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Substances manufactured or placed on the market at or above 1 tonne/year in the EU and UK must be registered with the agency unless exempted due to an obligation. One such exemption applies when a substance is used solely for product and process-orientated research and development (PPORD). According to REACH, PPORD consists of any scientific development related to product development or the further development of a substance, on its own, in mixtures or in articles in the course of which trials are used to develop the production process or to test the fields of application.

Substances used for the purpose of PPORD may be exempted from REACH Registration for 5 years. However, to benefit from this exemption, a PPORD Notification must be submitted to the agency.

In the PPORD Notification, companies have to include:

• information on the substance identity,

• the hazard classification of the substance,

• the identity of the manufacturer or importer;

• the quantity of the substance expected to be manufactured or imported during the five-year period of exemption

• the list of recipients (including names and addresses), if made available to third parties

• a description of the PPORD activity

• a copy of the Safety Data Sheet provided to recipients, where relevant

PPORD Notification: typical process

To complete a PPORD Notification, a dossier needs to be prepared in the IUCLID software and submitted to the agency for assessment. In order to complete this process the following typical steps need to be carried out:

• Create a PPORD Notification dossier with all of the required information;

• Export the PPORD dossier from IUCLID 6 and submit a dossier to the agency via the online platform;

• The agency will undertake a completeness check of the dossier;

• Notifier will need to pay a PPORD fee which will be invoiced by the agency;

• The agency provides a PPORD Notification number once the fee has been received and the dossier has passed TCC (technical completeness check).

How can Yordas help?

At Yordas, our team of experts can help your business submit a successful PPORD Notification that consists of the following activities:

• Advise on whether the proposed activity falls within the scope of PPORD

• Discuss substance identification methods and strategy

• Provide guidance on hazard classification and labelling

• Create reference substances to name and identify the material that is the subject of the PPORD

• Author the Substance Dataset for the PPORD Notification using IUCLID and generate the final Dossier.

• Submit the dossier to the agency.

• Help to manage prompt payment to the agency where necessary

• Advise on any questions or required modifications raised by the agency

• Update and re-submit the PPORD Notification as scientific development proceeds (or ceases) and the customer base expands

For more insight into PPORD Notifications, you can sign-up for our PPORD Notifications for EU and UK REACH webinar here. To begin the PPORD Notification process for your business, you can contact us here.