REACH Consortia for Industrial Minerals
The REACH Regulation, (EC) No 1907/2006, concerns the Registration, Evaluation, Authorisation and Restriction of Chemicals and entered into force in June 2007. All manufacturers and/or importers of chemical substances in the EU, i.e. boric acid and calcium oxide, in quantities exceeding one tonne per year, must submit a registration dossier to the European Chemicals Agency (ECHA). However, naturally occurring substances not chemically modified are exempted from REACH, and this is the case for most industrial minerals in the IMA-Europe portfolio.
The REACH Regulation requires companies registering the same substance to share data and jointly submit their registration dossier, following the “one substance, one registration” principle. ECHA has established the Substance Information Exchange Forums (SIEFs), which automatically groups companies who have pre-registered a substance to facilitate sharing information and avoid duplication of new studies. Companies, usually several SIEF members, group and voluntarily form a Consortium to organise the work needed to prepare the registration dossier with legal certainty.
Why is it important?
For the industrial minerals falling under the scope of REACH, IMA-Europe created the following REACH Consortia to help companies meet their obligations:
- REACH Consortium for Bentonite acid-leached
- REACH Borates Consortium
- REACH Consortium for Calcium Carbonate
- REACH Consortium for Kieselguhr soda ash flux-calcined
- REACH Lime Consortium
- REACH Consortium for Potassium Borates
As the Consortia coordinator, the Secretariat submits the joint registration dossier on behalf of the Lead Registrant (LR) to ECHA. The registration dossier must contain the Chemical Safety Report (CSR), which includes information on the chemical safety assessment of the substance, such as risk characterisation and exposure assessment concerning workers, consumers and the environment.
For the legal entities (manufacturers, importers, only representatives), who wish to register the substances covered under these Consortia, IMA-Europe provides them with the Letter-of-access (LoA), which gives them the right to refer to the joint registration dossier and its data. The LoA agreement is determined in a fair, transparent and non-discriminatory way, following the key principles for data-sharing and joint submission.
IMA-Europe encourages the legal entities to join the existing joint registrations to increase the efficiency of the registration system, reduce costs, and prevent duplicate testing, especially on vertebrate animals.
The Secretariat follows regulatory and scientific developments to ensure that the registration dossiers are compliant with the respective regulations and ECHA guidance documents and contain up-to-date information, notably newly available information regarding the health and safety of humans and the environment. IMA-Europe assesses yearly the need to update the joint registration dossiers and updates the dossiers based on Article 22 (1) of REACH and the Commission Implementing Regulation (EU) 2020/1435. This is managed with collaboration between the LR, the Consortium members and the co-registrants.
Finally, IMA-Europe co-operates with other industry REACH Consortia and shares know-how and experience on technical and administrative issues to ensure smooth and effective dossier updates. IMA-Europe is committed to continuously improving registration dossiers and securing a safe and sustainable use of chemicals.