Canada Reach Regulation for Various Sectors

The Canadian Environmental Protection Act, 1999 (CEPA 1999) is an important part of Canada's federal environmental legislation aimed at preventing pollution and protecting the environment and human health. The goal of CEPA 1999 is to contribute to sustainable development that meets the needs of the present generation without compromising the ability of future generations to meet their own needs.

CEPA 1999 came into force on March 31, 2000 following an extensive Parliamentary review of the first CEPA.

CEPA 1999 contains significant improvements for the protection of the environment over the previous Act.

Introduction  to  New  Substances  Program  of  the Chemicals Management Plan : Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Government of Canada uses a preventative approach to managing the risks new substances may pose to humans or to the Canadian

environment. Under the New Substance Program, Health Canada, Environment and Climate Change Canada examine the potential risks to Canadians and their environment before the substances enter the Canadian marketplace.

The New Substances Program is responsible for administrating the New Substances Notification Regulations (Chemicals and Polymers) of CEPA 1999). These regulations were created to ensure that no new substances (chemicals, polymers or organisms) are introduced into the Canadian marketplace before undergoing ecological and human health assessments. A substance is considered to be new to Canada if it is not listed on the Domestic Substances List (DSL).

Canadian chemical substance list includes two parts: the Domestic Substance List (DSL), which records more than 23000 substances, and Non-Domestic Substance List (NDSL) which records almost 58000 substances.

DSL is used to identify whether a substance is classified as a new substance in Canada. If the substance is not on the DSL, the substance is regarded as a new substance. It shall be notified prior to manufacturing or importing. The NDSL determines the information to be provided. If a new substance is listed on the NDSL, a reduced data for notification may be required.

When to submit a New Substance Notification?

If your substance (s) unique identifier has been located on the DSL and is not subject to a "Flag":

• The substance can be imported or manufactured in Canada without notification to the NS
• If your substance unique identifier has been located on the DSL and it is subject to a Flag
• Notification to the New Substances Division of Environment and Climate Change Canada must be made prior to import or manufacture

it is subject to a P Flag and a RRR version of the polymer is proposed for import or manufacture

it  is  subject  to  an  S  Flag  and  it  is  not  proposed  for  a  Significant  New  Activity If your substance unique identifier has not been located on the DSL:

• An NSN Package must be submitted to the NS program prior to import or
• If you suspect the substance is on the confidential portion of the DSL you can submit a Confidential Search
• Exemptions and substances "Not Subject" to the Regulations.

If your substance falls under one of the following exemptions or exclusions, then notification under the Regulations may not be required:

• NS -Substances regulated under an Act listed in Schedule 2 or 4 of CEPA 1999
• NS -Transient reaction intermediates
• NS -Impurities
• NS -Incidental reaction products
• NS - Low volumes
• NS -Naturally occurring substances
• E - Substances carried through Canada
• E - DSL listed bio/polymers modified by & lt; 2% by weight
• E - mixtures (includes hydrates and alloys)
• E - Organism and micro-organism Research & for Development.

What is a new substance? A new substance is a substance that requires notification prior to import or manufacture and includes:

1. All substances that do not appear on the Domestic Substances List (DSL). There are some exemptions.

• Substances listed on the DSL with a "S" Flag. "S" Flag substances are proposed for a significant new activity and,
• Polymers listed on the DSL with a "P" Flag for which non RRR (Reduced Regulatory Requirement) version of the polymer is being proposed for import or manufacture

2. If your substance found not be found in any of the published databases: NDSL & DSL

The DSL is a compilation of all known substances that were in Canadian commerce between 1984 and 1986 or that are added to the DSL in accordance with the Canadian Environmental Protection Act, 1999 (CEPA 1999). The DSL is amended regularly.

We can check to see if a substance we wish to import or manufacture is already on the DSL, with P or S Flags, or not on the DSL, by viewing the DSL.

Exclusions from the Regulations:

Substances described by the following circumstances are not subject to the Regulations and are therefore excluded from notification.

