Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers

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SECTION 2 - THE INVENTORIES

• 2.1 Role of the Domestic Substances List (DSL)
  • 2.1.1 The DSL — Definition of a "New" Substance
  • 2.1.2 Confidential Portion of the DSL
    • 2.1.2.1 Justification for Masking a Substance that is Listed on a Public Inventory
  • 2.1.3 Amendments to the DSL
  • 2.1.4 DSL Flags
    • 2.1.4.1 Regulatory Flags
    • 2.1.4.2 Administrative Flags
• 2.2 Role of the Non-domestic Substances List (NDSL)
  • 2.2.1 The NDSL
  • 2.2.2 Confidential Portion of the NDSL
  • 2.2.3 Amendments to the NDSL
    • 2.2.3.1 Updates Based on the USEPA TSCA Inventory
    • 2.2.3.2 Nominating a Substance to the NDSL or the Confidential Portion of the NDSL
    • 2.2.3.3 Applications Under the Four Corners Arrangement (4CA)
  • 2.2.4 NDSL Flags
    • 2.2.4.1 Administrative Flags
• 2.3 Determining the Presence of Substances on Inventories
  • 2.3.1 Notice of Bona Fide Intent to Manufacture or Import
  • 2.3.2 Copies of the DSL and NDSL

2.1 Role of the Domestic Substances List (DSL)

2.1.1 The DSL - Definition of a "New" Substance

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 are added to the DSL using a unique substance identifier (e.g., Chemical Abstracts Service [CAS] registry number, Enzyme Commission number).

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 (see section 2.1.4.1 of these Guidelines), or they no longer qualify as an RRR polymer (see section 3.4.1.3 of these Guidelines), as indicated by the "P" flag (see section 2.1.4.1 of these Guidelines). The DSL includes the original list, published in the Canada Gazette, Part II, on May 4, 1994; and all additions or deletions subsequently published in the Canada Gazette, Part II.

2.1.2 Confidential Portion of the DSL

A notifier may request that the substance they are notifying be added to the confidential portion of the DSL using a masked name submitted under the Masked Name Regulations. Substances eligible for addition on the confidential portion of the DSL are assigned a confidential DSL Accession Number even when a CAS registry number is available. This accession number will be provided to the notifier by the NS program only once the substance is eligible for addition on the DSL. Then, the confidential DSL Accession Number and acceptable masked name for the substance will be published in the Canada Gazette, Part II. Substances listed on the confidential portion of the DSL are treated the same as substances listed on the public portion of the DSL.

The NS program conducts a search for all substances that have been notified as confidential to verify whether these substances are on any public chemical inventory, such as the United States Environmental Protection Agency’s (USEPA) Toxic Substances Control Act (TSCA) Chemical Substances Inventory, the Australian Inventory of Chemical Substances (AICS), the Korean Existing Chemicals List (ECL) and the European Inventory of Existing Commercial Substances (EINECS). If the substance is listed on any one of these public inventories, the notifier will be informed of this fact and will be required to provide, within 20 calendar days, further justification for their request for confidentiality (see section 2.1.2.1 of these Guidelines). If the supporting documentation is deemed to be inadequate, the notifier will be informed that the NS program intends to publish the appropriate CAS registry number (see section 6.2.2.1of these Guidelines) on the DSL. The notifier will have the opportunity to appeal this decision before the information is published.

2.1.2.1 Justification for Masking a Substance that is Listed on a Public Inventory

If the NS program finds that the substance is listed on at least one public inventory in the world, such as the ones mentioned above, the notifier will be asked to provide a written justification, setting out a reason that the information should be treated as confidential. This information should provide substantive detail and be based on the following criteria:

1. the information constitutes a trade secret;
2. financial, commercial, scientific or technical information that is confidential information supplied to the NS program by the notifier and is treated consistently in a confidential manner by the notifier;
3. disclosure of the information could reasonably be expected to result in material financial loss or gain to, or could reasonably be expected to prejudice the competitive position of the notifier; or
4. disclosure of the information could reasonably be expected to interfere with contractual or other negotiations of the notifier.

The information to be provided for one of these claims must include the required information laid out in section 7.2.2 of these Guidelines for claiming a substance confidential.

Subsection 315(1) of the Act states that the Minister may, however, disclose information where:

1. the disclosure is in the interest of public health, public safety or the protection of the environment; and
2. the public interest in the disclosure clearly outweighs in importance:
   1. any material financial loss or prejudice to the competitive position of the person who provided the information or on whose behalf it was provided, and
   2. any damage to the privacy, reputation or human dignity of any individual that may result from the disclosure.

