OECD Parallel Process
OECD Parallel Process under its clearing house on new chemicals
The Organisation for Economic Co-operation and Development (OECD), through its Clearing House for New Chemicals, has encouraged efforts to maximise work-sharing arrangements in notifying and assessing new industrial chemicals, with a goal of Mutual Acceptance of Notifications. The Parallel Process was developed to facilitate these multilateral arrangements.
The Parallel Process reduces the time required for notifying new industrial chemicals to multiple jurisdictions. This work-sharing process also aims to improve decision making by sharing knowledge and expertise in the area of new chemical assessments, increasing work efficiencies among OECD member countries, and building on the efforts of all countries involved. Procedures are in place for confidentiality.
In the Parallel Process, a company notifies a new chemical to multiple jurisdictions (of their choice), providing an agreed set of data to all participating countries, namely, a lead country and secondary countries. In principle, the lead country conducts the hazard assessment, secondary countries provide input into the process, and then—once the hazard assessment is accepted by the notifier—each participating country uses the hazard assessment in conducting its own risk assessment.
Phases of the Parallel Process
The Parallel Process consists of 3 phases: Pre-notification, Notification and Assessment. These phases are described here.
1. Pre-notification phase
You identify and contact the potential lead country authority seeking their agreement to participate and be the lead authority. You then contact other selected country authorities seeking their agreement to participate as secondary countries. If any authority declines to participate, you revise your plans accordingly.
You can also identify countries to engage as observers. Observer status allows a country to receive information and monitor how assessments are conducted and provide informal input on the hazard assessment, without affecting the timing or content of the process.
In preparing for a Pre-Notification Consultation (PNC), you gather a draft Pre-determined Set of Information (PSI) for the chemical, based on the type of chemical, the quantity being introduced, and also the way that it will be introduced and used within the jurisdictions. While the PSI will be proposed by you on a case by case basis, it should be guided by the OECD Minimum Pre-marketing Dataset (which is similar to the standard NICNAS notification package). You may need to revise the PSI after PNC discussions.
You provide the draft PSI package to all participating authorities before the PNC so they can review it. The lead country chairs the PNC meeting, or teleconference, to lead discussion of the PSI and seek agreement on its content. The decision to accept any proposed testing and approaches—including how they satisfy participating country's jurisdictions—may require more than one meeting or teleconference before final acceptance by all countries. Participants are expected to work promptly to complete this process, within a timeframe agreed at the start of the PNC process.
2. Notification phase
You submit your notification package to the lead country, including any specific notification form required and payment of fees. The lead country assesses the notified substance within the legally required assessment time clock, following their national regulatory assessment procedures.
3. Assessment phase
The lead country prepares a draft hazard assessment report and sends it to secondary countries for comment. The lead authority develops a second draft hazard assessment incorporating comments as appropriate.The lead country issues this to you for comment, and then finalises and distributes the report to you.
After receiving the final hazard assessment, you supply national notification forms and the completed collective hazard assessment to all secondary countries, with fees required by them (although commonly notification forms and secondary country specific information—such as environmental release and occupational exposure data—are submitted to the secondary countries earlier).
Normal fees apply if Australia is the lead country. A reduced fee applies if Australia is the secondary country—contact NICNAS for further details. No fee applies if Australia is an observer only.
Last update 29 July 2018