Overview of international assessment options

Overview of international assessment options

There are several options from which notifiers can choose when seeking to submit a new chemical for assessment.

Overview of options for use of overseas assessments and international work-sharing in NICNAS new chemicals

Option

Approved Foreign Scheme— Canada only

Modular notification
(comparable agency)— Canada

Modular notification
(comparable agency)— United States

Modular notification (comparable agency)— European Union

OECD Parallel Process (work-sharing)

Status of chemical overseas

Previously assessed as a new chemical in Canada (Environment and Climate Change Canada)

Previously assessed as a new chemical in Canada (Environment and Climate Change Canada)

Previously assessed as a new chemical in the United States (US EPA)

Previously assessed as a new chemical in EU (ELINCS)

Does not apply to REACH

Planned to be notified in two or more OECD countries

Linkage with company in overseas country

Required-

Canadian notifier authorises release of Canadian reports to NICNAS

Required-

Canadian notifier authorises release of Canadian reports to NICNAS

Required-

United States notifier authorises release of US EPA information to NICNAS

Required-

EU notifier provides assessment report and letter of validation from EU authority to NICNAS

Required-

co-notification involves relevant government and industry representatives

NICNAS assessment category

STD, LTD or PLC

STD, LTD or PLC

STD, LTD or PLC

Usually STD or LTD

STD, LTD or PLC

Timing

Request to Environment and Climate Change Canada 60 days before notification to NICNAS

Request to Environment and Climate Change Canada 60 days before notification to NICNAS

Report provided to NICNAS before the start of NICNAS assessment

Report and validation letter to be provided to NICNAS at time of notification

Depends on preparation of hazard assessment by lead country

Other requirements

Conditions apply, including that the chemical must have been assessed in Canada in a comparable assessment category to that of the NICNAS notification

Can be used if requirements for Canada Approved Foreign Scheme are not met (for example, if notification is not in a comparable assessment category)

Of most benefit if assessed in a comparable assessment category

Dataset acceptable to all countries agreed during the process

Benefit to introducers

Specific Approved Foreign Scheme upfront fee applies. Assessment time frame reduced to 60 days instead of 90 days.

Specific modular (comparable agency) upfront fee applies

Specific modular (comparable agency) upfront fee applies

Specific modular (comparable agency) upfront fee applies

Usual upfront fee applies if Australia is the lead country. Otherwise a reduced fee applies (contact NICNAS for details)

Last update 8 April 2019