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. For this purpose a Consortium for Carbon Black has been formed.
The CB4REACH consortium is not competent to support individual companies in their REACH registration and cannot assist with general questions regarding REACH (Dossier updates, nanoform-related information, etc.).
Its role and obligations are limited to the registration of Carbon Black as described on the webpage https://www.cb4reach.eu/. The Consortium will answer questions on CB only by referring to the webpage https://www.cb4reach.eu/, where all relevant information for a joint submission is published. For further information and clarification, we encourage you to contact your national REACH helpdesk or the European Chemical Agency (ECHA).
2023-05-25 Letter to all registrants of Carbon Black / Compliance with EU sanctions
The CB4REACH Consortium sent out the email below to all registrants of Carbon Black on May 25, 2023; due to many invalid email addresses in REACH IT the Consortium has decided to publish the email here:
this is to inform you that the information which you have provided to us in response to our RFI dated April 18, 2023 is not complete. We kindly ask you to read the instructions on the questionnaire which we had provided to you and which can be found here very carefully and proceed accordingly. Please note that co-registrants who do not provide the requested information will be reported to ECHA for a decision on whether further communication with such co-registrants is permissible. Failure to provide the requested information means in particular that the CB4REACH Consortium (“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
- 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.
- 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.
- 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.
- 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 jurisdicitons such information must be provided under applicable securities laws.
- 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. We kindly ask for your understanding.
- given the fact that many co-registrants have informed us that they need more time to collate the requested information, the Consortium has decided to postpone the deadline for providing the information to
June 30, 2023
2023-04-18 Letter to all registrants of Carbon Black / Compliance with EU sanctions
The CB4REACH Consortium sent out the email below to all registrants of Carbon Black on April 18, 2023; due to many invalid email addresses in REACH IT the Consortium has decided to publish the email here:
Dear co-registrant of carbon black EC 215-609-9,
due to the EU sanctions against Russia and other countries the 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 CB4REACH Consortium is still applicable as signed, and
(ii) provide the requested data in the new form which is published on the webpage and attached to this email.
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 information for verification on or prior to
May 5, 2023
After the verification of the company data the Lead Registrant can update the dossier and publish a new information Letter on the webpage https://www.cb4reach.eu/; if any data are provided by the Lead Registrant for your individual registration (e.g., a new version of the CSR) this will be announced in the information letter; these data will be provided after the publication/update by the consortium manager upon request only.
2023-03-03: Compliance with REACH and EU sanctions against Russia
To ensure compliance with the EU sanctions against Russia and other countries, the CB4REACH Consortium must implement certain administrative procedures. In the context of the REACH regulation, the Consortium is obligated to verify the identity of each co-registrant before selling a Letter of Access or filing an update for the joint registration dossier. Co-registrants are expected to cooperate in this process by providing the requested information in a timely manner. This compliance check will lead to substantial administrative work and will result in additional costs. It may also cause delays for the dossier updates.
2022-10-21: LOA COST UPDATE – 2022
The recalculation is finalized, the new LoA cost are published under ‘Letter of Access: Cost’
2022-06-03 / LOA COST UPDATE – 2022
The CB4REACH Consortium is currently conducting a recalculation of and updating of the LoA cost to account for the “12-year rule” in Art. 25 para. 3 REACH. The result of this recalculation is expected in Q3 2022 and will lead to a substantial reduction in the LoA price for new registrants of carbon black since the costs for all those studies which were included in the original joint submission for carbon black which was filed with ECHA in 2009 will henceforth be disregarded. Please note that co-registrants who have bought their LoA prior to January 1, 2022 will not benefit from this recalculation since they had full market access in the EEA on the basis of the studies which were originally included in the joint submission at all times prior to January 1, 2020.
2022-03-15 / TESTING PROPOSAL
On behalf of the Lead Registrant, we would like to inform you that an update of the lead dossier for Carbon Black has been submitted to ECHA. The purpose of this update is to submit a testing proposal for a prenatal developmental study in the rabbit. The lead registrant has decided to submit this proposal based on data gaps in the Carbon Black dossier that were identified by ECHA in its 2018 evaluation of the carbon black dossier.
