Regulatory Updates

Distribution date: 09 April 2019

Products Covered: Milk and cream, not concentrated nor containing added sugar or other sweetening matter (HS code(s): 0401); Milk and cream, concentrated or containing added sugar or other sweetening matter (HS code(s): 0402); Buttermilk, curdled milk and cream, yogurt, képhir and other fermented or acidified milk and cream, whether or not concentrated or flavoured or containing added sugar or other sweetening matter, fruits, nuts or cocoa (HS code(s): 0403); Whey, whether or not concentrated or containing added sugar or other sweetening matter; products consisting of natural milk constituents, whether or not containing added sugar or other sweetening matter, n.e.s. (HS code(s): 0404); Butter, incl. dehydrated butter and ghee, and other fats and oils derived from milk; dairy spreads (HS code(s): 0405); Milk albumin "lactalbumin", incl. concentrates of two or more whey proteins containing by weight > 80% whey proteins, calculated on the dry matter (HS code(s): 350220); Milk and milk products (ICS code(s): 67.100)

Regulation Type: Addendum to Regular Notification

Distribution date: 08 April 2019 | Final date for Comment: 16 June 2019

Health Canada's Food Directorate completed a detailed safety assessment of two food additive submissions seeking approval for the use of steviol glycosides from Stevia rebaudiana Bertoni in canned fruits products. Steviol glycosides from Stevia rebaudiana Bertoni is already permitted for use in Canada as a sweetener in a variety of unstandardized foods. As no safety concerns were raised through Health Canada's assessment, the Department has enabled the use of steviol glycosides from Stevia rebaudiana Bertoni, as described in the information document below, by modifying the List of Permitted Sweeteners effective 3 April 2019. 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: Steviol glycosides from Stevia rebaudiana Bertoni (ICS Codes: 67.220.20, 67.080.10)

Regulation Type: Regular notification

Distribution date: 08 April 2019 | Final date for Comment: 16 June 2019

Health Canada's Food Directorate completed a detailed safety assessment of two food additive submissions seeking approval for the use of steviol glycosides from Stevia rebaudiana Bertoni in canned fruits products. Steviol glycosides from Stevia rebaudiana Bertoni is already permitted for use in Canada as a sweetener in a variety of unstandardized foods. As no safety concerns were raised through Health Canada's assessment, the Department has enabled the use of steviol glycosides from Stevia rebaudiana Bertoni, as described in the information document below, by modifying the List of Permitted Sweeteners effective 3 April 2019. 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: Steviol glycosides from Stevia rebaudiana Bertoni (ICS Codes: 67.220.20, 67.080.10)

Regulation Type: Regular notification

Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019

SENASA requires that establishments engaged in the storage, marketing, transportation, distribution and use of veterinary drugs and related products comply with the CAMEVET guide to good practices for the storage, transportation and distribution of products for veterinary use.

Products Covered: Medicines for veterinary use

Regulation Type: Regular notification

Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019

SENASA requires that establishments engaged in the storage, marketing, transportation, distribution and use of veterinary drugs and related products comply with the CAMEVET guide to good practices for the storage, transportation and distribution of products for veterinary use.

Products Covered: Medicines for veterinary use

Regulation Type: Regular notification

Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019

The Draft Uganda standard specifies the requirements, sampling and methods of test of medical ultrasound gels.

Products Covered: Medical ultrasound gel

Regulation Type: Regular notification

Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019

The Draft Uganda standard specifies the requirements, sampling and methods of test of medical ultrasound gels.

Products Covered: Medical ultrasound gel

Regulation Type: Regular notification

Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019

The notified Executive Decree prohibits the import, export, manufacture, sale, use, possession and marketing of veterinary products containing colistin in their composition, either alone or combined with other chemical products, in the raw material state, finished products or products incorporated in animal feed.

Products Covered: Veterinary products containing colistin in their composition

Regulation Type: Regular notification

Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019

The notified Executive Decree prohibits the import, export, manufacture, sale, use, possession and marketing of veterinary products containing colistin in their composition, either alone or combined with other chemical products, in the raw material state, finished products or products incorporated in animal feed.

Products Covered: Veterinary products containing colistin in their composition

Regulation Type: Regular notification

Distribution date: 05 April 2019 | Final date for Comment: 01 June 2019

The Food and Drug Administration (FDA) is proposing to revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L). This action, if finalized, will revise the current allowable levels for fluoride in domestically packaged and imported bottled water to which fluoride is added. We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the recommendation by the US Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action, if finalized, will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).

Products Covered: HS Code(s): 2201; ICS Code(s): 67

Regulation Type: Regular notification