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- Guest column: REACH 2018 - time is not on your side
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Article related to: REACH
Are you using chemicals for innovation?
One of the aims of the REACH Regulation is to encourage innovation. To help achieve this aim and to encourage innovating companies, chemicals intended for 'product and process orientated research and development (PPORD)' can be exempted from the obligation to register for five years.
Chemicals used in scientific development related to product and process innovation or further development of a substance may fall under the PPORDs definition. However, a substance used in a PPORD activity must not reach the general public at any time - they must be used for research alone.
PPORD substances are also subject to legislation that covers worker and environmental protection, and so ECHA may demand more information and impose conditions on use to make sure that these objectives are met.
Companies that want to benefit from the exemption must submit a PPORD notification to ECHA. This notification is very easy to prepare, with only little information required.
By submitting a notification, companies can get a five-year exemption from registration, which can be extended, on request, for another five years and in special cases for an additional 10 years. However, while doing the research and development work, the notifier may develop sufficient knowledge of the substance and the market leading him to decide to follow up with a REACH registration.
The initial notification should include at least the following information:
- the name of the manufacturer or importer;
- the identity of the substance;
- the classification of the substance;
- the estimated quantities to be used (during the five-year period);
- the list of customers (including names and addresses).
However, the information needs are greater if the notifier wants a prolongation of the exemption period for their PPORD notification. They will need to submit a research and development programme with sufficient information to justify their request.
How to prepare and submit a PPORD notification
Before getting started, have a look at the following manuals on ECHA's website:
- 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
1. Create your PPORD notification dossier in the latest version of IUCLID 5
Use the IUCLID 5 validation assistant plug-in (former technical completeness check plug-in) to detect any missing information and to pre-check that your dossier meets the basic 'business rules'.
Apply the IUCLID 5 fee calculation plug-in to estimate the fee to be paid for your PPORD notification dossier. The fee depends on the size of your company. Small and medium-sized enterprises (SMEs) benefit from lower fees.
|PPORD fee payable to ECHA||500 euros||350 euros||200 euros||50 euros|
2. Sign-up and submit your PPORD notification dossier through REACH-IT
If you do not already have a REACH-IT account, you need to create one. For step-by-step instructions, read the REACH-IT Industry User Manual – Part 6: Dossier Submission.
3. Follow-up your PPORD notification in REACH-IT
To complete your notification, you need to pay the invoice you receive through REACH-IT.
ECHA will provide the PPORD notification number after verifying the completeness of the information and the payment of the relevant PPORD fee.
If you need to submit new information or are planning to request an extension to your PPORD, you need to update the current notification in IUCLID 5 and then submit it to ECHA through REACH-IT.
If an update is submitted to request an extension, it should be done at least four months before the end of your exemption and the fee should be paid within 30 days to guarantee that the Agency has time to process it before the expiry date. More information about how to request a PPORD extension is available on ECHA's website.
Restrictions and authorisations may also apply to PPORD chemicals
Substances intended to be used for PPORD that are included in the Authorisation List (Annex XIV of REACH) and in the list of restrictions (Annex XVII of REACH) are subject to authorisation and restriction requirements unless the use for PPORD is specifically exempted.
Information on PPORD exemptions from authorisation is provided in the ‘exempted uses' column of the Authorisation List, while exemptions from restrictions as well as the maximum quantity exempted, are specified in the restriction entries of Annex XVII.
Additional information is available in the authorisation and restriction web pages on ECHA's website:
- PPORD exemption
- Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD)
Did you know?
REACH allows an exemption from registration for substances manufactured or imported at or above one tonne per year, for the purposes of product and process oriented research and development (PPORD).
Substances used for the purpose of PPORD will be exempted from REACH registration for five years. However, companies need to submit a PPORD notification to ECHA. Notifications can be extended for another five years (or in special cases as for medicinal products, for another 10 years), if proper justification is provided.
Article 3(22) of REACH outlines that ‘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 productions process and/or to test the fields of application'.
Workshop held on PPORDs
From 23 to 24 January 2014, ECHA hosted a workshop with Member State competent authorities to discuss the application of REACH requirements for PPORD notifications.
Since 1 June 2008, more than 1 200 PPORD notifications have been submitted and the Agency has now assessed a vast majority of them. ECHA has also prepared the implementation of two processes related to PPORDs.
The current processes are the result of ECHA assessing PPORD dossiers and of a pilot project set up with four volunteer Member States, which aimed at implementing a decision-making process for PPORD notifications.
In relation to both processes, REACH requires that the Agency will consult on any draft decisions imposing conditions or extending the exemption period. Comments made by the competent authorities of the concerned Member States will be taken into account by the Agency when making its final decisions. ECHA and the MSCAs will be cooperating to ensure that the key objectives of REACH - the protection of human health and environment - are upheld.
During the workshop, Member State competent authorities were informed of the PPORD processes and the principles applied. In particular, Member State competent authorities provided their feedback about:
- The assessment methodology and criteria used to identify PPORD notifications for further consideration;
- The request for further information on a PPORD notification;
- The conditions to be imposed on a PPORD notification; and
- The principles to justify an extension to be granted.
Text by Hanna-Kaisa Torkkeli and Rossella Demi
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Committee for Risk Assessment:
Committee for Socio-Economic
Biocidal Products Committee:
Member State Committee:
4-8 February (tentative)
Management Board meeting: