Application and assessment procedure

Companies will use electronic submission tools to apply for technical equivalence. Applications are submitted to ECHA through R4BP 3 as a IUCLID file.

This graph shows an overview of the application procedure for technical equivalence. 

 

Steps

The application process has several steps. Each step needs to be completed before the application can move to the next step. It is important that the applicant makes sure that all applicable deadlines are met otherwise the application will be rejected during the course of the process.

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ECHA checks that the application and data have been submitted in the correct format and sends the fees invoice through R4BP 3.

 
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The applicant pays the related fees to ECHA within 30 days from the invoice date.

 
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ECHA accepts the application and starts to assess the technical equivalence.

 
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If additional information is needed to carry out the assessment, ECHA will ask for the missing information from the applicant. At the same time, ECHA will specify a time limit for the applicant to submit this information.

 
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The applicant is given the possibility to comment on the outcome of the assessment.

 
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ECHA will take the final decision within 90 days from the payment of the application fee. If additional information was requested from the applicant during the process, the 90-day period will be suspended from the date when the request for further information was sent to the applicant until the information was received. The suspension may exceed 180 days only in exceptional circumstances.

 

Actors

The main actors in the dossier submission process are:

Applicants

Applicants have the responsibility to provide dossiers with all relevant information related to the technical equivalence assessment and to provide additional information if requested by ECHA. Applicants are responsible for the quality and format of the data in their dossiers.

ECHA

ECHA is responsible for checking that the information in the dossiers is in a correct format. ECHA also carries out the assessment of the technical equivalence dossiers and makes sure that the submission process proceeds within the set timelines.
 

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