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).
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.