Notice of Amendment the Prescription Drug List (PDL): Hydroquinone The Notice of Consultation and subsequent Notice of Intent to Amend for the proposal to add hydroquinone to the Prescription Drug List (PDL) when sold in a concentration greater than 2% in topical products was notified in G/TBT/N/CAN/516 (dated 7 February 2017) and in G/TBT/N/CAN/516/Add.1 (dated 15 February 2018). On 1 October 2018, Health Canada published on its website the Notice amendment indicating that Health Canada will add certain hydroquinone products to the Prescription Drug List (PDL). Only the Human part of the PDL has been revised. Health Canada has conducted a scientific review of hydroquinone against the criteria in section C.01.040.3 of the Food and Drug Regulations. The new listing remains unchanged from what was proposed in the 1 February 2017, Notice of Consultation. This revision will be in effect as of 30 June 2019. The full text of the adopted measure can be downloaded from the Internet addresses indicated below: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/notice-prescription-drug-list-2018-08-22.html (English) https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/liste-drogues-ordonnance/avis-concernant-modifications/avis-liste-drogues-ordonnance-2018-08-22.html (French) or requested from: Canada's SPS & TBT Notification Authority and Enquiry Point Global Affairs Canada Technical Barriers and Regulations Division 111 Sussex Drive, Ottawa, ON K1A 0G2 Canada Telephone: (343)203-4273 Fax: (613)943-0346 E-mail: [email protected]
Distribution date: 10 October 2018 | Final date for Comment: 28 April 2025
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
Notice of Amendment the Prescription Drug List (PDL): Hydroquinone The Notice of Consultation and subsequent Notice of Intent to Amend for the proposal to add hydroquinone to the Prescription Drug List (PDL) when sold in a concentration greater than 2% in topical products was notified in G/TBT/N/CAN/516 (dated 7 February 2017) and in G/TBT/N/CAN/516/Add.1 (dated 15 February 2018). On 1 October 2018, Health Canada published on its website the Notice amendment indicating that Health Canada will add certain hydroquinone products to the Prescription Drug List (PDL). Only the Human part of the PDL has been revised. Health Canada has conducted a scientific review of hydroquinone against the criteria in section C.01.040.3 of the Food and Drug Regulations. The new listing remains unchanged from what was proposed in the 1 February 2017, Notice of Consultation. This revision will be in effect as of 30 June 2019. The full text of the adopted measure can be downloaded from the Internet addresses indicated below: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/notice-prescription-drug-list-2018-08-22.html (English) https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/liste-drogues-ordonnance/avis-concernant-modifications/avis-liste-drogues-ordonnance-2018-08-22.html (French) or requested from: Canada's SPS & TBT Notification Authority and Enquiry Point Global Affairs Canada Technical Barriers and Regulations Division 111 Sussex Drive, Ottawa, ON K1A 0G2 Canada Telephone: (343)203-4273 Fax: (613)943-0346 E-mail: [email protected]
Distribution date: 10 October 2018 | Final date for Comment: 28 April 2025
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
DUS 2078, Organic — Inorganic compound fertilizer — Specification, First edition
Distribution date: 10 October 2018 | Final date for Comment: 09 December 2018
This Draft Uganda standard specifies the requirements, sampling and test methods of organic–inorganic compound fertilizers.
Products Covered: Organic-inorganic compound fertilizer
Regulation Type: Regular notification
DUS 2078, Organic — Inorganic compound fertilizer — Specification, First edition
Distribution date: 10 October 2018 | Final date for Comment: 09 December 2018
This Draft Uganda standard specifies the requirements, sampling and test methods of organic–inorganic compound fertilizers.
Products Covered: Organic-inorganic compound fertilizer
Regulation Type: Regular notification
FDUS 2040:2018, Standard Test Method for Flash and Fire Points by Cleveland Open Cup Tester, First Edition.
Distribution date: 11 October 2018 | Final date for Comment: 10 December 2018
This test method describes the determination of the flash point and fire point of petroleum products by a manual Cleveland open cup apparatus or an automated Cleveland open cup apparatus. This test method is applicable to all petroleum products with flash points above 79 °C (175 °F) and below 400 °C (752 °F) except fuel oils.
Products Covered: Petroleum products
Regulation Type: Regular notification
FDUS 2040:2018, Standard Test Method for Flash and Fire Points by Cleveland Open Cup Tester, First Edition.
Distribution date: 11 October 2018 | Final date for Comment: 10 December 2018
This test method describes the determination of the flash point and fire point of petroleum products by a manual Cleveland open cup apparatus or an automated Cleveland open cup apparatus. This test method is applicable to all petroleum products with flash points above 79 °C (175 °F) and below 400 °C (752 °F) except fuel oils.
Products Covered: Petroleum products
Regulation Type: Regular notification
Oakshire Naturals LP; Filing of Food Additive Petition; Notice of Petition
Distribution date: 12 October 2018 | Final date for Comment: 28 April 2025
The Food and Drug Administration (FDA) is announcing the filing of a petition, submitted by Oakshire Naturals LP, proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories.
Products Covered: HS Code(s): 293629; ICS Code(s): 67
Regulation Type: Regular notification
Oakshire Naturals LP; Filing of Food Additive Petition; Notice of Petition
Distribution date: 12 October 2018 | Final date for Comment: 28 April 2025
The Food and Drug Administration (FDA) is announcing the filing of a petition, submitted by Oakshire Naturals LP, proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 mushroom powder as a nutrient supplement in specific food categories.
Products Covered: HS Code(s): 293629; ICS Code(s): 67
Regulation Type: Regular notification
Food Additives Permitted for Direct Addition to Food for Human Consumption; Styrene; Final Rule
Distribution date: 15 October 2018 | Final date for Comment: 28 April 2025
The Food and Drug Administration (FDA) is amending the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned. FDA is taking this action in response to a food additive petition submitted by the Styrene Information and Research Center (SIRC). The rule is effective 9 October 2018.Text is available at: https://www.gpo.gov/fdsys/pkg/FR-2018-10-09/pdf/2018-21808.pdf.
Products Covered:
Regulation Type: Addendum to Regular Notification
Food Additives Permitted for Direct Addition to Food for Human Consumption; Styrene; Final Rule
Distribution date: 15 October 2018 | Final date for Comment: 28 April 2025
The Food and Drug Administration (FDA) is amending the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned. FDA is taking this action in response to a food additive petition submitted by the Styrene Information and Research Center (SIRC). The rule is effective 9 October 2018.Text is available at: https://www.gpo.gov/fdsys/pkg/FR-2018-10-09/pdf/2018-21808.pdf.
Products Covered:
Regulation Type: Addendum to Regular Notification
Submit your email ID to receive notifications about upcoming courses and events
