New Substances Notification   

What Substances Must be Notified?

If you sell a substance (chemical, polymer or organism) considered new to a particular regulatory jurisdiction, most jurisdictions require you to submit a notification package to the government of that jurisdiction that contains all the necessary information specified in the government’s Regulations.

The notification requirements vary by regulatory jurisdiction. In most jurisdictions the amount of information required for notification packages increases as the sales volumes increase.

GLOBALTOX can design your regulatory package in such a way as to maximize its utility for notifications in all the regulatory jurisdictions in which your substance will be sold. We can assist in the notification of new substances in Canada, the US, Europe and Australia.

Domestic Substances List (DSL) in Canada

In Canada the Canadian Environmental Protection Act of 1999 (CEPA '99) requires the submission of testing data and other technical and administrative information to Environment Canada and Health Canada for all chemicals, polymers and organisms that are new to Canadian commerce. The amount of information and data required depends on the sales volume of the new substance. As the sales volumes increase to increasing "trigger points" more data is required until the largest "trigger point" is reached and the substance is placed on the Canadian Domestic Substances List (DSL).

GLOBALTOX can assist with meeting these notification requirements through the following services:

• Determination of the appropriate information requirements;
• OECD GLP physical/chemical, toxicological and ecotoxicological testing services
• Waiver development;
• Use of alternative procedures and surrogate data, where appropriate;
• Completion and pre-screening of notification packages;
• Coordination of communications with government agencies, including pre- and post- notification consultations; and,
• Ensuring the testing is done in such a way as be acceptable in other jurisdictions where notifications may be filed.

US Toxic Substances Control Act Chemical Substance Inventory

In the United States, the Environmental Protection Agency (EPA) requires information to be submitted for substances that are new to US commerce through the US Pre-Manufacturing Notice (PMN). There are some exemptions from this requirement (most notably polymers of low concern). The US EPA only requires test data to be generated for special circumstances because it evaluates the submitted information and chemical properties primarily through internal resources. The evaluation will lead to a placement of the substance on the Toxic Substances Control Act's (TSCA) Chemical Substances Inventory.

GLOBALTOX can assist with meeting these notification requirements through the following services:

• Determination of the appropriate information requirements;
• Preparation of Pre-Manufacturing Notices;
• Preparation of PMN exemptions;
• Evaluation of polymers for the low polymer exemption; and,
• Coordination of communications with government agencies, including pre- and post- notification consultations.

REACH

On December 18, 2006, the European Council officially adopted the Registration and Authorization of Chemicals (REACH) Framework for the management of chemicals within the European Union (EU). The aim of this framework is to enable better characterization and understanding of the properties of chemicals while encouraging and enhancing the EU chemical industry. Related regulations come into force on June 1, 2007. The overall implementation schedule for REACH carries over several years (2007 - 2018) and involves several key elements with consideration for hazard and volume of use. Compliance may require the submission of testing data and other technical and administrative information to the European Council.

GLOBALTOX can assist with meeting these notification requirements through the following services:

• Determination of the appropriate information requirements;
• OECD GLP physical/chemical, toxicological and ecotoxicological testing services;
• Waiver development;
• Use of alternative procedures and surrogate data, where appropriate;
• Completion and pre-screening of notification packages;
• Coordination of communications with government agencies, including pre- and post- notification consultations; and,
• Ensuring the testing is done in such a way as be acceptable in other jurisdictions where notifications may be filed.

Australia's National Industrial Chemical Notification and Assessment Scheme (NICNAS)

Australia’s NICNAS and Canada's New Substances Notification Regulations fall under a bilateral agreement whereby any submissions made to the Australian authorities that have already undergone review in Canada, will be deemed to be essentially "reviewed" under the NICNAS assessment. The notifier, however, is still required to meet all the NICNAS data requirements. As for many other jurisdictions, Australia has requirements that become more data intensive as sales volumes increase.

GLOBALTOX can assist with meeting these notification requirements through the following services:

• Determination of the appropriate information requirements;
• OECD GLP physical/chemical, toxicological and ecotoxicological testing services;
• Waiver development;
• Use of alternative procedures and surrogate data, where appropriate;
• Completion and pre-screening of notification packages;
• Coordination of communications with government agencies, including pre- and post- notification consultations; and,
• Ensuring the testing is done in such a way as to be acceptable in other jurisdictions where notifications may be filed.