2.1.3 Amendments to the DSL

As a result of statutory requirements, the DSL is amended from time to time for the following reasons:

1. nomination of a substance to the DSL that were manufactured in or imported into Canada between January 1, 1984, and December 31, 1986 (subsection 66(1) of the Act); or
2. all prescribed information has been received under section 81 of the Act; an assessment has determined that no risk management measures should be imposed; and the manufacture or import has commenced after the most comprehensive NSN package was assessed or the prescribed volumes have been exceeded (section 87 of the Act).

Updates to the DSL are published in the Canada Gazette, Part II, within 120 days following the determination that a substance is eligible. Amendments may also be made to correct printing or eligibility errors. Amendments to the DSL are published in the Canada Gazette, Part II, approximately every six to eight weeks.

Eligibility requirements are described in detail in section 10 of these Guidelines.

2.1.4 DSL Flags

The DSL contains five different flags for substances, however, depending on different situations some flags can be combined together (e.g., T-S, N-S, T-P, N-P, T-P-S, etc.). Some of the flags are used for governmental tracking purposes, and others are used to indicate to notifiers that additional notification requirements may be necessary for the substance being manufactured or imported. The onus is on the notifier to search for flags and for any regulations that may be imposed on a substance to determine if additional notification requirements are necessary. The notifier may also contact the NSN Information Line (see Comments and Inquiries Section of these Guidelines) to determine if additional notification requirements are necessary.

2.1.4.1 Regulatory Flags

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

• The "S" flag: The letter "S" after a substance identifier indicates that the substance is subject to subsection 81(3) of the Act. This flag is used for a substance that was assessed under section 83 of the Act, and the assessment concluded that a significant new activity, in relation to the substance, may result in the substance becoming toxic according to the Act. The substance is therefore subject to a SNAc Notice under subsection 85(1) of the Act.
• The "S' (prime)" flag: The letter " S' " after a substance identifier indicates that the substance is subject to subsection 81(3) of the Act. This flag is used for a substance that was already listed on the DSL, but was subsequently assessed, and the assessment concluded that a significant new activity, in relation to the substance, may result in the substance becoming toxic according to the Act. The substance therefore had not previously been subject to a SNAc Notice under subsection 85(1) of the Act.

The purpose of the "S" and " S' " flags is to indicate that relevant information respecting the flagged substance must be notified if the substance is proposed for a significant new activity that is defined in the SNAc Notice which was published in the Canada Gazette, Part I. Anyone proposing a new activity must provide the prescribed information in the prescribed time prior to the commencement of the proposed new activity. This new information will permit the NS program to assess the environmental and human health risks associated with the new activities, modify the notices or implement risk management measures, if deemed necessary (see section 9.5.2 of these Guidelines).

• The "P" flag: The letter "P" after a substance identifier indicates that the substance, which was subject to subsection 81(1) or 81(2) of the Act, was assessed and added to the DSL on the basis that it met the RRR polymer criteria (see section 3.4.1.3 of these Guidelines) and that there was no suspicion of toxicity with this form of the substance.

The purpose of the "P" flag is to indicate that relevant information respecting the flagged polymer must be renotified if anyone, including the original notifier, manufactures or imports the polymer, in Canada, in a form that no longer meets the RRR polymer criteria.

In the case where the NS program assesses the renotified substance and concludes that there is no suspicion of toxicity for the non-RRR polymer and it is again eligible for the DSL, the DSL will be updated accordingly, and the "P" flag will be repealed. In the case where the NS program assesses the non-RRR form of the polymer and concludes that there is a suspicion of toxicity, appropriate risk management measures will be imposed.

2.1.4.2 Administrative Flags

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 letter "T" after a substance identifier indicates that the substance was manufactured or imported during the transitional period (e.g., between January 1, 1987, and July 1, 1994) and the prescribed information was provided to and assessed by the NS program in accordance with subsection 81(2) and section 83 of the Act, respectively. The assessment concluded that there was no suspicion of toxicity in relation to the substance and it was subsequently added to the DSL.
• The "N" flag: The letter "N" after a substance identifier indicates that the substance was manufactured or imported after July 1, 1994, and the prescribed information was provided to and assessed by the Minister in accordance with subsection 81(1) and section 83 of the Act, respectively. The assessment concluded that there was no suspicion of toxicity in relation to the substance, and it was subsequently added to the DSL.

When there is no flag associated with a substance that is listed on the DSL, the substance was added to the list via a nomination of the substance under section 66 of the Act (see section 2.1.3 of these Guidelines).

2.2 Role of the Non-domestic Substances List (NDSL)

2.2.1 The NDSL

The NDSL⁵ is an inventory of substances that are not on the DSL but are accepted as being in use internationally. The NDSL is based on the USEPA's TSCA Chemical Substances Inventory. Substances that are not on the DSL but are listed on the NDSL are subject to the Regulations. However, they are subject to fewer information requirements.

