PPORD

Summary

If your substance is subject to product and process orientated research and development (PPORD), you can submit a PPORD notification to ECHA in order to be exempted from the obligation to register.

You first need to be signed in REACH-IT.

Prepare your notification with the latest version of IUCLID 5 and submit it via REACH-IT.

Preparing and submitting a dossier

  1. Read the relevant manuals.
    - Data Submission Manual 1: How to prepare and submit a PPORD notification
    - Data Submission Manual 4: How to Pass Business Rule Verification ("Enforce Rules")
    - Data Submission Manual 5: How to complete a Technical Dossier for Registrations and PPORD Notifications
  2. Create your PPORD notification dossier in IUCLID 5.
  3. Use the IUCLID 5 technical completeness check plug-in to detect any missing information and pre-check certain 'Business Rules'.
  4. Apply the IUCLID 5 fee calculation plug-in to estimate the fee associated to your PPORD notification dossier.
  5. Submit your PPORD notification dossier via REACH-IT.

For Step by step instructions read the REACH-IT Industry User Manual - Part 6: Dossier Submission

ECHA will provide the PPORD notification number after verifying the completeness of the information and the payment of the relevant PPORD fee.

Preparing and submitting a dossier to request a PPORD extension

A request for extension of a PPORD shall be created in IUCLID 5 as a spontaneous update of the current notification and then be submitted through REACH-IT.

NB: please submit your request at least four months before the end of your exemption and ensure payment of the fee within 30 days to guarantee the timely processing by the Agency before the expiry date.

When preparing your dossier in IUCLID 5, please follow these instructions:

  1. Attach a document justifying the request for extension to section 1.9 "Product and process orientated research and development" of IUCLID 5. A template for providing information about the research and development programme and reasons for request for extension (see Related documents below) needs to be provided.
  2. Create your dossier. At step 6 of the IUCLID dossier creation wizard, please tick the box "The submission is an update" and then insert the last submission number related to the PPORD notification you are requesting an extension for ("Last submission number" field).
  3. Tick the box "Spontaneous update".
  4. Click the green cross button to create a new repeatable block of information.
    NB: In that block, it is mandatory to select "prolongation of the exemption period for PPORD" as the justification for the update. In case this information is not properly selected the update will not be processed as a request for extension.
  5. Use the IUCLID 5 technical completeness check plug-in tool to ensure no information is missing.
  6. Apply the IUCLID 5 fee calculation plug-in to estimate the charge associated to your request for extension of PPORD exemption.

Please consult Figure 64 of "Data Submission Manual Part 01 - How to prepare and submit a PPORD notification", if you need further clarification.