Canada Gazette II – Vol. 140, No. 21 — October 18, 2006
Whereas the Minister of the Environment has been provided with information under either paragraph 87(1)(a) or (5)(a) of the Canadian Environmental Protection Act, 1999 in respect of each substance referred to in the annexed Order;

Whereas, in respect of the substances being added to the Domestic Substances List pursuant to subsection 87(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that those substances have been manufactured in or imported into Canada in excess of the quantity prescribed under the New Substances Notification Regulations (Chemicals and Polymers) by the person who provided the information;

Whereas the period for assessing the information under section 83 of that Act has expired;

And whereas no conditions under paragraph 84(1)(a) of that Act in respect of the substances are in effect;

Therefore, the Minister of the Environment, pursuant to subsections 87(1), (3) and (5) of the Canadian Environmental Protection Act, 1999, hereby makes the annexed Order 2006-87-07-03 Amending the Domestic Substances List.

To view the amendments under this order, published in the Canada Gazette, please visit: Order 2006-87-07-03 Amending the Domestic Substances List

Canada Gazette I – Vol. 140, No. 41 — October 14, 2006

Whereas, pursuant to subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999, the Minister of the Environment has added the substances referred to in the annexed Order to the Domestic Substances List;

Therefore, the Minister of the Environment, pursuant to subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999, hereby makes the annexed Order 2006-87-07-04 Amending the Non-domestic Substances List.

To view the amendments under this order, published in the Canada Gazette, please visit: Order 2006-87-07-04 Amending the Non-domestic Substances List

Sunburn protectants are classified as natural health products (NHPs) if they contain ingredients from Table 1. Applicants applying for a natural product number (NPN) can access the appropriate forms and guidance at:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/form/index_e.html

Sunburn protectants are classified as drugs if they contain at least one ingredient from Table 2. Applicants applying for a drug identification number (DIN) can access the appropriate forms and templates at:
http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index_e.html

To view the entire monograph, posted on Health Canada’s website, complete with Tables 1 and 2, please visit: Natural Health Product Monograph – Sunburn Protectants

Antiseptic skin cleansers are classified as natural health products (NHPs) if they contain ingredients from Table 1. Applicants applying for a natural product number (NPN) can access the appropriate forms and guidance at:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/form/index_e.html

Antiseptic skin cleansers are classified as drugs if they contain any ingredients from Table 2. Applicants applying for a drug identification number (DIN) can access the appropriate forms and guidance at: http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index_e.html

To view the entire monograph, posted on Health Canada’s website, complete with Tables 1 and 2, please visit: Natural Health Product Monograph – Antiseptic Skin Cleansers

Acne therapies are classified as natural health products (NHPs) if they contain ingredients from Table 1. Applicants applying for a natural product number (NPN) can access the appropriate forms and guidance at:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/form/index_e.html

Acne therapies are classified as drugs if they contain benzoyl peroxide. Applicants applying for a drug identification number (DIN) can access the appropriate forms and guidance at:
http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index_e.html

To view the entire monograph, posted on Health Canada’s website, complete with Table 1, please visit: Natural Health Product Monograph – Acne Therapy

Anti-dandruff products are classified as natural health products (NHPs) if they contain ingredient(s) from Table 1. Applicants applying for a natural product number (NPN) can access the appropriate forms and guidance at:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/form/index_e.html

Anti-dandruff products are classified as drugs if they contain an ingredient from Table 2.
Applicants applying for a drug identification number (DIN) can access the appropriate forms and templates at: http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index_e.html

To view the entire monograph, posted on Health Canada’s website, complete with Tables 1 and 2, please visit: Natural Health Product Monograph – Anti-Dandruff Products

Canada Gazette I – Vol. 140, No. 40 — October 7, 2006

Significant New Activity Notice No. 14 446 in respect of the substance 1-Butanesulfonyl fluoride, 1,1,2,2,3,3,4,4,4-nonafluoro-, Chemical Abstracts Service No. 375-72-4, published in the Canada Gazette, Part I on October 7, 2006.

To view the entire notice, posted in the Canada Gazette I, please visit: Significant New Activity Notice No. 14 446

The New Substances Notification Technical Guidance Series was developed to help interpret specific information requirements of the New Substances Notification Regulations (Chemicals and Polymers) [NSNR (Chemicals and Polymers)] of the Canadian Environmental Protection Act, 1999.

This document addresses the reaction-scheme requirement prescribed in Schedule 9 of the NSNR (Chemicals and Polymers) for polymers that meet the Reduced Regulatory Requirement criteria. It also provides background information and suggested formats for reporting polymer reaction schemes.

To view the complete New Substances Notification Technical Guidance Document, posted on the Government of Canada’s website for New Substances, please visit: UPDATE: The New Substances Notification Technical Guidance Series

Summary:

If a product licence application (PLA) has been refused by the Natural Health Products Directorate, the submission number associated with that product becomes invalid. The Notice of Refusal issued to the applicant will indicate the reason(s) for the refusal and will also make reference to compliance and enforcement actions applied by Health Canada.

Unapproved natural health products (NHPs) that are for sale in Canada and have had their product licence applications refused will be subject to compliance action in accordance with the Compliance Policy for Natural Health Products. In the event that an application is refused due to concerns with the product’s safety, efficacy and/or quality, the applicant must stop sale and recall the product from the market or face immediate compliance and enforcement action.

In accordance with section 9(2) of the Natural Health Products Regulations, applicants receiving a Notice of Refusal have 30 days to appeal the decision and request that their application be reinstated. Should applicants fail to submit their appeal within the 30-day timeframe or, if following a review of the appeal, the refusal of the application stands, the compliance and enforcement approach described above will be applied.

Applicants intending to resubmit a product licence application are encouraged to carefully read the Notice of Refusal and ensure that the issues which lead to the refusal of their initial application are addressed in their new product licence application or else it will also be refused.

Applicants should refer to the following table for information on what constitutes a “complete” product licence application: Information Requirements for Product Licensing

Further details provided below in the BACKGROUND section.

To view the entire notice, posted on Health Canada’s site, please visit: IMPORTANT NOTICE – Health Canada’s Approach to the Refusal of Product Licence Applications

Canada Gazette II – Vol. 140, No. 19 — September 20, 2006

Whereas the Minister of the Environment has been provided with information under either paragraph 87(1)(a) or (5)(a) of the Canadian Environmental Protection Act, 1999 in respect of each substance referred to in the annexed Order;

Whereas, in respect of the substances being added to the Domestic Substances List pursuant to subsection 87(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that those substances have been manufactured in or imported into Canada in excess of the quantity prescribed under the New Substances Notification Regulations (Chemicals and Polymers) by the person who provided the information;

Whereas the period for assessing the information under section 83 of that Act has expired;

And whereas no conditions under paragraph 84(1)(a) of that Act in respect of the substances are in effect;

Therefore, the Minister of the Environment, pursuant to subsections 87(1), (3) and (5) of the Canadian Environmental Protection Act, 1999, hereby makes the annexed Order 2006-87-06-01 Amending the Domestic Substances List.

To view the amendments under this order, published in the Canada Gazette, please visit: Order 2006-87-06-01 Amending the Domestic Substances List