Regulatory Updates

Distribution date: 20 September 2018

Products Covered: Pharmaceutical products: Medicines, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;

Regulation Type: Addendum to Regular Notification

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018

Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of lipase from Trichoderma reesei RF10625 in bread, flour, whole wheat flour and unstandardized bakery products.  Lipase from other source organisms is already permitted for use in Canada as a food enzyme in the same foods as those requested by the petitioner. As no safety concerns were identified through Health Canada's assessment, the Department has enabled the use of the food additive lipase from T. reeseiRF10625, as described in the information document below, by modifying the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html), effective 6 September 2018. The purpose of this communication is to publically announce Health Canada's decision in this regard and to provide the appropriate contact information for inquiries or for submitting new scientific information relevant to the safety of this food additive.

Products Covered: Lipase from Trichoderma reesei RF10625 (ICS Codes: 67.220.20, 67.060)

Regulation Type: Regular notification

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018

Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of lipase from Trichoderma reesei RF10625 in bread, flour, whole wheat flour and unstandardized bakery products.  Lipase from other source organisms is already permitted for use in Canada as a food enzyme in the same foods as those requested by the petitioner. As no safety concerns were identified through Health Canada's assessment, the Department has enabled the use of the food additive lipase from T. reeseiRF10625, as described in the information document below, by modifying the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html), effective 6 September 2018. The purpose of this communication is to publically announce Health Canada's decision in this regard and to provide the appropriate contact information for inquiries or for submitting new scientific information relevant to the safety of this food additive.

Products Covered: Lipase from Trichoderma reesei RF10625 (ICS Codes: 67.220.20, 67.060)

Regulation Type: Regular notification

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018

Health Canada's Food Directorate received a food additive submission seeking approval for the use of calcium carbonate as a colouring agent in the manufacture of hard and soft candies and in inks for writing on various confections.  Calcium carbonate is already permitted as food additive for use in Canada in various foods, including unstandardized confectionery, in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/4-emulsifying-gelling-stabilizing-thickening-agents.html), the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/10-adjusting-agents.html), and the List of Permitted Food Additives with Other Accepted Uses (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/8-other-accepted-uses.html). As no safety concerns were raised through Health Canada's assessment, the Department has enabled the use of the food additive calcium carbonate, as described in the information document below, by updating the List of Permitted Colouring Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html) effective 6 September 2018. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.

Products Covered: Calcium carbonate (ICS Codes: 67.220.20)

Regulation Type: Regular notification

Distribution date: 14 September 2018 | Final date for Comment: 19 November 2018

Health Canada's Food Directorate received a food additive submission seeking approval for the use of calcium carbonate as a colouring agent in the manufacture of hard and soft candies and in inks for writing on various confections.  Calcium carbonate is already permitted as food additive for use in Canada in various foods, including unstandardized confectionery, in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/4-emulsifying-gelling-stabilizing-thickening-agents.html), the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/10-adjusting-agents.html), and the List of Permitted Food Additives with Other Accepted Uses (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/8-other-accepted-uses.html). As no safety concerns were raised through Health Canada's assessment, the Department has enabled the use of the food additive calcium carbonate, as described in the information document below, by updating the List of Permitted Colouring Agents (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/3-colouring-agents.html) effective 6 September 2018. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.

Products Covered: Calcium carbonate (ICS Codes: 67.220.20)

Regulation Type: Regular notification

Distribution date: 14 September 2018 | Final date for Comment: 13 November 2018

This Draft East African Standard specifies the requirements, sampling and test methods for toothpaste (fluoridated and non-fluoridated) for use with a toothbrush in the cleaning of natural teeth

Products Covered: Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 14 September 2018 | Final date for Comment: 13 November 2018

This Draft East African Standard specifies the requirements, sampling and test methods for toothpaste (fluoridated and non-fluoridated) for use with a toothbrush in the cleaning of natural teeth

Products Covered: Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 10 September 2018

Products Covered: Pharmaceutical products: biological products: biotech products, classified under Chapter 30 of the Harmonized System or Customs Tariff ;

Regulation Type: Addendum to Regular Notification

Distribution date: 10 September 2018

Products Covered: Pharmaceutical products: biological products: biotech products, classified under Chapter 30 of the Harmonized System or Customs Tariff ;

Regulation Type: Addendum to Regular Notification

Distribution date: 10 September 2018 | Final date for Comment: 09 November 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical Pesticide/Veterinary drug: Diflubenzuron

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09); - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04); - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08); - Products of animal origin (HS Code: 05.04); - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14); - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14); - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10); - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08); - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12); - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06);- Cocoa and cocoa preparations (HS Code: 18.01).

Regulation Type: Regular notification