What happens after the Registration?

Once your substance is registered, it does not mean that REACH obligations are over.

 

Dossier Maintenance

Article 22.1 of REACH requires registrant to update their registration dossiers without undue delay with relevant new information related to changes in status of the registrant, substance composition, uses, or any new data related to the hazard classification or potential risk of the substance to human health or environment.

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 Nickel REACH Consortia decided to voluntary 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, all the following updates are submitted every year:

  • Updates to compositions affecting classification 
  • Updates to classification & labelling following new classification rules (e.g. new CLP guidance)
  • Incorporation of new ES to cover new uses
  • Update to existing DNELs
  • Update to existing PNECs

Every two years, the following updates are included in the Registration dossiers:

  • Literature review and inclusion of new study records 
  • Updates to compositions not affecting classification 
  • New compositions not affecting classification          
  • Update of existing ES to include new exposure data

If you wish to report any new uses or submit new information on exposure, please visit the section Procedure to report new uses and updates

 

RMO analysis

When ECHA or authorities identify a potential concern resulting from the use of substances with certain hazardous properties, they can take several steps to clarify the concern and decide on the need to take regulatory measures. A Risk Management Option Analysis (RMOA) can then be carried out to help decide whether further regulatory risk management activities are required for a substance and to identify the most appropriate instrument to address a concern. RMOAs can conclude on a recommendation to apply regulatory instruments foreseen in REACH, CLP or other legislation. It can also conclude that no regulatory action is needed.  

In this context, three EU Member States (France, Germany and Hungary) have carried out RMOAs for nickel compounds. These RMOAs are representative for other nickel compounds. Nickel metal is not concerned by this process because it has a lower hazard classification. As a result of the RMOA process, the EU is prioritizing the setting of a binding Occupational Exposure Limit Value (binding OEL) as the most appropriate risk management measure for nickel compounds. Other regulatory risk management measures (e.g., Candidate Listing, restrictions or authorization) are not foreseen for nickel compounds.

For more information on the RMO Analysis on nickel compounds, please visit the dedicated page on the Nickel Institute website.

 

Evaluation

ECHA and the Member States evaluate the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.

Evaluation under REACH focuses on three different areas:

  • Examination of testing proposals submitted by registrants
  • Compliance check of the dossiers submitted by registrants
  • Substance evaluation

Once the evaluation is done, registrants may be required to submit further information on the substance.

For detailed information on the Evaluation process, visit the dedicated section on ECHA website.