What is PPORD notification?
Article 3(22) of REACH outlines that ‘product and process orientated research and development'(PPORD) 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 productions process and/or to test the fields of application.
Substances used for the purpose of PPORD will be exempted from REACH registration for 5 years. However, companies shall submit PPORD notifications to ECHA.
PPORD notification: what information is required?
Article 9(2) of REACH outlines that the following information is required for a PPORD notification:
- the identity of the manufacturer or importer;
- the identity of the substance;
- the classification of the substance;
- the estimated quantities;
- the list of customers (including names and addresses).
PPORD notification: typical process
To complete PPORD notification, a dossier needs to be made by software called IUCLID 6 and submitted to the European Chemical Agency for evaluation. In order to complete this process the following typical steps need to be carried out:
- Create the legal entities of the PPORD notifier and its customers;
- Create the reference substances related to the PPORD substances;
- Create the substance dataset for the PPORD substance;
- Create the PPORD notification dossier;
- Export the PPORD dossier from IUCLID 6 and submit dossier to ECHA via REACH-IT;
- ECHA will undertake a completeness check of the dossier;
- ECHA provides a notification number once PPORD fee has been received and dossier has passed TCC (technical completeness check).
PPORD notification: how much does it cost?
The total registration costs mainly consist of two parts:
A. Consultancy fees paid to consultancy firms to advise the whole PPORD notification process, gather data and prepare notification dossier in IUCLID 6.
B. ECHA fees paid to European Chemical Agency. The fee is dependent on the size of the company. Small and medium-sized enterprises (SME) enjoy discounts on ECHA fees (Euros).
SME criteria are listed as below:
Chemical Inspection and Regulation Service (CIRS) is a leading product safety and chemical management consulting firm providing valued product regulatory compliance service, tailored solutions and original information to help clients gain competitive advantage by reducing business risks associations with regulatory affairs and removing barriers to entry. CIRS has provided cost-effective regulatory support to over 4,000 companies while doing businesses in both the EU and China. CIRS is the largest REACH only representative in the world. Since 2007, we have:
- pre-registered over 10,000 substances;
- registered over 1,000 substances;
- served as lead registrant for over 100 substances;
- prepared over 5000 REACH SDS and CLP labels to date;
- acted as only representative for over 4,000 non-EU companies;
- served clients in more than 25 countries;
CIRS is a recommended service provider by China Inspection and Quarantine Bureau, the US Mission to the EU and IDA. CIRS is also a member of Helsinki REACH Centre.