will the Chemical Safety Report be a generic one onto which specific exposure scenarios can be added?
The CSR is complete. No exposure scenarios are required because carbon black is not classi-fied as a hazardous material.
Uses contained in the lead dossier
The “Uses” contained in the lead dossier and described in the “CB4REACH SIEF Information Letter 3” were determined using the “Guidance on information requirements and chemical safety assessment Chapter R.12: Use descriptor system.” This document was published by ECHA in May 2008 and updated, the latest version of the R.12 guidance (Version 3.0) is dated December 2015. The “Use Descriptors” incorporated in the carbon black joint registration dossier that was submitted and accepted by ECHA include the IU (Identified use), SU (Sector of use), PC (Chemical product category) and Process category (PROC) as defined in this document.
The Consortium is established as a taxable entity in Germany with a German VAT-number (DE-xxxxx). Services between the Consortium and LoA purchasers normally qualify as busi-ness 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 service is taxable in Germany. The purchaser will receive an invoice with 19% VAT added to the net total amount. Since the purchaser is acting as a taxable entity, paid tax can normally be deducted as input tax (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. The VAT Identification Number of the customer 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.
Invoices will be issued only to the name of the purchaser and to an EU address. We kindly ask to transmit payments by regular bank transfer rather than by SEPA. If a SEPA transfer is used, the additional expenses that are charged to the recipient need to be borne by the payor so that the full amount of the consideration is received by the Consortium.
The C&L Inventory includes several notifications for carbon black classified in different hazard classes. Does the joint submission dossier include a self-classification of carbon black?
Carbon black as registered in the lead dossier and as described on the webpage of the Consortium in the Sief Information Letters 1 - 3 is not classified according to Regulation (EU) No. 1272/2008.
Please be aware that the entries in the C&L inventory for carbon black do not reflect the legal position in the EU on the classification and labelling of carbon black, but rather they reflect the situation on the market because they are the self – classifications made by the respective notifiers/registrants. No verification of the content of the C&L Inventory is performed by ECHA.
The sole purpose of the CB4REACH Consortium is to enable registrants to comply with their registration obligations under EU law. In order to obtain access rights to data and information for use in other jurisdictions (including the UK post-Brexit), please contact the respective data owners and/or the competent authorities in the respective jurisdictions directly. The CB4REACH Consortium is not in a position to provide any advice or assistance in this regard. Since most studies are owned by the ICBA please contact david.pavlich[at]gmail.com
ECHA recommended to transfer registrations before the UK’s withdrawal; the CB4REACH Consortium will support existing co-registrants with the transfer and prepare the new documents after receiving the updated business information (form, see ‘How to register’ Step 3) and payment of the administrative cost (1,000€)
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 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 existing LoA agreement and the issuance of the corresponding letter of access.