2021-10-20 / PARTICLES AND HEALTH CONFERENCE
Poorly soluble low toxicity particles (PSLTs) such as carbon black and titanium dioxide, have been under review by regulatory authorities in the European Union and elsewhere, resulting in proposed hazard classifications. A scientific conference on medical and toxicology issues associated with PSLTs and corresponding regulatory issues was held in London on October 20-21, 2021 (https://www.particlesandhealth.org/). The conference, sponsored by the Institute of Occupational Medicine (IOM) in Edinburgh, was funded by the CB4REACH consortium, with additional funding from the Association of Synthetic Amorphous Silica Producers. The purpose of the conference was to present current scientific information on particles and health and to facilitate interaction and discussions between different disciplines (including toxicology, epidemiology, occupational and pulmonary medicine, exposure assessment and regulatory) to aid in the sound and evidence-based scientific underpinning of regulatory decisions regarding PSLTs. The scientific studies and information presented at the conference will help to ground future regulatory action and decisions on carbon black on the latest science. The conference had 151 enrollees, including 35 speakers and panelists. Approximately 25 government and regulatory representatives including delegates from US (NIOSH, EPA), and EU (various countries) participated. The conference presentations can be viewed on the conference web site until October 2022. Selected proceedings of the conference will be published in 2022 in the journal “Frontiers in Public Health” as a Special issue devoted to Particles and Health. A total of seventeen papers are expected to be published in this Special Issue. In addition, publication of an “e-book” on the conference proceedings is also planned.
2020-11-23 / CARBON BLACK DOSSIER UPDATE SUCCESSFULLY SUBMITTED TO ECHA
On October 27, 2020, the Carbon black dossier update has been submitted to ECHA. Its technical completeness was confirmed by ECHA on November 23, 2020. This version of the dossier addresses information on nanoforms of carbon black as laid down in and required by Commission Regulation (EU) 2018/1881 of 3 December 2018 amending the REACH Regulation (Regulation (EC) No 1907/2006). All co-registrants are encouraged to update their individual dossiers as soon as possible.
2020-11-06 / NEW SIEF INFORMATION LETTER
Update on nanoform-specific information requirements in accordance with Commission Regulation (EU) 1881/2019 of 3 December 2018
2020-01-08 / NANO – CB DOSSIER UPDATE
The Consortium together with the Lead Registrant is actively working on addressing the requirements imposed on registrants of substances with nanoforms by Regulation EU 2018/1881. We see this as a stepwise and iterative process which begins with the imperative identification of the respective (nano) forms and justified sets thereof for carbon black. The Consortium is currently at this stage of the process. Upon completion hereof, we will be able to map where gaps in the data exists, if any, and design a plan to address these gaps. Hence it is not possible currently to make a forecast of when a CSR addressing fully, the requirements of Regulation (EU) 2018/1881 will be available as we do not know yet if and which kinds of gaps may exist in the dossier. Compounding the situation is the rather late publication (December 2019) of ECHA’s Guidance on nanoform characterisation as well as a lack of guidance that reflects today’s state of affairs as regards the recently adopted nano-related changes to the annexes of REACH for the human health and environmental endpoints.
Rest assured that upon completion of its work on (nano)form identification, the consortium will inform the joint submission members of the preliminarily defined set(s) of (nano)forms relevant for the carbon black dossier and if indicated, any additional study that will need to be carried out. Based on feedback from the co-registrants, the boundaries of the set(s) may be readjusted, where feasible.
2019-12-20 / TERMINATION OF A COMPLIANCE CHECK PROCEDURE
ECHA has terminated the dossier compliance process; citing the arguments the CB4REACH Consortium submitted to ECHA on the draft decision. ECHA has informed the lead registrant that it plans to open a new dossier compliance process for the carbon black dossier after 7 January 2020, when it expects that the carbon back dossier will have been updated with information addressing requirements for nanomaterials in accordance with Commission regulation (EU) 1881/2019 of 3 December 2018 - amending Regulation (EC) No 1907 / 2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances.
2019-11-27 / EVALUATION CB
CB listed on CoRAP; start of the evaluation was postponed to 2022 (Draft Community Rolling Action Plan (CoRAP) update for years 2020-2022 Echa Europe Information)
2019-04-17 / NEW SIEF INFORMATION LETTER
Compliance of the Carbon Black REACh dossier with the amendments for nanomaterials in accordance with COMMISSION REGULATION (EU) 2018/1881
ECHA prepared a draft decision on a compliance check
2018-10-22 / EVALUATION CB
CB listed on CoRAP; start of the evaluation 2021
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.