Procedure for reporting new uses and updates

Introduction

Article 22.1 of REACH requires the registrant to update their registration dossier without undue delay with relevant new information and to submit it to ECHA. The main changes which need to be submitted to ECHA are related to changes in status of the Registrant, substance composition, identified uses or uses advised against, knowledge regarding the risk of the substance to human health or environment, and classification.

In addition, Article 22.2 states that a registrant can be requested by ECHA to update their dossier following Evaluation or Authorisation procedures by a deadline specified in the decision. In case of Evaluation (Article 42) or Authorisation (Article 65), it is worthwhile to always have available an up-to-date registration dossier reflecting the most accurate and recent knowledge of the substance.

Therefore, the Ni REACH Dossiers will be updated annually on a voluntarily basis to include any new data on Nickel and its compounds registered by the Ni Consortia. This includes new reported uses or effects data or information resulting in updates to existing GES. For any new uses reported, a generic exposure scenario (GES) must be drafted for inclusion in the updated CSR and sent to DUs via the eSDS.

 

Annual update of the exposure part of the registration dossier

Summary of the approval process and timing for annual updates

DATE	ACTIVITY	RESPONSIBILITY
July 1st	Final deadline to report new uses	Company/DU association
July – October	Drafting of exposure assessment reports	Nickel REACH Consortia Secretariat
September	Deadline to provide additional data for updating existing GES	Company/DU association
Nov-Feb	Drafting and review of New GES and updates to existing GES*	Nickel REACH Consortia Secretariat
March	Inclusion of new GES and updates in CSR/IUCLID	Nickel REACH Consortia Secretariat
April	Final approval of Dossiers from WG, ST, GA by written procedure, by conference call or during a meeting.	Nickel REACH Consortia members
May	Lead Registrant to receive final Dossier to submit update to ECHA	Nickel REACH Consortia Secretariat

* A comment period will also be scheduled for company/DU association and members of the Consortia

 

Conditions for including new GES and updating current GES

Ni 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 GES and updates to current GES in the Dossiers.

 

Conditions for inclusion of New GES 

• New uses must be reported to the Ni Consortia Secretariat 6 months before the beginning of Q1 of the year to be included in the update. To guarantee a new use is included in the dossier for the next update, it must be reported by July 1^st of the previous year.  For example, new uses to be included in 2012 must be reported no later than July 1, 2011.

• 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 GES is not covered elsewhere or is not similar to an already identified use. If the reported use is similar to an already identified use with a GES, we may consider grouping the two together and modifying it accordingly.
• The DU/Producer must remain available to actively participate in the drafting and approval of the GES.   

Conditions for updating current GES: 

• Consortia members and DUs can have up until September 1^st of the previous year to submit additional information to be considered for updating a current GES.
• New information may include: new monitoring data, revised information for modeling either for environmental/human health exposure (E.g. Tonnage, PROC codes, RMM), additional activities/processes not yet covered under a current GES, and use descriptors
•  New data will be reviewed by the Ni Secretariat to determine if the new information will have an impact on the GES or not. For example:
  • If new information falls outside the current boundaries of the GES (i.e. operational conditions and RMM)
  • If a new activity reported is not covered by one of the contributing exposure scenarios
  • If measured data are provided to replace modeled data

Other reasons the GES may be updated:

• Change in DNELs/PNECs
  • PNEC finalized for sediment
  • Change in assessment factors 
  • New effects data
  • New EU OEL developments

• New/Revised models for predicting exposure
  • Updates to MEASE or DU scaling tools
  • New more robust models become available

• Addition of more metal specific/relevant use descriptors
  • E.g. additional PROC codes, updates in SPERCs