2.2.2 Confidential Portion of the NDSL

A notifier may request that the substance they are notifying be added to the confidential portion of the NDSL using a masked name submitted under the Masked Name Regulations. Substances eligible for addition on the confidential portion of the NDSL (see section 2.2.3.2 of these Guidelines) are assigned a confidential NDSL Accession Number, even when a CAS registry number is available. This accession number will be provided to the notifier by the NS program only once the substance is eligible for addition on the NDSL. Then, the confidential NDSL Accession Number and acceptable masked name for the substance will be published in the Canada Gazette, Part I. Substances listed on the confidential portion of the NDSL, are treated the same as substances listed on the public portion of the NDSL and as such are subject to fewer information requirements. The confidential NDSL Accession Number should be used to identify the substance for all future notification purposes.

The NS program conducts a search for all substances that have been notified as confidential to verify whether these substances are on any public chemical inventory. If the substance is found to be listed on the public TSCA inventory, the masked name and confidentiality request will be rejected, and the full name and appropriate CAS registry number (see section 6.2.2.1 of these Guidelines) will be published on the NDSL. If the substance is located on any other public inventory in the world but is not located on the public TSCA inventory and if the masked name is acceptable, the confidentiality request will be accepted.

2.2.3 Amendments to the NDSL

As a result of statutory requirements, the NDSL is amended from time to time for the following reasons:

1. annual updates based on the USEPA TSCA inventory;
2. nomination of a substance to the NDSL or confidential portion of the NDSL through submission of a Domestic Substances List Reporting Form C (Form C);
3. applications under the Four Corners Arrangement (4CA) (www.ec.gc.ca/substances/nsb/eng/cp_int_e.shtml); and
4. DSL amendments (substances are deleted from the NDSL when they are added to the DSL).

Amendments may also be made to correct printing or eligibility errors. Amendments to the NDSL are published in the Canada Gazette, Part I, each time there is an amendment to the DSL published in the Canada Gazette, Part II. Amendments to the NDSL, based on the USEPA TSCA inventory, are published in the Canada Gazette, Part I bi-annually. Amendments to the NDSL due to nominations or applications under the 4CA are published in the Canada Gazette, Part I, two to three times per year under subsection 66(2) of the Act. There are no deadlines for publishing substances that become eligible for the NDSL through the annual update, the 4CA or submittal of a Form C.

2.2.3.1 Updates Based on the USEPA TSCA Inventory

The NDSL is based on substances that have been on the public portion of the USEPA's TSCA inventory for a minimum period of one year (e.g., the 2005 NDSL will be based on the 2004 TSCA inventory). It should be noted that substances for which the USEPA or the NS program has implemented risk management measures are not included in the updates of the NDSL.

2.2.3.2 Nominating a Substance to the NDSL or the Confidential Portion of the NDSL

Substances on the confidential portion of the TSCA inventory are not automatically added to the confidential portion of the NDSL in the annual update process. Substances will be added to the confidential portion of the NDSL or to the NDSL (if the notifier requests to remove the confidentiality request from the substance) only after a company provides the appropriate information required in a Form C including documentation demonstrating that the substance has existed on the confidential portion of the TSCA inventory for at least one year. In the case where a notifier wishes to have the substance added to the public portion of the NDSL a Form C is still required with a statement indicating that they wish to remove the confidentiality claim from their substance. Instructions for nominating substances to the NDSL can be found on the back of the Form C. This form can be obtained through the NSN Information Line (see Comments and Inquiries Section of these Guidelines) or on the NS program web site at www.ec.gc.ca/substances/nsb/pdf/formc_en.pdf

Although there are no fees associated with nominating a substance to the confidential portion of the NDSL, please note that there is a fee for the "Masked Name Application" (see Appendix 3 of these Guidelines).

2.2.3.3 Applications Under the Four Corners Arrangement (4CA)

The 4CA is a bilateral information-sharing arrangement that provides the NS program and the USEPA an opportunity to review the assessment results of a substance in another jurisdiction.

In response to a 4CA application and after an assessment of the substance there are three possible outcomes. These possible outcomes are:

1. the NS program may decide to add the substance to the NDSL early with a Four Corners "FC" flag;
2. the NS program may decide not to add the substance to the NDSL but will accept waivers for certain information requirements that are required when the higher Schedule NSN package is submitted; or
3. the NS program may decide not to add the substance to the NDSL and not accept any waivers for any information requirements.

These decisions are made on a case-by-case basis based on information received pursuant to the 4CA. The notifier will be informed of the decision usually within 90 days of receipt of the complete 4CA package (see Appendix 9 of these Guidelines).

2.2.4 NDSL Flags

2.2.4.1 Administrative Flags

The following flag is used for government purposes to track the number of substances added to the NDSL through the 4CA:

• The "FC" flag: The letters "FC" after a substance identifier indicates that the substance was accepted for addition to the NDSL after it was assessed under the 4CA (see section 2.2.3.3 and Appendix 9 of these Guidelines).

