Seminars 2024

IUCLID Seminar for REACH, 2-day seminar: 12th/13th of November 24 in Dresden  

Avoid accidents: HAZOP/ LOPA/ Human Factors/ Functional Safety Seminar;

Reach PPORD Service

 

There is the possibility of notification of ECHA of PPORD (Product and Process Oriented Research and Development) if the substance is manufactured / imported and used for scientific research and development. Such substances are exempted from the obligation to register twice for 5 years (for the second PPORD notification 10 years apply in case of the development of medicinal products). For quantities below one tonne per year there is no need for registration. Yearly tonnages of more than one tonne can be exempted if notified to the ECHA if the substance is used for product and process oriented research and development and it is not yet intended to be placed on the EU market to an unlimited number of customers.

PPORD = according to Art. 3 (22): "product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;"

The following applies for Importers/ Non-EU manufacturer (and its only representative):

The registration does not apply for 5 years (with a possible extention) to the importer/ only representative) in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development.

Data requirements for a PPORD:

For a PPORD less data on the substance is necessary (as per REACH Article 9). In case this substance is listed on ELINCS you have time to prepare the registration dossier and agree on usage of data from vertebrate tests from the competitor (the other registrant).

Our team will clarify if you meet the provisions for a PPORD notification for your substances.

For a quotation on our competent PPORD notification please contact us.