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Guidelines for the Notification and Testing of New Substances: Chemicals and PolymersAPPENDIX 3 - Guide To Paying Fees Associated With The Regulationss
DisclaimerNotifiers of new substances (chemicals and polymers) and persons requesting other services (see section 2 of this Appendix) are required to pay a fee as per the New Substances Fees Regulations (NSFR) and the Regulations Amending the New Substances Fees Regulations, which were made under section 328 of the Act. The information in this Appendix, however, is intended to provide general guidance to notifiers in understanding the NSFR and to assist in determining the applicable fees for: notifying a new substance; and other services. Notifiers and persons requesting other services should keep in mind that the examples provided in this Appendix do not cover all situations. In some cases, notifiers or persons requesting other services may be required to consult with the NS program through the NSN Information Line for specific individual cases. Please note, at this time the fees do not apply to biochemicals, biopolymers, research and development substances and substances that are manufactured or imported that are regulated under any other Act of Parliament or regulations not listed on Schedule 2 to the Act. This includes substances whose use is regulated by the Food and Drugs Act, the Fisheries Act and the Health of Animals Act. The fees also do not apply to SNANs (see sections 1.3 and 9.5.2 of these Guidelines) or to the submission of additional information required for special category Schedule 1 notifications (at 10 000 kg/yr) and for high release to the aquatic environment or significant high exposure to the substance (at 50 000 kg/yr) (see sections 4.2.2, 4.4.3 and 4.9.2 of these Guidelines, respectively). 1.0 Assessment FeesThis section explains the NSFR, including how they may apply to a particular situation. Examples are provided to help the notifier determine the applicable fees for the notification and assessment of a new substance. The maximum fees payable for the assessment of a single new substance on the basis of the information required under the Schedules of the Regulations are $3500 where the notifier's annual Canadian sales are greater than $40 million. The fees are broken down into three Tables:
When fees are based on the notifying company's annual Canadian sales being <$40 million, the notifier must provide sales reports for their most recent fiscal period (refer to section 5, "Proof of Annual Canadian Sales", of this Appendix for more information).
* NSNR [New
Substances Notification Regulations (Chemicals and Polymers)] Schedule
as per the Regulations.
1.1 Initial FeesScenario: A notifier provides an NSN package for a new chemical or polymer, which they are notifying to the NS program for the first time. It is not a final NSN package, and there will not be any matched notifications (see sections 1.3 and 1.4 of this Appendix for details on final and matched notifications, respectively). The fee required for their NSN package is: * the amount set out in Column 2 of Table A3.1, under the heading corresponding to the notifying company's annual Canadian sales for the last fiscal year. Initial fees are required for all Schedules of the Regulations. 1.1.1 Examples of Initial FeesExample 1A notifier's annual Canadian sales totaled $21.3 million in the last fiscal year and the notifier wants to import Chemical X into Canada. Chemical X has not been previously submitted by the notifier under any Schedule of the Regulations. After determining that Chemical X is not on the NDSL and that it requires a non-final Schedule 5 NSN package, the notifier:
Example 2A notifier's annual Canadian sales totaled $45 million in the last fiscal year and the notifier wants to manufacture Polymer Y in Canada. Polymer Y has not been previously submitted by the notifier under any Schedule of the Regulations. After determining that Polymer Y does not meet the RRR polymer criteria and that it requires a Schedule 10 NSN package, the notifier:
Example 3A notifier's annual Canadian sales totaled $12 million in the last fiscal year and the notifier wants to manufacture Polymer Y in Canada. Polymer Y has not been previously submitted by the notifier under any Schedule of the Regulations. After determining that Polymer Y does not meet the RRR polymer criteria and that it requires a non-final Schedule 9 NSN package, the notifier:
1.2 Subsequent FeesScenario: A notifier provides an NSN package for a new chemical or polymer, which they have previously notified to the NS program under another Schedule of the Regulations. It is not a final NSN package, and there will not be any matched notifications (see sections 1.3 and 1.4 of this Appendix for details on final and matched notifications, respectively). The fee required for their subsequent NSN package is:
