ECHA: Companies Must Update Their Registration Dossiers at the Start of the CORAP Substance Evaluation Process

The ECHA has increased the pressure on companies to comply with Article 22, Section 1 of REACH – so that each is “updating his registration without undue delay with relevant new information and submitting it to the Agency.” The ECHA is applying the push for compliance as part of the substance evaluation process.

The Agency is requiring companies affected by the update of the CORAP list to update their dossiers without delay. Doing so allows the national agencies of the member states that perform the evaluations to include this information in their 12-month evaluation (step one of the substance evaluation process). Once the Agency has created a draft decision, it will not consider updates after April 14, as it announced in a press release.

If registrants obtain new information on the substance after receipt of the draft decision, they can add it to the draft decision as a commentary. According to the press release, the Agency will consider the commentary and modify the draft decision if necessary.

The chemicals being evaluated are those on the CORAP list and potentially pose a risk to human health or the environment. The ECHA recently updated the list. Evaluation occurs according to the following model:   

  • Step 1: The responsible national agency evaluates the chemical. The result can be a conclusion (the information available is enough to overcome any concerns) or a decision that additional information is necessary. 
  • Step 2: The draft decision is transmitted to the registrant of the substance.  
  • Step 3: The registrant must submit the required information in a timely manner. 
  • Step 4: The information is evaluated. The chemical is then reclassified, its use is restricted or even
    prohibited, or more information is required. In the last case, a second draft decision is needed, and the decision-making process is repeated. 

If companies fail to provide the required information, they face the threat of national enforcement actions and/or regulatory risk management measures.

For more information on the substance evaluation and how registrants can approach it, see the updated Registrant’s guide – How to act in substance evaluation, published by the ECHA in April.

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