A) Mixtures

Any mixture that is a combination of substances and does not itself produce a substance that is different from the substances that were combined.

Mixtures that are prepared formulations or reaction mixtures that are fully characterized in terms of constituent substances are not considered substances for the purpose of the Regulations and, consequently, do not require notification.

B) Manufactured Items

Any manufactured item that is formed into a specific physicals

Substances described by the following circumstances are not subject to the Regulations and are therefore excluded from notification.
1.    Mixtures
Any mixture that is a combination of substances and does not itself produce a substance that is different from the substances that were combined. Mixtures that are prepared formulations or reaction mixtures that are fully characterized in terms of constituent substances are not considered substances for the purpose of the Regulations and, consequently, do not require notification.
2.     Manufactured Items
Any manufactured item that is formed into a specific physical
3.    Wastes
4.    Substances carried through Canada 
5.    Polymers subject to 2% rule
6.    Proteins subject to 2% rule

Those required to notify under the revised New Substances Notification Regulations (Chemicals and Polymers) [NSNR (Chemicals and Polymers)] are any person who intends to import or manufacture a new substance in Canada (i.e. the Canadian Importer, the Canadian Manufacturer or the Foreign Importer of Record and their Canadian Agent.

Foreign Importer of Record and Canadian Agent - Definitions

A Foreign Importer of Record is a company or individual that does not have a permanent physical residence in Canada. A Canadian Agent is a legal entity (whether individual or company) that represents a Foreign company (known as the Importer of Record). The Canadian Agent must have a permanent physical residence in Canada.

With respect to notifying substances intended to be imported into Canada under CEPA, there are three relevant parties for purposes of this discussion:

(1) The notifier;
(2) the importer; and
(3) a Canadian agent (if needed).

• Corporate headquarters of the Canadian Manufacturer or importer (Principle area of Business in Canada)
• Foreign supplier – If the studies are carried outside CANADA
• If the notifier providing the NSN package is not a Canadian resident they must identify, the Regulations a Canadian resident who is authorized to act on their behalf as the “Canadian Agent”. All notices and correspondence from the NS program will be sent to the “Canadian Agent” and he or she will be required to keep the information and any supporting data for a period of five

NSN Package:

Submissions must be made on the NSN form, Form 04-2622E (04/2000). This form is divided into two sections: Part A addresses administrative information and substance identity, and Part B is for physiochemical and toxicity test results and associated technical information. In addition to the information required by Parts A and B, there are several other components to a complete NSN.

A complete NSN package must clearly substantiate confidential business information (CBI) claims and chemical identity masking requests. Estimates of manufacture or import volumes for three years, use, disposal, and information on the mode of transportation, and a Canadian material safety data sheet (MSDS) must be provided. A submitter must also identify any other governments that have reviewed the substance.

Overview of the New Substances notification (NSN) Assessment Process Assessment Period

The assessment period refers to the allotted time in calendar days that the NS program has to assess an NSN package.

Day 1 of an assessment period is the day on which the complete NSN package is received by the NS program. The starting day of the assessment period may be affected by missing or incomplete information. For example:

1. If an NSN package is submitted without the required fees or with an unacceptable method of payment for the fees , the entire package will be returned, and the assessment period will not begin until a corrected package is received;
2. If an NSN package is grossly inadequate or incomplete, the entire package will be returned, and the assessment period will not begin until a complete package is received;
3. If proprietary information is being sent directly to the NS program by a foreign supplier, the assessment period will not start until all the required information has been received;
4. If an NSN package is missing minor information, the notifier will be contacted to provide this information.
5. if, during the assessment period, minor information is found to be missing or erroneous, the assessment period will continue, provided the correct information is supplied by a date specified by the program (usually within a couple of working days); or
6. If during the assessment period, the information within the NSN package is found to be incomplete or erroneous the NSN package will be deemed incomplete and the assessment period will be restarted on day 1 once a complete NSN package has been

