Procedure for reporting new uses and updates
The Nickel REACH Consortia has established a voluntary procedure to update all the REACH registration dossiers on a regular basis. These updates are based on two levels of priorities set by the Consortia members. According to these priorities, the most urgent updates (including the incorporation of new exposure scenarios to cover new identified uses, new DNELs or PNECs) are submitted every year. Other updates, such as the inclusion of new exposure data in the existing exposure scenarios, will be updated every two years.
In addition, a complete revision of all the exposure scenarios has been in 2017 for all the uses and substances covered by the Nickel REACH Consortia. The collaboration of manufacturers and downstream users is crucial to improve the exposure scenarios.
Conditions for including new ES and updating existing ES
The Nickel REACH Consortia dossiers will be updated in Q1 each year. Therefore any new uses to be covered in the next update need to be reported in the previous calendar year. See below the conditions for including new ES and updates to current ES in the Dossiers.
Conditions for inclusion of New ES
- New uses must be reported to the Nickel Consortia Secretariat at least 6 months before the beginning of Q1 of the year when the dossier update will be submitted. To guarantee that a new use is included in the dossier for the next update, it must be reported by June 1 of the previous year. For example, new uses to be included in 2022 must be reported no later than June 1, 2021.
- To guarantee inclusion in the Dossier, new uses must be reported by filling in this questionnaire.
- The Nickel Consortia Secretariat will verify first that this ES is not already covered by an existing ES. If the reported use is similar to an already identified use, we may consider grouping the two together and modifying it accordingly.
- The DU/Manufacturer must remain available to actively participate in the drafting and approval of the ES.
Conditions for updating current GES:
- Consortia members and DUs can submit additional information to be considered for updating existing ES until September of the previous year.
- New information may include: new monitoring data, revised information for modelling either for environmental/human health exposure (e.g. tonnage, use descriptors, risk management measures) or additional activities/processes not yet covered under a current ES.
- Monitoring data, in particular at the workplace, is very useful to develop good quality exposure scenarios. If you plan to collect workplace monitoring data, please read our Guidance for collection of inhalable and respirable Ni in dust.
- The Nickel REACH Consortia Secretariat is also gathering information on tonnages per use and per compositional profile at each site with the aim to reduce the risk of prioritisation for further regulatory risk management measures based on worst-case assumptions or unrealistic overestimations. We therefore encourage all EU manufacturers, importers and downstream users of nickel substances (or their mixtures/alloys) covered by the Nickel REACH Consortia to complete this questionnaire and send it to EBRC (email@example.com) and/or to the Nickel Consortia Secretariat firstname.lastname@example.org. Please note that your data will be handled as strictly confidential. If you encounter any problems while filling in your data or if you have any questions, please do not hesitate to contact us.