The same process is used to determine the fees required for subsequent NSN packages that are submitted after the revised Regulations come into force (see examples 6 through 8). Note that if NSN packages were submitted prior to the NSFR coming into force; the notifier is required to pay initial fees for any subsequent NSN packages for that substance. For example, if a Schedule I and a Schedule II NSN package were submitted, under the previous Regulations and prior to the NSFR coming into force and a Schedule 6 NSN package is currently being submitted, under the revised Regulations, the fee required for the Schedule 6 is the full amount of $3500 since there are no previous Schedule payments to be deducted (see example 9). If the subsequent fee results in a negative amount (e.g., the current fee is less than the fees previously paid by the same company for the same substance) the fee shall be deemed to be $0 (see example 10). This may occur, for example, if a notifier's annual Canadian sales figures have dropped between previous and subsequent NSN packages (see example 11). Note that the negative amount does not become a credit towards other services, such as notification of another substance or a request for a search on the confidential portion of the DSL/NDSL. In order to facilitate the processing of an NSN package, we request that the notifier clearly identify the NSN reference number(s) of any previous NSN package(s) with the submission. The NSN reference number is the number assigned to a specific file/NSN package in order to track it through the notification, assessment and post-assessment process (see section 9.2.3 of these Guidelines). 1.2.1 Examples of Subsequent FeesExample 4A notifier's annual Canadian sales totaled $31.2 million in the last fiscal year and the notifier wants to import Chemical X into Canada. A Schedule 4 NSN package for this substance was previously submitted by the notifier in the same fiscal year. After determining that Chemical X is not on the NDSL and that it requires a non-final Schedule 5 NSN package, the notifier:
Example 5A notifier's annual Canadian sales totaled $8 million in the last fiscal year and the notifier wants to manufacture Polymer Y in Canada. A non-final Schedule 9 NSN package for this substance was previously submitted by the notifier in a different fiscal year but with the same total annual Canadian sales. After determining that Polymer Y does not meet the RRR polymer criteria and that it requires a Schedule 11 NSN package, the notifier:
Example 6A notifier's annual Canadian sales totaled $45 million in the last fiscal year and the notifier wants to import Polymer Y into Canada. A Schedule VI NSN package for this substance was previously submitted by the notifier, in a different fiscal year under the previous Regulations but with the same total annual Canadian sales. After determining that Polymer Y does not meet the RRR polymer criteria and that it requires a Schedule 10 NSN package, the notifier:
Example 7A notifier's annual Canadian sales totaled $33.2 million in the last fiscal year and the notifier wants to import Chemical C into Canada. A Schedule I and II NSN package for this substance was previously submitted by the notifier, in a different fiscal year under the previous Regulations but with the same total annual Canadian sales. After determining that Chemical C requires a Schedule 6 NSN package, the notifier:
Example 8A notifier's annual Canadian sales totaled $34 million in the last fiscal year and the notifier wants to manufacture Chemical T in Canada. A Schedule II NSN package for this substance was previously submitted by the notifier, in a different fiscal year under the previous Regulations but with the same total annual Canadian sales. At the time of submitting the Schedule II the substance was not on the NDSL and therefore a Schedule III was required. After the revised Regulations came into force Chemical T was added to the NDSL prior to the submission of any subsequent Schedule. After determining that Chemical T now requires a final Schedule 5 NSN package (e.g. any required information prescribed in the final Schedule 5 that was not previously provided in the Schedule II NSN package), the notifier:
Example 9A notifier's annual Canadian sales totaled $48 million in the last fiscal year and the notifier wants to import Polymer Q into Canada. A Schedule VI NSN package for this substance was previously submitted by the notifier prior to the NSFR coming into force. After determining that Polymer Q does not meet the RRR polymer criteria and that it requires a Schedule 11, the notifier:
1.2.2 Examples of Varying Annual Canadian SalesExample 10A notifier's annual Canadian sales totaled $20 million in the last fiscal year and the notifier wants to manufacture Chemical B in Canada. A Schedule 4 and 5 NSN package for this substance was previously submitted by the notifier, in a different fiscal year where the total annual Canadian sales totaled $44 million. After determining that Chemical B requires a Schedule 6 NSN package, the notifier:
Example 11A notifier's annual Canadian sales totaled $25 million in the last fiscal year and the notifier wants to import Chemical X into Canada. A Schedule 4 NSN package was previously submitted by the notifier, in a different fiscal year where the total annual Canadian sales totaled $8 million. After determining that Chemical X is not on the NDSL and that it requires a non-final Schedule 5 NSN package, the notifier:
1.3 Fees for Final Schedule 5 and Final Schedule 9Different fees are required for new substances that are destined for listing on the DSL after a final Schedule 5 NSN package for NDSL chemicals or a final Schedule 9 NSN package for polymers meeting the RRR polymer criteria has been submitted and assessed. Table A3.2 below provides the fee requirements for these NSN packages.
* NSNR (New Substances Notification Regulations) Schedule as per the Regulations. Scenario 1: A notifier provides a final Schedule 5 NSN package for a new chemical that is listed on the NDSL. The notifier is not required to provide subsequent NSN packages for this substance and it is not a matched notification (see section 1.4 of this Appendix for details on matched notifications). The fee required for their final Schedule 5 NSN package is:
Scenario 2: A notifier provides a final Schedule 9 NSN package for a new polymer that meets the RRR polymer criteria. The notifier is not required to provide subsequent NSN packages for this substance and it is not a matched notification (see section 1.4 of this Appendix for details on matched notifications). The fee required for their final Schedule 9 NSN package is:
1.3.1 Examples of Fees for Final Schedule 5 and Final Schedule 9 NSN PackagesExample 12A notifier's annual Canadian sales totaled $39 million in the last fiscal year and the notifier wants to manufacture Chemical X in Canada. A Schedule 4 NSN package for this substance was previously submitted by the notifier in the same fiscal year. After determining that Chemical X is listed on the NDSL and that it requires a final Schedule 5 NSN package, the notifier:
Example 13A notifier's annual Canadian sales totaled $13.5 million in the last fiscal year and the notifier wants to import Polymer Y into Canada. Polymer Y has not been previously submitted by the notifier under any Schedule of the Regulations. After determining that Polymer Y meets the RRR polymer criteria and that it requires a final Schedule 9 NSN package, the notifier:
1.4 Matched NotificationScenario: A notifier requests to use information that was previously provided by another company for the same substance (see section 5.1 of these Guidelines). The notifier must obtain a letter of authorization from the initial company, who submitted the information, permitting the use of this information. After the NS program receives the letter of authorization the two NSN packages are "matched" together (see section 5.1 of these Guidelines). In this case, the notifier is required to pay a matched fee of $200. This fee is the same regardless of the notifier's annual Canadian sales. When using the matched notification option, there is no fee reductions for amounts previously paid when the notifier submitted a previous Schedule for assessment. 1.4.1 Example of Matched NotificationExample 14A notifier wants to manufacture Polymer Y in Canada. The notifier is aware that another company, Company B, previously submitted an NSN package for this same substance. The NS program must receive permission from Company B to use its information for the assessment of the notifier's NSN package. If this permission is obtained and submitted to the NS program, the NSN package is then considered a matched notification, and the notifier pays a flat assessment fee of $200. 1.5 Consolidated NotificationScenario: A consolidated notification takes place when two to six substances of the same class and Schedule are notified together but as separate NSN packages and where the information provided for one substance is acceptable for the assessment of the other(s) (see section 5.3 of these Guidelines). The notifier must pay the amount required for an initial, subsequent or final assessment (whichever applies) for one of the notified substances (as explained earlier in this section), plus a consolidated fee of $250 for the assessment of each of the other NSN packages in the consolidation. This fee is the same regardless of the notifier's annual Canadian sales. When using the consolidated notification option, the notifier can only deduct the fee from the previous Schedules of one of the consolidated substances. 1.5.1 Examples of Consolidated NotificationExample 15A notifier's annual Canadian sales totaled $42 million in the last fiscal year and the notifier wants to import five new polymers into Canada. None of the five polymers have been previously submitted by the notifier under any Schedule of the Regulations. The notifier determines that the five polymers are of the same class, do not meet the RRR polymer criteria and all require non-final Schedule 9 NSN packages. Since the information required for one of the polymers would be acceptable to be submitted for the assessment of the other four polymers, the notifier:
Example 16A notifier's annual Canadian sales totaled $30 million in the last fiscal year and the notifier wants to manufacture four new chemicals in Canada. Chemical A was previously submitted under a Schedule 4 NSN package by the notifier in the same fiscal year and Chemical B was previously submitted under both a Schedule 4 and 5 NSN packages by the notifier, in a different fiscal year but with the same total annual Canadian sales. The notifier determines that the four chemicals are of the same class and all require Schedule 6 NSN packages. Since the information required for one of the chemicals would be acceptable to be submitted for the assessment of the other three chemicals, the notifier:
Note: In this example, a higher required fee could have been calculated if Chemical A was the master file instead of Chemical B since only a Schedule 4 NSN package was previously submitted. The notifier must ensure that the fee required is calculated based on the master file substance which contains the test data. The notifier can only deduct the fees paid for previous Schedules submitted for the master file. 2.0 Fees for Other ServicesIn addition to the assessment of new substances, the NS program provides other services on a cost recovery basis, including:
Note that these services may be requested at anytime and they do not necessarily have to be requested with the submission of an NSN package. Also note that notifiers need only to submit and pay for a masked name request once per substance. For example, if a masked name request was submitted for a substance and the fee was included with the non-final Schedule 5 NSN package, then it does not have to be re-submitted with the Schedule 6 NSN package. Fees for other services can not be deducted from the fees required in Tables A3.1 and A3.2 for the assessment of NSN packages. Table A3.3 below provides the fee requirements for other services.
* Search of substances appearing on the DSL
or NDSL that have been published under masked names. ** Application for a masked name, as defined in the Masked Name Regulations, for a new substance (see section 7.2 of these Guidelines). *** Application for a service under the Arrangement for Sharing of Information Between the U.S. Environmental Protection Agency (USEPA) and Environment Canada and Health Canada (the "Four Corners Arrangement") (see section 2.2.3.3 and Appendix 9 of these Guidelines). 2.1 Examples of Fees for Other ServicesExample 17A notifier's annual Canadian sales totaled $35 million in the last fiscal year and the notifier wants to import Polymer Y into Canada. The notifier also wants to request a search of the confidential portion of the DSL and the NDSL to determine if the polymer is new to Canada, the notifier:
Example 18A notifier's annual Canadian sales totaled $56 million in the last fiscal year and the notifier wants to manufacture Chemical X in Canada. Chemical X has not been previously submitted by the notifier under any Schedule of the Regulations. The notifier wants to submit an NSN package as well as a masked name application for this substance. After determining that Chemical X requires a Schedule 4 NSN package, the notifier: a)
b)
c)
Example 19A notifier's annual Canadian sales totaled $18 million in the last fiscal year and the notifier wants to import Polymer Y into Canada. Polymer Y has not been previously submitted by the notifier under any Schedule of the Regulations. The notifier also wants to submit an application under the Four Corners Arrangement for this substance, in an attempt to add the substance to the NDSL early. After determining that Polymer Y does not meet the RRR polymer criteria and that it requires a non-final Schedule 9 NSN package the notifier: a)
b)
c)
2.2 Examples of Varying Annual Canadian Sales and Fees for Other ServicesExample 20A notifier's annual Canadian sales totaled $25 million in the last fiscal year and the notifier wants to import Chemical X into Canada. A Schedule 4 NSN package for this substance was previously submitted by the notifier in a different fiscal year when the notifier's annual Canadian sales totaled $8 million. The notifier wants to submit a higher Schedule NSN package for Chemical X, plus they would like to request a search of the confidential portion of the DSL and the NDSL for another substance. After determining that Chemical X is not on the NDSL and that it requires a non-final Schedule 5 NSN package, the notifier: a)
b)
c)
Example 21A notifier's annual Canadian sales totaled $13 million in the last fiscal year and the notifier wants to manufacture Polymer Y in Canada. A non-final Schedule 9 NSN package for this substance was previously submitted by the notifier in a different fiscal year when the notifier's annual Canadian sales totaled $39 million. The notifier wants to submit a higher Schedule NSN package for Polymer Y, plus they would like to submit a masked name application for this substance. After determining that Polymer Y requires a Schedule 10 NSN package, the notifier: a)