2.3 Determining the Presence of Substances on Inventories

To find out whether a substance is on the DSL or on the NDSL, the CAS registry number, the confidential accession number (if available) or the Enzyme Commission number can be entered into one of the search engines located on the NS program's web site at www.ec.gc.ca/ substances/nsb/eng/sub_e.htm. If the confidential accession number is unknown and the notifier wishes to determine if the substance is listed on the confidential portion of either the DSL or the NDSL, a Notice of Bona Fide Intent to Manufacture or Import the substance (see section 2.3.1 of these Guidelines) must be filed to the NS program. The CAS registry number or confidential accession number can also be provided directly to CAS, which will, for a fee, search all inventories for that substance. For more information on CAS, see Appendix 6 of these Guidelines.

It is important to note that the search engine does not show any flags. The onus is on the notifier to consult the Canada Gazette publication to ensure that there are no flags associated with a particular substance (see section 2.1.4 of these Guidelines). The NS program is working on having these flags added to the search engine.

2.3.1 Notice of Bona Fide Intent to Manufacture or Import

Substances listed on the confidential portion of the DSL or NDSL are published with confidential accession numbers using masked identities that are named in a manner prescribed by the Masked Name Regulations. Any notifier who intends to manufacture or import a substance that he or she believes to be listed on the confidential portion of either of these lists may seek confirmation to that effect from the NS program by providing a Notice of Bona Fide Intent to Manufacture or Import the substance.

A Notice of Bona Fide Intent to Manufacture or Import must include the following information and must be provided to the NS program at the address provided in the Comments and Inquiries Section at the beginning of these Guidelines:

1. the specific chemical identity of the substance established in accordance with the nomenclature rules of the International Union of Pure and Applied Chemistry (IUPAC), CAS or International Union of Biochemistry and Molecular Biology (IUBMB);
2. the CAS registry or Enzyme Commission number (if one exists);
3. a statement, signed by a person residing in Canada, declaring that the notifier intends to manufacture or import the substance and that the substance would be subject to the Regulations if it is not on the DSL;
4. if the manufacture of the substance occurs in Canada, a description of the research and development activities conducted to date (e.g., information such as manufacturing procedures, quantities manufactured, types of data generated on the substance and manufacturing history in international commerce) and the intended use of the substance;
5. if the substance is imported, a description of the manufacturing history of the substance in international commerce (if known);
6. an elemental analysis;
7. valid spectral analysis or analyses that confirm(s) the identity of the substance; and
8. the applicable fee (see Appendix 3 of these Guidelines).

If a notifier who wants to manufacture or import a substance is unable to supply all of the required information because a foreign supplier considers this information confidential, the notifier is required to ensure that the foreign supplier submits the confidential information directly to the NS program.

After the notifier has provided a Notice of Bona Fide Intent to Manufacture or Import the substance, the NS program will search the confidential portion of the DSL and NDSL, and will respond within 30 days of receipt of the complete documentation indicating whether or not the substance is on either of the lists.

2.3.2 Copies of the DSL and NDSL

The DSL and the NDSL are available for download in plain text (html) and Adobe Acrobat^® pdf format at the NS program web site: www.ec.gc.ca/substances/. Chemicals, biochemicals, polymers and biopolymers are listed by their respective CAS registry numbers, while biochemicals that are enzymes are listed by Enzyme Commission numbers designated by the IUBMB. Confidential substances are listed by their respective confidential accession numbers and also published using masked identities that are named in a manner prescribed by the Masked Name Regulations (see section 7 and Appendix 7 of these Guidelines).

The Canada Gazette is available in subscribing libraries and institutions as well as in the regional offices of Environment Canada (see Appendix 11 of these Guidelines). Published formats of the lists may be downloaded from the Canada Gazette web site at www.canadagazette.gc.ca or purchased through the following suppliers:

In Canada:

Publishing and Depository Group
Ottawa, Ontario
Canada K1A 0S9

Telephone:
1-800-661-2868; or
613-941-5995

Facsimile:
1-800-565-7757; or
613-954-5779

In the United States:

International Specialized Book Services Inc.
5602 NE Hassalo Street
Portland, OR 97213
U.S.A.

Telephone:
1-800-944-6190

Facsimile:
503-280-8832

In Europe:

Books Express
P.O. Box 10
Saffron Walden
Essex CB11 4EW
England

Telephone:
(0799) 513726

Facsimile:
(0799) 513248

Amendments to the DSL or NDSL must be ordered by date of publication.

⁵ The term Non-domestic Substances List (NDSL) is used inclusively in these Guidelines to specify substances listed on either the public or confidential portions of the inventory.