The assessment period will not begin until a complete package is received; after receiving a complete package foreign supplier will receive the followings:

Notice of Initiation

When a Foreign Supplier is involved in an NSN package the notifier must submit a partial NSN package to initiate the process. Initiation letters are issued to the notifier to acknowledge receipt of this partial information that is required to complete the NSN package. They are al

A rejection notice will be issued if the NSN package contains significant omissions or errors in the mandatory information requirements. This notice will describe all deficiencies in the NSN package. Original documentation may be returned. If the erroneous information is determined during the assessment period, the evaluators will attempt to contact the notifier by telephone to resolve the difficulties before a rejection notice is issued. If the file is rejected during the assessment period, the assessment period will be restarted on day 1 when the additional or corrected information is Received.

There are three possible outcomes of an assessment:

• There is no suspicion of toxicity, and no action is
• There is no suspicion of toxicity for the current activities associated with the substance, and a SNAc Notice is published for the
• There is a suspicion of toxicity, and risk management measures are

The notifier will be advised in writing, before the end of the assessment period or extended assessment period, if the NS program suspects that the substance is toxic or capable of becoming toxic, and what action will be taken. The notifier will also be advised in writing, before the end of the assessment period, if the NS program intends to develop a SNAc Notice in relation to the substance.

Payment must be made by certified cheque or money order (payable to the Receiver General for Canada), Visa, MasterCard or American Express at the time the service is requested. If the payment is not provided with the service request, the documentation will be returned and the service will not be rendered.

New Substances Notification Assessment Periods Assessment periods range from 5 to 75 calendar days, depending on the type and amount of substance being manufactured or imported. NSN packages must be provided prior to the number of calendar days prescribed and in advance of the prescribed trigger quantity being exceeded.

Schedule Numbers, Assessment Periods and Quantities Triggering the Requirement for New Substances Notification for Chemicals and Polymers There may be an additional assessment period for those substances that exceed 50, 000 kg/year if they meet one of the following criteria:

Releases anticipated exceeding 3 kg/day into the aquatic environment after wastewater treatment; or significant public exposure). If these criteria are not met, then Schedule 5 or 10 is the final requirement. E - Non-RRR polymers – Non-reduced Regulatory Requirement Polymers.

A separate Fee Form must be submitted for each NSN package, except for consolidated notification.

If the assessment period for the notified substance concludes or is terminated early, as indicated above, and the assessment of the substance determined that there is no suspicion that the substance is toxic or capable of becoming toxic, no action will be taken. A final assessment outcome letter will be sent to the notifier, once the environmental and human health assessment reports have been completed. This letter also provides information on any additional notification requirements that are necessary for the substance to become eligible for listing on the DSL. The notifier may begin manufacturing or importing the substance in amounts exceeding the quantity that triggered the notification after the end of the assessment period, even without receipt of the final assessment outcome letter. 

The DSL — Domestic Substances List

The DSL is a comprehensive compilation of all known substances that have been or continue to be in Canadian commerce. The DSL is the sole basis for determining whether a substance is new for the purposes of the Act and the Regulations. Substances listed on the DSL do not require notification unless they are subject to a SNAc Notice, as indicated by the “S” or “S’ ” flag or they no longer qualify as an RRR polymer as indicated by the “P” flag.

The following three regulatory flags indicate to notifier that additional notification requirements may be necessary prior to manufacturing or importing a specific substance

• The “S” flag; the “S' (prime)” flag; The “P” flag.

The following two administrative flags are used by the NS program to track the number of substances added to the DSL under specific scenarios: The “T” flag, The “N” flag.

Significant New Activity (SNAc) Notices:

If the assessment for the notified substance determines that there is no suspicion that the substance is toxic or capable of becoming toxic for the notified activities but there is a suspicion that a significant new activity in relation to the substance may result in the substance becoming “toxic”, the substance can be subject to a SNAc Notice. A SNAc Notice defines what is considered a significant new activity for the substance which communicates the criteria under which a notification will or will not be required.