b)
c)
Example 22A notifier's annual Canadian sales totaled $11 million in the last fiscal year and the notifier wants to import Chemical X into Canada. A non-final Schedule 5 NSN package for this substance was previously submitted by the notifier in a different fiscal year when the notifier's annual Canadian sales totaled $14 million. The notifier wants to submit a higher Schedule NSN package for Chemical X, plus they would like to request a confidential search for another substance. After determining that Chemical X requires a Schedule 6 NSN package, the notifier: a)
b)
c)
3.0 How to PayThe fees payable under sections 3 to 9 of the NSFR must be paid at the time the service is requested and must be provided by one of the following methods:
Payment for the assessment of a substance must be delivered to the NS program, along with the NSN package. Non-resident Importers (see section 6.2.1.3 of these Guidelines) must pay the required fees either directly to the NS program or through their "Canadian Agent". Notifiers who require data to be provided by a foreign supplier (see section 5.2 of these Guidelines) are still responsible for providing the fees required for the assessment of the NSN package. In these cases, additional fees may apply for a masked name application prior to the substance being eligible for listing on the DSL, if the foreign supplier wishes the name of the substance to be kept confidential. Refunds will be made in accordance with the Financial Administration Act and the Repayment of Receipts Regulations, 1997 in the appropriate circumstances (e.g., overestimation of applicable fee). A fee form has been developed to help notifiers determine the total fee applicable to their NSN package (see Appendix II of the NSN reporting form). A copy of this form should accompany the payment and assessment information. 4.0 Invalid Fees and RefundsThe payment and the NSN package will be immediately returned to the notifier and the assessment period will not commence if:
If a cheque or money order is provided but it is determined that the fee is not required, the payment will be returned to the notifier or, if already processed, a refund cheque will be issued to the notifier as soon as possible. If a payment is provided but it is determined that the fee is in excess of NSFR requirements, a refund cheque will be issued to the notifier as soon as possible. If a credit card is used to submit the fees and the amount authorized is insufficient; or the credit card is denied, a request for additional information letter for the missing fee amount will be written and the assessment period will not start until the correct amount of fees have been paid. If sufficient funds are authorized for and charged on the credit card, the assessment period will start and the amount charged to the credit card will be indicated in the acknowledgment letter. If a request for withdrawal of a NSN package is submitted prior to the assessment period starting, a complete refund of the fees will be provided. If the request is submitted after the assessment period has started no fees will be refunded. 5.0 Proof of Annual Canadian SalesWhen fees are based on the notifier's annual Canadian sales the notifier must provide sales reports for the notifier's most recent fiscal period with all NSN packages. Sales reports must be prepared in accordance with generally accepted accounting principles and must be certified by the notifier, or by the company's president, or chief financial officer. Statements indicating the notifier's annual Canadian sales, signed by the company's president, are also acceptable. In the absence of proof of annual Canadian sales, fees will be based on annual Canadian sales greater than $40 million. 5.1 Annual Canadian SalesAnnual Canadian sales refer to sales of any type (not just sales of the substance being notified) to Canadian merchants and sales from the Canadian affiliates, of the Corporate Headquarters of the company, to other merchants or countries. For example, Company A's headquarters is in the United States but they have subsidiaries in Canada. The total Canadian sales for Company A include those made by Company A to Canada and those made by the subsidiaries in Canada. |
Disclaimer: Although care has been taken to ensure that the information found on this website accurately reflects the requirements prescribed, you are advised that, should any inconsistencies be found, the legal documents, printed in the Canada Gazette, will prevail. |
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